Fixing member, method of making same and implantable medical device containing same

Abstract

The present application relates to the technical field of medical devices, in particular to the technical field of implantable medical devices in the lumen, and more particularly to a medical device implanted in the lumen through an interventional procedure, and specifically to a fixing component for an implantable medical device and a preparation method thereof, and to an implantable medical device containing the fixing component, such as a closure device, in particular a left atrial appendage closure device. The fixing component comprises a central tube and a plurality of support rods arranged in a ring shape and extending outward from one end of the central tube, and the plurality of support rods are first gathered on one side outside the tube opening of the central tube to form a cross arrangement and then extend to the periphery to form the radial outer edge of the fixing component. The fixing component has stable structure, good safety and wide applicability, and can achieve good positioning effect in the body cavity.

Description

Technical Field

[0001] This invention relates to the field of intraluminal implantable medical devices, and in particular to medical devices implanted into lumens via interventional procedures, such as occlusion devices. Background Technology

[0002] The applicant's prior PCT patent, publication number WO2017114348A, discloses a left atrial appendage occluder. The entire contents of WO2017114348A are incorporated herein by reference. This left atrial appendage occluder can be delivered externally to the left atrial appendage via a delivery catheter system through a vascular pathway established in the left atrial appendage for occlusion, thereby preventing risks such as stroke that may result from atrial fibrillation. The occluder includes an anchoring disc and an occlusion disc. Figure 14 An example of such an occluder is provided, wherein the anchoring disc, serving as the fixing component 101, can be composed of multiple rod members 102 cut from a nickel-titanium metal tube. One end of each rod member 102 converges at a tubular central member 103, while the other end is a free end. Multiple rod members on the free end side are arranged in a cross-shaped, elastic disc structure. The elastic disc structure of the anchoring disc can be compressed and restrained by the wall of the left atrial appendage, thus fixing the occluder to the left atrial appendage. The sealing disc, connected to the anchoring disc and serving as the sealing component 201, is positioned at the opening of the left atrial appendage and closes it. That is, the left atrium and the left atrial appendage are isolated by the sealing disc. See this application for details. Figure 15 .

[0003] To facilitate intracatheter delivery, the anchoring disc needs to be sufficiently elastic to be compressible to a very small diameter. Furthermore, after release into the left atrial appendage via the catheter, the disc must be able to expand and recover to the required larger diameter disc-shaped anchoring structure. Ideally, the multiple rods constituting the disc structure should be arranged in a cross-shaped configuration, allowing for adequate movement space for each individual rod. This movement can be understood as the elastic deformation of the rods caused by the free ends moving in any direction. However, an overly loose cross-shaped arrangement may result in undesirably large relative movement space between adjacent rods, potentially weakening the disc-shaped anchoring structure's ability to maintain its shape, thus reducing or negligibly improving the anchoring disc's positioning capability within the left atrial appendage. Summary of the Invention

[0004] One object of the present invention is to provide a fixation component for an implantable medical device, which forms part of the implantable medical device and functions to position the medical device at the implantation site. The implantation site can be the cavity or lumen of an organ or tissue, such as the left atrial appendage or a vascular cavity, but is not limited thereto.

[0005] Another object of the present invention is to provide a method for preparing the aforementioned fixing component.

[0006] Another object of the present invention is to provide an implantable medical device containing the aforementioned fixation components and a method for preparing the same.

[0007] Another object of the present invention is to provide an occlusion device containing the aforementioned fixation component, particularly a left atrial appendage occluder. The occlusion device further includes a sealing component connected to the fixation component for occluding the implantation site, such as occluding or sealing the lumen or tube of an organ or tissue to restrict the passage of blood, etc.

[0008] In one embodiment of the fixation component of the present invention, which can be used in implantable medical devices, the fixation component is elastically compressible and has a variable diameter. The fixation component includes a central tube and a plurality of support rods arranged in a ring extending outward from one end of the central tube. The plurality of support rods first converge on one side outside the opening of the central tube to form a cross arrangement and then extend outward to form the radial outer edge of the fixation component. At least one support rod has a horizontal section that substantially crosses the opening and forms the cross arrangement with other support rods at the horizontal section.

[0009] In one embodiment of the fixation component of the present invention for use in implantable medical devices, the fixation component is elastically compressible and has a variable diameter. The fixation component includes a central tube and a plurality of support rods arranged in a ring extending outward from one end of the central tube. The plurality of support rods first cross the opening of the central tube and thus form a cross arrangement on the outside of the central tube, and then extend outward to form the radial outer edge of the fixation component. The plurality of support rods cross the opening of the central tube in a staggered or non-sequential manner according to their ring arrangement to form the cross arrangement.

[0010] In one embodiment of the fixation component of the present invention, which can be used in implantable medical devices, the fixation component is elastically compressible and has a variable diameter. The fixation component includes a central tube and a plurality of support rods arranged in a ring extending outward from one end of the central tube. The plurality of support rods first converge on one side outside the opening of the central tube to form a cross arrangement and then extend outward to form the radial outer edge of the fixation component. The portions of the plurality of support rods at the cross arrangement are spatially distributed to form cylindrical portions with a diameter close to that of the central tube.

[0011] In one embodiment of the fixation component of the present invention for use in implantable medical devices, the fixation component is elastically compressible and has a variable diameter. The fixation component includes a central tube and a plurality of annularly arranged support rods branching outward from one end of the central tube. Each of the plurality of support rods extends across the opening of the central tube in a direction opposite to its respective end to form a radial outer edge of the fixation component. The support rod has an extension section extending substantially axially along the central tube from the central tube, a crossing section crossing the opening, and an extension section continuing to extend outward to form the radial outer edge of the fixation component. The extension section transitions to the crossing section via a first bend and then to the extension section via a second bend.

[0012] The implementation methods described above can generally be combined arbitrarily to obtain more preferred embodiments of the fixing component.

[0013] In one embodiment of the fixing component of the present invention, the extension segment includes an axially extending first portion and an obliquely outwardly extending second portion, the crossing segment transitions to the first portion of the extension segment via a second bend, and then transitions to the second portion of the extension segment via a third bend.

[0014] In one embodiment of the fixing component of the present invention, the length of the second part is much greater than that of the first part.

[0015] In one embodiment of the fixing component of the present invention, the length of the extension segment is much greater than that of the lead-out segment and the crossing segment.

[0016] The term "far greater than" as used above typically refers to more than three times. For example, the first part of the extensional segment can be 0.2-1 cm, and the second part can be 3-15 cm.

