CN113648023B - Repairing saccule for treating thrombus and calcified lesion - Google Patents

Repairing saccule for treating thrombus and calcified lesion Download PDF

Info

Publication number
CN113648023B
CN113648023B CN202110759203.9A CN202110759203A CN113648023B CN 113648023 B CN113648023 B CN 113648023B CN 202110759203 A CN202110759203 A CN 202110759203A CN 113648023 B CN113648023 B CN 113648023B
Authority
CN
China
Prior art keywords
balloon
balloon body
cutting
section
repairing
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
CN202110759203.9A
Other languages
Chinese (zh)
Other versions
CN113648023A (en
Inventor
吴明明
陈大凯
郭应强
程筒
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.)
Koka Nantong Lifesciences Co Ltd
Original Assignee
Koka Nantong Lifesciences Co Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Koka Nantong Lifesciences Co Ltd filed Critical Koka Nantong Lifesciences Co Ltd
Priority to CN202110759203.9A priority Critical patent/CN113648023B/en
Publication of CN113648023A publication Critical patent/CN113648023A/en
Application granted granted Critical
Publication of CN113648023B publication Critical patent/CN113648023B/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • 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
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/3205Excision instruments
    • A61B17/3207Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320725Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with radially expandable cutting or abrading elements
    • 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
    • A61B2017/22001Angioplasty, e.g. PCTA
    • 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
    • A61B2017/22061Implements 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 for spreading elements apart
    • 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
    • A61B2017/22071Steering
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B2017/320044Blunt dissectors
    • A61B2017/320048Balloon dissectors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/3205Excision instruments
    • A61B17/3207Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B2017/320741Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions for stripping the intima or the internal plaque from a blood vessel, e.g. for endarterectomy
    • 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
    • A61M2025/1004Balloons with folds, e.g. folded or multifolded
    • 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
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

The invention discloses a repairing balloon for treating thrombus and calcification lesions, which comprises a balloon body, a cutting piece, a guide tube and a converging tube, wherein the balloon body is provided with a first connecting section, two ends of the first connecting section are provided with openings, the cutting piece extends along the outer peripheral surface of the balloon body and is partially and fixedly connected with the outer periphery of the balloon body, the guide tube is communicated with the first connecting section of the balloon body, the converging tube is sleeved on the outer surface of the guide tube, and the proximal end of the cutting piece is converged in the converging tube and can slide relative to the converging tube. The repairing saccule has the advantages of small and exquisite structure and strong applicability, can reduce the damage to the vessel wall in the operation process, enables the repairing saccule to smoothly pass through tortuous vessels, reaches a focus to cut, shortens the operation time of the operation, enhances the use experience of a user, and is favorable for the popularization and application of the repairing saccule for treating thrombus and calcified lesions in the technical field of medical instruments.

