CN112354070A - Preparation method of medicine balloon and medicine balloon prepared by preparation method - Google Patents
Preparation method of medicine balloon and medicine balloon prepared by preparation method Download PDFInfo
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- CN112354070A CN112354070A CN202011410101.8A CN202011410101A CN112354070A CN 112354070 A CN112354070 A CN 112354070A CN 202011410101 A CN202011410101 A CN 202011410101A CN 112354070 A CN112354070 A CN 112354070A
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- balloon
- tube
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- outer tube
- preparation
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- 239000003814 drug Substances 0.000 title claims abstract description 71
- 238000002360 preparation method Methods 0.000 title claims abstract description 24
- 238000000576 coating method Methods 0.000 claims abstract description 11
- 238000000071 blow moulding Methods 0.000 claims abstract description 3
- 238000005507 spraying Methods 0.000 claims description 40
- 229940079593 drug Drugs 0.000 claims description 37
- 238000003466 welding Methods 0.000 claims description 24
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 19
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims description 19
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 18
- 238000000034 method Methods 0.000 claims description 10
- 239000002904 solvent Substances 0.000 claims description 7
- 238000004519 manufacturing process Methods 0.000 claims 4
- 210000005077 saccule Anatomy 0.000 abstract description 8
- 239000011248 coating agent Substances 0.000 abstract description 7
- 208000019553 vascular disease Diseases 0.000 abstract description 3
- 239000000243 solution Substances 0.000 description 21
- 210000004204 blood vessel Anatomy 0.000 description 11
- 238000001723 curing Methods 0.000 description 6
- 238000004080 punching Methods 0.000 description 5
- 238000001727 in vivo Methods 0.000 description 3
- 208000037803 restenosis Diseases 0.000 description 3
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 210000004351 coronary vessel Anatomy 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 238000003618 dip coating Methods 0.000 description 1
- 238000012377 drug delivery Methods 0.000 description 1
- 238000002651 drug therapy Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 239000004005 microsphere Substances 0.000 description 1
- 239000003186 pharmaceutical solution Substances 0.000 description 1
- 238000003825 pressing Methods 0.000 description 1
- 239000007921 spray Substances 0.000 description 1
- 229940126585 therapeutic drug Drugs 0.000 description 1
- 238000001029 thermal curing Methods 0.000 description 1
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- 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
- A61M25/1027—Making of balloon catheters
- A61M25/1029—Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
-
- 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
-
- 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
- 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
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/416—Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
-
- 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
- A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
- A61L2300/606—Coatings
-
- 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
- A61L2420/00—Materials or methods for coatings medical devices
- A61L2420/02—Methods for coating medical devices
-
- 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
- A61L2420/00—Materials or methods for coatings medical devices
- A61L2420/08—Coatings comprising two or more layers
-
- 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
- A61M25/1027—Making of balloon catheters
- A61M25/1029—Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
- A61M2025/1031—Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
-
- 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
- A61M2207/00—Methods of manufacture, assembly or production
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Abstract
The invention discloses a preparation method of a medicine balloon, which comprises the following steps: firstly, placing the saccule in a mould, and performing blow molding to obtain a saccule body with micro pits; then connecting the catheter seat, the hypotube, the outer tube and the balloon body in sequence; then connecting the balloon body with the tip tube; and finally, coating a medicine layer on the whole surface of the balloon with the micro pits. The invention also discloses the medicine balloon prepared by the preparation method. The invention prepares the saccule by taking the saccule body with the micro-pits as the core, the preparation process is simple, the prepared saccule has accurate size, the connection among all the parts is firm, and the invention can be applied to the treatment of various vascular diseases.
Description
Technical Field
The invention relates to the field of medical instruments, in particular to a preparation method of a medicine balloon and the medicine balloon prepared by the preparation method.
Background
Drug balloons are a form of drug delivery that is expandable on a catheter and are a well-established method of treating vascular disease. The drug balloon is usually arranged at the tail end of the catheter, the balloon catheter is conveyed into a human body, the drug balloon is physically expanded in a blood vessel to open the diseased blood vessel, and the drug attached to the surface of the balloon is used for feeding drug to the inner wall of the blood vessel to treat the diseased blood vessel. It is generally used for the treatment of restenosis in coronary arteries. The traditional treatment mode is usually stent treatment, but the restenosis rate is often high after the stent is implanted, and the metal stent has mechanical damage to the blood vessel in vivo and is not ideal enough to be used for treating the restenosis. There is also a new technology using a degradable drug-coated stent, which struts the inner wall of a blood vessel at the initial stage of use and releases therapeutic drugs, and at the later stage, after the drug release is completed, the blood vessel gradually enlarges the inner wall through drug therapy, and at the same time, the stent gradually degrades in vivo. However, the degradable stent is expensive, and the treatment effect is not proved by sufficient clinical experiments.