[0017] In one embodiment of the fixing component of the present invention, the width of the support rod varies along its length, wherein the width of the support rod in the spanning section is smaller than the width in the lead-out section and / or the extension section, or the width of the support rod in both the spanning section and the lead-out section is smaller than the maximum width in the extension section. This variation in the width of the support rod is generally advantageous for improving the stability and security of the fixing component configuration, because the width restricts the deformation and movement of the rod member, and also helps to increase the radial support force of the fixing component, thereby enhancing the fixing capability of the fixing component.

[0018] An embodiment of the present invention also provides a method for preparing the aforementioned fixing component, comprising the following steps:

[0019] Remove excess material from a raw material pipe fitting to obtain an intermediate body with multiple rods spaced apart around the pipe circumference of the raw material pipe fitting;

[0020] The intermediate rods are machined into the required shape and then heat-treated to set the shape.

[0021] The present invention also provides an embodiment of an implantable medical device comprising the aforementioned fixation component.

[0022] In one embodiment of the implantable medical device of the present invention, the fixation component is located at one end of the implantable medical device along its length and is connected to other parts of the implantable medical device through the central component.

[0023] The present invention also provides an embodiment of a sealing device comprising the aforementioned fixing component.

[0024] In one embodiment of the sealing device of the present invention, a sealing component connected to the fixing component is further included.

[0025] In one embodiment of the sealing device of the present invention, a sealing member that is elastically compressible and has a variable diameter is connected to the fixing member, the sealing member being located on one side of the fixing member, and the sealing member being connected at one end to the central tube of the fixing member.

[0026] In one embodiment of the sealing device of the present invention, the sealing component is connected at one end to the central tube of the fixing component via a connector.

[0027] In one embodiment of the sealing device of the present invention, the connector is elastically deformable and adjusts the distance between the sealing component and the fixing component when pulled by the sealing component and / or the fixing component.

[0028] In one embodiment of the sealing device of the present invention, the fixing component includes a flow-blocking membrane, which is sequentially connected to and fixed to each support rod, and the flow-blocking membrane forms a cover at least in the radial direction of the fixing component to block fluid from passing through the fixing component.

[0029] In summary, some embodiments of the fixing component of the present invention further restrict the position of the support rod at the intersection by at least the shape of the support rod, reducing its movement space and helping to improve the stability of the fixing component structure.

[0030] In some embodiments of the fixing component of the present invention, the stress concentration at the root of the support rod is reduced by the shape of the support rod, thereby improving its fatigue resistance and ensuring the safety of the fixing component during use.

[0031] In some embodiments of the fixing component of the present invention, at least by using the shape of the support rod to match the cross-limiting of adjacent support rods, the transmission of deformation or stress to the root of the support rod is further reduced, significantly improving the fatigue resistance of the support rod and ensuring the safety of the fixing component in use.

[0032] In some embodiments of the fixing component of the present invention, the spatial distribution of multiple support rods within the fixing component is improved by at least the cross arrangement of the support rods, thereby enhancing the radial isotropy and anti-axial tilting ability of the fixing component and ensuring the positioning effect of the fixing component. Attached Figure Description

[0033] The present invention will now be described in further detail with reference to the accompanying drawings.

[0034] Figure 1 A schematic diagram of one embodiment of the fixed component;

[0035] Figure 2 and Figure 3 for Figure 1 A simplified schematic diagram of the sequentially crisscrossed arrangement of the support rods of the fixed component shown;

[0036] Figure 4 for Figure 2 A bottom view of the nine support rods arranged in a crisscross pattern shown.

[0037] Figure 5 A schematic diagram of another embodiment of the fixing component;

[0038] Figure 6 and Figure 7 for Figure 5 A simplified schematic diagram of the non-sequentially crossed arrangement of the support rods of the fixed component shown;

[0039] Figure 8 for Figure 6 A bottom view of the nine support rods arranged in a crisscross pattern shown.

[0040] Figure 9 for Figure 5 Left view of the embodiment of the fixing component shown;

[0041] Figure 10 for Figure 5 A bottom view of the embodiment of the fixing component shown;

[0042] Figure 11 for Figure 5 Top view of the embodiment of the fixing component shown;

[0043] Figure 12 A schematic diagram of one embodiment of the sealing device;

[0044] Figure 13 for Figure 12 A schematic diagram of the sealing device from another angle;

[0045] Figure 14 This is a schematic diagram of a conventional left atrial appendage occluder.

[0046] Figure 15 A schematic diagram showing the implantation and closure of the left atrial appendage occluder;

[0047] Figure 16 The compression and radial support force variation curves of seven different specifications of the fixing component are shown, where LA18 represents the fixing component embodiment with an original diameter of 18 cm, and the others are similar.

[0048] The reference numerals in the accompanying drawings are explained as follows:

[0049] a. Central fitting; b. Support rod convergence intersection; b1. Empty area; b2. Dense area;

[0050] 1, 2, 3, 4, 5, 6, 7, 8, 9, each is a support rod;

[0051] 11, 61, Leading section; 12, 62, Crossing section; 131, First part of the extensional section; 132, Second part of the extensional section; 23, 63, Extensional section; 231, First width; 232, Second width; 14, Anchor spike; 15, Spherical end;

[0052] 101. Fixing component; 201. Sealing component. Detailed Implementation

[0053] The present invention will now be described in further detail with reference to the accompanying drawings and specific embodiments.

[0054] This invention provides embodiments of a fixation component that can be used in implantable medical devices. The fixation component can form part of the implantable medical device and functions to position the medical device at the implantation site. The implantation site is typically the cavity or tubule of an organ or tissue, such as the left atrial appendage or a vascular cavity. For example, the implantable medical device can be delivered to the patient's body cavity via interventional surgery. The components of the implantable medical device typically have a small diameter, or can be elastically compressed to a small diameter, so that they can be contained within a delivery sheath and delivered to the implantation site via the patient's vascular pathway. After being released from the sheath, the fixation component can elastically unfold and abut against the cavity wall of the implantation site, and is held within the cavity by the pressure of the cavity wall or its own radial tension, thereby achieving the positioning of the implantable medical device at the implantation site.

[0055] Implantable medical devices can be occlusion devices, such as left atrial appendage occluders. The fixation component can be placed in the left atrial appendage cavity to achieve the positioning of the left atrial appendage occluder at the left atrial appendage, thereby enabling the occlusion component to block the opening of the left atrial appendage.

[0056] Not limited to this, the occlusion device can also be other lumen occluders that use a fixing component for positioning within the lumen. For example, a patent ductus arteriosus occluder uses a fixing component placed on the patent ductus arteriosus to position the occluder, thus positioning the occluding component of the occluder at the aortic side opening to close the ductus arteriosus. Another example is a vascular occluder, which can have a basically similar principle as described above, with a fixing component placed within the blood vessel for positioning.

