CN114768057A - Cutting sacculus pipe of medicine carrying - Google Patents

Cutting sacculus pipe of medicine carrying Download PDF

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Publication number
CN114768057A
CN114768057A CN202210370352.0A CN202210370352A CN114768057A CN 114768057 A CN114768057 A CN 114768057A CN 202210370352 A CN202210370352 A CN 202210370352A CN 114768057 A CN114768057 A CN 114768057A
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CN
China
Prior art keywords
balloon
drug
cutting
balloon catheter
loaded
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Granted
Application number
CN202210370352.0A
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Chinese (zh)
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CN114768057B (en
Inventor
陈茂
冯沅
徐亚鹏
杨夏燕
虞奇峰
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Chengdu Newmai Biotechnology Co ltd
West China Hospital of Sichuan University
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Chengdu Newmai Biotechnology Co ltd
West China Hospital of Sichuan University
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Priority to CN202210370352.0A priority Critical patent/CN114768057B/en
Publication of CN114768057A publication Critical patent/CN114768057A/en
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Publication of CN114768057B publication Critical patent/CN114768057B/en
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    • 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
    • A61M25/1002Balloon catheters characterised by balloon shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • 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
    • A61M25/1011Multiple balloon catheters
    • 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
    • A61M25/1018Balloon inflating or inflation-control devices
    • A61M25/10181Means for forcing inflation fluid into the balloon
    • A61M25/10183Compressible bulbs
    • 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
    • A61M25/104Balloon catheters used for angioplasty
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22065Functions of balloons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22081Treatment of vulnerable plaque
    • 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
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/105Balloon 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
    • 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
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/1079Balloon catheters with special features or adapted for special applications having radio-opaque markers in the region of the balloon
    • 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
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/109Balloon catheters with special features or adapted for special applications having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Child & Adolescent Psychology (AREA)
  • Vascular Medicine (AREA)
  • Surgery (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

The invention relates to a drug-loaded cutting balloon catheter which comprises a full balloon, wherein a drug coating and a plurality of cutting members extending along the axial direction are arranged on the outer surface of the balloon, one or a plurality of high-flexibility sections are arranged on the cutting members to improve the bending performance of the balloon, enhance the capability of the balloon passing through tortuous blood vessels, particularly improve the conformal bending capability of the balloon on irregular lesion parts, enhance the operation convenience in the operation process and simultaneously improve the operation treatment effect.

Description

Cutting sacculus pipe of medicine carrying
Technical Field
The invention relates to the field of medical instruments for interventional operation, in particular to a cutting balloon catheter for carrying medicine.
Background
With the increasing incidence of coronary heart disease and the development of PCI (percutaneous coronary intervention) technology, the amount of PCI surgery in china has increased rapidly in recent years. Drug Eluting Stents (DES) are still the mainstay of angioplasty today; however, the efficacy, safety and efficacy of drug-coated balloons (DCB) as a new and mature interventional therapy technique have been confirmed by a number of clinical trials in ISR, stenotic lesions in coronary arteries, small vessel lesions, bifurcation lesions, etc. Pure DCB and implanted biodegradable stent are the development trend of future coronary intervention, but the expansion of a common balloon can cause the compression and rupture of plaque and the elastic expansion of blood vessels, so that intimal tear and even acute occlusion are easy to occur, and the elastic retraction and proliferative response to injury which occur later are also important reasons of restenosis.
The Cutting Balloon (Cutting Balloon) is a special Balloon, combines the micro-Cutting technology with the Balloon expansion, and compared with the blunt and disordered expansion of a common Balloon, the Cutting Balloon can obtain full expansion at lower pressure, has small irregular tearing on the intima of a blood vessel, has small injury on the blood vessel, reduces the proliferation of reactive smooth muscle cells and reduces the restenosis rate. Generalized cutting balloons include double-guidewire balloons, angiosuclpt balloons and spinous process balloons.
The spinous process balloon commonly used at present is an NSE balloon of Goodman corporation of Japan, three nylon spinous processes are distributed on the balloon in parallel, and the spinous processes protrude into plaques during expansion, so that the balloon has better expansion effect compared with a common balloon. The cutting saccule is longitudinally arranged on the surface of the non-compliant saccule by 3-4 sharp metal blades. Before the balloon reaches the lesion, the blade is tightly wrapped in the balloon material through special folding, and the normal blood vessel passing through the path cannot be damaged. When the balloon is inflated after reaching the lesion, the blade protrudes from the balloon outer surface to cause a longitudinal incision in the blood vessel tunica media, and the balloon can be made not to easily slide with respect to the lesion site. And a medicine layer can be formed on the surface of the balloon, so that the medicine is directionally released to the lesion position in the blood vessel.
