WO2012026717A2 - Balloon catheter in which film for drug delivery is provided - Google Patents

Balloon catheter in which film for drug delivery is provided Download PDF

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Publication number
WO2012026717A2
WO2012026717A2 PCT/KR2011/006163 KR2011006163W WO2012026717A2 WO 2012026717 A2 WO2012026717 A2 WO 2012026717A2 KR 2011006163 W KR2011006163 W KR 2011006163W WO 2012026717 A2 WO2012026717 A2 WO 2012026717A2
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WO
WIPO (PCT)
Prior art keywords
film
balloon
drug delivery
inflatable balloon
drug
Prior art date
Application number
PCT/KR2011/006163
Other languages
French (fr)
Korean (ko)
Other versions
WO2012026717A3 (en
Inventor
김용년
Original Assignee
(주)이화바이오메딕스
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
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Priority claimed from KR1020110049923A external-priority patent/KR101230657B1/en
Application filed by (주)이화바이오메딕스 filed Critical (주)이화바이오메딕스
Publication of WO2012026717A2 publication Critical patent/WO2012026717A2/en
Publication of WO2012026717A3 publication Critical patent/WO2012026717A3/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/08—Materials for coatings
    • A61L29/085—Macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A61L29/16—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/105—Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/109—Balloon catheters with special features or adapted for special applications having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow

Definitions

  • the present invention relates to a balloon catheter provided with a drug delivery film, and more particularly, to provide a film of a biocompatible material capable of supporting and continually releasing a drug on a inflatable balloon surface of the balloon catheter, thereby providing a drug to the treatment site.
  • the present invention relates to a balloon catheter provided with a film for drug delivery capable of delivering continuously.
  • the present invention is to apply the micro-projection structure to the inflatable balloon of the balloon catheter in order to more efficiently and safely deliver the required drug in the appropriate place, the micro-projection of the film of biocompatible material that can carry and release the required drug
  • the present invention relates to a balloon catheter provided with a film for drug delivery, which can accurately and continuously deliver a drug to a treatment site by providing a structure on the balloon surface to which the catheter is accurately positioned at the treatment site.
  • the present invention provides a microneedle by surface treatment on a film of biocompatible material capable of supporting and continually releasing the necessary drug, and then the film of the biocompatible material having the fine needle formed thereon is an inflatable balloon surface of a balloon catheter.
  • the balloon catheter is provided with a drug delivery film which provides a path for narrow blood vessels upon inflation of the balloon and accurately and reliably secures the microneedles on the film to the vessel wall while simultaneously delivering the drug accurately and continuously to the treatment site. It is about.
  • the present invention is a tactic by applying a bioadhesive on the surface of the film while reducing the risk of blood clots even if the catheter is introduced into a narrow vessel by hydrophilic surface treatment of a film of a biocompatible material that can carry and release the necessary drugs
  • the microneedles on the film as described above can be more effectively and stably fixed to the blood vessel wall, and the side of the film, in which the microneedles are not formed in the drug release process, is first biodegraded, and then the microneedles fixed to the blood vessel wall are sequentially biodegraded, thereby causing side effects such as thrombus formation.
  • the present invention relates to a balloon catheter provided with a drug delivery film capable of safely delivering a drug to a treatment site.
  • thrombolytics may be injected into blood vessels, and the treatment physician may increase the effectiveness of treatment through a procedure such as stent insertion, vasodilation or vascular bypass surgery.
  • a metal stent is introduced into the coronary artery, and the stent structure is spread out from the stenosis to treat the stenosis.
  • drugs such as thrombolytics are used.
  • Silver was injected separately from the stent, and there was a problem that the surgical treatment and the medication were performed separately from each other.
  • drug-released vascular stents coated with drugs on metallic stents have been developed and used.
  • the stent has a fundamental problem of the resorption of blood vessels due to long-term transplantation into the narrowed coronary arteries, etc., and thus stent thrombosis and late vessel restenosis may occur. Therefore, in the technical field to which the present invention belongs, it is required to develop a technology that can effectively deliver drugs to the treatment site inside the body without using a stent implanted in the blood vessel.
  • the catheter is a device that refers to a medical means that is directly inserted into the body, the catheter for a variety of body insertion, such as vascular injection, coronary artery dilation, urethral insertion, airway insertion, laparoscopic catheter in the medical field
  • a balloon catheter for coronary artery dilatation includes, for example, an inflatable balloon formed near a tip of a guide tube inserted into a narrow blood vessel, and fluid is introduced through the conduit connected to the balloon to expand the balloon.
  • a guide wire for facilitating insertion into the narrow vessel of the catheter and performing a procedure has a structure embedded in the conduit.
  • the drug is absorbed into a hydrogel-based balloon
  • the balloon is embedded in the catheter's internal space
  • the catheter is introduced into the vessel at the treatment site
  • the balloon is slid out of the catheter to inflate the balloon to inflate the drug and cause blood clots.
  • the tissue US Pat. No. 5,868,719
  • the drug delivery balloon catheter has a problem of having to absorb the drug in the balloon in advance and the problem of infection that may occur and the drug absorbed in the inflatable balloon
  • the catheter is moved to the treatment site, and the needle is passed through the catheter body through the drug delivery lumen in the catheter, and the needle is inserted through the hole formed on one side of the catheter to stab the flexible needle into the tissue to be treated and inject the drug.
  • US Patent Publication No. 2008/0004596 A1 US Patent Publication No. 2008/0004596 A1
  • the movement and fixation of the catheter to the treatment site is difficult, as well as exposing the needle through the catheter hole and precisely stabbing it in the tissue is not a highly skilled procedure. It was difficult to do the procedure.
  • the present invention belongs, it is a balloon-type catheter that is easy to manufacture and use and is hygienic and precisely inserted at the treatment site while being precisely inserted through blood vessels and urethra.
  • the conventional drug delivery and delivery to the treatment site using the balloon catheter has a limitation in the inconvenience of manufacturing and use, and the continuous delivery of the drug to the correct treatment site.
  • the inventors have intensively studied, and applied a micro-projection structure to the inflatable balloon of the balloon catheter, and a film of a biocompatible material capable of supporting and continuously releasing the necessary drug on the balloon surface to which the microprojection structure is applied.
  • the provided balloon catheter was designed, and after forming the fine needle by surface treatment on the film of the biocompatible material capable of supporting and continuously releasing the necessary drug, the film of the biocompatible material formed with the fine needle was expanded to the inflatable catheter.
  • the present invention provides a balloon catheter provided with a film for drug delivery, which can deliver a film of a biocompatible material capable of supporting and continuously releasing a necessary drug on the inflatable balloon surface of the balloon catheter and continuously delivering the drug to the treatment site.
  • the purpose is to provide.
  • the present invention applies a microprojection structure to an inflatable balloon of a balloon catheter in order to more efficiently and safely deliver a necessary drug, and a film of a biocompatible material capable of supporting and continually releasing a drug required by the microprojection. It is an object of the present invention to provide a balloon catheter provided with a film for drug delivery, which can accurately and continuously deliver a drug to a treatment site while accurately positioning the catheter at the treatment site by providing the structure on the balloon surface to which the structure is applied.
  • the present invention is to form a fine needle by the surface treatment on the film of the biocompatible material capable of supporting and continuously release the necessary drug and then the film of the biocompatible material on which the fine needle is formed, the inflatable balloon surface of the balloon catheter Balloon catheter provided with a film for drug delivery to secure narrow blood vessel passage during balloon inflation and to accurately and stably fix the microneedles on the film to the blood vessel wall while delivering the drug accurately and continuously to the treatment site.
  • the purpose is to provide.
  • the present invention is a hydrophilic surface treatment of a film of a biocompatible material capable of supporting and continuously release the necessary drug to apply the bioadhesive to the surface of the film while reducing the risk of blood clots even if the catheter is introduced into a narrow vessel
  • the microneedles on the film as described above can be more effectively and stably fixed to the blood vessel wall, and the side of the film, in which the microneedles are not formed in the drug release process, is first biodegraded, and then the microneedles fixed to the blood vessel wall are sequentially biodegraded, thereby causing side effects such as thrombus formation.
  • An object of the present invention is to provide a balloon catheter provided with a drug delivery film that can safely deliver a drug to a treatment site.
  • the present invention can not only continuously and continuously deliver various drugs by providing multiple films of biocompatible materials capable of supporting and continuously releasing various drugs in a multi-layer on the inflatable balloon surface.
  • the film by forming fine holes in the film, it provides biodegradability in which the film can be broken down into fine pieces during drug delivery, and also provides biocompatibility and elastic properties to prevent secondary diseases such as blood clots, re-epithelialization, and inflammatory reactions.
  • the purpose is to provide a balloon catheter that does not induce.
  • An inflatable catheter provided with a film for drug delivery of an embodiment of the present invention comprises an inflatable balloon, a conduit having a conduit in communication with the inflatable balloon and introducing a balloon for inflating the inflatable balloon with the inflatable balloon;
  • a film of biocompatible material capable of sustaining release comprising: a film provided surrounding the inflatable balloon; and a micro-projection formed on the inflatable balloon outer surface and positioned in the space between the inflatable balloon and the film;
  • the catheter when the inflatable balloon is introduced into the inflatable balloon through the connecting pipe, when the inflatable balloon is inflated, the catheter is secured at the correct position of the treatment site to secure the passage of blood vessels, and the inflatable balloon
  • the shape of the film is deformed like the micro protrusions, and the film portion deformed into the shape of the micro protrusions and the micro protrusions are fixed to the treatment part in the body so that the drug supported on the film is treated. It can be delivered accurately and slowly and continuously at the site.
  • a balloon catheter provided with a drug delivery film of another embodiment of the present invention comprises a conduit having an inflatable balloon and a conduit in communication with the inflatable balloon and introducing a balloon for inflating the inflatable balloon into the inflatable balloon;
  • a film of biocompatible material capable of supporting and continuously releasing a drug comprising: a film provided surrounding the inflatable balloon; and a fine needle formed on the surface of the film, wherein the inflatable balloon is used to expand the balloon.
  • the plurality of fine needles may be provided, the plurality of fine needles are formed at regular intervals in the axial direction of the catheter on the surface of the film It may be formed at regular intervals in the circumferential direction of the film surrounding the inflatable balloon.
  • a plurality of fine needles may be formed along a folding line of the film that occurs when the film surrounding the inflatable balloon is folded before the inflatable balloon is inflated.
  • the plurality of fine needles are in the axial direction of the catheter when the film surrounding the inflatable balloon is folded (folding) before the inflatable balloon is inflated Located in a lying state, when the inflatable balloon is inflated, the film surrounding the inflatable balloon is unfolded, and accordingly characterized in that it is erected with a constant angle with respect to the axial direction of the catheter.
  • the film before the balloon is expanded, the film is introduced into the narrow vessel in the folded state so that the fine needles formed along the folding line do not damage the vessel wall, and the vessel is narrowed when the balloon is inflated.
  • the microneedle on the film is erected toward the vessel wall while securing the passage of the film, so that the film is accurately and stably fixed to the vessel wall so that the drug contained in the film can be accurately and continuously delivered to the treatment site, for example, the tissue inside the vessel wall. do.
  • each fine needle has a larger diameter at the proximal end located on the film and a smaller diameter as it moves away from the proximal end, but at the tip of the fine needle.
  • the bulge is pointed and can be fixed accurately and stably in tissues such as blood vessel walls.
  • the fine needle may be formed in a streamline shape having a constant angle from the base end to the tip.
  • the microneedle is firmly fixed to the blood vessel wall by the blood flow, thereby reducing the risk of the drug delivery film falling off and making it adhere to the blood vessel wall, thereby facilitating drug delivery.
  • the fine needle may be formed by extending the hook structure downward from the tip portion. In this case, once the fine needle is fixed to a tissue such as a blood vessel wall, the fine needle is not easily separated by the hook structure.
  • the fine needle is formed by at least one surface treatment selected from the group consisting of corona surface treatment, high frequency surface treatment, plasma surface treatment and laser surface treatment.
  • the surface treatment is preferably a hydrophilic surface treatment, the hydrophilic surface treatment can reduce the risk of blood clots even if the catheter is introduced into a narrow vessel.
  • the present invention is not limited thereto, and various film processing and forming methods may be used.
  • the surface of the film can be applied to the bioadhesive to make the fine needle more effectively and stably fixed to the blood vessel wall.
  • biored glutamate examples include fibrinogen, blood coagulant XIII factor with fibrinogen, cyanoacrylate, dermalin glue, marine bioadhesive, and various biocompatible agents known in the art may be used. to be.
  • the film surrounding the inflatable balloon is expanded to take a substantially cylindrical shape, the circumference of the unfolded cylindrical film
  • the film may be formed to be stepped along the direction.
  • the fine needle may be formed on a thick projecting portion.
  • the holes are formed in the film so that the film can be decomposed into fine pieces during drug delivery to prevent the formation of blood clots.
  • any material may be used as the material of the film as long as it is a biocompatible material capable of supporting and continuously releasing a necessary drug, for example, PEG (polyethyleneglycol) Polymer material of -PCLA (poly (epsilon-caprolactone-co-D, L-lactide)), or polymer material of PEG (polyethyleneglycol) -PLGA (poly (lactic-co-glycolic acid)), or capro to such polymer material
  • Polymeric materials to which at least one substance selected from the group consisting of lactones, glycolides, lactide, paradioxanone and trimethylenecarbonate are added may be used (see Korean Patent Nos.
  • Balloon catheter provided with the drug delivery film of the present invention, the outer separation conduit that is directly bonded to the connection pipe, and is in close contact with the inner wall of the external separation conduit is located in communication with the connection pipe fluid for inflating the balloon in the connection pipe It may include an internal separation conduit for introducing the.
  • one end of the inner separation conduit preferably extends through the one end of the outer separation conduit to the inside of the connecting tube.
  • the outer separation conduit helps to firmly connect with the connector at the same time serves to guide the coupling of them when combined with the connector.
  • one end of the inner separation conduit preferably has a shape that is sharpened toward the tip.
  • a guide wire may be positioned at an interval from an inner wall of the inner separation conduit.
  • the guide wire extends deep inside the connecting pipe through one end of the inner separation conduit.
  • the balloon catheter provided with the drug delivery film of the present invention is provided with rigidity to the connective duct during a surgical procedure for inserting into the blood vessel, thereby facilitating the catheter's intravascular insertion and entry into the blood vessel.
  • the balloon inflation fluid is introduced through the gap between the inner wall of the inner separation conduit and the guide wire, the flow rate of the balloon inflation fluid can be adjusted by adjusting the gap.
  • the balloon catheter provided with the drug delivery film of the present invention may further include a joint member for connecting the outer separation conduit and the inner separation conduit with the fluid connection for balloon expansion.
  • the inflation port of the joint member is inserted and connected to the balloon inflation fluid tube, and the outlet port of the joint member is inserted into and connected to the outer separation conduit and the inner separation conduit.
  • the balloon expansion fluid connecting tube inserted through the inlet port is tightly inserted into the inlet guide tube formed in the joint member, and the outer separation conduit and the inner separation conduit inserted through the outlet port are the inlet guide.
  • the balloon-expanding fluid introduced through the balloon-expansion fluid connection tube is inserted into the outflow guide tube formed in the joint member in communication with the pipe and is introduced through the balloon-expansion fluid connection pipe through the inner separation conduit. It will be exported to the outflow port.
  • the balloon catheter provided with the drug delivery film of the present invention may further include a balloon inflation fluid injecting hub that connects the balloon inflation fluid connector with a fluid supply device.
  • the balloon catheter provided with the drug delivery film of the present invention the blood flow extending from the leading end of the conduit to the position of the connection pipe formed inside the inflatable balloon and the blood flow hole and is coupled to the blood flow hole formed in the connection pipe It may further include a flow tube.
  • the blood flow pipe is formed in a shape that is curved at a slightly upward angle at a portion coupled to the blood flow hole, and its opening is formed long in the longitudinal direction.
  • the blood flow tube must fit snugly into the blood flow hole of the connector, otherwise there is a risk of the balloon-inflating fluid leaking through the connector.
  • the inflatable balloon When the additional blood flow tube is installed, the inflatable balloon is inflated to secure the catheter in the correct position and secure the passage of blood vessels, and the drug contained in the film is delivered to the treated portion accurately and slowly and continuously.
  • the catheter may allow blood to flow smoothly through the blood flow tube without disturbing the flow of blood.
  • the balloon catheter provided with the drug delivery film of the present invention may further include a sealing cap for sealing between the inflatable balloon and the blood flow tube.
  • the sealing cap has a through passage formed in a portion corresponding to the inner passage of the blood flow tube so that blood can flow smoothly through the blood flow tube as described above.
  • the balloon inflation fluid may be air or contrast agent.
  • the inflatable balloon is preferably made of a material having elasticity (elasticity) which is easily expanded when an expansion fluid such as nylon, stretchable synthetic resin, polyamide, polyetheramide, etc. is introduced as a material suitable for living bodies.
  • the length of the fine protrusions may be approximately 100 ⁇ m, and it is preferable to configure the shape of the film when the balloon is inflated but does not penetrate the film.
  • the microprojection can be formed in a fine cylindrical shape on the outer surface of the inflatable balloon.
  • the present invention is not limited thereto, and may be made of balloons of various materials according to treatment conditions, such as the treatment site, the thickness of blood vessel into which the catheter is inserted, and the length and shape of the micro-projection may be variously selected.
  • the drug supported on the film and delivered to the treatment site includes a thrombolytic agent, antiproliferative agent, immunosuppressant agent, anti-inflammatory agent, vaccine, hormone, insulin, gene therapy agent, Protein therapeutics injection, or endothelial cell promoter.
  • a thrombolytic agent antiproliferative agent
  • immunosuppressant agent anti-inflammatory agent
  • vaccine anti-inflammatory agent
  • hormone hormone
  • insulin gene therapy agent
  • Protein therapeutics injection or endothelial cell promoter
  • the catheter can be accurately positioned at the treatment site and the drug can be delivered while being accurately and continuously released at the treatment site.
  • the present invention can deliver the necessary drugs more efficiently, safely and continuously where appropriate.
  • the present invention applies a micro-projection structure to an inflatable balloon of a balloon catheter, and provides a balloon of a biocompatible material capable of supporting and continuously releasing a necessary drug on the balloon surface to which the micro-projection structure is applied.
  • the drug is carried on the film is delivered to the vascular inner wall slowly and continuously released.
  • the present invention is to form a microneedle by surface treatment on a film of biocompatible material capable of supporting and continually release the necessary drug and then the film of the biocompatible material formed with the fine needle on the inflatable balloon surface of the balloon catheter to provide a narrow vessel passage during balloon inflation and to accurately and stably fix the microneedles on the film to the vessel wall, while the drug contained in the film is precisely and continuously applied to the treatment site, for example tissue inside the vessel wall. There is an advantage to deliver.
  • the present invention by applying a bioadhesive to the surface of the film while reducing the risk of blood clots, even if the catheter is introduced into a narrow vessel by hydrophilic surface treatment of the film of the biocompatible material that can carry and release the necessary drug
  • the microneedles on the film as described above are more effectively and stably fixed to the blood vessel wall, and during the drug release process, the film portion in which the microneedles are not formed is first biodegraded, and then the microneedles fixed to the blood vessel wall are biodegraded sequentially, without side effects such as thrombus generation.
  • the present invention can not only continuously and continuously deliver various drugs by providing multiple films of biocompatible materials capable of supporting and continuously releasing various drugs in a multi-layer on the inflatable balloon surface.
  • the present invention provides biodegradability in which the film can be broken down into fine pieces during drug delivery, and also provides biocompatibility and elastic properties to prevent secondary diseases such as blood clots, re-epithelialization, and inflammatory reactions. There are additional benefits that do not cause them.
  • FIG. 1 is a perspective view of a balloon catheter provided with a drug delivery film of the first embodiment of the present invention is coupled.
  • Figure 2 is an exploded perspective view of the balloon catheter provided with the drug delivery film of the first embodiment of the present invention in a disassembled state.
  • Figure 3 is a longitudinal cross-sectional view of the balloon catheter provided with the drug delivery film of the first embodiment of the present invention is coupled.
  • Figure 4 is an enlarged cross-sectional view showing an enlarged portion A of the balloon catheter provided with the drug delivery film of the first embodiment of the present invention shown in FIG.
  • FIG. 5 is an enlarged cross-sectional view illustrating an enlarged portion B of the balloon catheter provided with the drug delivery film of the first embodiment of the present invention shown in FIG. 3.
  • FIG. 6 is an enlarged cross-sectional view of a portion C of the balloon catheter provided with the drug delivery film of the first embodiment of the present invention shown in FIG. 3.
  • FIG. 7 is an enlarged cross-sectional view illustrating a portion D of the balloon catheter provided with the drug delivery film of the first embodiment of the present invention shown in FIG. 3.
  • FIG. 8 is an enlarged cross-sectional view showing an enlarged portion E of the balloon catheter provided with the drug delivery film of the first embodiment of the present invention shown in FIG.
  • FIG. 9 is a perspective view of the balloon catheter provided with the drug delivery film of the second embodiment of the present invention is coupled.
  • FIG. 10 is a perspective view and a partially enlarged view showing a state in which a film of the first form surrounding the inflatable balloon is folded in a balloon catheter provided with a drug delivery film of a second embodiment of the present invention.
  • FIG. 11 is a front view and a perspective view illustrating a state in which the film of the first form of FIG. 10 is coupled to the inflatable balloon in the folded state.
  • FIG. 12 is a perspective view and a partially enlarged view showing a state in which a second type of film surrounding the inflatable balloon is folded in a balloon catheter provided with a drug delivery film of a second embodiment of the present invention.
  • FIG. 13 is a front view and a perspective view illustrating a state in which the film of the second form of FIG. 12 is coupled to the inflatable balloon in the folded state.
  • FIG 14 to 16 are perspective views showing the microneedle and the unfolded state of the various types of film surrounding the inflatable balloon in the balloon catheter provided with the drug delivery film of the second embodiment of the present invention by the expansion of the balloon.
  • FIG. 17 is an enlarged cross-sectional view illustrating the E-section of the balloon catheter provided with the drug delivery film of the second embodiment of the present invention shown in FIG. 9 after being cut in the longitudinal direction.
  • Balloon catheter (100a) provided with the drug delivery film of the first embodiment of the present invention as shown in Figures 1, 2, 7 and 8 is introduced into the body through blood vessels for balloon expansion, such as air
  • An inflatable balloon 82 which is inflated by the fluid F and inserted into the treatment site T and connected to the inflatable balloon 82 is connected to the inflatable balloon 82 to flow the balloon-inflating fluid F into the inflatable balloon 82.
  • a conduit 80 having a connecting tube 84, a film 20a provided surrounding the inflatable balloon 82 as a film of a biocompatible material capable of supporting and continuously releasing the necessary drug M; And, as a major component, a micro-projection 88 formed on the outer surface of the inflatable balloon 82 and located in the space d between the inflatable balloon 82 and the film 20a.
  • the balloon catheter 100a provided with the drug delivery film of the first embodiment of the present invention protrudes from the shape of the film 20a when the inflatable balloon 82 is inflated.
  • the micro protrusions 88 are fixed along the outer circumferential surface so that the drug M supported on the film 20a is gradually and continuously delivered to the treatment site T by fixing the deformed film portion to the treatment site T by deforming to the treatment site T.
  • the film 20a provided while surrounding the inflatable balloon 82 as a film of a compatible material has a basic configuration.
  • the inflatable catheter 100a provided with the drug delivery film of the first embodiment of the present invention is inserted from the opening of the front end of the conduit 80 and expandable.
  • the blood flow tube 70 passing through the balloon 82 and the connecting tube 84 may be further assembled.
  • the blood flow pipe 70 extends to the blood flow hole 86 formed at one side of the outer circumferential surface of the connection pipe 84 and is fitted to fit the blood flow hole 86.
  • the blood flow tube 70 is formed in a curved shape at a slightly upward angle at a portion coupled to the blood flow hole 86 and the opening portion 76 has a length. It is formed long in the direction.
  • the blood flow pipe 70 should fit snugly into the blood flow hole 86, otherwise the risk of balloon inflation fluid F entering through the expansion fluid flow space fS of the connection pipe 84 will leak out. Because of this.
  • Figure 6 is an enlarged cross-sectional view showing a longitudinal cross-sectional view of the C portion of the balloon catheter provided with the drug delivery film of the first embodiment of the present invention
  • the blood flow pipe 70 is coupled to the blood flow hole 86 Partly blocks the expansion fluid flow space fS in the longitudinal direction, that is, the vertical direction, but there is a space in the transverse direction, that is, the horizontal direction, so that the flow of the balloon-inflating fluid F is not disturbed.
  • the inflatable balloon 82 When the blood flow tube 70 is further installed, the inflatable balloon 82 is inflated to secure the catheter 100a at the treatment site T while securing a passage of blood vessels, and when the inflatable balloon 82 is expanded, the inflatable balloon 82 is expanded. As the space d between the balloon 82 and the film 20a becomes narrow (d ⁇ d '), the film portion 20a is deformed like the microprojection 88 and deformed into the microprojection shape. When the micro-projection 88 is fixed to the treatment site T in the body and the drug M carried on the film 20a is delivered to the treatment site T while being released (see FIGS. 7 and 8), the catheter 100a may allow blood to flow smoothly through the inner passage BP and the opening 76 of the blood flow tube 70 without disturbing the flow of blood in the blood vessel BB (FIGS. 6 to 6). 8).