[0057] Depending on the need, the occlusion device can be designed for long-term implantation for several years or more, or it can be a temporary implantation for a few days or so.

[0058] Implantable medical devices can also be ventricular volume reduction devices. The fixation component can be placed at the bottom of the left ventricle and radially abut against the inner wall of the left atrial appendage, thereby fixing the volume reduction device at the bottom of the left ventricle. The left ventricle is isolated into two chambers above and below the barrier component by the barrier component above the fixation component, retaining only the upper chamber to achieve ventricular function and achieve the purpose of volume reduction.

[0059] Not limited to the above description, those skilled in the art can apply the fixation component to implantable medical devices with specific functions as needed.

[0060] Fixation components are typically elastically compressible and have a variable diameter for application in interventional procedures. The elastic compressibility of the fixation component is primarily achieved through the deformation or movement of the supporting rods that constitute it. Some embodiments of the fixation component are described in detail below.

[0061] In some embodiments, the fixing component includes a central tube and a plurality of support rods arranged in a ring extending outward from one end of the central tube. The plurality of support rods first converge on one side outside the opening of the central tube to form a cross arrangement and then extend outward to form the radial outer edge of the fixing component. At least one support rod has a horizontal section that substantially crosses the opening and forms a cross arrangement with other support rods at the horizontal section.

[0062] For reference Figure 1 or Figure 5 The illustration shows two specific embodiments of the fixing component. In one embodiment, multiple support rods are arranged in a ring, branching outwards from one end of the central tube a. These support rods first converge on one side outside the opening of the central tube to form a crisscross arrangement, and then extend outwards to form the radial outer edge of the fixing component. Further reference is available. Figure 3 Its simplified illustration Figure 1In cases where the support rods of the fixed component are arranged in a crisscross pattern, the main body of the support rods extending outwards is omitted. Support rod 1 extends from the central tube a, essentially crossing the opening of the central tube a, and then continues to extend away from the central tube a. It is generally advantageous for the cross-section 12 of support rod 1 to be horizontal. For example, compared to crossing the opening at an angle, the horizontal cross-section 12 has a shorter length and occupies less space. This allows the support rods to be more closely aligned with other support rods at the crisscrossing position, and multiple support rods can be stacked more densely, thereby reducing the space occupied by the crisscrossing arrangement of multiple support rods. This is crucial for implantable medical devices with smaller diameters and volumes, as larger implantable medical devices may not be effectively included in the delivery sheath or may be difficult to deliver.

[0063] Another important function of the horizontal and vertical spanning section 12 is to improve the limiting effect of the support rod, which can be referred to... Figure 1 The fixing component forms a cross arrangement of the support rods at the intersection b, with each support rod axially aligned with the central tube a. Each support rod then extends outwards, forming the outer diameter edge of the fixing component, such as portion 232 of the outer extension of the support rod. At the implantation site, the outer edge of the fixing component is compressed by the inner wall of the cavity. This compression causes the support rods to deform and move inwards towards the fixing component. Excessive deformation and movement may reduce the positioning ability of the fixing component and cause axial movement. The transverse spanning segment 12 extends in the direction opposite to the direction of compression, thus acting as a support, effectively resisting the inward movement of the outer extension of the support rod. Combined with the cross-limiting mechanism between the support rods, this ensures the stability of the fixing component's structure and position.

[0064] Furthermore, at the intersection b where the support rods converge, the horizontal span 12, being relatively short, allows for contact with other adjacent support rods within a shorter length when the fixation component is deformed by pressure within the implantation cavity. This results in less swaying of the support rods at the horizontal span 12 and a more stable position.

[0065] Also refer to Figure 7 Its simplified illustration Figure 5 In the case of the support rods of the fixed component arranged in a crisscross pattern, the main body of the outer extension 63 of the support rods extending outwards is omitted. The support rod 6 may have a relatively long lead-out section 61, extending from the central tube a, then generally across the opening of the central tube a to form a horizontal spanning section 62, and then continuing to extend outwards away from the central tube a to form the main body of the outer extension 63. Obviously, the horizontal spanning section 62 can be located between other support rods. Figure 7 It is located between support rod 3 and support rod 9.

[0066] See again Figure 3 and Figure 7 As a preferred embodiment, the transverse span 62 may extend laterally to or near the outer edge of the pipe opening. For example, the transverse span 62 may have a length similar to the diameter of the central pipe fitting a.

[0067] In some embodiments of the fixing component, the fixing component includes a central tube and a plurality of support rods arranged in annularly branching outward from one end of the central tube. Each of the support rods extends across the opening of the central tube in a direction to its respective opposite side to its respective end and forms the radial outer edge of the fixing component. The support rod has an extension section extending substantially axially along the central tube from the central tube, a crossing section crossing the opening, and an extension section continuing to extend outward to form the radial outer edge of the fixing component. The extension section transitions to the crossing section via a first bend and then to the extension section via a second bend.

[0068] For reference Figure 3 , Figure 3 The diagram shows the lead-out section 11, the spanning section 12, and the extension section of the support rod 1. The first portion 131 and the second portion 132 of the extension section are shown, while the main body of the extension section is not shown. (See reference...) Figure 1 An embodiment of the main body of the extended section is shown. The lead-out section 11 extends from the central tube and substantially along the axial direction of the central tube, transitioning via a first bend to a crossing section 12, which may be as follows: Figure 3 The basic horizontal crossing of the pipe opening shown can also be an oblique crossing of the pipe opening, and the crossing section 12 then transitions into the extension section through a second bend.

[0069] In this embodiment, the outer extension of the support rod 1 further includes a first portion 131 of the outer extension that extends substantially along the axial direction of the central tube from the second bend, and the first portion 131 then transitions into a second portion 132, extending outward to form the main body portion of the outer extension.

[0070] In another embodiment, reference Figure 7 The support rod 6 has an outer extension 63 that extends directly from the spanning section 62 through the second bend into its main body, without having a axially extending portion. The main body of the outer extension 63 of the support rod 6 can be referenced. Figure 5 The illustrated embodiment.

[0071] In some embodiments, the angle formed by the crossing section and the leading section at the first bend can be 70-110 degrees.

[0072] In some embodiments, the included angle formed by the extension segment and the crossing segment at the second bend is greater than 90 degrees, preferably 100-160 degrees.

[0073] The support rod is constructed through the aforementioned lead-out section, crossing section, and extension section, which is particularly beneficial for reducing the stress at the root of the support rod when it is subjected to compressive deformation, and significantly improving the fatigue resistance of the fixed component.