The medicine balloon requires fine structure and needs to be contacted with the human body in the human body, and the preparation of the medicine balloon requires higher precision and cannot cause damage to the human body, which is also a difficulty in the preparation of the medicine balloon.
Disclosure of Invention
Therefore, the technical problem to be solved by the invention is the difficulty in the preparation of the traditional medicine balloon, so that the preparation method of the medicine balloon and the prepared medicine balloon are provided.
Therefore, the invention adopts the following technical scheme:
the invention provides a preparation method of a medicine balloon, which comprises the following steps:
s1: placing the sacculus in a mould, and performing blow molding to obtain a sacculus body with micro pits;
s2: connecting the catheter seat, the hypotube, the outer tube and the balloon body in sequence;
s3: connecting the balloon body with the tip tube;
s4: the surface of the balloon body is coated with a drug layer.
Further, the mold in S1 has a plurality of protruding hemispheres in its internal design, and the balloon without dimple is placed therein and then blow-molded to form a balloon with dimples as a balloon body.
Further, the drug layer in S4 includes a polyvinylpyrrolidone layer and a drug solution layer.
Preferably, the polyvinylpyrrolidone layer is coated by immersing the whole balloon in a polyvinylpyrrolidone solution for 5-10s and then performing ultraviolet curing or thermal curing.
The coating method of the drug solution layer comprises the following steps of carrying out ultrasonic spraying on the balloon body by using the drug solution;
the flow range of the ultrasonic spraying is 1-20L/min, the back-and-forth spraying times are 50-300 times, the moving speed of a spraying gun is 0.5-50 mu m/s, and after the spraying is finished, the solvent is completely volatilized.
Further, the hypotube in the S2 is assembled with the catheter holder through the inner hole, and then the two ends of the outer tube are respectively laser-welded with the hypotube and the balloon body.
The connection method of the balloon body and the tip tube in the S3 includes connecting one end of the inner tube and the tip tube by laser welding, inserting the other end of the inner tube into the outer tube through the inside of the balloon body, and finally fixing the tip tube and the balloon body by laser welding.
Furthermore, the position of the side wall of the outer tube, which is 10-15cm away from the balloon body, also comprises a punched hole with the diameter of 0.5mm, and the inner tube is inserted into the outer tube and then extends out of the punched hole.
The inner tube is inserted into the outer tube until the tip tube protrudes out of the balloon body by 2mm, and then the tip tube and the balloon body are fixed by laser welding.
Preferably, the diameter of the micro pit is 0.2-0.8mm, the depth is 0.1-0.5mm, the transverse spacing of every two micro pits is 0.1-1.0mm, and the longitudinal spacing is 0.1-1.0 mm.
The invention also provides a medicine balloon, which is prepared by the preparation method.
The technical scheme of the invention has the following advantages:
(1) the invention prepares the saccule by taking the saccule body with the micro-pits as the core, the preparation process is simple, the prepared saccule has accurate size, the connection among all the parts is firm, and the invention can be applied to the treatment of various vascular diseases.
(2) The micro-pits on the balloon body can store more drug microspheres, and compared with a smooth surface, the drug falling amount in the micro-pits is small in folding, pressing and conveying processes in blood vessels, and the balloon can be guaranteed to contain enough drug at the position where the balloon is conveyed to a target blood vessel; after entering the expansion part and expanding, the micro-pits tend to be in a smooth state in the deformation process of the balloon, so that the medicine stored in the micro-pits is fully released.
(3) The invention firstly dip-coats the polyvinylpyrrolidone layer and then sprays the drug solution layer, and uses different coating methods according to the different properties of the 2 coatings, and because the polyvinylpyrrolidone layer is coated by adopting the dip-coating process and the coating is very thin, the content of the effective drug stored in the micro-pits can not be influenced. During the conveying process of the folded balloon in vivo, the balloon shuttles in a tortuous and narrow blood vessel, so that part of effective medicines fall off due to the fact that the balloon contacts the blood vessel wall, and the conveying process loss is less compared with that of the smooth balloon due to the design that the surface of the balloon is inwards sunken and is provided with micro pits.
