CN109011112B - Drug-coated balloon catheter capable of reducing drug loss - Google Patents
Drug-coated balloon catheter capable of reducing drug loss Download PDFInfo
- Publication number
- CN109011112B CN109011112B CN201810934947.8A CN201810934947A CN109011112B CN 109011112 B CN109011112 B CN 109011112B CN 201810934947 A CN201810934947 A CN 201810934947A CN 109011112 B CN109011112 B CN 109011112B
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- Prior art keywords
- balloon
- protective sleeve
- drug
- balloon catheter
- coated
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- 239000003814 drug Substances 0.000 title claims abstract description 137
- 229940079593 drug Drugs 0.000 title claims abstract description 100
- 230000001681 protective effect Effects 0.000 claims abstract description 93
- 239000011248 coating agent Substances 0.000 claims abstract description 57
- 238000000576 coating method Methods 0.000 claims abstract description 57
- 230000002439 hemostatic effect Effects 0.000 claims abstract description 14
- 239000003638 chemical reducing agent Substances 0.000 claims description 9
- -1 KYNER Polymers 0.000 claims description 7
- RYGMFSIKBFXOCR-UHFFFAOYSA-N Copper Chemical compound [Cu] RYGMFSIKBFXOCR-UHFFFAOYSA-N 0.000 claims description 6
- 229910052782 aluminium Inorganic materials 0.000 claims description 6
- 229910052802 copper Inorganic materials 0.000 claims description 6
- 239000010949 copper Substances 0.000 claims description 6
- 239000000203 mixture Substances 0.000 claims description 6
- 229910001220 stainless steel Inorganic materials 0.000 claims description 6
- 239000010935 stainless steel Substances 0.000 claims description 6
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims description 5
- 239000000463 material Substances 0.000 claims description 5
- 229910052751 metal Inorganic materials 0.000 claims description 5
- 239000002184 metal Substances 0.000 claims description 5
- 238000003618 dip coating Methods 0.000 claims description 4
- 230000000149 penetrating effect Effects 0.000 claims description 4
- 238000005507 spraying Methods 0.000 claims description 4
- 239000004812 Fluorinated ethylene propylene Substances 0.000 claims description 3
- 239000004677 Nylon Substances 0.000 claims description 3
- 239000004696 Poly ether ether ketone Substances 0.000 claims description 3
- 229920002614 Polyether block amide Polymers 0.000 claims description 3
- 239000004676 acrylonitrile butadiene styrene Substances 0.000 claims description 3
- 229920000122 acrylonitrile butadiene styrene Polymers 0.000 claims description 3
- JUPQTSLXMOCDHR-UHFFFAOYSA-N benzene-1,4-diol;bis(4-fluorophenyl)methanone Chemical compound OC1=CC=C(O)C=C1.C1=CC(F)=CC=C1C(=O)C1=CC=C(F)C=C1 JUPQTSLXMOCDHR-UHFFFAOYSA-N 0.000 claims description 3
- 229920000295 expanded polytetrafluoroethylene Polymers 0.000 claims description 3
- 229920001903 high density polyethylene Polymers 0.000 claims description 3
- 239000004700 high-density polyethylene Substances 0.000 claims description 3
- 229920001778 nylon Polymers 0.000 claims description 3
- 229920003229 poly(methyl methacrylate) Polymers 0.000 claims description 3
- 229920000515 polycarbonate Polymers 0.000 claims description 3
- 239000004417 polycarbonate Substances 0.000 claims description 3
- 229920000728 polyester Polymers 0.000 claims description 3
- 229920002530 polyetherether ketone Polymers 0.000 claims description 3
- 239000004926 polymethyl methacrylate Substances 0.000 claims description 3
- 229920000098 polyolefin Polymers 0.000 claims description 3
- 229920001343 polytetrafluoroethylene Polymers 0.000 claims description 3
- 239000004810 polytetrafluoroethylene Substances 0.000 claims description 3
- 229920003225 polyurethane elastomer Polymers 0.000 claims description 3
- 239000011347 resin Substances 0.000 claims description 3
- 229920005989 resin Polymers 0.000 claims description 3
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 2
- 230000001680 brushing effect Effects 0.000 claims description 2
- 239000000741 silica gel Substances 0.000 claims description 2
- 229910002027 silica gel Inorganic materials 0.000 claims description 2
- 238000000034 method Methods 0.000 abstract description 18
- 210000005077 saccule Anatomy 0.000 abstract description 5
