CN114617592B

CN114617592B - Anchoring device and anchoring system

Info

Publication number: CN114617592B
Application number: CN202011462933.4A
Authority: CN
Inventors: 庄镇平; 张庭超; 李阳
Original assignee: Hangzhou Valgen Medtech Co Ltd
Current assignee: Hangzhou Valgen Medtech Co Ltd
Priority date: 2020-12-11
Filing date: 2020-12-11
Publication date: 2024-09-20
Anticipated expiration: 2040-12-11
Also published as: CN114617592A

Abstract

The invention discloses an anchoring device and an anchoring system. The anchoring device includes an anchor assembly, a drive assembly, and a release assembly. The proximal end of the release member of the anchoring assembly is provided with a first release structure, the distal end of the driving member of the driving assembly is provided with a second release structure, the release member and the driving member are connected in a matched manner through the first release structure and the second release structure, and the release rod of the release assembly axially penetrates through the driving member and the release member. The first release structure and the second release structure each comprise two opposite and parallel guide surfaces, and an included angle between each guide surface and the central axis of the anchoring device is larger than 0 degrees and smaller than 90 degrees. When the driving assembly is released, the releasing rod is only required to be moved to a preset position from the far end to the near end, so that the driving assembly and the anchoring assembly can be released in a self-guiding manner, and the driving assembly does not need to be subjected to enough radial displacement by external force. In addition, the driving piece is smaller in radial release space required by releasing from the release piece, so that the release is convenient, and the surgical traumas and risks are reduced.

Description

Anchoring device and anchoring system

Technical Field

The invention relates to the technical field of medical instruments, in particular to an anchoring device and an anchoring system.

Background

In some interventional procedures, it is necessary to anchor a corresponding implant (e.g., spacer, anchor, etc.) at the lesion by an anchoring device for therapeutic/repair purposes. After the implant is anchored, the distal end of the anchoring device needs to be released or separated from the implant, and the anchoring device is withdrawn to complete the interventional procedure.

As shown in fig. 1 and 2, the existing anchoring device includes a first member, a second member, and a third member, where the first member and the second member are fastened to each other, and are fixedly coupled together by the third member. The distal end of the second member is releasably connected to the proximal end of the first member, wherein the first member is part of the implant. The release principle is that the third component is pulled away from the buckling position of the first component and the second component, and the first component and the second component are released after being displaced sufficiently in the radial direction.

In the releasing process, the first component and the second component can be released only by at least one buckling depth displacement under the action of external force in the radial direction. Since the first part is part of the implant, the delivery system connected to the second part is required to provide an external force to allow sufficient radial displacement of the second part to disengage from the first part. However, the delivery system is typically a flexible long tube to conform to the tortuous vasculature, and when the second component is radially displaced by an external force applied to the proximal end of the delivery system, the flexible delivery system may wear out or even completely counteract the radial displacement, thereby rendering the second component indistinguishable from the first component. In addition, when the radial release space is limited, there is a risk of difficulty in release, and the probability of surgical failure is high. Further, when the vessel diameter is small, if the radial displacement required for releasing the second member from the first member is forcibly obtained, the inner wall of the vessel is easily damaged and even other organs are displaced, which is traumatic and risky.

Disclosure of Invention

Accordingly, there is a need for an anchoring device and an anchoring system for solving the above problems.

In a first aspect, an embodiment of the present invention provides an anchoring device, including an anchoring assembly, a driving assembly and a releasing assembly, where the anchoring assembly includes a releasing member, the driving assembly includes a driving member, the releasing assembly includes a releasing rod, a first releasing structure is disposed at a proximal end of the releasing member, a second releasing structure is disposed at a distal end of the driving member, the releasing member and the driving member are cooperatively connected through the first releasing structure and the second releasing structure, the releasing rod axially penetrates the driving member and the releasing member, the first releasing structure and the second releasing structure each include two opposite and parallel guide surfaces, and an included angle between each guide surface and a central axis of the anchoring device is greater than 0 degrees and less than 90 degrees.