However, when the cutting balloon catheter in the prior art is delivered to a lesion site in a blood vessel, the cutting balloon catheter may need to pass through a tortuous blood vessel or an irregular lesion site, and it is easily foreseen that the tracking performance of the balloon (i.e. the ability of the balloon to reach a target lesion under the guidance of a guide wire) is reduced due to the restriction of a linear cutting element (such as a spinous process) on the surface of the balloon, so that the cutting balloon catheter cannot pass through the tortuous blood vessel or the irregular lesion site well to reach the target lesion site, thereby bringing operational difficulty to a physician during a treatment process, further affecting the subsequent treatment effect of a patient, and even causing treatment failure.
Disclosure of Invention
The invention discloses a cutting balloon catheter for carrying medicine, and aims to solve the technical problems in the prior art.
The invention adopts the following technical scheme:
a drug-loaded cutting balloon catheter comprising:
-an outer tube, the distal end of which is provided with an inflatable or collapsible section, the section forming a balloon;
an inner tube, which is fixedly connected to the outer tube at the distal end, and an annular cavity between the inner tube and the outer tube forms a liquid injection channel of the balloon;
at least partial area of the outer surface of the balloon is covered with a drug coating; the outer surface of the balloon is provided with a plurality of axially extending cutting members, at least one of which is provided with at least one high-flexibility section in the direction of extension thereof.
As a preferred technical solution, the cutting member is disposed from the proximal end of the outer surface of the balloon and extends to the distal end along the axial direction of the balloon;
alternatively, the cutting member is provided only to a partial section of the balloon.
Preferably, the cutting member is provided linearly on the outer surface of the balloon.
Preferably, the cutting member is spirally wound around the outer surface of the balloon.
As a preferred solution, the cutting member comprises a spinous process.
As the preferred technical scheme, the surface of the cutting member is provided with a medicine carrying groove extending axially, and a medicine coating is arranged in the medicine carrying groove.
As a preferred solution, the cutting member is made of polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyamide, nylon, polyethylene terephthalate PET or polyether block amide PEBAX material.
Preferably, the cutting member is provided with a plurality of high-flexibility sections in the extending direction of the cutting member, and the axial lengths of the high-flexibility sections are the same.
As a preferred technical solution, the cutting member is provided with several high-flexibility sections in the extending direction thereof, and the axial length of at least one high-flexibility section is different from the axial lengths of the other high-flexibility sections.
Preferably, the axial length of the high-flexibility section arranged on the same cutting member decreases from the distal end to the proximal end.
Preferably, the high-flexibility section has an axial length of 0.2-5.0 mm.
As a preferred technical solution, the high-flexibility section includes one or more of a groove, a slit, and a blind hole arranged on the cutting member;
alternatively, the cutting member comprises a discrete structure of a plurality of individual cutting elements, with the spaces between adjacent cutting elements forming the high-flexibility section.
Preferably, the high-flexibility section is provided with a drug coating.
As a preferable technical scheme, the outer surface of the drug coating in the high-flexibility section is also covered with a drug protective film.
As a preferred technical scheme, the drug coating is coated on the outer surface of the balloon at intervals.
As a preferred technical scheme, the length of the balloon is 5.0-50mm, and the diameter is 1.0-5.0 mm.
As the preferred technical scheme, the material of sacculus is nylon, polyethylene terephthalate PET or polyether block amide PEBAX.
As a preferable technical scheme, the far end of the balloon is also provided with a tip, and the tip is connected with the balloon in a welding, pressing or bonding mode.
As a preferable technical proposal, the device also comprises a developing ring, a guide wire outlet and a catheter seat; the developing rings are arranged at two ends of the saccule; the guide wire outlet is formed by an inner tube and an outer tube and is arranged on the side wall of the outer tube; the catheter holder is arranged at the near end of the drug-carrying balloon catheter.
According to a preferable technical scheme, a hypotube is further fixedly connected between the outer tube and the catheter base, and a marking belt is further arranged on the hypotube.