[0074] In some embodiments, the extension segment first extends obliquely away from the central component, then flips outward and extends towards the end of the support rod closer to the central component. It will be understood that those skilled in the art can also choose other suitable shapes for the extension segment.

[0075] The inventors discovered that when the support rod is directly extended obliquely from the central tube a across the tube opening to form an extension section for constructing the outer edge of the fixing component, the root of the support rod connecting to the central tube a is a concentrated area of ​​deformation stress. When the implantation site is a movable cavity, such as the left atrial appendage, the cavity maintains continuous contraction and relaxation, forming a compressive force on the fixing component. The root of the support rod is prone to fatigue fracture during continuous deformation.

[0076] In view of this, the axially extending lead-out section in the embodiments of the present invention does not have a deformation shaped into an oblique direction, and therefore does not accumulate deformation stress. Through the first and second bends spanning both ends of the section, the transmission of deformation stress from the extension section to the root of the support rod is significantly reduced. The support rod can reduce stress transmission through bending deformation at the first and second bends, which are in opposite directions. In some embodiments, the change in the included angle caused by the bending deformation at the first and second bends is very small.

[0077] Specifically, because the spanning segments of multiple support rods form a cross arrangement, the deformation or movement of the outer extension of the support rod causes the spanning segment to move and contact with the spanning segment of one or more adjacent support rods. The contact between the support rods provides additional support force to resist further deformation or movement of the support rods, thereby ensuring that the stress at the root of the support rod is at a low level. This is particularly advantageous in certain situations, such as when the outer extension of the support rod is typically long and forms the outer edge of the fixation component. The outer contour of the fixation component composed of multiple support rods usually needs to match the shape of the inner cavity of the implantation site to form a favorable fit and fixation. In embodiments of the present invention, the outer extension of the support rod can be configured to provide the ability to meet the deformation requirements. At the same time, the shape of the support rod in the lead-out segment and spanning segment imparts low stress transmission, and the additional support provided by the cross-arrangement contact between the support rods maintains a stable support rod arrangement structure and low root stress in the fixation component, avoiding disintegration and failure of the fixation component configuration due to large deformation and movement of the outer extension of the support rod.

[0078] In some embodiments of the present invention, the number of support rods for the fixing component can be 3-50, preferably 5-15. Figure 1 and Figure 5 In the embodiments shown, there are 9 support rods.

[0079] As a preferred option, the number of support rods is usually chosen to be an odd number. The odd number of support rods arranged in a ring can be evenly spaced, which facilitates the placement of a gap between two additional support rods on the opposite side of the initial support rod. This support rod extends in the opposite direction, passing through the gap. For example, see reference... Figure 3 and Figure 4 Support rod 1 extends to its opposite side through the gap between support rod 5 and support rod 6. It is understood that the width or diameter of the support rod can be similar to the width of the gap, for example, the latter being 2 to 1.2 times the former. This arrangement is advantageous in certain situations, as the width or diameter of the support rod being similar to the width of the gap allows the support rods on both sides of the gap to form a circumferential restraint on the support rod passing through the gap. This helps to further reduce the sway amplitude of the support rod in the circumferential direction of the fixation component and provides additional support for the support rod, thereby enhancing the fixation capability of the fixation component at the implantation site.

[0080] As described above, the annularly arranged support rods preferably extend in the opposite direction, meaning that the overall width variation of the support rods is negligible and can be considered to be substantially in one plane. Within this extending plane, the support rods may have upward or downward bending, such as the first and second bending mentioned above. Although in some embodiments the support rods may have significant deflection portions that are not in one plane, this may be disadvantageous in certain situations because it may cause the support rods to twist axially around the fixation component within the implantation site cavity during retraction into the sheath, potentially causing uncontrollable damage to the inner wall of the implantation site cavity.

[0081] In some embodiments of the fixing component, there is a central tube and a plurality of support rods arranged in a ring extending outward from one end of the central tube. The plurality of support rods first cross the opening of the central tube and thus form a cross arrangement on the outside of the central tube, and then extend outward to form the radial outer edge of the fixing component. The plurality of support rods cross the opening of the central tube in a staggered order according to their ring arrangement position.

[0082] For reference Figure 5-11 ,in particular Figure 6-8 The nine support rods constituting the fixed component can be sequentially named support rod 1 to support rod 9 along their arrangement on the outer periphery of the fixed component. Since each support rod extends to its opposite side, this order is the same as the order in which the nine support rods are arranged in a ring at the central pipe a. In a preferred embodiment of the invention, the support rods do not cross the pipe opening in this order, but rather cross the opening of the central pipe in a staggered manner, forming a cross arrangement. Specifically, refer to... Figure 6In this embodiment, along the axial direction of the central pipe, support rod 1 first crosses the pipe opening, followed by support rod 4, and then support rods 7, 2, 5, 8, 3, 6, and 9 in sequence, ultimately forming the support rod convergence intersection b of the fixed component. The advantage of this arrangement is that the spatial distribution of the support rods at the support rod convergence intersection b tends to be uniform, without significant gaps or dense areas. In a particularly preferred embodiment, the spatial distribution of the support rods causes the support rod convergence intersection b to form a cylindrical shape, the diameter of which can be close to the diameter of the central pipe.

[0083] For comparison, Figure 1-4 In the illustrated embodiment, the nine support rods of the fixing component cross the pipe opening sequentially in the aforementioned order, forming the support rod converging intersection b. (See reference...) Figure 2 Along the axial direction of the central pipe fitting, support rod 1 first crosses the pipe opening, followed by support rod 2, and then support rods 3, 4, 5, 6, 7, 8, and 9 in that order. At the intersection b where the support rods converge, although they roughly form a columnar shape, the spatial distribution of the support rods is significantly uneven, with obvious empty areas b1 and dense areas b2. This arrangement may not be optimal because it can lead to uneven performance of the fixing component in the axial and circumferential directions. For example, it may cause the fixing component to be offset towards the outer circumferential empty area b1, resulting in inaccurate positioning, and reduce the axial resistance of the fixing component to compression at the empty area b1.

[0084] It should be understood that the staggered arrangement of multiple support rods does not necessarily require the following: Figure 6 The arrangement order in the embodiments is regular, but it can also be a staggered and disordered order such as support rods 1, 4, 2, 5, 3, 9, 6, 8, 7, as long as it is not... Figure 2 The order shown is acceptable and can help improve the spatial distribution of the support rods. However, a preferred staggered sorting method is to group the support rods evenly according to their number and position, and then select one support rod from each group to cross the pipe opening in turn. (See reference...) Figure 6 The support rods are arranged in a ring and divided into three groups: support rods 1, 2, and 3; support rods 4, 5, and 6; and support rods 7, 8, and 9. Each time, a corresponding support rod is selected from each group to cross the pipe opening. This optimized arrangement makes it easier to form a uniform spatial distribution of the support rods at the intersection b.

