A scored balloon dilatation catheter

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

Technical Field

[0001] The invention relates to the technical field of interventional treatment instruments, and in particular to a scored balloon dilatation catheter. Background Art

[0002] In vascular interventional treatment, the scored balloon is a commonly used treatment tool, which is mainly used to repair diseases such as atherosclerotic stenosis. The scored balloon has the functions of cutting vascular lesions, dilating blood vessels and improving blood flow, which can help patients restore vascular patency.

[0003] The scoring member of the existing scored balloon is usually fixedly mounted on the outer surface of the balloon, and the radial scoring range of the scoring member is the filling and expansion range of the balloon. The scoring member cannot reach deeper into the diseased tissue in the radial direction.

[0004] Therefore, how to make the notching member reach deeper into the diseased tissue in the radial direction is a technical problem that needs to be solved urgently by those skilled in the art. Summary of the invention

[0005] In view of this, the present invention provides a scoring balloon dilatation catheter to solve the problems of the radial scoring range of the scoring member of the existing scoring balloon dilatation catheter and the poor scoring effect on the diseased tissue.

[0006] In order to solve the above technical problems, the technical solution of the present invention is as follows:

[0007] A scored balloon dilatation catheter, comprising:

[0008] catheter;

[0009] A balloon connected to the distal end of the catheter and capable of expanding in the radial direction of the catheter;

[0010] The scoring mechanism includes a base, a connecting rod assembly and a scoring member, wherein the base is fixedly connected to the outer wall of the balloon, and the scoring member is connected to the base through the connecting rod assembly; the connecting rod assembly includes a plurality of support rods arranged side by side along the length extension direction of the scoring member, and a force transmission member connected to the plurality of support rods in a transmission manner; one end of the support rod is rotatably connected to the base, and the other end is connected to the scoring member; 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 scoring members at the other ends of the plurality of support rods move in a direction away from the balloon.

[0011] Furthermore, the length extension direction of the notched member and the length extension direction of the base are both in the same direction as the axial direction of the balloon.

[0012] Furthermore, the force transmission member is a pull rod, the length extension direction of the pull rod is the same as the length extension direction of the notching member, and the pull rod is rotatably connected to the plurality of support rods via a pin.

[0013] Furthermore, a groove is provided on one side of the notched member facing the base, and the other ends of the plurality of support rods are slidably connected in the groove.

[0014] Furthermore, a pull wire is connected to the proximal end of the force transmission member, and the pull wire extends to the proximal end of the catheter.

[0015] Furthermore, the catheter is provided with a fixing ring for constraining the pull wire to the outer wall of the catheter.

[0016] Furthermore, a drug loading cavity for loading drugs is formed between the scoring member and the base.

[0017] Furthermore, a limiting column arranged along the radial direction of the balloon is provided between the base and the scoring part, one of the base and the scoring part is fixedly connected to the limiting column, and the other is provided with a socket for the limiting column to perform linear motion along the axial direction of the limiting column; the limiting column is also sleeved with an elastic part located between the base and the scoring part and in an elastically stretched state.

[0018] Furthermore, the length extension direction of the base is the same as the axial direction of the balloon; two limiting columns are provided, and the two limiting columns are respectively located at two ends of the length extension direction of the base, and the elastic member is sleeved on each limiting column.

[0019] Furthermore, the scoring mechanisms are provided in number of three or more at even intervals around the circumference of the balloon.

[0020] The technical solution of the present invention has the following advantages: a connecting rod assembly consisting of a force transmission member and a plurality of support rods can be used to achieve expansion of the scoring member, so that the scoring member can move away from the balloon to reach deeper into the diseased tissue, and the expansion depth of the scoring member is controllable; in addition, a drug loading cavity for loading drugs is formed between the scoring member and the base, which can deliver the drugs to deeper into the diseased tissue. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0022] Figure 1 It is a schematic diagram of the three-dimensional structure of the scored balloon dilatation catheter in an embodiment of the present invention when the balloon is in a fully expanded state and the scored member is in a contracted state;