The technical scheme adopted by the invention can achieve the following beneficial effects:
(1) the invention provides a medicine-carrying cutting balloon catheter which comprises an inflatable balloon, wherein a medicine coating and a plurality of cutting members extending along the axial direction are arranged on the outer surface of the balloon, one or a plurality of high-flexibility sections are arranged on the cutting members, so that the bending performance of the balloon is improved, the capability of the balloon for passing through tortuous blood vessels is enhanced, particularly, the conformal bending capability of the balloon on irregular diseased parts can be improved, the operation convenience in the operation process is enhanced, and the operation treatment effect is improved.
(2) In order to adapt to patients with complicated lesion parts, the cutting member is a spinous process, can be a linear or curved shape extending along the axial direction of the balloon when being arranged, can be a continuous structure or a series of discrete structures, can be specifically selected or arranged according to the actual conditions of the lesion parts of the patients, and simultaneously sets the number and the positions of the high-flexibility sections according to the actual conditions of the patients, so that the cutting member can be axially compressed, curled and folded along with the balloon, and can also ensure that the cutting member can be bent and deformed in a targeted manner according to the forms of the lesion parts, the surfaces of the balloon and the lesion parts are ensured to be fully and effectively attached, and meanwhile, the medicine is more uniformly released in an area protruding towards the inner lesion part in the blood vessel.
(3) When the sacculus reachs pathological change position and full back, the inner membrance can be torn to the cutting member orientation to can buckle the laminating effectively to anomalous pathological change position, guarantee the medicine coating on sacculus surface and the abundant contact at pathological change position, can strengthen the release effect of medicine, promote the transport efficiency of medicine.
(4) And a drug coating containing drugs such as anti-intimal hyperplasia, anti-inflammation or anti-thrombosis and the like can be arranged in the high-flexibility section, and after the saccule is inflated, due to the deformation extrusion force applied to the surface of the saccule by the high-flexibility section on the cutting member, the drugs in the high-flexibility section can be released at irregular lesion parts in an accelerated manner, so that the therapeutic effect of the drugs is improved. Along with the continuous release of the medicine, the bending capability of the high-flexibility section is further improved, and the subsequent operation is further developed.
(5) And the outer surface of the drug coating of the high-flexibility section is also covered with a drug protection film, and the protection film can prevent unnecessary loss caused by blood scouring of the drug in the process of delivering the balloon catheter to a human body. When the saccule is delivered to a lesion part of a human body, along with the expansion of the saccule, the medicine shielded by the medicine protective film in the high-flexibility section can be gradually released to the lesion part under the action of surrounding extrusion force, so that the medicine treatment efficiency is improved, and the conformal bending capability of the saccule is ensured.
(6) Axial medicine carrying grooves can be formed in the surface of the cutting member, so that the medicine carrying efficiency of the balloon is further improved, and the medicine is fully acted on a pathological change part in a blood vessel.
(7) And in combination with preoperative or intraoperative imaging observation, different regions on the balloon are selectively provided or not provided with drug coatings so as to adapt to different lesion types/lesion positions.
(8) In a preferred embodiment of the invention, a section of hypotube is also connected between the outer tube and the catheter hub, which has a high strength, thus enabling efficient transmission of forces and torques to the distal end of the catheter.
(9) In a preferred embodiment of the invention, the balloon is provided with a developing piece, and the developing property of the balloon catheter can be improved under X-ray fluoroscopy by the arrangement of the developing piece, so that a doctor can know the accurate position of the balloon, and the doctor can conveniently position the balloon for medical operation.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the description of the embodiments are briefly introduced below to form a part of the present invention, and the exemplary embodiments and the description thereof illustrate the present invention and do not limit the present invention. In the drawings:
fig. 1 is a schematic structural view of a drug-loaded cutting balloon catheter disclosed in a preferred embodiment of example 1 of the present invention when the balloon is inflated;
FIG. 2 is an enlarged view of a portion A of FIG. 1;
FIG. 3 is a perspective view of the disclosed drug-loaded cutting balloon catheter after balloon inflation in accordance with a preferred embodiment of example 1 of the present invention;
FIG. 4 is a front view of FIG. 3;
FIG. 5 is a left side view of FIG. 3;
FIG. 6 is a perspective view of the disclosed drug-loaded cutting balloon catheter after balloon inflation in accordance with a preferred embodiment of example 2 of the present invention;
fig. 7 is a front view of fig. 6.
