CN113877043B

CN113877043B - Scoring wire balloon and scoring wire balloon dilation catheter device

Info

Publication number: CN113877043B
Application number: CN202111148549.1A
Authority: CN
Inventors: 吴凌波; 黄君仪; 张志军; 李斌
Original assignee: Guangdong Bomai Medical Technology Co Ltd
Current assignee: Guangdong Bomai Medical Technology Co Ltd
Priority date: 2021-09-28
Filing date: 2021-09-28
Publication date: 2023-06-27
Anticipated expiration: 2041-09-28
Also published as: CN113877043A

Abstract

The utility model provides a nick silk sacculus and nick silk sacculus inflation pipe device, nick silk sacculus includes the sacculus, sets up the nick silk in the sacculus outside, the distal end and the proximal end of nick silk connect respectively in the both ends of sacculus, nick silk sacculus still includes elastic fixation structure, elastic fixation structure is located the sacculus outside, just elastic fixation structure's both ends are connected respectively the position between the distal end and the proximal end of nick silk, elastic fixation structure can correspond the flexible of sacculus is flexible. The notch wire is connected to the outer side of the balloon through the elastic fixing structure, so that the notch wire is connected with the balloon more stably, and the notch wire is not easy to tangle on the balloon. The scoring wire balloon dilation catheter device has the advantages of the scoring wire balloon of the application because of the scoring wire balloon of the application.

Description

Scoring wire balloon and scoring wire balloon dilation catheter device

Technical Field

The present application relates to medical devices, and more particularly, to a scoring balloon and a scoring balloon dilation catheter device.

Background

Coronary calcification rate generally increases with age, with about 80% occurring in the 60-69 year old population. The higher the degree of coronary stenosis, the greater the probability of calcification. Advanced age, abnormal lipid metabolism, diabetes, hyperthyroidism, chronic kidney disease, renal replacement therapy, hypercalcemia, and past coronary artery bypass grafting are highly advanced populations of coronary calcification lesions. Coronary arteriosclerosis can lead to increased vascular stiffness, reduced compliance, impaired myocardial perfusion, etc., and pose a significant threat to human health. The percutaneous coronary intervention can rapidly open the infarcted coronary artery, improve the myocardial blood supply, realize ischemia myocardial reperfusion, and effectively treat angina pectoris, myocardial infarction, acute coronary syndrome and the like. As a common vascular reconstruction mode, the vascular interventional therapy has the advantages of high opening rate, ideal effect and the like. At present, the conventional working balloon can treat superficial calcification lesions, but has low success rate of dilating the middle calcification lesions and high complication rate. The scoring wire balloon is based on a conventional working balloon and is more suitable for treatment equipment of medium calcified lesion blood vessels. However, in the existing scoring wire balloon, only two ends of the scoring wire are generally fixed on the balloon, and the whole scoring wire is not fixed on the surface of the balloon. Therefore, when the stent mesh is expanded or in other use conditions, if the balloon is rotated, the surface score wires are entangled, so that the operation difficulty of a doctor is increased, and the operation is not facilitated.

Disclosure of Invention

An object of the embodiment of the application is to provide a scoring wire balloon and a scoring wire balloon dilatation catheter device, so as to solve the technical problem that the scoring wire in the scoring wire balloon is unstable in connection with the balloon and the scoring wire is easy to generate entanglement phenomenon during use in the prior art.

In order to achieve the above purpose, the technical scheme adopted in the application is as follows:

the utility model provides a scoring wire balloon, include the sacculus, set up the scoring wire in the sacculus outside, the distal end and the proximal end of scoring wire connect respectively in the both ends of sacculus, scoring wire sacculus still includes elastic fixation structure, elastic fixation structure is located the sacculus outside, just elastic fixation structure's both ends are connected respectively the position between the distal end and the proximal end of scoring wire, elastic fixation structure can correspond the flexible and flexible of sacculus.

As a further improvement of the above technical scheme:

optionally, the number of the elastic fixing structures is multiple, the elastic fixing structures are arranged at intervals along the axial direction of the balloon, and multiple parts between the distal end and the proximal end of the score line are connected to the balloon through the elastic fixing structures.

Optionally, the elastic fixing structure includes a plurality of bending fixing units connected in sequence, the score wire is connected to the bending fixing units, and the plurality of bending fixing units are arranged outside the balloon along the circumferential direction of the balloon.