[0023] Figure 2 for Figure 1 Side view of

[0024] Figure 3 for Figure 1 A front view of

[0025] Figure 4 for Figure 2 Sectional view of the AA plane;

[0026] Figure 5 for Figure 4 The enlarged view of point I in the middle;

[0027] Figure 6 for Figure 3 Sectional view of the middle BB plane;

[0028] Figure 7 for Figure 6 The enlarged view of II in the middle;

[0029] Figure 8 It is a structural schematic diagram of a connecting rod assembly in an embodiment of the present invention;

[0030] Fig. 9 It is a schematic diagram of the three-dimensional structure of the scored balloon dilatation catheter in an embodiment of the present invention when the balloon is in a fully expanded state and the scored member is in an expanded state;

[0031] Fig.10 for Fig. 9 Side view of

[0032] Fig.11 for Fig. 9 A front view of

[0033] Fig.12 for Fig.10 Sectional view of the AA plane;

[0034] Fig.13 for Fig.12 The enlarged view of point I in the middle;

[0035] Fig.14 for Fig.11 Sectional view of the middle BB plane;

[0036] Fig.15 for Fig.14 Enlarged view of point II in the middle.

[0037] Explanation of the accompanying drawings: 1. catheter; 2. balloon; 3. notching mechanism; 31. base; 32. notching member; 322. socket; 33. support rod; 34. pull rod; 35. drug loading chamber; 36. limiting column; 37. elastic member; 38. pin; 4. pull wire; 5. fixing ring. DETAILED DESCRIPTION

[0038] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0039] In the description of this application, it should be understood that the terms "proximal end" and "distal end" used throughout the text refer to near and far relative to the operator. When the present invention is used, the end close to the doctor or operator is the "proximal end", that is, the end where the operator is located, and the end away from the doctor or operator is the "distal end", that is, the end where the balloon is located. The above-mentioned description of the orientation is only for the convenience of describing this application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on this application.

[0040] In the description of this application, it should be noted that the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a direct connection, or an indirect connection through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the invention can be understood according to specific circumstances.

[0041] like Figure 1 The scoring balloon dilatation catheter shown in the figure comprises a catheter 1, a balloon 2, a scoring mechanism 3 and a catheter seat (not shown). The balloon 2 is connected to the distal end of the catheter 1, the scoring mechanism 3 is connected to the outside of the balloon 2, and the catheter seat is connected to the proximal end of the catheter 1. The balloon 2 can expand radially relative to the catheter 1. Figure 2 As shown, three notching mechanisms 3 are evenly spaced around the circumference of the balloon 2. Of course, the number of notching mechanisms 3 can also be more than three.

[0042] Specifically, the catheter 1 includes an inner tube and an outer tube, the inner tube passes through the inner part 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 is formed between the inner tube and the outer tube, which is connected to the inner cavity of the balloon 2. The catheter seat is provided with a balloon filling joint, which is connected to the balloon filling channel; the inner cavity of the balloon 2 can be filled with a fluid medium through the balloon filling joint and the balloon filling channel, so that the balloon 2 can expand radially relative to the catheter 1.

[0043] like Figure 3-Figure 7 , Figure 9-13 As shown, the scoring mechanism 3 includes a base 31, a connecting rod assembly and a scoring member 32; the base 31 is fixedly connected to the outer wall of the balloon 2, and the scoring member 32 is connected to the base 31 through the connecting rod assembly. The connecting rod assembly can drive the scoring member 32 to move away from the balloon 2. Under the thrust of the connecting rod assembly, the scoring member 32 has an expanded state in which it expands outward relative to the balloon 2, and a contracted state in which it contracts outside the balloon 2 before being pushed by the connecting rod assembly. Figure 1-Figure 7 is a schematic diagram of the scoring member 32 in a contracted state, Figure 9-Figure 15 is a schematic diagram of the scoring member 32 in an expanded state,

