Intraluminal implantable medical device

Abstract

The present invention relates to the technical field of medical devices, in particular to the technical field of implantable medical devices within a lumen, especially to medical devices implanted into a lumen through an intervention technique, and specifically discloses an implantable medical device within a lumen, which has an anchoring structure formed by support bodies with different widths and has a good anchoring effect.

Description

Technical Field

[0001] The present invention relates to the technical field of implantable medical devices in a lumen, and particularly to medical devices implanted into a lumen through an intervention technique, such as a left atrial appendage occluder. Background Art

[0002] The applicant's prior PCT patent with a publication number of WO2017114348A discloses a left atrial appendage occluder, which is incorporated herein by reference in its entirety. The left atrial appendage occluder can establish a delivery path in the blood vessel lumen from outside the subject to the left atrial appendage through a delivery catheter system. The occluder can be delivered to the left atrial appendage for occlusion to treat atrial fibrillation. The occluder includes an anchoring disc and an occluding disc. This application Figure 1 gives an example of such an occluder, in which the anchoring disc 101 can be composed of multiple rod members 102 cut from a nitinol metal tube. One end of the rod member 102 converges on a tubular central member 103, and the other end is a free end. The free ends of multiple rod members on the free end side are cross-arranged to form an elastic disc-shaped structure. The elastic disc-shaped structure of the anchoring disc can be compressed and constrained by the inner wall of the left atrial appendage lumen, so that the occluder is fixed in the left atrial appendage. The occluding disc 201 connected to the anchoring disc is positioned at the mouth of the left atrial appendage and closes the left atrial appendage, that is, the left atrium and the left atrial appendage are isolated by the occluding disc. See this application Figure 2 .

[0003] Among them, in order to keep the anchoring disc having sufficient elasticity to be compressed to an extremely small size to meet the delivery in the catheter and be able to expand and recover to the required disc-shaped anchoring structure after being released outward through the catheter, it is desirable to reserve appropriate movement space for a single rod member when multiple rod members forming the disc-shaped structure are cross-arranged. This movement can be understood as the elastic deformation of the rod member caused by the movement of the free end of the rod in any direction. However, too loose cross-arrangement may cause an undesirably large relative movement space between adjacent rod members, which may cause the disc-shaped anchoring structure to have a weak ability to maintain the disc shape, resulting in a decrease or insufficiency in the positioning ability of the anchoring disc in the left atrial appendage. Summary of the Invention

[0004] An object of the present invention is to provide an implantable medical device in a lumen, which has a specific anchoring structure so that the medical device can be positioned in the lumen where it is implanted.

[0005] The present invention also provides an embodiment of an implantable medical device in a lumen, which can effectively reduce the risk of migration of the medical device along the lumen or tilting towards one side lumen wall.

[0006] Specifically, an implantable medical device within a lumen is provided, including a central member and an elastic portion with a periphery. The elastic portion is formed by arranging a plurality of rod-shaped supports branched from the central member to one side thereof; after branching from the central member, the plurality of supports first tend to extend towards the center of the elastic portion to form an intersecting arrangement, and then extend towards the surroundings respectively to form a disc-shaped structure. The support has a greater width at a position adjacent to the intersecting arrangement than at the intersecting arrangement position.

[0007] In one embodiment, one end of the support located at the central member is the proximal end of the support, and the other end of the support is the distal end. The support has a greater width at a position adjacent to the intersecting arrangement on its distal side than at the intersecting arrangement position.

[0008] In another embodiment, the support has a greater width at positions adjacent to the intersecting arrangement on both of its sides than at the intersecting arrangement position.

[0009] Optionally, the width of the support at a position adjacent to the intersecting arrangement is 1.1 to 5 times the width at the intersecting arrangement position. For example, the width of the support at a position adjacent to the intersecting arrangement can be 1.75 to 3.5 times the width at the intersecting arrangement position.

[0010] Further improvement, the support has a bent section in the intersecting arrangement position or the disc-shaped structure, and the bent section has a smaller width compared to the adjacent straight section.

[0011] The supports within the disc-shaped structure of the implantable medical device within a lumen can be fixedly or non-fixedly connected.

[0012] The present invention provides a preferred embodiment in which the supports are not fixedly connected. The non-fixed connection method provides a greater deformation space for the supports within the disc-shaped structure compared to the fixed connection method, and the disc-shaped structure can better adapt to the inner circumference of the implanted lumen.

