CN115253030A - Balloon dilatation catheter and coating method of biological coating thereof - Google Patents
Balloon dilatation catheter and coating method of biological coating thereof Download PDFInfo
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- CN115253030A CN115253030A CN202210618236.6A CN202210618236A CN115253030A CN 115253030 A CN115253030 A CN 115253030A CN 202210618236 A CN202210618236 A CN 202210618236A CN 115253030 A CN115253030 A CN 115253030A
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- Prior art keywords
- balloon
- catheter
- coating
- sirolimus
- ethyl acetate
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- 238000000576 coating method Methods 0.000 title claims abstract description 68
- 239000011248 coating agent Substances 0.000 title claims abstract description 62
- XEKOWRVHYACXOJ-UHFFFAOYSA-N ethyl acetate Substances CCOC(C)=O XEKOWRVHYACXOJ-UHFFFAOYSA-N 0.000 claims abstract description 60
- 230000002093 peripheral effect Effects 0.000 claims abstract description 30
- 229920001577 copolymer Polymers 0.000 claims abstract description 15
- 238000005507 spraying Methods 0.000 claims description 18
- 230000010339 dilation Effects 0.000 claims description 17
- 238000004132 cross linking Methods 0.000 claims description 15
- ZAHRKKWIAAJSAO-UHFFFAOYSA-N rapamycin Natural products COCC(O)C(=C/C(C)C(=O)CC(OC(=O)C1CCCCN1C(=O)C(=O)C2(O)OC(CC(OC)C(=CC=CC=CC(C)CC(C)C(=O)C)C)CCC2C)C(C)CC3CCC(O)C(C3)OC)C ZAHRKKWIAAJSAO-UHFFFAOYSA-N 0.000 claims description 15
- QFJCIRLUMZQUOT-HPLJOQBZSA-N sirolimus Chemical compound C1C[C@@H](O)[C@H](OC)C[C@@H]1C[C@@H](C)[C@H]1OC(=O)[C@@H]2CCCCN2C(=O)C(=O)[C@](O)(O2)[C@H](C)CC[C@H]2C[C@H](OC)/C(C)=C/C=C/C=C/[C@@H](C)C[C@@H](C)C(=O)[C@H](OC)[C@H](O)/C(C)=C/[C@@H](C)C(=O)C1 QFJCIRLUMZQUOT-HPLJOQBZSA-N 0.000 claims description 15
- 229960002930 sirolimus Drugs 0.000 claims description 15
- 239000007788 liquid Substances 0.000 claims description 11
- 238000000034 method Methods 0.000 claims description 11
- 239000004322 Butylated hydroxytoluene Substances 0.000 claims description 9
- NLZUEZXRPGMBCV-UHFFFAOYSA-N Butylhydroxytoluene Chemical compound CC1=CC(C(C)(C)C)=C(O)C(C(C)(C)C)=C1 NLZUEZXRPGMBCV-UHFFFAOYSA-N 0.000 claims description 9
- 229940095259 butylated hydroxytoluene Drugs 0.000 claims description 9
- 235000010354 butylated hydroxytoluene Nutrition 0.000 claims description 9
- 239000004005 microsphere Substances 0.000 claims description 9
- 230000001681 protective effect Effects 0.000 claims description 8
- 239000011265 semifinished product Substances 0.000 claims description 6
- 239000011247 coating layer Substances 0.000 claims description 3
- 239000011259 mixed solution Substances 0.000 claims 1
- 230000002792 vascular Effects 0.000 description 24
- 239000002184 metal Substances 0.000 description 11
- 210000004204 blood vessel Anatomy 0.000 description 9
- 206010061218 Inflammation Diseases 0.000 description 7
- 230000004054 inflammatory process Effects 0.000 description 7
- 230000000694 effects Effects 0.000 description 4
- 210000005259 peripheral blood Anatomy 0.000 description 4
- 239000011886 peripheral blood Substances 0.000 description 4
- 239000010410 layer Substances 0.000 description 3
- 239000012528 membrane Substances 0.000 description 3
- 229930012538 Paclitaxel Natural products 0.000 description 2
- 208000018262 Peripheral vascular disease Diseases 0.000 description 2
- 238000011161 development Methods 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 229960001592 paclitaxel Drugs 0.000 description 2
- 230000008092 positive effect Effects 0.000 description 2
- 239000000047 product Substances 0.000 description 2
- RCINICONZNJXQF-MZXODVADSA-N taxol Chemical compound O([C@@H]1[C@@]2(C[C@@H](C(C)=C(C2(C)C)[C@H](C([C@]2(C)[C@@H](O)C[C@H]3OC[C@]3([C@H]21)OC(C)=O)=O)OC(=O)C)OC(=O)[C@H](O)[C@@H](NC(=O)C=1C=CC=CC=1)C=1C=CC=CC=1)O)C(=O)C1=CC=CC=C1 RCINICONZNJXQF-MZXODVADSA-N 0.000 description 2
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
Images
Classifications
-
- 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
- A61M25/1002—Balloon catheters characterised by balloon shape
-
- 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
