Expandable member and tubular interventional assembly

Abstract

The utility model discloses an expandable member and tubular intervening subassembly, the expandable member includes: an expandable main body, the expandable main body includes a main body portion that can switch between an expanded state and a contracted state, and fixed portions located at the two axial ends of the main body portion, the inside of the wall surface of the main body portion is provided with at least one accommodating groove; the limiting piece is arranged in the accommodating groove and is used for limiting the expansion degree of the main body part; according to the utility model, the limiting piece is arranged in the expandable main body to reinforce and support the expansion of the expandable main body, so that the tensile strength, the pressure resistance and the overall stability of the expandable main body can be obviously improved, the expandable main body can controllably, uniformly and noninvasively expand, the plaque improvement is promoted, and the treatment effect is improved. It is intended to reduce strain and damage on the vessel wall.

Description

Technical Field

[0001] The utility model relates to the technical field of blood vessel dilation, in particular to an expandable member and a tubular interventional assembly. Background Art

[0002] For the treatment of human blood vessel stenosis, the common methods usually include conservative treatment, surgical treatment, and interventional treatment. Specifically, conservative treatment is mainly applicable to mild and moderate blood vessel stenosis. When the patient has no discomfort symptoms, drug treatment is feasible. The patient takes medicine regularly, exercises under medical advice, controls blood sugar and blood lipids, etc. It is necessary to regularly review relevant adverse reactions and disease changes in order to adjust the drug dosage or treatment plan in time. Conservative treatment requires long-term medication and has poor effects. It can only be used for patients in the middle and early stages or as an adjunct to surgical treatment. Surgical treatment is mainly applicable to severe blood vessel stenosis. An artificial blood vessel or autologous great saphenous vein is used to establish a bypass between the normal blood vessels near and far from the target diseased blood vessel. Interventional treatment uses percutaneous transluminal angioplasty, and percutaneous balloon dilation, stent implantation, intraluminal grinding, etc. are performed through puncture. Among the above treatment methods, the effect of conservative treatment is poor, and it is currently less used or used as an adjunct to surgical treatment; surgical treatment causes greater trauma to the patient and is not conducive to the patient's recovery. With the development of interventional surgery, it is also gradually less used.

[0003] Compared with stent implantation, balloon interventional surgery provides convenience for the re-treatment of blood vessel stenosis because there is no implant in the patient's body after the operation. The current balloons are limited by the material strength and have risks such as balloon rupture, insufficient inflation, or displacement and deformation during long-term use, which pose risks to surgical treatment. Summary of the Utility Model

[0004] The purpose of the utility model is to provide an expandable member and a tubular implant assembly to solve the technical problem that the existing balloons are limited by the material strength and have risks such as balloon rupture, insufficient inflation, or displacement and deformation during long-term use, which pose risks to surgical treatment.

[0005] To achieve one of the above-mentioned utility model purposes, an embodiment of the utility model provides an expandable member, which includes: a tubular expandable main body, the expandable main body includes a main body part for switching between an expanded state and a contracted state, and fixing parts located at both axial ends of the main body part. At least one receiving groove is arranged inside the wall surface of the main body part;

[0006] A limiting member arranged in the receiving groove, and the limiting member is used to limit the expansion degree of the main body part.

[0007] As a further improvement of the present utility model, the inflatable member further includes: the inflatable body includes at least two nested balloons, and there are a plurality of connecting segments arranged at intervals along the axial direction between every two adjacent balloons, and a receiving groove is formed between two adjacent connecting segments along the axial direction.

[0008] As a further improvement of the present utility model, the inflatable member further includes: the receiving groove is in a spiral shape around the central axis of the inflatable body and extends along the axial direction of the inflatable body, and the limiting member is in a spiral coil structure matching the receiving groove.

[0009] As a further improvement of the present utility model, the inflatable member further includes: both ends of the limiting member are respectively fixed to the two fixing parts.

[0010] As a further improvement of the present utility model, the inflatable member further includes: the receiving groove is circular around the central axis of the inflatable body, and the limiting member is in a circular structure matching the receiving groove.

