CN115414575B - cutting balloon catheter - Google Patents

cutting balloon catheter Download PDF

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Publication number
CN115414575B
CN115414575B CN202210994540.0A CN202210994540A CN115414575B CN 115414575 B CN115414575 B CN 115414575B CN 202210994540 A CN202210994540 A CN 202210994540A CN 115414575 B CN115414575 B CN 115414575B
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CN
China
Prior art keywords
balloon
sleeve
guide
cutting
cutter
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
CN202210994540.0A
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Chinese (zh)
Other versions
CN115414575A (en
Inventor
杨武锋
黄君仪
刘朝生
张志军
李斌
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Guangdong Bomai Medical Technology Co Ltd
Original Assignee
Guangdong Bomai Medical Technology Co Ltd
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Publication date
Application filed by Guangdong Bomai Medical Technology Co Ltd filed Critical Guangdong Bomai Medical Technology Co Ltd
Priority to CN202210994540.0A priority Critical patent/CN115414575B/en
Publication of CN115414575A publication Critical patent/CN115414575A/en
Application granted granted Critical
Publication of CN115414575B publication Critical patent/CN115414575B/en
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/3209Incision instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082Catheter tip comprising a tool
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B2017/320052Guides for cutting instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B2017/320056Tunnelers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2210/00Anatomical parts of the body
    • A61M2210/12Blood circulatory system

Abstract

The application is applicable to the technical field of medical instruments, and provides a cutting balloon catheter, which comprises: the catheter comprises a catheter body, a catheter body and a catheter body, wherein the catheter body comprises a balloon outer tube and an outer sleeve movably sleeved on the balloon outer tube, and the distal end of the balloon outer tube is provided with a balloon part; the cutter part is arranged outside the balloon part, or is movably sleeved on the balloon outer tube and can reach the outside of the balloon part; the outer sleeve is provided with a shielding position for covering the balloon part and an avoiding position for avoiding the balloon part. The cutting balloon catheter provided by the application is used for vascular interventional operation, so that the damage risk of the cutting balloon catheter provided by the application to normal blood vessels can be effectively reduced.

Description

Cutting balloon catheter
Technical Field
The application belongs to the technical field of medical instruments, and particularly relates to a cutting balloon catheter.
Background
Vascular intervention is an important treatment mode for carrying out vascular stenosis blood circulation reconstruction treatment. In vascular interventional therapy, for some intravascular stenotic lesions such as calcification, plaque or fibrosis, special balloon products such as cutting and scoring are often adopted for treatment, wherein the cutting balloon is axially provided with a plurality of rows of blades on the outer circumferential surface of the balloon, and the blades are contacted with the lesion when the balloon is expanded, so that the lesion is incised, and elastic retraction after the lesion expansion is reduced. Before the balloon is expanded, the blade is positioned in the groove of the balloon folding zone, when the balloon is expanded to the lesion, the blade extends out of the balloon to regularly cut vascular lesions, irregular tearing of the blood vessels caused by the mode is small, and restenosis can be reduced.
However, the cutting balloon in the market at present is relatively large in diameter after being folded due to the existence of the blade and the blade base and the special folding mode, and is relatively poor in passing ability when treating stenotic lesions, and is generally required to be pretreated by other instruments, meanwhile, the blade is made of stainless steel materials and is fixed on the balloon, and the overall hardness is relatively high. Although the prior art adopts a plurality of short blades to be arranged at intervals of a certain length, the blade base of the cutting balloon is still integrally adhered to the balloon by glue, the cutting balloon still can only bear smaller bending, because of the sharp and inflexible characteristics of the cutting edge, the cutting balloon can not pass through a tortuous vascular part in the conveying process, the normal vascular wall is damaged when the cutting balloon is excessively bent, and the adverse events such as vascular perforation and the like are easily caused when the cutting balloon expands at a lesion part with larger angulation, so the cutting balloon is not suitable for treating tortuous lesions and lesions with angulation of more than 45 degrees.
Disclosure of Invention
The embodiment of the application aims to provide a cutting balloon catheter, which aims to solve the technical problems that a cutting balloon in the prior art cannot be used in a tortuous blood vessel and is easy to cause perforation of the blood vessel.