- 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
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
- A61L2300/204—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials with nitrogen-containing functional groups, e.g. aminoxides, nitriles, guanidines
-
- 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
-
- 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
- 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
Abstract
The invention discloses a balloon dilatation catheter and a coating method of a biological coating thereof, wherein the balloon dilatation catheter comprises a catheter body, a catheter seat, a balloon main body and the biological coating, wherein the catheter seat is arranged at one end of the catheter body and communicated with the catheter body; the catheter base is provided with a guide wire cavity and a pressure cavity, an included angle is formed between the pressure cavity and the guide wire cavity, and the included angle is converged towards the catheter base; the balloon main body is sleeved on the tube body and is fixed at the position of the inner tube in the tube body; the balloon main body comprises a sleeve joint part and a peripheral ring part, and the sleeve joint part is sleeved with the tube body and extends outwards in an inclined manner; the peripheral ring part is arranged along the extending direction of the pipe body and is connected with the sleeving part; the outer diameter of the peripheral ring part is larger than that of the pipe body; the biological coating is coated on the balloon main body, covers the circumferential ring part and is exposed on the outer surface of the balloon dilatation catheter; the biological coating is sirolimus-ethyl acetate cross-linked copolymer and can diffuse to the vessel wall tissue when contacting with the vessel wall intima.
Description
Technical Field
The invention relates to the technical field of balloon dilatation catheters, in particular to a balloon dilatation catheter and a coating method of a biological coating thereof.
Background
With the development of science and technology, medical interventional devices are gradually applied to hospitals, and the existing medical interventional devices for treating peripheral vascular diseases comprise a peripheral common balloon, a peripheral metal stent and a peripheral paclitaxel drug balloon, wherein the peripheral metal stent is provided with a metal foreign body, and the metal foreign body is remained in the peripheral blood vessel for a long time, so that the peripheral blood vessel generates an inflammatory reaction, and the blood vessel is easy to generate the inflammatory reaction in the later period.
Disclosure of Invention
In order to solve the technical problems, the invention adopts the following technical scheme:
according to one aspect of the present invention, there is provided a balloon dilation catheter comprising:
a pipe body, in which an inserting channel is arranged;
the catheter seat is arranged at one end of the catheter body and communicated with the catheter body; the catheter seat is provided with a guide wire cavity and a pressurizing cavity, an included angle is formed between the pressurizing cavity and the guide wire cavity, and the guide wire cavity and the pressurizing cavity converge towards the catheter seat;
the balloon main body is sleeved on the pipe body and is fixed at the position of the inner pipe in the pipe body; the balloon main body comprises a sleeve joint part and a circumferential ring part, and the sleeve joint part is sleeved with the tube body and extends outwards in an inclined manner; the circumferential ring part is arranged along the extending direction of the pipe body and is connected with the sleeve part; the outer diameter of the peripheral ring part is larger than that of the pipe body;
a biological coating coated on the balloon main body, covering the circumferential ring part and exposed on the outer surface of the balloon dilatation catheter; the biological coating is sirolimus-ethyl acetate cross-linked copolymer and can diffuse to the vessel wall tissue when contacting with the vessel wall intima.
