CN118846348B

CN118846348B - Scoring saccule dilating catheter

Info

Publication number: CN118846348B
Application number: CN202411356458.0A
Authority: CN
Inventors: 李玉习; 牛冬子; 翁玉麟
Original assignee: Dk Medical Technology Co ltd
Current assignee: Suzhou Dingke Medical Technology Co Ltd
Priority date: 2024-09-27
Filing date: 2024-09-27
Publication date: 2025-02-18
Anticipated expiration: 2044-09-27
Also published as: CN118846348A

Abstract

The present invention discloses a notched balloon dilatation catheter, which belongs to the technical field of interventional treatment instruments, and comprises: a catheter; a balloon connected to the distal end of the catheter and capable of radial expansion relative to the catheter; a notching mechanism, comprising a base fixedly connected to the outer wall of the balloon and a notching member connected to the base through a connecting rod assembly; the connecting rod assembly comprises a plurality of support rods rotatably connected to the base at one end and connected to the notching member at the other end, and a force transmission member rotatably connected to the plurality of support rods through a pin; the force transmission member is used to drive one end of the plurality of support rods to rotate relative to the base so that the notching member at the other end moves in a direction away from the balloon. The notching member can be expanded by using a connecting rod assembly composed of a force transmission member and a plurality of support rods, so that the notching member can move in a direction away from the balloon to reach a deeper part of the diseased tissue, and the expansion depth of the notching member is controllable; in addition, drugs are loaded between the notching member and the base, so that the drugs can be delivered to a deeper part of the diseased tissue.

Description

Scoring saccule dilating catheter

Technical Field

The invention relates to the technical field of interventional therapy instruments, in particular to a scoring balloon dilation catheter.

Background

In vascular interventional therapy, a scoring balloon is a common therapeutic tool, and is mainly used for repairing diseases such as atherosclerosis stenosis and the like. The nick saccule has the functions of cutting vascular lesion plaque, dilating blood vessels, improving blood flow and the like, and can help patients recover vascular patency.

The scoring component of the prior scoring balloon is usually fixedly arranged on the outer surface of the balloon, the radial scoring range of the scoring component is the full expansion range of the balloon, and the scoring component cannot reach deeper into lesion tissues in the radial direction.

Therefore, how to reach the score member radially deeper into the lesion tissue is a technical problem to be solved by those skilled in the art.

Disclosure of Invention

In view of the above, the present invention provides a scoring balloon dilation catheter to solve the problem of poor effect on the scoring of lesion tissue due to the radial scoring range of the scoring member of the existing scoring balloon dilation catheter.

In order to solve the technical problems, the technical scheme of the invention is as follows:

a scored balloon dilation catheter comprising:

A conduit;

A balloon connected to a distal end of the catheter and capable of radial expansion relative to the catheter;

The scoring mechanism comprises a base, a connecting rod assembly and a scoring piece, wherein the base is fixedly connected to the outer wall of the balloon, the scoring piece is connected with the base through the connecting rod assembly, the connecting rod assembly comprises a plurality of supporting rods which are arranged side by side along the length extending direction of the scoring piece and a force transmission piece which is in transmission connection with the plurality of supporting rods, one end of each supporting rod is rotatably connected to the base, the other end of each supporting rod is connected to the scoring piece, and the force transmission piece is used for driving one end of each supporting rod to rotate relative to the base so that the scoring piece at the other end of each supporting rod moves in a direction away from the balloon.

Further, the length extension direction of the scoring piece and the length extension direction of the base are both in the same direction as the axial direction of the balloon.

Further, the force transmission piece is a pull rod, the length extension direction of the pull rod is the same as the length extension direction of the scoring piece, and the pull rod is rotationally connected with a plurality of support rods through pins.

Further, a groove is formed in one side, facing the base, of the scoring piece, and the other ends of the supporting rods are slidably connected in the groove.

Further, a pull wire is connected to the proximal end of the force-transmitting member, the pull wire extending to the proximal end of the catheter.

Further, the catheter is provided with a fixing ring for restraining the stay wire on the outer wall of the catheter.

Further, a drug-carrying cavity for carrying a drug is formed between the scoring member and the base.

Further, a limit post arranged along the radial direction of the saccule is arranged between the base and the scoring piece, one of the base and the scoring piece is fixedly connected with the limit post, the other is provided with a jack for the limit post to do linear motion in the axial direction of the limit post, and an elastic piece which is positioned between the base and the scoring piece and is in an elastic stretching state is sleeved on the limit post.

