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CN-116942236-B - Fixing part, preparation method thereof and implantable medical device comprising fixing part

CN116942236BCN 116942236 BCN116942236 BCN 116942236BCN-116942236-B

Abstract

The invention relates to the technical field of medical instruments, in particular to the technical field of implantable medical instruments in a lumen, in particular to a medical instrument implanted in the lumen through an interventional operation, and particularly discloses a fixing part for the implantable medical instrument and a preparation method thereof, and also discloses an implantable medical instrument containing the fixing part, such as a plugging device, in particular to a left auricle plugging device. The fixing component comprises a central pipe fitting and a plurality of support rods which are distributed outwards from one end of the central pipe fitting in an annular mode, wherein the support rods are converged at one side outside a pipe orifice of the central pipe fitting to form cross arrangement, and then extend to the periphery to form the radial outer edge of the fixing component. The fixing part has stable structure, good safety and wide applicability, and can realize good positioning effect in a body cavity.

Inventors

  • YU ZUNXIONG
  • CHEN YILONG

Assignees

  • 深圳市科奕顿生物医疗科技有限公司

Dates

Publication Date
20260505
Application Date
20230619
Priority Date
20220623

Claims (16)

  1. 1. A fixing member for an implantable medical device, the fixing member being elastically compressible to have a variable diameter, the fixing member comprising a central tube and a plurality of support rods arranged in a ring shape separated from one end of the central tube outward, wherein the support rods are disposed opposite to the support rods in correspondence to a gap between the other two support rods, the support rods extend in opposite directions thereof, the plurality of support rods pass through the gap, the plurality of support rods are gathered at one side outside the tube opening of the central tube to form a cross arrangement, and then extend around to form a radial outer edge of the fixing member, at least one support rod has a straight section substantially crossing the tube opening, and the cross arrangement is formed at the straight section with the other support rods, and portions of the plurality of support rods at the cross arrangement form cylindrical portions having diameters close to the central tube in spatial distribution.
  2. 2. A fixing member for an implantable medical device, the fixing member being elastically compressible to have a variable diameter, the fixing member comprising a central tube and a plurality of support rods arranged in a ring shape outwardly from one end of the central tube, wherein the plurality of support rods each cross the tube orifice of the central tube and thereby form a cross arrangement at the outside of the central tube, and each extend circumferentially to form a radially outer edge of the fixing member, wherein the support rods are disposed opposite the support rods in correspondence to gaps between the other two support rods, the support rods extend in opposite directions thereof through the gaps, the plurality of support rods sequentially cross the mouth of the central tube in a staggered arrangement in an annularly arranged position thereof, the at least one support rod has a straight section substantially crossing the tube orifice, and forms the cross arrangement with the other support rods at the straight section, and portions of the plurality of support rods at the cross arrangement form cylindrical portions having diameters close to the central tube in spatial distribution.
  3. 3. A fixing member for an implantable medical device, the fixing member being elastically compressible to have a variable diameter, the fixing member comprising a central tube and a plurality of support rods arranged in an annular fashion outwardly from one end of the central tube, the support rods being disposed opposite to the support rods in correspondence to a gap between the other two support rods, the support rods extending in opposite directions thereof, through which gap the plurality of support rods each extend across the mouth of the central tube to their respective opposite directions to form a radially outer edge of the fixing member, wherein at least one support rod has a spanning section extending substantially axially of the central tube from the central tube, spanning the mouth of the tube, and an extension section continuing to extend outwardly to form a radially outer edge of the fixing member, the spanning section transitioning through a first bend and transitioning through a second bend to form an extension section, the at least one support rod having a substantially transverse section of the mouth of the tube and forming a cross arrangement with the other support rods at the transverse section, the plurality of support rods being arranged in a staggered fashion across the transverse section, the plurality of support rods sequentially forming a plurality of tubular segments arranged in a staggered fashion at the central tube at the intersection in a sequentially staggered arrangement at the central space.
  4. 4. A fixation member for an implantable medical device according to claim 3, characterized in that the extension section comprises an axially extending first portion and an obliquely outwardly extending second portion, the spanning section being transited via a second bend to the first portion of the extension section and further via a third bend to the second portion of the extension section.
  5. 5. The fixation component for an implantable medical device according to claim 4, wherein the second portion has a length substantially greater than the first portion.
  6. 6. A fixation member for an implantable medical device as claimed in claim 3, characterized in that the extension section has a length substantially greater than the lead-out section and the span section.
  7. 7. A fixation member for an implantable medical device according to claim 3, characterized in that the support bar has a varying width, wherein the support bar has a smaller width at the spanning section than at the lead-out section and/or the extension section, or the support bar has a smaller width at both the spanning section and the lead-out section than at the maximum width of the extension section.
  8. 8. A method of manufacturing a fastening component according to any one of claims 1 to 7, comprising the steps of: removing redundant materials from a raw material pipe fitting to obtain an intermediate body with a plurality of rods distributed at intervals on the periphery of the raw material pipe fitting; the plurality of rods of the intermediate body are processed into a desired shape and shaped by heat treatment.
  9. 9. An implantable medical device comprising the fixation means of any one of claims 1-7.
  10. 10. The implantable medical device according to claim 9, wherein the fixing member is located at one end in a longitudinal direction of the implantable medical device and is connected to other portions of the implantable medical device through the central tube.
  11. 11. An occlusion device comprising a fixation means according to any of claims 1-7.
  12. 12. The occlusion device of claim 11, further comprising a resiliently compressible sealing member of variable diameter coupled to said securing member, said sealing member being located on one side of said securing member, said sealing member being coupled at one end thereof to a central tube of said securing member.
  13. 13. The occlusion device of claim 12, wherein said sealing member is connected at one end thereof to a central tube of said securing member by a connector.
  14. 14. The occlusion device of claim 13, wherein said connector is elastically deformable and adjusts the distance between said sealing member and said securing member when pulled by said sealing member and/or said securing member.
  15. 15. The occlusion device of claim 11, wherein said securing means comprises a fluid-blocking membrane, said fluid-blocking membrane being in turn attached to and secured to each of said support rods, said fluid-blocking membrane forming a cover at least in a radial direction of said securing means to block fluid flow through said securing means.
  16. 16. The occlusion device of claim 11, wherein said occlusion device is a left atrial appendage occlusion device.