- 238000004804 winding Methods 0.000 abstract description 2
- 238000004519 manufacturing process Methods 0.000 description 5
- 208000037803 restenosis Diseases 0.000 description 5
- 238000011282 treatment Methods 0.000 description 5
- 238000002399 angioplasty Methods 0.000 description 4
- 150000002739 metals Chemical class 0.000 description 3
- 238000010586 diagram Methods 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 230000003902 lesion Effects 0.000 description 2
- 201000001320 Atherosclerosis Diseases 0.000 description 1
- 208000035965 Postoperative Complications Diseases 0.000 description 1
- XUIMIQQOPSSXEZ-UHFFFAOYSA-N Silicon Chemical compound [Si] XUIMIQQOPSSXEZ-UHFFFAOYSA-N 0.000 description 1
- 206010057469 Vascular stenosis Diseases 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 210000004204 blood vessel Anatomy 0.000 description 1
- 230000010339 dilation Effects 0.000 description 1
- 239000003292 glue Substances 0.000 description 1
- 230000002209 hydrophobic effect Effects 0.000 description 1
- 238000002513 implantation Methods 0.000 description 1
- 238000011866 long-term treatment Methods 0.000 description 1
- 238000007726 management method Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 229920001296 polysiloxane Polymers 0.000 description 1
- 238000011268 retreatment Methods 0.000 description 1
- 229910052710 silicon Inorganic materials 0.000 description 1
- 239000010703 silicon Substances 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
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
- A61M25/104—Balloon catheters used for angioplasty
-
- 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
- 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
- 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
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1081—Balloon catheters with special features or adapted for special applications having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
-
- 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/02—General characteristics of the apparatus characterised by a particular materials
Abstract
The invention discloses a drug-coated balloon catheter capable of reducing drug loss, and belongs to the field of medical instruments. The method can reduce the drug loss in the balloon conveying process, and the protective sleeve B is inserted into the introducer to avoid the loss of the drug coating caused by the friction force between the drug balloon and the hemostatic valve; because the protective sleeve A can be torn from the distal end, the friction force of the saccule when the saccule exits the protective sleeve A can be reduced, so that the loss of the medicine in the process of exiting the protective sleeve A is avoided; the protective sleeve B is used for simply winding the balloon, so that the passing diameter of the balloon is reduced, the friction force between the balloon and the hemostatic valve is reduced, and the passing performance of the balloon for reuse is improved.
Description
Technical Field
The invention relates to the field of medical instruments, in particular to a drug coating balloon catheter capable of reducing drug loss.
Background
Endoluminal balloon angioplasty has been widely used to treat vascular stenosis caused by atherosclerosis since its formation in the seventies of the last century. Although the immediate management effect of balloon angioplasty is satisfactory, the incidence of postoperative complications, particularly restenosis, is high, and thus the goal of long-term treatment cannot be achieved.
The stent is placed in a narrow position while the saccule is expanded in the angioplasty, so that the treatment purpose is achieved, particularly, the occurrence of a drug coating stent greatly reduces the occurrence probability of vascular restenosis, but the restenosis in the stent caused by intimal tearing during the angioplasty increases the difficulty of retreatment.
The drug coated balloon is an emerging means for intracavity treatment in the recent years, can reduce the probability of restenosis, can be used for any part of a blood vessel, and can not increase the difficulty of re-operation after restenosis, thereby showing good application prospect of the drug coated balloon.