Optionally, the biological coating is a product generated by a cross-linking reaction of sirolimus and ethyl acetate, and is coated with butylated hydroxytoluene microspheres.
Optionally, the sirolimus and the ethyl acetate are subjected to a crosslinking reaction in a scene at a temperature of 220 ℃ ± 10 ℃ for at least 10 minutes;
the sirolimus-ethyl acetate crosslinked copolymer and the butylated hydroxytoluene microspheres are wrapped in a scene at the temperature of minus 20 +/-2 ℃, and are treated by ultrasonic waves with the frequency of 50 HZ.
Optionally, the molecular formula of the biological coating is C51H78NO12-C4H7O2.
Optionally, the bio-coating is attached to the socket portion and the peripheral ring portion along the annular direction, and is uniformly distributed on the outer surface of the socket portion and the outer surface of the peripheral ring portion.
Optionally, the balloon dilatation catheter further comprises a balloon protective sleeve, the balloon protective sleeve is arranged on the front side of the balloon main body and is sleeved with the catheter body; the sacculus protective sheath orientation the one end of sacculus main part is equipped with extension portion, extension portion is the splayed, and the orientation the sacculus main part extends.
Optionally, the balloon dilatation catheter further comprises a lining wire, wherein the lining wire is connected with the tube body and is positioned on the front side of the tube body; the lining wires are arranged on one side, back to the balloon main body, of the balloon protective sleeve, are arc-shaped and extend inwards.
According to an aspect of the present invention, there is provided a method for coating a bio-coating layer of a balloon catheter, applied to the balloon catheter, the method comprising:
performing the tube body and the catheter seat, and forming a semi-finished product of the balloon dilatation catheter;
placing the balloon main body in a spraying space of a spraying chamber, and setting a functional coefficient of a spraying head in the spraying space;
mixing sirolimus and ethyl acetate in a reaction chamber and generating a cross-linking reaction to form a sirolimus-ethyl acetate cross-linked copolymer, wherein the sirolimus and the ethyl acetate are subjected to the cross-linking reaction in a scene with the temperature of 220 ℃ +/-10 ℃ for at least 10 minutes;
wrapping the sirolimus-ethyl acetate crosslinked copolymer and the butylated hydroxytoluene microspheres in a scene with the temperature of minus 20 +/-2 ℃, and processing by adopting ultrasonic waves with the frequency of 50HZ to output mixed liquid of the biological coating;
spraying the mixed liquid of the biological coating on the balloon main body through a spraying head, attaching the mixed liquid to the sleeving part and the peripheral ring part along the annular direction, and uniformly distributing the mixed liquid on the outer surface of the sleeving part and the outer surface of the peripheral ring part;
loading the balloon body with the biological coating into a semi-finished balloon dilation catheter and forming the balloon dilation catheter.
Optionally, the method further includes:
the molecular formula of the biological coating is C51H78NO12-C4H7O2; the sirolimus and the ethyl acetate are subjected to a crosslinking reaction in a scene at a temperature of 220 ℃ +/-10 ℃ for at least 10 minutes.
According to the technical scheme, the embodiment of the invention at least has the following advantages and positive effects:
in the balloon dilatation catheter and the coating method of the biological coating thereof of the embodiment of the invention, the inside of the catheter body is provided with the inserting channel; the catheter seat is arranged at one end of the catheter body and communicated with the catheter body; the catheter base is provided with a guide wire cavity and a pressure cavity, an included angle is formed between the pressure cavity and the guide wire cavity, and the included angle is converged towards the catheter base; the balloon main body is sleeved on the tube body and is fixed at the position of the inner tube in the tube body; the balloon main body comprises a sleeve joint part and a peripheral ring part, and the sleeve joint part is sleeved with the tube body and extends outwards in an inclined manner; the circumferential ring part is arranged along the extension direction of the pipe body and is connected with the sleeve joint part; the outer diameter of the peripheral ring part is larger than that of the pipe body; the biological coating is coated on the balloon main body, covers the peripheral ring part and is exposed on the outer surface of the balloon dilatation catheter; the biological coating is sirolimus-ethyl acetate crosslinked copolymer, and can diffuse to the vascular wall tissue when contacting with the vascular wall intima, wherein, enter into to the blood vessel at sacculus expansion pipe, the entering of sacculus expansion pipe is followed to the sacculus main part, and be in the outer biological coating of sacculus expansion pipe can be preferentially with the vascular wall intima contact, and diffuse to the vascular wall tissue, so that be absorbed by the vascular wall intima based on the factor that biological coating released, so that carry out fixed point treatment to the vascular wall intima, and not remain metal, avoid subsequent neogenetic inflammatory reaction of vascular wall intima, improve the treatment effect of sacculus expansion pipe to the vascular wall intima.