[0013] Further improvement, the adjacent supports within the disc-shaped structure are movably connected.

[0014] For example, the adjacent supports within the disc-shaped structure are movably connected by a cord, a mesh or an elastic connecting member, and the elastic connecting member can be an elastic polymer member, a spring, etc.

[0015] Among them, in a preferred embodiment, the support is provided with through holes in the wider section for binding of a cord or a mesh, or the adjacent supports within the disc-shaped structure are movably connected by the elastic connecting member in the wider section.

[0016] In another preferred embodiment, the disc-shaped structure is covered with a net or an elastic film, and the net or the elastic film is circumferentially fixed to the wider section of the support body.

[0017] The present invention also provides another implantable medical device in a lumen, including a central member and an elastic portion having an outer periphery, and the elastic portion is formed by arranging a plurality of rod-shaped support bodies branched from the central member to one side thereof; the support body has an outermost section away from the central member, and at least one support body has a smaller width compared to the outermost section at a position adjacent to the outermost section.

[0018] The present invention provides an embodiment of a medical device, in which the plurality of support bodies extend circumferentially in all directions after branching from the central member to form an annular arrangement, and the elastic portion has a cone-like shape.

[0019] The present invention provides another embodiment of a medical device, in which the plurality of support bodies extend circumferentially in all directions after branching from the central member and form a disc-shaped structure after crossing or non-crossing.

[0020] In a preferred embodiment, the end of the support body located at the central member is the proximal end of the support body, the other end of the support body is the distal end, and the support body has a smaller width compared to the outermost section at a position adjacent to the outermost section on the distal side thereof.

[0021] Based on the description of any of the above-mentioned implantable medical devices in a lumen, the present invention further provides an improved embodiment, in which the central member is a tubular member, and the plurality of support bodies are led out from the side wall of one end opening of the tubular member. For example, the central member and the support body are of an integral structure.

[0022] The implantable medical device in a lumen of the present invention may further include a functional portion, and the functional portion is connected to the other end of the tubular member.

[0023] In one embodiment, the implantable medical device in a lumen is a occluder, and the functional portion is an occluding disc for closing the lumen in which the occluder is implanted.

[0024] In another embodiment, the implantable medical device in a lumen is a filter, and the functional portion is a filter body for forming a filtering function in the implanted lumen. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] The following further describes the present invention in detail with reference to the drawings.

[0026] Figure 1 is a schematic structural diagram of a left atrial appendage occluder in the prior art;

[0027] Figure 2 is a schematic diagram of the state of a left atrial appendage occluder implanted and closing the left atrial appendage;

[0028] Figure 3 Schematic structural diagram of a left atrial appendage occluder provided by the present invention;

[0029] Figure 4 is Figure 3 Schematic diagram of another angle of the left atrial appendage occluder shown;

[0030] Figure 5 Schematic diagram of the state of a filter implanted in a blood vessel lumen;

[0031] Figure 6 is Figure 5 Structural embodiment of part A of a support in

[0032] In each of the accompanying drawings, the reference numerals are explained as follows:

[0033] 1. Blood vessel; 101. Anchoring disc; 102. Support; 1021. First wide section; 1022. Second wide section; 103. Central member; 104. Cross arrangement position; 105. Filter body; 201. Occluding disc. Detailed implementation manners

[0034] The present invention will be further described in detail below with reference to the accompanying drawings and specific implementation manners.

[0035] The embodiment of the present invention first provides an anchoring structure, which can be used to form a medical device implantable in a lumen, and can enable the medical device to be anchored in the implanted lumen to realize the positioning and implantation of the medical device.

[0036] Referring to Figure 3 and Figure 4 , there is shown a left atrial appendage occluder, which includes an anchoring structure composed of a central member 103 and an elastic part with an outer periphery. The elastic part is formed by arranging a plurality of rod-shaped supports 102 branched from the central member 103 to one side thereof; after the plurality of supports 102 are branched from the central member 103, they first tend to extend towards the center of the elastic part to form a cross arrangement, and then extend towards the surroundings respectively to form a disc-shaped structure. The support 102 has a greater width at a position adjacent to the cross arrangement position 104 compared to the cross arrangement position 104.

