Tubular interventional assembly

Abstract

The utility model provides a tubular intervention assembly which comprises a catheter and an expandable component which is arranged at the far end of the catheter in a sleeved mode and connected to the far end of the catheter, and the expandable component has an expansion state. The expandable component comprises a main body section and a connecting section for connecting the two ends of the main body section to the catheter; in the length direction of the main body section, the main body section in the expanded state is in an arc shape, and the main body section in the expanded state is arranged in a reducing mode; the expandable member can be rotated according to the bending direction of the blood vessel, so that the bending direction of the expandable member in an expanded state is consistent with the bending direction of the blood vessel to be expanded, and therefore, an ideal expansion effect is achieved, and the expandable member can adapt to more vasculopathy; comprise bifurcated blood vessels, tortuous blood vessels, bent blood vessels and the like.

Description

Technical Field

[0001] The utility model relates to the field of medical instruments, in particular to a tubular intervention component. Background Art

[0002] As a global health problem, stroke is the leading cause of life expectancy due to disability. my country is the country with the highest incidence of stroke in the world, and intracranial artery stenosis is the main cause of stroke onset and recurrence. Currently, the treatments for this patient include medication, surgery, or endovascular treatment. Compared with surgery, endovascular treatment has the characteristics of less trauma, less pain for patients, and faster recovery, and has received more and more attention.

[0003] Intravascular treatment is to use stent implantation or simply use a tubular interventional component with an expandable component to expand and shape the blood vessel. The most commonly used expandable component in intravascular treatment is a standard balloon. The structure of the standard balloon is mainly divided into a main body section and a tapered connecting section that fixes the main body section to the corresponding catheter. Among them, the main body section is a cylinder, which plays a role in providing expansion force to the blood vessel wall during intravascular treatment surgery and is the actual working part. However, the vascular structure of the human body is complex, and lesions often occur in bifurcated or tortuous blood vessels. In addition, the blood vessels in the human body themselves also gradually shrink. At the lesions of bifurcated or tortuous blood vessels, the left and right sides of the main body section of the standard balloon will form a certain angle. When expanding, due to the constraints of the lesion position, the two sides of the balloon main body section will expand first, which may cause certain damage to the blood vessels near the lesion position, thereby affecting the surgical effect. At the same time, the balloon at the lesion position has not been able to achieve the ideal expansion effect. At this time, if the balloon is further expanded by increasing pressure, the risk of surgery will increase. Utility Model Content

[0004] The purpose of the utility model is to provide a tubular intervention component.

[0005] In order to solve the above problems, the utility model provides a tubular interventional component, including a catheter, an expandable component sleeved and connected to the distal end of the catheter, and the expandable component has an expanded state; the expandable component includes a main body section and a connecting section connecting the two ends of the main body section to the catheter; along the length direction of the main body section, the main body section in the expanded state is arc-shaped, and the main body section in the expanded state is set with a variable diameter.

[0006] As an optional technical solution, the main body section has a first end and a second end that are opposite to each other, and in a direction from the first end toward the second end, the main body section in an expanded state is tapered.

[0007] As an optional technical solution, the main body segment is divided into segments along its length direction; the main body segment has a first end and a second end that are opposite to each other, and when the expandable member is in an expanded state, in the direction from the first end toward the second end, the diameter of the first segment close to the first end of the two adjacent segments is larger than the diameter of the second segment close to the second end.

[0008] As an optional technical solution, the catheter includes an inner tube and an outer tube sleeved on the outer circumference of the inner tube, the proximal end of the expandable member is connected to the distal end of the outer tube, and the distal end of the expandable member is connected to the distal end of the inner tube; the inner tube includes a tubular metal reinforcement layer, an outer layer located outside the metal reinforcement layer, and an inner layer located inside the metal reinforcement layer.

[0009] As an optional technical solution, the hardness of the metal reinforcement layer gradually decreases from the proximal end to the distal end.