Description of reference numerals:
the catheter comprises a tip 1, a balloon 2, a developing ring 3, a spinous process 4, a high-flexibility section 5, a drug coating 6, a drug-carrying groove 7, an inner tube 8, an outer tube 9, a guide wire outlet 10, a hypotube 11, a marker band 12 and a catheter seat 13.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the technical solutions of the present invention will be clearly and completely described below with reference to the specific embodiments of the present invention and the accompanying drawings. In the description of the present invention, it is noted that the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise.
In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly and may be, for example, fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in a specific case to those of ordinary skill in the art.
It is to be understood that the described embodiments are merely exemplary of the invention, and not restrictive of the full scope of the invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
In order to solve the problems in the prior art, the embodiment of the application provides a drug-loaded cutting balloon catheter which mainly comprises an inner tube, an outer tube and a balloon; wherein the distal end of the outer tube is provided with an inflatable or collapsible section which forms a balloon; the inner tube and the outer tube are fixedly connected at the far end, and an annular cavity between the inner tube and the outer tube forms a liquid injection channel of the balloon and is used for injecting contrast medium to enable the balloon to be full; the outer surface of the balloon is covered with a drug coating at least in partial area, furthermore, the outer surface of the balloon is also provided with a plurality of cutting members extending along the axial direction, at least one cutting member is provided with high-flexibility sections in the extending direction, and the number of the high-flexibility sections is at least 1.
Example 1
In view of the restriction of the linear cutting element on the surface of the balloon when the cutting balloon catheter in the prior art passes through a tortuous vessel or an irregular lesion area, the tracking performance of the balloon is reduced, so that the balloon cannot well follow the tortuous vessel or the irregular lesion to reach a target lesion part, and the operation process is influenced. To solve this problem, this embodiment 1 provides a drug-loaded cutting balloon catheter, which includes one or more high-flexibility sections disposed on the cutting member on the surface of the balloon, so that the bending performance of the balloon is greatly improved, so as to enhance the ability of the balloon to pass through tortuous blood vessels.
Referring to fig. 1-5, in a preferred embodiment, a drug-loaded cutting balloon catheter is provided that includes an inner tube 8, an outer tube 9, a balloon 2, a visualization ring 3, a hypotube 11, and a catheter hub 13. The outer tube 9 and the inner tube 8 are fixedly connected at the far end, the outer tube and the inner tube form a balloon catheter together, the outer tube 9 is connected with a catheter seat 13 used for injecting contrast medium through a hypotube 11, the far end of the outer tube 9 is provided with the balloon 2 capable of being filled or collapsed, and an annular cavity between the outer tube 9 and the inner tube 8 forms a liquid injection channel of the balloon 2. Preferably, the far end of the balloon 2 is also provided with a tip 1, the tip 1 is molded by a tip molding machine and is connected with the balloon 2 in a welding, compression or bonding manner; the tip 1 is used for a guide wire to penetrate into the inner tube 8 and is beneficial to the operation of the balloon catheter in a blood vessel; further, a guide wire outlet 10 is provided in the side wall of the outer tube 9, and the guide wire outlet 10 is formed by the inner tube 8 and the outer tube 9.
Preferably, the developing rings 3 are made of an opaque material and are pressed and held on the inner tube 8, and the number of the developing rings 3 is preferably 2, and the developing rings are respectively arranged at two ends of the balloon 2; furthermore, the hypotube 11 is arranged between the outer tube 9 and the catheter seat 13 and is connected with the outer tube 9 through a hot melting or laser welding process, the hypotube 11 is further provided with a mark belt 12, the mark belt 12 is a small section of PE or FEP which is good in biocompatibility and thin, and is formed through a thermal shrinkage process, or is marked with laser to form a mark zone for prompting a doctor to find the distance of the saccule entering the body.
In a preferred embodiment, the balloon 2 has a length of 5.0-50mm and a diameter of 1.0-5.0 mm. However, since the patients have different ages, sexes, heights, weights, lesion positions, lesion conditions, and the like, in order to ensure that the balloon 2 can be well attached to the blood vessel of the affected part to function, the size of the balloon 2 can be adaptively adjusted or selected, and details are not repeated herein. Preferably, the balloon 2 may be made using nylon or polyether block amide PEBAX materials.