To achieve the above object, according to one aspect of the present application, there is provided a cutting balloon catheter including: the catheter comprises a catheter body, a catheter body and a catheter body, wherein the catheter body comprises a balloon outer tube and an outer sleeve movably sleeved on the balloon outer tube, and the distal end of the balloon outer tube is provided with a balloon part; the cutter part is arranged outside the balloon part, or is movably sleeved on the balloon outer tube and can reach the outside of the balloon part; the outer sleeve is provided with a shielding position for covering the balloon part and an avoiding position for avoiding the balloon part.
Optionally, the tube body portion further comprises a guide portion, two ends of the guide portion are connected with the balloon outer tube, two ends of the guide portion are located at two ends of the balloon portion respectively, and the cutter portion is movably sleeved on the guide portion.
Optionally, the cutter part is movably sleeved on the balloon outer tube, the tube body part further comprises a push-type cutter sleeve, the push-type cutter sleeve is movably sleeved on the balloon outer tube and is positioned between the balloon outer tube and the outer layer sleeve, and the push-type cutter sleeve is used for pushing the cutter part to the outside of the balloon part.
Optionally, a limiting protrusion is provided at an end of the guiding portion near the distal end of the balloon portion for limiting movement of the cutter portion in a direction away from the balloon portion.
Optionally, the guiding part comprises a guiding flat wire, the cutter part comprises a plurality of blades, the blades are provided with guiding flat holes, and the blades are sleeved on the guiding flat wire through the guiding flat holes.
Optionally, the cutter part further comprises a plurality of buffer hoses, the buffer hoses are sleeved on the guide flat wires, and the buffer hoses are respectively located in gaps between a plurality of adjacent two blades.
Optionally, the guide part and the cutter part are all a plurality of, and a plurality of guide parts and a plurality of cutter parts set up in a one-to-one correspondence, and the guide part sets up along the circumference interval of sacculus.
Optionally, the distal end of the outer sleeve is provided with a first marker; the distal end of the push broach sleeve is provided with a second marker.
Optionally, the cutting balloon catheter further comprises a tip structure and a balloon inner tube, wherein the tip structure is fixedly connected with the distal end of the balloon inner tube, and the balloon inner tube is arranged inside the balloon outer tube; the balloon inner tube is provided with a third marking part which is positioned in the balloon.
Optionally, the cutting balloon catheter further comprises a control portion disposed at the proximal end of the tube body portion, the control portion comprising: the control handle is provided with a first long hole, a second long hole and a balloon control port, and the balloon control port is communicated with the inside of the balloon outer tube and is used for inputting or outputting a medium to the balloon part; the outer part of the first control rod is movably arranged in the first long hole, and the inner part of the first control rod is connected with the proximal end of the outer sleeve and is used for controlling the outer sleeve to move; and the outer part of the second control rod is movably arranged in the second long hole, and the inner part of the second control rod is connected with the proximal end of the push-type knife sleeve and is used for controlling the push-type knife sleeve to move.
The cutting balloon catheter provided by the application has the beneficial effects that: compared with the prior art, the cutting balloon catheter provided by the application has the advantages that the outer sleeve is movably sleeved on the balloon outer tube, the cutter part is arranged outside the balloon part, or the cutter part is movably sleeved on the balloon outer tube, and the outer sleeve is provided with the shielding position for covering the balloon part and the avoiding position for avoiding the balloon part, so that the cutting balloon catheter provided by the application can be used in a tortuous vessel by movably sleeved on the balloon outer tube, and the trafficability of the cutting balloon catheter provided by the application is effectively improved, so that the cutting balloon catheter provided by the application can normally work in the tortuous vessel; meanwhile, under the condition that the cutting balloon catheter provided by the application needs to be used in a normal blood vessel, the position of the outer sleeve provided by the application is set as a shielding position, so that the cutter part can be effectively shielded by the outer sleeve, the damage risk of the cutting balloon catheter provided by the application to the normal blood vessel is effectively reduced, and under the condition that the cutting balloon catheter provided by the application reaches a lesion position, the cutter part can be effectively used for cutting the lesion by switching the outer sleeve from the shielding position to the avoiding position, and after the vascular intervention operation is completed, the cutting balloon catheter provided by the application can be safely withdrawn from the blood vessel by switching the outer sleeve to the shielding position.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings that are needed in the embodiments or the description of the prior art will be briefly described below, it being obvious that the drawings in the following description are only some embodiments of the present application, and that other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.