[0010] As an optional technical solution, the catheter includes an inner tube and an outer tube sleeved on the outer circumference of the inner tube, the proximal end of the expandable member is connected to the distal end of the outer tube, and the distal end of the expandable member is connected to the distal end of the inner tube; a connector connecting the inner tube and the outer tube is provided between the inner tube and the outer tube, and the connector includes a connecting portion connecting the inner tube and the outer tube and a through portion that is through along the axial direction of the catheter.

[0011] As an optional technical solution, at least two connectors are provided between the inner tube and the outer tube to connect the inner tube and the outer tube, and the at least two connectors are spaced apart along the axial direction of the conduit.

[0012] As an optional technical solution, the tubular interventional component further includes a developing portion for determining a bending direction of the main body segment in an expanded state.

[0013] As an optional technical solution, the main body segment in the expanded state has a concave side concave toward its center line and a convex side convex away from its center line, and the developing portion is a developing coating provided on the concave side or the convex side.

[0014] As an optional technical solution, the catheter includes an inner tube and an outer tube sleeved on the outer circumference of the inner tube, the proximal end of the expandable member is connected to the distal end of the outer tube, and the distal end of the expandable member is connected to the distal end of the inner tube; the main body segment in the expanded state has a concave side concave inward toward its center line and a convex side convex outward away from its center line, and the developing part is a developing ring arranged at a position of the inner tube corresponding to the expandable member, and the developing ring has a first developing part corresponding to the concave side and a second developing part corresponding to the convex side, and the first developing part and the second developing part have different developing forms.

[0015] Compared with the prior art, the tubular interventional component in the utility model, by setting the main body segment in the expandable member so that the main body segment in the expanded state is arc-shaped, and the main body segment in the expanded state is set to have a variable diameter, can rotate the expandable member according to the bending direction of the blood vessel so that the bending direction of the expandable member in the expanded state is consistent with the bending direction of the blood vessel to be expanded, thereby achieving an ideal expansion effect, and enabling the expandable member to adapt to more vascular lesions, including bifurcated blood vessels, tortuous blood vessels, curved blood vessels, etc. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 It is a schematic structural diagram of a tubular intervention assembly in a first embodiment of the utility model (the expandable member is in an expanded state, and the inner tube is shown at the same time);

[0017] Figure 2 It is a structural schematic diagram of a tubular intervention assembly in a second embodiment of the utility model (the expandable member is in an expanded state, and the inner tube is shown at the same time);

[0018] Figure 3 It is a structural schematic diagram of the first embodiment of the developing unit in the utility model;

[0019] Figure 4 It is a structural schematic diagram of a second embodiment of the developing unit in the present utility model;

[0020] Figure 5 It is a structural schematic diagram of a third embodiment of the developing unit in the present utility model. DETAILED DESCRIPTION

[0021] In order to make the purpose, technical solution and advantages of the utility model more clear, the utility model is further described in detail below in conjunction with specific implementation methods and drawings. It should be understood that the specific embodiments described here are only used to explain the utility model and are not used to limit the utility model.

[0022] The words expressing positions and directions described in the present invention are all based on the instrument operator as a reference, the end close to the instrument operator is the proximal end, and the end far from the instrument operator is the distal end.

[0023] Please refer to Figure 1As shown, the utility model provides a tubular interventional component 10, comprising a catheter 1, a catheter seat 2 connected to the proximal end of the catheter 1, and an expandable member 3 sleeved and connected to the distal end of the catheter 1. The catheter 1 has a pressure-charging and pressure-releasing channel 4 in communication with the expandable member 3, and the catheter seat 2 has a pressure-charging and pressure-releasing port 21 in communication with the pressure-charging and pressure-releasing channel 4. After the tubular interventional component 10 is inserted until the expandable member 3 is located at the lesion site, the pressure-charging and pressure-releasing channel 4 is filled with a pressurized medium through the pressure-charging and pressure-releasing port 21 so that the expandable member 3 can switch from a radially self-folding state to an expanded state to expand the lesion site. After the expansion is completed, the expandable member 3 is depressurized through the pressure-charging and pressure-releasing port 21 so that the expandable member 3 can switch from a radially self-expanding state to a folded state, thereby reducing the outer diameter of the expandable member 3, so as to facilitate the withdrawal of the tubular interventional component 10 and a second passage through a stenotic site.