[0044] like Figure 3-Figure 5 , Figure 11-13 As shown, the connecting rod assembly includes multiple support rods 33 and a force transmission member; one end of the support rod 33 is rotatably connected to the base 31, and the other end of the support rod 33 is movably connected to the scoring member 32; the force transmission member is simultaneously connected to the multiple support rods 33 in a transmission manner, and the proximal end of the force transmission member is connected to a pull wire 4, which extends to the proximal end of the catheter 1. During the expansion of the balloon 2, the scoring member 32 can move a distance along the radial direction of the catheter 1 as the balloon 2 expands. After the balloon 2 is in a fully filled state, the operator pulls the pull wire 4, which can drive one end of the multiple support rods 33 to rotate relative to the base 31 through the force transmission member, and then drive the scoring member 32 at the other end of the multiple support rods 33 to move in a direction away from the balloon 2; in this way, the moving distance of the scoring member 32 in the radial direction of the catheter 1 is magnified, and the scoring member 32 can reach deeper into the diseased tissue, and a balloon 2 with a small outer diameter can be used to achieve the scoring of a large outer diameter diseased tissue.

[0045] In some embodiments, Figure 3-Figure 5 As shown, Figure 11-13As shown, the balloon 2 is a structure with a middle cylinder and two end cones, the base 31 is fixed outside the middle cylindrical area of ​​the balloon 2, and the notched member 32 is located on the side of the base 31 facing away from the balloon 2. The base 31 and the notched member 32 are both in the shape of long strips, and the length extension direction of the notched 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 base 31 can also be spirally wound around the periphery of the balloon 2, and the notched member 32 is in the same spiral shape as the base 31; or the base 31 is arc-shaped and wound around the periphery of the balloon 2, and the notched member 32 is in the same arc shape as the base 31. It can be understood here that the base 31 and the notched member 32 can also be other shapes, as long as the notched member 32 can move in the direction away from the balloon 2 under the action of the connecting rod assembly.

[0046] In some embodiments, Figure 5 , Figure 8 and Fig.13 As shown, multiple support rods 33 are arranged side by side along the length extension direction of the notched member 32, and the multiple support rods 33 have the same length and are arranged in parallel. The force transmission member is specifically a pull rod 34, and the pull rod 34 is rotatably connected to the multiple support rods 33 through a pin 38, and the length extension direction of the pull rod 34 is the same as the length extension direction of the notched member 32. With such an arrangement, the pull rod 34 can drive the multiple support rods 33 to rotate in the same direction at the same time under the action of the pull wire 4, thereby driving the notched member 32 to move in a direction away from the balloon 2. In other alternative embodiments, the force transmission member is not limited to the structural form of a single pull rod 34, and the force transmission member can also be various structural forms such as elastic pull ropes, multi-links, etc. that can be transmitted between multiple support rods 33.

[0047] like Figure 1 , Figure 3 , Fig. 9 and Fig.11 As shown, the catheter 1 is provided with a fixing ring 5 for constraining 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 is provided in the outer peripheral wall of the fixing ring 5 for the pull wire 4 to pass through. In other alternative embodiments, the fixing ring 5 can also be omitted, and a wiring channel for the pull wire 4 to extend to the proximal end of the catheter 1 can be provided inside the catheter 1.

[0048] In some embodiments, Figure 5-Figure 7 , Figure 13-Figure 15 As shown, a groove is provided on one 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 cavity is provided on one side of the base 31 facing the scoring member 32, and a drug loading cavity 35 for loading drugs is formed between the scoring member 32 and the base 31. Figure 5-Figure 7As shown, when the scoring member 32 is in the contracted state, the end surface of the scoring member 32 facing the base 31 and the end surface of the base 31 facing the scoring member 32 are in contact with each other to close the drug loading cavity 35. Figure 13-Figure 15 As shown, when the scoring member 32 is in the expanded state, the scoring member 32 moves away from the base 31 and cuts the diseased tissue, the drug loading cavity 35 is opened, and the drug in the drug loading cavity 35 can be released deeper into the diseased tissue cut by the scoring member 32. Further, when the scoring member 32 is in the contracted state, the mutually fitting surface of the scoring member 32 and the base 31 is a concave and convex irregular surface, which can improve the sealing of the mutually fitting surface of the scoring member 32 and the base 31, and prevent the drug in the drug loading cavity 35 from leaking.