Fig. 1 is a schematic structural view of a cutting balloon catheter according to an embodiment of the present application;
FIG. 2 is a partial cross-sectional view of a cutting balloon catheter provided in an embodiment of the present application;
fig. 3 is a schematic structural view of a cutter portion and a guide portion according to an embodiment of the present application;
FIG. 4 is a schematic view of a blade according to an embodiment of the present application;
fig. 5 is a schematic structural view of a guide part according to an embodiment of the present application;
fig. 6 is a schematic structural view of a cutting balloon catheter according to an embodiment of the present application in a working state;
fig. 7 is a schematic structural view of a cutting balloon catheter according to an embodiment of the present application in another working state;
fig. 8 is a schematic structural view of a cutting balloon catheter according to an embodiment of the present application in yet another working state;
reference numerals related to the above figures are as follows:
10. a tube body portion; 11. a balloon outer tube; 12. an outer sleeve; 121. a first marking part; 13. a guide part; 131. a limit protrusion; 132. guiding the flat wire; 14. push broach sleeve; 141. a second marking section; 15. a balloon inner tube; 151. a third marking section; 152. a guidewire lumen;
20. a balloon portion;
30. a cutter section; 31. a blade; 311. a guide flat hole; 32. a buffer hose;
40. a tip structure; 41. the guide wire penetrates through the hole;
50. a control unit; 51. a control handle; 511. a second long hole; 512. a balloon control port; 52. a first control lever; 53. and a second control lever.
Detailed Description
In order to make the technical problems, technical schemes and beneficial effects to be solved more clear, the application is further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are for purposes of illustration only and are not intended to limit the scope of the application.
It will be understood that when an element is referred to as being "mounted" or "disposed" on another element, it can be directly on the other element or be indirectly on the other element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or be indirectly connected to the other element. Embodiments of the application and features of the embodiments may be combined with each other without conflict. The application will be described in detail below with reference to the drawings in connection with embodiments.
It is to be understood that the terms "length," "width," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," and the like are merely for convenience in describing and simplifying the description based on the orientation or positional relationship shown in the drawings, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus are not to be construed as limiting the application.
Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include one or more such feature. In the description of the present application, the meaning of "plurality" is two or more unless specifically defined otherwise.
As noted in the background, vascular intervention is currently an important treatment modality for the revascularization of stenotic lesions. In vascular interventional therapy, for some intravascular stenotic lesions such as calcification, plaque or fibrosis, special balloon products such as cutting and scoring are often adopted for treatment, wherein the cutting balloon is axially provided with a plurality of rows of blades on the outer circumferential surface of the balloon, and the blades are contacted with the lesion when the balloon is expanded, so that the lesion is incised, and elastic retraction after the lesion expansion is reduced. Before the balloon is expanded, the blade is positioned in the groove of the balloon folding zone, when the balloon is expanded to the lesion, the blade extends out of the balloon to regularly cut vascular lesions, irregular tearing of the blood vessels caused by the mode is small, and restenosis can be reduced. However, the cutting balloon in the market at present is relatively large in diameter after being folded due to the existence of the blade and the blade base and the special folding mode, and is relatively poor in passing ability when treating stenotic lesions, and is generally required to be pretreated by other instruments, meanwhile, the blade is made of stainless steel materials and is fixed on the balloon, and the overall hardness is relatively high. Although the prior art adopts a plurality of short blades to be arranged at intervals of a certain length, the blade base of the cutting balloon is still integrally adhered to the balloon by glue, the cutting balloon still can only bear smaller bending, because of the sharp and inflexible characteristics of the cutting edge, the cutting balloon can not pass through a tortuous vascular part in the conveying process, the normal vascular wall is damaged when the cutting balloon is excessively bent, and the adverse events such as vascular perforation and the like are easily caused when the cutting balloon expands at a lesion part with larger angulation, so the cutting balloon is not suitable for treating tortuous lesions and lesions with angulation of more than 45 degrees.