Optionally, the elastic fixing structure is arranged on the outer side of the balloon.

Optionally, the score wire includes a bending section between the distal and proximal ends.

Optionally, a plurality of bending sections are arranged between the distal end and the proximal end of the score line, and a plurality of bending sections are arranged at intervals.

Optionally, the score wire is axially arranged along the balloon, and distal and proximal ends of the score wire are respectively fixed to two ends of the balloon.

Optionally, the elastic fixing structure is provided with a score wire mounting structure for increasing the connection area between the score wire and the elastic fixing structure.

Optionally, the score wire mounting structure is an extended mounting surface that extends along a length direction of the score wire.

Optionally, the number of the score lines is multiple, and the multiple score lines are arranged at intervals along the circumferential direction of the balloon.

Optionally, the elastic fixing structure is made of a memory material.

A scoring wire saccule dilating catheter device comprises a catheter seat, a stress tube, an intermediate catheter and the scoring wire saccule which are connected in sequence.

The beneficial effect that this application provided the indentation silk sacculus and indentation silk sacculus inflation pipe device lies in:

the utility model provides a nick wire sacculus connects the distal end and the proximal end of nick wire in the sacculus respectively, prevents that the both ends of nick wire from freeing on the sacculus. The part of the score wire between the distal end and the proximal end is connected to the balloon through the elastic fixing structure, so that the movement of the part of the score wire between the distal end and the proximal end can be limited, and the entanglement phenomenon between the score wires caused by the large movement range of the part between the distal end and the proximal end can be prevented. The elastic fixing structure can stretch when the balloon is inflated by means of self elasticity; the elastic fixing structure can also automatically shrink to an initial state when the sacculus is contracted by means of self elasticity. The elastic fixing structure not only can drive the score wire to move corresponding to the telescopic movement of the balloon all the time, but also is beneficial to preventing the balloon from being excessively expanded, and the balloon is enabled to be quickly retracted to an initial state. Compared with the prior art, the scoring wire balloon has the advantages that the scoring wire is connected with the balloon more stably, and the scoring wire is not easy to be intertwined on the balloon during use. The scoring wire balloon dilation catheter device has the advantages of the scoring wire balloon of the application because of the scoring wire balloon of the application.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings that are required for the embodiments or the description of the prior art will be briefly described below, it being obvious that the drawings in the following description are only some embodiments of the present application, and that other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

FIG. 1 is a schematic view of a front view of a score wire balloon provided herein;

FIG. 2 is a schematic view of a partial enlarged structure of a score wire balloon provided herein;

FIG. 3 is a schematic view of a partial enlarged structure at A in FIG. 2;

FIG. 4 is a schematic view of a partially enlarged structure of the elastic fixation structure of the score-wire balloon provided in the present application;

FIG. 5 is a schematic view of a second enlarged partial structure of the elastic attachment structure of the score-wire balloon provided herein;

FIG. 6 is a schematic view of a partial enlarged structure of a connection of a score wire balloon provided herein with an elastic fixation structure;

fig. 7 is a schematic diagram showing a partially enlarged structure of the connection between the score wire and the elastic fixing structure of the score wire balloon provided by the present application.

Wherein, each reference sign in the figure:

1. balloon 2, score wire

21. Distal end 22, proximal end

23. Bending section 3, elastic fixing structure

31. Bending fixing unit 4 and score wire mounting structure

5. Intermediate conduit 6, stress tube

7. Catheter hub

Detailed Description

In order to make the technical problems, technical schemes and beneficial effects to be solved by the present application more clear, the present application is further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are for purposes of illustration only and are not intended to limit the present application.

It will be understood that when an element is referred to as being "mounted" or "disposed" on another element, it can be directly on the other element or be indirectly on the other element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or be indirectly connected to the other element.

It is to be understood that the terms "length," "width," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," and the like indicate or are based on the orientation or positional relationship shown in the drawings, merely to facilitate description of the present application and simplify description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be configured and operated in a particular orientation, and therefore should not be construed as limiting the present application.

Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include one or more such feature. In the description of the present application, the meaning of "a plurality" is two or more, unless explicitly defined otherwise.

In this application, terms of positional relationship such as "proximal", "distal", and the like are relative to an operator of the score wire balloon dilation catheter apparatus of the present application, and the end closer to the operator is referred to as the proximal end and the end farther from the operator is referred to as the distal end.