[0049] In some embodiments, Figure 5-Figure 7 , Figure 13-Figure 15 As shown, in the radial cross-section direction of the balloon 2, the radial cross-section of the notch member 32 is V-shaped, and the blade of the notch member 32 is located at one end of the notch member 32 away from the base 31. In other alternative embodiments, the radial cross-section of the notch member 32 can also be triangular.

[0050] In some embodiments, Figure 5-Figure 7 , Figure 13-Figure 15 As shown, a limiting column 36 is provided between the base 31 and the scoring member 32 along the radial direction of the balloon 2, one end of the limiting column 36 is fixedly connected to the base 31, and a plug hole 322 is provided inside the scoring member 32, and the other end of the limiting column 36 extends into the plug hole 322, and the limiting column 36 can make a linear motion inside the plug hole 322 along the axial direction of the limiting column 36. An elastic member 37 is also sleeved on the limiting column 36, which is located between the base 31 and the scoring member 32 and is in an elastically stretched state. When the scoring member 32 moves in a direction away from the balloon 2 under the action of the multiple support rods 33, due to the limiting and restraining effect of the limiting column 36 on the scoring member 32, the scoring member 32 can only move along the axial direction of the limiting column 36, that is, the radial direction of the balloon 2, which is conducive to improving the scoring force and scoring depth of the scoring member 32. When the force exerted on the notched member 32 by the plurality of support rods 33 disappears, the notched member 32 moves toward the balloon 2 under the elastic restoring force of the elastic member 37 until it returns to the contracted state against the base 31 .

[0051] In some embodiments, Figure 5 and Fig.13 As shown, there are two limit posts 36, which are respectively located at the two ends of the length extension direction of the base 31, and each limit post 36 is sleeved with an elastic member 37. The provision of two limit posts 36 can improve the guiding effect of the moving direction of the notching member 32.

[0052] like Figure 1-Figure 7is a schematic diagram showing that the balloon 2 is in a fully expanded state and the notched member 32 is in a contracted state. Figure 9-Figure 15 It is a schematic diagram showing that the balloon 2 is in a fully inflated state and the scoring member 32 is in an expanded state. The operator pulls the pull wire 4, and the pull rod 34 drives the multiple support rods 33 to rotate, thereby driving the scoring member 32 to move along the axial direction of the limiting column 36 in a direction away from the balloon 2, and the scoring member 32 reaches a deeper part of the lesion, and the drug between the scoring member 32 and the base 31 is released to a deeper part of the lesion tissue incised 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; when the scoring member 32 expands, the elastic member 37 is further stretched, and when the operator loosens the pull wire 4, the scoring member 32 moves in a direction close to the balloon 2 due to the elastic restoring force of the elastic member 37, and returns to the initial contracted state; the operator can pull the pull wire 4 again to expand the scoring member 32 outward again, and the process of expansion and contraction of the scoring member 32 can be performed multiple times.

[0053] When the above-mentioned notched balloon dilatation catheter is in use, the notched balloon dilatation catheter with the balloon 2 in a folded and contracted state and the notched member 32 also in a contracted state is first transported to the lesion site, and then fluid is filled into the balloon 2 to make the balloon 2 fill and expand. As the balloon 2 expands, the notched member 32 also reaches the location of the lesion tissue; then the operator pulls the pull wire 4, and the pull rod 34 drives the multiple support rods 33 to rotate in the same direction, thereby driving the notched member 32 to move along the axial direction of the limiting column 36 in the direction away from the balloon 2, and the notched member 32 reaches deeper into the lesion tissue, the elastic member 37 is further stretched, and the drug between the notched member 32 and the base 31 is released to the notched The diseased tissue incised by the scoring piece 32 is deeper; the feeding depth of the scoring piece 32 can be quantitatively controlled by the pulling force of the pull wire 4; thereafter, the operator loosens the pull wire 4, and the scoring piece 32 moves toward the direction close to the balloon 2 due to the elastic restoring force of the elastic piece 37, and returns to the initial contracted state; as needed, the operator can pull the pull wire 4 again to expand the scoring piece 32 outward again, and the expansion and contraction process of the scoring piece 32 can be performed multiple times; when it is necessary to withdraw the scored balloon dilatation catheter from the body, loosen the pull wire 4, put the scoring piece 32 in a contracted state, depressurize and contract the balloon 2, and then the scored balloon dilatation catheter can be withdrawn from the body.