Referring to fig. 1 to 8, in order to solve the above problems, according to an aspect of the present application, there is provided a cutting balloon catheter, a tube body 10 and a cutter portion 30, wherein the tube body 10 includes a balloon outer tube 11, and an outer sleeve 12 movably sleeved on the balloon outer tube 11, and a balloon portion 20 is provided at a distal end of the balloon outer tube 11; the cutter part 30 is arranged outside the balloon part 20, or the cutter part 30 is movably sleeved on the balloon outer tube 11 and can reach the outside of the balloon part 20; the outer sleeve 12 has a shielding position for covering the balloon portion 20 and an avoidance position for avoiding the balloon portion 20. The cutting balloon catheter provided in this embodiment is capable of effectively improving the trafficability of the cutting balloon catheter provided in this embodiment by movably sleeving the outer sleeve 12 on the balloon outer tube 11 and the cutter portion 30 outside the balloon portion 20, or movably sleeving the cutter portion 30 on the balloon outer tube 11 and having the shielding position covering the balloon portion 20 and the avoiding position avoiding the balloon portion 20, so that the cutting balloon catheter provided in this embodiment can be used in a tortuous vessel by movably sleeving the cutter portion 30 on the balloon outer tube 11, thereby enabling the cutting balloon catheter provided in this embodiment to normally operate in the tortuous vessel; meanwhile, in the case that the cutting balloon catheter provided in this embodiment needs to be used in a normal blood vessel, the position of the outer layer sleeve 12 provided in this embodiment can be set to be a shielding position, so that the outer layer sleeve 12 can effectively shield the cutter portion 30, and therefore the damage risk of the cutting balloon catheter provided in this embodiment to the normal blood vessel is effectively reduced, in the case that the cutting balloon catheter provided in this embodiment reaches a lesion position, the cutter portion 30 can effectively perform cutting operation on the lesion by switching the outer layer sleeve 12 from the shielding position to the avoiding position, and after the vascular intervention operation is completed, the cutting balloon catheter of this embodiment can be safely withdrawn from the blood vessel by switching the outer layer sleeve 12 to the shielding position.
In a specific embodiment, in order to improve the capability of the cutting balloon catheter provided by the embodiment to pass through a tortuous blood vessel, the cutter portion 30 in the embodiment is movably sleeved on the balloon outer tube 11, and meanwhile, the cutter portion 30 provided by the embodiment can reach the outside of the balloon portion 20, and by movably sleeved on the balloon outer tube 11, the capability of the cutting balloon catheter provided by the embodiment to pass through a tortuous blood vessel can be effectively improved.
In a preferred embodiment, the material of the balloon portion 20 in this embodiment is a semi-compliant or non-compliant material.
In a preferred embodiment, the material of the outer sleeve 12 in this embodiment is nylon, and in other embodiments, the material of the outer sleeve 12 in this embodiment may be polyether block polyamide, a multi-layer woven tube, a metal spiral cut tube, or the like.
Referring to fig. 1 and 5, in order to enable the cutter portion 30 provided in the present embodiment to move to the outside of the balloon portion 20 along a fixed track, the tube body portion 10 in the present embodiment further includes a guide portion 13, both ends of the guide portion 13 are connected with the balloon outer tube 11, both ends of the guide portion 13 are respectively located at both ends of the balloon portion 20, and the cutter portion 30 is movably sleeved on the guide portion 13. By providing the guide portion 13 on the balloon outer tube 11 and providing both ends of the guide portion 13 on both ends of the balloon portion 20, respectively, the cutter portion 30 provided in this embodiment can be effectively moved to the outside of the balloon portion 20 along a fixed track, so that the cutter portion 30 provided in this embodiment can effectively perform a cutting operation on a lesion.