[0037] The support body 102 has a greater width at its position adjacent to the cross-arrangement position 104 compared to the cross-arrangement position 104. On the one hand, the wider section can improve the supporting ability of the support body 102. At the cross-arrangement, the small width of the wide section of the support body 102 helps to implement the cross-shaping process of adjacent support bodies 102, and it is easier to obtain the required cross-arrangement structure, such as providing a certain curvature. On the other hand, near the cross-arrangement position 104, the wider sections of adjacent support bodies 102 form a smaller movement space. More importantly, along the length direction of the support body 102, the wider section is difficult to cross the cross-arrangement position 104, and along the width direction of the support body 102, adjacent support bodies 102 limit each other, so a more stable disc-shaped structure can be formed, which helps to improve the anchoring ability of the elastic part in the lumen.

[0038] For the sake of convenience of description, one end of the support body 102 located at the central member 103 is referred to as the proximal end of the support body 102, and the other end of the support body 102 is referred to as the distal end. Among them, Figure 3 and Figure 4 It is shown that the support body 102 has a greater width at its position adjacent to the cross-arrangement position 104 on the distal side, that is, the first wide section 1021 of the support body 102 is wider than the width of the support body 102 at the cross-arrangement position 104.

[0039] However, those skilled in the art can also choose to make the support body 102 have a greater width at its positions adjacent to the cross-arrangement position 104 on both sides compared to the cross-arrangement position 104.

[0040] Optionally, the width of the support body 102 at its position adjacent to the cross-arrangement position 104 is 1.1 to 5 times the width at the cross-arrangement position 104, and the preferred width ratio is 1.2 - 2 times. Those skilled in the art can choose according to needs.

[0041] In order to form the required disc-shaped structure or the cross-arrangement of the support body 102, the support body 102 can have a bent section at the cross-arrangement position 104 or in the disc-shaped structure. The present invention provides a preferred embodiment, and the bent section has a smaller width compared to the adjacent straight section. For example, see Figure 3 and Figure 4 , the first wide section 1021 and the second wide section 1022 are straight sections, and they have a greater width compared to the bent section between these two sections.

[0042] The first wide section 1021 and the second wide section 1022 can be regarded as a kind of stabilizing body, which helps the supporting bodies 102 arranged in a cross pattern to maintain a stable anchoring structure. The stabilizing body is arranged along the length direction of the supporting body, and multiple stabilizing bodies distributed at intervals can be arranged on a single supporting body. The stabilizing body has a larger width than the non-stabilizing body part of the supporting body, which can be manifested as the difference in the diameter, width or thickness of the rod when the supporting body is rod-shaped.

[0043] Furthermore, an embodiment of an anchoring structure can also be provided. A plurality of rod-shaped supporting bodies 102 branch out from one side of the central member 103 and extend radially to form a disc-shaped structure. At least two stabilizing bodies distributed at intervals are arranged on the supporting body 102. Among them, each supporting body 102 can Figure 3 and Figure 4 first converge and cross each other, or each supporting body 102 may not form a cross pattern. For example, a plurality of rod-shaped supporting bodies 102 branch out from one side of the central member 103 and directly extend radially to form a disc-shaped structure.

[0044] The setting of the stabilizing body is very beneficial for maintaining the stability of the anchoring structure in which the supporting bodies 102 are not fixedly connected. For example, the larger width or volume of the stabilizing body itself forms a space occupancy effect, thus reducing the movement space of the supporting body. At the same time, the stabilizing body also makes it more difficult for the supporting body to deform or displace, which helps to maintain the spatial arrangement of each supporting body 102.

[0045] Moreover, it is difficult for the supporting bodies to form cross-winding at the position of the stabilizing body. Therefore, the stabilizing body can prevent the formation of unwanted winding between the supporting bodies. Especially when all the supporting bodies are converged, for example, when the instrument is in the delivery state built in the delivery catheter or the instrument is retracted into the delivery catheter, the winding between the supporting bodies will cause the preset anchoring structure not to be formed, and the anchoring function will be weakened or lost.