In a second aspect, embodiments of the present invention provide an anchoring system comprising an anchoring device as described above and a handle assembly comprising a drive portion and a release portion disposed in sequence from a distal end to a proximal end;

The release part is fixedly connected with the proximal end of the release assembly, and is used for driving the release rod to move from the distal end of the anchoring device to a preset position from the proximal end to enable the driving piece to move along the guide surface of the first release structure, so that the second release structure is separated from the first release structure;

the driving part is fixedly connected with the proximal end of the driving assembly, and the driving part is used for providing driving force for the driving piece so that the driving piece drives the anchoring assembly to axially move.

In the anchoring device and the anchoring system provided by the embodiment of the invention, the release piece of the anchoring assembly and the driving piece of the driving assembly are connected in a matched manner through the first release structure and the second release structure, and the release rod axially penetrates through the driving piece and the release piece. Because the guide surface of the disengaging structure forms a certain included angle with the central axis of the anchoring device, the driving piece can be separated from the disengaging piece along the guide surface of the first disengaging structure only by moving the disengaging rod from the far end to the preset position from the near end during disengaging, so that the driving component and the anchoring component are automatically guided and disengaged, and the driving component does not need to generate enough radial displacement through external force. In addition, the driving piece is smaller in radial release space required by releasing from the release piece, so that the release is convenient, and the surgical traumas and risks are reduced.

Drawings

In order to more clearly illustrate the embodiments of the invention or the technical solutions of the prior art, the drawings which are used in the description of the embodiments or the prior art will be briefly described, it being obvious that the drawings in the description below are only some embodiments of the invention, and that other drawings can be obtained from these drawings without inventive faculty for a person skilled in the art.

Fig. 1 is a schematic view of the structure of an anchoring device provided in the prior art.

Fig. 2 is a schematic illustration of the release of the anchoring device provided by the prior art.

Fig. 3 is a schematic structural view of an anchoring system according to an embodiment of the present invention.

Fig. 4 is a partial structural schematic view of an anchoring device of the anchoring system in fig. 3.

Fig. 5 is an exploded view of the anchoring device of fig. 4.

Fig. 6 is a schematic view of the structure of the release member of the anchoring device of fig. 5.

Fig. 7 is a schematic view of the structure of the anchor device of fig. 5 with the release member and the driving member in a released state.

Fig. 8 is a schematic view of the structure of the release member and the driving member in fig. 7 in an assembled state.

Fig. 9 is a schematic view of a partially cut-away structure of the driving member in fig. 8.

Fig. 10 is a cross-sectional view of the anchoring device of fig. 4 taken along line VII-VII.

Fig. 11 is a schematic cross-sectional view of the anchor assembly and outer sleeve of the anchor device of fig. 4.

Fig. 12 is an enlarged view of region I of the anchoring device of fig. 10.

Fig. 13 is a schematic view in partial cross-section of the trip assembly of fig. 5.

Fig. 14 is a cross-sectional view of the anchoring system of fig. 3 taken along line XIV-XIV.

Fig. 15 is an enlarged view of the handle assembly of the anchoring system of fig. 14.

Fig. 16-27 are schematic views of the use of the anchoring system of fig. 3.

Fig. 28 is a force-receiving schematic view of the driving member of the anchoring device of fig. 5 in a use-process state.

Detailed Description

The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

It is to be understood that the terminology used in the description and claims of the invention and in the above description and drawings is for the purpose of describing particular embodiments only, and is not intended to be limiting of the invention. The terms first, second and the like in the description and in the claims and in the above-described figures, are used for distinguishing between different objects and not necessarily for describing a sequential or chronological order. The singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The term "comprising" and any variations thereof is intended to cover a non-exclusive inclusion. Furthermore, the present invention may be embodied in many different forms and is not limited to the embodiments described in the present embodiment. The following specific examples are provided to facilitate a more thorough understanding of the present disclosure, in which terms indicating orientations of the components, up, down, left, right, etc., are merely for the locations of the illustrated structures in the corresponding drawings.