[0011] As a further improvement of the present utility model, the inflatable member further includes: the elongation rate of the limiting member is less than the elongation rate of the inflatable body.

[0012] As a further improvement of the present utility model, the inflatable member further includes: the inflatable member is at least one of a compliant balloon or a super-compliant balloon material, and the material of the limiting member includes at least one of nylon, polypropylene, polyvinyl alcohol, polyethylene, and thermoplastic elastomer.

[0013] As a further improvement of the present utility model, the inflatable member further includes: the limiting member has a stretched state and a relaxed state. When the inflatable body is in a contracted state, the limiting member switches to the relaxed state. When the inflatable body is in an inflated state, the limiting member switches to the stretched state.

[0014] As a further improvement of the present utility model, the inflatable member further includes: the width of the receiving groove is at least twice larger than the diameter of the limiting member.

[0015] To achieve one of the above-mentioned utility model purposes, the present utility model also provides a tubular intervention assembly, and the tubular intervention assembly includes the inflatable member as described in any one of the above.

[0016] Compared with the prior art, the utility model has the following beneficial effects: By arranging a restricting member inside the expandable body to strengthen the support for the expansion of the expandable body, the tensile strength, pressure resistance performance and overall stability of the expandable body can be significantly improved, enabling the expandable body to expand controllably, evenly and non-invasively, promoting plaque improvement, and aiming to reduce the strain and damage on the blood vessel wall. Through this mechanism of action, the shear stress can be minimized, uniform and consistent filling and rapid deflation of the balloon can be achieved, effectively reducing the occurrence of dissection and the implantation of rescue stents. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 FIG. is a schematic installation view of an expandable member on a dilation catheter in an embodiment of the utility model.

[0018] Figure 2 FIG. is a schematic structural view of an expandable member in an embodiment of the utility model.

[0019] Figure 3 FIG. is a schematic structural view of at least two balloons nested in an embodiment of the utility model.

[0020] Figure 4 FIG. is a schematic view of the restricting member switching from the self-relaxed state to the stretched state in an embodiment of the utility model.

[0021] Figure 5 FIG. is a schematic structural view of a tubular intervention assembly in an embodiment of the utility model. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0022] The present utility model will be described in detail below in conjunction with the specific embodiments shown in the drawings. However, these embodiments do not limit the present utility model, and any structural, method, or functional transformation made by those of ordinary skill in the art based on these embodiments is included in the protection scope of the present utility model.

[0023] The words expressing position and direction described within the present utility model are all referenced with respect to the operator of the instrument. The end closer to the operator of the instrument is the proximal end, and the end farther from the operator of the instrument is the distal end. Correspondingly, "proximal direction" refers to the direction towards the proximal end, and "distal direction" refers to the direction towards the distal end.

[0024] The present utility model provides an expandable member and a tubular intervention assembly having the expandable member. The tubular intervention assembly can be applied to blood vessel dilation surgery.

[0025] Below, taking the tubular intervention assembly for blood vessel dilation surgery as an example, a specific elaboration will be made. In combination with Figure 1As shown, the tubular intervention component further includes a dilation catheter 3, and the inflatable member is disposed at the distal end of the dilation catheter 3. During the operation, the inflatable member is pushed into the vascular stenosis through the dilation catheter 3, and then gas or liquid is injected into the inflatable member through the dilation catheter 3 to expand the inflatable member, so as to dilate the blood vessel. After the filled gas / liquid is depressurized from the proximal end of the self-dilation catheter 3, the inflatable member contracts, so as to facilitate the withdrawal of the tubular intervention component. However, it should be noted that the technical spirit involved in the following embodiments can be alternatively applied to other tubular intervention components.

[0026] As Figure 2 shown, the inflatable member includes a tubular inflatable body 1, and the inflatable body 1 includes a main body portion 11 for switching between an inflated state and a contracted state, and fixing portions 12 located at both axial ends of the main body portion 11.