At present, the companies such as Belgo medical treatment, mei Dun Li and Pade develop drug coating balloons in sequence, and the drug coating balloons on the market in China are treated by Belgo medical treatment, beijing first Ruida and Liaoning boundary medical treatment. Although the drug coated balloon can alleviate the side effects of balloon dilation and stent implantation, the drug coated balloon can suffer drug loss during delivery, thereby affecting the final efficacy. To address drug loss during delivery, the invention is controlled from the manufacturing process and provides a method of reducing drug loss during balloon delivery. Because the loss of the medicine in the conveying process of the medicine coating balloon mainly comes from the friction between the surface of the medicine coating balloon and the conveying device, different folding wings on the surface of the balloon can be coated with different medicine amounts under the condition that the total medicine carrying capacity of the balloon is unchanged, the medicine coating amount of the folding wings exposed outside is less, and the medicine coating amount contained below the folding wings is more. So that the amount of drug eventually reaching the lesion increases.
Disclosure of Invention
The invention aims to solve the problems of reducing the loss in the balloon conveying process and being incapable of controlling the thickness of a drug coating on the surface of a balloon, and provides a drug coated balloon catheter capable of reducing the drug loss, which effectively reduces the loss in the balloon conveying process and controls the thickness of the drug coating on the surface of the balloon.
In order to achieve the above purpose, the present invention adopts the following technical scheme:
the utility model provides a can reduce medicine loss's medicine coating sacculus pipe, includes protective sheath A, protective sheath B, sacculus and medicine coating instrument, protective sheath A includes inner lumen, tearable fin and reducing pipe A, reducing pipe A right side and inner lumen fixed connection, inner lumen right side and tearable fin fixed connection, protective sheath B includes reducing pipe B, main part pipe and pointed end pipe, reducing pipe B right-hand member and main part pipe fixed connection, main part pipe right-hand member and pointed end pipe left side fixed connection, sacculus left side and sacculus pipe right-hand member fixed connection;
the medicine coating tool comprises a longitudinal strip and a fixing ring, wherein the left end and the right end of the longitudinal strip are movably connected with the inner side of the fixing ring.
Preferably, the method comprises the following steps:
s1, taking a balloon in a natural state, penetrating the balloon into a drug coating tool, inflating the balloon, and coating the balloon with the drug;
s2, negative pressure is pumped to the balloon, the balloon is taken out of the drug coating tool after the negative pressure is pumped, the protecting sleeve A is sleeved outside the folded balloon, and then the protecting sleeve B is sleeved outside the protecting sleeve A;
s3, inserting the distal end part of the protective sleeve B into the introducer through the hemostatic valve;
s4, the protective sleeve A is withdrawn from the protective sleeve B, the tearable wing piece on the protective sleeve A of the torn part is exposed out of the balloon in the protective sleeve A, the distal end of the tearable wing piece is left outside the protective sleeve B, and then the balloon is conveyed along the protective sleeve B, so that the balloon completely enters the introducer;
s5, after the balloon completely enters the introducer, moving the protective sleeve B to the proximal end of the balloon catheter along the balloon catheter;
s6, after the balloon is completely expanded and taken out of the introducer, negative pressure is pumped to the balloon, then the protective sleeve B is moved from the proximal end of the balloon catheter to the distal end of the balloon catheter, the balloon is sleeved inside the protective sleeve B, then the distal end part of the protective sleeve B is inserted into the introducer through the hemostatic valve, and then the balloon enters the introducer along the protective sleeve B.
Preferably, the inner diameter of the inner lumen is greater than the outer diameter of the balloon, and the inner diameter of the main body tube is greater than the outer diameter of the inner lumen.
Preferably, the length of the longitudinal strip is greater than or equal to the length of the straight section of the balloon, the longitudinal strip is provided with an integer of N strips (N=2, 3,4,5,6,7, 8), the medicine is coated by adopting a spraying, dip-coating or brush-coating mode, the thickness of the longitudinal strip is between 0.05mm and 0.30mm, and the inner diameter of the fixing ring (0202) is greater than the outer diameter of the balloon (0100).
Preferably, the inner lumen (0301) and the main body tube (0402) are made of medical grade metals such as expanded polytetrafluoroethylene, HDPE, KYNER, FEP, PEEK, stainless steel, aluminum and copper or a mixture of the above materials.
Preferably, the drug coating tool (0200) is made of stainless steel, copper and aluminum metals or Peek, polytetrafluoroethylene, ABS, polycarbonate and polymethyl methacrylate.