[0085] In one embodiment of the fixing component, reference is made to... Figure 3The outer extension of support rod 1 includes an axially extending first portion 131 and an obliquely outward extending second portion 132. The crossing section 12 transitions into the first portion of the outer extension via a second bend, and then into the second portion via a third bend. Clearly, this configuration can be one or more of multiple support rods in a fixed component. Besides reducing stress transmission to the root of the support rod due to deformation, another significant advantage of this configuration is that it facilitates the formation of a smaller diameter at the support rod converging intersection b, which particularly aids in its retraction into the delivery sheath. Since the diameter of the support rod converging intersection b can be similar to the diameter of the central tube a, it can be directly retracted into the delivery sheath without additional compression. In a preferred embodiment, the length of the second portion is significantly greater than that of the first portion.

[0086] In some embodiments, reference is made to Figure 1 and Figure 5 The length of the extension segment can usually be much larger than that of the lead-out segment and the span segment to provide the diameter required for the fixed component and sufficient elastic deformation capacity.

[0087] In one embodiment of the fixing component of the present invention, the width of the support rod varies along its length, wherein the width of the support rod in the spanning section is smaller than the width in the lead-out section and / or the extension section, or the width of the support rod in both the spanning section and the lead-out section is smaller than the maximum width in the extension section, as referenced. Figure 1 and Figure 5 .

[0088] See again Figure 1 and Figure 5 The support rod may also be optionally equipped with anchors 14 on its outer extension to provide additional fixation to the implantation site cavity. In a preferred embodiment, the end of the support rod is provided with a spherical end 15 to reduce unnecessary scratches to the inner cavity wall.

[0089] In this embodiment of the invention, multiple support rods are arranged in a ring extending outward from one end of a central tube. The central tube and the multiple support rods can be an integral structure or a separate structure. For example, the support rods and the central tube can be detachably connected. In one example, the circumference of the central tube can be provided with insertion slots for the support rods. The multiple support rods typically extend from the wall of the central tube, but they can also extend from the outer circumference of the central tube wall. The support rods can be fixed to the central tube in various ways.

[0090] The lumen of the central tube can be closed at one or both ends, or the two ends can be connected. The fixing components can be connected to other components of the implantable medical device using the lumen or periphery of the central tube, such as by snap-fitting, welding, bonding, etc.

[0091] In one embodiment of a left atrial appendage occlusion device, in addition to the fixing component, it also includes a mesh-like, elastically compressible sealing component made of multiple woven wires, having two axial ends, one end of which can be directly connected to the central tube, as shown in the reference. Figure 12 and Figure 13 Alternatively, it can be connected to the central pipe via connectors. The specific connection methods are all conventional techniques that can be implemented by those skilled in the art.

[0092] In a preferred embodiment, the aforementioned method for preparing the fixing component may include the following steps:

[0093] Remove excess material from a raw material pipe fitting to obtain an intermediate body with multiple rods spaced apart around the pipe circumference of the raw material pipe fitting;

[0094] The intermediate rods are machined into the required shape and then heat-treated to set the shape.

[0095] Excess material is removed from the material tubing, typically by laser cutting, but also by etching with an etchant. The material tubing is usually made of metal, such as stainless steel or nickel-titanium alloy, but can also be a polymer. In some embodiments, the material tubing can also be absorbable or biodegradable within the body, resulting in a fixation device that can be absorbed or self-degraded at the implantation site within a controlled period without requiring additional surgical removal.

[0096] Similarly, an implantable medical device containing the aforementioned fixation component can be further prepared, and the fixation component prepared by the aforementioned method can be connected to other components of the implantable medical device at the central tube.

[0097] In some embodiments of implantable medical devices, the fixation component is located at one end of the implantable medical device along its length and is connected to other parts of the implantable medical device via a central component.

[0098] The fixation component is mainly fixed within the cavity by the radial support force generated by the radial compression of the cavity wall under pressure from the implantation site. For example, when the cavity pulsates at the implantation site, the volume or diameter of the cavity changes with contraction and relaxation. The compression diameter of the fixation component also changes. The amount of diameter change can be divided by the percentage of its original diameter when it is not restrained as an evaluation of the compression amount of the fixation component.

[0099] In some embodiments, the fixation member is elastically compressible and has a variable diameter. The fixation member is configured such that the increase in radial support force does not exceed 20% within a range where its radial compression increases from 10% to 30%. This configuration may be advantageous because, in a suitable implantation state, the compression of the fixation member should not be too large or too small, for example, within the range of 10% to 30%. Given that the dimensions of the implantation site cavity are not always precisely measured, it is essential that the fixation member achieves stable fixation within a certain range of compression. However, excessive changes in radial support force with small variations in compression may be undesirable; excessive radial support force may cause excessive damage to the cavity wall or tissue, while insufficient radial support force may not ensure stable fixation of the fixation member at the implantation site. The fixation member can be any of the aforementioned embodiments comprising a central tube and a plurality of annularly arranged support rods branching outwards from one end of the central tube. However, it is not limited to this. The fixing component can also be a mesh structure woven from braided filaments or multiple support rods constructed in other ways known in the art. The fixing component can also be a disc-shaped, column-shaped, cone-shaped or other required shape.

[0100] In some embodiments of the present invention, the fixing member is configured to satisfy that the increase in radial support force of the fixing member does not exceed 20% within the range of its radial compression increasing from 10% to 20%.

[0101] In some embodiments of the present invention, the fixing member is configured to ensure that the increase in radial support force of the fixing member does not exceed 20% within the range of its radial compression increasing from 10% to 15%.

[0102] In some embodiments of the present invention, the fixing member is configured to satisfy that the increase in radial support force of the fixing member does not exceed 20% within the range of its radial compression increasing from 15% to 20%.

[0103] In some embodiments of the present invention, the fixing member is configured to satisfy that the increase in radial support force of the fixing member does not exceed 20% within the range of its radial compression increasing from 20% to 30%.

[0104] In some embodiments of the present invention, the fixing member is configured to satisfy that the increase in radial support force of the fixing member does not exceed 20% within the range of its radial compression increasing from 20% to 25%.