(4) The parts of the invention are connected by laser welding, which can ensure accurate size, and meanwhile, the laser welding can not influence the structure of a welding point too much, thereby avoiding the damage to the inside of a human body caused by the use in the human body.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.
Fig. 1 is a schematic structural view at the balloon body of a drug balloon made in various embodiments of the present disclosure;
FIG. 2 is a schematic diagram of the overall structure of a drug balloon according to various embodiments of the present invention;
fig. 3 is a schematic cross-sectional view of a balloon body of a drug balloon made in accordance with various embodiments of the present invention.
Reference numerals:
1-a balloon body; 2-an outer tube; 3-a hypotube; 4-a catheter hub; 5-micro pits; 6-inner tube; 7-a tip tube; 8-a developing ring; 9-polyvinylpyrrolidone layer; 10-a layer of a pharmaceutical solution; 11-sheath.
Detailed Description
The following examples are provided to further understand the present invention, not to limit the scope of the present invention, but to provide the best mode, not to limit the content and the protection scope of the present invention, and any product similar or similar to the present invention, which is obtained by combining the present invention with other prior art features, falls within the protection scope of the present invention.
The examples do not show the specific experimental steps or conditions, and can be performed according to the conventional experimental steps described in the literature in the field.
The following specific examples are further illustrative of the present invention, and the examples do not exemplify all the embodiments of the present invention, but only some of the embodiments are exemplified, and the specific examples are as follows:
example 1
The embodiment provides a preparation method of a drug balloon, which specifically comprises the following steps:
firstly, preparing a mould, wherein the interior of the mould is designed with a raised hemisphere, the diameter of the hemisphere is 0.25mm, the height of the hemisphere is 0.13mm, the transverse spacing of the hemisphere is 0.56mm, and the longitudinal spacing of the hemisphere is 0.56mm, forming a balloon with micro-pits 5 as a balloon body 1 after the balloon is blown in the mould, wherein the front and the back of the balloon body 1 are asymmetrical, and the diameter of a welding part at the near end is larger and is closer to the diameter of an outer tube 2; the diameter of the welding position at the far end is smaller and is close to that of the tip tube 7, so that the welding is facilitated.
The catheter seat 4 is clamped into the sheath 11, the hypotube 3 is assembled through the inner hole and the catheter seat 4, the other end of the hypotube 3 is welded with one end of the outer tube 2, and finally the other end of the outer tube 2 is welded with the balloon body 1 through laser, and the structure of the balloon is shown in fig. 2.
A lining core penetrates through the inner pipe 6, the developing ring 8 is sleeved on the inner pipe, and the developing rings 8 at two ends are pressed on the inner pipe 6; the end of the inner tube 6 and the tip tube 7 are laser welded, a core wire is inserted, a punched hole with the diameter of 0.5mm is punched at a position 10cm away from the balloon body 1 on the side wall of the outer tube 2 by using a punching die, the inner tube 6 and the tip tube 7 are inserted into the outer tube 2 to be pushed, the inner tube and the tip tube 7 extend out of the punched hole until the tip tube 7 protrudes 2mm beyond the balloon body 1, and the tip tube 7 and the balloon body 1 are welded, and the structure is shown in fig. 1.
And (3) the drug balloon is wholly immersed in a polyvinylpyrrolidone solution for 10s, and then ultraviolet curing is adopted to obtain the polyvinylpyrrolidone layer 9.
Then the medicine sacculus is integrally arranged on a medicine sacculus spraying machine, the core wire at the tip of the sacculus body 1 is clamped, and then the medicine solution is used for ultrasonic spraying. The flow rate of ultrasonic spraying is 8L/min, the spraying times are 50 times, the moving speed of a spraying gun is 3 μm/s, after the spraying is finished, a medicinal solution layer 10 is obtained after the solvent is volatilized, and the medicinal balloon is taken down, wherein the coating structure is shown in fig. 3.