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, it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the structures shown in the drawings without creative efforts.
Fig. 1 is a schematic view of a balloon dilation catheter in accordance with the present invention;
FIG. 2 is an enlarged view of a portion of FIG. 1 taken along line A;
FIG. 3 is a schematic flow chart of a method for coating a bio-coating layer of a balloon dilation catheter according to the present invention;
FIG. 4 is a schematic view of a method of applying a bio-coating of a balloon dilation catheter in accordance with the present invention;
the implementation, functional features and advantages of the objects of the present invention will be further explained with reference to the accompanying drawings.
Detailed Description
The technical solutions in the embodiments of the present invention will be described clearly and completely with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be obtained by a person skilled in the art without inventive step based on the embodiments of the present invention, are within the scope of protection of the present invention.
It should be noted that all directional indicators (such as up, down, left, right, front, back \8230;) in the embodiments of the present invention are only used to explain the relative positional relationship between the components, the motion situation, etc. in a specific posture (as shown in the attached drawings), and if the specific posture is changed, the directional indicator is changed accordingly.
In the present invention, unless otherwise expressly stated or limited, the terms "connected," "secured," and the like are to be construed broadly, and for example, "secured" may be a fixed connection, a removable connection, or an integral part; can be mechanically or electrically connected; they may be directly connected or indirectly connected through intervening media, or they may be connected internally or in any other suitable relationship, unless expressly stated otherwise. The specific meanings of the above terms in the present invention can be understood according to specific situations by those of ordinary skill in the art.
With the development of science and technology, medical interventional instruments are gradually applied to hospitals, and the existing medical interventional instruments for treating peripheral vascular diseases comprise a peripheral common ball, a peripheral metal stent and a peripheral paclitaxel drug balloon, wherein the peripheral metal stent is provided with metal foreign matters, and the metal foreign matters are remained in peripheral blood vessels for a long time to cause the inflammatory reaction of the peripheral blood vessels and cause the blood vessels to easily generate the inflammatory reaction in the later period.
Referring to fig. 1 and 2, the present invention provides a balloon dilatation catheter, which includes a catheter body 10, a catheter hub 20, a balloon body 30, a bio-coating 40, a balloon protection sheath 50, and a lining wire 60.
The tube body 10 serves as the main component of the balloon dilation catheter and connects the catheter hub 20, the balloon body 30, the bio-coating 40, the balloon protective sheath 50 and the lining wire 60.
The tube body 10 comprises an outer tube 11 and an inner tube 12 which are connected, the inner tube 12 is sleeved in the outer tube 11 and communicated with the outer tube 11, at the moment, the inner tube 12 is positioned in the front half part of the tube body 10 and preferentially enters the blood vessel relative to the appearance, and the outer diameter of the inner tube 12 is smaller than that of the outer tube 11. The tube body 10 is provided with an insertion passage formed by communicating an inner cavity of the outer tube 11 and an inner cavity of the inner tube 12.
The catheter seat 20 is arranged at one end of the catheter body 10 and communicated with the catheter body 10; catheter seat 20 is equipped with wire guide chamber 21 and pressurizes chamber 22, pressurize the chamber 22 with contained angle has between the wire guide chamber 21, and the orientation catheter seat 20 assembles to the combined action interlude passageway, so that liquid or gas enter into to interlude passageway.