The description is then made of the preferred embodiments for carrying out the invention, but the above description is made for the purpose of illustrating the general principles of the invention and is not meant to limit the scope of the invention. The scope of the invention is defined by the appended claims.

Referring to fig. 3 to 5, fig. 3 is a schematic structural diagram of an anchoring system 1000 according to an embodiment of the invention; fig. 4 is a schematic view showing a part of the structure of an anchoring device 100 according to an embodiment of the present invention; fig. 5 shows an exploded view of an anchoring device 100 according to an embodiment of the present invention. The anchoring system 1000 includes an anchoring device 100 and a handle assembly 300. The proximal end of the anchor 100 is connected to the handle assembly 300. The anchor 100 includes an anchor assembly 10, a drive assembly 20, and a release assembly 30. The anchor assembly 10 comprises a release member 11, the drive assembly 20 comprises a drive member 21, the release assembly 30 comprises a release rod 31, a first release structure 12 is arranged at the proximal end of the release member 11, a second release structure 22 is arranged at the distal end of the drive member 20, the release member 11 and the drive member 21 are connected in a matched mode through the first release structure 12 and the second release structure 22, and the release rod 31 axially penetrates through the drive member 21 and the release member 11. The first release structure 12 comprises two opposing and parallel guide surfaces 1201 and the second release structure 22 comprises two opposing and parallel guide surfaces 2201, each guide surface 1201, 2201 having an angle with the central axis P1 of the anchoring device 100 of more than 0 degrees and less than 90 degrees.

In this way, since the guide surfaces 1201, 2201 of the release structures 12, 22 form a certain angle with the central axis P1 of the anchoring device 100, the driving member 21 can be separated from the release member 11 along the guide surface 1201 of the first release structure 12 only by moving the release rod 31 from the distal end to the proximal end to the preset position during release, so that the driving assembly 20 and the anchoring assembly 10 are released from guiding, and no external force is required to cause the driving assembly 20 to generate enough radial displacement. In addition, the drive member 21 requires less radial disengagement space to disengage from the disengagement member 11, facilitating disengagement and reducing surgical trauma and risk.

The included angle refers to an included angle β or β '(see fig. 6), β=β', formed by the projection of the central axis P1 of the anchoring device 100 on the guiding surfaces 1201, 2201 and the central axis P1. Optionally, to ensure self-guided disengagement of the drive assembly 20 from the anchor assembly 10, the mating connection of the drive assembly 20 to the anchor assembly 10 is ensured with an included angle β greater than 0 and less than 45 degrees. In this embodiment, the included angle β is 30 degrees. The proximal movement of the release lever 31 from the distal end to the preset position means that the release lever 31 moves from the distal end to the proximal end to disengage the mating connection area of the first release structure 12 of the release member 11 and the second release structure 22 of the driving member 21.

It will be appreciated by those skilled in the art that fig. 3 is merely an example of the anchoring system 1000 and is not intended to limit the anchoring system 1000, and that the anchoring system 1000 and the anchoring device 100 may include more or less components than those shown in fig. 3, or may be combined with certain components, or different components, such as the anchoring device 100 may further include an outer sleeve assembly 40, etc., and the anchoring system 1000 may further include an energy generator, a negative pressure aspirator, etc., circumscribing an active device.

Wherein one of the first and second release structures 12, 22 is configured as a protrusion and the other of the first and second release structures 12, 22 is configured as a recess. In the present embodiment, the first release structure 12 is configured as a protrusion and the second release structure 22 is configured as a groove. In other embodiments, the first release structure 12 is configured as a groove and the second release structure 22 is configured as a protrusion. The recess cooperates with the projection to effect a mating connection of the release member 11 and the drive member 21.

The protrusion comprises two opposite and spaced release blocks. The two release blocks are symmetrically distributed about the central axis P1 of the anchoring device 100. The release rod 31 is movably disposed between the two release blocks, so that the release rod 31 can be disposed in the release member 11 and the driving member 21 while ensuring self-guiding release of the anchor assembly 10 and the driving assembly 20.