  • the catheter 100 may be inserted into the balloon catheter 100a provided with the drug delivery film of the present invention. 80) the rigidity is given to the whole to facilitate insertion of the catheter 100a into the blood vessel and entry into the blood vessel.
  • the blood flow tube 70 may be composed of various materials, for example, biocompatible plastics, synthetic resins, and the like, in addition to the above materials.
  • the balloon catheter 100a provided with the drug delivery film of the first embodiment of the present invention has a tip between the inflatable balloon 82 and the blood flow tube 70. It may be further provided with a sealing cap 90 for sealing the. Accordingly, the balloon-expanding fluid F is prevented from flowing out of the tip of the catheter 100a by the sealing cap 90, and the sealing cap 90 is an internal passage of the blood flow pipe 70.
  • a through passage 92 is formed at a portion corresponding to the BP to allow blood to flow smoothly through the inner passage BP and the opening 76 of the blood flow tube 70 as described above.
  • the balloon catheter 100a provided with the drug delivery film of the first embodiment of the present invention by the combination of the above components, the balloon is inflated through the connecting pipe 84 as shown in FIGS. 5, 7 and 8.
  • the catheter 100a is secured at the correct position of the treatment site T to secure the passage of blood vessels.
  • the space d between the inflatable balloon 82 and the film 20a is narrowed (d ⁇ d ')
  • the shape of the film 20a is deformed like the fine protrusions 88 and then deformed into the shape of the fine protrusions.
  • the film portion 20a and the micro-projection 88 are fixed to the treatment site T in the body so that the drug M loaded on the film 20a can be delivered while being accurately and continuously released to the treatment site T. Can be.
  • the balloon-inflating fluid (F) such as air flows into the connecting pipe 84 through the expansion fluid passage (P), as shown in FIG.
  • the inflatable balloon 82 is expanded to expand the inflatable balloon 82.
  • the portion of the film deformed into the shape of the fine protrusions before and after the shape of the film 20a is deformed like the fine protrusions 88 while the space d between the 82 and the film 20a is narrowed (d ⁇ d ').
  • 20a and the micro-projection 88 are fixed to the treatment site T in the body so that the drug M supported on the film 20a can be delivered while being accurately and continuously continuously released to the treatment site T ( 7 and 8).
  • the balloon inflation fluid F as described above may be air or a contrast agent.
  • the balloon-inflating fluid F of the present invention is not limited thereto, and any material capable of inflating the inflatable balloon 82 as a fluid may be used.
  • the inflatable balloon 82 is made of a material having elasticity (elasticity) that is easily expanded when a balloon-inflating fluid (F) such as nylon, stretchable synthetic resin, polyamide, and polyetheramide is introduced as a material suitable for living body. It is desirable to. However, it will be readily understood by those skilled in the art that the present invention is not limited thereto and may be made using balloon materials known in the art with respect to balloon catheter.
  • F balloon-inflating fluid
  • the length of the inflatable balloon 82 may range from approximately 5 mm to 50 mm, and its inner diameter may vary within the range of approximately 0.5 mm to 5 mm.
  • the connecting pipe 84 may be made integrally with the same material as that of the inflatable balloon 82, or alternatively manufactured separately from a biocompatible polymer material such as polyurethane, nylon, or PET, and then UV or heat adhesive. A type of adhesive can be used to attach to the inflatable balloon 82.
  • the length of the connector 84 may range from approximately 100 mm to 2000 mm, and its inner diameter may range from approximately 0.2 mm to 2.0 mm.
  • a plurality of fine protrusions 88 are formed on the outer surface of the inflatable balloon 82 at regular intervals, and the shape of the inflatable balloon 82 may be configured to deform the shape of the film but not penetrate the film.
  • the microprojection 88 can be formed in a fine cylindrical shape on the outer surface of the inflatable balloon.
  • the fine protrusions 88 may be formed by applying a microneedle forming method using a nylon material known in the art.
  • the present invention is not limited thereto, and may be made of balloons of various materials according to treatment conditions, such as the treatment site, the thickness of blood vessel into which the catheter is inserted, and the length and shape of the fine protrusion may be variously selected.
  • the length of the fine protrusions 88 may be approximately 100 ⁇ m.
  • the film is deformed into a protrusion by the micro-projection 88 and the micro-projection by adjusting the expansion degree of the inflatable balloon 82 by adjusting the length of the micro-projection 88 or the amount of inflow of the balloon-inflating fluid F.
  • the portion 20a can adjust the depth at which it is inserted into the tissue inside the blood vessel wall and thus the delivery depth of the drug.
  • the balloon catheter 100a provided with the drug delivery film of the first embodiment of the present invention is an outer separation conduit 40 which is directly bonded and bonded to the connecting pipe 84,
  • the inner separation conduit is placed in close contact with the inner wall of the outer separation conduit 40 and communicates with the connection pipe 84 to introduce the balloon expansion fluid F into the connection pipe 84 through the expansion fluid passage P. And 50.
  • one end of the outer separation conduit 40 is joined with the connection tube 84.
  • the outer separation conduit 40 is manufactured separately from the same material as the connecting pipe 84, for example, a biocompatible polymer material such as polyurethane, nylon or PET, and then using an ultraviolet or heat adhesive type adhesive. It can be attached to the connecting pipe (84).
  • the inner separation conduit 50 is inserted into the outer separation conduit 40 and assembled, wherein one end of the inner separation conduit 50 is It may extend beyond one end of the outer separation conduit 40 to the interior of the connection tube 84.
  • the inner separation conduit 50 serves to guide the coupling of the outer separation conduit 40 and the connection pipe 84 as described above when the outer separation conduit ( 40 helps to firmly engage the connector 84.
  • one end of the inner separation conduit 50 preferably has a shape that is sharpened toward the tip.
  • the guide wire 60 is inserted and positioned at intervals with the inner wall of the inner separation conduit 50, the expansion fluid passage (P) ).
  • the guide wire 60 preferably extends deep inside the connection pipe 84 through one end of the internal separation conduit 50.
  • the balloon catheter 100a provided with the drug delivery film of the first embodiment of the present invention is provided with rigidity to the connecting pipe 84, for example, in a surgical procedure of inserting the blood vessel into the blood vessel of the catheter and the blood vessel. It is easy to enter inside.
  • the expansion fluid passage by adjusting the interval since the balloon expansion fluid (F) is introduced through the interval between the inner wall of the inner separation conduit 50 and the guide wire 60, that is, the expansion fluid passage (P). It is possible to adjust the flow amount of the balloon for expanding fluid (F) flowing through (P).
  • the guide wire 60 may be made of a material such as stainless steel or super-elastic alloy, in addition to a variety of materials, for example, biocompatible plastic, synthetic resin, etc. Those skilled in the art will readily understand.
  • the balloon catheter 100a provided with the drug delivery film of the first embodiment of the present invention has a fluid for inflating the external separation conduit 40 and the internal separation conduit 50. It may further include a joint member 30 for connecting to the connecting pipe 18.
  • the inflation port 32 of the joint member 30 is inserted and connected to the balloon inflation fluid tube 18, and the outlet port 36 of the joint member 30 is connected to the inlet port 32.
  • An outer separation conduit and an inner separation conduit 40, 50 and the guide wire 60 are inserted and connected.
  • the balloon-inflating fluid connection pipe 18 inserted through the inflow port 32 is tightly inserted into the inflow guide tube 31 formed in the joint member 30. It is caught by the step portion 324, and the external separation conduit and the internal separation conduit 40, 50 and the guide wire 60 inserted through the outlet port 36 is in communication with the inlet guide tube 31 Being in close contact with the outflow guide tube 33 formed in the joint member 30 is in communication with the balloon expansion fluid connection tube 18 to inflate the balloon introduced through the balloon expansion fluid connection pipe 18 Fluid F is directed to the outlet port 36 between the inner separation conduit 50 and the guide wire 60. That is, the balloon expansion fluid (F) is the expansion passage (P) formed between the inner passage (19) of the balloon expansion fluid connection pipe 18, and the inner separation conduit (50) and the guide wire (60). Through the outlet port 36 of the joint member 30.
  • the balloon catheter 100a provided with the drug delivery film of the first embodiment of the present invention is a fluid supply device (not shown) for the balloon expansion fluid connector 18 It may further include a balloon injecting hub 10 for inflating the balloon.
  • the balloon inflation hub 10 includes a body 12, a coupling part 13, and a handle part 14.
  • the handle portion 14 is formed in the shape of a wing on both sides of the body 12 is easy to grip and the coupling portion 13 is formed with a screw thread. Therefore, in the state where the user grasps both wings of the handle part 14 by hand, the fluid supply device (not shown) may be coupled to the coupling part 13 by screwing and detaching.
  • the balloon inflation fluid injection hub 10 Balloon inflation fluid (F) through the inlet (15) and the inner passage (19) of the balloon inflation fluid connector (18) coupled to the balloon inflation fluid injection hub (10) as described above The same flows into the joint member 30.
  • the following describes the filter device 100b of the second embodiment which is a modification of the filter device 100a of the first embodiment of the present invention as described above.
  • the same reference numerals are assigned to the same components as the above-described first embodiment, and the detailed description will be omitted.
  • the filter device 100b of the second embodiment of the present invention is in communication with the inflatable balloon 82 and the inflatable balloon 82, and the balloon for expanding the fluid (F) is the inflatable balloon (
  • the balloon catheter 100b provided with the drug delivery film of the second embodiment of the present invention communicates with the inflatable balloon 82 and the inflatable balloon 82 and the fluid for inflating the balloon.
  • a film 20a of biocompatible material which is introduced into the patient's narrow blood vessels in a folded state prior to expansion of the inflatable balloon 82 and on its surface while securing a passage of narrow blood vessels upon expansion of the inflatable balloon 82.
  • the formed fine needle 250 is erected toward the vessel wall of the treatment site (T), thereby accurately and stably fixed to the vessel wall to carry the film (20a) to accurately and continuously deliver the drug (M) to the treatment site (T). Let it be the basic structure.
  • the balloon inflation fluid injecting hub 10 and the balloon inflation fluid connector 18 constituting the balloon catheter 100b provided with the drug delivery film of the second embodiment of the present invention as shown in FIG. 9.
  • the balloon catheter 100b provided with the delivery film will be described.
  • FIG. 10 and FIG. 11 show a state in which the first type film 20b surrounding the inflatable balloon 82 is folded in the balloon catheter 100b provided with the drug delivery film of the second embodiment of the present invention.
  • the state in which the first type of film 20b is coupled to the inflatable balloon 82 in the folded state is shown.
  • the film 20b of the first form in the folded state extends corresponding to the length of the inflatable balloon 82 such that its cross section surrounds the inflatable balloon 82 in the form of a pinwheel or windmill. It is.
  • the first type film 20b in the folded state includes a first wing part 210, a second wing part 220, a third wing part 230, and a fourth wing part 240 in a clockwise direction.
  • the center is empty for insertion of the inflatable balloon 82.
  • the space between the first wing 210, the second wing 220, the third wing 230, and the fourth wing 240 is relatively sufficient, and they meet each other at the base thereof to form a film of the first type. Form a folding line of the film resulting from the folded state (20b).
  • a plurality of fine needles 250 may be formed on the film 20b of the first shape, and the plurality of fine needles 250 may be formed on the surface of the film 20b of the first shape in the axial direction of the catheter. And formed at regular intervals, and may also be formed at regular intervals in the circumferential direction of the film 20b of the first form surrounding the inflatable balloon 82. For example, as shown in FIGS. 10 and 11, a folding line of the film 20b of the first form as described above, which occurs when the film 20b of the first form is folded. A plurality of fine needles 250 of the first shape in the space between the first wing 210, the second wing 220, the third wing 230 and the fourth wing 240 along the It is formed on the film 20b.
  • FIG. 12 and Figure 13 the second state of the film 20b surrounding the inflatable balloon 82 in the balloon catheter 100b provided with the drug delivery film of the second embodiment of the present invention is folded, The state in which the second type of film 20b is coupled to the inflatable balloon 82 in the folded state is shown.
  • the film 20b of the second form has a slight structural difference with respect to the film 20b of the first form, with a larger space in the center for the insertion of the inflatable balloon 82 compared to the film 20b of the first form.
  • the space between the first wing 210, the second wing 220, the third wing 230, and the fourth wing 240 is narrower than that of the film 20b of the first type. have.
  • a plurality of fine needles 250 are formed on the surface of the film 20b of the second type at regular intervals in the axial direction of the catheter, and surround the inflatable balloon 82. It is formed also in the circumferential direction of the film 20b of a 2nd aspect at regular intervals. For example, as illustrated in FIGS. 12 and 13, a first line is formed along a folding line of the second type film 20b that is generated when the second type film 20b is folded. In the space between the wing portion 210, the second wing portion 220, the third wing portion 230, and the fourth wing portion 240, the plurality of fine needles 250 are formed of the second type film 20b.
  • the plurality of fine needles 250 are disposed in the space between the wing portions in such a manner as to be in close contact with or in contact with the bottom surface of the adjacent wing portion.
  • the volume of the first type film 20b and the second type film 20b must be minimized in a folded state to prevent friction with the blood vessel wall.
  • the fine needle 250 formed on the second type film 20b also does not damage the blood vessel wall unless exposed to the outside of the folded first type film 20b and the second type film 20b. Therefore, in the balloon catheter 100b provided with the drug delivery film of the second embodiment of the present invention, it is important to manufacture the folded film 20b so that the fine needle 250 is not exposed to the outside of the film 20b.
  • the film 20b of the first shape has a fine needle because there is enough space between the first wing portion 210, the second wing portion 220, the third wing portion 230, and the fourth wing portion 240. While there is an advantage of sufficient space for arranging 250 along the folding line, it is disadvantageous to introduce into narrow vessels due to the large diameter of the imaginary cylinder that connects the end of the wing (see FIG. 11 (b)).
  • the film 20b of the second form has a narrow space between the first wing 210, the second wing 220, the third wing 230, and the fourth wing 240.
  • the space for arranging the needle 250 along the folding line is narrow, it is difficult to manufacture the film 20b by folding the film 20b so that the fine needle 250 formed on the film 20b is not exposed to the outside. Since the diameter of the imaginary cylinder is almost the same as that of the inflatable balloon 82, it is advantageous to introduce into narrow vessels (see FIG. 13 (b)).
  • 100b may introduce the film 20b into a narrow vessel in a folded state before the balloon is inflated, and the fine needle 250 formed along the folding line may not damage the vessel wall.
  • the fine needle 250 formed on the film 20b may be formed on the film by at least one surface treatment selected from the group consisting of corona surface treatment, high frequency surface treatment, plasma surface treatment, and laser surface treatment.
  • the surface treatment is preferably a hydrophilic surface treatment that can reduce the risk of blood clots even if the catheter 100b is introduced into a narrow vessel.
  • the present invention is not limited thereto, and various film processing and forming methods may be used.
  • any biocompatible material that can carry and release the necessary drug can be used.
  • a polymer of polyethyleneglycol (PEG) -PCLA poly (epsilon-caprolactone-co-D, L-lactide)) may be used.
  • biodegradable PLGA poly (lactic-co-glycolic acid)
  • PEG polyethyleneglycol
  • a polymer material to which the above-described materials are added at least one material selected from the group consisting of caprolactone, glycolide, lactide, paradioxanone and trimethylene carbonate, which shows long-term biodegradability, may be used. It can be used as a material of (see Korean Patent Nos. 10-0668046 and 10-0832552).
  • the drug (M) can be continuously and accurately released and delivered to the treatment area, as well as providing elasticity, biocompatibility, and biodegradability, causing secondary diseases such as re-epithelialization and inflammatory reaction. It also offers the advantages of For example, since the film 20a used in the first embodiment of the present invention uses a stretchable biocompatible material, the shape of the film 20a protrudes by the microprojection 88 when the balloon 82 is inflated as described above. As it is transformed into a treatment site (T) to move forward and fixed, thereby supporting the drug (M) is slowly and continuously released to the treatment site (T) can be delivered.
  • the film of the present invention is not limited to the film of the material as described above, it will be readily understood by those skilled in the art that various drugs may be supported on the film and used.
  • the fine needle 250 formed on the surface of the film 20b has a large diameter of the proximal end 252 located on the film 20b and the proximal end ( The farther away from the 252, the smaller the diameter, the tip 254, which is the end of the fine needle 250, is sharply formed and can be accurately and stably fixed to a tissue such as a blood vessel wall.
  • the fine needle 250 may be formed in a streamlined shape having a constant angle from the proximal end 252 to the tip 254.
  • the fine needle 250 when the fine needle 250 is formed to have a directionality, the fine needle 250 firmly fixes the film 20b to the blood vessel wall by blood flow, thereby reducing the risk of the film 20b falling off and the blood vessel wall.
  • the drug delivery can be facilitated by being in close contact with.
  • the fine needle 250 may be formed by extending the fish hook structure 256 downward from the tip 254 (see FIGS. 10, 12 and 15). In this case, once the fine needle 250 is fixed to the treatment site T, the fine needle 250 is not easily separated from the treatment site T by the fish hook structure 256.
  • the fine needle 250 may be more effectively and stably fixed to the blood vessel wall.
  • biored glutamate examples include fibrinogen, blood coagulant XIII factor with fibrinogen, cyanoacrylate, dermalin glue, marine bioadhesive, and various biocompatible agents known in the art may be used. to be.
  • the film 20b surrounding the inflatable balloon is expanded to take a substantially cylindrical shape.
  • 14 to 16 illustrate the microneedle 250 and the state in which the various shapes of the film 20b surrounding the inflatable balloon are unfolded by the expansion of the balloon.
  • the unfolded cylindrical film 20b may be composed of a flat portion 260 and a thick projecting portion 270.
  • the fine needle 250 may be formed on the protruding portion 270 having a thick thickness.
  • drugs supported on the films 20a and 20b of the present invention and delivered to the treatment site include thrombolytic agents, antiproliferative agents, immunosuppressants, anti-inflammatory agents, vaccines, hormones, insulin, gene therapy, protein therapeutic injections, or endothelial cells. It may be a promoter.
  • minute holes 262 may be formed in the film 20b.
  • the film 20b may be decomposed into fine pieces during drug delivery to prevent the formation of blood clots.
  • the balloon inflation fluid injection hub 10 of the balloon catheter 100a, 100b provided with the drug delivery films of the first and second embodiments of the present invention is coupled to a fluid supply device (not shown).
  • a fluid supply device not shown.
  • the surgeon uses the sealing cap 90 as a tip to make the balloon catheter 100a, 100b provided with the drug delivery film.
  • it is inserted into the body through blood vessels.
  • the guide wire 60 and the blood flow tube 70 inserted and installed inside the catheter 100a and 100b give rigidity to the catheter 100a and 100b to facilitate the insertion and advancement of the catheter 100a and 100b in the blood vessel. Let's do it.
  • the film 20b surrounding the inflatable balloon 82 of the balloon catheter 100b provided with the drug delivery film of the second embodiment of the present invention is introduced into a narrow vessel in a folded state, which is formed in the film 20b.
  • the fine needle 250 is positioned in the axial direction of the catheter 100b in a state in which the film 20b is folded before the expandable balloon 82 is inflated so that the fine needle 250 is formed along the folding line. ) Does not damage the vessel wall.
  • the surgeon confirms that the front ends of the catheters 100a and 100b enter the treatment site T through an imaging device (not shown), and the balloon-inflating fluid F accommodated in the fluid supply device (not shown).
  • the inflatable balloon 82 expands and the space between the inflatable balloon 82 and the blood flow tube 70 Expands and thus expands inflatable balloon 82.
  • the surgeon passes the balloon-inflating fluid F, which is a contrast medium, to the sealing cap 90 from the balloon-inflating fluid injection hub 10 of the catheter 100a, 100b before the catheter 100a, 100b is inserted into the blood vessel.
  • the catheter (100a, 100b) of the insertion After only injecting enough to expand the expansion fluid (P) of the catheter (100a, 100b) is inserted into the body through the blood vessels, the catheter (100a, 100b) of the insertion, advancing and reaching the treatment site (T) imaging device (Not shown) can be more easily confirmed.
  • the drug is delivered.
  • Balloon inflation fluid through inflatable fluid path (P) and expansion fluid flow space (fS) from the balloon inflation fluid injection hub (10) of the balloon catheter (100a, 100b) provided with the film to the sealing cap (90)
  • the inflow of (F) is increased to inflate the inflatable balloon 82.
  • the space between the inflatable balloon 82 and the blood flow tube 70 is expanded and accordingly.
  • the inflatable balloon 82 is also expanded so that the space d between the inflatable balloon 82 and the film 20a is narrowed (d ⁇ d ') and the shape of the film 20a is deformed like the fine protrusions 88.
  • the film portion 20a and the microprojection 88 deformed into the shape of the microprojection are fixed to the treatment site T in the body, so that the drug M supported on the film 20a is eventually treated at the treatment site ( It is precisely and slowly and continuously released in T).
  • the balloon catheter 100a provided with the drug delivery film of the first embodiment of the present invention is the inflatable balloon 82 while fixing the inflatable balloon 82 accurately to the desired treatment site T in the body through the micro-projection 88. ),
  • the film 20a surrounding the inflatable balloon 82 is deformed like the shape of the micro-projection 88 by the expansion of) and is fixed to the treatment site T to gradually sustain the drug M supported on the film 20a.
  • the degree of deformation (before ⁇ after) of the shape of the film 20a like the fine protrusions 88 is also adjusted, so that the film 20a and the fine protrusions 88 are adjusted.
  • the space between the inflatable balloon 82 and the blood flow tube 70 is expanded and thus expandable.
  • the balloon 82 is also expanded so that the inflatable balloon 82 secures a narrow passage of blood vessels. Then, when the inflatable balloon 82 expands, the film 20b surrounding the inflatable balloon 82 is unfolded and the fine needle 250 has a constant angle with respect to the axial direction of the catheter, and the blood vessel wall of the treatment site T is expanded.
  • the tip 254 of the fine needle 250 is inserted into the blood vessel wall while being accurately and stably fixed to the film 20b on the treatment site T, and the drug M supported on the film 20b is the treatment site. (T), for example, correctly and continuously delivered to tissues inside the vascular lining.
  • the fine needle 250 is formed.
  • the fine needle 250 is not easily pulled out of the treatment site T by the fish hook structure 256
  • the fine needle 252 is the tip 254 from the proximal end 252
  • the cylindrical film 20b is composed of a flat portion 260 and a thick protruding portion 270 and a fine needle 250.
  • the thin flat portion 260 in which the fine needle 250 is not formed in the drug release process is first biodegraded, and then the fine needle 250 fixed to the blood vessel wall is formed.

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Abstract

The present invention provides a balloon catheter in which a film for drug delivery is provided, wherein a film made of a biocompatible material, capable of supporting a necessary drug and continuously releasing the drug is provided on the surface of an expandable balloon of a balloon catheter, thereby allowing the drug to be delivered to a treatment region while continuously releasing the drug. The present invention can precisely and stably fix a film made of a biocompatible material, capable of supporting the necessary drug and continuously releasing the drug to the walls of blood of a treatment region, and can precisely and continuously deliver the drug to a treatment region, for example, the tissue inside the inner wall of a blood vessel. In addition, according to the present invention, it is possible to sequentially and continuously deliver various drugs while reducing the risk of thrombus, and biodegradability, biocompatibility and elasticity are provided to a film capable of supporting the necessary drug and continuously releasing the drug, thereby inducing no secondary diseases such as the generation of thombus, re-epithelialization, inflammatory response and the like.

Description

약물 전달용 필름이 제공된 풍선 카테터Balloon catheter with film for drug delivery
본 발명은 약물 전달용 필름이 제공된 풍선 카테터에 관한 것으로서, 보다 상세하게는 필요한 약물을 담지하고 지속적으로 방출할 수 있는 생체적합성 재료의 필름을 풍선 카테터의 팽창성 풍선 표면 상에 제공하여 치료부위에 약물을 지속적으로 방출하면서 전달할 수 있는 약물 전달용 필름이 제공된 풍선 카테터에 관한 것이다. The present invention relates to a balloon catheter provided with a drug delivery film, and more particularly, to provide a film of a biocompatible material capable of supporting and continually releasing a drug on a inflatable balloon surface of the balloon catheter, thereby providing a drug to the treatment site. The present invention relates to a balloon catheter provided with a film for drug delivery capable of delivering continuously.
또한, 본 발명은 필요한 약물을 적절한 곳에 보다 효율적이고 안전하게 전달하기 위해 풍선 카테터의 팽창성 풍선에 미세 돌출부 구조를 적용하고, 필요한 약물을 담지하고 지속적으로 방출할 수 있는 생체적합성 재료의 필름을 상기 미세 돌출부 구조가 적용된 풍선 표면 상에 제공함으로써 치료 부위에 카테터를 정확하게 위치시키는 동시에 약물을 치료부위에 정확하게 그리고 지속적으로 전달할 수 있는 약물 전달용 필름이 제공된 풍선 카테터에 관한 것이다.In addition, the present invention is to apply the micro-projection structure to the inflatable balloon of the balloon catheter in order to more efficiently and safely deliver the required drug in the appropriate place, the micro-projection of the film of biocompatible material that can carry and release the required drug The present invention relates to a balloon catheter provided with a film for drug delivery, which can accurately and continuously deliver a drug to a treatment site by providing a structure on the balloon surface to which the catheter is accurately positioned at the treatment site.