[0027] It should be noted that during the state switching process of the above-mentioned inflatable body 1, when the inflatable body 1 is in the contracted state, its diameter is smaller, and it can pass through the blood vessel better and faster so as to quickly reach the specified stenosis position, and it is also more convenient for secondary transfer; when the inflatable body 1 is in the inflated state, its diameter is larger than that in the contracted state, so as to support the blood vessel and facilitate surgical treatment.

[0028] The fixing portion 12 is used to fix the inflatable body 1 at the distal end of the dilation catheter 3, and a filling space is formed between the main body portion 11 and the dilation catheter 3. The operator injects gas or liquid into the filling space at the proximal end of the dilation catheter 3 so that the main body portion 11 is supported by the gas or liquid and thus switches from the contracted state to the inflated state, and the diameter of the inflatable body 1 becomes larger to dilate the blood vessel. The operator withdraws the gas or liquid from the filling space at the proximal end of the dilation catheter 3 so that the main body portion 11 switches from the inflated state to the contracted state, and the diameter of the inflatable body 1 becomes smaller, which is convenient for withdrawal.

[0029] In a specific embodiment, the thickness of the fixing portion 12 is 0.01 mm - 2 mm, specifically 0.02 mm - 1 mm. Of course, this is not a limitation.

[0030] At least one receiving groove 13 is provided inside the wall surface of the main body portion 11, and the inflatable member further includes a restricting member 2 disposed in the receiving groove 13, and the restricting member 2 is used to restrict the degree of expansion of the main body portion 11, so as to effectively limit the degree of expansion of the main body portion 11 and avoid structural damage or functional failure caused by excessive expansion of the main body portion 11.

[0031] In a specific embodiment, as Figure 3 shown, the inflatable body 1 includes at least two nested balloons, and a plurality of connecting segments are arranged at intervals along the axial direction between each adjacent two balloons, and a receiving groove 13 is formed between two adjacent connecting segments along the axial direction.

[0032] Specifically, adjacent partial segments of two balloons can be connected together by laser welding or bonding to form a connecting segment. Of course, in other embodiments, it is not limited to using laser welding or bonding.

[0033] In one embodiment, the receiving groove 13 is spiral and extends along the axial direction of the inflatable body 1 around the central axis of the inflatable body 1, and the limiting member 2 has a spiral coil structure that mates with the receiving groove 13.

[0034] Specifically, the receiving groove 13 is spiral and located between adjacent balloons. The limiting member 2 is spiral and located between adjacent two balloons and within the receiving groove 13 to mate with the spiral shape of the receiving groove 13.

[0035] Furthermore, both ends of the limiting member 2 are respectively fixed to the two fixing portions 12. Thereby, the position of the limiting member 2 can be strengthened.

[0036] In this way, for the spiral-structured receiving groove 13 and the limiting member 2, due to the high structural matching degree, the limiting member 2 can be more easily aligned and inserted when installed into the receiving groove 13. The tight fit can ensure that the limiting member 2 will not loosen or shift due to vibration or impact during the working process. And the design of the spiral structure usually has relatively high strength and stiffness, which can improve the load-bearing capacity and stability.

[0037] The number of the limiting members 2 is 1 - 30, preferably 5 - 20, and they are all wound in a spiral structure around the communicating and spiral-space-structured receiving groove 13. The number of turns of the limiting member 2 is 1 - 30 turns; similarly, the spiral-space receiving groove 13 is also 1 - 30 turns.

[0038] In another embodiment, the receiving groove 13 is circular around the central axis of the inflatable body 1, and the limiting member 2 has a circular structure that mates with the receiving groove 13.

[0039] In this way, the circular-structured limiting member 2 can achieve uniform distribution of force when stressed, which not only helps to improve the load-bearing capacity of the limiting member 2, but also can avoid material fatigue and damage caused by stress concentration.

[0040] Specifically, there is at least one receiving groove 13 between adjacent two balloons, and the receiving groove 13 is circularly structured around the balloon. The limiting member 2 is also circularly structured and located within the receiving groove 13.