Preferably, the balloon (0100) is made of polyurethane elastomer, nylon, block polyether amide resin, polyolefin, polyester, and silicone or a mixture of any two of the above.
Compared with the prior art, the invention provides the drug coating balloon catheter capable of reducing the drug loss, which has the following beneficial effects:
(1) The method can reduce the drug loss in the balloon conveying process, and the protective sleeve B is inserted into the introducer to avoid the loss of the drug coating caused by the friction force between the drug balloon and the hemostatic valve;
(2) Because the protective sleeve A can be torn from the distal end, the friction force of the saccule when the saccule exits the protective sleeve A can be reduced, so that the loss of the medicine in the process of exiting the protective sleeve A is avoided;
(3) The protective sleeve B is used for simply winding the balloon, so that the passing diameter of the balloon is reduced, the friction force between the balloon and the hemostatic valve is reduced, and the passing performance of the balloon for reuse is improved;
(4) The purposes of accurately controlling the content of the medicine on the surface of the balloon and the uniformity of the medicine coating on the surface of the balloon can be achieved by controlling the thickness of the medicine coating on the surface of the balloon;
(5) Because the loss of the medicine in the conveying process of the medicine coating balloon mainly comes from the friction between the surface of the medicine coating and the conveying device, different medicine doses can be coated on different folding wings on the surface of the balloon under the condition of unchanged total medicine loading, the medicine coating quantity of the folding wings exposed outside is less, and the medicine coating quantity contained below the folding wings is more. So that the content of the drug which finally reaches the lesion is increased;
(6) The normal sacculus can have the medicine to glue on the folder in folding process to cause the medicine loss in the production process, finally the medicine content on sacculus surface will reduce, and the sacculus production of exempting from to fold, the folder is not being used in the production process, thereby has avoided the loss of sacculus surface medicine in the production process.
Drawings
FIG. 1 is a schematic diagram showing an assembled structure of a balloon and a drug-coated tool of a drug-coated balloon catheter capable of reducing drug loss according to the present invention;
fig. 2 is a schematic structural view of a protective sleeve a of a drug-coated balloon catheter capable of reducing drug loss according to the present invention;
fig. 3 is a schematic structural view of a protective sheath B of a drug-coated balloon catheter capable of reducing drug loss according to the present invention;
FIG. 4 is a front view and an isometric view of a drug-coated tool of a drug-coated balloon catheter with reduced drug loss in accordance with the present invention;
FIG. 5 is a cross-sectional view of a drug coated balloon catheter according to the present invention showing reduced drug loss in the radial direction of the balloon after drug coating is completed;
FIG. 6 is a cross-sectional view of a drug-coated balloon catheter according to the present invention showing reduced drug loss in the axial direction of the balloon after drug coating is completed;
FIG. 7 is a cross-sectional view of a balloon of a drug-coated balloon catheter according to the present invention with reduced drug loss in the radial direction of the balloon after the balloon is subjected to negative pressure;
FIG. 8 is a schematic diagram illustrating the assembly of a balloon catheter, a protective sheath A and a protective sheath B of a drug-coated balloon catheter capable of reducing drug loss according to the present invention;
FIG. 9 is a cross-sectional view of a balloon catheter, protective sheath A and protective sheath B of a drug-coated balloon catheter according to the present invention for reducing drug loss;
FIG. 10 is a schematic illustration of a balloon delivery process for a drug-coated balloon catheter with reduced drug loss in accordance with the present invention;
FIG. 11 is a cross-sectional view of a balloon delivery process of a drug-coated balloon catheter with reduced drug loss in accordance with the present invention;
FIG. 12 is a schematic illustration of a drug-coated balloon catheter with reduced drug loss in accordance with the present invention, with a balloon fully inserted into protective sheath B;
fig. 13 is a cross-sectional view of a drug coated balloon catheter with reduced drug loss in accordance with the present invention, the balloon fully entering the protective sheath 4.