추가로, 본 발명은 필요한 약물을 담지하고 지속적으로 방출할 수 있는 생체적합성 재료의 필름 상에 표면 처리에 의해 미세 니들을 형성한 후 상기 미세 니들이 형성된 생체적합성 재료의 필름을 풍선 카테터의 팽창성 풍선 표면 상에 제공함으로써 풍선의 팽창시 좁은 혈관의 통로를 확보하고 필름 상의 미세 니들을 혈관벽에 정확하고 안정적으로 고정시키는 동시에 약물을 치료부위에 정확하게 그리고 지속적으로 전달할 수 있는 약물 전달용 필름이 제공된 풍선 카테터에 관한 것이다.In addition, the present invention provides a microneedle by surface treatment on a film of biocompatible material capable of supporting and continually releasing the necessary drug, and then the film of the biocompatible material having the fine needle formed thereon is an inflatable balloon surface of a balloon catheter. The balloon catheter is provided with a drug delivery film which provides a path for narrow blood vessels upon inflation of the balloon and accurately and reliably secures the microneedles on the film to the vessel wall while simultaneously delivering the drug accurately and continuously to the treatment site. It is about.
뿐만아니라, 본 발명은 필요한 약물을 담지하고 지속적으로 방출할 수 있는 생체적합성 재료의 필름을 친수성 표면 처리하여 좁은 혈관으로 카테터가 도입되더라도 혈전이 생길 위험을 줄이면서 필름 표면에 생체 접착제를 적용하여 전술한 바와 같은 필름 상의 미세 니들이 혈관벽에 보다 효과적이고 안정적으로 고정되도록 하며, 약물 방출 과정에서 미세 니들이 형성되지 않은 필름 부분이 먼저 생분해된 후 혈관벽에 고정된 미세 니들이 순차적으로 생분해되도록 하여 혈전 생성 등의 부작용없이 안전하게 약물을 치료부위에 전달할 수 있는 약물 전달용 필름이 제공된 풍선 카테터에 관한 것이다.In addition, the present invention is a tactic by applying a bioadhesive on the surface of the film while reducing the risk of blood clots even if the catheter is introduced into a narrow vessel by hydrophilic surface treatment of a film of a biocompatible material that can carry and release the necessary drugs The microneedles on the film as described above can be more effectively and stably fixed to the blood vessel wall, and the side of the film, in which the microneedles are not formed in the drug release process, is first biodegraded, and then the microneedles fixed to the blood vessel wall are sequentially biodegraded, thereby causing side effects such as thrombus formation. The present invention relates to a balloon catheter provided with a drug delivery film capable of safely delivering a drug to a treatment site.
환자에게 약물을 전달하는 약물전달시스템(drug delivery system)으로는 정제나 캅셀제를 이용한 경구투여, 경피투여 또는 주사제를 이용한 혈관내 투여 등이 전통적으로 사용되어 왔다. 그러나, 이러한 전통적인 약물전달시스템은 신체 내부의 치료부위에는 효과적으로 약물을 전달할 수 없는 문제가 있었고, 생체내 대사과정에서 해당 약물이 분해되거나 변형되어 약효가 떨어지는 문제가 있었다.As a drug delivery system that delivers drugs to patients, oral administration using tablets or capsules, transdermal administration, or intravascular administration using injections have been traditionally used. However, such a conventional drug delivery system has a problem that the drug can not be delivered effectively to the treatment site inside the body, the drug is degraded or modified in the metabolic process in vivo, there is a problem that the drug efficacy.
이러한 문제점을 감안하여 환자의 신체 내부 환부에 약물을 직접적으로 투여하는 방안이 효과적인 방안으로 제시되고 있으며, 이와 관련한 의료기구 및 약물전달시스템이 개발되고 있다.In view of these problems, a method of directly administering a drug to a patient's internal affected area has been proposed as an effective method, and related medical devices and drug delivery systems have been developed.
예를 들어, 심혈관계 질환의 경우 혈전용해제를 혈관으로 투입하고 치료의가 스텐트 삽입술, 혈관확장술 또는 혈관우회술 등의 시술을 통해 치료의 효과를 높일 수 있다. 관상동맥이 협착된 경우 관상동맥에 금속재질의 스텐트를 도입한 후 스텐트 구조를 협착 부위에서 펼치게 하여 협착 부위를 치료하는데, 이러한 스텐트 치료가 효과적임에도 불구하고 재협착 문제가 발생하며 혈전용해제와 같은 약물은 스텐트와는 별도로 주사되어 외과적 수술 치료와 약물 치료가 서로 분리되어 시행되는 문제가 있었다. 이러한 문제점을 감안하여 최근에는 금속재질의 스텐트에 약물을 코팅한 약물방출형 혈관스텐트가 개발되어 사용되고 있다.For example, in the case of cardiovascular diseases, thrombolytics may be injected into blood vessels, and the treatment physician may increase the effectiveness of treatment through a procedure such as stent insertion, vasodilation or vascular bypass surgery. In the case of coronary artery stenosis, a metal stent is introduced into the coronary artery, and the stent structure is spread out from the stenosis to treat the stenosis. Although the stent treatment is effective, a restenosis problem occurs and drugs such as thrombolytics are used. Silver was injected separately from the stent, and there was a problem that the surgical treatment and the medication were performed separately from each other. In view of these problems, recently, drug-released vascular stents coated with drugs on metallic stents have been developed and used.
그러나, 스텐트는 협착된 관상 동맥 등으로의 장기적 이식에 따른 혈관 재흡착의 문제점을 근본적인 문제점을 갖고 있어 스텐트 혈전과 후기 혈관 재발협착증이 발생할 수 있다. 따라서, 본 발명이 속한 기술분야에서는 혈관 내 장식 이식되는 스텐트를 사용하지 않으면서 신체 내부의 치료부위에는 효과적으로 약물을 전달할 수 있는 기술의 개발이 요구되고 있다고 하겠다.However, the stent has a fundamental problem of the resorption of blood vessels due to long-term transplantation into the narrowed coronary arteries, etc., and thus stent thrombosis and late vessel restenosis may occur. Therefore, in the technical field to which the present invention belongs, it is required to develop a technology that can effectively deliver drugs to the treatment site inside the body without using a stent implanted in the blood vessel.
한편, 카테터는 직접 신체에 삽입되는 의료용 수단을 포괄적으로 지칭하는 기구로서, 의료 현장에서는 혈관 주사용, 관상동맥 확장용, 요도 삽입용, 기도삽입용, 복강경 수술용 카테터 등 다양한 신체 삽입을 위한 카테터들이 사용되고 있다.그 중 관상동맥 확장을 위한 풍선 카테터는 예를 들면, 좁은 혈관 내로 삽입되는 안내관 선단 부근에 팽창성 풍선이 형성되어 있고 이 풍선에 연통되어 있는 도관을 통해 유체가 도입되어 풍선을 팽창시키게 되며 카테터의 좁은 혈관 내 삽입을 용이하게 하고 시술을 수행하는 역할을 하는 가이드 와이어가 상기 도관에 내장된 구조를 갖추고 있다.On the other hand, the catheter is a device that refers to a medical means that is directly inserted into the body, the catheter for a variety of body insertion, such as vascular injection, coronary artery dilation, urethral insertion, airway insertion, laparoscopic catheter in the medical field Among them, a balloon catheter for coronary artery dilatation includes, for example, an inflatable balloon formed near a tip of a guide tube inserted into a narrow blood vessel, and fluid is introduced through the conduit connected to the balloon to expand the balloon. And a guide wire for facilitating insertion into the narrow vessel of the catheter and performing a procedure has a structure embedded in the conduit.
최근에는 이러한 풍선 카테터를 이용하여 약물을 전달하는 기술이 제안되고 있다. 예를 들어, 하이드로겔 성분의 풍선에 약물을 흡수시키고 풍선을 카테터 내부 공간에 내장한 후 치료 부위 혈관 내로 카테터를 도입한 다음, 풍선을 카테터 외부로 슬라이딩 방식으로 나오게 하여 풍선을 팽창시키면 약물이 혈전이나 조직으로 방출되는 방식이 있는데(미국특허 제5,868,719호), 상기 약물전달 풍선 카테터는 사전에 풍선에 약물을 흡수시켜야 하는 불편과 이때 발생할 수 있는 감염의 문제가 있고 팽창된 풍선에 흡수된 약물이 혈관 내벽 안의 조직으로 정확하면서도 효과적으로 침투하는데 한계가 있는 단점이 있다. Recently, a technique for delivering a drug using such a balloon catheter has been proposed. For example, the drug is absorbed into a hydrogel-based balloon, the balloon is embedded in the catheter's internal space, the catheter is introduced into the vessel at the treatment site, and the balloon is slid out of the catheter to inflate the balloon to inflate the drug and cause blood clots. Or to the tissue (US Pat. No. 5,868,719), the drug delivery balloon catheter has a problem of having to absorb the drug in the balloon in advance and the problem of infection that may occur and the drug absorbed in the inflatable balloon There is a drawback that there is a limit to penetrate accurately and effectively into the tissue inside the blood vessel wall.
또한, 카테터를 치료 부위로 이동시키고 니들을 카테터 내의 약물전달루멘을 통해 카테터 본체 내부를 통과시키고 카테터의 일측에 형성된 홀을 통해 니들을 노출시켜 치료 대상 조직에 가요성의 니들을 찌른 후 약물을 주입하는 방식(미국공개특허 제2008/0004596 A1호)이 제안되기도 하였으나 치료부위로의 카테터의 이동 및 고정이 어려울 뿐만아니라 니들을 카테터 홀을 통해 노출시키고 조직 내에 정확하게 찌르는 동작은 매우 숙련된 시술의가 아니면 하기 어려운 시술상의 난점을 갖고 있었다.In addition, the catheter is moved to the treatment site, and the needle is passed through the catheter body through the drug delivery lumen in the catheter, and the needle is inserted through the hole formed on one side of the catheter to stab the flexible needle into the tissue to be treated and inject the drug. Although the method (US Patent Publication No. 2008/0004596 A1) has been proposed, the movement and fixation of the catheter to the treatment site is difficult, as well as exposing the needle through the catheter hole and precisely stabbing it in the tissue is not a highly skilled procedure. It was difficult to do the procedure.
따라서, 본 발명이 속한 기술분야에서는 제작 및 사용이 편리하고 위생적이며 혈관 및 요도 등을 통해 정밀하게 삽입되면서 치료 부위에서 조정이 미세하게 이루어질 수 있는 풍선형 카테터로서, 특히 약물이나 치료용 유체를 원하는 치료 부위, 예를 들면 좁은 혈관 내벽 안의 조직으로 정확하면서도 지속적으로 전달할 수 있는 새로운 풍선형 카테터의 개발이 꾸준히 요구되고 있다. 즉, 기존의 풍선 카테터를 이용한 약물 담지 및 치료부위로의 약물 전달 기술은 제작 및 사용 상의 불편, 그리고 정확한 치료부위로 약물을 지속적으로 전달하는데에는 한계가 있었다.Therefore, in the technical field to which the present invention belongs, it is a balloon-type catheter that is easy to manufacture and use and is hygienic and precisely inserted at the treatment site while being precisely inserted through blood vessels and urethra. There is a continuing need for the development of new balloon-type catheters that can accurately and consistently deliver to the treatment site, for example tissue within the narrow vascular lining. In other words, the conventional drug delivery and delivery to the treatment site using the balloon catheter has a limitation in the inconvenience of manufacturing and use, and the continuous delivery of the drug to the correct treatment site.
이에 본 발명자는 예의 연구를 거듭한 결과, 풍선 카테터의 팽창성 풍선에 미세 돌출부 구조를 적용하고 필요한 약물을 담지하고 지속적으로 방출할 수 있는 생체적합성 재료의 필름을 상기 미세 돌출부 구조가 적용된 풍선 표면 상에 제공한 풍선 카테터를 고안하였고, 필요한 약물을 담지하고 지속적으로 방출할 수 있는 생체적합성 재료의 필름 상에 표면 처리에 의해 미세 니들을 형성한 후 상기 미세 니들이 형성된 생체적합성 재료의 필름을 풍선 카테터의 팽창성 풍선 표면 상에 제공한 풍선 카테터를 고안함으로써, 좁은 혈관 내로 도입된 카테터를 혈관벽에 효과적이고 안정적으로 고정시키는 동시에 혈전 생성 등의 부작용없이 안전하게 약물을 치료부위, 예를 들면 혈관 내벽 안쪽의 조직에 정확하게 그리고 지속적으로 전달할 수 있는 기술을 구현하기에 이르렀다.Accordingly, the inventors have intensively studied, and applied a micro-projection structure to the inflatable balloon of the balloon catheter, and a film of a biocompatible material capable of supporting and continuously releasing the necessary drug on the balloon surface to which the microprojection structure is applied. The provided balloon catheter was designed, and after forming the fine needle by surface treatment on the film of the biocompatible material capable of supporting and continuously releasing the necessary drug, the film of the biocompatible material formed with the fine needle was expanded to the inflatable catheter. By devising a balloon catheter provided on the balloon surface, the catheter introduced into the narrow vessel can be effectively and stably fixed to the vessel wall while the drug is safely fixed to the treatment site, for example tissue inside the vessel wall, without side effects such as thrombus formation. And the technology that can deliver It's time to implement it.
본 발명은 필요한 약물을 담지하고 지속적으로 방출할 수 있는 생체적합성 재료의 필름을 풍선 카테터의 팽창성 풍선 표면 상에 제공하여 치료부위에 약물을 지속적으로 방출하면서 전달할 수 있는 약물 전달용 필름이 제공된 풍선 카테터를 제공하는데 그 목적이 있다. 우선, 본 발명은 필요한 약물을 적절한 곳에 보다 효율적이고 안전하게 전달하기 위해 풍선 카테터의 팽창성 풍선에 미세 돌출부 구조를 적용하고, 필요한 약물을 담지하고 지속적으로 방출할 수 있는 생체적합성 재료의 필름을 상기 미세 돌출부 구조가 적용된 풍선 표면 상에 제공함으로써 치료 부위에 카테터를 정확하게 위치시키는 동시에 약물을 치료부위에 정확하게 그리고 지속적으로 전달할 수 있는 약물 전달용 필름이 제공된 풍선 카테터를 제공하는데 그 목적이 있다.The present invention provides a balloon catheter provided with a film for drug delivery, which can deliver a film of a biocompatible material capable of supporting and continuously releasing a necessary drug on the inflatable balloon surface of the balloon catheter and continuously delivering the drug to the treatment site. The purpose is to provide. First of all, the present invention applies a microprojection structure to an inflatable balloon of a balloon catheter in order to more efficiently and safely deliver a necessary drug, and a film of a biocompatible material capable of supporting and continually releasing a drug required by the microprojection. It is an object of the present invention to provide a balloon catheter provided with a film for drug delivery, which can accurately and continuously deliver a drug to a treatment site while accurately positioning the catheter at the treatment site by providing the structure on the balloon surface to which the structure is applied.
또한, 본 발명은 필요한 약물을 담지하고 지속적으로 방출할 수 있는 생체적합성 재료의 필름 상에 표면 처리에 의해 미세 니들을 형성한 후 상기 미세 니들 이 형성된 생체적합성 재료의 필름을 풍선 카테터의 팽창성 풍선 표면 상에 제공함으로써 풍선의 팽창시 좁은 혈관의 통로를 확보하고 필름 상의 미세 니들을 혈관벽에 정확하고 안정적으로 고정시키는 동시에 약물을 치료부위에 정확하게 그리고 지속적으로 전달할 수 있는 약물 전달용 필름이 제공된 풍선 카테터를 제공하는데 그 목적이 있다. 추가로, 본 발명은 필요한 약물을 담지하고 지속적으로 방출할 수 있는 생체적합성 재료의 필름을 친수성 표면 처리하여 좁은 혈관으로 카테터가 도입되더라도 혈전이 생길 위험을 줄이면서 필름 표면에 생체 접착제를 적용하여 전술한 바와 같은 필름 상의 미세 니들이 혈관벽에 보다 효과적이고 안정적으로 고정되도록 하며, 약물 방출 과정에서 미세 니들이 형성되지 않은 필름 부분이 먼저 생분해된 후 혈관벽에 고정된 미세 니들이 순차적으로 생분해되도록 하여 혈전 생성 등의 부작용없이 안전하게 약물을 치료부위에 전달할 수 있는 약물 전달용 필름이 제공된 풍선 카테터를 제공하는데 그 목적이 있다.In addition, the present invention is to form a fine needle by the surface treatment on the film of the biocompatible material capable of supporting and continuously release the necessary drug and then the film of the biocompatible material on which the fine needle is formed, the inflatable balloon surface of the balloon catheter Balloon catheter provided with a film for drug delivery to secure narrow blood vessel passage during balloon inflation and to accurately and stably fix the microneedles on the film to the blood vessel wall while delivering the drug accurately and continuously to the treatment site. The purpose is to provide. In addition, the present invention is a hydrophilic surface treatment of a film of a biocompatible material capable of supporting and continuously release the necessary drug to apply the bioadhesive to the surface of the film while reducing the risk of blood clots even if the catheter is introduced into a narrow vessel The microneedles on the film as described above can be more effectively and stably fixed to the blood vessel wall, and the side of the film, in which the microneedles are not formed in the drug release process, is first biodegraded, and then the microneedles fixed to the blood vessel wall are sequentially biodegraded, thereby causing side effects such as thrombus formation. An object of the present invention is to provide a balloon catheter provided with a drug delivery film that can safely deliver a drug to a treatment site.
그리고, 본 발명은 다양한 약물을 담지하고 지속적으로 방출할 수 있는 생체적합성 재료의 여러개의 필름들을 팽창성 풍선 표면 상에 다중 층(multi-layer)으로 제공함으로써 다양한 약물을 순차적이면서 지속적으로 전달할 수 있을 뿐만 아니라 필름에 미세한 홀들이 형성됨으로써 약물 전달 과정 중 필름이 미세한 조각으로 분해될 수 있는 생분해성을 제공하고, 생체 적합성 및 탄성력의 물성도 제공하여 혈전 생성, 재상피화 및 염증반응 등의 2차적 질병을 유발하지 않는 풍선 카테터를 제공하는데 그 목적이 있다.In addition, the present invention can not only continuously and continuously deliver various drugs by providing multiple films of biocompatible materials capable of supporting and continuously releasing various drugs in a multi-layer on the inflatable balloon surface. In addition, by forming fine holes in the film, it provides biodegradability in which the film can be broken down into fine pieces during drug delivery, and also provides biocompatibility and elastic properties to prevent secondary diseases such as blood clots, re-epithelialization, and inflammatory reactions. The purpose is to provide a balloon catheter that does not induce.
본 발명의 일실시예의 약물 전달용 필름이 제공된 풍선 카테터는, 팽창성 풍선과, 이 팽창성 풍선과 연통되고 풍선 팽창용 유체를 상기 팽창성 풍선에 유입시키는 연결관을 구비하는 도관과, 필요한 약물을 담지하고 지속적으로 방출할 수 있는 생체적합성 재료의 필름으로서, 상기 팽창성 풍선을 둘러싸면서 제공되는 필름과, 상기 팽창성 풍선 외부 표면 상에 형성되고 상기 팽창성 풍선과 상기 필름 사이의 공간 내에 위치하는 미세 돌출부를 포함하고, 상기 팽창성 풍선으로 풍선 팽창용 유체가 유입되어 상기 팽창성 풍선이 팽창되면 상기 팽창성 풍선과 상기 필름 사이의 공간이 좁아지면서 상기 필름의 형상이 상기 미세 돌출부 처럼 변형되고 상기 미세 돌출부 형상으로 변형된 필름 부분과 상기 미세 돌출부가 신체 내의 치료부위에 고정되어 상기 필름에 담지된 약물이 상기 치료부위에 방출되면서 전달되는 것을 특징으로 한다.An inflatable catheter provided with a film for drug delivery of an embodiment of the present invention comprises an inflatable balloon, a conduit having a conduit in communication with the inflatable balloon and introducing a balloon for inflating the inflatable balloon with the inflatable balloon; A film of biocompatible material capable of sustaining release, comprising: a film provided surrounding the inflatable balloon; and a micro-projection formed on the inflatable balloon outer surface and positioned in the space between the inflatable balloon and the film; When the inflatable balloon is introduced into the inflatable balloon and the inflatable balloon is inflated, the space between the inflatable balloon and the film is narrowed, and the film portion is deformed like the fine protrusion, and the film portion is deformed into the fine protrusion shape. And the microprojection is fixed to the treatment site in the body The drug loading in the film is characterized in that the transmission as discharge to the treatment site.
본 발명의 일실시예에 따르면, 상기 연결관을 통해 풍선 팽창용 유체가 상기 팽창성 풍선에 도입되어 팽창성 풍선이 팽창되면 카테터를 치료 부위의 정확한 위치에 고정하면서 혈관의 통로를 확보하고, 상기 팽창성 풍선과 상기 필름 사이의 공간이 좁아지면서 상기 필름의 형상이 상기 미세 돌출부 처럼 변형되며 상기 미세 돌출부 형상으로 변형된 필름 부분과 상기 미세 돌출부가 신체 내의 치료부위에 고정되어 상기 필름에 담지된 약물이 상기 치료부위에 정확하면서도 서서히 지속적으로 방출되면서 전달될 수 있다.According to an embodiment of the present invention, when the inflatable balloon is introduced into the inflatable balloon through the connecting pipe, when the inflatable balloon is inflated, the catheter is secured at the correct position of the treatment site to secure the passage of blood vessels, and the inflatable balloon As the space between the film and the film is narrowed, the shape of the film is deformed like the micro protrusions, and the film portion deformed into the shape of the micro protrusions and the micro protrusions are fixed to the treatment part in the body so that the drug supported on the film is treated. It can be delivered accurately and slowly and continuously at the site.
대안으로서, 본 발명의 다른 일실시예의 약물 전달용 필름이 제공된 풍선 카테터는, 팽창성 풍선과, 이 팽창성 풍선과 연통되고 풍선 팽창용 유체를 상기 팽창성 풍선에 유입시키는 연결관을 구비하는 도관과, 필요한 약물을 담지하고 지속적으로 방출할 수 있는 생체적합성 재료의 필름으로서, 상기 팽창성 풍선을 둘러싸면서 제공되는 필름과, 상기 필름의 표면 상에 형성된 미세 니들을 포함하고, 상기 팽창성 풍선으로 풍선 팽창용 유체가 유입되어 상기 팽창성 풍선이 팽창되면, 상기 팽창성 풍선을 둘러싸는 필름의 표면 상에 형성된 미세 니들이 신체 내의 치료부위에 고정되고 상기 필름에 담지된 약물이 상기 치료부위에 방출되면서 전달되는 것을 특징으로 한다.Alternatively, a balloon catheter provided with a drug delivery film of another embodiment of the present invention comprises a conduit having an inflatable balloon and a conduit in communication with the inflatable balloon and introducing a balloon for inflating the inflatable balloon into the inflatable balloon; A film of biocompatible material capable of supporting and continuously releasing a drug, comprising: a film provided surrounding the inflatable balloon; and a fine needle formed on the surface of the film, wherein the inflatable balloon is used to expand the balloon. When the inflatable balloon is inflated, the fine needle formed on the surface of the film surrounding the inflatable balloon is fixed to the treatment site in the body and the drug contained in the film is delivered while being released to the treatment site.
본 발명의 다른 일실시예의 약물 전달용 필름이 제공된 풍선 카테터에 있어서, 상기 미세 니들은 복수개가 제공될 수 있는데, 복수개의 미세 니들들이 상기 필름의 표면 상에 카테터의 축 방향으로 일정 간격으로 형성되고, 상기 팽창성 풍선을 둘러싸는 필름의 원주방향으로도 일정 간격으로 형성될 수 있다. 예를 들어, 상기 팽창성 풍선이 팽창하기 전에 상기 팽창성 풍선을 둘러싸는 필름이 폴딩(folding)된 상태에서 생기는 필름의 폴링 라인(folding line)을 따라 복수개의 미세 니들들이 형성될 수 있다.In a balloon catheter provided with a drug delivery film of another embodiment of the present invention, the plurality of fine needles may be provided, the plurality of fine needles are formed at regular intervals in the axial direction of the catheter on the surface of the film It may be formed at regular intervals in the circumferential direction of the film surrounding the inflatable balloon. For example, a plurality of fine needles may be formed along a folding line of the film that occurs when the film surrounding the inflatable balloon is folded before the inflatable balloon is inflated.
본 발명의 다른 일실시예의 약물 전달용 필름이 제공된 풍선 카테터에 있어서, 상기 복수개의 미세 니들들은 상기 팽창성 풍선이 팽창하기 전에 상기 팽창성 풍선을 둘러싸는 필름이 폴딩(folding)된 상태에서는 카테터의 축 방향으로 누워 있는 상태로 위치하고, 상기 팽창성 풍선이 팽창하면 상기 팽창성 풍선을 둘러싸는 필름이 펴지게 되면서 이에 따라 카테터의 축 방향에 대해 일정한 각도를 가지면서 세워지는 것을 특징으로 한다. In a balloon catheter provided with a drug delivery film of another embodiment of the present invention, the plurality of fine needles are in the axial direction of the catheter when the film surrounding the inflatable balloon is folded (folding) before the inflatable balloon is inflated Located in a lying state, when the inflatable balloon is inflated, the film surrounding the inflatable balloon is unfolded, and accordingly characterized in that it is erected with a constant angle with respect to the axial direction of the catheter.