Example 2
The embodiment provides a preparation method of a drug balloon, which specifically comprises the following steps:
firstly, preparing a mould, wherein the interior of the mould is designed with a raised hemisphere, the diameter of the hemisphere is 0.25mm, the height of the hemisphere is 0.13mm, the transverse spacing of the hemisphere is 0.56mm, and the longitudinal spacing of the hemisphere is 0.56mm, forming a balloon with micro-pits 5 as a balloon body 1 after the balloon is blown in the mould, wherein the front and the back of the balloon body 1 are asymmetrical, and the diameter of a welding part at the near end is larger and is closer to the diameter of an outer tube 2; the diameter of the welding position at the far end is smaller and is close to that of the tip tube 7, so that the welding is facilitated.
The catheter seat 4 is clamped into the sheath 11, the hypotube 3 is assembled through the inner hole and the catheter seat 4, the other end of the hypotube 3 is welded with one end of the outer tube 2, and finally the other end of the outer tube 2 is welded with the balloon body 1 through laser, and the structure of the balloon is shown in fig. 2.
A lining core penetrates through the inner pipe 6, the developing ring 8 is sleeved on the inner pipe, and the developing rings 8 at two ends are pressed on the inner pipe 6; the end of the inner tube 6 and the tip tube 7 are laser welded, a core wire is inserted, a punched hole with the diameter of 0.5mm is punched at a position 15cm away from the balloon body 1 on the side wall of the outer tube 2 by using a punching die, the inner tube 6 and the tip tube 7 are inserted into the outer tube 2 to be pushed, the inner tube and the tip tube 7 extend out of the punched hole until the tip tube 7 protrudes out of the balloon body 1 by 2mm, and the tip tube 7 and the balloon body 1 are welded, and the structure is shown in fig. 1.
And (3) the drug balloon is wholly immersed in a polyvinylpyrrolidone solution for 5s, and then ultraviolet curing is adopted to obtain the polyvinylpyrrolidone layer 9.
Then the medicine sacculus is integrally arranged on a medicine sacculus spraying machine, the core wire at the tip of the sacculus body 1 is clamped, and then the medicine solution is used for ultrasonic spraying. The flow rate of ultrasonic spraying is 1L/min, the spraying times are 20 times, the moving speed of a spraying gun is 0.5 μm/s, after the spraying is finished, a medicinal solution layer 10 is obtained after the solvent is volatilized, and the medicinal balloon is taken down, wherein the coating structure is shown in fig. 3.
Example 3
The embodiment provides a preparation method of a drug balloon, which specifically comprises the following steps:
firstly, preparing a mould, wherein the interior of the mould is designed with a raised hemisphere, the diameter of the hemisphere is 0.25mm, the height of the hemisphere is 0.13mm, the transverse spacing of the hemisphere is 0.56mm, and the longitudinal spacing of the hemisphere is 0.56mm, forming a balloon with micro-pits 5 as a balloon body 1 after the balloon is blown in the mould, wherein the front and the back of the balloon body 1 are asymmetrical, and the diameter of a welding part at the near end is larger and is closer to the diameter of an outer tube 2; the diameter of the welding position at the far end is smaller and is close to that of the tip tube 7, so that the welding is facilitated.
The catheter seat 4 is clamped into the sheath 11, the hypotube 3 is assembled through the inner hole and the catheter seat 4, the other end of the hypotube 3 is welded with one end of the outer tube 2, and finally the other end of the outer tube 2 is welded with the balloon body 1 through laser, and the structure of the balloon is shown in fig. 2.
A lining core penetrates through the inner pipe 6, the developing ring 8 is sleeved on the inner pipe, and the developing rings 8 at two ends are pressed on the inner pipe 6; the end of the inner tube 6 and the tip tube 7 are laser welded, a core wire is inserted, a punched hole with the diameter of 0.5mm is punched at a position 12cm away from the balloon body 1 on the side wall of the outer tube 2 by using a punching die, the inner tube 6 and the tip tube 7 are inserted into the outer tube 2 to be pushed, the inner tube and the tip tube 7 extend out of the punched hole until the tip tube 7 protrudes out of the balloon body 1 by 2mm, and the tip tube 7 and the balloon body 1 are welded, and the structure is shown in fig. 1.
And (3) the drug balloon is wholly immersed in a polyvinylpyrrolidone solution for 6s, and then ultraviolet curing is adopted to obtain the polyvinylpyrrolidone layer 9.