[0024] Specifically, the material of the expandable member 3 is at least one of nylon, pebax, and TPU. The pressurized medium includes but is not limited to gas and liquid.

[0025] Furthermore, combined with Figure 1 As shown, the expandable member 3 includes a main body section 31 and a connecting section 32 that connects the two ends of the main body section 31 to the catheter 1. Along the length direction of the main body section 31, the main body section 31 in the expanded state is arc-shaped, and the main body section 31 in the expanded state is set with a variable diameter. On the one hand, the main body section 31 in the expanded state is arc-shaped. When the tubular interventional assembly 10 is applied to a curved blood vessel with a complex structure, the expandable member 3 can be rotated according to the curvature of the blood vessel so that the curvature of the expandable member 3 in the expanded state is consistent with the curvature of the blood vessel to be expanded, thereby achieving an ideal expansion effect, and enabling the expandable member 3 to adapt to more vascular lesions, including bifurcated blood vessels, tortuous blood vessels, curved blood vessels, etc.; on the other hand, by setting the main body section 31 in the expanded state to be set with a variable diameter, When the diameter of the main section 31 is set to be smaller at the proximal end and larger at the distal end, the expandable component 3 can be used for the simultaneous expansion of two blood vessels at the bifurcation of the bifurcated blood vessels, which can effectively reduce overlap and avoid excessive expansion and damage of the overlapping blood vessels. When the diameter of the main section 31 is set to be larger at the proximal end and smaller at the distal end, because the intracranial blood vessels themselves become thinner toward the distal end, it is suitable for the expansion of diseased parts of the intracranial blood vessels, and is also suitable for the expansion of tortuous blood vessels with inconsistent expansion size requirements at the proximal and distal ends, so that the expandable component 3 can have a better expansion effect in the tortuous blood vessels.

[0026] It is known that when the expandable member 3 is in a folded state, the expandable member 3 is embraced at the position corresponding to the expandable member 3 in the catheter 1, and at this time, the shape of the expandable member is consistent with the shape of the position corresponding to the expandable member 3 in the catheter 1. For example, when transporting in a straight blood vessel, the catheter 1 is straight, and the folded expandable member 3 is straight; when transporting in a curved blood vessel, the position corresponding to the expandable member 3 of the catheter 1 is curved to conform to the curved blood vessel, and the folded expandable member 3 is curved to conform to the curved shape of the catheter 1 corresponding to the expandable member 3.

[0027] Combination Figure 1 As shown, the tubular interventional component 10 in the first embodiment of the utility model, the main body section 31 has a first end A and a second end B relative to each other, and the main body section 31 in the expanded state is tapered from the first end A toward the second end B, that is, from the first end A toward the second end B, the diameter of the main body section 31 in the expanded state gradually decreases and is quasi-conical. In this embodiment, the first end A is located at the proximal end of the tubular interventional component 10, and the second end B is located at the distal end of the tubular interventional component 10, so that the tubular interventional component 10 can be suitable for the expansion of tortuous blood vessels or intracranial blood vessels. Of course, this is not limited to this. In other embodiments, it can also be set according to specific needs that the first end A is the distal end of the tubular interventional component 10 and the second end B is the proximal end of the tubular interventional component 10.

[0028] Combination Figure 2 As shown, the tubular intervention component 10a in the second embodiment of the utility model, the main body section 31a in the expandable member 3a is arranged in sections along its length direction; the main body section 31a has a first end A and a second end B relative to each other. When the expandable member 3a is in an expanded state, from the first end A to the second end B, the diameter of the first section near the first end of the two adjacent sections is greater than the diameter of the second section near the second end, that is, the main body section 31a in the expanded state has multiple sections, and the multiple sections correspond to different diameters. At the same time, from the first end A to the second end B, the diameters corresponding to the multiple sections decrease in sequence. In this embodiment, the first end A is the distal end of the expandable member 3, and the second end B is the proximal end of the expandable member 3, so that the tubular intervention component 10a can be used for the simultaneous expansion of two blood vessels at the bifurcation of the bifurcated blood vessel. Of course, it is not limited to this. In other embodiments, it can also be set as the first end A is the proximal end of the tubular intervention component 10a and the second end B is the distal end of the tubular intervention component 10 according to specific needs.