따라서, 본 발명의 다른 일실시예에 따르면, 풍선의 팽창 전에는 폴딩된 상태로 필름을 좁은 혈관으로 도입하여 폴딩 라인을 따라 형성된 미세니들들이 혈관벽에 손상을 주지 않게 하고, 풍선의 팽창시에는 좁은 혈관의 통로를 확보하면서 필름 상의 미세 니들이 혈관벽을 향해 세워지게 함으로써 필름을 혈관벽에 정확하고 안정적으로 고정시켜 필름에 담지된 약물을 치료부위, 예를 들면 혈관 내벽 안쪽의 조직에 정확하게 그리고 지속적으로 전달할 수 있게 된다. Therefore, according to another embodiment of the present invention, before the balloon is expanded, the film is introduced into the narrow vessel in the folded state so that the fine needles formed along the folding line do not damage the vessel wall, and the vessel is narrowed when the balloon is inflated. The microneedle on the film is erected toward the vessel wall while securing the passage of the film, so that the film is accurately and stably fixed to the vessel wall so that the drug contained in the film can be accurately and continuously delivered to the treatment site, for example, the tissue inside the vessel wall. do.
본 발명의 다른 일실시예의 약물 전달용 필름이 제공된 풍선 카테터에 있어서, 각각의 미세 니들은 상기 필름 상에 위치한 기단부의 직경이 크고 기단부로부터 멀어질 수록 직경이 작아지되 미세 니들의 가장 끝부분인 첨단부는 뽀족하게 형성되어 혈관벽과 같은 조직에 정확하면서 안정적으로 고정될 수 있다. 또한, 상기 미세 니들은 상기 기단부로부터 상기 첨단부에 이르기까지 일정한 각도를 가지면서 유선형으로 형성될 수 있다. 이와 같이 미세 니들이 방향성을 가지도록 형성되면 혈류에 의해 미세 니들이 약물전달용 필름을 혈관벽에 단단히 고정시키도록 하여 약물전달용 필름이 떨어져서 발생하는 위험을 감소시키고 혈관벽에 밀착되도록 함으로써 약물전달을 용이하게 할 수 있다. 바람직하게는 상기 미세 니들은 상기 첨단부로부터 하방으로 낚시 바늘 구조가 연장되어 형성될 수 있다. 이 경우 일단 미세 니들이 혈관벽과 같은 조직에 고정되면 낚시 바늘 구조에 의해 미세 니들이 쉽게 이탈되지 않게 된다. In a balloon catheter provided with a drug delivery film according to another embodiment of the present invention, each fine needle has a larger diameter at the proximal end located on the film and a smaller diameter as it moves away from the proximal end, but at the tip of the fine needle. The bulge is pointed and can be fixed accurately and stably in tissues such as blood vessel walls. In addition, the fine needle may be formed in a streamline shape having a constant angle from the base end to the tip. When the fine needle is formed to have a directional direction, the microneedle is firmly fixed to the blood vessel wall by the blood flow, thereby reducing the risk of the drug delivery film falling off and making it adhere to the blood vessel wall, thereby facilitating drug delivery. Can be. Preferably, the fine needle may be formed by extending the hook structure downward from the tip portion. In this case, once the fine needle is fixed to a tissue such as a blood vessel wall, the fine needle is not easily separated by the hook structure.
본 발명의 다른 일실시예의 약물 전달용 필름이 제공된 풍선 카테터에 있어서, 상기 미세 니들은 코로나 표면 처리, 고주파 표면 처리, 플라즈마 표면 처리 및 레이저 표면처리로 구성된 군으로부터 선택된 적어도 하나의 표면처리에 의해 형성될 수 있다. 상기 표면 처리로는 친수성 표면 처리가 바람직하며, 친수성 표면처리를 하면 좁은 혈관으로 카테터가 도입되더라도 혈전이 생길 위험을 줄일 수 있다. 그러나, 본 발명은 이에 제한되는 것이 아니며 다양한 필름 가공 및 성형방법이 사용될 수 있음은 물론이다.In a balloon catheter provided with a drug delivery film of another embodiment of the present invention, the fine needle is formed by at least one surface treatment selected from the group consisting of corona surface treatment, high frequency surface treatment, plasma surface treatment and laser surface treatment. Can be. The surface treatment is preferably a hydrophilic surface treatment, the hydrophilic surface treatment can reduce the risk of blood clots even if the catheter is introduced into a narrow vessel. However, the present invention is not limited thereto, and various film processing and forming methods may be used.
본 발명의 다른 일실시예의 약물 전달용 필름이 제공된 풍선 카테터에 있어서, 상기 필름 표면에는 생체 접착제를 적용하여 미세 니들이 혈관벽에 보다 효과적이고 안정적으로 고정되도록 할 수 있다. 생체 적찹제의 예로는 피브리노겐, 피브리노겐을 첨가한 혈액응고제 XIII인자, 시아노아크릴레이트, 피부린 글루, 해양 생체접착제를 들 수 있으며, 본 발명의 기술분야에 알려진 다양한 생체적합제가 사용될 수 있음을 물론이다. In the balloon catheter provided with the drug delivery film of another embodiment of the present invention, the surface of the film can be applied to the bioadhesive to make the fine needle more effectively and stably fixed to the blood vessel wall. Examples of biored glutamate include fibrinogen, blood coagulant XIII factor with fibrinogen, cyanoacrylate, dermalin glue, marine bioadhesive, and various biocompatible agents known in the art may be used. to be.
본 발명의 다른 일실시예의 약물 전달용 필름이 제공된 풍선 카테터에 있어서, 상기 팽창성 풍선이 팽창하면 상기 팽창성 풍선을 둘러싸는 필름은 펼쳐지면서 대략 원통형의 형상을 취하게 되는데, 상기 펼쳐진 원통형의 필름의 원주방향을 따라 필름을 단차지도록 형성할 수 있다. 이때 미세 니들은 두께가 두꺼운 돌출 부분 상에 형성될 수 있다. 이와 같이 필름과 미세 니들을 구성할 경우, 약물 방출 과정에서 미세 니들이 형성되지 않은 얇은 필름 부분이 먼저 생분해된 후 혈관벽에 고정된 미세 니들이 순차적으로 생분해되도록 하여 혈전 생성 등의 부작용없이 안전하게 약물을 치료부위에 전달할 수 있는 추가적 장점이 있다. In the balloon catheter provided with the drug delivery film of another embodiment of the present invention, when the inflatable balloon is inflated, the film surrounding the inflatable balloon is expanded to take a substantially cylindrical shape, the circumference of the unfolded cylindrical film The film may be formed to be stepped along the direction. At this time, the fine needle may be formed on a thick projecting portion. As such, when the film and the fine needle are composed, the thin film portion in which the fine needle is not formed is first biodegraded during the drug release process, and then the microneedles fixed on the vessel wall are sequentially biodegraded to safely treat the drug without side effects such as blood clot formation. There are additional advantages that can be delivered to.
본 발명의 약물 전달용 필름이 제공된 풍선 카테터에 있어서, 다양한 약물을 담지하고 지속적으로 방출할 수 있는 생체적합성 재료의 다수개의 필름들을 상기 팽창성 풍선 표면 상에 다중 층(multi-layer)으로 제공하면 다양한 약물을 순차적이면서 지속적으로 전달할 수 있다.In the balloon catheter provided with the film for drug delivery of the present invention, if a plurality of films of biocompatible materials capable of supporting and continuously releasing various drugs are provided in a multi-layer on the inflatable balloon surface, Drugs can be delivered sequentially and continuously.
또한, 본 발명의 약물 전달용 필름이 제공된 풍선 카테터에 있어서, 상기 필름에는 미세한 홀들이 형성됨으로써 약물 전달 과정 중 필름이 미세한 조각으로 분해될 수 있도록 하여 혈전 생성을 방지하도록 하는 것이 바람직하다In addition, in the balloon catheter provided with the drug delivery film of the present invention, it is preferable that the holes are formed in the film so that the film can be decomposed into fine pieces during drug delivery to prevent the formation of blood clots.
한편, 본 발명의 약물 전달용 필름이 제공된 풍선 카테터에 있어서, 상기 필름의 재료로는 필요한 약물을 담지하고 지속적으로 방출할 수 있는 생체적합성 재료이면 어느 것이나 사용가능하나, 예를 들어 PEG(polyethyleneglycol)-PCLA(poly(epsilon-caprolactone-co-D,L-lactide))의 중합체 재료, 또는 PEG(polyethyleneglycol)-PLGA(poly(lactic-co-glycolic acid))의 중합체 재료, 또는 이러한 중합체 재료에 카프로락톤, 글리콜라이드, 락타이드, 파라다이옥사논 및 트리메틸렌카보네이트로 구성된 군으로부터 선택된 적어도 하나의 물질이 첨가된 중합체 재료를 사용할 수 있다(대한민국 등록특허 제10-0668046호 및 제10-0832552호 참조). 이러한 재질의 필름을 사용할 경우, 약물을 치료부위에 정확하게 지속적으로 방출하여 전달할 수 있을 뿐만 아니라 탄성력, 생체적합성 및 생분해성의 물성을 제공하게 되어 재상피화 및 염증반응 등의 2차적 질병을 유발하지 않는 장점도 제공한다.Meanwhile, in the balloon catheter provided with the drug delivery film of the present invention, any material may be used as the material of the film as long as it is a biocompatible material capable of supporting and continuously releasing a necessary drug, for example, PEG (polyethyleneglycol) Polymer material of -PCLA (poly (epsilon-caprolactone-co-D, L-lactide)), or polymer material of PEG (polyethyleneglycol) -PLGA (poly (lactic-co-glycolic acid)), or capro to such polymer material Polymeric materials to which at least one substance selected from the group consisting of lactones, glycolides, lactide, paradioxanone and trimethylenecarbonate are added may be used (see Korean Patent Nos. 10-0668046 and 10-0832552). . When using the film of this material, it is possible to release and deliver the drug accurately and continuously to the treatment area, and to provide elasticity, biocompatibility, and biodegradability, which does not cause secondary diseases such as re-epithelialization and inflammatory reaction. Also provides.
본 발명의 약물 전달용 필름이 제공된 풍선 카테터는, 상기 연결관에 직접 접합되어 결합되는 외부 분리 도관과, 상기 외부 분리 도관 내벽에 밀착되면서 위치하고 상기 연결관과 연통되어 상기 연결관에 풍선 팽창용 유체를 유입시키는 내부 분리 도관을 포함할 수 있다.Balloon catheter provided with the drug delivery film of the present invention, the outer separation conduit that is directly bonded to the connection pipe, and is in close contact with the inner wall of the external separation conduit is located in communication with the connection pipe fluid for inflating the balloon in the connection pipe It may include an internal separation conduit for introducing the.
본 발명의 약물 전달용 필름이 제공된 풍선 카테터에 있어서, 상기 내부 분리 도관의 일단(一端)은 상기 외부 분리 도관의 일단(一端)을 지나 상기 연결관 내부까지 연장되는 것이 바람직한데, 상기 외부 분리 도관과 상기 연결관과의 결합시 이들의 결합을 안내하는 역할을 하는 동시에 상기 외부 분리 도관이 상기 연결관과 견고하게 결합시키는 것을 도와준다. 특히, 이를 위해 상기 내부 분리 도관의 일단(一端)은 선단으로 갈수록 뾰족해 지는 형상을 갖추는 것이 바람직하다.In the balloon catheter provided with the drug delivery film of the present invention, one end of the inner separation conduit preferably extends through the one end of the outer separation conduit to the inside of the connecting tube. And the outer separation conduit helps to firmly connect with the connector at the same time serves to guide the coupling of them when combined with the connector. In particular, for this purpose, one end of the inner separation conduit preferably has a shape that is sharpened toward the tip.
본 발명의 약물 전달용 필름이 제공된 풍선 카테터에 있어서, 상기 내부 분리 도관 내부에는 가이드 와이어가 상기 내부 분리 도관의 내벽과 간격을 두고 위치할 수 있다. 상기 가이드 와이어는 상기 내부 분리 도관의 일단(一端)을 지나 상기 연결관 내부에 깊숙이 연장되는 것이 바람직하다. 이러한 경우, 본 발명의 약물 전달용 필름이 제공된 풍선 카테터를 예를 들어 혈관 내에 삽입하는 수술 과정에서 연결관에 강직성을 부여하여 카테터의 혈관 내 삽입 및 혈관 내에서의 진입이 용이하게 된다. 뿐만아니라, 상기 내부 분리 도관의 내벽과 상기 가이드 와이어 사이의 간격을 통해 풍선 팽창용 유체가 유입되므로 상기 간격을 조정함으로써 풍선 팽창용 유체의 유동량을 조정할 수 있는 장점도 있게 된다.In the balloon catheter provided with the drug delivery film of the present invention, a guide wire may be positioned at an interval from an inner wall of the inner separation conduit. Preferably, the guide wire extends deep inside the connecting pipe through one end of the inner separation conduit. In such a case, the balloon catheter provided with the drug delivery film of the present invention is provided with rigidity to the connective duct during a surgical procedure for inserting into the blood vessel, thereby facilitating the catheter's intravascular insertion and entry into the blood vessel. In addition, since the balloon inflation fluid is introduced through the gap between the inner wall of the inner separation conduit and the guide wire, the flow rate of the balloon inflation fluid can be adjusted by adjusting the gap.
또한, 본 발명의 약물 전달용 필름이 제공된 풍선 카테터는 상기 외부 분리 도관 및 내부 분리 도관을 풍선 팽창용 유체 연결관과 연결시켜 주는 조인트 부재를 더 포함할 수 있다. 상기 조인트 부재의 유입 포트에는 상기 풍선 팽창용 유체 연결관이 삽입되어 연결되고, 상기 조인트 부재의 유출 포트에는 상기 외부 분리 도관 및 내부 분리 도관이 삽입되어 연결된다. In addition, the balloon catheter provided with the drug delivery film of the present invention may further include a joint member for connecting the outer separation conduit and the inner separation conduit with the fluid connection for balloon expansion. The inflation port of the joint member is inserted and connected to the balloon inflation fluid tube, and the outlet port of the joint member is inserted into and connected to the outer separation conduit and the inner separation conduit.
구체적으로, 상기 유입 포트를 통해 삽입된 상기 풍선 팽창용 유체 연결관은 상기 조인트 부재 내에 형성된 유입안내관에 밀착삽입되고, 상기 유출 포트를 통해 삽입된 상기 외부 분리 도관 및 내부 분리 도관은 상기 유입안내관과 연통되는 상기 조인트 부재 내에 형성된 유출안내관에 밀착삽입되면서 상기 풍선 팽창용 유체 연결관과 연통하게 되어 상기 풍선 팽창용 유체 연결관을 통해 유입되는 풍선 팽창용 유체를 상기 내부 분리 도관을 통해 상기 유출 포트로 내보내게 된다. Specifically, the balloon expansion fluid connecting tube inserted through the inlet port is tightly inserted into the inlet guide tube formed in the joint member, and the outer separation conduit and the inner separation conduit inserted through the outlet port are the inlet guide. The balloon-expanding fluid introduced through the balloon-expansion fluid connection tube is inserted into the outflow guide tube formed in the joint member in communication with the pipe and is introduced through the balloon-expansion fluid connection pipe through the inner separation conduit. It will be exported to the outflow port.
추가적으로, 본 발명의 약물 전달용 필름이 제공된 풍선 카테터는, 상기 풍선 팽창용 유체 연결관을 유체 공급장치와 연결시켜 주는 풍선 팽창용 유체 주입용 허브를 더 포함할 수 있다. Additionally, the balloon catheter provided with the drug delivery film of the present invention may further include a balloon inflation fluid injecting hub that connects the balloon inflation fluid connector with a fluid supply device.
한편, 본 발명의 약물 전달용 필름이 제공된 풍선 카테터는, 상기 도관의 선단(先端)으로부터 상기 팽창성 풍선 내부 그리고 혈류 구멍이 형성된 상기 연결관 위치까지 연장하고 상기 연결관에 형성된 혈류 구멍에 결합되는 혈류 유동관을 더 포함할 수 있다. 상기 혈류 유동관은 상기 혈류 구멍에 결합되는 부분에서 약간 상방으로 완만한 각도로 꼬부라진 형상으로 형성되어 있고 그 개방부는 길이방향으로 길게 형성되어 있다. 상기 혈류 유동관은 상기 연결관의 혈류 구멍에 꼭 들어맞아야 하는데, 그렇지 않으면 상기 연결관을 통해 유입되는 풍선 팽창용 유체가 새어나갈 위험이 있기 때문이다. On the other hand, the balloon catheter provided with the drug delivery film of the present invention, the blood flow extending from the leading end of the conduit to the position of the connection pipe formed inside the inflatable balloon and the blood flow hole and is coupled to the blood flow hole formed in the connection pipe It may further include a flow tube. The blood flow pipe is formed in a shape that is curved at a slightly upward angle at a portion coupled to the blood flow hole, and its opening is formed long in the longitudinal direction. The blood flow tube must fit snugly into the blood flow hole of the connector, otherwise there is a risk of the balloon-inflating fluid leaking through the connector.
이와 같은 혈류 유동관을 추가로 설치하면 팽창성 풍선을 팽창시켜 카테터를 치료 부위에 정확한 위치에 고정하면서 혈관의 통로를 확보하고 필름에 담지된 약물이 상기 치료부위에 정확하면서도 서서히 지속적으로 방출되면서 전달되는 경우에도, 카테터가 혈액의 흐름을 방해하지 않고 혈류 유동관을 통해 원활하게 혈액이 흐를 수 있게 할 수 있다.When the additional blood flow tube is installed, the inflatable balloon is inflated to secure the catheter in the correct position and secure the passage of blood vessels, and the drug contained in the film is delivered to the treated portion accurately and slowly and continuously. In addition, the catheter may allow blood to flow smoothly through the blood flow tube without disturbing the flow of blood.
또한, 본 발명의 약물 전달용 필름이 제공된 풍선 카테터는, 상기 팽창성 풍선과 상기 혈류 유동관 사이를 밀봉하는 밀봉 캡을 추가로 구비할 수 있다. 밀봉 캡은 상기 혈류 유동관의 내부 통로에 대응되는 부분에 관통 통로가 형성되어 전술한 바와 같은 혈류 유동관을 통해 원활하게 혈액이 흐를 수 있게 한다.In addition, the balloon catheter provided with the drug delivery film of the present invention may further include a sealing cap for sealing between the inflatable balloon and the blood flow tube. The sealing cap has a through passage formed in a portion corresponding to the inner passage of the blood flow tube so that blood can flow smoothly through the blood flow tube as described above.
본 발명의 약물 전달용 필름이 제공된 풍선 카테터에 있어서, 상기 풍선 팽창용 유체는 공기 또는 조영제일 수 있다. In the balloon catheter provided with the drug delivery film of the present invention, the balloon inflation fluid may be air or contrast agent.
또한, 상기 팽창성 풍선 재질은 생체에 적합한 재질로서 나일론, 신축성 합성수지, 폴리아미드, 폴리에테르아미드 등 팽창용 유체가 도입되면 용이하게 팽창되는 탄성(신축성)을 가진 재질로서 구성하는 것이 바람직하다. 그리고, 미세 돌출부의 길이는 대략 100㎛일 수 있고, 풍선 팽창시 필름의 형상을 변형시키되 필름을 뚫고 나가지 않는 형상으로 구성하는 것이 바람직하다. 예를 들어, 미세돌출부는 팽창성 풍선의 외부 표면 상에 미세 원통형으로 형성될 수 있다. 그러나, 본 발명은 이에 제한되는 것이 아니며 치료부위, 카테터가 삽입되는 혈관의 굵기 등 치료조건에 따라 다양한 재질의 풍선으로 제작가능하며, 미세 돌출부의 길이 및 형상도 다양하게 선택할 수 있다.In addition, the inflatable balloon is preferably made of a material having elasticity (elasticity) which is easily expanded when an expansion fluid such as nylon, stretchable synthetic resin, polyamide, polyetheramide, etc. is introduced as a material suitable for living bodies. In addition, the length of the fine protrusions may be approximately 100 μm, and it is preferable to configure the shape of the film when the balloon is inflated but does not penetrate the film. For example, the microprojection can be formed in a fine cylindrical shape on the outer surface of the inflatable balloon. However, the present invention is not limited thereto, and may be made of balloons of various materials according to treatment conditions, such as the treatment site, the thickness of blood vessel into which the catheter is inserted, and the length and shape of the micro-projection may be variously selected.
그리고, 본 발명의 약물 전달용 필름이 제공된 풍선 카테터에 있어서, 상기 필름에 담지되어 치료부위에 전달되는 약물로는 혈전용해제, 항증식제, 면역억제제, 항염증제, 백신, 호르몬, 인슐린, 유전자 치료제, 단백질 치료제 주사, 또는 내피세포촉진제일 수 있다. 그러나, 본 발명은 이에 제한되는 것이 아니며, 다양한 약물이 필름에 담지되어 사용될 수 있음을 본 발명이 속하는 기술분야의 당업자라면 용이하게 이해할 것이다.In the balloon catheter provided with the drug delivery film of the present invention, the drug supported on the film and delivered to the treatment site includes a thrombolytic agent, antiproliferative agent, immunosuppressant agent, anti-inflammatory agent, vaccine, hormone, insulin, gene therapy agent, Protein therapeutics injection, or endothelial cell promoter. However, the present invention is not limited thereto, and it will be readily understood by those skilled in the art that various drugs may be supported on a film and used.
본 발명에 따르면 치료 부위에 카테터를 정확하게 위치시키는 동시에 약물을 치료 부위에 정확하면서도 지속적으로 방출하면서 전달할 수 있다. 즉, 본 발명은 필요한 약물을 적절한 곳에 보다 효율적이고 안전하게 그리고 지속적으로 전달할 수 있다.According to the present invention, the catheter can be accurately positioned at the treatment site and the drug can be delivered while being accurately and continuously released at the treatment site. In other words, the present invention can deliver the necessary drugs more efficiently, safely and continuously where appropriate.
우선, 본 발명은 풍선 카테터의 팽창성 풍선에 미세 돌출부 구조를 적용하고, 필요한 약물을 담지하고 지속적으로 방출할 수 있는 생체적합성 재료의 필름을 상기 미세 돌출부 구조가 적용된 풍선 표면 상에 제공함으로써, 풍선을 팽창시켜 카테터를 치료 부위의 정확한 위치에 고정하면서 혈관의 통로를 확보하고, 풍선이 팽창하면 미세 돌출부 구조가 필름의 형상을 미세 돌출부 처럼 변형시켜 혈관 내벽에 돌출부 형상으로 변형된 필름과 미세 돌출부가 고정되어 필름에 담지된 약물이 혈관 내벽에 서서히 지속적으로 방출되면서 전달되는 장점이 있다.First, the present invention applies a micro-projection structure to an inflatable balloon of a balloon catheter, and provides a balloon of a biocompatible material capable of supporting and continuously releasing a necessary drug on the balloon surface to which the micro-projection structure is applied. Inflate the catheter to secure the catheter in the correct position at the treatment site while securing the passage of blood vessels, and when the balloon is inflated, the microprojection structure deforms the shape of the film like a microprojection, thereby fixing the film and the microprojection deformed to the shape of the protrusion on the inner wall of the blood vessel. There is an advantage that the drug is carried on the film is delivered to the vascular inner wall slowly and continuously released.
또한, 본 발명은 필요한 약물을 담지하고 지속적으로 방출할 수 있는 생체적합성 재료의 필름 상에 표면 처리에 의해 미세 니들을 형성한 후 상기 미세 니들이 형성된 생체적합성 재료의 필름을 풍선 카테터의 팽창성 풍선 표면 상에 제공함으로써 풍선의 팽창시 좁은 혈관의 통로를 확보하고 필름 상의 미세 니들을 혈관벽에 정확하고 안정적으로 고정시키는 동시에 필름에 담지된 약물을 치료부위, 예를 들면 혈관 내벽 안쪽의 조직에 정확하게 그리고 지속적으로 전달할 수 있는 장점이 있다.In addition, the present invention is to form a microneedle by surface treatment on a film of biocompatible material capable of supporting and continually release the necessary drug and then the film of the biocompatible material formed with the fine needle on the inflatable balloon surface of the balloon catheter To provide a narrow vessel passage during balloon inflation and to accurately and stably fix the microneedles on the film to the vessel wall, while the drug contained in the film is precisely and continuously applied to the treatment site, for example tissue inside the vessel wall. There is an advantage to deliver.
또한, 본 발명은 필요한 약물을 담지하고 지속적으로 방출할 수 있는 생체적합성 재료의 필름을 친수성 표면 처리하여 좁은 혈관으로 카테터가 도입되더라도 혈전이 생길 위험을 줄이면서 필름 표면에 생체 접착제를 적용하여 전술한 바와 같은 필름 상의 미세 니들이 혈관벽에 보다 효과적이고 안정적으로 고정되도록 하며, 약물 방출 과정에서 미세 니들이 형성되지 않은 필름 부분이 먼저 생분해된 후 혈관벽에 고정된 미세 니들이 순차적으로 생분해되도록 하여 혈전 생성 등의 부작용없이 안전하게 약물을 치료부위에 전달할 수 있는 추가적 장점이 있다. In addition, the present invention by applying a bioadhesive to the surface of the film while reducing the risk of blood clots, even if the catheter is introduced into a narrow vessel by hydrophilic surface treatment of the film of the biocompatible material that can carry and release the necessary drug The microneedles on the film as described above are more effectively and stably fixed to the blood vessel wall, and during the drug release process, the film portion in which the microneedles are not formed is first biodegraded, and then the microneedles fixed to the blood vessel wall are biodegraded sequentially, without side effects such as thrombus generation. There is an additional advantage to safely deliver the drug to the treatment site.