Then the medicine sacculus is integrally arranged on a medicine sacculus spraying machine, the core wire at the tip of the sacculus body 1 is clamped, and then the medicine solution is used for ultrasonic spraying. The flow rate of ultrasonic spraying is 20L/min, the number of times of back and forth spraying is 100, the moving speed of a spraying gun is 50 μm/s, after the spraying is finished, a medicinal solution layer 10 is obtained after the solvent is volatilized, the medicinal balloon is taken down, and the coating structure is shown in fig. 3.
Example 4
The embodiment provides a preparation method of a drug balloon, which specifically comprises the following steps:
firstly, preparing a mould, wherein the inside of the mould is designed with a raised hemisphere, the diameter of the hemisphere is 0.30mm, the height of the hemisphere is 0.15mm, the transverse interval is 0.60mm, and the longitudinal interval is 0.56mm, forming a balloon with micro-pits 5 as a balloon body 1 after the balloon is blown in the mould, wherein the front and the back of the balloon body 1 are asymmetrical, and the diameter of a welding part at the near end is larger and is closer to the diameter of an outer tube 2; the diameter of the welding position at the far end is smaller and is close to that of the tip tube 7, so that the welding is facilitated.
The catheter seat 4 is clamped into the sheath 11, the hypotube 3 is assembled through the inner hole and the catheter seat 4, the other end of the hypotube 3 is welded with one end of the outer tube 2, and finally the other end of the outer tube 2 is welded with the balloon body 1 through laser, and the structure of the balloon is shown in fig. 2.
A lining core penetrates through the inner pipe 6, the developing ring 8 is sleeved on the inner pipe, and the developing rings 8 at two ends are pressed on the inner pipe 6; the end of the inner tube 6 and the tip tube 7 are laser welded, a core wire is inserted, a punched hole with the diameter of 0.5mm is punched at a position 13cm away from the balloon body 1 on the side wall of the outer tube 2 by using a punching die, the inner tube 6 and the tip tube 7 are inserted into the outer tube 2 to be pushed, the inner tube and the tip tube 7 extend out of the punched hole until the tip tube 7 protrudes out of the balloon body 1 by 2mm, and the tip tube 7 and the balloon body 1 are welded, and the structure is shown in fig. 1.
And (3) the drug balloon is wholly immersed in a polyvinylpyrrolidone solution for 7s, and then ultraviolet curing is adopted to obtain the polyvinylpyrrolidone layer 9.
Then the medicine sacculus is integrally arranged on a medicine sacculus spraying machine, the core wire at the tip of the sacculus body 1 is clamped, and then the medicine solution is used for ultrasonic spraying. The flow rate of ultrasonic spraying is 10L/min, the number of spraying times is 150, the moving speed of a spraying gun is 4 μm/s, after the spraying is finished, a medicinal solution layer 10 is obtained after the solvent is volatilized, and the medicinal balloon is taken down, wherein the coating structure is shown in fig. 3.
Example 5
The embodiment provides a preparation method of a drug balloon, which specifically comprises the following steps:
firstly, preparing a mould, wherein the inside of the mould is designed with a raised hemisphere, the diameter of the hemisphere is 0.30mm, the height of the hemisphere is 0.15mm, the transverse interval is 0.60mm, and the longitudinal interval is 0.56mm, forming a balloon with micro-pits 5 as a balloon body 1 after the balloon is blown in the mould, wherein the front and the back of the balloon body 1 are asymmetrical, and the diameter of a welding part at the near end is larger and is closer to the diameter of an outer tube 2; the diameter of the welding position at the far end is smaller and is close to that of the tip tube 7, so that the welding is facilitated.
The catheter seat 4 is clamped into the sheath 11, the hypotube 3 is assembled through the inner hole and the catheter seat 4, the other end of the hypotube 3 is welded with one end of the outer tube 2, and finally the other end of the outer tube 2 is welded with the balloon body 1 through laser, and the structure of the balloon is shown in fig. 2.