The balloon main body 30 is sleeved on the tube body 10 and is fixed at the position of the inner tube 12 in the tube body 10; the balloon main body 30 comprises a sleeve joint part and a circumferential ring part, and the sleeve joint part is sleeved on the tube body 10 and extends outwards in an inclined manner; the peripheral ring part is arranged along the extending direction of the pipe body 10 and connected with the socket part; the outer diameter of the peripheral ring portion is larger than the outer diameter of the pipe body 10.
A biological coating 40 is applied to the balloon main body 30, covers the peripheral ring part and is exposed to the outer surface of the balloon dilatation catheter; the biological coating 40 is sirolimus-ethyl acetate crosslinked copolymer, and can diffuse to the vascular wall tissue when contacting with the vascular wall intima, wherein, in sacculus expansion pipe entering to blood vessel, the entering of sacculus expansion pipe is followed to sacculus main part 30, and the biological coating 40 that is in the outer layer of sacculus expansion pipe can be preferentially contacted with the vascular wall intima, and diffuse to the vascular wall tissue, so that the factor based on the release of biological coating 40 is absorbed by the vascular wall intima, so that the fixed point treatment is carried out to the vascular wall intima, and metal is not remained, avoid subsequent inflammatory reaction of the vascular wall intima, improve the treatment effect of the sacculus expansion pipe to the vascular wall intima.
The biological coating 40 is a product generated by a cross-linking reaction of sirolimus and ethyl acetate, and is coated with butylated hydroxytoluene microspheres. Wherein the sirolimus and the ethyl acetate are subjected to a cross-linking reaction in a scene with the temperature of 220 +/-10 ℃ for at least 10 minutes;
the sirolimus-ethyl acetate crosslinked copolymer and the butylated hydroxytoluene microspheres are subjected to wrapping treatment in a scene with the temperature of-20 +/-2 ℃, and ultrasonic waves with the frequency of 50HZ are adopted for treatment, and at the moment, the molecular formula of the biological coating 40 is C51H78NO12-C4H7O2.
In addition, the balloon dilatation catheter further comprises a balloon protection sleeve 50, wherein the balloon protection sleeve 50 is arranged on the front side of the balloon main body 30 and is sleeved with the catheter body 10; one end of the balloon protection sleeve 50 facing the balloon main body 30 is provided with an expansion part which is splayed and extends towards the balloon main body 30.
In addition, the balloon dilatation catheter further comprises a lining wire 60, wherein the lining wire 60 is connected with the tube body 10 and is arranged on the front side of the tube body 10; the lining wires 60 are disposed on a side of the balloon protection sheath 50 facing away from the balloon body 30, and the lining wires 60 are arc-shaped and extend inward.
According to an aspect of the present invention, referring to fig. 3 and 4, the present invention provides a method for coating a bio-coating 40 of a balloon dilatation catheter, which is applied to the balloon dilatation catheter, wherein the method for coating the bio-coating 40 of the balloon dilatation catheter comprises the following steps:
s11, carrying out the tube body 10 and the catheter seat 20, and forming a semi-finished product of the balloon dilatation catheter;
s12, placing the balloon main body 30 in a spraying space of a spraying chamber, and setting a functional coefficient of a spraying head in the spraying space;
s13, mixing sirolimus and ethyl acetate in a reaction chamber, and carrying out a crosslinking reaction to form a sirolimus-ethyl acetate crosslinked copolymer, wherein the sirolimus and the ethyl acetate are subjected to the crosslinking reaction in a scene with the temperature of 220 +/-10 ℃ for at least 10 minutes;
s14, carrying out wrapping treatment on the sirolimus-ethyl acetate crosslinked copolymer and the butylated hydroxytoluene microspheres in a scene with the temperature of minus 20 +/-2 ℃, and carrying out treatment by adopting ultrasonic waves with the frequency of 50HZ to output mixed liquor of the biological coating 40;
s15, spraying the mixed liquid of the biological coating 40 on the balloon main body 30 through a spraying head, attaching the mixed liquid to the sleeving part and the peripheral ring part along the annular direction, and uniformly distributing the mixed liquid on the outer surface of the sleeving part and the outer surface of the peripheral ring part;
s16, the balloon main body 30 with the biological coating 40 is arranged into a semi-finished product of the balloon dilatation catheter, and the balloon dilatation catheter is formed.