[0105] In some embodiments of the present invention, the fixing member is configured to satisfy that the increase in radial support force of the fixing member does not exceed 20% within the range of its radial compression increasing from 25% to 30%.

[0106] Further reference is available. Figure 16The diagram illustrates the variation curves of compression and radial support force in certain embodiments of the fixing component, wherein the fixing component embodiment is... Figure 1 or Figure 5 The structure shown has a radial support force in the range of 0.5N ± 0.1N within a compression range of 10%-35%.

[0107] The testing of radial support force is a well-known technique in this field. For example, the iris method test can be referred to in ASTM F3067-14 or industry standard YY / T 1660-2019.

[0108] In some embodiments of the present invention, a fixation member for an implantable medical device is provided. The fixation member is elastically compressible and has a variable diameter. The fixation member is configured to have a radial support force of 0.4N-0.7N within a range where its radial compression increases from 10% to 30%. In some embodiments, the fixation member is configured to have a radial support force of 0.4N-0.6N within a range where its radial compression increases from 10% to 20% or 25%. In some embodiments, the fixation member is configured to have a radial support force of 0.4N-0.7N within a range where its radial compression increases from 10% to 20% or 25%.

[0109] The fixing component can be any of the aforementioned embodiments comprising a central tube and a plurality of support rods arranged in a ring extending outward from one end of the central tube. The plurality of support rods first converge on one side outside the opening of the central tube to form a crisscross arrangement, and then extend outward to form the radial outer edge of the fixing component. However, this is not limited to this; the fixing component can also be a mesh structure woven from braided yarns or multiple support rods constructed in other ways known in the art. The fixing component can also be a desired shape such as a disc, column, or cone.

[0110] The radial support force generated by the fixation component during operation should not be too large or too small. In particular, the inventors found that a radial support force of 0.4N-0.6N is suitable within the left atrial appendage or similar physiological tissue structures. This reduces excessive friction between the instrument and tissue, maintains the necessary load and fixation capacity, and does not excessively restrict the contraction or pulsation of the atrial appendage. Animal experiments confirmed no significant tissue damage within the atrial appendage.

[0111] It is understood that the deformation of the fixation component in the implanted state in this embodiment of the invention mainly occurs due to the deformation of the portion of the support rod extending outwards from the cross-arranged position. For example, the support rod may experience increased bending, axial elongation, or displacement towards the interior of the fixation component. In some embodiments, the deformation of the fixation component in the implanted state is within the range of 10% to 30% of its radial compression.

[0112] In some embodiments of the present invention, a fixation component for an implantable medical device is provided. The fixation component is elastically compressible and has a variable diameter. The fixation component is configured to satisfy that, within a range where its radial compression increases from 10% to 30%, the average increase rate of the radial support force of the fixation component is k1; the fixation component is configured to satisfy that, within a range where its radial compression increases from 0 to 10%, the average increase rate of the radial support force of the fixation component is k2; and the fixation component is configured to satisfy that, within a range where its radial compression increases from 30% to 50%, the average increase rate of the radial support force of the fixation component is k3.

[0113] Where k1 is less than k2 and k1 is less than k3;

[0114] Wherein, the average rate of increase k of the radial support force of the fixed component is the reciprocal of the absolute value of the ratio of the difference before and after the change in the radial compression of the fixed component to the difference before and after the change in the corresponding radial support force of the fixed component.

[0115] For example, one Figure 5 The fixed component of the structure shown is configured to satisfy radial compression of 10%, 30%, and 50%, and its radial support force is measured to be 0.4N, 0.6N, and 0.9N, respectively. The average increase rate k of the radial support force of the corresponding fixed component can be calculated as follows.

[0116] k1=1 / ((30%-10%) / (0.6-0.4))=1

[0117] k2=1 / ((10%-0%) / (0.4-0))=4

[0118] k3=1 / ((50%-30%) / (0.9-0.6))=1.5

[0119] In some embodiments, the fixing member is configured to satisfy that the average increase rate of the radial support force of the fixing member is k1 within the range of its radial compression amount increasing from 10% to 25%; the fixing member is configured to satisfy that the average increase rate of the radial support force of the fixing member is k2 within the range of its radial compression amount increasing from 0 to 10%; and the fixing member is configured to satisfy that the average increase rate of the radial support force of the fixing member is k3 within the range of its radial compression amount increasing from 25% to 35% or 40%.

[0120] Where k1 is less than k2 and k1 is less than k3.

[0121] In some embodiments, the fixing member is configured to satisfy that the average increase rate of the radial support force of the fixing member is k1 within the range of its radial compression amount increasing from 10% to 20%; the fixing member is configured to satisfy that the average increase rate of the radial support force of the fixing member is k2 within the range of its radial compression amount increasing from 0 to 10%; and the fixing member is configured to satisfy that the average increase rate of the radial support force of the fixing member is k3 within the range of its radial compression amount increasing from 20% to 30%, 35%, or 40%.

[0122] Where k1 is less than k2 and k1 is less than k3.

[0123] In some embodiments of the present invention, a fixation component for an implantable medical device is provided. The fixation component is elastically compressible and has a variable diameter. The fixation component includes a central tube and a plurality of support rods arranged in a ring extending outward from one end of the central tube. The support rods first converge on one side outside the opening of the central tube to form a cross arrangement, and then extend outward to form the radial outer edge of the fixation component. At the cross arrangement points, at least one support rod is in contact with one or more other support rods. (Reference) Figure 1-7 In the unrestrained state, at the aforementioned cross-arrangement positions of the fixing components, there may be gaps between the support rods, and in the compressed state, some or all of the support rods may be forced to touch. However, this is not the only possibility. In some embodiments, in the unrestrained state, some of the support rods may also be in direct contact, which further enhances the support and limiting effect on the support rods.

[0124] In some embodiments of the present invention, a fixation component for an implantable medical device is provided. The fixation component is elastically compressible and has a variable diameter. The fixation component includes a central tube and a plurality of support rods arranged in a ring extending outward from one end of the central tube. The plurality of support rods first converge on one side outside the opening of the central tube to form a cross arrangement and then extend outward to form the radial outer edge of the fixation component. At the cross arrangement, at least one support rod is restricted in movement by three or four other support rods in the surrounding space around its extension direction.

[0125] The present invention has been described in detail above. Specific examples have been used to illustrate the implementation of the present invention. The above description of the embodiments is only for the purpose of helping to understand the present invention. It should be noted that those skilled in the art can make several improvements to the present invention without departing from the principle of the present invention, and these improvements also fall within the protection scope of the claims of the present invention.