As shown in fig. 1 and 2, the scoring wire balloon of the present embodiment includes a balloon 1, a scoring wire 2 disposed outside the balloon 1, a distal end 21 and a proximal end 22 of the scoring wire 2 are respectively connected to two ends of the balloon 1, the scoring wire balloon further includes an elastic fixing structure 3, the elastic fixing structure 3 is located outside the balloon 1, two ends of the elastic fixing structure 3 are respectively connected to a portion between the distal end 21 and the proximal end 22 of the scoring wire 2, and the elastic fixing structure 3 can stretch and retract corresponding to stretching of the balloon 1.

In the blood vessel of calcified stenosis, the problems of strong pain felt by a patient in the treatment process, blood vessel interlayer possibly occurring after operation, short-term serious restenosis in the vascular repair disordered tearing process and the like are effectively reduced due to the fact that the high-pressure burst disordered tearing expansion under the prior art means is effectively reduced by the expansion of the saccule 1 and the micro-cutting action of the score wire 2 at the outer side of the saccule 1 under the lower expansion pressure.

The distal end 21 and the proximal end 22 of the score wire 2 are connected to the balloon 1, respectively, preventing the two ends of the score wire 2 from being free on the balloon 1. In a specific embodiment, the distal end 21 and the proximal end 22 of the score wire 2 are secured to the balloon 1 by bonding; in another embodiment, the score wire distal 21 and proximal 22 ends are secured by welding with a fixed metal ring at both ends of the balloon. The portion between the distal end 21 and the proximal end 22 of the score wire 2 is connected to the balloon 1 by the elastic fixing structure 3, so that the movement of the portion between the distal end 21 and the proximal end 22 of the score wire 2 can be limited, and the entanglement phenomenon between the score wires 2 caused by the large movement range of the portion between the distal end 21 and the proximal end 22 can be prevented. The elastic fixing structure 3 can be stretched by virtue of self elasticity when the balloon 1 is inflated; the elastic fixing structure 3 can also automatically contract to an initial state when the balloon 1 contracts by means of self elasticity. The elastic fixing structure 3 not only can drive the score wire 2 to move corresponding to the telescopic movement of the balloon 1 all the time, but also helps to prevent the balloon 1 from being excessively inflated, and enables the balloon 1 to be quickly retracted to an initial state. Compared with the existing scoring wire balloon, the scoring wire balloon has the advantages that the scoring wire 2 is connected with the balloon 1 more stably, and the scoring wire 2 is not easy to intertwine on the balloon 1 during use.

As shown in fig. 1 and 2, in the present embodiment, the number of the elastic fixing structures 3 is plural, the plural elastic fixing structures 3 are disposed at intervals along the axial direction of the balloon 1, and plural portions of the score line 2 between the distal end 21 and the proximal end 22 are connected to the balloon 1 by the respective elastic fixing structures 3. The plurality of parts between the distal end 21 and the proximal end 22 of the score wire 2 are connected through the plurality of elastic fixing structures 3, so that more parts of the score wire 2 are connected to the outer side of the balloon 1 through the elastic fixing structures 3, the stability of the score wire 2 connected to the outer side of the balloon 1 is further improved, and the entanglement probability of the score wire 2 is further reduced.

As shown in fig. 4, in the present embodiment, the elastic fixing structure 3 includes a plurality of bending fixing units 31 connected in sequence, the score line 2 is connected to the bending fixing units 31, and the plurality of bending fixing units 31 are arranged on the balloon 1 along the circumferential direction of the balloon 1. The plurality of bending fixing units 31 which are sequentially connected are connected in a tail-end mode to form a ring shape, namely the elastic fixing structure 3. The bending fixing unit 31 can achieve stretching or shrinking of the elastic fixing structure 3 by stretching or shrinking the bending portion. Referring to fig. 6 and 7, the bending fixing units 31 constituting the elastic fixing structure 3 may be springs, elastic sheets, hairsprings, etc. Preferably, the score line 2 is connected to the center vertical line portion of the bending fixing unit 31. The sequential connection referred to in this embodiment should be understood not only simply as that the plurality of bending fixing units 31 are sequentially connected end to end, but also as that the elastic fixing structure 3 integrally formed by the plurality of bending fixing units 31 sequentially connected.