Description

Repairing saccule for treating thrombus and calcified lesion
Technical Field
The invention relates to the technical field of medical appliances, in particular to a repairing saccule for treating thrombus and calcification lesions.
Background
Interventional procedures are emerging therapeutic approaches between surgical and medical treatments, including endovascular interventions and non-endovascular interventions. In simple terms, the interventional therapy is a minimally invasive treatment method for locally treating the focus under the guidance of an angiography machine, a fluoroscopy machine, CT, MR and B ultrasonic of imaging equipment by making a micro-channel with a diameter of a few millimeters on blood vessels and skin or by passing through an original pipeline of a human body under the condition of exposing the focus without opening the operation.
Currently, there are three main configurations of cutting balloons used in interventional procedures. The cutting balloon is structurally characterized in that a blade is adhered to the surface of the balloon at intervals of 120 degrees, the blade is contacted and torn through the inflation expanding balloon, the difficult-to-expand lesion with higher hardness is formed, the cutting balloon has a better effect on restenosis in a stent and more narrow of proximal vascular fibers, but the cutting balloon has a larger outer size, has the problem of poor trafficability, and is difficult to pass through complex tortuous vessels. In addition, in order to avoid the cutting saccule from damaging other parts of blood vessels in the using process, the hardness of the existing cutter body is generally smaller, and the cutting edge part is easy to deform; the second is a double-guide wire balloon, which is structurally characterized in that a guide wire is added to the outer side of the balloon wall of a common balloon, and the guide wire is contacted with and extruded against the vessel wall through the inflation and expansion balloon, so that a longitudinal groove is left, and a weak part is formed. The defect is that the guide wire needs to pass through the outer surface of the balloon, the contact length of the guide wire and the balloon catheter is greatly reduced, so that the tracking capability of the balloon catheter along the guide wire is reduced, and the balloon catheter is not suitable for entering into serious occlusion lesions; thirdly, the spinous process balloon is designed by adding 3 special nylon spinous processes with 120-degree intervals from the proximal end to the distal end of the balloon, and the spinous process balloon is easy to intertwine when a guide wire or other products pass through the balloon.
Disclosure of Invention
In order to overcome the defects in the prior art, the invention aims to provide the repairing balloon for treating the thrombus and the calcified lesions, which has small and exquisite structure and strong applicability, can reduce the damage to the vessel wall in the operation process, enables the repairing balloon to smoothly pass through tortuous vessels to reach a focus to realize cutting, shortens the operation time, enhances the use experience of a user, and is beneficial to the popularization and the application of the repairing balloon for treating the thrombus and the calcified lesions in the technical field of medical instruments.
In order to achieve the aim, the invention adopts the following technical scheme that the repairing balloon for treating thrombus and calcification lesions comprises a balloon body, a cutting piece, a guide tube and a converging tube, wherein the balloon body is provided with a first connecting section, two ends of the first connecting section are provided with openings, the cutting piece extends along the outer peripheral surface of the balloon body and is partially and fixedly connected with the outer periphery of the balloon body, the guide tube is communicated with the first connecting section of the balloon body, the converging tube is sleeved on the outer surface of the guide tube, and the proximal end of the cutting piece is converged in the converging tube and can slide relative to the converging tube.
As a preferable mode of the present invention, the outer peripheral surface of the balloon body is provided with a plurality of first guide grooves along the axial direction, and at least part of the cutting members can slide along the first guide grooves.
As a preferable mode of the invention, the guide tube is coaxially arranged with the converging tube, a plurality of second guide grooves are arranged on the outer surface of the guide tube facing the converging tube, and part of the cutting pieces can slide along the second guide grooves.
As a preferable scheme of the invention, the inner side surface of the converging tube is fixedly connected with the cutting piece, and the proximal end of the converging tube is fixedly connected with the external handle so as to adjust the binding force between the cutting piece and the balloon body through the external handle.
As a preferable scheme of the invention, the cutting piece comprises a repairing section, an extending section and a converging section which are connected in sequence, and at least one side of the repairing section, which is away from the saccule body, is provided with a cutting edge; when the balloon body is in a filling state, the repairing section is in contact with a cutting support section of the balloon body, and the converging section is positioned in the converging tube; at least the repair section forms a cutting portion on a side of the cutting member facing away from the balloon body to resect calcified lesions or thrombi in the body.
As a preferable scheme of the invention, a first notch is arranged at the joint of the repair section and the extension section, a second notch is arranged at the joint of the extension section and the constriction section, the first notch faces the balloon body, and the second notch faces away from the balloon body.
As a preferred aspect of the present invention, the repair balloon further includes a puncture catheter penetrating the balloon body and the guide tube and extending out of the distal end of the balloon body as a passage for an external guide wire.
As a preferable scheme of the invention, the repairing balloon is further provided with at least one developing ring, and the developing ring is sleeved on the puncture catheter and corresponds to the repairing section so as to mark the repairable position.
As a preferable mode of the present invention, the balloon body has a plurality of fold portions along which the balloon body is foldable; in the folded state, at least the repair section of the cutting element is wrapped in the pleat.
As a preferred embodiment of the invention, the outer surface of the cutting member is provided with a hydrophilic coating made of silicone oil.