The release member 11 or the driving member 21 includes a main body and two release blocks protruding from one end of the main body. In the present embodiment, the release member 11 includes a main body 111 and two release blocks 121 protruding from the proximal end of the main body 111. In other embodiments, the driver 21 includes a body and two release blocks protruding from the distal end of the body.

Specifically, two disengagement blocks 121 extend upwardly or downwardly at an end face of the body 111 offset from the central axis P1 of the anchor 100 to effect engagement and disengagement of the drive assembly 20 with the anchor assembly 10. In the present embodiment, two release blocks 121 are provided extending obliquely upward on the proximal end face 1110 of the main body 111 of the release member 11. In other embodiments, two trip blocks 121 are provided extending obliquely downward on the proximal face 1110 of the body 111 of the trip 11.

Referring to fig. 5 and 6 together, fig. 6 is a schematic view of the release member 11 of the anchoring device 100. The body 111 and the two release blocks 121 are smoothly connected in transition. Specifically, the interface of the body 111 and the two relief blocks 121 form two arcuate transition fillets 1210, respectively. Each release block 121 forms two arcuate transition rounded corners 1212 at an end facing away from the body 111. The transition rounded corner 1210 of each release block 121 is curved in the opposite direction to the transition rounded corner 1212. In this way, the release piece 11 can avoid the damage to the tissue caused by the release block 121 before and after release, and the sliding and guiding action between the first release structure 12 and the second release structure 22 can be realized during the assembly process or the release process.

The body 111 and the two release blocks 121 are integrally formed, thus facilitating the machining of the release member 11. In other embodiments, the two release blocks 121 are fixedly connected to the body 111 independent of the body 111, and the body 111 and the two release blocks 121 may be connected together by welding, gluing, snapping, or the like.

The two release blocks 121 divide the end face 1110 of the body 111 into a first region 1111 and a second region 1113, the first region 1111 having an area larger than that of the second region 1113. The projections of the two release blocks 121 on the end face 1110 of the body 111 partially overlap the first region 1111 and meet the second region 1113 and do not overlap. In this way, sufficient radial release space is provided for the drive member 21 to release from the release member 11, thereby facilitating release and reducing surgical trauma and risk.

The body 111 includes opposed inner and outer peripheral surfaces 1112, 1114. Each release block 121 includes two opposing and parallel arcuate faces 1211, 1213. One of the arcuate surfaces 1211 is contiguous and coplanar with the inner circumferential surface 1112 of the body 111, and the other arcuate surface 1213 is contiguous and coplanar with the outer circumferential surface 1114 of the body 111. In this way, the disengaging member 11 or the driving member 21 is formed as a complete outer side wall, so that the risk of collision due to an irregular outer side wall in a narrow and crowded space can be avoided, or the difficulty in installation due to an irregular outer side wall can be avoided, and the anchoring device 100 is more attractive.