[0046] The stabilizing body can be set according to the shape of the supporting body or the mutual arrangement of the supporting bodies. As an example of one setting method, the first wide section 1021 is used as the first stabilizing body and is arranged at a position on the supporting body close to the cross arrangement position 104 of each supporting body, which is particularly helpful for the stability of the cross arrangement method. Refer to Figure 3 and Figure 4 As shown, in a single supporting body, the first stabilizing body forms an effect similar to an anchor, and its larger weight makes the supporting body stable at the cross arrangement position 104. In addition, the first stabilizing body is difficult to deform and displace, and can effectively prevent a single supporting body from slipping out between the two supporting bodies that cross it.

[0047] As an example of another setting method, a second wide section 1022 is set as the second stabilizing body at the part of the supporting body that forms the outer periphery of the disc-shaped anchoring structure, which helps to improve the stable anchoring effect of a single supporting body. Refer to Figure 3 andFigure 4 The second stabilizer forms the outer peripheral part of the disc structure and can contact and press against the inner wall of the lumen into which the device is implanted. For example, when the lumen is the left atrial appendage or an artery, it contracts and expands repeatedly with the heartbeat, and the force applied to the support body is a vector, with its magnitude and direction constantly changing. The second stabilizer can maintain close contact with the inner wall of the lumen and is not easily deformed. Therefore, it can serve as a stable force-receiving point for the support body, thereby keeping a single support body stably anchored to the inner wall of the lumen and preventing the support body from shifting.

[0048] Another setting method, referring again to Figure 3 and Figure 4 , includes: the first wide section 1021 as the first stabilizer and the second wide section 1022 as the second stabilizer. Within a single support body, the first stabilizer and the second stabilizer are located in different extending directions of the support body, which helps the support body maintain a stable shape in the spatial form and further enables the disc structure formed by the arrangement of the support bodies to be maintained. Obviously, more stabilizers can also be provided on a single support body, and each stabilizer is located in a different extending direction of the support body.

[0049] When the support bodies form a disc structure in a cross-arrangement manner, Figure 3 and Figure 4 the shown shape of the support body, as well as the first wide section 1021 as the first stabilizer and the second wide section 1022 as the second stabilizer, are preferred implementation schemes, which can reduce the deformation stress at the root of the support body or the cross position of the support bodies, and greatly reduce the risk of fatigue fracture of the support body. There is an arc-shaped bending section that is narrower than the stabilizer between the first stabilizer and the second stabilizer. This arc-shaped bending section has a buffering effect and can reduce the impact of the pressure exerted by the lumen on the support body, weakening the maximum deformation stress at the root of the support body or the cross position of the support bodies. Among them, the first stabilizer obviously enhances the buffering effect of this arc-shaped bending section and hinders the transmission of force to the root of the support body or the cross position of the support bodies.

[0050] In each embodiment, the stabilizer is preferably arranged on the straight section part of the support body along the length direction of the support body, that is, the stabilizer can be not arranged on the bending section part of the support body. Among them, in one embodiment, the length direction of the stabilizer is consistent with the length direction of the straight section part of the support body where it is located, and they can have the same or different thicknesses but different widths.

[0051] The support body can be selected from nitinol alloy materials, stainless steel, cobalt-based alloys, or even polymer materials with certain strength and toughness.

[0052] The support body can be arranged in a rod shape as shown in Figure 3 , 4 , and it can have a cross-sectional shape such as circular, oval, or square.

[0053] For example, each support body and the central member 103 are obtained by cutting a pipe. The central member 103 can be one end of the pipe, and each support body is obtained by cutting from the circumference of the pipe and then forming to obtain an anchoring structure. For example Figure 3 , 4 as shown. When the pipe is a nickel-titanium alloy pipe, for example, the thickness of the alloy pipe can be selected to be in the range of 0.2 mm - 0.3 mm, such as a wall thickness of 0.25 mm. Correspondingly, the rod width range of the first wide section 1021 and the second wide section 1022 constituting the stable body can be taken as 0.7 mm - 1.1 mm, and the rod width range of other parts of the support body can be taken as 0.2 mm - 0.4 mm.

[0054] It should be noted that those skilled in the art can, based on the description of this application, select to process the support body 102 to form different disc-shaped structures as long as they can form the outer circumference of the elastic part. Among them, the support bodies 102 within the disc-shaped structure can be selectively fixedly or non-fixedly connected.