In a preferred embodiment, a drug coating 6 and a cutting member are provided on the outer surface of the balloon 2, wherein the drug coating 6 can be selected from drugs for inhibiting the growth of neointima of blood vessels, and the drug coating 6 can be continuously or intermittently coated on the outer surface of the balloon 2, and a specific drug can be selected according to the actual lesion type; the cutting member is used for biting into a lesion part in a blood vessel after the balloon 2 is inflated, can make the balloon 2 not easy to slide relative to the lesion part, and is beneficial to the release of the medicament in the medicament coating 6 and fully contacts with the lesion part of the blood vessel.
Preferably, the cutting component is a spinous process 4, the spinous process 4 is fixedly adhered to the balloon 2 and has elasticity, and when the balloon 2 bears large pressure, the spinous process 4 can not damage the balloon 2 or the inner wall of the blood vessel, so that the safety is good; in particular, the spinous process 4 may be made of polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyamide, nylon or PEBAX material.
Preferably, the cross section of the spinous process 4 is triangular, wedge-shaped, rectangular or trapezoidal, the height of which is 0.2-1.0mm, and the width of which is 0.2-1.0 mm; more preferably, the surface of the spinous process 4 is further provided with a drug carrying groove 7 extending axially, and a drug coating 6 is arranged in the drug carrying groove 7, so that the drug carrying efficiency of the balloon 2 can be further improved, and the drug can be fully acted on a diseased region in a blood vessel.
Preferably, the spinous processes 4 are uniformly distributed along the circumferential direction of the balloon 2 and linearly extend along the axial direction of the balloon 2, and the size of each spinous process 4 is the same; preferably, the number of spinous processes 4 is not less than 3, more preferably 3 to 10.
In a preferred embodiment, the spinous processes 4 are disposed starting from the proximal end of the outer surface of the balloon 2 and extending in the axial direction of the balloon 2 to the distal end, the length or width of the plurality of spinous processes 4 is kept uniform, and the plurality of spinous processes 4 are uniformly distributed in the circumferential direction of the balloon 2.
In another preferred embodiment, the spinous processes 4 are only arranged on a partial section of the balloon 2, and at least one spinous process 4 has a size different from the size of the other spinous processes 4 so as to adapt to the specific shape of the vascular lesion; further, the plurality of spinous processes 4 are unevenly distributed in the circumferential direction of the balloon 2, that is, the intervals between the adjacent spinous processes 4 are not equal.
In a more preferred embodiment, the number, size and placement of the spinous processes 4 can be specifically selected to better fit the plaque of the vascular lesion based on the imaging of the lesion.
Preferably, in order to improve the bending performance of the linear spinous processes 4, at least one high-flexibility section 5 is arranged on the surface of the balloon 2 in the extending direction of at least one spinous process 4; optionally, the high-flexibility section 5 is a groove, a slit or a blind hole arranged on the spinous process 4, preferably, the spinous process 4 is a discrete structure composed of a plurality of independent cutting units, and the high-flexibility section 5 is formed by gaps between adjacent cutting units; preferably, the high-flexibility section 5 has an axial length of 0.2 to 5.0 mm.
In a preferred embodiment, each spinous process 4 is provided with a plurality of high-flexibility sections 5, and the positions and lengths of the high-flexibility sections 5 arranged on each spinous process 4 are the same, so that the production and preparation efficiency of the balloon catheter can be improved.
In another preferred embodiment, each spinous process 4 is provided with several high-flexibility sections 5 in the extension direction thereof, and the axial length of at least one high-flexibility section 5 is different from the length of the other high-flexibility sections 5.
Optionally, the positions and axial lengths of the high-flexibility sections 5 disposed on different spinous processes 4 are aligned with each other, and the axial lengths of the high-flexibility sections 5 disposed on the same spinous process 4 are sequentially decreased from the proximal end to the distal end, or are increased, then decreased, and then increased from the proximal end to the distal end, or are decreased, then increased, and then decreased from the proximal end to the distal end; preferably, the positions and axial lengths of the high-flexibility sections 5 arranged on different spinous processes 4 are aligned with each other, the axial lengths of the high-flexibility sections 5 arranged on the same spinous process 4 are sequentially increased from the proximal end to the distal end, the bending performance and flexibility of the distal end of the balloon 2 are better when the distal end passes through a tortuous blood vessel, and the bending performance is relatively lower due to the smaller length of the high-flexibility section 5 at the proximal end of the spinous process 4, but the force and the torque can be effectively transmitted to the distal end of the balloon 2, so that the propelling performance of the balloon 2 is better.