[0029] It is known that the diameter of each section in the main body section 31a can be set to be of equal diameter or of variable diameter that gradually decreases from the first end A toward the second end B.

[0030] The second embodiment of the present invention is the same as the first embodiment except for the above differences, and will not be described in detail herein.

[0031] In a specific embodiment, in combination Figure 1 As shown, the catheter 1 includes an inner tube 11, an outer tube 12 sleeved on the outer circumference of the inner tube 11, the proximal end of the expandable member 3 is fixedly connected to the distal end of the outer tube 12, the distal end of the expandable member 3 is fixedly connected to the distal end of the inner tube 11, and the pressure-charging and pressure-relieving channel 4 is formed between the inner tube 11 and the outer tube 12, that is, the expandable member 3 is connected to the pressure-charging and pressure-relieving channel 4 from the distal end of the outer tube 12. Of course, it is not limited to this, and in other embodiments, it can also be set that the distal end of the outer tube 12 is closed and connected to the distal end of the inner tube 11, and the expandable member 3 is sleeved and fixed on the outer tube 12. At this time, the pressure-charging and pressure-relieving channel 4 is formed between the inner tube 11 and the outer tube 12, and the outer tube 12 is provided with a connecting port connecting the expandable member 3 and the pressure-charging and pressure-relieving channel 4.

[0032] Furthermore, the inner tube 11 includes a tubular metal reinforcement layer, an outer layer located outside the metal reinforcement layer, and an inner layer located inside the metal reinforcement layer. The metal reinforcement layer has good torsional performance, and can drive the distal end of the catheter 1 to rotate by rotating the proximal end of the catheter 1, thereby driving the expandable member 3 to rotate, that is, the direction of the expandable member 3 can be adjusted by rotating the proximal end of the catheter 1, so that the direction of the expandable member 3 can be adjusted according to the bending direction of the blood vessel, so that the bending direction of the expandable member 3 after expansion is the same as the bending direction of the blood vessel.

[0033] Furthermore, the hardness of the metal reinforcement layer gradually decreases from the proximal end to the distal end. On the one hand, the catheter 1 can meet the support and pushing ability of the proximal end, and the catheter 1 has good pushing ability and torsion performance; on the other hand, the flexibility and softness of the distal end can be ensured, so that the distal end of the catheter 1 can pass through the tortuous section of the blood vessel, and the tubular interventional component 10 can be highly positioned.

[0034] Specifically, when the metal reinforcement layer is a stainless steel spring tube, the pitch of the stainless steel spring tube gradually increases from the proximal end to the distal end to satisfy the gradual decrease in hardness of the metal reinforcement layer. When the metal reinforcement layer is a hypotube, the proportion of the through slots in the hypotube unit volume is set to gradually increase from the proximal end to the distal end to satisfy the gradual decrease in hardness of the metal reinforcement layer. When the metal reinforcement layer is a stainless steel braided tube, the braiding density of the stainless steel braided tube gradually decreases from the proximal end to the distal end to satisfy the gradual decrease in hardness of the metal reinforcement layer.

[0035] Furthermore, a connector 5 is provided between the inner tube 11 and the outer tube 12 to connect the inner tube 11 and the outer tube 12. The connector 5 includes a connecting portion connecting the inner tube 11 and the outer tube 12 and a through portion that is through along the axial direction of the catheter 1, so that the connector 5 can realize the connection between the inner tube 11 and the outer tube 12 without affecting the connectivity of the charging and discharging passage 4.

[0036] In the present invention, the connector 5 is provided to connect the inner tube 11 and the outer tube 12 , so that when the proximal end of the catheter 1 is rotated, the rotation consistency between the inner tube 11 and the outer tube 12 can be ensured.

[0037] Specifically, the connection between the outer tube 12 and the inner tube 11 can be achieved by spot welding from the outside of the outer tube 12 to form the connecting piece 5 between the outer tube 12 and the inner tube 11. Of course, this is not limited to this.