As shown in fig. 1 and 2, in the present embodiment, the elastic fixing structure 3 is provided on the outer side of the balloon 1. When the balloon 1 is inflated, the elastic fixing structure 3 is expanded; when the balloon 1 is contracted, the elastic fixing structure 3 automatically retracts under the elastic action. The elastic fixing structures 3 enable a plurality of positions between the distal end 21 and the proximal end 22 of the score wire 2 to be connected to the outer side of the balloon 1 through the elastic fixing structures 3, so that the score wire 2 is prevented from sliding on the balloon 1 and the score wire 2 is prevented from being intertwined. Furthermore, the elastic fixing structure 3 is arranged outside the balloon 1, so that the elastic fixing structure 3 is convenient to install.

As shown in fig. 3, in this embodiment, score wire 2 includes a bent segment 23 between distal end 21 and proximal end 22. Since the balloon 1 changes in volume as the balloon 1 expands and contracts, the length of the balloon 1 correspondingly increases or decreases, and thus the increase or decrease in length of the balloon 1 is accommodated by the bend 23 between the distal end 21 and the proximal end 22. When the balloon 1 is inflated, the volume of the balloon 1 increases, the length of the balloon 1 increases, and the distal end 21 and the proximal end 22 move toward both ends of the balloon 1 along with the inflation of the balloon 1, thereby pulling the straightening bending section 23, and lengthening the length of the score wire 2 to accommodate the increase in the length of the balloon 1. When the balloon 1 is contracted, the volume of the balloon 1 is reduced, the length of the balloon 1 is reduced, and the distal end 21 and the proximal end 22 move towards the center of the balloon 1 along with the contraction of the balloon 1, so that the bending section 23 is bent and contracted again, and the length of the score line 2 is reduced to adapt to the reduction of the length of the balloon 1.

In this embodiment, a plurality of bending segments 23 are disposed between the distal end 21 and the proximal end 22 of the score wire 2, and the bending segments 23 are disposed at intervals. The plurality of bending sections 23 can adapt to the requirements of different expansion and contraction amounts of different parts of the score line 2. For example, when the balloon 1 is inflated, the deformation amount of the middle part of the balloon 1 is larger than the deformation amount of the two ends of the balloon 1, the bending sections 23 of the middle part of the score line 2 adapt to the deformation amount of the middle part of the balloon 1, and the bending sections 23 of the two ends of the score line 2 adapt to the deformation amount of the two ends of the balloon 1, so that the expansion deformation of the whole part of the score line 2 is more adaptive to the expansion deformation of the balloon 1.

As shown in fig. 1 and 2, in the present embodiment, the score wire 2 is disposed along the axial direction of the balloon 1, and the distal end 21 and the proximal end 22 of the score wire 2 are fixed to both ends of the balloon 1, respectively. When the balloon 1 is inflated, the distal end 21 and the proximal end 22 pull the score wire 2 to stretch towards the two ends of the balloon 1; when the balloon 1 is contracted, the distal end 21 and the proximal end 22 draw the score wire 2 to contract toward the center of the balloon 1.

As shown in fig. 6 and 7, in the present embodiment, the number of score lines 2 is plural, and the plurality of score lines 2 are arranged at intervals along the circumferential direction of the balloon 1. Preferably, the number of score wires 2 is three. Three score wires 2 are disposed 120 ° apart around the outer circumference of the balloon 1. In other embodiments, the number of score wires 2 may also be four, five, six.

As shown in fig. 5, in the present embodiment, the elastic fixing structure 3 is provided with a score wire mounting structure 4 for increasing the connection area of the score wire 2 and the elastic fixing structure 3. Because the contact area between the score line 2 and the elastic fixing structure 3 is small (similar to point contact), the stress between the score line 2 and the elastic fixing structure 3 is too concentrated, the connection between the score line 2 and the elastic fixing structure 3 is easy to break, and the connection stability between the score line 2 and the elastic fixing structure 3 is poor. The connecting area between the score wire 2 and the elastic fixing structure 3 can be increased through the score wire mounting structure 4, stress concentration between the score wire 2 and the elastic fixing structure 3 is avoided, the fracture probability between the score wire 2 and the elastic fixing structure 3 is reduced, and the connecting stability between the score wire 2 and the elastic fixing structure 3 is enhanced.