Compared with the prior art, the invention has the beneficial effects that: according to the repairing balloon for treating thrombus and calcification lesions, the conventional cutting piece is changed into the metal guide wire, the size of the protruding part of the balloon body is reduced, a plurality of cutting pieces are axially arranged on the surface of the balloon body, and a certain gap is reserved between two adjacent guide wires, so that the repairing balloon has strong trafficability, damage to the vessel wall in the operation process is reduced, and the repairing balloon smoothly passes through tortuous vessels to reach a focus to cut.
According to the invention, only one end of the cutting piece is fixed with the balloon body, and other parts are movably connected, so that the cutting piece has a telescopic degree of freedom along the axial direction of the balloon body, and the banana deformation effect of the balloon body caused by the hardness of the cutting piece is overcome.
The contact length of the cutting piece with the balloon body and the converging tube is not changed, and in the filling or converging process of the balloon body, the cutting piece is changed only in the length distribution of the balloon body and the converging tube, so that the cutting piece is more attached to the balloon body and the converging tube. In addition, because the cutting piece is fixedly connected with the converging tube, the axial movement of the converging tube can be controlled manually, so that the cutting piece can be accurately controlled to shrink or expand along with the sacculus body, and the operability is high.
The cutting member is tightly wrapped within the folded balloon body folds before the balloon body does not reach the lesion, without damaging the vessel during the access or retraction of the repair balloon. After reaching the pathological change, when the sacculus body fills up the state, the cutting member stretches out the sacculus surface, waits to repair position extrusion sacculus body to thrombus or calcification pathological change, and the cutting member forms vertical incision at the position of waiting to repair, reduces the damage to other positions, helps patient's postoperative to resume, is favorable to above-mentioned treatment thrombus and calcification pathological change's restoration sacculus to promote and be applied in medical instrument technical field.
Drawings
FIG. 1 is a schematic illustration of a prosthetic balloon in an embodiment for treating thrombosis and calcification lesions;
FIG. 2 is a schematic illustration of the structural separation of a prosthetic balloon for treatment of thrombosis and calcification lesions in practice;
FIG. 3 is an enlarged schematic view of the structure shown at I in FIG. 2;
FIG. 4 is a schematic view of the assembly of a cutting element, balloon and puncture catheter in an embodiment;
FIG. 5 is a cross-sectional view of the assembled schematic view of FIG. 4 with a guide tube assembled;
FIG. 6 is a schematic illustration of the structure of a repair balloon in the repair balloon for treating thrombosis and calcification lesions in one embodiment;
FIG. 7 is a schematic illustration of a partially collapsed condition of a prosthetic balloon in an embodiment;
fig. 8 is a schematic view of the structure of a cutting member in a prosthetic balloon for treating thrombosis and calcification lesions in practice.
Reference numerals: 1. a balloon body; 2. a cutting member; 3. a converging tube; 4. a guide tube; 5. a puncture catheter; 6. a developing ring; 11. cutting the support section; 12. a first transition section; 13. a first connection section; 14. a second transition section; 15. a second connection section; 21. repairing the section; 22. an extension section; 23. a converging section; 24. a first notch; 25. a second notch; 41. a guide tube body; 42. embedding the pipe section; 51. a conical head; 52. a guidewire lumen body; 53. developing points; 111. a first guide groove; 112. a fold portion; 411. and a second guide groove.
Detailed Description
In order that the above objects, features and advantages of the invention will be readily understood, a more particular description of the invention will be rendered by reference to the appended drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. The invention may be embodied in many other forms than described herein and similarly modified by those skilled in the art without departing from the spirit or scope of the invention, which is therefore not limited to the specific embodiments disclosed below.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.
In the field of interventional medical devices, "distal" is defined as the end of the procedure that is distal to the operator, and "proximal" is defined as the end of the procedure that is proximal to the operator. "axial" refers to a direction parallel to the line connecting the distal center and the proximal center of the medical device, and "radial" refers to a direction perpendicular to the axial direction.
In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "circumferential", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, are merely for convenience in describing the present invention and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be configured and operated in a specific orientation, and thus should not be construed as limiting the present invention.
In the present invention, unless explicitly specified and limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally formed; the device can be mechanically connected, electrically connected and communicated; either directly, or indirectly, through intermediaries, may be in communication with each other, or may be in interaction with each other, unless explicitly defined otherwise. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances.
Examples: as shown in fig. 1 to 8, a repairing balloon for treating thrombus and calcified lesions mainly comprises a balloon body 1, a cutting member 2, a guide tube 4, a converging tube 3 and a puncture catheter 5, wherein the balloon body 1 is provided with a first connecting section 13 and two ends are opened, the cutting member 2 extends along the outer peripheral surface of the balloon body 1 and is partially fixedly connected with the outer periphery of the balloon body 1 by means of glue adhesion and the like, the guide tube 4 is communicated with the first connecting section 13 of the balloon body 1, the converging tube 3 is sleeved on the outer surface of the guide tube 4, and the proximal end of the cutting member 2 is converged in the converging tube 3 and can slide relative to the converging tube 3.