The reference numerals in the figures illustrate:
0100 balloon, 0101 balloon catheter, 0200 drug coating tool, 0201 longitudinal bar, 0202 fixing ring, 0300 protecting tube a, 0301 inner lumen, 0302 tearable fin, 0303 reducing tube a, 0400 protecting tube B, 0401 reducing tube B, 0402 main body tube, 0403 tip tube, 0501 hemostatic valve, 0502 introducer.
Detailed Description
The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments.
In the description of the present invention, it should be understood that the terms "upper," "lower," "front," "rear," "left," "right," "top," "bottom," "inner," "outer," and the like indicate or are based on the orientation or positional relationship shown in the drawings, merely to facilitate description of the present invention and to simplify the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be configured and operated in a specific orientation, and thus should not be construed as limiting the present invention.
Example 1:
a drug-coated balloon catheter capable of reducing drug loss comprising the steps of:
s1, taking a balloon 0100 in a natural state, penetrating the balloon 0100 into a drug coating tool 0200, inflating the balloon 0100, and coating the balloon 0100 with drugs;
s2, negative pressure is pumped to the balloon 0100, the balloon 0100 is taken out of a drug coating tool 0200 after the negative pressure is pumped, a protective sleeve A0300 is sleeved outside the folded balloon 0100, and then a protective sleeve B0400 is sleeved outside the protective sleeve A0300;
s3, inserting the distal end part of the protective sleeve B0400 into the introducer 0502 through the hemostatic valve 0501;
s4, withdrawing the protective sleeve A0300 from the protective sleeve B0400, tearing the tearable tab 0302 on the partial protective sleeve A0300 to expose the balloon 0100 in the protective sleeve A0300, leaving the distal end of the tearable tab 0302 outside the protective sleeve B0400, and then conveying the balloon 0100 along the protective sleeve B0400 to enable the balloon 0100 to completely enter the introducer 0502;
s5, after the balloon 0100 completely enters the introducer 0502, moving the protective sleeve B0400 along the balloon catheter 0101 to the proximal end of the balloon catheter 0101;
s6, after the balloon 0100 is completely expanded and taken out of the introducer 0502, negative pressure is pumped to the balloon 0100, then the protective sleeve B0400 is moved from the proximal end of the balloon catheter 0101 to the distal end of the balloon catheter 0101, the balloon 0100 is internally sleeved into the balloon 0100, then the distal end portion of the protective sleeve B0400 is inserted into the introducer 0502 through the inside of the hemostatic valve 0501, and then the balloon 0100 is led into the interior of the introducer 0502 along the protective sleeve B0400.
The inner lumen 0301 and the main body tube 0402 are made of medical grade metals such as expanded polytetrafluoroethylene, HDPE, KYNER, FEP, PEEK, stainless steel, aluminum, copper and the like or a mixture of the above materials.
Drug-coated tool 0200 is fabricated from stainless steel, copper, aluminum, etc. metals or Peek, polytetrafluoroethylene, ABS, polycarbonate, and polymethyl methacrylate.
The balloon 0100 is made of polyurethane elastomer, nylon, block polyether amide resin, polyolefin, polyester, silica gel or a mixture of any two of the above materials.
In the use process, firstly, a balloon catheter assembly is provided, wherein the balloon catheter assembly comprises a balloon catheter 0101 and a balloon 0100, and the balloon has a folding structure; protective sleeve a0300 is mounted on balloon 0100 such that balloon 0100 is in a folded configuration but not compressed, while protecting the drug coating on the surface of balloon 0100; protective sheath B0400 is distally presented from protective sheath a0300 and does not compress protective sheath a0300. The distal portion of protective sheath B0400 is inserted through hemostatic valve 0501 and into introducer 0502, then sheath a0300 is retracted by hand, tearable tab 0302 of protective sheath a0300 is exposed to protective sheath B0400, then tearable tab 0302 is peeled off by hand, but the exposed portion of balloon 0100 is not completely peeled off, and the peeled-off tab remains outside of protective sheath B0400, the balloon 0100 is transported along protective sheath B0400 by holding the sheath a0300 tube portion by hand, and the tearable tab 0302 is peeled off while balloon 0100 is transported, and the hand is not allowed to access balloon 0100 throughout the transport process. When balloon 0100 is fully delivered into introducer 0502, protective sheath a0300 is fully stripped from balloon 0100. The reducer B on the sheath B0400 is primarily designed to prevent the sheath B0400 from fully entering the introducer 0502, where the sheath B0400 moves along the catheter to the proximal end of the balloon catheter 0101, once the balloon 0100 has fully entered the introducer 0502.