[0041] Preferably, a plurality of receiving grooves 13 are provided and are uniformly arranged in an array along the axial direction of the inflatable body 1. Each receiving groove 13 is provided with at least one limiting member 2 。

[0042] In another embodiment, the receiving groove 13 may also be a strip-shaped structure extending along the axial direction of the inflatable body 1. At this time, the limiting member 2 is a strip-shaped structure that cooperates with the receiving groove 13. The limiting member 2 is located in the receiving groove 13, and both ends of the limiting member 2 are fixedly connected to both ends of the receiving groove 13.

[0043] It should be noted that a plurality of receiving grooves 13 may be provided along the circumference of the inflatable body 1.

[0044] In a specific embodiment, the elongation rate of the limiting member 2 is less than that of the inflatable body 1.

[0045] After the inflatable body 1 expands until the limiting member 2 is fully unfolded, when the inflatable body 1 continues to expand, an expansion force that causes the limiting member 2 to further expand will be applied to the limiting member 2. At this time, since the elongation rate of the limiting member 2 is less than that of the inflatable body 1, the limiting member 2 can effectively limit the further expansion of the inflatable body 1. Thus, the limiting member 2 can limit the expansion degree of the inflatable body and prevent the inflatable body 1 from being over-expanded, resulting in structural damage or functional failure.

[0046] Among them, the elongation rate refers to the percentage of the increase in length to the original length of the material when the material is subjected to a preset tensile force, and is used to describe the plastic deformation ability of the material during the stretching process. During the expansion of the inflatable body 1, the limiting member 2 can provide a radially contracting force to the inflatable body 1, thereby preventing excessive expansion.

[0047] The elongation rate of the limiting member 2 is crucial for ensuring the safety and effectiveness of the surgery. By precisely controlling the elongation rate of the limiting member 2, precise dilation of blood vessels or heart valves can be achieved, reducing surgical risks and improving treatment effects.

[0048] In a specific embodiment, the inflatable body 1 is at least one of a compliant balloon or a super-compliant balloon material.

[0049] The material of the compliant balloon can be a composition of styrene vinyl rubber and hydrogenated isoprene.

[0050] The material of the super-compliant balloon can be polyurethane.

[0051] These materials have good elasticity and compliance, and can ensure that the inflatable member maintains a stable shape during the expansion process.

[0052] The material of the limiting member 2 includes at least one of nylon, polypropylene, polyvinyl alcohol, polyethylene, and thermoplastic elastomer.

[0053] The restraining member 2 made of these materials has good strength and elasticity, which can ensure that it is not easily broken or deformed during the stretching process. At the same time, the elongation rate of the material of the restraining member 2 is less than that of the expandable body 1 described above, so as to realize the control of the expansion degree of the expandable member through the restraining member 2.

[0054] In a specific embodiment, as Figure 4 shown, the restraining member 2 has a stretched state and a relaxed state. When the expandable body 1 is in the contracted state, the restraining member 2 switches to the relaxed state. When the expandable body 1 is in the expanded state, the restraining member 2 switches to the stretched state.

[0055] It should be noted that when the expandable body 1 is in the contracted state, the length of the restraining member 2 is not less than the length of the receiving groove 13. The stretched state means that the restraining member 2 has a certain elastic elongation.

[0056] When the expandable body 1 is in the contracted state, the restraining member 2 is in the relaxed state in the receiving groove 13. As the receiving groove 13 expands outward, that is, the length of the receiving groove 13 becomes larger, the restraining member 2 expands outward synchronously until it is fully opened. As the receiving groove 13 expands further, the restraining member 2 generates a radial acting force to limit the expansion degree of the main body portion 11.

[0057] In a specific embodiment, the width of the receiving groove 13 is at least twice larger than the diameter of the restraining member 2. In this way, it can be ensured that the restraining member 2 has enough space for movement in the receiving groove 13 to avoid damage due to excessive extrusion.

[0058] Furthermore, the radius of the restraining member 2 is preferably 1 - 100 um.

[0059] During use, the expandable member is installed on the dilation catheter 3, and the expandable body 1 is inflated by injecting an appropriate amount of physiological saline or contrast agent into the dilation catheter 3. As the expandable body 1 expands, the restraining member 2 gradually changes from the relaxed state to the stretched state. At this time, because the elongation rate of the restraining member 2 is less than that of the expandable body 1, the radially contracting force generated by the restraining member 2 limits the expansion degree of the main body portion 11. By adjusting the amount of injected liquid, the expansion degree of the expandable member can be controlled, so as to realize the precise dilation of blood vessels or heart valves.