[0054] In summary, the scoring balloon dilatation catheter provided by the embodiment of the present invention uses a connecting rod assembly composed of a pull rod 34 and a plurality of support rods 33 to achieve the re-expansion of the scoring member 32, so that the scoring member 32 can move away from the balloon 2 to reach deeper into the diseased tissue; at the same time, the expansion depth of the scoring member 32 can be controlled by controlling the tension of the pull wire 4. In addition, a drug loading cavity 35 for loading drugs is formed between the scoring member 32 and the base 31, which can deliver the drugs to deeper into the diseased tissue.

[0055] Obviously, the above embodiments are merely examples for the purpose of clear explanation, and are not intended to limit the implementation methods. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the implementation methods here. The obvious changes or modifications derived therefrom are still within the scope of protection of the invention.

Claims

1. A scored balloon dilatation catheter, characterized in that: include: Catheter (1); A balloon (2) is connected to the distal end of the catheter (1) and is capable of radial expansion relative to the catheter (1); the balloon (2) is a structure with a cylinder in the middle and cones at both ends; A notching mechanism (3) comprising a base (31), a connecting rod assembly and a notching member (32), wherein the base (31) is fixedly connected to the outer wall of the middle cylindrical region of the balloon (2), and the notching member (32) is connected to the base (31) via the connecting rod assembly; The connecting rod assembly comprises a plurality of support rods (33) arranged side by side along the length extension direction of the notched member (32), and a force transmission member connected to the plurality of support rods (33); one end of the support rod (33) is rotatably connected to the base (31), and the other end is connected to the notched member (32); the force transmission member is used to drive one end of the plurality of support rods (33) to rotate relative to the base (31), so that the notched member (32) at the other end of the plurality of support rods (33) moves in a direction away from the balloon (2); A drug loading cavity (35) for loading drugs is formed between the notched member (32) and the base (31).

2. The scored balloon dilatation catheter according to claim 1, characterized in that: The length extension direction of the notched 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).

3. The scored balloon dilatation catheter according to claim 1, characterized in that: The force transmission member is a pull rod (34), the length extension direction of the pull rod (34) is the same as the length extension direction of the notched member (32), and the pull rod (34) is rotatably connected to the plurality of support rods (33) via a pin (38).

4. The scored balloon dilatation catheter according to claim 1, characterized in that: The notched member (32) is provided with a groove on one side facing the base (31), and the other ends of the plurality of support rods (33) are all slidably connected in the groove.

5. The scored balloon dilatation catheter according to claim 1, characterized in that: The proximal end of the force transmission member is connected to a pull wire (4), and the pull wire (4) extends to the proximal end of the catheter (1).

6. The scored balloon dilatation catheter according to claim 5, characterized in that: The catheter (1) is provided with a fixing ring (5) for constraining the pull wire (4) to the outer wall of the catheter (1).

7. The scored balloon dilatation catheter according to any one of claims 1 to 6, characterized in that: A limiting column (36) is provided between the base (31) and the notched member (32) and is arranged along the radial direction of the balloon (2); one of the base (31) and the notched member (32) is fixedly connected to the limiting column (36), and the other is provided with a socket (322) inside which the limiting column (36) can move linearly along the axial direction of the limiting column (36); an elastic member (37) is also sleeved on the limiting column (36) and is located between the base (31) and the notched member (32) and is in an elastically stretched state.

8. The scored balloon dilatation catheter according to claim 7, characterized in that: The length extension direction of the base (31) is the same as the axial direction of the balloon (2); two limiting columns (36) are provided, and the two limiting columns (36) are respectively located at two ends of the length extension direction of the base (31), and each limiting column (36) is sleeved with the elastic member (37).

9. The scored balloon dilatation catheter according to claim 1, characterized in that: The notch mechanisms (3) are arranged in a number of three or more at even intervals around the circumference of the balloon (2).

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