A lining core penetrates through the inner pipe 6, the developing ring 8 is sleeved on the inner pipe, and the developing rings 8 at two ends are pressed on the inner pipe 6; the end of the inner tube 6 and the tip tube 7 are laser welded, a core wire is inserted, a punched hole with the diameter of 0.5mm is punched at a position 10cm away from the balloon body 1 on the side wall of the outer tube 2 by using a punching die, the inner tube 6 and the tip tube 7 are inserted into the outer tube 2 to be pushed, the inner tube and the tip tube 7 extend out of the punched hole until the tip tube 7 protrudes 2mm beyond the balloon body 1, and the tip tube 7 and the balloon body 1 are welded, and the structure is shown in fig. 1.
And (3) the drug balloon is wholly immersed in a polyvinylpyrrolidone solution for 6s, and then ultraviolet curing is adopted to obtain the polyvinylpyrrolidone layer 9.
Then the medicine sacculus is integrally arranged on a medicine sacculus spraying machine, the core wire at the tip of the sacculus body 1 is clamped, and then the medicine solution is used for ultrasonic spraying. The flow rate of ultrasonic spraying is 12L/min, the number of times of back and forth spraying is 100, the moving speed of a spraying gun is 6 μm/s, after the spraying is finished, a medicinal solution layer 10 is obtained after the solvent is volatilized, the medicinal balloon is taken down, and the coating structure is shown in fig. 3.
It should be understood that the above examples are only for clarity of illustration and are not intended to limit the embodiments. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. And are neither required nor exhaustive of all embodiments. And obvious variations or modifications therefrom are within the scope of the invention.
Claims (10)
1. The preparation method of the medicine balloon is characterized by comprising the following steps:
s1: placing the sacculus in a mould, and performing blow molding to obtain a sacculus body with micro pits;
s2: connecting the catheter seat, the hypotube, the outer tube and the balloon body in sequence;
s3: connecting the balloon body with the tip tube;
s4: the surface of the balloon body is coated with a drug layer.
2. The method of claim 1, wherein the drug layer in S4 comprises a polyvinylpyrrolidone layer and a drug solution layer.
3. The preparation method according to claim 2, wherein the polyvinylpyrrolidone layer is coated by immersing the whole balloon in a polyvinylpyrrolidone solution for 5-10s and then curing by ultraviolet or heat.
4. The production method according to claim 2 or 3, wherein the coating method of the drug solution layer is an ultrasonic spraying of the balloon body with the drug solution;
the flow range of the ultrasonic spraying is 1-20L/min, the back-and-forth spraying times are 50-300 times, the moving speed of a spraying gun is 0.5-50 mu m/s, and after the spraying is finished, the solvent is completely volatilized.
5. The preparation method according to any one of claims 1 to 4, wherein the hypotube in S2 is assembled by its inner hole and the catheter holder, and then the two ends of the outer tube are respectively laser-welded with the hypotube and the balloon body.
6. The manufacturing method according to claim 5, wherein the balloon body and the tip tube are joined in S3 by laser welding one end of an inner tube and the tip tube, inserting the other end thereof into the outer tube through the inside of the balloon body, and finally laser welding the tip tube and the balloon body.
7. The method for preparing the balloon of claim 6, wherein the side wall of the outer tube is 10-15cm away from the balloon body and further comprises a punched hole with the diameter of 0.5mm, and the inner tube is inserted into the outer tube and then extends out of the punched hole.
8. The production method according to claim 7, wherein the inner tube is inserted into the outer tube until the tip tube protrudes 2mm from the balloon body, and then the tip tube and the balloon body are fixed by laser welding.
9. The method according to any one of claims 1 to 8, wherein the micro-pits have a diameter of 0.2 to 0.8mm and a depth of 0.1 to 0.5mm, and each two micro-pits have a transverse interval of 0.1 to 1.0mm and a longitudinal interval of 0.1 to 1.0 mm.
10. A drug balloon produced by the production method according to any one of claims 1 to 9.
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| CN113144389A (en) * | 2021-03-16 | 2021-07-23 | 科塞尔医疗科技（苏州）有限公司 | Double-layer sand blasting balloon, preparation method thereof and multi-layer sand blasting balloon |
| CN114699632A (en) * | 2022-03-30 | 2022-07-05 | 深圳市顺美医疗股份有限公司 | Drug balloon for cerebral blood vessels and preparation method thereof |
| CN115501457A (en) * | 2022-05-17 | 2022-12-23 | 辽宁垠艺生物科技股份有限公司 | Preparation process of drug-loaded balloon with micro blind holes on surface |
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Application publication date: 20210212 |