The balloon body 1 sequentially comprises a first connecting section 13, a first transition section 12, a cutting support section 11, a second transition section 14 and a second connecting section 15 which are communicated with each other from the proximal end to the distal end. The fixed connection position of the cutting member 2 and the balloon body 1 can be slightly increased, or the cutting member 2 can be moved towards the proximal direction, so that the cutting member 2 is not required to be completely fixed on the cutting support section 11, the cutting member 2 can be correspondingly kept to be attached to the surface of the balloon body 1 along with the change of the volume of the balloon body 1 all the time when the balloon body 1 is in a filling or shrinking state, and the probability of the occurrence of a doming phenomenon is reduced. The cutting support section 11 is of a hollow cylinder structure, and the cutting member 2 positioned on the outer surface of the cutting support section 11 can be used for cutting thrombus and calcified lesion sites to relieve the completeness.
In order to further facilitate the movement of the cutting member 2 along the surface of the balloon body 1, a plurality of first guide grooves 111 are further provided on the outer circumferential surface of the balloon body 1, and the first guide grooves 111 preferably extend along the axial direction of the balloon 2, wherein the first guide grooves 111 can not only provide sliding guide for the cutting member 2 in the axial direction, but also limit the cutting member 2 in the first guide grooves 111 in the radial direction, so that the situation that the cutting member 2 is separated from the balloon body 1 to damage a blood vessel or a balloon wall in the filling or collapsing process of the balloon body 1 is avoided.
The guide tube 4 and the converging tube 3 are coaxially disposed, that is, the central axis of the guide tube 4 and the central axis of the converging tube 3 are positioned on the same straight line, and a plurality of second guide grooves 411 may be provided on the outer peripheral surface of the guide tube 4, and the second guide grooves preferably extend along the axial direction of the guide tube 4. The cutter 2 is slidable along the second guide slot 411 while further restricting rotation of the cutter 2 in the circumferential direction.
The inner side surface of the converging tube 3 can be fixedly connected with the cutting element 2, the proximal end of the converging tube 3 is fixedly connected with an external handle, so that the binding force between the cutting element 2 and the balloon body 1 is regulated through the external handle, and when the cutting element 2 is not perfectly contacted with the balloon body 1 and/or the guide tube 4, the converging tube 3 can be controlled through an external conveyer, the cutting element 2 is driven to move, and finally, the cutting element 2 is kept in an optimal working state.
The cutting member 2 comprises a repairing section 21, an extending section 22 and a converging section 23 which are sequentially connected from the distal end to the proximal end, in this embodiment, a cutting edge is arranged on one side of the repairing section 21, which is away from the balloon body 1, and after the repairing balloon is conveyed to a designated focus, liquid is filled into the balloon body 1 to enable the balloon body 1 to be gradually in a filling state, in the process, the contact part of the cutting member 2 and the balloon body 1 is gradually transferred from the inside of the balloon body 1 to the surface of the balloon body 1, the repairing section 21 and the cutting support section 11 of the balloon body 1 are in contact with one side of the cutting member 2, which is away from the balloon body 1, at least the repairing section 21 forms a cutting part to cut off calcified lesions or thrombi in vivo. The constriction section 23 is located inside the constriction tube 3, and the extension section 22 is located on the surface of the first transition section 12 of the balloon body 1.
In order to ensure that thrombus or calcification lesions can be effectively cut and other parts cannot be scratched, one side of the extension section 22 and the constriction section 23, which is away from the balloon body 1, can be arc-shaped, and softer high polymer materials and the like can be selected. The balloon body 1 is filled with heparin physiological saline or the like by inputting liquid thereto.
In order to facilitate the bending of the junction between the different parts of the cutting member 2 when the balloon is inflated, a first notch 24 is provided at the junction between the repair section 21 and the extension section 22, a second notch 25 is provided at the junction between the extension section 22 and the converging section 23, the first notch 24 faces the balloon body 1, and the second notch 25 faces away from the balloon body 1. The balloon body 1 is a hollow cavity with a large middle diameter and two ends gradually closing to the central axis, the first transition section 12 and the second transition section 14 are respectively positioned at two ends of the cutting support section 11, are respectively and gradually reduced from the cross section of the part communicated with the cutting support section 11, and are finally fixedly connected/communicated with the guide tube 4 and the puncture catheter 5 penetrating through the balloon body 1 and the guide tube 4. After the first notch 24 and the second notch 25 are arranged, the cutting member 2 can be more suitable for the diameter change of different sections of the balloon in the filling process of the balloon body 1, so that the cutting member 2 is matched with the outer surface of the balloon body 1 or the guide tube 4 in each section.
The puncture catheter 5 comprises a conical head 51, a guide wire cavity main body 52 and a developing point 53 for displaying a focus, which are beneficial to realizing rapid puncture, and the puncture catheter 5 sequentially passes through the guide tube 4 and the balloon body 1 from the proximal end and passes out of the distal end of the balloon body 1, and is mainly used as a channel of an external guide wire. When the repairing saccule is actually used, the external guide wire can be stretched into a blood vessel, the distal end of the puncture catheter 5 of the repairing saccule gradually enters the lesion position in the blood vessel along the guide wire from the proximal end of the guide wire, then the saccule body 1 is filled, the cutting edge of the cutting piece 2 is used for cutting thrombus or calcified lesion, and the repairing of the lesion position is completed.
In order to mark the repairable position, the repairing balloon is further provided with at least one developing ring 6, in this embodiment, two developing rings 6 are sleeved on the puncture catheter 5, and the two developing rings 6 respectively correspond to two ends of the repairing section 11 so as to mark the repairable axial range.