The length extension direction of the base is the same as the axial direction of the saccule, two limiting columns are arranged, the two limiting columns are respectively positioned at two ends of the length extension direction of the base, and each limiting column is sleeved with the elastic piece.

Further, the scoring mechanism is provided with three or more numbers at even intervals around the circumference of the balloon.

The technical scheme of the invention has the advantages that the expansion of the notch part can be realized by adopting the connecting rod assembly consisting of the force transmission part and the plurality of supporting rods, so that the notch part can move in the direction away from the saccule to reach deeper parts of pathological tissues, the expansion depth of the notch part is controllable, and in addition, a medicine carrying cavity for carrying medicine is formed between the notch part and the base, so that the medicine can be sent to the deeper parts of pathological tissues.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings that are needed in the description of the embodiments or the prior art will be briefly described, and it is obvious that the drawings in the description below are some embodiments of the present invention, and other drawings can be obtained according to the drawings without inventive effort for a person skilled in the art.

FIG. 1 is a schematic perspective view of a scoring balloon dilation catheter in accordance with an embodiment of the present invention with a balloon in a fully inflated state and a scoring member in a contracted state;

FIG. 2 is a side view of FIG. 1;

FIG. 3 is a front view of FIG. 1;

FIG. 4 is a cross-sectional view taken along the A-A plane in FIG. 2;

FIG. 5 is an enlarged view of the portion I of FIG. 4;

FIG. 6 is a cross-sectional view of the B-B plane of FIG. 3;

FIG. 7 is an enlarged view at II in FIG. 6;

FIG. 8 is a schematic view of a connecting rod assembly according to an embodiment of the present invention;

FIG. 9 is a schematic perspective view of a scoring balloon dilation catheter in accordance with an embodiment of the present invention in which the balloon is in a fully inflated state and the scoring member is in an inflated state;

FIG. 10 is a side view of FIG. 9;

FIG. 11 is a front view of FIG. 9;

FIG. 12 is a cross-sectional view taken along the A-A plane in FIG. 10;

FIG. 13 is an enlarged view of the portion I of FIG. 12;

FIG. 14 is a cross-sectional view taken along the B-B plane in FIG. 11;

Fig. 15 is an enlarged view at II in fig. 14.

The reference numerals are 1, a catheter, 2, a balloon, 3, a scoring mechanism, 31, a base, 32, a scoring piece, 322, a jack, 33, a supporting rod, 34, a pull rod, 35, a medicine carrying cavity, 36, a limit post, 37, an elastic piece, 38, a pin, 4, a pull wire and 5, and a fixing ring.

Detailed Description

The following description of the embodiments of the present invention will be made apparent and fully in view of the accompanying drawings, in which some, but not all embodiments of the invention are shown. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

In the description of the present application, it is to be understood that the terms "proximal" and "distal" are used throughout to refer to proximal and distal with respect to an operator, and that the end of the present application that is proximal to the physician or operator, i.e., the end at which the operator is located, is "distal" to the physician or operator, i.e., the end at which the balloon is located, when used. The foregoing description of orientations is presented only to facilitate a description of the application and to simplify the description, and is not intended to indicate or imply that the devices or elements referred to must have a particular orientation, be configured and operate in a particular orientation, and therefore should not be construed as limiting the application.

In the description of the present application, it should be noted that the terms "mounted," "connected," and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected, or may be directly connected, or may be indirectly connected through an intermediate medium, or may be communication between two elements. The specific meaning of the terms in the application will be understood by those of ordinary skill in the art in a specific context.

A scoring balloon dilation catheter as shown in fig. 1 comprises a catheter 1, a balloon 2, a scoring mechanism 3 and a catheter hub (not shown). Wherein, balloon 2 connects in the distal end of pipe 1, and scoring mechanism 3 connects in the outside of balloon 2, and the catheter hub is connected in the proximal end of pipe 1, and balloon 2 can radially expand relative to pipe 1. As shown in fig. 2, the scoring mechanism 3 is provided with three at regular intervals around the circumference of the balloon 2. Of course, the number of the scoring mechanisms 3 may be three or more.

Specifically, the catheter 1 includes an inner tube and an outer tube, the inner tube passes through from the inside of the outer tube, the distal end of the balloon 2 is connected to the inner tube, the proximal end of the balloon 2 is connected to the outer tube, the inner tube passes through the balloon 2, the proximal end of the outer tube is connected to the catheter seat, and a balloon filling channel communicated with the inner cavity of the balloon 2 is formed between the inner tube and the outer tube. The catheter seat is provided with a balloon filling joint which is communicated with the balloon filling channel, and fluid medium can be filled into the inner cavity of the balloon 2 through the balloon filling joint and the balloon filling channel, so that the balloon 2 radially expands relative to the catheter 1.