Referring to fig. 1, in order to effectively push the cutter portion 30 provided in the present embodiment to the outside of the balloon portion 20, the cutter portion 30 in the present embodiment is movably sleeved on the balloon outer tube 11, the tube body portion 10 further includes a push-type cutter sleeve 14, the push-type cutter sleeve 14 is movably sleeved on the balloon outer tube 11 and is located between the balloon outer tube 11 and the outer layer sleeve 12, and the push-type cutter sleeve 14 is used for pushing the cutter portion 30 to the outside of the balloon portion 20. By movably fitting the push-type cutter portion 14 over the balloon outer tube 11 with the push-type cutter portion 14 interposed between the balloon outer tube 11 and the outer layer sleeve 12, the cutter portion 30 provided in the present embodiment can be pushed to the outside of the balloon portion 20 by the push-type cutter portion 14.
In a preferred embodiment, the push-broach sleeve 14 in this embodiment is disposed coaxially with the outer sleeve 12, and the push-broach sleeve 14 in this embodiment is made of nylon, however, in other embodiments, the push-broach sleeve 14 in this embodiment may be made of polyether block polyamide, a multi-layer woven tube, a metal spiral cut tube, or the like.
Referring to fig. 1 and 5, in order to enable the cutter portion 30 provided in the present embodiment to move to a designated position outside the balloon portion 20, one end of the guide portion 13 near the distal end of the balloon portion 20 in the present embodiment is provided with a stopper protrusion 131 for restricting movement of the cutter portion 30 in a direction of being separated from the balloon portion 20. By providing the stopper protrusion 131 at one end of the guide portion 13 near the distal end of the balloon portion 20, the cutter portion 30 can be effectively restricted from moving in a direction away from the balloon portion 20, so that the cutter portion 30 provided in the present embodiment can be moved to a specified position outside the balloon portion 20.
Referring to fig. 5, in order to ensure that the cutter portion 30 provided in this embodiment can effectively cut a lesion, the guide portion 13 in this embodiment includes a guide flat wire 132, the cutter portion 30 includes a plurality of blades 31, a guide flat hole 311 is provided on the blades 31, and the blades 31 are sleeved on the guide flat wire 132 through the guide flat hole 311. Through setting up the guide part 13 into the direction flat wire 132 to set up the direction flat hole 311 on blade 31, and make blade 31 pass through the direction flat hole 311 cover and establish on the direction flat wire 132, alright effectual rotation of restriction blade 31 makes blade 31 point to fixed direction for direction flat wire 132 all the time, thereby guarantees that the cutter portion 30 that this embodiment provided can effectually cut the pathological change.
In a preferred embodiment, the material of the blade 31 in this embodiment is an alloy, but in other embodiments, the material of the blade 31 in this embodiment may be a material with high hardness such as pure metal, plastic, or ceramic.
In a preferred embodiment, the height of the blade 31 in this embodiment is in the range of 0.05 to 5mm and the length of the blade 31 is in the range of 1 to 50mm.
In a preferred embodiment, the number of blades 31 in this embodiment is determined based on the length of the balloon portion 20.
In a preferred embodiment, the shape of the guide flat wire 132 in this embodiment may be other shapes that can limit the direction of the blade 31, and the guide flat hole 311 on the blade 31 is adapted to the shape of the guide flat wire 132.
Referring to fig. 3, in order to improve the capability of the cutting balloon catheter according to the present embodiment to pass through tortuous vessels, the cutter portion 30 in the embodiment further includes a plurality of buffer hoses 32, the buffer hoses 32 are sleeved on the guide flat wire 132, and the plurality of buffer hoses 32 are respectively located in gaps between a plurality of adjacent two blades 31. The ability of the cutting balloon catheter provided by the embodiment to pass through tortuous vessels can be effectively improved by sleeving a plurality of buffer hoses 32 on the guide flat wires 132 and arranging the buffer hoses 32 in gaps between a plurality of adjacent two blades 31.
In a preferred embodiment, the length of the buffer hose 32 in this embodiment ranges from 0.5 to 10mm, the material of the buffer hose 32 is silica gel, and in other embodiments, the material of the buffer hose 32 in this embodiment may be a polymer material with good flexibility, such as thermoplastic polyurethane elastomer, polyether block polyamide, nylon, etc.