The balloon body 1 further comprises a plurality of folds 112, such as 5-10, preferably 6-8, such as 7, etc., the balloon body 1 can be folded along the folds 112, and in the folded state, the cutting element 2 (at least the repairing section 21) is wrapped in the folds 112, so as to prevent the repairing balloon from scratching the blood vessel or damaging the balloon during the conveying process.
In order to achieve excellent cutting effect, the number of the cutting members 2 may be designed to be 3 to 20, such as 16, 18, more preferably 4 to 15, such as 6, 8, 10, 12, etc., and may be set as desired. The shape of the contact part of the cutting member 2 with the balloon body 1 or the guide tube 4 may be designed to be a shape that is matched with the contact surface, and may be a plane, an upwardly concave or downwardly concave arc surface. When the cross section of the cutting member 2 is circular or circular-like, a convex blade portion is provided at the free end of the repair section 21 to facilitate cutting. The other parts of the cutting piece 2 are arc-shaped or plane on the side far away from the balloon body 1 or the guide tube 5, so that the safety of the repairing balloon is further improved, and the vascular or other parts of the repairing balloon are prevented from being scratched by the non-cutting section due to sharp.
In order to reduce the surface tension between the cutting member 2 and the thrombus or calcified lesion, the outer surface of the cutting member 2 may also be provided with a hydrophilic coating, preferably a silicone oil coating.
In order to maintain excellent cutting performance of the cutting member 2, the hardness of the repair section 21 of the cutting member 2 is HB200-600, such as 240, 500, 550, etc., preferably HB350-400, such as 360, 380, etc.
Further, the first connecting section 13 of the balloon is sleeved on the outer peripheral surface of the embedded pipe section 42 of the guide pipe 4, and in order to ensure the connection stability, the first connecting section and the second connecting section are fixedly connected, more preferably by a hot air or laser welding mode.
The proximal ends of the guide tube 4, the constriction tube 3 and the puncture catheter 5 can be connected with an external Y joint, heparin physiological saline is introduced into the constriction tube 3 from one inlet of the Y joint to enable the sacculus to be filled, and the puncture catheter 5 passes out from the other inlet of the Y joint to form a guide wire passage.
In order to ensure the operation effect and efficiency, four cutting pieces 2 can be arranged, the four cutting pieces 2 are axially arranged on the outer circumferential surface of the balloon body 1, one end of each cutting piece 2 is fixed on the outer surface of the balloon body 1, the other end of each cutting piece 2 is fixed on the inner wall of the corresponding converging tube 3, and the cutting pieces 2 are distributed around the balloon body 1 at equal intervals. Before the repair balloon reaches the lesion site needing to be cut, the cutting piece 2 fixed on the outer surface of the balloon body 1 is wrapped in the balloon body 1, so that the damage of the repair balloon to the blood vessel is avoided. When the balloon to be repaired reaches the lesion site to be cut, the balloon body 1 is gradually pressurized to drive the cutting piece 2 to protrude out of the outer surface of the balloon body 1, so as to cut the calcified lesion. When the repairing saccule is withdrawn, the saccule body 1 is gradually depressurized, and the manual withdrawing beam tube 3 drives the cutting piece 2 to be wrapped by the saccule body 1 again so as to ensure the safety.
The number of cutting members 2 is specifically dependent on the diameter of the cutting support section 11 of the balloon body 1, and typically, three to six cutting members 2 are provided on the outer circumferential surface of the cutting support section 11. For example, when the diameter of the cutting support section 11 is less than 3.5 mm, three to four cutting pieces may be provided on the outer circumferential surface of the balloon body 1, and when the diameter of the cutting support section 11 is 3.5 mm or more, five to six cutting pieces may be provided on the outer circumferential surface of the balloon body 1. In this embodiment, 4 cutting pieces are provided on the outer circumferential surface of the balloon body 1.
In order to reliably fix the cutting element 2 to the balloon body 1 and the cinch tube 3, an adhesive is used between the distal end of the cutting element 2 and the balloon body 1. An adhesive means is used between the proximal end of the cutting member 2 and the inner wall of the convergent tube 3, which glue is a UV glue, since this material is non-toxic and can harden under UV light.
The cutting member 2 is made of a metal material such as medical stainless steel, shape memory metal or other medical alloy. In addition, the hardness of the cutting member 2 can be further improved by vacuum heat treatment so that the hardness of the cutting member 2 is controlled to be between HB 350-400. The cutting member 2 is formed by laser cutting to prevent the risk of burrs remaining at the edges of the cutting member 2.
In order to facilitate the operation, the repairing saccule can better enter the lesion, and hydrophilic coatings can be coated on the outer surfaces of the saccule body 1, the cutting piece 2 and the converging tube 3.
According to the repairing balloon for treating thrombus and calcification lesions, the conventional cutting sheets are changed into the metal guide wires, the size of the protruding part of the balloon body 1 is reduced, a plurality of cutting pieces 2 are axially arranged on the surface of the balloon body 1, and a certain gap is reserved between two adjacent guide wires, so that the repairing balloon has strong trafficability, damage to the vessel wall in the operation process is reduced, and the repairing balloon smoothly passes through tortuous vessels to reach a focus to cut.
The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention; thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.
Although the reference numerals in the figures are used more herein: 1. a balloon body; 2. a cutting member; 3. a converging tube; 4. a guide tube; 5. a puncture catheter; 6. a developing ring; 11. cutting the support section; 12. a first transition section; 13. a first connection section; 14. a second transition section; 15. a second connection section; 21. repairing the section; 22. an extension section; 23. a converging section; 24. a first notch; 25. a second notch; 41. a guide tube body; 42. embedding the pipe section; 51. a conical head; 52. a guidewire lumen body; 53. developing points; 111. a first guide groove; 112. a fold portion; 411. second guide slot, etc., but does not exclude the possibility of using other terms. These terms are used merely for convenience in describing and explaining the nature of the invention; they are to be interpreted as any additional limitation that is not inconsistent with the spirit of the present invention.