As shown in fig. 3-7 and 9-13, the scoring mechanism 3 comprises a base 31, a connecting rod assembly and a scoring member 32, wherein the base 31 is fixedly connected to the outer wall of the balloon 2, and the scoring member 32 is connected with the base 31 through the connecting rod assembly. The linkage assembly is capable of driving the scoring member 32 in a direction away from the balloon 2, the scoring member 32 having an expanded state in which it expands outwardly relative to the balloon 2 under the urging of the linkage assembly and a contracted state in which it contracts outside the balloon 2 before being urged by the linkage assembly. Wherein fig. 1-7 are schematic views of the score member 32 in a contracted state, fig. 9-15 are schematic views of the score member 32 in an expanded state,

As shown in fig. 3-5 and fig. 11-13, the connecting rod assembly comprises a plurality of support rods 33 and a force transmission member, one end of each support rod 33 is rotatably connected to the base 31, the other end of each support rod 33 is movably connected to the notch member 32, the force transmission member is simultaneously in transmission connection with the plurality of support rods 33, a pull wire 4 is connected to the proximal end of each force transmission member, and the pull wire 4 extends to the proximal end of the catheter 1. The scoring 32 is able to move a distance in the radial direction of the catheter 1 as the balloon 2 expands during the balloon 2 expansion. After the balloon 2 is in a complete filling state, an operator pulls the stay wire 4, one end of the plurality of support rods 33 can be driven to rotate relative to the base 31 by the force transmission piece, and then the nick pieces 32 at the other ends of the plurality of support rods 33 are driven to move in a direction away from the balloon 2, so that the moving distance of the nick pieces 32 in the radial direction of the catheter 1 is enlarged, the nick pieces 32 can reach deeper parts of lesion tissues, and the nick of the lesion tissues with large outer diameters can be realized by using the balloon 2 with small outer diameters.

In some embodiments, as shown in fig. 3-5 and 11-13, the balloon 2 has a middle cylindrical, two-end conical structure, the base 31 is fixed outside the middle cylindrical region of the balloon 2, and the scoring member 32 is located on the side of the base 31 facing away from the balloon 2. Both the base 31 and the scoring member 32 are elongated, and the length extension direction of the scoring member 32 and the length extension direction of the base 31 are both in the same direction as the axial direction of the balloon 2. In other alternative embodiments, the bases 31 may be all spirally wound around the outer periphery of the balloon 2, in which case the scoring 32 is spirally wound like the bases 31, or the bases 31 may be circularly wound around the outer periphery of the balloon 2, in which case the scoring 32 is circularly wound like the bases 31. It will be appreciated herein that the base 31 and scoring member 32 may be other shapes as long as the scoring member 32 is capable of moving away from the balloon 2 under the influence of the linkage assembly.

In some embodiments, as shown in fig. 5, 8 and 13, a plurality of support bars 33 are arranged side by side along the length extension direction of the score member 32, and the plurality of support bars 33 are identical in length and arranged in parallel. The force transmission member is specifically a pull rod 34, the pull rod 34 is rotationally connected with the plurality of support rods 33 through pins 38, and the length extension direction of the pull rod 34 is the same as the length extension direction of the scoring member 32. So set up, pull rod 34 can drive a plurality of bracing pieces 33 simultaneously to the same direction rotation under the effect of acting as go-between 4, and then drive nick piece 32 to the direction motion that keeps away from sacculus 2. In other alternative embodiments, the force-transmitting member is not limited to the single pull rod 34, but may be a flexible pull rope, multiple links, or other various structures that can be transmitted between the multiple support rods 33.

As shown in fig. 1, 3, 9 and 11, the catheter 1 is provided with a fixing ring 5 for restraining the pull wire 4 on the outer wall of the catheter 1, the fixing ring 5 is sleeved and fixed on the outer wall of the catheter 1, and a through hole for the pull wire 4 to pass through is arranged in the outer peripheral wall of the fixing ring 5. In other alternative embodiments, the securing ring 5 may be omitted and a routing channel provided inside the catheter 1 for the pull wire 4 to extend to the proximal end of the catheter 1.