Please refer to fig. 5 and fig. 7-9 together; fig. 7 is a schematic view showing a structure in which the release member 11 and the driving member 21 of the anchoring device 100 are in a released state; fig. 8 shows a schematic view of the structure of the release member 11 and the driving member 21 in an assembled state; fig. 9 is a schematic sectional view of the driving member 21. The embodiment of the present invention will be described in detail taking the first release structure 12 as a protrusion and the second release structure 22 as a recess as an example. Wherein, the protrusion 12 includes two opposite and spaced releasing blocks 121, each releasing block 121 includes two opposite and parallel guiding surfaces 1201 (for convenience of description, the guiding surfaces 1201 of the protrusion 12 are hereinafter referred to as "protrusion"), and the groove 22 forms two opposite and parallel guiding surfaces 2201. The projection 12 and the groove 22 are clearance-fitted so that the guide surface 2201 of the groove 22 makes sliding friction on the guide surface 1201 of the projection 12, and the processing and assembling processes of the projection 12 and the groove 22 are simplified. To ensure the assemblability between the projection 12 and the recess 22, the respective dimensions of the projection 12 and the recess 22 satisfy the following relation: l1< L1',lw-W' |=2t1, α=α ', β=β', R1< R1', R2> R2', R3> R3', R4< R4', wherein L1 represents the length of the protrusion 12 (i.e., the first relief structure) along the axial direction of the relief 11, L1 'represents the length of the groove 22 (i.e., the second relief structure) along the axial direction of the driver 21, W represents the distance between the two guide surfaces 1201 of the protrusion 12, W' represents the distance between the two guide surfaces 2201 of the groove 22, t1 represents the distance between one of the guide surfaces 1201 of the protrusion 12 and the guide surface 2201 of its mating adjacent groove 22, β represents the angle between any one of the guide surfaces 1201 of the protrusion 12 and the central axis P1 of the anchor device 100, α represents the complementary angle between any one of the guide surfaces 1201 of the protrusion 12 and the central axis P1 of the anchor device 100, β 'represents the angle between any one of the guide surfaces 2201 of the groove 22 and the central axis P1 of the anchor device 100, α' represents the complementary angle between any one of the guide surfaces 2201 of the groove 22 and the central axis P1 of the anchor device 100, and R1 'R4' represents the rounded angle between any guide surfaces 1201 of the protrusion 12 and the central axis P1 of the anchor device 100, R1, R4 'and R4' R2 'R4, R1, R4', R4, R2, R4.

To ensure stability of the projection 12 and the groove 22, the length of the projection 12 in the axial direction of the release member 11 satisfies the following relationship: Wherein L1 represents the length of the protrusion 12 in the axial direction of the release member 11, D1 represents the outer diameter of the release member 11, and α represents the remaining angle of the included angle β. Preferably, the method comprises the steps of, In the present embodiment of the present invention, in the present embodiment,

The distance W between the two guide surfaces 1201 of the projection 12 is: I.e. To the point ofPreferably, W is approximately: To the point of In the present embodiment, W isThe value range of t1 is between 0.01 and 0.03 mm. In this way, each release block 121 of the protrusion 12 is provided with a proper thickness, ensuring the strength of the release block 121.

It will be appreciated that to ensure that the radial displacement required to disengage the recess 22 from the projection 12 is small, while at the same time ensuring that the drive assembly 20 is self-guided disengaged from the anchor assembly 10, α satisfies the following relationship: 0 ° < α <75 °. In this embodiment, α=60°. The radial displacement required to disengage the groove 22 from the projection 12 satisfies the following relationship: h=l1/tan α, where H represents the radial displacement required for the groove 22 to separate from the projection 12. In the present embodiment of the present invention, in the present embodiment,

Referring to fig. 5 and 10-12, fig. 10 shows a cross-sectional view of the anchoring device 100 along line VII-VII; fig. 11 is a schematic cross-sectional view of anchor assembly 10 and outer sleeve 41; fig. 12 is an enlarged view of region I of the anchoring device 100 of fig. 10. As shown in fig. 5, the anchoring device 100 further includes an outer sleeve assembly 40. The outer sleeve assembly 40 includes an outer sleeve 41. Anchor assembly 10 also includes an anchor 13. The proximal end of the anchor 13 is fixedly attached to the release member 11, the distal end of the anchor 13 is a free end having a pointed configuration 131, and the anchor 13 is movably attached to the outer sleeve 41.

The proximal end of the anchor 13 is sleeved outside the release member 11 and is fixed to the release member 11, and no relative movement exists between the anchor 13 and the release member 11. For example, the anchor 13 may be secured to the release member 11 by welding, bonding, clamping, or by mounting structures, etc. In other embodiments, the anchor 13 is integrally formed with the release 11. Both the anchor 11 and the release 12 are made of biocompatible materials including, but not limited to, at least one of nitinol, 316 stainless steel. The anchor 13 is movably coupled to the outer sleeve 41, and the driving assembly 20 can drive the release member 11 to extend the anchor 13 from the outer sleeve 41, so that the pointed structure 131 at the distal end of the anchor 13 can be anchored into tissue to implant the anchor assembly 10.