Example 2: based on example 1 but with the difference that;
when the balloon 0100 is completely taken out of the introducer 0502 after the first expansion, the circumferential outer diameter of the balloon 0100 is relatively large because the balloon 0100 is expanded, so that the friction force of the balloon 0100 entering the introducer 0502 through the hemostatic valve 0501 again can be increased; after the balloon 0100 is taken out of the introducer 0502 for the first time, the protective sleeve B0400 moves from the proximal end to the distal end of the balloon catheter 0101, the balloon 0100 keeps a negative pressure state in the moving process, and when the distal end of the balloon catheter 0101 completely enters the protective sleeve B0400, the movement of the protective sleeve B0400 is stopped, so that the protective sleeve B0400 is ensured not to completely separate from the balloon 0100. The distal portion of protective sheath B0400 is then inserted into hemostatic valve 0501 and into introducer 0502, and balloon 0100 is then advanced along protective sheath B0400 into introducer 0502, and after balloon 0100 is fully advanced, protective sheath B0400 is moved along the catheter to the proximal end of balloon catheter 0101, which can be reused on the same balloon catheter 0101.
Example 3: based on examples 1 and 2 but with the difference that;
the protective sleeve A0300 comprises an inner cavity 0301, a tearable fin 0302 and a reducer A0303, the right side of the reducer A0303 is fixedly connected with the inner cavity 0301, the right side of the inner cavity 0301 is fixedly connected with the tearable fin 0302, the protective sleeve B0400 comprises a reducer B0401, a main body tube 0402 and a tip tube 0403, the right end of the reducer B0401 is fixedly connected with the main body tube 0402, the right end of the main body tube 0402 is fixedly connected with the left side of the tip tube 0403, and the left side of the balloon 0100 is fixedly connected with the right end of the balloon catheter 0101; the inner diameter of the inner lumen 0301 is larger than the outer diameter of the balloon 0100, and the inner diameter of the main body tube 0402 is larger than the outer diameter of the inner lumen 0301.
When the invention is used, the outer surface of the balloon 0100 is coated with a drug coating, the balloon 0100 is provided with a folding structure and a protective sleeve A0300, the protective sleeve A0300 is connected and arranged on the balloon 0100 so as to protect the drug coating on the surface of the balloon 0100 from being damaged, and the inner diameter of an inner cavity 0301 of the protective sleeve A0300 is adapted to or only slightly larger than the outer diameter of the balloon 0100 in a contracted folding structure. Inner lumen 0301 is configured to hold balloon 0100 in a collapsed folded configuration without compressing balloon 0100. The number of the tearable wing 0302 on the protective sleeve A0300 is an integer with N more than 2. The tearable tab 0302 extends partially axially and the tab includes a nub at its end so as to enhance the tearing properties, the nub may protrude from the first tab. The inner lumen 0301 portion may include, but is not limited to, slits, scores, or perforations extending along the length, i.e., extending partially or fully along its length; the inner diameter of the main body tube 0402 on the protective sleeve B0400 is only slightly larger than the outer diameter of the inner lumen 0301. The inner and outer surfaces of protective sleeve B0400 can be coated with any coating including, but not limited to, a silicon coating and a hydrophilic or hydrophobic coating.