Description

Fixing part, preparation method thereof and implantable medical device comprising fixing part Technical Field The present invention relates to the field of intraluminal implantable medical devices, and in particular to medical devices, such as occlusion devices, for implantation into a lumen via an interventional procedure. Background PCT patent publication No. WO2017114348a, previously by applicant, discloses a left atrial appendage occlusion device, incorporated herein in its entirety by WO2017114348a, which can be delivered to a left atrial appendage endo occlusion by a delivery catheter system to prevent the risk of stroke or the like that may be caused by atrial fibrillation in a subject via a delivery passageway established in the vascular lumen of the left atrial appendage in the subject's body. The occluder comprises an anchor disc and an occluding disc, an example of which is shown in fig. 14 of the present application, wherein the anchor disc as a fixing part 101 may be formed of a plurality of rod members 102 cut from a nitinol tube, one ends of the rod members 102 are gathered in a tubular central member 103, the other ends are free ends, and the plurality of rod members on the free end sides are arranged in a crossing manner to have an elastic disc-shaped structure. The elastic disc-shaped structure of the anchoring disc can be pressed and restrained by the inner cavity wall of the left auricle so that the plugging device is fixed on the left auricle, the plugging disc which is connected with the anchoring disc and used as a sealing part 201 is positioned at the opening of the left auricle and seals the left auricle, namely, the left atrium and the left auricle are isolated by the plugging disc, and the figure 15 of the application can be seen. Wherein for satisfying the intra-ductal delivery, the anchor disc needs to be sufficiently elastic to be compressible to an extremely small diameter, and, after being released from the intra-auricular left through the ductal delivery, must be able to expand back to a desired disc-shaped anchoring structure of a larger diameter, it is desirable that the plurality of rod members constituting the disc-shaped structure retain a proper movable space of the individual rod members when arranged crosswise, such movement being understood as elastic deformation of the rod members caused by movement of the free ends of the rods in any direction. However, too loose a cross-over arrangement may result in an undesirably large relative movement space for adjacent rod members, which may result in a disc-shaped anchoring structure having a weak ability to maintain a disc shape, resulting in reduced or insufficient positioning of the anchor disc within the left atrial appendage. Disclosure of Invention It is an object of the present invention to provide a fixation element for an implantable medical device, which forms part of the implantable medical device, functioning to position the medical device at the implantation site. The implanted site may be, but is not limited to, a lumen or lumen of an organ or tissue, such as the left atrial appendage, a vascular lumen, etc. Another object of the present invention is to provide a method for manufacturing the aforementioned fastening member. It is a further object of the present invention to provide an implantable medical device comprising the aforementioned fixation means and a method of manufacturing the same. It is a further object of the present invention to provide an occlusion device, in particular a left atrial appendage occlusion device, comprising the aforementioned fixation means. The occlusion device further comprises a sealing member connected to the fixation member for effecting occlusion of the implanted site, e.g. occlusion or sealing of a lumen or lumen of an organ or tissue, for restricting passage of blood flow or the like. In one embodiment of the fixation element for an implantable medical device of the present invention, the fixation element is elastically compressible to have a variable diameter, the fixation element comprises a central tube and a plurality of support rods arranged in a ring shape and separated from one end of the central tube, wherein the plurality of support rods are gathered to form a cross arrangement at one side outside the orifice of the central tube and then extend to the periphery to form a radial outer edge of the fixation element, at least one support rod has a transverse section substantially crossing the orifice, and the cross arrangement is formed with other support rods at the transverse section. In one embodiment of the fixing element for an implantable medical device according to the present invention, the fixing element is elastically compressible to have a variable diameter, and the fixing element includes a central tube and a plurality of support rods annularly arranged to be separated from one end of the central tube, wherein the plurality of support rods each cross the