그리고, 본 발명은 다양한 약물을 담지하고 지속적으로 방출할 수 있는 생체적합성 재료의 여러개의 필름들을 팽창성 풍선 표면 상에 다중 층(multi-layer)으로 제공함으로써 다양한 약물을 순차적이면서 지속적으로 전달할 수 있을 뿐만 아니라 필름에 미세한 홀들이 형성됨으로써 약물 전달 과정 중 필름이 미세한 조각으로 분해될 수 있는 생분해성을 제공하고, 생체 적합성 및 탄성력의 물성도 제공하여 혈전 생성, 재상피화 및 염증반응 등의 2차적 질병을 유발하지 않는 추가적인 장점도 있다. In addition, the present invention can not only continuously and continuously deliver various drugs by providing multiple films of biocompatible materials capable of supporting and continuously releasing various drugs in a multi-layer on the inflatable balloon surface. In addition, by forming fine holes in the film, it provides biodegradability in which the film can be broken down into fine pieces during drug delivery, and also provides biocompatibility and elastic properties to prevent secondary diseases such as blood clots, re-epithelialization, and inflammatory reactions. There are additional benefits that do not cause them.
본 발명의 상기 및 다른 기술적 과제와 특징은 다음과 같은 도면을 참조하여 이루어지는 본 발명의 실시예에 대한 설명을 통하여 당업자에게 명확해 질 수 있을 것이다.The above and other technical problems and features of the present invention will be apparent to those skilled in the art through the description of the embodiments of the present invention made with reference to the accompanying drawings.
도 1은 본 발명의 제1실시예의 약물 전달용 필름이 제공된 풍선 카테터가 결합된 상태의 사시도이다.1 is a perspective view of a balloon catheter provided with a drug delivery film of the first embodiment of the present invention is coupled.
도 2는 본 발명의 제1실시예의 약물 전달용 필름이 제공된 풍선 카테터가 분해된 상태의 분해사시도이다.Figure 2 is an exploded perspective view of the balloon catheter provided with the drug delivery film of the first embodiment of the present invention in a disassembled state.
도 3은 본 발명의 제1실시예의 약물 전달용 필름이 제공된 풍선 카테터가 결합된 상태의 종단면도이다.Figure 3 is a longitudinal cross-sectional view of the balloon catheter provided with the drug delivery film of the first embodiment of the present invention is coupled.
도 4는 도 3에 도시된 본 발명의 제1실시예의 약물 전달용 필름이 제공된 풍선 카테터의 A 부분을 확대하여 도시한 확대 단면도이다.Figure 4 is an enlarged cross-sectional view showing an enlarged portion A of the balloon catheter provided with the drug delivery film of the first embodiment of the present invention shown in FIG.
도 5는 도 3에 도시된 본 발명의 제1실시예의 약물 전달용 필름이 제공된 풍선 카테터의 B 부분을 확대하여 도시한 확대 단면도이다.FIG. 5 is an enlarged cross-sectional view illustrating an enlarged portion B of the balloon catheter provided with the drug delivery film of the first embodiment of the present invention shown in FIG. 3.
도 6은 도 3에 도시된 본 발명의 제1실시예의 약물 전달용 필름이 제공된 풍선 카테터의 C 부분을 확대하여 도시한 확대 단면도이다.FIG. 6 is an enlarged cross-sectional view of a portion C of the balloon catheter provided with the drug delivery film of the first embodiment of the present invention shown in FIG. 3.
도 7은 도 3에 도시된 본 발명의 제1실시예의 약물 전달용 필름이 제공된 풍선 카테터의 D 부분을 확대하여 도시한 확대 단면도이다.FIG. 7 is an enlarged cross-sectional view illustrating a portion D of the balloon catheter provided with the drug delivery film of the first embodiment of the present invention shown in FIG. 3.
도 8은 도 3에 도시된 본 발명의 제1실시예의 약물 전달용 필름이 제공된 풍선 카테터의 E 부분을 확대하여 도시한 확대 단면도이다.8 is an enlarged cross-sectional view showing an enlarged portion E of the balloon catheter provided with the drug delivery film of the first embodiment of the present invention shown in FIG.
도 9는 본 발명의 제2실시예의 약물 전달용 필름이 제공된 풍선 카테터가 결합된 상태의 사시도이다.9 is a perspective view of the balloon catheter provided with the drug delivery film of the second embodiment of the present invention is coupled.
도 10은 본 발명의 제2실시예의 약물 전달용 필름이 제공된 풍선 카테터에서 팽창성 풍선을 둘러싸는 제1형태의 필름이 폴딩된 상태를 도시하는 사시도 및 일부 확대도이다.FIG. 10 is a perspective view and a partially enlarged view showing a state in which a film of the first form surrounding the inflatable balloon is folded in a balloon catheter provided with a drug delivery film of a second embodiment of the present invention.
도 11은 도 10의 제1형태의 필름이 폴딩된 상태에서 팽창성 풍선에 결합된 상태를 도시하는 정면도와 사시도이다.FIG. 11 is a front view and a perspective view illustrating a state in which the film of the first form of FIG. 10 is coupled to the inflatable balloon in the folded state.
도 12는 본 발명의 제2실시예의 약물 전달용 필름이 제공된 풍선 카테터에서 팽창성 풍선을 둘러싸는 제2형태의 필름이 폴딩된 상태를 도시하는 사시도 및 일부 확대도이다.12 is a perspective view and a partially enlarged view showing a state in which a second type of film surrounding the inflatable balloon is folded in a balloon catheter provided with a drug delivery film of a second embodiment of the present invention.
도 13은 도 12의 제2형태의 필름이 폴딩된 상태에서 팽창성 풍선에 결합된 상태를 도시하는 정면도와 사시도이다.FIG. 13 is a front view and a perspective view illustrating a state in which the film of the second form of FIG. 12 is coupled to the inflatable balloon in the folded state.
도 14 내지 도 16은 본 발명의 제2실시예의 약물 전달용 필름이 제공된 풍선 카테터에서 팽창성 풍선을 둘러싸는 다양한 형태의 필름이 풍선의 팽창에 의해 펼쳐진 상태와 미세 니들을 도시하는 사시도이다.14 to 16 are perspective views showing the microneedle and the unfolded state of the various types of film surrounding the inflatable balloon in the balloon catheter provided with the drug delivery film of the second embodiment of the present invention by the expansion of the balloon.
도 17은 도 9에 도시된 본 발명의 제2실시예의 약물 전달용 필름이 제공된 풍선 카테터의 E 부분을 종방향으로 절단한 후 확대하여 도시한 확대 단면도이다.FIG. 17 is an enlarged cross-sectional view illustrating the E-section of the balloon catheter provided with the drug delivery film of the second embodiment of the present invention shown in FIG. 9 after being cut in the longitudinal direction.
이하, 첨부된 도면을 참조하여 본 발명의 바람직한 실시예를 설명하면 다음과 같다. 본 발명의 하기 실시예는 본 발명을 구체화하기 위한 것일 뿐 본 발명의 권리범위를 제한하거나 한정하는 것이 아님은 물론이다. 본 발명의 상세한 설명 및 실시예로부터 본 발명이 속하는 기술분야의 전문가가 용이하게 유추할 수 있는 것은 본 발명의 권리범위에 속하는 것으로 해석된다. 본 발명에 인용된 참고문헌은 본 발명에 참고로서 통합된다.Hereinafter, exemplary embodiments of the present invention will be described with reference to the accompanying drawings. The following examples of the present invention are not intended to limit or limit the scope of the present invention only to embody the present invention. From the detailed description and examples of the present invention, those skilled in the art to which the present invention pertains can easily be interpreted as belonging to the scope of the present invention. References cited in the present invention are incorporated herein by reference.
도 1, 도 2, 도 7 및 도 8에 도시된 바와 같은 본 발명의 제1실시예의 약물 전달용 필름이 제공된 풍선 카테터(100a)는 혈관 등을 통해 신체로 도입된 후 공기와 같은 풍선 팽창용 유체(F)에 의해 팽창하고 치료부위(T)에 삽입되는 팽창성 풍선(82) 및 상기 팽창성 풍선(82)에 연통되도록 연결되어 풍선 팽창용 유체(F)를 상기 팽창성 풍선(82)에 유입시키는 연결관(84)을 구비하는 도관(80)과, 필요한 약물(M)을 담지하고 지속적으로 방출할 수 있는 생체적합성 재료의 필름으로서 상기 팽창성 풍선(82)을 둘러싸면서 제공되는 필름(20a)과, 상기 팽창성 풍선(82) 외부 표면 상에 형성되고 상기 팽창성 풍선(82)과 상기 필름(20a) 사이의 공간(d) 내에 위치하는 미세 돌출부(88)를 주요 구성요소로서 포함한다.Balloon catheter (100a) provided with the drug delivery film of the first embodiment of the present invention as shown in Figures 1, 2, 7 and 8 is introduced into the body through blood vessels for balloon expansion, such as air An inflatable balloon 82 which is inflated by the fluid F and inserted into the treatment site T and connected to the inflatable balloon 82 is connected to the inflatable balloon 82 to flow the balloon-inflating fluid F into the inflatable balloon 82. A conduit 80 having a connecting tube 84, a film 20a provided surrounding the inflatable balloon 82 as a film of a biocompatible material capable of supporting and continuously releasing the necessary drug M; And, as a major component, a micro-projection 88 formed on the outer surface of the inflatable balloon 82 and located in the space d between the inflatable balloon 82 and the film 20a.
구체적으로, 도 2, 도 4 내지 도 8을 참조하면, 본 발명의 제1실시예의 약물 전달용 필름이 제공된 풍선 카테터(100a)는 팽창성 풍선(82) 팽창시 필름(20a)의 형상을 돌출형으로 변형시켜 변형된 필름 부위를 치료부위(T)에 고정시킴으로써 필름(20a)에 담지된 약물(M)이 서서히 지속적으로 치료부위(T)에 전달되도록 하는 미세 돌출부(88)들이 외주면을 따라 일정 간격으로 다수개 제공된 팽창성 풍선(82) 및 이 팽창성 풍선(82)과 연통되도록 연결된 연결관(84)을 구비하는 도관(80)과, 필요한 약물(M)을 담지하고 지속적으로 방출할 수 있는 생체적합성 재료의 필름으로서 상기 팽창성 풍선(82)을 둘러싸면서 제공되는 필름(20a)을 그 기본 구성으로 한다.Specifically, referring to FIGS. 2 and 4 to 8, the balloon catheter 100a provided with the drug delivery film of the first embodiment of the present invention protrudes from the shape of the film 20a when the inflatable balloon 82 is inflated. The micro protrusions 88 are fixed along the outer circumferential surface so that the drug M supported on the film 20a is gradually and continuously delivered to the treatment site T by fixing the deformed film portion to the treatment site T by deforming to the treatment site T. A conduit 80 having a plurality of inflatable balloons 82 provided at intervals and a connecting tube 84 connected in communication with the inflatable balloons 82, and a living body capable of supporting and continuously releasing the necessary drug M The film 20a provided while surrounding the inflatable balloon 82 as a film of a compatible material has a basic configuration.
또한, 도 2, 도 6 내지 도 8를 참조하면, 본 발명의 제1실시예의 약물 전달용 필름이 제공된 풍선 카테터(100a)에는 상기 도관(80)의 선단(先端)의 개방부로부터 삽입되어 팽창성 풍선(82) 내부 및 연결관(84) 내부를 통과하는 혈류 유동관(70)이 추가로 조립될 수 있다. 상기 혈류 유동관(70)은 상기 연결관(84)의 외주면 일측에 형성된 혈류 구멍(86)까지 연장하여 이 혈류 구멍(86)에 꼭 들어맞게 결합된다.2, 6 to 8, the inflatable catheter 100a provided with the drug delivery film of the first embodiment of the present invention is inserted from the opening of the front end of the conduit 80 and expandable. The blood flow tube 70 passing through the balloon 82 and the connecting tube 84 may be further assembled. The blood flow pipe 70 extends to the blood flow hole 86 formed at one side of the outer circumferential surface of the connection pipe 84 and is fitted to fit the blood flow hole 86.
도 6을 참조하여 상세하게 설명하면, 상기 혈류 유동관(70)은 상기 혈류 구멍(86)에 결합되는 부분에서 약간 상방으로 완만한 각도로 꼬부라진 형상으로 형성되어 있고 그 개방부(76)는 길이방향으로 길게 형성되어 있다. 상기 혈류 유동관(70)은 상기 혈류 구멍(86)에 꼭 들어맞아야 하는데, 그렇지 않으면 상기 연결관(84)의 팽창유체유동공간(fS)을 통해 유입되는 풍선 팽창용 유체(F)가 새어나갈 위험이 있기 때문이다. 한편, 도 6은 본 발명의 제1실시예의 약물 전달용 필름이 제공된 풍선 카테터의 C 부분의 종단면도를 확대하여 도시한 확대 단면도로서, 상기 혈류 유동관(70)이 상기 혈류 구멍(86)에 결합되는 부분에서 팽창유체유동공간(fS)을 종방향, 즉 수직방향으로는 일부 차단하지만, 횡방향, 즉 수평방향으로는 공간이 존재하므로 풍선 팽창용 유체(F)의 흐름은 방해되지 않는다.Referring to FIG. 6, the blood flow tube 70 is formed in a curved shape at a slightly upward angle at a portion coupled to the blood flow hole 86 and the opening portion 76 has a length. It is formed long in the direction. The blood flow pipe 70 should fit snugly into the blood flow hole 86, otherwise the risk of balloon inflation fluid F entering through the expansion fluid flow space fS of the connection pipe 84 will leak out. Because of this. On the other hand, Figure 6 is an enlarged cross-sectional view showing a longitudinal cross-sectional view of the C portion of the balloon catheter provided with the drug delivery film of the first embodiment of the present invention, the blood flow pipe 70 is coupled to the blood flow hole 86 Partly blocks the expansion fluid flow space fS in the longitudinal direction, that is, the vertical direction, but there is a space in the transverse direction, that is, the horizontal direction, so that the flow of the balloon-inflating fluid F is not disturbed.
이와 같은 혈류 유동관(70)을 추가로 설치하면 팽창성 풍선(82)을 팽창시켜 카테터(100a)를 치료 부위(T)에 정확히 고정하면서 혈관의 통로를 확보하고, 팽창성 풍선(82)이 팽창되면 팽창성 풍선(82)과 필름(20a) 사이의 공간(d)이 좁아지면서(d→d') 필름(20a)의 형상이 미세 돌출부(88) 처럼 변형되고 미세 돌출부 형상으로 변형된 필름 부분(20a)과 미세 돌출부(88)가 신체 내의 치료부위(T)에 고정되어 필름(20a)에 담지된 약물(M)이 치료부위(T)에 방출되면서 전달될 때(도 7 및 도 8 참조), 카테터(100a)가 혈관(BB) 내에서 혈액의 흐름을 방해하지 않고 혈류 유동관(70)의 내부 통로(BP) 및 개방부(76)을 통해 원활하게 혈액이 흐를 수 있게 할 수 있다(도 6 내지 도 8 참조). When the blood flow tube 70 is further installed, the inflatable balloon 82 is inflated to secure the catheter 100a at the treatment site T while securing a passage of blood vessels, and when the inflatable balloon 82 is expanded, the inflatable balloon 82 is expanded. As the space d between the balloon 82 and the film 20a becomes narrow (d → d '), the film portion 20a is deformed like the microprojection 88 and deformed into the microprojection shape. When the micro-projection 88 is fixed to the treatment site T in the body and the drug M carried on the film 20a is delivered to the treatment site T while being released (see FIGS. 7 and 8), the catheter 100a may allow blood to flow smoothly through the inner passage BP and the opening 76 of the blood flow tube 70 without disturbing the flow of blood in the blood vessel BB (FIGS. 6 to 6). 8).
또한, 혈류 유동관(70)을 스테인레스강 또는 초탄성 합금과 같은 재질로 구성하면 본 발명의 약물 전달용 필름이 제공된 풍선 카테터(100a)를 예를 들어 혈관(BB) 내에 삽입하는 수술 과정에서 도관(80) 전체에 강직성을 부여하여 카테터(100a)의 혈관 내 삽입 및 혈관 내에서의 진입이 용이하게 된다. 그러나, 혈류 유동관(70)은 상기와 같은 재질 이외에도 다양한 재질, 예를 들어 생체적합성 플라스틱, 합성 수지 등으로 구성할 수 있음을 본 발명이 속하는 기술분야의 당업자라면 용이하게 이해할 것이다.In addition, if the blood flow tube 70 is made of a material such as stainless steel or super-elastic alloy, the catheter 100 may be inserted into the balloon catheter 100a provided with the drug delivery film of the present invention. 80) the rigidity is given to the whole to facilitate insertion of the catheter 100a into the blood vessel and entry into the blood vessel. However, those skilled in the art will readily understand that the blood flow tube 70 may be composed of various materials, for example, biocompatible plastics, synthetic resins, and the like, in addition to the above materials.
추가로, 도 2 및 도 8을 참조하면, 본 발명의 제1실시예의 약물 전달용 필름이 제공된 풍선 카테터(100a)는 상기 팽창성 풍선(82)과 상기 혈류 유동관(70) 사이의 선단(先端)을 밀봉하는 밀봉 캡(90)을 추가로 구비할 수 있다. 따라서, 상기 밀봉 캡(90)에 의해 풍선 팽창용 유체(F)가 카테터(100a)의 선단(先端)으로부터 유출되는 것이 방지되고, 상기 밀봉 캡(90)은 상기 혈류 유동관(70)의 내부 통로(BP)에 대응되는 부분에 관통 통로(92)가 형성되어 전술한 바와 같은 혈류 유동관(70)의 내부 통로(BP) 및 개방부(76)를 통해 원활하게 혈액이 흐를 수 있게 한다.2 and 8, the balloon catheter 100a provided with the drug delivery film of the first embodiment of the present invention has a tip between the inflatable balloon 82 and the blood flow tube 70. It may be further provided with a sealing cap 90 for sealing the. Accordingly, the balloon-expanding fluid F is prevented from flowing out of the tip of the catheter 100a by the sealing cap 90, and the sealing cap 90 is an internal passage of the blood flow pipe 70. A through passage 92 is formed at a portion corresponding to the BP to allow blood to flow smoothly through the inner passage BP and the opening 76 of the blood flow tube 70 as described above.
상기와 같은 구성요소들의 조합에 의해 본 발명의 제1실시예의 약물 전달용 필름이 제공된 풍선 카테터(100a)에서는 도 5, 도 7 및 도 8에 도시된 바와 같이 연결관(84)을 통해 풍선 팽창용 유체(F)가 팽창성 풍선(82)에 도입되어 팽창성 풍선(82)이 팽창되면(before→after), 카테터(100a)를 치료 부위(T)의 정확한 위치에 고정하면서 혈관의 통로를 확보하고 팽창성 풍선(82)과 필름(20a) 사이의 공간(d)이 좁아지면서(d→d') 필름(20a)의 형상이 미세 돌출부(88)처럼 변형되고(before→after) 미세 돌출부 형상으로 변형된 필름 부분(20a)과 미세 돌출부(88)가 신체 내의 치료부위(T)에 고정되어 필름(20a)에 담지된 약물(M)이 치료부위(T)에 정확하면서도 서서히 지속적으로 방출되면서 전달될 수 있다.In the balloon catheter 100a provided with the drug delivery film of the first embodiment of the present invention by the combination of the above components, the balloon is inflated through the connecting pipe 84 as shown in FIGS. 5, 7 and 8. When the fluid F is introduced into the inflatable balloon 82 and the inflatable balloon 82 expands (before → after), the catheter 100a is secured at the correct position of the treatment site T to secure the passage of blood vessels. As the space d between the inflatable balloon 82 and the film 20a is narrowed (d → d '), the shape of the film 20a is deformed like the fine protrusions 88 and then deformed into the shape of the fine protrusions. The film portion 20a and the micro-projection 88 are fixed to the treatment site T in the body so that the drug M loaded on the film 20a can be delivered while being accurately and continuously released to the treatment site T. Can be.
즉, 도 4 및 도 5에 도시된 바와 같이, 팽창유체통로(P)를 통해 상기 연결관(84) 내부로 공기와 같은 풍선 팽창용 유체(F)가 유입되고, 도 7에 도시된 바와 같이 유입된 풍선 팽창용 유체(F)가 신축성을 가진 팽창성 풍선(82)과 혈류 유동관(70) 사이의 팽창유체유동공간(fS)을 통해 유입된 후 상기 팽창성 풍선(82)을 팽창시키면 팽창성 풍선(82)과 필름(20a) 사이의 공간(d)이 좁아지면서(d→d') 필름(20a)의 형상이 미세 돌출부(88)처럼 변형되고(before→after) 미세 돌출부 형상으로 변형된 필름 부분(20a)과 미세 돌출부(88)가 신체 내의 치료부위(T)에 고정되어 필름(20a)에 담지된 약물(M)이 치료부위(T)에 정확하면서도 서서히 지속적으로 방출되면서 전달될 수 있다(도 7 및 도 8 참조).That is, as shown in Figures 4 and 5, the balloon-inflating fluid (F), such as air flows into the connecting pipe 84 through the expansion fluid passage (P), as shown in FIG. When the introduced balloon inflation fluid F flows through the expansion fluid flow space fS between the inflatable balloon 82 and the blood flow tube 70 having elasticity, the inflatable balloon 82 is expanded to expand the inflatable balloon 82. The portion of the film deformed into the shape of the fine protrusions before and after the shape of the film 20a is deformed like the fine protrusions 88 while the space d between the 82 and the film 20a is narrowed (d → d '). 20a and the micro-projection 88 are fixed to the treatment site T in the body so that the drug M supported on the film 20a can be delivered while being accurately and continuously continuously released to the treatment site T ( 7 and 8).
한편, 전술한 바와 같은 풍선 팽창용 유체(F)는 공기 또는 조영제일 수 있다. 그러나, 본 발명의 풍선 팽창용 유체(F)는 이에 제한되는 것이 아니며 유체로서 팽창성 풍선(82)을 팽창시킬 수 있는 물질이라면 어느 것이라도 사용가능한 것임은 물론이다.Meanwhile, the balloon inflation fluid F as described above may be air or a contrast agent. However, the balloon-inflating fluid F of the present invention is not limited thereto, and any material capable of inflating the inflatable balloon 82 as a fluid may be used.
또한, 상기 팽창성 풍선(82) 재질은 생체에 적합한 재질로서 나일론, 신축성 합성수지, 폴리아미드, 폴리에테르아미드 등 풍선 팽창용 유체(F)가 도입되면 용이하게 팽창되는 탄성(신축성)을 가진 재질로서 구성하는 것이 바람직하다. 그러나, 본 발명은 이에 제한되는 것이 아니며, 풍선 카테터와 관련한 기술분야에 알려진 풍선 재료를 이용하여 제조될 수 있음을 본 발명이 속하는 기술분야의 당업자라면 용이하게 이해할 것이다.In addition, the inflatable balloon 82 is made of a material having elasticity (elasticity) that is easily expanded when a balloon-inflating fluid (F) such as nylon, stretchable synthetic resin, polyamide, and polyetheramide is introduced as a material suitable for living body. It is desirable to. However, it will be readily understood by those skilled in the art that the present invention is not limited thereto and may be made using balloon materials known in the art with respect to balloon catheter.
일반적으로, 상기 팽창성 풍선(82)의 길이는 대략 5mm 내지 50mm의 범위일 수 있고, 그 내부 직경은 대략 0.5mm 내지 5mm 범주 내에서 가변될 수 있다.In general, the length of the inflatable balloon 82 may range from approximately 5 mm to 50 mm, and its inner diameter may vary within the range of approximately 0.5 mm to 5 mm.
상기 연결관(84)은 상기 팽창성 풍선(82) 재질과 동일한 재질로서 일체로 제작될 수도 있고, 대안으로 폴리우레탄, 나일론 또는 PET와 같은 생체적합형 폴리머 재료로 별도로 제조한 후 자외선 또는 열접착 방식 타입의 접착제를 사용하여 상기 팽창성 풍선(82)과 부착시킬 수 있다. 또한, 상기 연결관(84)의 길이는 대략 100mm 내지 2000 mm 범위일 수 있고, 그 내부 직경은 대략 0.2mm 내지 2.0 mm의 범위일 수 있다.The connecting pipe 84 may be made integrally with the same material as that of the inflatable balloon 82, or alternatively manufactured separately from a biocompatible polymer material such as polyurethane, nylon, or PET, and then UV or heat adhesive. A type of adhesive can be used to attach to the inflatable balloon 82. In addition, the length of the connector 84 may range from approximately 100 mm to 2000 mm, and its inner diameter may range from approximately 0.2 mm to 2.0 mm.