In some embodiments, as shown in fig. 5-7 and 13-15, a groove is formed on a side of the scoring member 32 facing the base 31, and the other ends of the plurality of support rods 33 are slidably connected in the groove. A concave cavity is arranged on one side of the base 31 facing the scoring member 32, and a medicine carrying cavity 35 for carrying medicine is formed between the scoring member 32 and the base 31. As shown in fig. 5-7, when the score member 32 is in the contracted state, the side end surface of the score member 32 facing the base 31 and the side end surface of the base 31 facing the score member 32 are fitted to close the medicine carrying chamber 35. 13-15, when the scoring member 32 is in the expanded state, the scoring member 32 moves away from the base 31 and dissects the diseased tissue, the drug-carrying chamber 35 is open, and the drug within the drug-carrying chamber 35 can be released deeper into the diseased tissue dissected by the scoring member 32. Further, when the scoring member 32 is in the contracted state, the mutually abutting surfaces of the scoring member 32 and the base 31 are irregular surfaces with concave-convex relief, so that the sealing performance of the mutually abutting surfaces of the scoring member 32 and the base 31 can be improved, and the medicine in the medicine carrying cavity 35 can be prevented from leaking.

In some embodiments, as shown in fig. 5-7 and 13-15, the radial cross-section of the scoring member 32 is V-shaped in the radial cross-section of the balloon 2, with the edge of the scoring member 32 located at the end of the scoring member 32 remote from the base 31. In other alternative embodiments, the radial cross-section of the score member 32 may also be triangular.

In some embodiments, as shown in fig. 5-7 and fig. 13-15, a limiting post 36 is disposed between the base 31 and the scoring member 32 along the radial direction of the balloon 2, one end of the limiting post 36 is fixedly connected to the base 31, a jack 322 is disposed in the scoring member 32, the other end of the limiting post 36 extends into the jack 322, and the limiting post 36 can move linearly in the jack 322 along the axial direction of the limiting post 36. The limiting post 36 is also sleeved with an elastic piece 37 which is positioned between the base 31 and the scoring piece 32 and is in an elastic stretching state. When the scoring member 32 moves away from the balloon 2 under the action of the plurality of support rods 33, the scoring member 32 can only move along the axial direction of the spacing posts 36, i.e., the radial direction of the balloon 2 due to the spacing constraint action of the spacing posts 36 on the scoring member 32, which is beneficial to improving the scoring strength and scoring depth of the scoring member 32. When the force applied to the score member 32 by the plurality of support rods 33 is removed, the score member 32 moves in a direction approaching the balloon 2 by the elastic restoring force of the elastic member 37 until the score member returns to the contracted state against the base 31.

In some embodiments, as shown in fig. 5 and 13, two limiting columns 36 are provided, and two limiting columns 36 are respectively located at two ends of the base 31 in the length extending direction, and each limiting column 36 is sleeved with an elastic member 37. The provision of two stop posts 36 may enhance the guiding effect on the direction of movement of the score member 32.

Fig. 1-7 are schematic views of the balloon 2 in a fully expanded state and the scoring member 32 in a contracted state, fig. 9-15 are schematic views of the balloon 2 in a fully expanded state and the scoring member 32 in an expanded state, an operator pulls the pull wire 4, the pull rod 34 drives the plurality of support rods 33 to rotate, the scoring member 32 is further driven to move along the axial direction of the limit post 36 away from the balloon 2, the scoring member 32 reaches deeper into a lesion, the medicine between the scoring member 32 and the base 31 is released to the deeper depth of the lesion tissue cut by the scoring member 32, the feeding depth of the scoring member 32 can be quantitatively controlled by the pulling force of the pull wire 4, the elastic member 37 is further stretched when the scoring member 32 is expanded, when the operator releases the pull wire 4 due to the elastic restoring force of the elastic member 37, the scoring member 32 moves towards the direction close to the balloon 2, the original contracted state is returned, the operator can pull the pull wire 4 again to expand the scoring member 32 outwards, and the scoring member 32 can be expanded and contracted repeatedly.

When the scored balloon dilation catheter is used, firstly, the scored balloon dilation catheter with the balloon 2 in a folded and contracted state and the scored piece 32 in a contracted state is conveyed to a lesion position, then fluid is filled into the balloon 2 to enable the balloon 2 to be inflated, along with the expansion of the balloon 2, the scored piece 32 also reaches the position of lesion tissues, then an operator pulls the stay wire 4, the pull rod 34 drives the support rods 33 to rotate in the same direction, the scored piece 32 is driven to move in the direction away from the balloon 2 along the axial direction of the limit post 36, the scored piece 32 reaches the deeper side of the lesion tissues, the elastic piece 37 is further stretched, the medicine between the scored piece 32 and the base 31 is released to the deeper side of the lesion tissues cut by the scored piece 32, the feeding depth of the scored piece 32 can be quantitatively controlled through the pulling force of the stay wire 4, then the operator releases the stay wire 4, the scored piece 32 is enabled to move towards the direction close to the balloon 2 due to the elastic restoring force of the elastic piece 37, the scored piece 32 returns to the initial contracted state, the operator can pull the stay wire 4 again to enable the scored piece 32 to move outwards according to the requirement, the scored piece 32 to be pulled outwards, the scored piece 32 can be withdrawn from the balloon dilation catheter is withdrawn, the contracted and the balloon dilation catheter can be in the contracted state when the balloon dilation catheter is required to be in the contracted, and the outer body is in the contracted and the contracted state, the balloon dilation catheter can be in a plurality of times, and the expanded.