Claims (6)

1. A prosthetic balloon for treating thrombosis and calcification lesions, characterized in that: the novel cutting device comprises a balloon body (1), a cutting part (2), a guide tube (4) and a converging tube (3), wherein the balloon body (1) is provided with a first connecting section (13) and is provided with openings at two ends, the cutting part (2) extends along the outer peripheral surface of the balloon body (1) and is partially fixedly connected with the outer periphery of the balloon body (1), the guide tube (4) is communicated with the first connecting section (13) of the balloon body (1), the converging tube (3) is sleeved on the outer surface of the guide tube (4), and the proximal end of the cutting part (2) is converged in the converging tube (3) and can slide relative to the converging tube (3);
the cutting piece (2) comprises a repairing section (21), an extending section (22) and a converging section (23) which are connected in sequence, and at least one side of the repairing section (21) which is away from the balloon body (1) is provided with a cutting edge; when the balloon body (1) is in a filling state, the repair section (21) is in contact with a cutting support section (11) of the balloon body (1), and the converging section (23) is positioned inside the converging tube (3); at least the repair section (21) forms a cutting part on the side of the cutting member (2) facing away from the balloon body (1) to cut off calcified lesions or thrombi in the body;
the outer peripheral surface of the balloon body (1) is provided with a plurality of first guide grooves (111) along the axial direction, and at least part of the cutting pieces (2) can slide along the first guide grooves (111);
the guide pipe (4) and the converging pipe (3) are coaxially arranged, a plurality of second guide grooves (411) are formed in the outer surface of the guide pipe (4) facing the converging pipe (3), and part of the cutting piece (2) can slide along the second guide grooves (411);
the inner side surface of the converging tube (3) is fixedly connected with the cutting piece (2), and the proximal end of the converging tube (3) is fixedly connected with an external handle so as to adjust the binding force of the cutting piece (2) and the saccule body (1) through the external handle.
2. A repair balloon for treating thrombosis and calcification as recited in claim 1, wherein: the repairing device is characterized in that a first notch (24) is formed in the joint of the repairing section (21) and the extending section (22), a second notch (25) is formed in the joint of the extending section (22) and the converging section (23), the first notch (24) faces the balloon body (1), and the second notch (25) faces away from the balloon body (1).
3. A repair balloon for treating thrombosis and calcification as recited in claim 2, wherein: the repair balloon further comprises a puncture catheter (5), and the puncture catheter (5) penetrates through the balloon body (1) and the guide tube (4) and extends out of the distal end of the balloon body (1) to serve as a channel of an external guide wire.
4. A repair balloon for treating thrombosis and calcification as recited in claim 3 wherein: the repairing saccule is also provided with at least one developing ring (6), and the developing ring (6) is sleeved on the puncture catheter (5) and corresponds to the repairing section (21) so as to mark the repairable position.
5. A repair balloon for treating thrombosis and calcification as recited in claim 4 wherein: the balloon body (1) is provided with a plurality of fold parts (112), and the balloon body (1) can be folded along the fold parts (112); in the folded state, at least the repair section (21) of the cutting element (2) is wrapped in the fold (112).
6. A repair balloon for treating thrombosis and calcification as recited in claim 5, wherein: the outer surface of the cutting member (2) is provided with a hydrophilic coating made of silicone oil.
CN202110759203.9A 2021-07-05 2021-07-05 Repairing saccule for treating thrombus and calcified lesion Active CN113648023B (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202110759203.9A CN113648023B (en) 2021-07-05 2021-07-05 Repairing saccule for treating thrombus and calcified lesion