그리고, 상기 팽창성 풍선(82)의 외부 표면 상에는 일정 간격으로 다수개의 미세 돌출부(88)들이 형성되어 있고, 풍선 팽창시 필름의 형상을 변형시키되 필름을 뚫고 나가지 않는 형상으로 구성하는 것이 바람직하다. 예를 들어, 미세돌출부(88)는 팽창성 풍선의 외부 표면 상에 미세 원통형으로 형성될 수 있다. 미세돌출부(88)는 당업계에 알려진 나일론 재질을 이용한 마이크로 니들 형성방법을 응용하여 형성될 수 있다. 그러나, 본 발명은 이에 제한되는 것이 아니며 치료부위, 카테터가 삽입되는 혈관의 굵기 등 치료조건에 따라 다양한 재질의 풍선으로 제작가능하며, 미세 돌출부의 길이 및 형상도 다양하게 선택할 수 있다. 한편, 미세 돌출부(88)의 길이는 대략 100㎛일 수 있다. In addition, a plurality of fine protrusions 88 are formed on the outer surface of the inflatable balloon 82 at regular intervals, and the shape of the inflatable balloon 82 may be configured to deform the shape of the film but not penetrate the film. For example, the microprojection 88 can be formed in a fine cylindrical shape on the outer surface of the inflatable balloon. The fine protrusions 88 may be formed by applying a microneedle forming method using a nylon material known in the art. However, the present invention is not limited thereto, and may be made of balloons of various materials according to treatment conditions, such as the treatment site, the thickness of blood vessel into which the catheter is inserted, and the length and shape of the fine protrusion may be variously selected. On the other hand, the length of the fine protrusions 88 may be approximately 100㎛.
또한, 미세 돌출부(88)의 길이 조정이나 풍선 팽창용 유체(F)의 유입량 조정에 의한 팽창성 풍선(82)의 팽창 정도의 조정으로 미세 돌출부(88) 및 미세 돌출부에 의해 돌출형으로 변형되는 필름 부분(20a)이 혈관 내벽 안쪽의 조직으로 삽입되는 깊이를 조절할 수 있고 이에 따라 약물의 전달 깊이를 조절할 수 있다.In addition, the film is deformed into a protrusion by the micro-projection 88 and the micro-projection by adjusting the expansion degree of the inflatable balloon 82 by adjusting the length of the micro-projection 88 or the amount of inflow of the balloon-inflating fluid F. The portion 20a can adjust the depth at which it is inserted into the tissue inside the blood vessel wall and thus the delivery depth of the drug.
도 2, 도 4 및 도 5를 참조하면, 본 발명의 제1실시예의 약물 전달용 필름이 제공된 풍선 카테터(100a)는 연결관(84)에 직접 접합되어 결합되는 외부 분리 도관(40)과, 상기 외부 분리 도관(40) 내벽에 밀착되면서 위치하고 상기 연결관(84)과 연통되어 팽창유체통로(P)를 통해 상기 연결관(84) 내부에 풍선 팽창용 유체(F)를 유입시키는 내부 분리 도관(50)을 포함한다.2, 4 and 5, the balloon catheter 100a provided with the drug delivery film of the first embodiment of the present invention is an outer separation conduit 40 which is directly bonded and bonded to the connecting pipe 84, The inner separation conduit is placed in close contact with the inner wall of the outer separation conduit 40 and communicates with the connection pipe 84 to introduce the balloon expansion fluid F into the connection pipe 84 through the expansion fluid passage P. And 50.
도 5에 도시된 바와 같이, 상기 외부 분리 도관(40)의 일단(一端)은 상기 연결관(84)과 접합된다. 상기 외부 분리 도관(40)은 상기 연결관(84)과 동일한 재질, 예를 들어 폴리우레탄, 나일론 또는 PET와 같은 생체적합형 폴리머 재료로 별도로 제조한 후 자외선 또는 열접착 방식 타입의 접착제를 사용하여 상기 연결관(84)과 부착시킬 수 있다.As shown in FIG. 5, one end of the outer separation conduit 40 is joined with the connection tube 84. The outer separation conduit 40 is manufactured separately from the same material as the connecting pipe 84, for example, a biocompatible polymer material such as polyurethane, nylon or PET, and then using an ultraviolet or heat adhesive type adhesive. It can be attached to the connecting pipe (84).
그리고, 도 4 및 도 5에 도시된 바와 같이, 상기 내부 분리 도관(50)은 상기 외부 분리 도관(40) 내부에 삽입되어 조립되는데, 이때 상기 내부 분리 도관(50)의 일단(一端)은 상기 외부 분리 도관(40)의 일단(一端)을 지나 상기 연결관(84) 내부까지 연장될 수 있다. 이와 같은 구성에 의해 상기 내부 분리 도관(50)은 전술한 바와 같은 상기 외부 분리 도관(40)과 상기 연결관(84)과의 결합시 이들의 결합을 안내하는 역할을 하는 동시에 상기 외부 분리 도관(40)이 상기 연결관(84)과 견고하게 결합시키는 것을 도와준다.4 and 5, the inner separation conduit 50 is inserted into the outer separation conduit 40 and assembled, wherein one end of the inner separation conduit 50 is It may extend beyond one end of the outer separation conduit 40 to the interior of the connection tube 84. By such a configuration, the inner separation conduit 50 serves to guide the coupling of the outer separation conduit 40 and the connection pipe 84 as described above when the outer separation conduit ( 40 helps to firmly engage the connector 84.
특히, 도 5에 도시된 바와 같이 상기 내부 분리 도관(50)의 일단(一端)은 선단으로 갈수록 뾰족해 지는 형상을 갖추는 것이 바람직하다.In particular, as shown in FIG. 5, one end of the inner separation conduit 50 preferably has a shape that is sharpened toward the tip.
또한, 도 4 및 도 5에 도시된 같이, 상기 내부 분리 도관(50) 내부에는 가이드 와이어(60)가 상기 내부 분리 도관(50)의 내벽과 간격을 두고 삽입 조립되어 위치함으로써 팽창유체통로(P)를 형성하게 된다. 이때, 도 5에 도시된 바와 같이, 상기 가이드 와이어(60)는 상기 내부 분리 도관(50)의 일단(一端)을 지나 상기 연결관(84) 내부에 깊숙이 연장되는 것이 바람직하다. In addition, as shown in FIG. 4 and FIG. 5, the inner space of the inner separation conduit 50, the guide wire 60 is inserted and positioned at intervals with the inner wall of the inner separation conduit 50, the expansion fluid passage (P) ). In this case, as shown in FIG. 5, the guide wire 60 preferably extends deep inside the connection pipe 84 through one end of the internal separation conduit 50.
이러한 경우, 본 발명의 제1실시예의 약물 전달용 필름이 제공된 풍선 카테터(100a)를 예를 들어 혈관 내에 삽입하는 수술 과정에서 상기 연결관(84)에 강직성을 부여하여 카테터의 혈관 내 삽입 및 혈관 내에서의 진입이 용이하게 된다. 뿐만아니라, 상기 내부 분리 도관(50)의 내벽과 상기 가이드 와이어(60) 사이의 간격, 즉 팽창유체통로(P)를 통해 풍선 팽창용 유체(F)가 유입되므로 상기 간격을 조정함으로써 팽창유체통로(P)를 통해 유입되는 풍선 팽창용 유체(F)의 유동량을 조정할 수 있게 된다.In this case, the balloon catheter 100a provided with the drug delivery film of the first embodiment of the present invention is provided with rigidity to the connecting pipe 84, for example, in a surgical procedure of inserting the blood vessel into the blood vessel of the catheter and the blood vessel. It is easy to enter inside. In addition, the expansion fluid passage by adjusting the interval since the balloon expansion fluid (F) is introduced through the interval between the inner wall of the inner separation conduit 50 and the guide wire 60, that is, the expansion fluid passage (P). It is possible to adjust the flow amount of the balloon for expanding fluid (F) flowing through (P).
한편, 상기 가이드 와이어(60)는 스테인레스강 또는 초탄성 합금과 같은 재질로 구성할 수 있고, 이외에도 다양한 재질, 예를 들어 생체적합성 플라스틱, 합성 수지 등으로 구성할 수 있음을 본 발명이 속하는 기술분야의 당업자라면 용이하게 이해할 것이다.On the other hand, the guide wire 60 may be made of a material such as stainless steel or super-elastic alloy, in addition to a variety of materials, for example, biocompatible plastic, synthetic resin, etc. Those skilled in the art will readily understand.
한편, 도 2 및 도 4에 도시된 바와 같이 본 발명의 제1실시예의 약물 전달용 필름이 제공된 풍선 카테터(100a)는 상기 외부 분리 도관(40) 및 내부 분리 도관(50)을 풍선 팽창용 유체 연결관(18)과 연결시켜 주는 조인트 부재(30)를 더 포함할 수 있다. Meanwhile, as shown in FIGS. 2 and 4, the balloon catheter 100a provided with the drug delivery film of the first embodiment of the present invention has a fluid for inflating the external separation conduit 40 and the internal separation conduit 50. It may further include a joint member 30 for connecting to the connecting pipe 18.
도 4에 도시된 바와 같이 상기 조인트 부재(30)의 유입 포트(32)에는 상기 풍선 팽창용 유체 연결관(18)이 삽입되어 연결되고, 상기 조인트 부재(30)의 유출 포트(36)에는 상기 외부 분리 도관 및 내부 분리 도관(40, 50)과 상기 가이드 와이어(60)가 삽입되어 연결된다. As shown in FIG. 4, the inflation port 32 of the joint member 30 is inserted and connected to the balloon inflation fluid tube 18, and the outlet port 36 of the joint member 30 is connected to the inlet port 32. An outer separation conduit and an inner separation conduit 40, 50 and the guide wire 60 are inserted and connected.
구체적으로, 도 4에 도시된 바와 같이, 상기 유입 포트(32)를 통해 삽입된 상기 풍선 팽창용 유체 연결관(18)은 상기 조인트 부재(30) 내에 형성된 유입안내관(31)에 밀착삽입되면서 그 단턱부(324)에 걸리게 되고, 상기 유출 포트(36)를 통해 삽입된 상기 외부 분리 도관 및 내부 분리 도관(40, 50)과 상기 가이드 와이어(60)는 상기 유입안내관(31)과 연통되는 상기 조인트 부재(30) 내에 형성된 유출안내관(33)에 밀착삽입되면서 상기 풍선 팽창용 유체 연결관(18)과 연통하게 되어 상기 풍선 팽창용 유체 연결관(18)을 통해 유입되는 풍선 팽창용 유체(F)를 상기 내부 분리 도관(50)과 상기 가이드 와이어(60) 사이를 통해 유출 포트(36)로 내보내게 된다. 즉, 풍선 팽창용 유체(F)는 상기 풍선 팽창용 유체 연결관(18)의 내부 통로(19), 그리고 상기 내부 분리 도관(50) 및 상기 가이드 와이어(60) 사이에 형성된 팽창유체통로(P)를 통해 상기 조인트 부재(30)의 유출 포트(36)로 나가게 된다.Specifically, as shown in FIG. 4, the balloon-inflating fluid connection pipe 18 inserted through the inflow port 32 is tightly inserted into the inflow guide tube 31 formed in the joint member 30. It is caught by the step portion 324, and the external separation conduit and the internal separation conduit 40, 50 and the guide wire 60 inserted through the outlet port 36 is in communication with the inlet guide tube 31 Being in close contact with the outflow guide tube 33 formed in the joint member 30 is in communication with the balloon expansion fluid connection tube 18 to inflate the balloon introduced through the balloon expansion fluid connection pipe 18 Fluid F is directed to the outlet port 36 between the inner separation conduit 50 and the guide wire 60. That is, the balloon expansion fluid (F) is the expansion passage (P) formed between the inner passage (19) of the balloon expansion fluid connection pipe 18, and the inner separation conduit (50) and the guide wire (60). Through the outlet port 36 of the joint member 30.
추가적으로, 도 1 내지 도 3에 도시된 바와 같이, 본 발명의 제1실시예의 약물 전달용 필름이 제공된 풍선 카테터(100a)는 상기 풍선 팽창용 유체 연결관(18)을 유체 공급장치(미도시)와 연결시켜 주는 풍선 팽창용 유체 주입용 허브(10)를 더 포함할 수 있다. In addition, as shown in Figures 1 to 3, the balloon catheter 100a provided with the drug delivery film of the first embodiment of the present invention is a fluid supply device (not shown) for the balloon expansion fluid connector 18 It may further include a balloon injecting hub 10 for inflating the balloon.
도 1에 도시된 바와 같이, 상기 풍선 팽창용 유체 주입용 허브(10)는 몸체(12)와, 결합부(13)와, 손잡이부(14)로 구성된다. 손잡이부(14)는 몸체(12)의 양쪽에 날개 형태로 형성되어 있어 파지하기가 용이하고 결합부(13)에는 나사산이 형성되어 있다. 따라서, 사용자가 손잡이부(14)의 양 날개를 손으로 잡은 상태에서 유체 공급장치(미도시)를 결합부(13)에 나사결합방식으로 결합고정 및 분리시킬 수 있다. 상기 풍선 팽창용 유체 주입용 허브(10)가 유체 공급장치(미도시)에 결합된 상태에서 유체 공급장치에 수용된 풍선 팽창용 유체(F)를 주입하면, 상기 풍선 팽창용 유체 주입용 허브(10)의 유입구(15)와, 상기 풍선 팽창용 유체 주입용 허브(10)에 결합된 풍선 팽창용 유체 연결관(18)의 내부 통로(19)를 통해 풍선 팽창용 유체(F)가 전술한 바와 같은 조인트 부재(30)로 유입된다.As shown in FIG. 1, the balloon inflation hub 10 includes a body 12, a coupling part 13, and a handle part 14. The handle portion 14 is formed in the shape of a wing on both sides of the body 12 is easy to grip and the coupling portion 13 is formed with a screw thread. Therefore, in the state where the user grasps both wings of the handle part 14 by hand, the fluid supply device (not shown) may be coupled to the coupling part 13 by screwing and detaching. When the balloon inflation fluid F contained in the fluid supply device is injected while the balloon inflation fluid injection hub 10 is coupled to a fluid supply device (not shown), the balloon inflation fluid injection hub 10 Balloon inflation fluid (F) through the inlet (15) and the inner passage (19) of the balloon inflation fluid connector (18) coupled to the balloon inflation fluid injection hub (10) as described above The same flows into the joint member 30.
이하에서는, 전술한 바와 같은 본 발명의 제1실시예의 필터장치(100a)의 변형예인 제2실시예의 필터장치(100b)에 대해 설명한다. 한편, 본 발명의 제2실시예에 대한 설명에 앞서, 전술한 제1실시예와 동일한 구성요소에 대해서는 동일한 도면부호를 부기하고, 그 상세한 설명을 일부 생략함을 밝힌다.The following describes the filter device 100b of the second embodiment which is a modification of the filter device 100a of the first embodiment of the present invention as described above. On the other hand, prior to the description of the second embodiment of the present invention, the same reference numerals are assigned to the same components as the above-described first embodiment, and the detailed description will be omitted.
도 9 내지 도 13에 도시된 바와 같이 본 발명의 제2실시예의 필터장치(100b)는 팽창성 풍선(82) 및 이 팽창성 풍선(82)과 연통되고 풍선 팽창용 유체(F)를 상기 팽창성 풍선(82)에 유입시키는 연결관(84)을 구비하는 도관(80)과, 필요한 약물(M)을 담지하고 지속적으로 방출할 수 있는 생체적합성 재료의 필름으로서, 상기 팽창성 풍선(82)을 둘러싸면서 제공되는 필름(20b)과, 상기 필름(20b)의 표면 상에 형성된 미세 니들(250)을 주요 구성요소로서 포함한다.9 to 13, the filter device 100b of the second embodiment of the present invention is in communication with the inflatable balloon 82 and the inflatable balloon 82, and the balloon for expanding the fluid (F) is the inflatable balloon ( A conduit 80 having a conduit 84 which enters 82 and a film of biocompatible material capable of supporting and continually releasing the necessary drug M, which is provided surrounding the inflatable balloon 82 And a fine needle 250 formed on the surface of the film 20b as a main component.
구체적으로, 도 9 및 도 17을 참조하면, 본 발명의 제2실시예의 약물 전달용 필름이 제공된 풍선 카테터(100b)는 팽창성 풍선(82) 및 이 팽창성 풍선(82)과 연통되고 풍선 팽창용 유체(F)를 상기 팽창성 풍선(82)에 유입시키는 연결관(84)을 구비하는 도관(80)과, 필요한 약물(M)을 담지하고 지속적으로 방출할 수 있고 상기 팽창성 풍선(82)을 둘러싸는 생체적합성 재료의 필름(20a)으로서, 상기 팽창성 풍선(82) 팽창 전에는 폴딩된 상태로 환자의 좁은 혈관 내로 도입되고 상기 팽창성 풍선(82)의 팽창시에는 좁은 혈관의 통로를 확보하면서 그 표면 상에 형성된 미세 니들(250)이 치료부위(T)의 혈관벽을 향해 세워짐으로써 혈관벽에 정확하고 안정적으로 고정되어 담지된 약물(M)을 치료부위(T)에 정확하게 그리고 지속적으로 전달하는 필름(20a)을 그 기본 구성으로 한다.Specifically, referring to FIG. 9 and FIG. 17, the balloon catheter 100b provided with the drug delivery film of the second embodiment of the present invention communicates with the inflatable balloon 82 and the inflatable balloon 82 and the fluid for inflating the balloon. A conduit 80 having a conduit 84 for introducing (F) into the inflatable balloon 82, and capable of carrying and releasing the necessary drug (M) and surrounding the inflatable balloon (82) A film 20a of biocompatible material, which is introduced into the patient's narrow blood vessels in a folded state prior to expansion of the inflatable balloon 82 and on its surface while securing a passage of narrow blood vessels upon expansion of the inflatable balloon 82. The formed fine needle 250 is erected toward the vessel wall of the treatment site (T), thereby accurately and stably fixed to the vessel wall to carry the film (20a) to accurately and continuously deliver the drug (M) to the treatment site (T). Let it be the basic structure.
한편, 도 9에 도시된 바와 같은 본 발명의 제2실시예의 약물 전달용 필름이 제공된 풍선 카테터(100b)를 구성하는 풍선 팽창용 유체 주입용 허브(10), 풍선 팽창용 유체 연결관(18), 조인트 부재(30), 외부 분리 도관(40), 내부 분리 도관(50), 가이드 와이어(60), 혈류 유동관(70), 도관(80), 팽창성 풍선(82), 연결관(84) 및 밀봉캡(90)의 구성 및 기능은 본 발명의 제1실시예의 약물 전달용 필름이 제공된 풍선 카테터(100a)의 경우와 실질적으로 동일하므로 그 상세한 설명을 생략한다. 따라서, 이하에서는 본 발명의 제2실시예의 약물 전달용 필름이 제공된 풍선 카테터(100b)의 핵심구성인 미세 니들(250)이 표면에 형성된 필름(20a)을 중심으로 본 발명의 제2실시예의 약물 전달용 필름이 제공된 풍선 카테터(100b)를 설명하고자 한다. Meanwhile, the balloon inflation fluid injecting hub 10 and the balloon inflation fluid connector 18 constituting the balloon catheter 100b provided with the drug delivery film of the second embodiment of the present invention as shown in FIG. 9. , Joint member 30, external separation conduit 40, internal separation conduit 50, guide wire 60, blood flow flow tube 70, conduit 80, inflatable balloon 82, connecting tube 84 and Since the configuration and function of the sealing cap 90 is substantially the same as the case of the balloon catheter 100a provided with the drug delivery film of the first embodiment of the present invention, a detailed description thereof will be omitted. Therefore, hereinafter, the drug of the second embodiment of the present invention centering on the film 20a on which the fine needle 250, which is a core component of the balloon catheter 100b provided with the film for drug delivery, of the second embodiment of the present invention is formed on the surface thereof. The balloon catheter 100b provided with the delivery film will be described.
우선, 도 10 및 도 11에는 각각 본 발명의 제2실시예의 약물 전달용 필름이 제공된 풍선 카테터(100b)에서 팽창성 풍선(82)을 둘러싸는 제1형태의 필름(20b)이 폴딩된 상태와, 제1형태의 필름(20b)이 폴딩된 상태에서 팽창성 풍선(82)에 결합된 상태가 도시되어 있다. First, FIG. 10 and FIG. 11 show a state in which the first type film 20b surrounding the inflatable balloon 82 is folded in the balloon catheter 100b provided with the drug delivery film of the second embodiment of the present invention. The state in which the first type of film 20b is coupled to the inflatable balloon 82 in the folded state is shown.
도 10 및 도 11에 도시된 바와 같이 폴딩된 상태의 제1형태의 필름(20b)은 그 단면이 바람개비 혹은 풍차 형태로서 팽창성 풍선(82)을 둘러싸도록 팽창성 풍선(82)의 길이에 대응되어 연장되어 있다. 상기 폴딩된 상태의 제1형태의 필름(20b)은 시계방향으로 제1날개부(210), 제2날개부(220), 제3날개부(230) 및 제4날개부(240)로 구성되며 가운데는 팽창성 풍선(82)의 삽입을 위해 비어 있다. 그리고 제1날개부(210), 제2날개부(220), 제3날개부(230) 및 제4날개부(240) 사이의 공간은 비교적 충분하며 이들은 그 기저부에서 서로 만나서 제1형태의 필름(20b)이 폴딩(folding)된 상태에서 생기는 필름의 폴링 라인(folding line)을 형성한다. As shown in FIGS. 10 and 11, the film 20b of the first form in the folded state extends corresponding to the length of the inflatable balloon 82 such that its cross section surrounds the inflatable balloon 82 in the form of a pinwheel or windmill. It is. The first type film 20b in the folded state includes a first wing part 210, a second wing part 220, a third wing part 230, and a fourth wing part 240 in a clockwise direction. The center is empty for insertion of the inflatable balloon 82. The space between the first wing 210, the second wing 220, the third wing 230, and the fourth wing 240 is relatively sufficient, and they meet each other at the base thereof to form a film of the first type. Form a folding line of the film resulting from the folded state (20b).
그리고, 제1형태의 필름(20b) 상에는 복수개의 미세 니들들(250)이 형성될 수 있는데, 복수개의 미세 니들들(250)이 제1형태의 필름(20b)의 표면 상에 카테터의 축 방향으로 일정 간격으로 형성되고, 팽창성 풍선(82)을 둘러싸는 제1형태의 필름(20b)의 원주방향으로도 일정 간격으로 형성될 수 있다. 예를 들어, 도 10 및 도 11에 도시된 바와 같이 제1형태의 필름(20b)이 폴딩(folding)된 상태에서 생기는 전술한 바와 같은 제1형태의 필름(20b)의 폴링 라인(folding line)을 따라 제1날개부(210), 제2날개부(220), 제3날개부(230) 및 제4날개부(240) 사이의 공간에서 복수개의 미세 니들들(250)이 제1형태의 필름(20b) 상에 형성된다.In addition, a plurality of fine needles 250 may be formed on the film 20b of the first shape, and the plurality of fine needles 250 may be formed on the surface of the film 20b of the first shape in the axial direction of the catheter. And formed at regular intervals, and may also be formed at regular intervals in the circumferential direction of the film 20b of the first form surrounding the inflatable balloon 82. For example, as shown in FIGS. 10 and 11, a folding line of the film 20b of the first form as described above, which occurs when the film 20b of the first form is folded. A plurality of fine needles 250 of the first shape in the space between the first wing 210, the second wing 220, the third wing 230 and the fourth wing 240 along the It is formed on the film 20b.
또한, 도 12 및 도 13에는 각각 본 발명의 제2실시예의 약물 전달용 필름이 제공된 풍선 카테터(100b)에서 팽창성 풍선(82)을 둘러싸는 제2형태의 필름(20b)이 폴딩된 상태와, 제2형태의 필름(20b)이 폴딩된 상태에서 팽창성 풍선(82)에 결합된 상태가 도시되어 있다. 제1형태의 필름(20b)에 대해 제2형태의 필름(20b)은 약간의 구조적 차이를 보이는데, 팽창성 풍선(82)의 삽입을 위한 가운데의 공간이 제1형태의 필름(20b)에 비해 큰 반면에 제1날개부(210), 제2날개부(220), 제3날개부(230) 및 제4날개부(240) 사이의 공간은 제1형태의 필름(20b)에 비해 좁게 형성되어 있다. In addition, Figure 12 and Figure 13, the second state of the film 20b surrounding the inflatable balloon 82 in the balloon catheter 100b provided with the drug delivery film of the second embodiment of the present invention is folded, The state in which the second type of film 20b is coupled to the inflatable balloon 82 in the folded state is shown. The film 20b of the second form has a slight structural difference with respect to the film 20b of the first form, with a larger space in the center for the insertion of the inflatable balloon 82 compared to the film 20b of the first form. On the other hand, the space between the first wing 210, the second wing 220, the third wing 230, and the fourth wing 240 is narrower than that of the film 20b of the first type. have.
도 12 및 도 13에 도시된 바와 같이 복수개의 미세 니들들(250)이 제2형태의 필름(20b)의 표면 상에 카테터의 축 방향으로 일정 간격으로 형성되고, 팽창성 풍선(82)을 둘러싸는 제2형태의 필름(20b)의 원주방향으로도 일정 간격으로 형성되어 있다. 예를 들어, 도 12 및 도 13에 도시된 바와 같이 제2형태의 필름(20b)이 폴딩(folding)된 상태에서 생기는 제2형태의 필름(20b)의 폴링 라인(folding line)을 따라 제1날개부(210), 제2날개부(220), 제3날개부(230) 및 제4날개부(240) 사이의 공간에서 복수개의 미세 니들들(250)이 제2형태의 필름(20b) 상에 형성되는데, 제1날개부(210), 제2날개부(220), 제3날개부(230) 및 제4날개부(240) 사이의 공간이 제1형태의 필름(20b)에 비해 좁기 때문에 복수개의 미세 니들들(250)은 인접하는 날개부의 아래면에 거의 접촉할 정도로 또는 접촉하면서 빽빽하게 날개부 사이의 공간에 배치되어 있다. 12 and 13, a plurality of fine needles 250 are formed on the surface of the film 20b of the second type at regular intervals in the axial direction of the catheter, and surround the inflatable balloon 82. It is formed also in the circumferential direction of the film 20b of a 2nd aspect at regular intervals. For example, as illustrated in FIGS. 12 and 13, a first line is formed along a folding line of the second type film 20b that is generated when the second type film 20b is folded. In the space between the wing portion 210, the second wing portion 220, the third wing portion 230, and the fourth wing portion 240, the plurality of fine needles 250 are formed of the second type film 20b. It is formed on the, the space between the first wing portion 210, the second wing portion 220, the third wing portion 230 and the fourth wing portion 240 compared to the film 20b of the first type Because of the narrowness, the plurality of fine needles 250 are disposed in the space between the wing portions in such a manner as to be in close contact with or in contact with the bottom surface of the adjacent wing portion.