In summary, the embodiment of the present invention provides a scoring balloon dilation catheter, which adopts a connecting rod assembly composed of a pull rod 34 and a plurality of support rods 33 to realize re-dilation of the scoring member 32, so that the scoring member 32 can move away from the balloon 2 to reach deeper depth of the lesion tissue, and simultaneously, the dilation depth of the scoring member 32 can be controlled by controlling the pulling force of the pull wire 4. In addition, a drug-carrying cavity 35 for carrying a drug is formed between the scoring member 32 and the base 31, and the drug can be delivered deeper into the diseased tissue.

It is apparent that the above examples are given by way of illustration only and are not limiting of the embodiments. Other variations or modifications of the above teachings will be apparent to those of ordinary skill in the art. It is not necessary here nor is it exhaustive of all embodiments. While still being apparent from variations or modifications that may be made by those skilled in the art are within the scope of the invention.

Claims

1. A scoring balloon dilation catheter, comprising:

A conduit (1);

the balloon (2) is connected to the distal end of the catheter (1) and can radially expand relative to the catheter (1), and the balloon (2) has a structure of a middle cylinder and two cones at two ends;

The scoring mechanism (3) comprises a base (31), a connecting rod assembly and a scoring piece (32), wherein the base (31) is fixedly connected to the outer wall of the middle cylindrical area of the balloon (2), and the scoring piece (32) is connected with the base (31) through the connecting rod assembly;

The connecting rod assembly comprises a plurality of support rods (33) which are arranged side by side along the length extension direction of the scoring piece (32), and a force transmission piece which is in transmission connection with the plurality of support rods (33), wherein one end of each support rod (33) is rotatably connected to the base (31), and the other end of each support rod is connected to the scoring piece (32), and the force transmission piece is used for driving one end of each support rod (33) to rotate relative to the base (31) so as to enable the scoring piece (32) at the other end of each support rod (33) to move in a direction away from the balloon (2);

a drug-carrying cavity (35) for carrying a drug is formed between the scoring member (32) and the base (31).

2. The scoring balloon dilation catheter according to claim 1 characterized in that the length extension direction of the scoring member (32) and the length extension direction of the base (31) are both co-directional with the axial direction of the balloon (2).

3. The scoring balloon dilation catheter according to claim 1 wherein the force transfer member is a pull rod (34), the length extension of the pull rod (34) is the same as the length extension of the scoring member (32), and the pull rod (34) is rotationally connected to a plurality of support rods (33) by pins (38).

4. The scoring balloon dilation catheter according to claim 1 wherein a side of the scoring member (32) facing the base (31) is provided with a groove in which the other ends of a plurality of support rods (33) are slidably connected.

5. A scoring balloon dilation catheter according to claim 1 wherein a pull wire (4) is connected to the proximal end of the force transfer member, the pull wire (4) extending to the proximal end of the catheter (1).

6. The scoring balloon dilation catheter according to claim 5 characterized in that the catheter (1) is provided with a securing ring (5) for constraining the pull wire (4) to the outer wall of the catheter (1).

7. The scoring balloon dilation catheter according to any one of claims 1-6 wherein a spacing post (36) is disposed between the base (31) and the scoring member (32) along a radial direction of the balloon (2), one of the base (31) and the scoring member (32) is fixedly connected to the spacing post (36), the other is provided with a jack (322) for the spacing post (36) to move linearly along an axial direction of the spacing post (36) in the interior thereof, and an elastic member (37) which is disposed between the base (31) and the scoring member (32) and is in an elastic stretched state is further sleeved on the spacing post (36).

8. The scoring balloon dilation catheter according to claim 7 is characterized in that the length extending direction of the base (31) is the same as the axial direction of the balloon (2), two limiting columns (36) are arranged, the two limiting columns (36) are respectively positioned at two ends of the length extending direction of the base (31), and each limiting column (36) is sleeved with the elastic piece (37).

9. The scoring balloon dilation catheter according to claim 1 wherein the scoring mechanisms (3) are evenly spaced around the circumference of the balloon (2) by three or more numbers.