In order to improve the effect of the cutting balloon catheter for cutting lesions provided in the present embodiment, the guide portions 13 and the cutter portions 30 in the present embodiment are all plural, the plural guide portions 13 are disposed in one-to-one correspondence with the plural cutter portions 30, and the guide portions 13 are disposed at intervals along the circumferential direction of the balloon. The guide portions 13 and the cutter portions 30 are provided in plurality, the guide portions 13 and the cutter portions 30 are provided in one-to-one correspondence, and the guide portions 13 are provided at intervals along the circumferential direction of the balloon, so that the cutting effect of the cutting balloon catheter provided by the embodiment on lesions can be effectively improved.
Referring to fig. 1, in order to facilitate monitoring of the positions of the outer sleeve 12 and the push broach sleeve 14, the distal end of the outer sleeve 12 in this embodiment is provided with a first marker 121; the distal end of the push sleeve 14 is provided with a second marker 141. By providing the first marker 121 at the distal end of the outer sleeve 12 and the second marker 141 at the distal end of the push sleeve 14, the position of the outer sleeve 12 and push sleeve 14 can be effectively monitored.
In a preferred embodiment, the first marking portion 121 and the second marking portion 141 in this embodiment are used to mark the positions of the outer sleeve 12 and the push sleeve 14, respectively, under X-rays.
Referring to fig. 1, in order to facilitate the movement of the cutting balloon catheter in the blood vessel and also facilitate the monitoring of the balloon position, the cutting balloon catheter in the embodiment further includes a tip structure 40 and a balloon inner tube 15, the tip structure 40 is fixedly connected with the distal end of the balloon inner tube 15, and the balloon inner tube 15 is disposed inside the balloon outer tube 11; the balloon inner tube 15 is provided with a third marking portion 151, and the third marking portion 151 is located in the balloon. By providing the tip structure 40 at the distal end of the balloon inner tube 15, the cutting balloon catheter provided by the present embodiment can be effectively moved in the blood vessel, and by providing the third marking portion 151 on the balloon inner tube 15, the position of the balloon can be effectively monitored.
In a preferred embodiment, the third marking portion 151 in this embodiment includes a first marking ring and a second marking ring, where the first marking ring and the second marking ring respectively correspond to positions of two shoulders of the balloon portion 20, so as to indicate an effective expansion distance of the balloon portion 20.
In a preferred embodiment, the material of the tip structure 40 in this embodiment is a polymer material, the shape of the tip structure 40 is a step shape, and the tip structure 40 is fixedly connected to the distal end of the balloon inner tube 15 by welding or bonding.
In a preferred embodiment, the tip end of the outer sleeve 12 in this embodiment is sized to fit the stepped shape of the tip structure 40, and the tip structure 40 serves to limit the outer sleeve 12 from excessive movement of the outer sleeve 12.
In a preferred embodiment, the surface of the outer sleeve 12 in this embodiment is provided with a hydrophilic coating.
In a preferred embodiment, the guide flat wires 132 in this embodiment are evenly distributed over the outer surface of the balloon portion 20 at 360 °/N angular intervals. The number of N is determined according to the diameter of the balloon portion 20 and the diameter of the intended blood vessel. The ends of the guide flat wire 132 are attached to the tip structure 40 and the proximal end of the balloon outer tube 11 by welding, bonding, or the like.