제1형태의 필름(20b) 및 제2형태의 필름(20b) 모두 혈관 내로 도입될 때에는 혈관벽과 마찰이 일어나지 않도록 폴딩된 상태로 그 부피를 최소화하여야 하는데, 이때 제1형태의 필름(20b) 및 제2형태의 필름(20b) 상에 형성된 미세 니들(250) 역시 폴딩된 제1형태의 필름(20b) 및 제2형태의 필름(20b)의 외부로 노출되지 않아야 혈관벽에 손상을 주지 않게 된다. 따라서, 본 발명의 제2실시예의 약물 전달용 필름이 제공된 풍선 카테터(100b)에서는 미세 니들(250)이 필름(20b) 외부로 노출되지 않도록 폴딩된 필름(20b)을 제작하는 것이 중요하다. When both the first type film 20b and the second type film 20b are introduced into blood vessels, the volume of the first type film 20b and the second type film 20b must be minimized in a folded state to prevent friction with the blood vessel wall. The fine needle 250 formed on the second type film 20b also does not damage the blood vessel wall unless exposed to the outside of the folded first type film 20b and the second type film 20b. Therefore, in the balloon catheter 100b provided with the drug delivery film of the second embodiment of the present invention, it is important to manufacture the folded film 20b so that the fine needle 250 is not exposed to the outside of the film 20b.
한편, 제1형태의 필름(20b)은 제1날개부(210), 제2날개부(220), 제3날개부(230) 및 제4날개부(240) 사이의 공간이 충분하여 미세 니들(250)을 폴딩 라인을 따라 배치할 공간이 충분한 장점이 있는 반면에 날개부의 끝부분을 이은 가상의 원통의 직경이 크기 때문에 좁은 혈관에 도입하기에는 불리하다(도 11의 (b) 참조). 반면에, 제2형태의 필름(20b)은 제1날개부(210), 제2날개부(220), 제3날개부(230) 및 제4날개부(240) 사이의 공간이 협소하여 미세 니들(250)을 폴딩 라인을 따라 배치할 공간이 좁아 필름(20b) 상에 형성된 미세 니들(250)이 외부로 노출되지 않도록 필름(20b)을 폴딩하여 제작하는데 어려움이 있지만 날개부의 끝부분을 이은 가상의 원통의 직경이 팽창성 풍선(82)의 직경과 거의 동일하기 때문에 좁은 혈관에 도입하기에 유리하다(도 13의 (b) 참조).On the other hand, the film 20b of the first shape has a fine needle because there is enough space between the first wing portion 210, the second wing portion 220, the third wing portion 230, and the fourth wing portion 240. While there is an advantage of sufficient space for arranging 250 along the folding line, it is disadvantageous to introduce into narrow vessels due to the large diameter of the imaginary cylinder that connects the end of the wing (see FIG. 11 (b)). On the other hand, the film 20b of the second form has a narrow space between the first wing 210, the second wing 220, the third wing 230, and the fourth wing 240. Although the space for arranging the needle 250 along the folding line is narrow, it is difficult to manufacture the film 20b by folding the film 20b so that the fine needle 250 formed on the film 20b is not exposed to the outside. Since the diameter of the imaginary cylinder is almost the same as that of the inflatable balloon 82, it is advantageous to introduce into narrow vessels (see FIG. 13 (b)).
결국, 전술한 바와 같은 제1형태의 필름(20b) 및 제2형태의 필름(20b)의 구조와 미세 니들(250)의 배치에 의해 본 발명의 제2실시예의 약물 전달용 필름이 제공된 풍선 카테터(100b)는 풍선의 팽창 전에는 폴딩된 상태로 필름(20b)을 좁은 혈관으로 도입할 수 있고 폴딩 라인을 따라 형성된 미세 니들(250)은 혈관벽에 손상을 주지 않게 되는 것이다. As a result, the balloon catheter provided with the drug delivery film of the second embodiment of the present invention by the arrangement of the fine needle 250 and the structure of the film 20b of the first form and the film 20b of the second form as described above. 100b may introduce the film 20b into a narrow vessel in a folded state before the balloon is inflated, and the fine needle 250 formed along the folding line may not damage the vessel wall.
또한, 필름(20b)에 형성된 미세 니들(250)은 코로나 표면 처리, 고주파 표면 처리, 플라즈마 표면 처리 및 레이저 표면처리로 구성된 군으로부터 선택된 적어도 하나의 표면처리에 의해 필름 상에 형성될 수 있다. 그리고, 상기 표면 처리는 좁은 혈관으로 카테터(100b)가 도입되더라도 혈전이 생길 위험을 줄일 수 있는 친수성 표면 처리가 바람직하다. 그러나, 본 발명은 이에 제한되는 것이 아니며 다양한 필름 가공 및 성형방법이 사용될 수 있음은 물론이다.In addition, the fine needle 250 formed on the film 20b may be formed on the film by at least one surface treatment selected from the group consisting of corona surface treatment, high frequency surface treatment, plasma surface treatment, and laser surface treatment. The surface treatment is preferably a hydrophilic surface treatment that can reduce the risk of blood clots even if the catheter 100b is introduced into a narrow vessel. However, the present invention is not limited thereto, and various film processing and forming methods may be used.
그리고, 전술한 바와 같은 본 발명의 다양한 카테터에서 채택가능하고 상기 표면 처리 대상이 될 수 있는 필름의 재료로는 필요한 약물을 담지하고 지속적으로 방출할 수 있는 생체적합성 재료이면 어느 것이나 사용가능하나, 예를 들어 PEG(polyethyleneglycol)-PCLA(poly(epsilon-caprolactone-co-D,L-lactide))의 중합체를 사용할 수 있다. And, as the material of the film which can be adopted in the various catheter of the present invention as described above and can be the surface treatment object, any biocompatible material that can carry and release the necessary drug can be used. For example, a polymer of polyethyleneglycol (PEG) -PCLA (poly (epsilon-caprolactone-co-D, L-lactide)) may be used.
이외에도 생체적합성이며 친수성인 PEG(polyethyleneglycol)에 생분해성 PLGA(poly(lactic-co-glycolic acid))이 중합된 재료를 필름(20a, 20b)의 재료로서 사용할 수 있다.In addition, a material in which biodegradable PLGA (poly (lactic-co-glycolic acid)) is polymerized to a biocompatible and hydrophilic polyethyleneglycol (PEG) may be used as the material of the films 20a and 20b.
또한, 전술한 재료들에 장기간의 생분해성을 보이는 카프로락톤, 글리콜라이드, 락타이드, 파라다이옥사논 및 트리메틸렌카보네이트로 구성된 군으로부터 선택된 적어도 하나의 물질이 첨가된 중합체 물질을 필름(20a, 20b)의 재료로서 사용할 수 있다(대한민국 등록특허 제10-0668046호 및 제10-0832552호 참조).In addition, a polymer material to which the above-described materials are added, at least one material selected from the group consisting of caprolactone, glycolide, lactide, paradioxanone and trimethylene carbonate, which shows long-term biodegradability, may be used. It can be used as a material of (see Korean Patent Nos. 10-0668046 and 10-0832552).
이러한 재질의 필름을 사용할 경우, 약물(M)을 치료부위에 정확하게 지속적으로 방출하여 전달할 수 있을 뿐만 아니라 탄성력, 생체적합성 및 생분해성의 물성을 제공하게 되어 재상피화 및 염증반응 등의 2차적 질병을 유발하지 않는 장점도 제공한다. 예를 들어, 본 발명의 제1실시예에서 사용되는 필름(20a)은 신축성을 가진 생체적합성 재료를 사용하기 때문에 전술한 바와 같이 풍선(82) 팽창시 미세돌출부(88)에 의해 그 형상이 돌출형으로 변형되면서 치료부위(T)로 전진하여 고정되고 이로써 담지된 약물(M)을 치료 부위(T)에 서서히 지속적으로 방출 전달할 수 있게 된다. In case of using the film of this material, the drug (M) can be continuously and accurately released and delivered to the treatment area, as well as providing elasticity, biocompatibility, and biodegradability, causing secondary diseases such as re-epithelialization and inflammatory reaction. It also offers the advantages of For example, since the film 20a used in the first embodiment of the present invention uses a stretchable biocompatible material, the shape of the film 20a protrudes by the microprojection 88 when the balloon 82 is inflated as described above. As it is transformed into a treatment site (T) to move forward and fixed, thereby supporting the drug (M) is slowly and continuously released to the treatment site (T) can be delivered.
그러나, 본 발명의 필름은 전술한 바와 같은 재료의 필름에 제한되는 것이 아니며, 다양한 약물이 필름에 담지되어 사용될 수 있음을 본 발명이 속하는 기술분야의 당업자라면 용이하게 이해할 것이다.However, the film of the present invention is not limited to the film of the material as described above, it will be readily understood by those skilled in the art that various drugs may be supported on the film and used.
도 10, 도 12, 도 14 내지 도 17에 도시된 바와 같이, 필름(20b)의 표면 상에 형성된 미세 니들(250)은 상기 필름(20b) 상에 위치한 기단부(252)의 직경이 크고 기단부(252)로부터 멀어질 수록 직경이 작아지되 미세 니들(250)의 가장 끝부분인 첨단부(254)는 뽀족하게 형성되어 혈관벽과 같은 조직에 정확하면서 안정적으로 고정될 수 있다. 또한, 미세 니들(250)은 기단부(252)로부터 첨단부(254)에 이르기까지 일정한 각도를 가지면서 유선형으로 형성될 수 있다. 이와 같이 미세 니들(250)이 방향성을 가지도록 형성되면 혈류에 의해 미세 니들(250)이 상기 필름(20b)을 혈관벽에 단단히 고정시키도록 하여 상기 필름(20b)이 떨어져서 발생하는 위험을 감소시키고 혈관벽에 밀착되도록 함으로써 약물전달을 용이하게 할 수 있다. 뿐만아니라 미세 니들(250)은 첨단부(254)로부터 하방으로 낚시 바늘 구조(256)가 연장되어 형성될 수 있다(도 10, 도 12 및 도 15 참조). 이 경우 일단 미세 니들(250)이 치료 부위(T)에 고정되면 낚시 바늘 구조(256)에 의해 미세 니들(250)이 치료 부위(T)로부터 쉽게 이탈되지 않게 된다.As shown in FIGS. 10, 12, 14, and 17, the fine needle 250 formed on the surface of the film 20b has a large diameter of the proximal end 252 located on the film 20b and the proximal end ( The farther away from the 252, the smaller the diameter, the tip 254, which is the end of the fine needle 250, is sharply formed and can be accurately and stably fixed to a tissue such as a blood vessel wall. In addition, the fine needle 250 may be formed in a streamlined shape having a constant angle from the proximal end 252 to the tip 254. As such, when the fine needle 250 is formed to have a directionality, the fine needle 250 firmly fixes the film 20b to the blood vessel wall by blood flow, thereby reducing the risk of the film 20b falling off and the blood vessel wall. The drug delivery can be facilitated by being in close contact with. In addition, the fine needle 250 may be formed by extending the fish hook structure 256 downward from the tip 254 (see FIGS. 10, 12 and 15). In this case, once the fine needle 250 is fixed to the treatment site T, the fine needle 250 is not easily separated from the treatment site T by the fish hook structure 256.
또한, 도시하지는 않았으나 필름(20b)의 표면 표면에는 생체 접착제를 적용하여 미세 니들(250)이 혈관벽에 보다 효과적이고 안정적으로 고정되도록 할 수 있다. 생체 적찹제의 예로는 피브리노겐, 피브리노겐을 첨가한 혈액응고제 XIII인자, 시아노아크릴레이트, 피부린 글루, 해양 생체접착제를 들 수 있으며, 본 발명의 기술분야에 알려진 다양한 생체적합제가 사용될 수 있음을 물론이다. In addition, although not shown, by applying a bioadhesive to the surface of the film 20b, the fine needle 250 may be more effectively and stably fixed to the blood vessel wall. Examples of biored glutamate include fibrinogen, blood coagulant XIII factor with fibrinogen, cyanoacrylate, dermalin glue, marine bioadhesive, and various biocompatible agents known in the art may be used. to be.
도 14 내지 도 16에 도시된 바와 같이, 팽창성 풍선(설명의 편의상 미도시)이 팽창하면 팽창성 풍선을 둘러싸는 필름(20b)은 펼쳐지면서 대략 원통형의 형상을 취하게 된다. 도 14 내지 도 16에는 팽창성 풍선을 둘러싸는 다양한 형태의 필름(20b)이 풍선의 팽창에 의해 펼쳐진 상태와 미세 니들(250)이 도시되어 있다.As shown in FIGS. 14 to 16, when the inflatable balloon (not shown for convenience of description) is inflated, the film 20b surrounding the inflatable balloon is expanded to take a substantially cylindrical shape. 14 to 16 illustrate the microneedle 250 and the state in which the various shapes of the film 20b surrounding the inflatable balloon are unfolded by the expansion of the balloon.
도 14 및 도 15에는 펼쳐진 원통형의 필름(20b)이 원주방향을 따라 단차진 것이 도시되어 있다. 즉, 펼쳐진 원통형의 필름(20b)은 평편한 부분(260)과 두께가 두꺼운 돌출 부분(270)으로 구성될 수 있다. 이때 미세 니들(250)은 두께가 두꺼운 돌출 부분(270) 상에 형성될 수 있다. 이와 같이 필름(20b)과 미세 니들(250)을 구성하면, 약물 방출 과정에서 미세 니들(250)이 형성되지 않은 얇은 평편한 부분(260)이 먼저 생분해된 후 혈관벽에 고정된 미세 니들(250)이 순차적으로 생분해되도록 하여 혈전 생성 등의 부작용없이 안전하게 약물(M)을 치료부위(T)에 전달할 수 있게 된다. 14 and 15 show the unfolded cylindrical film 20b stepped along the circumferential direction. That is, the unfolded cylindrical film 20b may be composed of a flat portion 260 and a thick projecting portion 270. In this case, the fine needle 250 may be formed on the protruding portion 270 having a thick thickness. When the film 20b and the fine needle 250 are configured as described above, the thin flat portion 260 in which the fine needle 250 is not formed in the drug release process is first biodegraded and then the fine needle 250 fixed to the blood vessel wall. The sequential biodegradation can safely deliver the drug (M) to the treatment site (T) without side effects such as blood clot production.
또한, 미세 니들(250)의 길이 조정이나 풍선 팽창용 유체(F)의 유입량 조정에 의한 팽창성 풍선(82)의 팽창 정도의 조정으로 미세 니들(250)이 혈관 내벽 안쪽의 조직으로 삽입되는 깊이를 조절할 수 있고 이에 따라 약물의 전달 깊이를 조절할 수 있다. 한편, 본 발명의 필름(20a, 20b)에 담지되어 치료부위에 전달되는 약물로는 혈전용해제, 항증식제, 면역억제제, 항염증제, 백신, 호르몬, 인슐린, 유전자 치료제, 단백질 치료제 주사, 또는 내피세포촉진제일 수 있다.In addition, by adjusting the length of the fine needle 250 or the degree of expansion of the inflatable balloon 82 by adjusting the inflow amount of the balloon-inflating fluid F, the depth at which the fine needle 250 is inserted into the tissue inside the blood vessel wall is adjusted. It can be controlled and thus the delivery depth of the drug. Meanwhile, drugs supported on the films 20a and 20b of the present invention and delivered to the treatment site include thrombolytic agents, antiproliferative agents, immunosuppressants, anti-inflammatory agents, vaccines, hormones, insulin, gene therapy, protein therapeutic injections, or endothelial cells. It may be a promoter.
추가로, 도시하지는 않았으나 전술한 바와 같은 다양한 약물(M)을 담지하고 지속적으로 방출할 수 있는 생체적합성 재료의 다수개의 필름들을 팽창성 풍선(82) 표면 상에 다중 층(multi-layer)으로 제공하면 다양한 약물(M)을 순차적이면서 지속적으로 전달할 수 있게 된다.In addition, providing a plurality of films of biocompatible materials capable of supporting and sustaining release of various drugs (M) as described above, in a multi-layer on the surface of the inflatable balloon 82 Various drugs (M) can be delivered sequentially and continuously.
또한, 도 16에 도시된 바와 같이 필름(20b)에 미세한 홀(262)들을 형성할 수 있는데, 이 경우 약물 전달 과정 중 필름(20b)이 미세한 조각으로 분해되어 혈전 생성을 방지할 수 있다. In addition, as shown in FIG. 16, minute holes 262 may be formed in the film 20b. In this case, the film 20b may be decomposed into fine pieces during drug delivery to prevent the formation of blood clots.
상기한 바와 같이 구성된 본 발명의 제1실시예 및 제2실시예의 약물 전달용 필름이 제공된 풍선 카테터(100a, 100b)의 작동을 도 1 내지 도 17을 참조하여 예시로서 설명하면 다음과 같다.The operation of the balloon catheter 100a, 100b provided with the drug delivery films of the first and second embodiments of the present invention configured as described above will be described with reference to FIGS. 1 to 17 as follows.
우선, 본 발명의 제1실시예 및 제2실시예의 약물 전달용 필름이 제공된 풍선 카테터(100a, 100b)의 풍선 팽창용 유체 주입용 허브(10)를 유체 공급장치(미도시)에 결합시킨다. 약물 전달용 필름이 제공된 풍선 카테터(100a)의 사용을 위한 준비상태가 완료되면, 시술의는 밀봉 캡(90)을 선단(先端)으로 하여 약물 전달용 필름이 제공된 풍선 카테터(100a, 100b)를 예를 들어 혈관을 통해 신체 내에 삽입한다. 이때, 카테터(100a, 100b) 내부에 삽입되어 설치된 가이드 와이어(60) 및 혈류 유동관(70)이 카테터(100a, 100b)에 강직성을 부여하여 카테터(100a, 100b)의 혈관 내 삽입과 전진을 용이하게 한다. First, the balloon inflation fluid injection hub 10 of the balloon catheter 100a, 100b provided with the drug delivery films of the first and second embodiments of the present invention is coupled to a fluid supply device (not shown). When the preparation for use of the balloon catheter 100a provided with the drug delivery film is completed, the surgeon uses the sealing cap 90 as a tip to make the balloon catheter 100a, 100b provided with the drug delivery film. For example, it is inserted into the body through blood vessels. At this time, the guide wire 60 and the blood flow tube 70 inserted and installed inside the catheter 100a and 100b give rigidity to the catheter 100a and 100b to facilitate the insertion and advancement of the catheter 100a and 100b in the blood vessel. Let's do it.
이때, 본 발명의 제2실시예의 약물 전달용 필름이 제공된 풍선 카테터(100b)의 팽창성 풍선(82)을 둘러싸는 필름(20b)은 폴딩된 상태로 좁은 혈관으로 도입되는데, 필름(20b)에 형성된 미세 니들(250)은 팽창성 풍선(82)이 팽창하기 전 필름(20b)이 폴딩(folding)된 상태에서는 카테터(100b)의 축 방향으로 누워 있는 상태로 위치하여 폴딩 라인을 따라 형성된 미세 니들(250)이 혈관벽에 손상을 주지 않게 한다.At this time, the film 20b surrounding the inflatable balloon 82 of the balloon catheter 100b provided with the drug delivery film of the second embodiment of the present invention is introduced into a narrow vessel in a folded state, which is formed in the film 20b. The fine needle 250 is positioned in the axial direction of the catheter 100b in a state in which the film 20b is folded before the expandable balloon 82 is inflated so that the fine needle 250 is formed along the folding line. ) Does not damage the vessel wall.
그리고, 카테터(100a, 100b)의 선단이 치료부위(T)까지 진입하는 것을 영상장치(미도시)를 통해 시술의가 확인하고, 유체 공급장치(미도시)에 수용된 풍선 팽창용 유체(F)를 카테터(100a, 100b)의 풍선 팽창용 유체 주입용 허브(10)로부터 팽창성 풍선(82)까지 충분히 유입시키면 팽창성 풍선(82)이 팽창하면서 팽창성 풍선(82)과 혈류 유동관(70) 사이의 공간이 확장되고, 이에 따라 팽창성 풍선(82)도 확장된다. 이 경우 시술의가 카테터(100a, 100b)의 혈관 내 삽입 전에 조영제인 풍선 팽창용 유체(F)를 카테터(100a, 100b)의 풍선 팽창용 유체 주입용 허브(10)로부터 밀봉 캡(90)까지의 팽창유체통로(P)를 채울 정도만 주입한 후, 카테터(100a, 100b)를 혈관을 통해 신체 내에 삽입하면 카테터(100a, 100b)의 삽입, 전진 및 치료부위(T)까지의 도달을 영상장치(미도시)를 통해 보다 용이하게 확인할 수 있다.Then, the surgeon confirms that the front ends of the catheters 100a and 100b enter the treatment site T through an imaging device (not shown), and the balloon-inflating fluid F accommodated in the fluid supply device (not shown). When the inflow of the balloon-inflating fluid injection hub 10 of the catheter 100a, 100b to the inflatable balloon 82 is enough, the inflatable balloon 82 expands and the space between the inflatable balloon 82 and the blood flow tube 70 Expands and thus expands inflatable balloon 82. In this case, the surgeon passes the balloon-inflating fluid F, which is a contrast medium, to the sealing cap 90 from the balloon-inflating fluid injection hub 10 of the catheter 100a, 100b before the catheter 100a, 100b is inserted into the blood vessel. After only injecting enough to expand the expansion fluid (P) of the catheter (100a, 100b) is inserted into the body through the blood vessels, the catheter (100a, 100b) of the insertion, advancing and reaching the treatment site (T) imaging device (Not shown) can be more easily confirmed.
시술의가 영상장치(미도시)를 통해 카테터(100a, 100b)의 팽창성 풍선(82)을 둘러싸는 필름(20a, 20b)이 치료부위(T)의 혈관 내벽에 정확하게 위치한 것을 확인하면, 약물 전달용 필름이 제공된 풍선 카테터(100a, 100b)의 풍선 팽창용 유체 주입용 허브(10)로부터 밀봉 캡(90)까지의 팽창유체통로(P) 및 팽창유체유동공간(fS)을 통해 풍선 팽창용 유체(F)의 유입량을 증가시켜 팽창성 풍선(82)을 팽창시킨다.When the practitioner confirms that the films 20a and 20b surrounding the inflatable balloon 82 of the catheter 100a and 100b are accurately positioned on the inner wall of the treatment site T through the imaging device (not shown), the drug is delivered. Balloon inflation fluid through inflatable fluid path (P) and expansion fluid flow space (fS) from the balloon inflation fluid injection hub (10) of the balloon catheter (100a, 100b) provided with the film to the sealing cap (90) The inflow of (F) is increased to inflate the inflatable balloon 82.
이때, 본 발명의 제1실시예의 약물 전달용 필름이 제공된 풍선 카테터(100a)에서는 도 7 및 도 8에 도시된 바와 같이 팽창성 풍선(82)과 혈류 유동관(70) 사이의 공간이 확장되고 이에 따라 팽창성 풍선(82)도 확장되어 팽창성 풍선(82)과 필름(20a) 사이의 공간(d)이 좁아지면서(d→d') 필름(20a)의 형상이 미세 돌출부(88)처럼 변형되고(before→after), 미세 돌출부 형상으로 변형된 필름 부분(20a)과 미세 돌출부(88)가 신체 내의 치료부위(T)에 고정됨으로써, 종국에는 필름(20a)에 담지된 약물(M)이 치료부위(T)에 정확하면서도 서서히 지속적으로 방출되면서 전달된다.At this time, in the balloon catheter 100a provided with the drug delivery film of the first embodiment of the present invention, as shown in FIGS. 7 and 8, the space between the inflatable balloon 82 and the blood flow tube 70 is expanded and accordingly. The inflatable balloon 82 is also expanded so that the space d between the inflatable balloon 82 and the film 20a is narrowed (d → d ') and the shape of the film 20a is deformed like the fine protrusions 88. → After), the film portion 20a and the microprojection 88 deformed into the shape of the microprojection are fixed to the treatment site T in the body, so that the drug M supported on the film 20a is eventually treated at the treatment site ( It is precisely and slowly and continuously released in T).