[0038] Furthermore, at least two connectors 5 are provided between the inner tube 11 and the outer tube 12 to connect the inner tube 11 and the outer tube 12, and the at least two connectors 5 are spaced apart along the axial direction of the catheter 1 to further improve the rotation consistency between the inner tube 11 and the outer tube 12.

[0039] Furthermore, the tubular interventional assembly 10 further includes a developing unit 6 for determining the bending direction of the main body segment 31 in the expanded state. Thus, the medical staff can confirm the bending direction of the main body segment 31 in the expanded state according to the developing unit 6, so that the medical staff can rotate the proximal end of the catheter 1 to adjust the direction of the expandable member 3, so that after the expandable member 3 is in the expanded state, the bending direction of the main body segment 31 is consistent with the bending direction of the blood vessel.

[0040] Specifically, combined Figure 3As shown, the main body segment 31 in the expanded state has a concave side F1 concave inward toward its center line and a convex side F2 convex away from its center line. It can be seen that the concave side F1 refers to the curved inner side of the main body segment 31 in the expanded state, and the convex side F2 refers to the curved outer side of the main body segment 31 in the expanded state.

[0041] Combination Figure 3 , which is a first embodiment of the developing portion 6 in the present invention. In this embodiment, the developing portion 6 is a developing coating layer provided on the concave side F1, that is, the developing portion 6 is located at the inner side of the curve of the main body section 31 in the expanded state. Of course, this is not limiting. In other embodiments, the developing portion 6 may also be a developing layer provided on the convex side F2, that is, the developing portion 6 is located at the outer side of the curve of the main body section 31 in the expanded state.

[0042] Combination Figure 4 As shown, it is a second embodiment of the developing part in the utility model, the developing part is a developing ring provided at a position corresponding to the inner tube 11 and the expandable member 3, the developing ring has a first developing part corresponding to the concave side F1, and a second developing part corresponding to the convex side F2, and the developing forms of the first developing part and the second developing part are different. Therefore, medical staff can confirm the bending direction of the main body section 31 in the expanded state according to the different developing forms of the first developing part and the second developing part, so that it is convenient for medical staff to rotate the proximal end of the catheter 1 to adjust the direction of the expandable member 3, so that after the expandable member 3 is in the expanded state, the bending direction of the main body section 31 is consistent with the bending direction of the blood vessel.

[0043] Specifically, the development form includes a development shape, a development state, and the like.

[0044] In this embodiment, the developing portion 6a is annular and T-shaped. Specifically, the developing portion 6a includes a longer first developing portion 61a and a shorter second developing portion 62a. The first developing portion 61a corresponds to the convex side F2, and the second developing portion 62a corresponds to the concave side F1. At this time, the shapes of the first developing portion 61a and the second developing portion 62a are different. Medical staff can confirm the bending direction of the main body segment 31 in the expanded state according to the different developing shapes of the first developing portion 61a and the second developing portion 62a. Of course, this is not limited to this. In other embodiments, such as Figure 5In the third embodiment of the developing portion 6b shown in the figure, the developing ring is C-shaped. At this time, the first developing portion 61b is the portion that can be developed in the ring circle where the developing ring is located, and the second developing portion 62b is the portion that is not developed in the ring circle where the developing ring is located. At this time, the developing states of the first developing portion 61b and the second developing portion 62b are different. Medical staff can confirm the bending direction of the main body segment 31 in the expanded state according to the different developing states of the first developing portion 61b and the second developing portion 62b.

[0045] Specifically, the developing ring is forged on the inner tube 11. Of course, this is not limited to this.

[0046] Furthermore, along the direction away from the main body section 31 , the connecting section 32 is tapered to connect the expandable member 3 to the catheter 1 .

[0047] To sum up, the tubular interventional component 10 in the utility model, by setting the main body segment 31 in the expandable member 3 so that the main body segment 31 in the expanded state is arc-shaped, and the main body segment 31 in the expanded state is set with a variable diameter, can rotate the expandable member 3 according to the bending direction of the blood vessel so that the bending direction of the expandable member 3 in the expanded state is consistent with the bending direction of the blood vessel to be expanded, thereby achieving an ideal expansion effect, and enabling the expandable member 3 to adapt to more vascular lesions, including bifurcated blood vessels, tortuous blood vessels, curved blood vessels, etc.