Referring to fig. 1 and 2, in order to effectively control the movement of the outer sheath 12 and the push sleeve 14, the cutting balloon catheter of the present embodiment further includes a control portion 50, the control portion 50 being disposed at the proximal end of the tube body 10, the control portion 50 including: a control handle 51, a first control lever 52, and a second control lever 53; the control handle 51 is provided with a first long hole, a second long hole 511 and a balloon control opening 512, and the balloon liquid inlet is communicated with the interior of the balloon outer tube 11 and is used for inputting or outputting media to the balloon part 20; the outer portion of the first control rod 52 is movably mounted in the first elongated hole, and the inner portion of the first control rod 52 is connected to the proximal end of the outer sleeve 12 for controlling the movement of the outer sleeve 12; the outer portion of the second control rod 53 is movably mounted in the second elongated hole 511, and the inner portion of the second control rod 53 is connected to the proximal end of the push sleeve 14 for controlling the movement of the push sleeve 14. The control handle 51 is provided with the first long hole, the second long hole 511 and the balloon control port 512, and the balloon control port 512 is communicated with the interior of the balloon outer tube 11, so that the medium is effectively input or output to the balloon portion 20 through the balloon control port 512; the movement of the outer sleeve 12 is effectively controlled by movably mounting the outer portion of the first control rod 52 in the first elongated hole and connecting the inner portion of the first control rod 52 with the proximal end of the outer sleeve 12; by movably mounting the outer portion of the second control rod 53 in the second elongated hole 511 and connecting the inner portion of the second control rod 53 with the proximal end of the push sleeve 14, the push sleeve 14 can be effectively controlled to move.
In a preferred embodiment, the balloon control port 512 in this embodiment is a luer fitting that is disposed on the side of the control handle 51.
In a preferred embodiment, the outer sleeve 12 and the first control rod 52 are fixed by glue, and the push sleeve 14 and the second control rod 53 are fixed by glue.
In a preferred embodiment, the proximal end of the control handle 51 in this embodiment is provided with a lumen, with the proximal end of the balloon inner tube 15 communicating with the lumen.
In a specific embodiment, a guide wire cavity 152 is disposed in the balloon inner tube 15 in this embodiment, a guide wire penetrating hole 41 is disposed on the tip structure 40 and is communicated with the first end of the guide wire cavity 152, and when in operation, the guide wire is penetrated into a blood vessel, so that the guide wire enters the guide wire cavity 152 through the guide wire penetrating hole 41, and a guiding effect on cutting the balloon catheter is achieved.
In summary, implementing the cutting balloon catheter provided by this embodiment has at least the following beneficial technical effects: when the cutting balloon catheter provided by the embodiment moves in a normal blood vessel, the outer sleeve is at the shielding position, and the cutter part can be effectively shielded by the outer sleeve at the moment, so that the damage risk of the cutting balloon catheter provided by the embodiment to the normal blood vessel is effectively reduced, when the cutting balloon catheter provided by the embodiment reaches a lesion position, the outer sleeve can be switched from the shielding position to the avoiding position, so that the lesion is effectively cut, the balloon without a blade can be used for preprocessing the lesion before the lesion is cut, the subsequent blade can be conveniently moved into the balloon working area, and the outer sleeve can be switched to the shielding position after the vascular intervention operation is completed, so that the cutting balloon catheter of the embodiment can be safely withdrawn from the blood vessel.
The foregoing description of the preferred embodiments of the application is not intended to be limiting, but rather is intended to cover all modifications, equivalents, and alternatives falling within the spirit and principles of the application.

Claims (6)

1. A cutting balloon catheter, the cutting balloon catheter comprising:
the catheter comprises a catheter body (10), wherein the catheter body (10) comprises a balloon outer tube (11) and an outer sleeve (12) movably sleeved on the balloon outer tube (11), and a balloon part (20) is arranged at the distal end of the balloon outer tube (11);
a cutter part (30), wherein the cutter part (30) is movably sleeved on the balloon outer tube (11) and can reach the outside of the balloon part (20);
wherein the outer sleeve (12) has a shielding position for covering the balloon portion (20) and an avoiding position for avoiding the balloon portion (20); the pipe body part (10) further comprises a guide part (13), two ends of the guide part (13) are connected with the balloon outer pipe (11), two ends of the guide part (13) are respectively positioned at two ends of the balloon part (20), and the cutter part (30) is movably sleeved on the guide part (13);
the guide part (13) comprises a guide flat wire (132), the cutter part (30) comprises a plurality of blades (31), guide flat holes (311) are formed in the blades (31), and the blades (31) are sleeved on the guide flat wire (132) through the guide flat holes (311);
the tube body part (10) further comprises a push-type knife sleeve (14), the push-type knife sleeve (14) is movably sleeved on the balloon outer tube (11) and is positioned between the balloon outer tube (11) and the outer layer sleeve (12), and the push-type knife sleeve (14) is used for pushing the knife part (30) to the outside of the balloon part (20);
the cutter part (30) further comprises a plurality of buffer hoses (32), the buffer hoses (32) are sleeved on the guide flat wires (132), and the buffer hoses (32) are respectively positioned in gaps between a plurality of adjacent blades (31).