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202110759203.9A CN113648023B (en) 2021-07-05 2021-07-05 Repairing saccule for treating thrombus and calcified lesion

Publications (2)

Publication Number Publication Date
CN113648023A CN113648023A (en) 2021-11-16
CN113648023B true CN113648023B (en) 2023-06-16

Family

ID=78489943

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202110759203.9A Active CN113648023B (en) 2021-07-05 2021-07-05 Repairing saccule for treating thrombus and calcified lesion

Country Status (1)

Country Link
CN (1) CN113648023B (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114469322B (en) * 2022-01-25 2022-08-23 广东博迈医疗科技股份有限公司 Cutting actuating mechanism and cutting balloon catheter
CN115414575B (en) * 2022-08-18 2023-08-29 广东博迈医疗科技股份有限公司 cutting balloon catheter

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0163502A2 (en) * 1984-05-30 1985-12-04 Devices For Vascular Intervention Inc. Atherectomy device
US6306151B1 (en) * 1998-03-31 2001-10-23 Interventional Technologies Inc. Balloon with reciprocating stent incisor
CN201564947U (en) * 2009-10-30 2010-09-01 业聚医疗器械(深圳)有限公司 Balloon conduit
CN110270002A (en) * 2019-06-24 2019-09-24 杭州巴泰医疗器械有限公司 A kind of sacculus tie bracket with cutting function and the blood vessel expansion appliance using the bracket
CN211301684U (en) * 2019-06-24 2020-08-21 杭州巴泰医疗器械有限公司 Sacculus restraint support and applied this support's vasodilatation device with cutting function