[0060] As Figure 5 shown, the tubular interventional assembly further includes a two-way connector 4, and the two-way connector 4 is installed at the proximal end of the dilation catheter 3. On the one hand, the two-way connector 4 is used to control the dilation catheter 3 to extend into the blood vessel and control the expandable member to reach the specified narrow area. On the other hand, the two-way connector 4 is used to inject gas or liquid into the expandable member through the inside of the dilation catheter 3 so as to inflate the main body portion 11 of the expandable body 1. The two-way connector 4 is also used to extract the gas or liquid in the expandable body 1 so that the expandable body 1 returns to the contracted state.

[0061] In summary, for the expandable member in the present utility model, by arranging a restricting member 2 inside the wall surface of the expandable body 1 to strengthen the support for the expansion of the expandable body 1, the tensile strength, pressure resistance performance and overall stability of the expandable body 1 can be significantly improved. The expandable body 1 can be controllably, uniformly and non-invasively expanded to promote plaque improvement, aiming to reduce the strain and damage on the blood vessel wall. Through this action mechanism, the shear stress can be minimized, uniform and consistent filling and rapid deflation can be achieved, effectively reducing the occurrence of dissection and the implantation of rescue stents.

[0062] It should be understood that although this specification is described according to embodiments, not every embodiment only contains an independent technical solution. This narrative way of the specification is only for clarity. Those skilled in the art should regard the specification as a whole, and the technical solutions in each embodiment can also be appropriately combined to form other embodiments that can be understood by those skilled in the art.

[0063] The series of detailed descriptions listed above are only specific descriptions of the feasible embodiments of the present utility model, and they are not intended to limit the protection scope of the present utility model. Any equivalent embodiments or modifications made without departing from the technical spirit of the present utility model should be included within the protection scope of the present utility model.

Claims

1. An inflatable member, characterized in that, Comprising: A tubular inflatable body, the inflatable body including a body portion for switching between an inflated state and a contracted state, and fixing portions located at both axial ends of the body portion, at least one receiving groove being provided inside the wall surface of the body portion; A restricting member disposed in the receiving groove, the restricting member being used for restricting the degree of inflation of the body portion.

2. The expandable member according to claim 1, wherein The inflatable body includes at least two nested balloons, and a plurality of connecting segments are arranged at intervals along the axial direction between every two adjacent balloons, and the receiving groove is formed between two adjacent connecting segments along the axial direction.

3. The expandable member according to claim 2, wherein The receiving groove is in a spiral shape that winds around the central axis of the inflatable body and extends along the axial direction of the inflatable body, and the restricting member is in a spiral coil structure that matches the receiving groove.

4. The expandable member according to claim 3, wherein, Both ends of the restricting member are respectively fixed to the two fixing portions.

5. The expandable member according to claim 2, wherein, The receiving groove is circular around the central axis of the inflatable body, and the restricting member is in a circular structure that matches the receiving groove.

6. The expandable member according to any one of claims 1 to 5, characterized in that, The elongation rate of the restricting member is less than the elongation rate of the inflatable body.

7. The expandable member according to claim 6, wherein The inflatable member is at least one of a compliant balloon or a super-compliant balloon material, and the material of the restricting member includes at least one of nylon, polypropylene, polyvinyl alcohol, polyethylene, and thermoplastic elastomer.

8. The expandable member according to claim 6, wherein The restricting member has a stretched state and a relaxed state. When the inflatable body is in the contracted state, the restricting member switches to the relaxed state. When the inflatable body is in the inflated state, the restricting member switches to the stretched state.

9. The inflatable member according to claim 1, wherein The width of the receiving groove is at least twice larger than the diameter of the restricting member.

10. A tubular interventional component, characterized in that, The tubular intervention assembly includes the inflatable member according to any one of claims 1-9.

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