따라서, 본 발명의 제1실시예의 약물 전달용 필름이 제공된 풍선 카테터(100a)는 미세 돌출부(88)를 통해 신체 내의 원하는 치료 부위(T)에 정확하게 팽창성 풍선(82)을 고정시키면서 팽창성 풍선(82)의 팽창에 의해 팽창성 풍선(82)을 둘러싸는 필름(20a)이 미세 돌출부(88)의 형상 처럼 변형되면서 치료 부위(T)에 고정되어 필름(20a)에 담지된 약물(M)을 서서히 지속적으로 전달할 수 있다. 특히, 미세 돌출부(88)의 길이 조정이나 풍선 팽창용 유체(F)의 유입량 조정에 의한 팽창성 풍선(82)의 팽창 정도의 조정으로 팽창성 풍선(82)과 필름(20a) 사이의 공간(d)이 좁아지는 정도(d→d')를 조정할 수 있고, 이에 따라 필름(20a)의 형상이 미세 돌출부(88)처럼 변형되는 정도(before→after) 역시 조정되어 필름(20a)과 미세돌출부(88)가 치료 부위(T)로 삽입되는 깊이를 조절할 수 있고 이에 따라 약물의 전달 깊이를 조절할 수 있다. Therefore, the balloon catheter 100a provided with the drug delivery film of the first embodiment of the present invention is the inflatable balloon 82 while fixing the inflatable balloon 82 accurately to the desired treatment site T in the body through the micro-projection 88. ), The film 20a surrounding the inflatable balloon 82 is deformed like the shape of the micro-projection 88 by the expansion of) and is fixed to the treatment site T to gradually sustain the drug M supported on the film 20a. Can be delivered as In particular, the space d between the inflatable balloon 82 and the film 20a by adjusting the length of the fine protrusion 88 or the degree of expansion of the inflatable balloon 82 by adjusting the flow rate of the balloon-inflating fluid F. This narrowing degree (d → d ') can be adjusted. Accordingly, the degree of deformation (before → after) of the shape of the film 20a like the fine protrusions 88 is also adjusted, so that the film 20a and the fine protrusions 88 are adjusted. ) Can be adjusted to the depth to be inserted into the treatment site (T) and thus the delivery depth of the drug.
반면에, 본 발명의 제2실시예의 약물 전달용 필름이 제공된 풍선 카테터(100b)에서는 도 17에 도시된 바와 같이, 팽창성 풍선(82)과 혈류 유동관(70) 사이의 공간이 확장되고 이에 따라 팽창성 풍선(82)도 확장되어 팽창성 풍선(82)이 좁은 혈관의 통로를 확보하게 된다. 그리고, 팽창성 풍선(82)이 팽창하면 팽창성 풍선(82)을 둘러싸는 필름(20b)이 펴지게 되면서 미세 니들(250)이 카테터의 축 방향에 대해 일정한 각도를 가지면서 치료부위(T)의 혈관벽을 향해 세워지게 된다. 미세 니들(250)의 첨단부(254)는 혈관벽을 찌르면서 삽입되어 정확하고 안정적으로 치료부위(T)에 필름(20b)이 고정되고, 필름(20b)에 담지된 약물(M)이 치료부위(T), 예를 들면 혈관 내벽 안쪽의 조직에 정확하게 그리고 지속적으로 전달된다. On the other hand, in the balloon catheter 100b provided with the drug delivery film of the second embodiment of the present invention, as shown in FIG. 17, the space between the inflatable balloon 82 and the blood flow tube 70 is expanded and thus expandable. The balloon 82 is also expanded so that the inflatable balloon 82 secures a narrow passage of blood vessels. Then, when the inflatable balloon 82 expands, the film 20b surrounding the inflatable balloon 82 is unfolded and the fine needle 250 has a constant angle with respect to the axial direction of the catheter, and the blood vessel wall of the treatment site T is expanded. Will be erected toward The tip 254 of the fine needle 250 is inserted into the blood vessel wall while being accurately and stably fixed to the film 20b on the treatment site T, and the drug M supported on the film 20b is the treatment site. (T), for example, correctly and continuously delivered to tissues inside the vascular lining.
특히, 본 발명의 제2실시예의 약물 전달용 필름이 제공된 풍선 카테터(100b)에서는 미세 니들(250)의 첨단부(254)로부터 하방으로 낚시 바늘 구조(256)가 연장되어 형성된 경우 미세 니들(250)이 치료 부위(T)에 고정되면 낚시 바늘 구조(256)에 의해 미세 니들(250)이 치료 부위(T)로부터 쉽게 빠지지 않게 되고, 미세 니들(252)이 기단부(252)로부터 첨단부(254)에 이르기까지 일정한 각도를 가지면서 유선형으로 형성됨으로써 혈류에 의해 미세 니들(250)이 필름(20b)을 혈관벽에 단단히 고정시키도록 하여 필름(20b)의 이탈을 미연에 방지하면서도 혈관벽에 밀착되도록 함으로써 약물전달을 용이하게 할 수 있다.In particular, in the balloon catheter 100b provided with the drug delivery film of the second embodiment of the present invention, when the fish needle structure 256 is extended downward from the tip portion 254 of the fine needle 250, the fine needle 250 is formed. ) Is fixed to the treatment site T, the fine needle 250 is not easily pulled out of the treatment site T by the fish hook structure 256, the fine needle 252 is the tip 254 from the proximal end 252 By forming a streamlined shape with a constant angle up to) by the blood flow to ensure that the fine needle 250 firmly fixed the film (20b) to the blood vessel wall to prevent close detachment of the film (20b) in close contact with the blood vessel wall Drug delivery can be facilitated.
뿐만 아니라 본 발명의 제2실시예의 약물 전달용 필름이 제공된 풍선 카테터(100b)에서 원통형의 필름(20b)을 평편한 부분(260)과 두께가 두꺼운 돌출 부분(270)으로 구성하고 미세 니들(250)을 두께가 두꺼운 돌출 부분(270) 상에 형성하면, 약물 방출 과정에서 미세 니들(250)이 형성되지 않은 얇은 평편한 부분(260)이 먼저 생분해된 후 혈관벽에 고정된 미세 니들(250)이 순차적으로 생분해되도록 하여 혈전 생성 등의 부작용없이 안전하게 약물(M)을 치료부위(T)에 전달할 수 있다.In addition, in the balloon catheter 100b provided with the drug delivery film of the second embodiment of the present invention, the cylindrical film 20b is composed of a flat portion 260 and a thick protruding portion 270 and a fine needle 250. ) Is formed on the protruding portion 270 having a thick thickness, the thin flat portion 260 in which the fine needle 250 is not formed in the drug release process is first biodegraded, and then the fine needle 250 fixed to the blood vessel wall is formed. By sequentially biodegrading it is possible to safely deliver the drug (M) to the treatment site (T) without side effects such as blood clot production.
이상, 본 발명을 상기 실시예를 들어 설명하였으나, 본 발명은 이에 제한되는 것이 아니다. 당업자라면 본 발명의 취지 및 범위를 벗어나지 않고 수정, 변경을 할 수 있으며 이러한 수정과 변경 또한 본 발명에 속하는 것임을 알 수 있을 것이다.As mentioned above, although this invention was demonstrated to the said Example, this invention is not limited to this. Those skilled in the art can make modifications and changes without departing from the spirit and scope of the present invention, and it will be appreciated that such modifications and changes also belong to the present invention.

Claims (26)

  1. 팽창성 풍선과, 이 팽창성 풍선과 연통되고 풍선 팽창용 유체를 상기 팽창성 풍선에 유입시키는 연결관을 구비하는 도관과,A conduit having an inflatable balloon, a conduit in communication with the inflatable balloon and having a connector for introducing a balloon inflation fluid into the inflatable balloon;
    필요한 약물을 담지하고 지속적으로 방출할 수 있는 생체적합성 재료의 필름으로서, 상기 팽창성 풍선을 둘러싸면서 제공되는 필름과,A film of biocompatible material capable of supporting and continually releasing a desired drug, comprising: a film provided surrounding the inflatable balloon,
    상기 팽창성 풍선 외부 표면 상에 형성되고 상기 팽창성 풍선과 상기 필름 사이의 공간 내에 위치하는 미세 돌출부를 포함하고, A micro-projection formed on the inflatable balloon outer surface and located in a space between the inflatable balloon and the film,
    상기 팽창성 풍선으로 풍선 팽창용 유체가 유입되어 상기 팽창성 풍선이 팽창되면 상기 팽창성 풍선과 상기 필름 사이의 공간이 좁아지면서 상기 필름의 형상이 상기 미세 돌출부 처럼 변형되고 상기 미세 돌출부 형상으로 변형된 필름 부분과 상기 미세 돌출부가 신체 내의 치료부위에 고정되어 상기 필름에 담지된 약물이 상기 치료부위에 방출되면서 전달되는 것을 특징으로 하는 약물 전달용 필름이 제공된 풍선 카테터.When the inflatable balloon is introduced into the inflatable balloon and the inflatable balloon is inflated, the space between the inflatable balloon and the film is narrowed, and the film portion is deformed like the microprojection, and the film portion is deformed into the microprojection shape. The balloon catheter is provided with a film for drug delivery, characterized in that the micro-projection is fixed to the treatment site in the body is delivered while the drug carried on the film is released to the treatment site.
  2. 팽창성 풍선과, 이 팽창성 풍선과 연통되고 풍선 팽창용 유체를 상기 팽창성 풍선에 유입시키는 연결관을 구비하는 도관과,A conduit having an inflatable balloon, a conduit in communication with the inflatable balloon and having a connector for introducing a balloon inflation fluid into the inflatable balloon;
    필요한 약물을 담지하고 지속적으로 방출할 수 있는 생체적합성 재료의 필름으로서, 상기 팽창성 풍선을 둘러싸면서 제공되는 필름과,A film of biocompatible material capable of supporting and continually releasing a desired drug, comprising: a film provided surrounding the inflatable balloon,
    상기 필름의 표면 상에 형성된 미세 니들을 포함하고, A fine needle formed on the surface of the film,
    상기 팽창성 풍선으로 풍선 팽창용 유체가 유입되어 상기 팽창성 풍선이 팽창되면, 상기 팽창성 풍선을 둘러싸는 필름의 표면 상에 형성된 미세 니들이 신체 내의 치료부위에 고정되고 상기 필름에 담지된 약물이 상기 치료부위에 방출되면서 전달되는 것을 특징으로 하는 약물 전달용 필름이 제공된 풍선 카테터.When the inflatable balloon is introduced into the inflatable balloon and the inflatable balloon is inflated, fine needles formed on the surface of the film surrounding the inflatable balloon are fixed to the treatment site in the body and the drug loaded on the film is applied to the treatment site. Balloon catheter provided with a film for drug delivery, characterized in that is delivered while being released.
  3. 제2항에 있어서,The method of claim 2,
    상기 미세 니들은 복수개가 제공되고, 복수개의 미세 니들들이 상기 필름의 표면 상에 카테터의 축 방향으로 일정 간격으로 형성되고, 상기 팽창성 풍선을 둘러싸는 필름의 원주방향으로도 일정 간격으로 형성되는 것을 특징으로 하는 약물 전달용 필름이 제공된 풍선 카테터.A plurality of fine needles are provided, and the plurality of fine needles are formed at regular intervals in the axial direction of the catheter on the surface of the film, and are formed at regular intervals in the circumferential direction of the film surrounding the inflatable balloon. Balloon catheter provided with a film for drug delivery.
  4. 제3항에 있어서,The method of claim 3,
    상기 팽창성 풍선이 팽창하기 전에 상기 팽창성 풍선을 둘러싸는 필름이 폴딩(folding)된 상태에서 생기는 필름의 폴링 라인(folding line)을 따라 상기 복수개의 미세 니들들이 형성되는 것을 특징으로 하는 약물 전달용 필름이 제공된 풍선 카테터.The drug delivery film, characterized in that the plurality of fine needles are formed along the folding line (folding line) of the film that occurs when the film surrounding the inflatable balloon is folded (folding) before the inflatable balloon is inflated Provided balloon catheter.
  5. 제3항 또는 제4항에 있어서,The method according to claim 3 or 4,
    상기 복수개의 미세 니들들은 상기 팽창성 풍선이 팽창하기 전에 상기 팽창성 풍선을 둘러싸는 필름이 폴딩(folding)된 상태에서는 카테터의 축 방향으로 누워 있는 상태로 위치하고, 상기 팽창성 풍선이 팽창하면 상기 팽창성 풍선을 둘러싸는 필름이 펴지게 되면서 이에 따라 카테터의 축 방향에 대해 일정한 각도를 가지면서 세워지는 것을 특징으로 하는 약물 전달용 필름이 제공된 풍선 카테터.The plurality of fine needles are positioned in the axial direction of the catheter when the film surrounding the inflatable balloon is folded before the inflatable balloon is inflated, and when the inflatable balloon expands, the fine needle surrounds the inflatable balloon. The balloon catheter provided with a film for drug delivery, characterized in that the film is erected and thus standing at an angle with respect to the axial direction of the catheter.
  6. 제2항에 있어서,The method of claim 2,
    상기 미세 니들은 상기 필름 상에 위치한 기단부의 직경이 크고 기단부로부터 멀어질 수록 직경이 작아지되 상기 미세 니들의 가장 끝부분인 첨단부는 뽀족하게 형성된 것을 특징으로 하는 약물 전달용 필름이 제공된 풍선 카테터.The microneedle is a balloon catheter provided with a film for drug delivery, characterized in that the diameter of the proximal end located on the film and the smaller the farther away from the proximal end, the tip of the fine needle is sharply formed.
  7. 제6항에 있어서,The method of claim 6,
    상기 미세 니들은 상기 기단부로부터 상기 첨단부에 이르기까지 일정한 각도를 가지면서 유선형으로 형성된 것을 특징으로 하는 약물 전달용 필름이 제공된 풍선 카테터.The fine needle is a balloon catheter provided with a film for drug delivery, characterized in that formed in a streamlined at a constant angle from the proximal end to the tip.
  8. 제6항 또는 제7항에 있어서,The method according to claim 6 or 7,
    상기 미세 니들은 상기 첨단부로부터 하방으로 낚시 바늘 구조가 연장되어 형성되어 있는 것을 특징으로 하는 약물 전달용 필름이 제공된 풍선 카테터.The fine needle is a balloon catheter provided with a film for drug delivery, characterized in that the fish hook structure extends downward from the tip.
  9. 제2항에 있어서,The method of claim 2,
    상기 필름 표면에는 피브리노겐, 피브리노겐을 첨가한 혈액응고제 XIII인자, 시아노아크릴레이트, 피부린 글루 및 해양 생체접착제로 구성된 군으로부터 선택된 적어도 하나의 생체 접착제를 적용한 것을 특징으로 하는 약물 전달용 필름이 제공된 풍선 카테터.Balloon provided with a film for drug delivery, characterized in that the film surface is applied with at least one bioadhesive selected from the group consisting of fibrinogen, blood coagulant XIII factor added with fibrinogen, cyanoacrylate, dermatin glue and marine bioadhesive agent. Catheter.
  10. 제2항에 있어서,The method of claim 2,
    상기 팽창성 풍선이 팽창하면 상기 팽창성 풍선을 둘러싸는 상기 필름은 펼쳐지면서 원통형의 형상을 취하고, 상기 펼쳐진 원통형의 필름의 원주방향을 따라 상기 필름은 단차진 형상을 갖는 것을 특징으로 하는 약물 전달용 필름이 제공된 풍선 카테터.When the inflatable balloon is expanded, the film surrounding the inflatable balloon is unfolded and takes a cylindrical shape, and the film for drug delivery is characterized in that the film has a stepped shape along the circumferential direction of the unfolded cylindrical film. Provided balloon catheter.
  11. 제10항에 있어서,The method of claim 10,
    상기 미세 니들은 상기 단차진 형상 중 돌출 부분 상에 형성되는 것을 특징으로 하는 약물 전달용 필름이 제공된 풍선 카테터.The balloon catheter provided with the drug delivery film, characterized in that the fine needle is formed on the protruding portion of the stepped shape.
  12. 제2항에 있어서,The method of claim 2,
    다양한 약물을 담지하고 지속적으로 방출할 수 있는 다수개의 필름들을 상기 팽창성 풍선 표면 상에 다중 층(multi-layer)으로 제공한 것을 특징으로 하는 약물 전달용 필름이 제공된 풍선 카테터.Balloon catheter provided with a film for drug delivery, characterized in that it provides a multi-layer on the inflatable balloon surface a plurality of films that can carry and continuously release a variety of drugs.
  13. 제2항에 있어서,The method of claim 2,
    상기 필름에는 미세한 홀이 형성된 것을 특징으로 하는 약물 전달용 필름이 제공된 풍선 카테터.Balloon catheter provided with a film for drug delivery, characterized in that the fine hole is formed in the film.
  14. 제1항 또는 제2항에 있어서,The method according to claim 1 or 2,
    상기 연결관에 직접 접합되어 결합되는 외부 분리 도관과, 상기 외부 분리 도관 내벽에 밀착되면서 위치하고 상기 연결관과 연통되어 상기 연결관에 풍선 팽창용 유체를 유입시키는 내부 분리 도관을 더 포함하는 약물 전달용 필름이 제공된 풍선 카테터.Drug delivery further comprises an external separation conduit that is directly bonded to and coupled to the connecting tube, and an internal separation conduit positioned in close contact with the inner wall of the external separating conduit and in communication with the connecting tube to introduce a balloon-expanding fluid into the connecting tube. Balloon catheter provided with film.
  15. 제14항에 있어서,The method of claim 14,
    상기 내부 분리 도관의 일단(一端)은 상기 외부 분리 도관의 일단(一端)을 지나 상기 연결관 내부까지 연장되어 있는 것을 특징으로 하는 약물 전달용 필름이 제공된 풍선 카테터.A balloon catheter provided with a film for drug delivery, wherein one end of the inner separation conduit extends through one end of the outer separation conduit to the inside of the connecting conduit.
  16. 제14항에 있어서,The method of claim 14,
    상기 내부 분리 도관 내부에는 가이드 와이어가 상기 내부 분리 도관의 내벽과 간격을 두고 위치하는 것을 특징으로 하는 약물 전달용 필름이 제공된 풍선 카테터.A balloon catheter provided with a film for drug delivery, wherein the guide wire is positioned at an interval from the inner wall of the inner separation conduit.
  17. 제16항에 있어서,The method of claim 16,
    상기 가이드 와이어는 상기 내부 분리 도관의 일단(一端)을 지나 상기 연결관 내부에 깊숙이 연장되는 것을 특징으로 하는 약물 전달용 필름이 제공된 풍선 카테터.And the guide wire extends deep inside the connecting tube through one end of the inner separation conduit.
  18. 제14항에 있어서,The method of claim 14,
    상기 외부 분리 도관 및 내부 분리 도관을 풍선 팽창용 유체가 도입되는 풍선 팽창용 유체 연결관과 연결시켜 주는 조인트 부재를 더 포함하는 약물 전달용 필름이 제공된 풍선 카테터.And a joint member for connecting the outer separation conduit and the inner separation conduit with a balloon inflation fluid connection tube through which the balloon inflation fluid is introduced.
  19. 제18항에 있어서,The method of claim 18,
    상기 조인트 부재의 유입 포트에는 상기 풍선 팽창용 유체 연결관이 삽입되어 연결되고, 상기 조인트 부재의 유출 포트에는 상기 외부 분리 도관 및 내부 분리 도관이 삽입되어 연결되는 것을 특징으로 하는 약물 전달용 필름이 제공된 풍선 카테터.The inflation port of the joint member is inserted and connected to the balloon expansion fluid connection pipe, the outflow port of the joint member is provided with a drug delivery film, characterized in that the outer separation conduit and the inner separation conduit is inserted and connected. Balloon catheter.
  20. 제19항에 있어서,The method of claim 19,
    상기 유입 포트를 통해 삽입된 상기 풍선 팽창용 유체 연결관은 상기 조인트 부재 내에 형성된 유입안내관에 밀착삽입되고, 상기 유출 포트를 통해 삽입된 상기 외부 분리 도관 및 내부 분리 도관은 상기 유입안내관과 연통되는 상기 조인트 부재 내에 형성된 유출안내관에 밀착삽입되면서 상기 풍선 팽창용 유체 연결관과 연통하게 되어 상기 풍선 팽창용 유체 연결관을 통해 유입되는 풍선 팽창용 유체를 상기 내부 분리 도관을 통해 상기 유출 포트로 내보내는 것을 특징으로 하는 약물 전달용 필름이 제공된 풍선 카테터.The balloon-inflating fluid connecting tube inserted through the inlet port is tightly inserted into the inlet guide tube formed in the joint member, and the outer separation conduit and the inner separation conduit inserted through the outlet port communicate with the inlet guide tube. Being in close contact with the outflow guide tube formed in the joint member and communicating with the balloon inflation fluid connection tube, the inflation fluid flowing through the balloon inflation fluid connection tube is introduced into the outlet port through the inner separation conduit. Balloon catheter provided with a film for drug delivery, characterized in that the export.
  21. 제18항에 있어서,The method of claim 18,
    상기 풍선 팽창용 유체 연결관을 유체 공급장치와 연결시켜 주는 풍선 팽창용 유체 주입용 허브를 더 포함하는 약물 전달용 필름이 제공된 풍선 카테터.Balloon catheter provided with a drug delivery film further comprises a balloon inflation fluid injecting hub that connects the balloon inflation fluid connector with a fluid supply.
  22. 제1항 또는 제2항에 있어서,The method according to claim 1 or 2,
    상기 도관의 선단(先端)으로부터 상기 팽창성 풍선 내부 그리고 혈류 구멍이 형성된 상기 연결관 위치까지 연장하고 상기 연결관에 형성된 혈류 구멍에 결합되는 혈류 유동관을 더 포함하는 약물 전달용 필름이 제공된 풍선 카테터.And a blood flow flow tube extending from the distal end of the conduit to the position of the connection tube formed in the inflatable balloon and the blood flow hole, and coupled to the blood flow hole formed in the connection pipe.
  23. 제22항에 있어서,The method of claim 22,
    상기 혈류 유동관은 상기 혈류 구멍에 결합되는 부분에서 상방으로 완만한 각도로 꼬부라진 형상으로 형성되어 있고 그 개방부는 길이방향으로 길게 형성되어 있는 것을 특징으로 하는 약물 전달용 필름이 제공된 풍선 카테터.The blood flow pipe is provided with a drug delivery film is provided with a film for drug delivery, characterized in that formed in a curved shape at a gentle angle upwards from the portion that is coupled to the blood flow hole and the opening is formed long in the longitudinal direction.
  24. 제22항에 있어서,The method of claim 22,
    상기 팽창성 풍선과 상기 혈류 유동관 사이를 밀봉하는 밀봉 캡을 더 포함하는 약물 전달용 필름이 제공된 풍선 카테터.Balloon catheter provided with a film for drug delivery further comprising a sealing cap for sealing between the inflatable balloon and the blood flow pipe.
  25. 제24항에 있어서,The method of claim 24,
    상기 밀봉 캡은 상기 혈류 유동관의 내부 통로에 대응되는 부분에 관통통로가 형성된 것을 특징으로 하는 약물 전달용 필름이 제공된 풍선 카테터.The sealing cap is a balloon catheter provided with a film for drug delivery, characterized in that the through passage formed in a portion corresponding to the inner passage of the blood flow pipe.
  26. 제1항 또는 제2항에 있어서,The method according to claim 1 or 2,
    상기 필름은 PEG(polyethyleneglycol)-PCLA(poly(epsilon-caprolactone-co-D,L-lactide))의 중합체 재료, 또는 PEG(polyethyleneglycol)-PLGA(poly(lactic-co-glycolic acid))의 중합체 재료, 또는 이러한 중합체 재료에 카프로락톤, 글리콜라이드, 락타이드, 파라다이옥사논 및 트리메틸렌카보네이트로 구성된 군으로부터 선택된 적어도 하나의 물질이 첨가된 중합체 재료로 구성되는 것을 특징으로 하는 약물 전달용 필름이 제공된 풍선 카테터.The film may be a polymer material of polyethyleneglycol (PEG) -PCLA (poly (epsilon-caprolactone-co-D, L-lactide)), or a polymer material of polyethyleneglycol) -PLGA (poly (lactic-co-glycolic acid)) Or a balloon provided with a film for drug delivery, characterized in that the polymer material consists of a polymer material to which at least one substance selected from the group consisting of caprolactone, glycolide, lactide, paradioxanone and trimethylene carbonate is added. Catheter.
PCT/KR2011/006163 2010-08-25 2011-08-20 Balloon catheter in which film for drug delivery is provided WO2012026717A2 (en)

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KR10-2011-0049923 2011-05-26
KR1020110049923A KR101230657B1 (en) 2010-08-25 2011-05-26 Balloon catheter provided with film containing and delivering medicine

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0663145A (en) * 1992-08-19 1994-03-08 Buaayu:Kk Balloon catheter for intravascular dosing
JP2000517213A (en) * 1996-08-30 2000-12-26 デルカス システムズ，インコーポレイテッド Balloon catheter with occlusion bypass
US20030097116A1 (en) * 2001-11-16 2003-05-22 Putz David A. Drug delivery catheter assembly with inflatable balloon
KR20060048258A (en) * 2004-06-08 2006-05-18 코디스 코포레이션 Drug delivery device using microprojections
US20090227949A1 (en) * 2008-03-06 2009-09-10 Boston Scientific Scimed, Inc. Balloon catheter devices with folded balloons

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0663145A (en) * 1992-08-19 1994-03-08 Buaayu:Kk Balloon catheter for intravascular dosing
JP2000517213A (en) * 1996-08-30 2000-12-26 デルカス システムズ，インコーポレイテッド Balloon catheter with occlusion bypass
US20030097116A1 (en) * 2001-11-16 2003-05-22 Putz David A. Drug delivery catheter assembly with inflatable balloon
KR20060048258A (en) * 2004-06-08 2006-05-18 코디스 코포레이션 Drug delivery device using microprojections
US20090227949A1 (en) * 2008-03-06 2009-09-10 Boston Scientific Scimed, Inc. Balloon catheter devices with folded balloons

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