[0055] The present invention provides a preferred disc-shaped structure in which the support bodies 102 are not fixedly connected. The non-fixed connection method has a larger deformation space within the disc-shaped structure compared to the fixed connection method between the support bodies 102, and the disc-shaped structure can better adapt to the inner circumference of the implanted lumen.

[0056] A more preferred embodiment of the disc-shaped structure is that the adjacent support bodies 102 within the disc-shaped structure are movably connected. For example, the adjacent support bodies 102 within the disc-shaped structure can be movably connected by a cord, a net, or an elastic connecting member, and the elastic connecting member can be an elastic polymer member, a spring, etc.

[0057] More specifically, it can be selected that the support body 102 is provided with through holes in the wider section for binding a cord or a net. Or, the adjacent support bodies 102 within the disc-shaped structure are movably connected by an elastic connecting member in the wider section. Or, a net or an elastic film is covered on the disc-shaped structure, and the net or the elastic film is circumferentially fixed to the wider section of the support body 102.

[0058] Taking Figure 3 and Figure 4 the disc-shaped structures shown as an example, the first wide section 1021 and the second wide section 1022 can be provided with the aforementioned through holes for binding, and the adjacent support bodies 102 are movably connected through their first wide sections 1021 and / or second wide sections 1022.

[0059] Those skilled in the art can also select to open a window in the second wide section 1022 to form outwardly extending anchor spikes to further improve the anchoring ability of the anchoring structure.

[0060] The embodiment of the present invention also provides another anchoring structure.

[0061] Specifically, another anchoring structure includes a central member 103 and an elastic portion with an outer periphery, and the elastic portion is formed by arranging a plurality of rod-shaped supports 102 branched from the central member 103 to one side thereof; the supports 102 have outermost segments away from the central member 103, and at least one support 102 has a smaller width compared to the outermost segment at a position adjacent to its outermost segment.

[0062] The outermost segments of the supports 102 usually contact the inner wall of the implanted lumen and have a large width, which can provide better support performance. More significantly, this anchoring structure also has the properties of easy release and easy recovery.

[0063] In an embodiment of a medical device, a plurality of supports 102 extend radially outward in a crossed or uncrossed manner after branching from the central member 103 to form a disc-shaped structure. Refer to Figure 3 and Figure 4 for the occluder, which shows a disc-shaped structure formed by supports 102 that extend radially outward after crossing. Among them, the supports 102 have outermost segments 1022 away from the central member 103, that is, the second wide segments 1022, and the second wide segments 1022 are wider than the wide segments of the supports 102 at their adjacent distal side segments. The distal ends of the supports 102 are bent and point towards the center line of the anchoring structure. The widths of the bent segments on both sides of the second wide segments 1022 of the supports 102 are smaller, so the stress is small, and the anchoring structure can be more easily released outward from the catheter or retracted into the catheter.

[0064] Referring to Figure 3 and Figure 4 for the occluder, those skilled in the art can also choose a disc-shaped structure formed by a plurality of supports 102 that extend radially outward in an uncrossed manner after branching from the central member 103. For example, after the supports 102 are emitted from the central member 103, they directly extend outward in the lateral direction on their respective sides and then bend to form a disc-shaped structure similar to Figure 3 .

[0065] In another embodiment of a medical device, a plurality of supports 102 extend radially outward from the central member 103 to form an annular arrangement, and the elastic portion has a similar conical shape. Refer to Figure 5 , which shows a filter including a central member 103 and an elastic portion filter body 105 formed by a plurality of supports 102 led out from one side of the central member 103, and it has a similar conical shape. One support 102 of the filter is bent to form the outermost segment away from the central member 103. Refer to Figure 5 Part A of Figure 6 and

[0066] Based on the foregoing description, in a preferred embodiment, the central member 103 is a tubular member, and a plurality of support members 102 are led out from the side wall of one end of the tubular member. For example, the support members 102 are spaced apart and led out from the annular end face of the pipe orifice.

[0067] In a preferred embodiment, the central member 103 and the support members 102 are of an integral structure, for example, obtained by cutting an alloy pipe and then processing and shaping. The elasticity of the support members 102 can be obtained through heat setting.

[0068] The present invention also provides an implantable medical device in a lumen containing any of the above-mentioned anchoring structures.