In a more preferred embodiment, the positions and axial lengths of the high-flexibility sections 5 disposed on different spinous processes 4 are staggered, and the positions and lengths of the high-flexibility sections 5 on the same spinous process 4 can be specifically selected or set according to imaging observation of a diseased region, so that the balloon 2 can be suitable for patients with more complicated diseased regions, and meanwhile, the spinous processes 4 can be ensured to be bent and deformed in a targeted manner according to the shapes of the diseased regions, the surface of the balloon 2 is ensured to be fully and effectively attached to the diseased regions, and meanwhile, the drugs are more uniformly released in regions protruding toward the interior diseased regions in the blood vessel.
Preferably, a drug coating 6 is also arranged in the high-flexibility section 5, and after the balloon 2 is inflated by injecting the contrast agent, due to the deformation extrusion force applied to the surface of the balloon 2 by the high-flexibility section 5 on the spinous process 4, the drug in the high-flexibility section can accelerate the release at irregular lesion sites, and the drug treatment effect is improved. With the continuous release of the drug, the bending capability of the high-flexibility section 5 is further improved, which is beneficial to the further development of the subsequent operation.
In a preferred embodiment, the outer surface of the drug coating 6 in the high-flexibility section 5 is further covered with a drug protection film, and the drug protection film may be provided with micropores; the drug protection film can prevent unnecessary loss of the drug due to blood wash during delivery of the balloon 2. When the saccule 2 is delivered to a lesion part of a human body, along with the expansion of the saccule 2, the medicine in the high-flexibility section 5, which is shielded by the medicine protective film, can be gradually released to the lesion part under the action of peripheral extrusion force, so that the medicine treatment efficiency is improved, and the conformal bending capability of the saccule 2 is ensured.
In this embodiment 1, the operation method of the above drug-loaded cutting balloon catheter is as follows:
under the monitoring of medical imaging equipment, percutaneous puncture is carried out to put in a catheter sheath, then the catheter sheath penetrates into a guide catheter, the guide wire is conveyed to the position along the guide catheter, then the guide wire penetrates into the balloon catheter of the invention from the tip end 1 and penetrates out from a guide wire outlet 10, the balloon catheter is conveyed along the guide wire, when a tortuous blood vessel is encountered in the conveying process, as the spinous process 4 is provided with a plurality of high-flexibility sections 5, the bending property of the spinous process 4 relative to other positions without the high-flexibility sections 5 is better, so that the balloon 2 and the spinous process 4 can be ensured to be bent and deformed in a targeted manner according to the shape of the tortuous blood vessel, after a narrow coronary artery is reached, a contrast agent is injected into the balloon 2 through a catheter seat 13, the balloon 2 is expanded, the spinous process 4 on the outer surface of the balloon 2 can be embedded into a plaque at a lesion position on the inner wall of the blood vessel, the stability of the position of the balloon 2 is ensured, and a medicine coating 6 arranged on the surface of the balloon 2 can be fully and effectively attached to the lesion position, to enhance the release effect of the drug. When the medicine is completely released, the pump is started to pump vacuum to enable the saccule 2 to be completely retracted, and then the saccule catheter is withdrawn.
Example 2
Referring to fig. 6-7, the present embodiment provides a cutting balloon catheter carrying drug, and the present embodiment changes the specific arrangement of the cutting member and the high-flexibility section 5 on the outer surface of the balloon 2 based on the structure of embodiment 1.
In a preferred embodiment, the cutting means are still provided as spinous processes 4, the spinous processes 4 being curved and extending in the axial direction of the balloon 2, and more preferably, the spinous processes 4 are provided helically around the outer surface of the balloon 2 in order to provide better compliance of the balloon 2 while ensuring that the spinous processes 4 can be compressed, curled and folded axially and/or radially along with the balloon 2.
Preferably, the number of the spinous processes 4 is not less than 3, more preferably 3 to 10; the spiral spinous processes 4 are uniformly distributed along the circumferential direction of the balloon 2, and each spinous process 4 has the same size, and specifically, since the specific length of the spinous process 4 depends on the size of the thread pitch, and the thread pitch may be specifically set according to the actual shape of a tortuous blood vessel or a diseased region of a patient, which is not described in detail, it should be noted that when the thread pitch is too small, the thread pitch may negatively affect the compliance of the balloon 2 and the function of the spinous process 4, and therefore, the thread pitch may select a larger value according to the specific size of the balloon 2.