In this embodiment, the anchor 13 is configured as a hollow screw, and the distal end of the release member 11 is embedded inside the screw. In this manner, assembly between the release member 11 and the anchor member 13 is facilitated, making the anchor assembly 10 compact, simplified, and advantageous for reducing the size of the anchor device 100.

As shown in fig. 5 and fig. 7 to 8, in order to ensure that the stress is uniform after the release member 11 is fixedly connected with the screw, and simultaneously ensure that the free end of the screw reaches a preset working length, the engagement length L2 between the release member 11 and the screw is greater than or equal to the pitch S of the screw, wherein the engagement length L2 is the axial length of the portion of the release member 11 embedded in the screw, and the preset working length refers to the axial length of the screw embedded in the tissue.

The inner wall of the outer sleeve 41 is provided with a thread section 411 in threaded connection with the screw, the pitch of the thread section 411 is equal to the pitch S of the screw, and the rotation direction of the thread section 411 is the same as the rotation direction of the screw. In this way, the screw is screwed to the inner wall of the outer sleeve 41. The thread segments 411 have a left or right hand thread. The screw is screwed in or out along the central axis P1 of the anchoring device 100 by the driving member 21 so that the screw can be screwed from the outer sleeve 41 to embed the screw in the tissue.

The screw includes opposing inner and outer screw surfaces. The inner spiral surface is attached to the outer side wall of the release member 11 and the outer spiral surface is screwed to the threaded section 411 of the outer sleeve 41. In this embodiment, the screw is in transition fit with the release member 11, and the screw is coaxially disposed with the release member 11. The internal diameter D2 of the screw is substantially equal to the external diameter D1 of the trip 11, the internal helicoidal surface of the screw being welded to the external lateral wall of the trip 11. To ensure that the anchor assembly 10 can pass smoothly through the outer sleeve 41, the height of the weld between the anchor 13 and the release 11 satisfies the following relationship: h1.ltoreq.1/2 (D3-D1), where h1 represents the height of the weld between the anchor 13 and the stripper 11, and D3 represents the minimum inside diameter of the threaded section 411 of the outer sleeve 41 (hereinafter the minor diameter of the outer sleeve 41 for convenience of description). While the screw is in clearance fit with the inner wall of the outer sleeve 41, the screw has an outer diameter D2 slightly smaller than the maximum inner diameter D3 of the threaded section 411 of the outer sleeve 41 (hereinafter the larger diameter of the threads of the outer sleeve 41 for ease of description).

To ensure that the driver 21 and the release member 11 can be smoothly released after the screw has been inserted into the tissue, the distal end of the inner wall of the outer sleeve 41 is provided with a non-threaded section 413 adjacent to the threaded section 411, the axial length L3 of the non-threaded section 413 being greater than or equal to the mating length L2. In this manner, during the disengagement process, the interior of the distal end (i.e., the non-threaded section 413) of the outer sleeve 41 is able to reserve space for receiving the disengagement member 11 so that the drive assembly 20 and the anchor assembly 10 self-guide the disengagement within the outer sleeve 41, thereby avoiding the problems of damaging the inner wall of the blood vessel or other organs that occur during the disengagement process, thereby improving the success rate of the procedure, and reducing the trauma and risk of the procedure.

The outer sleeve 41 comprises a first barrel 42 and a second barrel 44 fixedly connected to the proximal end of the first barrel 42, a threaded section 411 is arranged at the proximal end of the first barrel 42, a non-threaded section 413 is arranged at the distal end of the first barrel 42, the outer sleeve assembly 40 further comprises a first flexible sheath 43 connected with the second barrel 44, and the first flexible sheath 43 is of a hollow structure.