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6951566B2 (en) * 2002-01-25 2005-10-04 Scimed Life Systems, Inc. Reciprocating cutting and dilating balloon
US7771447B2 (en) * 2003-12-19 2010-08-10 Boston Scientific Scimed, Inc. Balloon refolding device
CN103260692B (en) * 2010-12-21 2016-10-26 因瓦泰克技术中心有限公司 For treating narrow medicament elution sacculus and the method manufacturing sacculus
US9050127B2 (en) * 2012-06-27 2015-06-09 Boston Scientific Limited Consolidated atherectomy and thrombectomy catheter
CN203564643U (en) * 2013-09-11 2014-04-30 乐普(北京)医疗器械股份有限公司 Cutting balloon
CN103949002A (en) * 2014-05-04 2014-07-30 广东博迈医疗器械有限公司 Single-guide wire cutting balloon catheter
CN109381783A (en) * 2017-08-02 2019-02-26 杭州唯强医疗科技有限公司 Drug coated balloon catheter
CN209107491U (en) * 2017-11-07 2019-07-16 上海形状记忆合金材料有限公司 A kind of Cutting balloon
CN108577937B (en) * 2018-05-18 2020-09-18 鼎科医疗技术(苏州)有限公司 Cutting balloon and balloon catheter
CN113057719B (en) * 2019-12-30 2022-05-20 先健科技(深圳)有限公司 Balloon catheter
CN112472228B (en) * 2020-12-03 2022-05-06 广东博迈医疗科技股份有限公司 Calcified plaque cutting balloon
CN112971876B (en) * 2021-05-14 2021-08-31 上海心瑞医疗科技有限公司 Atrium diverging device

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0163502A2 (en) * 1984-05-30 1985-12-04 Devices For Vascular Intervention Inc. Atherectomy device
US6306151B1 (en) * 1998-03-31 2001-10-23 Interventional Technologies Inc. Balloon with reciprocating stent incisor
CN201564947U (en) * 2009-10-30 2010-09-01 业聚医疗器械(深圳)有限公司 Balloon conduit
CN110270002A (en) * 2019-06-24 2019-09-24 杭州巴泰医疗器械有限公司 A kind of sacculus tie bracket with cutting function and the blood vessel expansion appliance using the bracket
CN211301684U (en) * 2019-06-24 2020-08-21 杭州巴泰医疗器械有限公司 Sacculus restraint support and applied this support's vasodilatation device with cutting function

Also Published As

Publication number Publication date
CN113648023A (en) 2021-11-16

Similar Documents

Publication Publication Date Title
US11697005B2 (en) Inflatable medical devices
JP4504349B2 (en) Cutting device and stenosis incision device
CN113648023B (en) Repairing saccule for treating thrombus and calcified lesion
JP2009520575A (en) Cutting balloon catheter assembly
JP3467268B2 (en) Fiber optic laser catheter
JP2918502B2 (en) Balloon catheter for stent insertion
US6951566B2 (en) Reciprocating cutting and dilating balloon
EP1542593B9 (en) Septal puncture device
US20100121258A1 (en) Lateral intravascular excision/incision devices
JP6728181B2 (en) Endovascular devices, systems and methods for controlled dissection of body cavities
RU2185859C2 (en) Device for removing stenoses and supporting vascular walls
WO2019218711A1 (en) Cutting balloon and balloon catheter
US20220151634A1 (en) Vascular access devices, systems, and methods
WO2012001826A1 (en) Medical device
US7763043B2 (en) Dilatation catheter with enhanced distal end for crossing occluded lesions
JP2007503914A (en) Devices and methods across chronic total occlusion
JPH0724058A (en) Aspiration catheter device
JP2012512002A (en) Eccentric balloon laser catheter
JP2008512196A (en) Expandable transluminal sheath
JP2003521989A (en) Surgical fasteners
JP2004504111A (en) Stiffened balloon catheters for dilatation and stenting
JP2019521802A (en) Catheter sheath emitting liquid laser induced pressure waves
JP2009511149A (en) Balloon catheter system for treating vascular occlusion
JP2019500951A (en) Introducer system, apparatus and method for heart valve reduction
EP2076186B1 (en) Instrument with an inflatable balloon

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
CB03 Change of inventor or designer information

Inventor after: Wu Mingming

Inventor after: Chen Dakai

Inventor after: Guo Yingqiang

Inventor after: Cheng Tong

Inventor before: Wu Mingming

Inventor before: Chen Dakai

Inventor before: Cheng Tong

CB03 Change of inventor or designer information
GR01 Patent grant
GR01 Patent grant