2. The cutting balloon catheter according to claim 1, wherein an end of the guide portion (13) near the distal end of the balloon portion (20) is provided with a limit protrusion (131) for limiting movement of the cutter portion (30) in a direction of detachment from the balloon portion (20).
3. The cutting balloon catheter according to claim 1, wherein the guide portions (13) and the cutter portions (30) are plural, the plural guide portions (13) are provided in one-to-one correspondence with the plural cutter portions (30), and the guide portions (13) are provided at intervals along the circumferential direction of the balloon.
4. The cutting balloon catheter according to claim 1, wherein the distal end of the outer sheath (12) is provided with a first marker (121); the distal end of the push broach sleeve (14) is provided with a second marking part (141).
5. The cutting balloon catheter according to claim 1, further comprising a tip structure (40) and a balloon inner tube (15), the tip structure (40) being fixedly connected with the distal end of the balloon inner tube (15), the balloon inner tube (15) being arranged inside the balloon outer tube (11); a third marking part (151) is arranged on the balloon inner tube (15), and the third marking part (151) is positioned in the balloon.
6. The cutting balloon catheter according to claim 1 or 4, further comprising a control portion (50), the control portion (50) being disposed at a proximal end of the tube body portion (10), the control portion (50) comprising:
a control handle (51), wherein a first long hole, a second long hole (511) and a balloon control opening (512) are arranged on the control handle (51), and the balloon control opening (512) is communicated with the inside of the balloon outer tube (11) and is used for inputting or outputting a medium to the balloon part (20);
a first control rod (52), an outer portion of the first control rod (52) being movably mounted in the first elongated hole, an inner portion of the first control rod (52) being connected to a proximal end of the outer sleeve (12) for controlling movement of the outer sleeve (12);
a second control rod (53), wherein the outer part of the second control rod (53) is movably arranged in the second long hole (511), and the inner part of the second control rod (53) is connected with the proximal end of the push broach sleeve (14) and is used for controlling the push broach sleeve (14) to move.
CN202210994540.0A 2022-08-18 2022-08-18 cutting balloon catheter Active CN115414575B (en)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2011226821A1 (en) * 2010-10-06 2012-04-26 Rex Medical, L.P. Cutting wire assembly for use with a catheter
CN103930156A (en) * 2011-09-13 2014-07-16 约翰·P·皮戈特 Intravascular catheter having an expandable incising portion
CN110063768A (en) * 2019-04-04 2019-07-30 深圳市业聚实业有限公司 A kind of Cutting balloon
CN113081185A (en) * 2021-04-08 2021-07-09 哈尔滨医科大学 Thrombus cutting system
CN113648023A (en) * 2021-07-05 2021-11-16 科凯(南通)生命科学有限公司 Repairing saccule for treating thrombus and calcified lesion

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Publication number Priority date Publication date Assignee Title
US9808276B2 (en) * 2013-04-25 2017-11-07 Invatec S.P.A. Angioplasty balloon having selectively deployable cutting or scoring element and related methods
WO2020032918A1 (en) * 2018-08-06 2020-02-13 C.R. Bard, Inc. Catheter with guided, translatable cutter for active slicing/scoring and related methods

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2011226821A1 (en) * 2010-10-06 2012-04-26 Rex Medical, L.P. Cutting wire assembly for use with a catheter
CN103930156A (en) * 2011-09-13 2014-07-16 约翰·P·皮戈特 Intravascular catheter having an expandable incising portion
CN110063768A (en) * 2019-04-04 2019-07-30 深圳市业聚实业有限公司 A kind of Cutting balloon
CN113081185A (en) * 2021-04-08 2021-07-09 哈尔滨医科大学 Thrombus cutting system
CN113648023A (en) * 2021-07-05 2021-11-16 科凯(南通)生命科学有限公司 Repairing saccule for treating thrombus and calcified lesion

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