[0069] Obviously, the medical device may further include a functional part, and the functional part is connected to the other end of the tubular member. For example, the implantable medical device in the lumen is a occluder, and the functional part is a occluding disc 201 for closing the lumen where the occluder is implanted. Another example, the implantable medical device in the lumen is a filter, and the functional part is a filter body for forming a function of filtering blood in the implanted lumen. For an example of a filter, refer to Figure 5 the filter body and Figure 3 the anchoring structure, the filter body and the anchoring structure are respectively led out from both ends of the tubular member to form a filter.

[0070] The implantable medical device in the lumen of the embodiment of the present invention can effectively reduce the risk of the medical device migrating along the lumen or tilting towards one side wall of the lumen.

[0071] The above has introduced the present invention in detail. Specific examples are used in the present invention to illustrate the embodiments of the present invention. The description of the above embodiments is only for helping to understand the present invention. It should be noted that for those skilled in the art of this technology, without departing from the principle of the present invention, several improvements can still be made to the present invention, and these improvements also fall within the protection scope of the claims of the present invention.

Claims

1. An implantable medical device in a lumen, characterized in that It includes a central member and an elastic part with an outer periphery. The elastic part is formed by arranging a plurality of rod-shaped supports branched from the central member to one side thereof. One end of the support located on the central member is the proximal end of the support, and the other end of the support is the distal end. After the plurality of supports are branched from the central member, they first tend to extend towards the center of the elastic part and converge to form an intersecting arrangement, and then extend towards the surroundings respectively to form a disc-shaped structure. The supports within the disc-shaped structure are not fixedly connected to each other. The support has a greater width at a position adjacent to the intersecting arrangement than at the intersecting arrangement position. The part with the greater width of the support forms a stabilizer at a position adjacent to the intersecting arrangement. The stabilizers of adjacent supports reduce the movement space of the supports near the intersecting arrangement position and prevent entanglement between the supports.

2. The intraluminal implantable medical device according to claim 1, characterized in that: The support has a greater width at a position adjacent to the intersecting arrangement on its distal side than at the intersecting arrangement position.

3. The intraluminal implantable medical device according to claim 1, characterized in that: The support has a greater width at positions adjacent to the intersecting arrangement on both of its sides than at the intersecting arrangement position.

4. The intraluminal implantable medical device according to any one of claims 1-3, characterized in that: The width of the support at a position adjacent to the intersecting arrangement is 1.1 to 5 times the width at the intersecting arrangement position.

5. The intraluminal implantable medical device according to claim 1, characterized in that: The support has a bent section at the intersecting arrangement position or in the disc-shaped structure, and the bent section has a smaller width compared to the adjacent straight section.

6. The intraluminal implantable medical device according to claim 1, characterized in that: Along the length direction of the support, a plurality of spaced stabilizers are provided on a single support.

7. The intraluminal implantable medical device according to claim 1, characterized in that: The adjacent supports within the disc-shaped structure are movably connected.

8. The intraluminal implantable medical device according to claim 7, wherein: The adjacent supports within the disc-shaped structure are movably connected by a cord, a net or an elastic connecting member. The elastic connecting member is an elastic polymer member or a spring.

9. The intraluminal implantable medical device according to claim 8, characterized in that: The support is provided with through holes in the wider section for binding the cord or the net.

10. The intraluminal implantable medical device according to claim 8, characterized in that: The adjacent supports within the disc-shaped structure are movably connected by the elastic connecting member in the wider section.

11. The intraluminal implantable medical device according to claim 8, wherein: The disc-shaped structure is covered with a net or an elastic film, and the net or the elastic film is fixed circumferentially to the wider section of the support.

12. The intraluminal implantable medical device according to claim 1, wherein: The central member is a tubular member, and the plurality of supports are led out from the side wall of one end opening of the tubular member.

13. The intraluminal implantable medical device according to claim 1, characterized in that: The central member and the support are of an integral structure.

14. The intraluminal implantable medical device according to claim 12, wherein: It further includes a functional part, and the functional part is connected to the other end of the tubular member.

15. The intraluminal implantable medical device according to claim 14, wherein: The implantable medical device in the lumen is a plug, and the functional part is a plugging disc for closing the lumen where the plug is implanted.

16. The intraluminal implantable medical device according to claim 14, wherein: The implantable medical device in the lumen is a filter, and the functional part is a filtering body for forming a filtering function in the implanted lumen.

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