In a preferred embodiment, the spinous processes 4 are disposed starting from the proximal end of the outer surface of the balloon 2 and spirally extending in the axial direction of the balloon 2 to the distal end, the length or width of the plurality of spinous processes 4 is kept uniform, and the plurality of spinous processes 4 are uniformly distributed in the circumferential direction of the balloon 2.
In another preferred embodiment, the spinous processes 4 are still evenly distributed along the circumference of the balloon 2, but the spinous processes 4 are only provided in a partial section of the balloon 2, and the length and/or width of adjacent spinous processes 4 may not be equal.
In a more preferred embodiment, the number, size and placement of the spinous processes 4 can be specifically selected to better fit the plaque of the vascular lesion based on the imaging of the lesion.
Preferably, at least one high flexibility section 5 is provided in the extension direction of at least one spinous process 4; alternatively, the high-flexibility section 5 is a groove, a slit, or a blind hole formed on the spinous process 4, preferably, the spinous process 4 is a discrete structure composed of a plurality of independent cutting units, and the high-flexibility section 5 is formed by the space between the adjacent cutting units.
In a preferred embodiment, each spinous process 4 has a plurality of high flexibility sections 5, each spinous process 4 has the same high flexibility section 5 position and length, and the high flexibility sections 5 on adjacent spinous processes 4 are aligned in position and axial length.
In another preferred embodiment, each spinous process 4 has several high-flexibility sections 5 in the extending direction, and the axial length of at least one high-flexibility section 5 is different from the length of the other high-flexibility sections 5, and the high-flexibility sections 5 on adjacent spinous processes 4 can be aligned or staggered.
Preferably, the high-flexibility sections 5 arranged on different spinous processes 4 are aligned with each other, the axial length of the high-flexibility sections 5 arranged on the same spinous process 4 increases from the proximal end to the distal end, the distal end of the balloon 2 has better bending performance and flexibility when passing through tortuous vessels, and the high-flexibility section 5 at the proximal end of the spinous process 4 has smaller length, so that the bending performance is relatively lower, but force and torque can be effectively transmitted to the distal end of the balloon 2, so that the propelling performance of the balloon 2 is better.
More preferably, the positions and axial lengths of the high-flexibility sections 5 disposed on different spinous processes 4 are staggered from each other, and the positions and lengths of the high-flexibility sections 5 on the same spinous process 4 can be specifically selected or set according to the imaging observation of the lesion site, so that the balloon 2 can be applied to patients with more complicated lesion sites.
Example 3
This embodiment provides a drug-loaded cutting balloon catheter, and the specific arrangement of the cutting member and the high-flexibility section 5 on the outer surface of the balloon 2 is changed again in this embodiment based on the structures of embodiment 1 and embodiment 2.
In a preferred embodiment, the balloon 2 is provided with a plurality of axially extending spinous processes 4 on the surface thereof, and at least one high-flexibility segment 5 is provided on each spinous process 4.
Preferably, the number, size and arrangement position of the spinous processes 4 are specifically arranged according to the imaging observation of the lesion site, and the linear spinous process 4, the curved spinous process 4 or the spiral spinous process 4 may be simultaneously arranged on the balloon 2.
Preferably, the high-flexibility section 5 can be a groove, a slit, a blind hole or a combination of gaps formed by cutting off the spinous process 4, and the specific position, length and number of the high-flexibility section 5 are also specifically selected or set according to the imaging observation of the lesion.
More preferably, the high-flexibility segments 5 provided on the different spinous processes 4 are offset from each other in position, so that the balloon 2 can be adapted to patients with more complex lesions.
While the present invention has been described with reference to the embodiments shown in the drawings, the present invention is not limited to the embodiments, which are illustrative and not restrictive, and it will be apparent to those skilled in the art that various changes and modifications can be made therein without departing from the spirit and scope of the invention as defined in the appended claims.