Example 4: based on examples 1, 2 and 3 but with the differences;
the medicine coating tool 0200 comprises a longitudinal bar 0201 and a fixed ring 0202, wherein the left end and the right end of the longitudinal bar 0201 are movably connected with the inner side of the fixed ring 0202, the length of the longitudinal bar 0201 is larger than or equal to the length of a straight section of the balloon 0100, the longitudinal bar 0201 is provided with an integer N of N=2, 3,4,5,6,7,8, the medicine coating adopts the mode of spraying, dip-coating or brush-coating and the like, the thickness of the longitudinal bar 0201 is between 0.05mm and 0.30mm, and the inner diameter of the fixed ring 0202 is larger than the outer diameter of the balloon 0100;
under the natural state of the balloon 0100, penetrating the balloon 0100 into a drug coating tool 0200, and then inflating to tightly combine the balloon 0100 and the drug coating tool 0200, so that the balloon 0100 cannot slide to be optimal; the length of the longitudinal strips 0201 on the drug coating tool 0200 can be equal to or larger than the length of the straight section of the balloon 0100, and the number of the longitudinal strips is 5; after the balloon 0100 is inflated, medicine coating equipment is adopted to coat medicine on the balloon 0100, but the medicine coating modes such as spraying, dip coating, brushing and the like can be adopted, but the medicine coating mode is not limited, after the medicine coating is finished, a strip-shaped coated belt and a strip-shaped non-coated belt are arranged on the surface of the balloon 0100, the width of the non-coated belt is consistent with the width of the longitudinal strip 0201, negative pressure is pumped on the balloon 0100, the surface coated belt of the balloon 0100 can naturally form folding wings, and the non-coated belt forms a part tightly attached to the inner tube. After the balloon 0100 forms folding wings, taking out the balloon 0100 from the drug coating tool 0200 and sleeving the protective sleeve A0300; the thickness of the coating can be controlled by the thickness of the longitudinal strips 0201, and the thickness of the longitudinal strips 0201 can be selected from 0.05mm to 0.30mm, and the thickness is selected to be 0.15mm at this time; different thicknesses of longitudinal strips 0201 may be coated with different thicknesses of drug coating.
The foregoing is only a preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any person skilled in the art, who is within the scope of the present invention, should make equivalent substitutions or modifications according to the technical scheme of the present invention and the inventive concept thereof, and should be covered by the scope of the present invention.
Claims (6)
1. A drug-coated balloon catheter capable of reducing drug loss, comprising a protective sleeve a (0300), a protective sleeve B (0400), a balloon (0100) and a drug-coated tool (0200), characterized in that: the protective sleeve A (0300) comprises an inner cavity (0301), a tearable fin (0302) and a reducer A (0303), wherein the right side of the reducer A (0303) is fixedly connected with the inner cavity (0301), the right side of the inner cavity (0301) is fixedly connected with the tearable fin (0302), the protective sleeve B (0400) comprises a reducer B (0401), a main pipe (0402) and a tip pipe (0403), the right end of the reducer B (0401) is fixedly connected with the main pipe (0402), the right end of the main pipe (0402) is fixedly connected with the left side of the tip pipe (0403), and the left side of the balloon (0100) is fixedly connected with the right end of the balloon catheter (0101);
the medicine coating tool (0200) comprises a longitudinal strip (0201) and a fixed ring (0202), wherein the left end and the right end of the longitudinal strip (0201) are movably connected with the inner side of the fixed ring (0202);
the drug-coated balloon catheter capable of reducing drug loss comprises the following steps:
s1, taking a balloon (0100) in a natural state, penetrating the balloon (0100) into a drug coating tool (0200), inflating the balloon (0100), and coating the balloon (0100) with drugs;
s2, negative pressure is pumped to the balloon (0100), the balloon (0100) is taken out of the drug coating tool (0200) after the negative pressure is pumped, a protective sleeve A (0300) is sleeved outside the folded balloon (0100), and a protective sleeve B (0400) is sleeved outside the protective sleeve A (0300);
s3, inserting the distal end part of the protective sleeve B (0400) into the introducer (0502) through the hemostatic valve (0501);
s4, withdrawing the protective sleeve A (0300) from the protective sleeve B (0400), tearing the tearable wing (0302) on the part protective sleeve A (0300) to expose the balloon (0100) inside the protective sleeve A (0300), leaving the distal end of the tearable wing (0302) outside the protective sleeve B (0400), and then conveying the balloon (0100) along the protective sleeve B (0400) to enable the balloon (0100) to completely enter the introducer (0502);
s5, after the balloon (0100) completely enters the introducer (0502), moving the protective sleeve B (0400) to the proximal end of the balloon catheter (0101) along the balloon catheter (0101);
s6, after the balloon (0100) is expanded and taken out of the introducer (0502), negative pressure is pumped to the balloon (0100), then the protective sleeve B (0400) is moved from the proximal end of the balloon catheter (0101) to the distal end of the balloon catheter (0101), the protective sleeve B (0400) is sleeved into the balloon (0100), then the distal end part of the protective sleeve B (0400) is inserted into the introducer (0502) through the hemostatic valve (0501), and then the balloon (0100) enters the interior of the introducer (0502) along the protective sleeve B (0400).