[0048] The present invention has been described by the above-mentioned relevant embodiments, but the above-mentioned embodiments are only examples for implementing the present invention. In addition, the technical features involved in the different embodiments of the present invention described above can be combined with each other as long as they do not conflict with each other. It must be pointed out that the present invention can also have many other embodiments. Without departing from the spirit and essence of the present invention, technicians familiar with the field can make various corresponding changes and deformations according to the present invention, but these corresponding changes and deformations should all belong to the protection scope of the claims attached to the present invention.

Claims

1. A tubular interventional assembly, comprising a catheter, an expandable member sleeved and connected to the distal end of the catheter, wherein the expandable member has an expanded state; characterized in that: The expandable component includes a main body section and a connecting section that connects the two ends of the main body section to the catheter; along the length direction of the main body section, the main body section in the expanded state is in an arc shape bent in the bending direction, the shape of the main body section in the folded state is consistent with the shape of the position corresponding to the main body section in the catheter, and the main body section in the expanded state is set to have a variable diameter.

2. The tubular interventional assembly according to claim 1, characterized in that: The main body section has a first end and a second end opposite to each other. In a direction from the first end toward the second end, the main body section in an expanded state is gradually contracted.

3. The tubular interventional assembly according to claim 1, characterized in that: The main body section is divided into sections along its length direction; the main body section has a first end and a second end opposite to each other. When the expandable member is in an expanded state, in the direction from the first end toward the second end, the diameter of the first section near the first end of the two adjacent sections is larger than the diameter of the second section near the second end.

4. The tubular interventional assembly according to claim 1, characterized in that: The catheter includes an inner tube and an outer tube sleeved on the outer circumference of the inner tube. The proximal end of the expandable member is connected to the distal end of the outer tube, and the distal end of the expandable member is connected to the distal end of the inner tube. The inner tube includes a tubular metal reinforcement layer, an outer layer located outside the metal reinforcement layer, and an inner layer located inside the metal reinforcement layer.

5. The tubular interventional assembly according to claim 4, characterized in that: The hardness of the metal reinforcement layer gradually decreases from the proximal end to the distal end.

6. The tubular interventional assembly according to claim 1, characterized in that: The catheter includes an inner tube and an outer tube sleeved on the outer circumference of the inner tube, the proximal end of the expandable member is connected to the distal end of the outer tube, and the distal end of the expandable member is connected to the distal end of the inner tube; a connector connecting the inner tube and the outer tube is provided between the inner tube and the outer tube, and the connector includes a connecting portion connecting the inner tube and the outer tube and a through portion that is through along the axial direction of the catheter.

7. The tubular interventional assembly according to claim 6, characterized in that: At least two connectors are arranged between the inner tube and the outer tube to connect the inner tube and the outer tube, and the at least two connectors are arranged at intervals along the axial direction of the catheter.

8. The tubular interventional assembly according to claim 1, characterized in that: The tubular interventional assembly further includes a developing portion for determining a bending direction of the main body segment in an expanded state.

9. The tubular interventional assembly according to claim 8, characterized in that: The main body segment in the expanded state has a concave side concave toward its center line and a convex side convex away from its center line, and the developing portion is a developing coating disposed on the concave side or the convex side.

10. The tubular interventional assembly according to claim 8, characterized in that: The catheter includes an inner tube and an outer tube sleeved on the outer circumference of the inner tube, the proximal end of the expandable member is connected to the distal end of the outer tube, and the distal end of the expandable member is connected to the distal end of the inner tube; the main body segment in the expanded state has a concave side concave inward toward its center line and a convex side convex outward away from its center line, the developing part is a developing ring arranged at a position of the inner tube corresponding to the expandable member, the developing ring has a first developing part corresponding to the concave side and a second developing part corresponding to the convex side, and the first developing part and the second developing part have different developing forms.

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