Claims

1. A fixation component for an implantable medical device, said fixation component being elastically compressible to have a variable diameter, characterized in that, The fixing component is configured to ensure that the increase in radial support force of the fixing component does not exceed 20% within the range of its radial compression increasing from 10% to 30%; the fixing component includes a central tube and a plurality of support rods arranged in a ring extending outward from one end of the central tube, wherein the plurality of support rods first converge on one side outside the opening of the central tube to form a cross arrangement and then extend outward to form the radial outer edge of the fixing component, and at least one support rod has a horizontal section that substantially crosses the opening, and forms the cross arrangement with other support rods at the horizontal section.

2. The fixing component according to claim 1, characterized in that, The fixing component includes a central tube and a plurality of support rods arranged in a ring extending outward from one end of the central tube. The plurality of support rods extend outward to form the radial outer edge of the fixing component.

3. The fixing component according to claim 1, characterized in that, The fixing component includes a central tube and a plurality of support rods arranged in a ring extending outward from one end of the central tube. The plurality of support rods first converge on one side outside the opening of the central tube to form a cross arrangement, and then extend outward to form the radial outer edge of the fixing component.

4. The fixing component according to claim 3, characterized in that, The deformation of the fixed component within the range of 10% to 30% of its radial compression is mainly caused by the deformation of the portion of the support rod extending outwards from the cross-arranged position.

5. The fixation component for an implantable medical device according to claim 1, characterized in that, The fixing component includes a central tube and a plurality of support rods arranged in a ring extending outward from one end of the central tube. The plurality of support rods first converge on one side outside the opening of the central tube to form a cross arrangement and then extend outward to form the radial outer edge of the fixing component. At the cross arrangement, at least one support rod is in contact with one or more other support rods.

6. The fixation component for an implantable medical device according to claim 1, characterized in that, The fixing component includes a central tube and a plurality of support rods arranged in a ring extending outward from one end of the central tube. Each of the plurality of support rods first crosses the opening of the central tube and thus forms a cross arrangement on the outside of the central tube, and then extends outward to form the radial outer edge of the fixing component. The plurality of support rods cross the opening of the central tube in a staggered manner according to their ring arrangement position to form the cross arrangement.

7. The fixation component for an implantable medical device according to claim 1, characterized in that, The fixing component includes a central tube and a plurality of support rods arranged in a ring extending outward from one end of the central tube. The plurality of support rods first converge on one side outside the opening of the central tube to form a cross arrangement, and then extend outward to form the radial outer edge of the fixing component. The portions of the plurality of support rods at the cross arrangement are spatially distributed to form cylindrical portions with a diameter close to that of the central tube.

8. The fixation component for an implantable medical device according to claim 1, characterized in that, The fixing component includes a central tube and a plurality of support rods arranged in a ring extending outward from one end of the central tube. Each of the plurality of support rods extends across the opening of the central tube in a direction opposite to its respective end and forms the radial outer edge of the fixing component. At least one support rod has an extension section extending substantially axially along the central tube from the central tube, a crossing section crossing the opening, and an extension section continuing to extend outward to form the radial outer edge of the fixing component. The extension section transitions to the crossing section via a first bend and then to the extension section via a second bend.

9. The fixation component for an implantable medical device according to claim 8, characterized in that, The extension segment includes an axially extending first portion and an obliquely outward extending second portion. The crossing segment transitions into the first portion of the extension segment via a second bend and then transitions into the second portion of the extension segment via a third bend.

10. The fixation component for an implantable medical device according to claim 9, characterized in that, The second part is much longer than the first part.

11. The fixation component for an implantable medical device according to claim 8, characterized in that, The length of the extension segment is much greater than that of the lead-out segment and the crossing segment.

12. The fixation component for an implantable medical device according to claim 8, characterized in that, The support rod has a varying width, wherein the width of the support rod in the spanning section is less than the width in the lead-out section and / or the extension section, or the width of the support rod in both the spanning section and the lead-out section is less than the maximum width in the extension section.

13. A fixation component for an implantable medical device, said fixation component being elastically compressible to have a variable diameter, characterized in that, The fixing component is configured to provide a radial support force of 0.4N-0.7N within a range where its radial compression increases from 10% to 30%, in order to reduce excessive friction with the tissue and maintain the necessary load and fixation capacity. The fixing component includes a central tube and a plurality of support rods arranged in a ring extending outward from one end of the central tube. The plurality of support rods first converge on one side outside the opening of the central tube to form a cross arrangement and then extend outward to form the radial outer edge of the fixing component. At least one support rod has a horizontal section that substantially crosses the opening and forms the cross arrangement with other support rods at the horizontal section.

14. The fixing component according to claim 13, characterized in that, The fixing component includes a central tube and a plurality of support rods arranged in a ring extending outward from one end of the central tube. The plurality of support rods extend outward to form the radial outer edge of the fixing component.

15. The fixing component according to claim 13, characterized in that, The fixing component includes a central tube and a plurality of support rods arranged in a ring extending outward from one end of the central tube. The plurality of support rods first converge on one side outside the opening of the central tube to form a cross arrangement, and then extend outward to form the radial outer edge of the fixing component.

16. The fixing component according to claim 15, characterized in that, The deformation of the fixed component within the range of 10% to 30% of its radial compression is mainly caused by the deformation of the portion of the support rod extending outwards from the cross-arranged position.

17. The fixation component for an implantable medical device according to claim 13, characterized in that, The fixing component includes a central tube and a plurality of support rods arranged in a ring extending outward from one end of the central tube. The plurality of support rods first converge on one side outside the opening of the central tube to form a cross arrangement and then extend outward to form the radial outer edge of the fixing component. At the cross arrangement, at least one support rod is in contact with one or more other support rods.

18. The fixation component for an implantable medical device according to claim 13, characterized in that, The fixing component includes a central tube and a plurality of support rods arranged in a ring extending outward from one end of the central tube. Each of the plurality of support rods first crosses the opening of the central tube and thus forms a cross arrangement on the outside of the central tube, and then extends outward to form the radial outer edge of the fixing component. The plurality of support rods cross the opening of the central tube in a staggered manner according to their ring arrangement position to form the cross arrangement.

19. The fixation component for an implantable medical device according to claim 13, characterized in that, The fixing component includes a central tube and a plurality of support rods arranged in a ring extending outward from one end of the central tube. The plurality of support rods first converge on one side outside the opening of the central tube to form a cross arrangement, and then extend outward to form the radial outer edge of the fixing component. The portions of the plurality of support rods at the cross arrangement are spatially distributed to form cylindrical portions with a diameter close to that of the central tube.