Wherein the bio-coating 40 may be attached to an outer layer of the balloon body 30 and assembled with the assembly of the balloon body 30 with respect to a semi-finished product of the balloon dilation catheter so as to form the balloon dilation catheter, and the process treatment efficiency of the balloon body 30 is improved and the production efficiency and the assembly efficiency of the balloon dilation catheter are improved by the individual attachment of the bio-coating 40 to the balloon body 30.
In addition, the molecular formula of the bio-coating 40 is C51H78NO12-C4H7O2; the sirolimus and the ethyl acetate are subjected to a crosslinking reaction in a scene at a temperature of 220 ℃ +/-10 ℃ for at least 10 minutes.
According to the technical scheme, the embodiment of the invention at least has the following advantages and positive effects:
in the balloon dilatation catheter and the coating method of the biological coating 40 thereof of the embodiment of the invention, the tube body 10 is internally provided with an inserting channel; the catheter holder 20 is arranged at one end of the catheter body 10 and communicated with the catheter body 10; the catheter base 20 is provided with a guide wire cavity 21 and a pressurizing cavity 22, an included angle is formed between the pressurizing cavity 22 and the guide wire cavity 21, and the included angle converges towards the catheter base 20; the balloon main body 30 is sleeved on the tube body 10 and is fixed at the position of the inner tube 12 in the tube body 10; the balloon main body 30 comprises a sleeve joint part and a circumferential ring part, and the sleeve joint part is sleeved with the tube body 10 and extends obliquely outwards; the circumferential ring part is arranged along the extending direction of the pipe body 10 and connected with the socket part; the outer diameter of the peripheral ring part is larger than that of the pipe body 10; the biological coating 40 is coated on the balloon main body 30, covers the peripheral ring part and is exposed on the outer surface of the balloon dilatation catheter; the biological coating 40 is sirolimus-ethyl acetate crosslinked copolymer, and can diffuse to the vascular wall tissue when contacting with the vascular wall intima, wherein, in sacculus expansion pipe entering to the blood vessel, the entering of sacculus expansion pipe is followed to sacculus main part 30, and the biological coating 40 that is in the outer layer of sacculus expansion pipe can be preferentially contacted with the vascular wall intima, and diffuse to the vascular wall tissue, so that the factor based on the release of biological coating 40 is absorbed by the vascular wall intima, so that the fixed point treatment is carried out to the vascular wall intima, and metal is not remained, avoid subsequent inflammatory reaction of the vascular wall intima, improve the treatment effect of sacculus expansion pipe to the vascular wall intima.
The above description is only an alternative embodiment of the present invention, and is not intended to limit the scope of the present invention, and all modifications and equivalents made by the contents of the present specification and the accompanying drawings, or directly/indirectly applied to other related technical fields, which are within the spirit of the present invention, are included in the scope of the present invention.
Claims (9)
1. A balloon dilation catheter, comprising:
a pipe body, in which an inserting channel is arranged;
the catheter seat is arranged at one end of the catheter body and communicated with the catheter body; the catheter seat is provided with a guide wire cavity and a pressurizing cavity, an included angle is formed between the pressurizing cavity and the guide wire cavity, and the guide wire cavity and the pressurizing cavity converge towards the catheter seat;
the balloon main body is sleeved on the tube body and is fixed at the position of the inner tube in the tube body; the balloon main body comprises a sleeve joint part and a circumferential ring part, and the sleeve joint part is sleeved with the tube body and extends outwards in an inclined manner; the circumferential ring part is arranged along the extending direction of the pipe body and is connected with the sleeve part; the outer diameter of the peripheral ring part is larger than that of the pipe body;
a biological coating which is coated on the balloon main body, covers the peripheral ring part and is exposed on the outer surface of the balloon dilatation catheter; the biological coating is sirolimus-ethyl acetate cross-linked copolymer and can diffuse to the vessel wall tissue when contacting with the vessel wall intima.