As shown in fig. 5, in this embodiment, the score wire mounting structure 4 is an extended mounting surface that extends along the length of the score wire 2. The extending mounting surface extends along the length direction of the score wire 2, so that the unstable connection length between the score wire 2 and the elastic fixing structure 3 is increased, and the connection area between the score wire 2 and the elastic fixing structure 3 is increased. In other embodiments, the score wire mounting structure 4 may also be a mounting hole, a mounting groove, a mounting buckle, or the like provided on the elastic fixing structure 3 for increasing the connection area of the score wire 2 and the elastic fixing structure 3.

In this embodiment, the elastic fixing structure 3 is made of a memory material. The memory material may be a shape memory alloy. Shape memory alloys have found wide application in the clinical medical field, such as artificial bones, bone fracture fixation pressers, dental orthodontics, various endoluminal stents, embolizers, cardiac prostheses, thrombus filters, interventional guidewires and surgical sutures, and the like, and memory alloys are playing an irreplaceable role in modern medical practice. The shape memory alloy is a material composed of two or more metal elements having a shape memory effect by thermoelasticity and martensitic transformation and inversion thereof. The memory material may be a member having an elastic expansion function such as rubber.

As shown in fig. 1, the present application further provides a scoring wire balloon dilatation catheter device, which comprises a catheter seat 7, a stress tube 6, an intermediate catheter 5 and the scoring wire balloon of the above embodiment, which are connected in sequence.

In use, the catheter hub 7 is connected to an external pressure source, and pressure medium (e.g. liquid medium, etc.) is delivered into the score-wire balloon by inputting the pressure medium and sequentially passing through the stress tube 6 and the intermediate catheter 5, thereby controlling the expansion and contraction of the score-wire balloon. The scoring wire balloon dilation catheter device has the scoring wire balloon of the embodiment, and therefore has the advantages of the scoring wire balloon of the embodiment.

The foregoing description of the preferred embodiments of the present application is not intended to be limiting, but is intended to cover any and all modifications, equivalents, and alternatives falling within the spirit and principles of the present application.

Claims

1. The scoring wire balloon is characterized by comprising a balloon (1) and a scoring wire (2) arranged on the outer side of the balloon (1), wherein the distal end (21) and the proximal end (22) of the scoring wire (2) are respectively connected to the two ends of the balloon (1), the scoring wire balloon further comprises an elastic fixing structure (3), the elastic fixing structure (3) is positioned on the outer side of the balloon (1), the two ends of the elastic fixing structure (3) are respectively connected to the part between the distal end (21) and the proximal end (22) of the scoring wire (2), and the elastic fixing structure (3) can stretch and retract corresponding to the stretching of the balloon (1);

the number of the elastic fixing structures (3) is multiple, the elastic fixing structures (3) are arranged at intervals along the axial direction of the balloon (1), and multiple parts between the distal end (21) and the proximal end (22) of the score wire (2) are connected to the balloon (1) through the elastic fixing structures (3);

the elastic fixing structure (3) comprises a plurality of bending fixing units (31) which are sequentially connected, the score wires (2) are connected to the bending fixing units (31), and the bending fixing units (31) are arranged outside the balloon (1) along the circumferential direction of the balloon (1);

a plurality of bending sections (23) are arranged between the distal end (21) and the proximal end (22) of the score line (2), and a plurality of bending sections (23) are arranged at intervals.

2. The scoring wire balloon according to claim 1, characterized in that the elastic fixation structure (3) is provided outside the balloon (1).

3. The score-wire balloon according to claim 1, wherein the score-wire (2) comprises a bending section (23) between the distal end (21) and the proximal end (22).

4. The score-wire balloon according to claim 1, characterized in that the score-wire (2) is arranged axially along the balloon (1), the distal end (21) and the proximal end (22) of the score-wire (2) being fixed to the balloon (1) at both ends, respectively.

5. A score wire balloon according to claim 1, wherein the elastic fixation structure (3) is provided with a score wire mounting structure (4) for increasing the connection area of the score wire (2) with the elastic fixation structure (3).

6. The score wire balloon of claim 1, wherein the score wire mounting structure (4) is an extended mounting surface that extends along the length of the score wire (2).

7. The score-wire balloon according to claim 1, characterized in that the number of the score-wires (2) is plural, and the score-wires (2) are arranged at intervals along the circumference of the balloon (1).

8. The score wire balloon of claim 1, wherein the elastic fixation structure is made of a memory material.

9. A scoring balloon dilation catheter device comprising a catheter hub (7), a stress tube (6), an intermediate catheter (5) and the scoring balloon of any one of claims 1-8 connected in sequence.