20. The fixation component for an implantable medical device according to claim 13, characterized in that, The fixing component includes a central tube and a plurality of support rods arranged in a ring extending outward from one end of the central tube. Each of the plurality of support rods extends across the opening of the central tube in a direction opposite to its respective end and forms the radial outer edge of the fixing component. At least one support rod has an extension section extending substantially axially along the central tube from the central tube, a crossing section crossing the opening, and an extension section continuing to extend outward to form the radial outer edge of the fixing component. The extension section transitions to the crossing section via a first bend and then to the extension section via a second bend.

21. The fixation component for an implantable medical device according to claim 20, characterized in that, The extension segment includes an axially extending first portion and an obliquely outward extending second portion. The crossing segment transitions into the first portion of the extension segment via a second bend and then transitions into the second portion of the extension segment via a third bend.

22. The fixation component for an implantable medical device according to claim 21, characterized in that, The second part is much longer than the first part.

23. The fixation component for an implantable medical device according to claim 20, characterized in that, The length of the extension segment is much greater than that of the lead-out segment and the crossing segment.

24. The fixation component for an implantable medical device according to claim 20, characterized in that, The support rod has a varying width, wherein the width of the support rod in the spanning section is less than the width in the lead-out section and / or the extension section, or the width of the support rod in both the spanning section and the lead-out section is less than the maximum width in the extension section.

25. A fixation component for an implantable medical device, said fixation component being elastically compressible to have a variable diameter, characterized in that, The fixing component is configured such that, within the range of its radial compression increasing from 10% to 30%, the average increase rate of the radial support force of the fixing component is k1; the fixing component is configured such that, within the range of its radial compression increasing from 0 to 10%, the average increase rate of the radial support force of the fixing component is k2; the fixing component is configured such that, within the range of its radial compression increasing from 30% to 50%, the average increase rate of the radial support force of the fixing component is k3. Where k1 is less than k2 and k1 is less than k3; Wherein, the average increase rate k of the radial support force of the fixed component is the reciprocal of the absolute value of the ratio of the difference before and after the change in the radial compression of the fixed component to the difference before and after the change in the corresponding radial support force of the fixed component; the fixed component includes a central tube and a plurality of support rods arranged in a ring extending outward from one end of the central tube, wherein the plurality of support rods first converge on one side outside the pipe opening of the central tube to form a cross arrangement and then extend outward to form the radial outer edge of the fixed component, at least one support rod has a horizontal section that substantially crosses the pipe opening, and forms the cross arrangement with other support rods at the horizontal section.

26. The fixation component for an implantable medical device according to claim 25, characterized in that, The fixing component includes a central tube and a plurality of support rods arranged in a ring extending outward from one end of the central tube. The plurality of support rods first converge on one side outside the opening of the central tube to form a cross arrangement and then extend outward to form the radial outer edge of the fixing component. At the cross arrangement, at least one support rod is in contact with one or more other support rods.

27. The fixation component for an implantable medical device according to claim 25, characterized in that, The fixing component includes a central tube and a plurality of support rods arranged in a ring extending outward from one end of the central tube. Each of the plurality of support rods first crosses the opening of the central tube and thus forms a cross arrangement on the outside of the central tube, and then extends outward to form the radial outer edge of the fixing component. The plurality of support rods cross the opening of the central tube in a staggered manner according to their ring arrangement position to form the cross arrangement.

28. The fixation component for an implantable medical device according to claim 25, characterized in that, The fixing component includes a central tube and a plurality of support rods arranged in a ring extending outward from one end of the central tube. The plurality of support rods first converge on one side outside the opening of the central tube to form a cross arrangement, and then extend outward to form the radial outer edge of the fixing component. The portions of the plurality of support rods at the cross arrangement are spatially distributed to form cylindrical portions with a diameter close to that of the central tube.

29. The fixation component for an implantable medical device according to claim 25, characterized in that, The fixing component includes a central tube and a plurality of support rods arranged in a ring extending outward from one end of the central tube. Each of the plurality of support rods extends across the opening of the central tube in a direction opposite to its respective end and forms the radial outer edge of the fixing component. At least one support rod has an extension section extending substantially axially along the central tube from the central tube, a crossing section crossing the opening, and an extension section continuing to extend outward to form the radial outer edge of the fixing component. The extension section transitions to the crossing section via a first bend and then to the extension section via a second bend.

30. The fixation component for an implantable medical device according to claim 29, characterized in that, The extension segment includes an axially extending first portion and an obliquely outward extending second portion. The crossing segment transitions into the first portion of the extension segment via a second bend and then transitions into the second portion of the extension segment via a third bend.

31. The fixation component for an implantable medical device according to claim 30, characterized in that, The second part is much longer than the first part.

32. The fixation component for an implantable medical device according to claim 29, characterized in that, The length of the extension segment is much greater than that of the lead-out segment and the crossing segment.

33. The fixation component for an implantable medical device according to claim 29, characterized in that, The support rod has a varying width, wherein the width of the support rod in the spanning section is less than the width in the lead-out section and / or the extension section, or the width of the support rod in both the spanning section and the lead-out section is less than the maximum width in the extension section.

34. A method for preparing a fixing component as described in any one of claims 1-33, characterized in that, Includes the following steps: Remove excess material from a raw material pipe fitting to obtain an intermediate body with multiple rods spaced apart around the pipe circumference of the raw material pipe fitting; The intermediate rods are machined into the required shape and then heat-treated to set the shape.

35. An implantable medical device, characterized in that... Includes the fixing component as described in any one of claims 1-33.

36. The implantable medical device according to claim 35, characterized in that, The fixation component is located at one end of the implantable medical device along its length and is connected to the other parts of the implantable medical device through the central tube.

37. A sealing device, characterized in that... Includes the fixing component as described in any one of claims 1-33.

38. The sealing device according to claim 37, characterized in that, It also includes a resiliently compressible sealing component with a variable diameter connected to the fixing component, the sealing component being located on one side of the fixing component, and the sealing component being connected at one end to the central tube of the fixing component.

39. The sealing device according to claim 38, characterized in that, The sealing component is connected at one end to the central tube of the fixing component via a connector.

40. The sealing device according to claim 39, characterized in that, The connector is elastically deformable and adjusts the distance between the sealing component and the fixing component when pulled by the sealing component and / or the fixing component.

41. The sealing device according to claim 37, characterized in that, The fixing component includes a flow-blocking membrane, which is sequentially connected to and fixed to each support rod. The flow-blocking membrane forms a cover at least in the radial direction of the fixing component to block fluid from passing through the fixing component.

42. The sealing device according to claim 37, characterized in that, The occlusion device is a left atrial appendage occluder.

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