2. The balloon dilatation catheter of claim 1 wherein the bio-coating is formed by cross-linking sirolimus and ethyl acetate and is coated with butylated hydroxytoluene microspheres.
3. The balloon dilation catheter of claim 2 wherein said sirolimus and said ethyl acetate undergo a cross-linking reaction in a scene having a temperature of 220 ℃ ± 10 ℃ for at least 10 minutes;
the sirolimus-ethyl acetate crosslinked copolymer and the butylated hydroxytoluene microspheres are wrapped in a scene at the temperature of minus 20 +/-2 ℃, and are treated by ultrasonic waves with the frequency of 50 HZ.
4. The balloon dilation catheter of claim 3 wherein the bio-coating has a molecular formula of C51H78NO12-C4H7O2.
5. The balloon dilation catheter of claim 3 wherein the biological coating is attached to the hub and the circumferential collar along an annular direction and is evenly distributed over an outer surface of the hub and an outer surface of the circumferential collar.
6. The balloon dilatation catheter of claim 1 further comprising a balloon protective sleeve disposed on the front side of the balloon body and sleeved over the tube; the sacculus protective sheath orientation the one end of sacculus main part is equipped with extension portion, extension portion is the splayed, and the orientation the sacculus main part extends.
7. The balloon dilation catheter according to claim 6 wherein the balloon dilation catheter further comprises a backing wire attached to the tube and located on an anterior side of the tube; the lining wires are arranged on one side, back to the balloon main body, of the balloon protective sleeve, are arc-shaped and extend inwards.
8. A method for coating a bio-coating layer of a balloon catheter, which is applied to the balloon catheter according to any one of claims 1 to 7, the method comprising:
performing the tube body and the catheter seat, and forming a semi-finished product of the balloon dilatation catheter;
placing the balloon main body in a spraying space of a spraying chamber, and setting a functional coefficient of a spraying head in the spraying space;
mixing sirolimus and ethyl acetate in a reaction chamber and generating a cross-linking reaction to form a sirolimus-ethyl acetate cross-linked copolymer, wherein the sirolimus and the ethyl acetate are subjected to the cross-linking reaction in a scene with the temperature of 220 ℃ +/-10 ℃ for at least 10 minutes;
wrapping the sirolimus-ethyl acetate crosslinked copolymer and the butylated hydroxytoluene microspheres in a scene at the temperature of-20 +/-2 ℃, and treating by adopting ultrasonic waves with the frequency of 50HZ to output a mixed solution of the biological coating;
spraying the mixed liquid of the biological coating on the balloon main body through a spraying head, attaching the mixed liquid to the sleeve joint part and the peripheral ring part along the annular direction, and uniformly distributing the mixed liquid on the outer surface of the sleeve joint part and the outer surface of the peripheral ring part;
and (3) loading the balloon main body with the biological coating into a semi-finished product of the balloon dilatation catheter and forming the balloon dilatation catheter.
9. The method of coating a bio-coating of a balloon dilation catheter according to claim 5, further comprising:
the molecular formula of the biological coating is C51H78NO12-C4H7O2; the sirolimus and the ethyl acetate are subjected to a crosslinking reaction in a scene at a temperature of 220 ℃ +/-10 ℃ for at least 10 minutes.
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| Application Number | Priority Date | Filing Date | Title |
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| CN202210618236.6A CN115253030A (en) | 2022-06-01 | 2022-06-01 | Balloon dilatation catheter and coating method of biological coating thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN202210618236.6A CN115253030A (en) | 2022-06-01 | 2022-06-01 | Balloon dilatation catheter and coating method of biological coating thereof |
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| CN115253030A true CN115253030A (en) | 2022-11-01 |
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| CN202210618236.6A Pending CN115253030A (en) | 2022-06-01 | 2022-06-01 | Balloon dilatation catheter and coating method of biological coating thereof |
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