2. A drug-coated balloon catheter for reducing drug loss according to claim 1, wherein: the inner diameter of the inner tube cavity (0301) is larger than the outer diameter of the balloon (0100), and the inner diameter of the main body tube (0402) is larger than the outer diameter of the inner tube cavity (0301).
3. A drug-coated balloon catheter capable of reducing drug loss according to claim 1 or 2, wherein: the length of the longitudinal strips (0201) is greater than or equal to the length of the straight section of the balloon (0100), the length of the longitudinal strips (0201) is provided with an integer of N strips (N=2, 3,4,5,6,7, 8), the medicine is coated in a spraying, dip-coating or brushing mode, the thickness of the longitudinal strips (0201) is between 0.05mm and 0.30mm, and the inner diameter of the fixing ring (0202) is greater than the outer diameter of the balloon (0100).
4. A drug-coated balloon catheter for reducing drug loss according to claim 1, wherein: the inner lumen (0301) and the main body tube (0402) are made of expanded polytetrafluoroethylene, HDPE, KYNER, FEP, PEEK, stainless steel, aluminum, copper medical grade metal or a mixture of the above materials.
5. A drug-coated balloon catheter for reducing drug loss according to claim 1, wherein: the drug coating tool (0200) is made of stainless steel, copper, aluminum or Peek, polytetrafluoroethylene, ABS, polycarbonate and polymethyl methacrylate.
6. A drug-coated balloon catheter for reducing drug loss according to claim 1, wherein: the balloon (0100) is made of polyurethane elastomer, nylon, block polyether amide resin, polyolefin, polyester, silica gel or a mixture of any two materials.
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| CN201810934947.8A CN109011112B (en) | 2018-08-16 | 2018-08-16 | Drug-coated balloon catheter capable of reducing drug loss |
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| CN201810934947.8A CN109011112B (en) | 2018-08-16 | 2018-08-16 | Drug-coated balloon catheter capable of reducing drug loss |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN113289214B (en) * | 2021-06-15 | 2022-08-19 | 南京吉米医疗科技有限公司 | Low-loss medicine balloon |
| CN217067377U (en) * | 2021-12-29 | 2022-07-29 | 上海蓝脉医疗科技有限公司 | Balloon system |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105307716A (en) * | 2013-05-03 | 2016-02-03 | C·R·巴德公司 | Peelable protective sheath |
| JP2016029983A (en) * | 2014-07-25 | 2016-03-07 | テルモ株式会社 | Catheter, protective sheath, and catheter system |
| CN209137705U (en) * | 2018-08-16 | 2019-07-23 | 北京先瑞达医疗科技有限公司 | A kind of novel drug coated balloon catheter for reducing drug loss |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7105013B2 (en) * | 2002-09-30 | 2006-09-12 | Advanced Cardiovascular Systems, Inc. | Protective sleeve assembly for a balloon catheter |
| US20120296313A1 (en) * | 2011-05-20 | 2012-11-22 | Abbott Cardiovascular Systems Inc. | Drug Coated Balloon Hemostatic Valve Insertion/Balloon Sheath |
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2018
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105307716A (en) * | 2013-05-03 | 2016-02-03 | C·R·巴德公司 | Peelable protective sheath |
| JP2016029983A (en) * | 2014-07-25 | 2016-03-07 | テルモ株式会社 | Catheter, protective sheath, and catheter system |
| CN209137705U (en) * | 2018-08-16 | 2019-07-23 | 北京先瑞达医疗科技有限公司 | A kind of novel drug coated balloon catheter for reducing drug loss |
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