Claims (20)

1. A cutting balloon catheter for carrying drugs, comprising:
-an outer tube, the distal end of which is provided with an inflatable or collapsible section, which forms a balloon;
-an inner tube, which is fixedly connected to the outer tube at the distal end, and an annular cavity between the inner tube and the outer tube forms a liquid injection channel of the balloon;
the outer surface of the balloon is covered with a drug coating at least in partial area; the outer surface of the balloon is provided with a plurality of cutting members extending along the axial direction, and at least one cutting member is provided with at least one high-flexibility section in the extending direction.
2. The drug-loaded cutting balloon catheter of claim 1, wherein the cutting member is disposed from a proximal end of the balloon outer surface and extends in an axial direction of the balloon to a distal end;
alternatively, the cutting member is provided only to a partial section of the balloon.
3. The drug-loaded cutting balloon catheter of claim 1, wherein the cutting member is linearly disposed on an outer surface of the balloon.
4. The drug-loaded cutting balloon catheter of claim 1, wherein the cutting member is helically disposed around an outer surface of the balloon.
5. The drug-loaded cutting balloon catheter of claim 1, wherein the cutting member comprises a spinous process.
6. The drug-loaded cutting balloon catheter according to claim 1, wherein the cutting member surface is provided with an axially extending drug-loaded groove, the drug-loaded groove being provided with the drug coating.
7. The drug-loaded cutting balloon catheter of claim 1, wherein the cutting member is made of polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyamide, nylon, polyethylene terephthalate PET, or polyether block amide PEBAX material.
8. The drug-loaded cutting balloon catheter according to claim 1, wherein the cutting member is provided with a plurality of the high-flexibility sections in an extending direction thereof, and axial lengths of the high-flexibility sections are all the same.
9. The drug-loaded cutting balloon catheter of claim 1, wherein the cutting member has a plurality of the high-flexibility sections in a direction of extension of the cutting member, and an axial length of at least one of the high-flexibility sections is different from an axial length of the other high-flexibility sections.
10. The drug-loaded cutting balloon catheter of claim 9, wherein the axial length of the high-flexibility sections disposed on the same cutting member decreases sequentially from the distal end to the proximal end.
11. The drug-loaded cutting balloon catheter of claim 1, wherein the high-flexibility section has an axial length of 0.2-5.0 mm.
12. The drug-loaded cutting balloon catheter of claim 1, wherein the high-flexibility section comprises one or more combinations of grooves, slits, blind holes disposed on the cutting member;
alternatively, the cutting member comprises a discrete structure of a plurality of individual cutting units, the spaces between adjacent cutting units forming the high-flexibility section.
13. The drug-loaded cutting balloon catheter of claim 1, wherein the drug coating is disposed within the high-flexibility section.
14. The drug-loaded cutting balloon catheter of claim 13, wherein the outer surface of the drug coating in the high-flexibility section is further covered with a drug protective film.
15. The drug-loaded cutting balloon catheter of claim 1, wherein the drug coating is spaced apart over the outer surface of the balloon.
16. The drug-loaded cutting balloon catheter of claim 1, wherein the balloon has a length of 5.0-50mm and a diameter of 1.0-5.0 mm.
17. The drug-loaded cutting balloon catheter according to claim 1, wherein the balloon is made of nylon, polyethylene terephthalate (PET) or polyether block amide (PEBAX).
18. The drug-loaded cutting balloon catheter according to any one of claims 1-17, wherein the distal end of the balloon is further provided with a tip, and the tip is connected with the balloon by welding, crimping or bonding.
19. The drug-loaded cutting balloon catheter of claim 18, further comprising a visualization ring, a guide wire outlet, and a catheter hub; the developing rings are arranged at two ends of the saccule; the guide wire outlet consists of the inner tube and the outer tube, and is arranged on the side wall of the outer tube; the catheter holder is arranged at the near end of the drug-carrying balloon catheter.
20. The drug-loaded cutting balloon catheter according to claim 19, wherein a hypotube is further fixedly connected between the outer tube and the catheter hub, and a marking tape is further arranged on the hypotube.
CN202210370352.0A 2022-04-09 2022-04-09 Medicine-carrying cutting balloon catheter Active CN114768057B (en)

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WO2024120532A1 (en) * 2022-12-09 2024-06-13 鑫易舟(上海)医疗器械有限公司 Apparatus for using balloon to achieve drug delivery, drug administration apparatus, and minimally invasive medical system
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CN118078382A (en) * 2024-04-26 2024-05-28 鼎科医疗技术(苏州)有限公司 Drug-loaded nick saccule and saccule catheter

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