It will be appreciated that the design of the outer sleeve 41 as a separate first barrel 42 and second barrel 44 facilitates the threaded assembly of the threaded section 411 on the inner wall of the first barrel 42 with the screw of the anchor assembly 10 while simplifying the processing of the outer sleeve 41. Wherein the first cylinder 42 and the second cylinder 44 may be fixedly connected together by welding or bonding; or can be detachably and fixedly connected together in a threaded connection, a clamping connection and the like.

In some embodiments, the proximal end of the second barrel 44 is provided with a reduced mouth section 441. The outer sleeve 41 is connected to the primary flexible sheath 43 by a reduced mouth section 441. The reduced section 441 has an outer diameter smaller than an inner diameter of the second cylinder 44. A limiting step is formed between the necking section 441 and the second cylinder 44, so that the connection end of the second cylinder 44 and the first cylinder 42 can be conveniently identified, and the first cylinder 42 and the second cylinder 44 can be conveniently and quickly assembled.

The connection mode of the necking section 441 and the primary flexible sheath 43 can adopt welding; alternatively, glue bonding or fusion bonding may be used. Specifically, the reduced section 441 is provided with a first through hole 442. The first through hole 442 is used for accommodating a filler, such as an adhesive or welding points, to facilitate the connection of the second cylinder 44 of the outer sleeve 41 to the first flexible sheath 43. The shape of the first through hole 442 is, for example, but not limited to, circular, waist-shaped, square, or shaped. The number of the first through holes 442 is at least two. The plurality of first through holes 442 are uniformly or randomly spaced along the circumferential direction of the reduced mouth section 441.

The primary flexible sheath 43 includes an inner membrane, a woven mesh, and an outer membrane three-layer structure. The inner membrane, the woven mesh and the outer membrane are stacked from inside to outside to form a first flexible sheath 43. The inner membrane can be made of polytetrafluoroethylene (Poly tetra fluoroethylene, PTFE), the woven mesh is woven by stainless steel wires or tungsten wires, and the outer membrane can be made of polyether block Polyamide (PEBAX). The outer sleeve 41 may be made of a metallic or non-metallic material. The metallic material is, for example, but not limited to, 304 stainless steel, 316 stainless steel, titanium alloy. Nonmetallic materials such as, but not limited to, acrylonitrile-butadiene-styrene copolymer (Acrylonitrile Butadiene Styrene, ABS), polycarbonate (PC), etc. When the outer sleeve 41 and the first flexible sheath 43 are both made of metal materials, the outer sleeve 41 and the first flexible sheath 43 may be connected by glue or welded. When at least one of the outer sleeve 41 and the primary flexible sheath 43 is made of a metal material, the outer sleeve 41 and the primary flexible sheath 43 may be connected by glue or fusion.

Referring to fig. 10, 11 and 12, a limiting boss 24 is disposed at the proximal end of the driving member 21. The drive assembly 20 further includes a second flexible sheath 23 fixedly attached to the limit boss 24. The second flexible sheath 23 is hollow. The connection length L4 of the driver 21 and the secondary flexible sheath 23 is less than or equal to the axial length between the limit boss 24 and the proximal face of the driver 21. Specifically, the inner wall of the proximal end of the driver 21 is recessed to form an annular stop boss 24. The inner diameter of the limit boss 24 is larger than the inner diameter of the driving member 21, i.e., the inner diameter of the proximal end side of the driving member 21 is larger than the inner diameter of the distal end side of the driving member 21, so that the limit boss 24 can play a role in positioning the connection length between the driving member 21 and the second flexible sheath 23.

The connection mode of the limiting boss 24 and the second flexible sheath 23 can be welding; alternatively, glue bonding or fusion bonding may be used. Specifically, the proximal end of the driving member 21 is provided with a second through hole 242 near the circumference of the limit boss 24. The second through hole 242 is used for accommodating a filler, such as an adhesive or a welding point, so as to facilitate the connection between the limiting boss 24 and the second flexible sheath 23. The shape of the second through hole 242 is, for example, but not limited to, circular, waist-shaped, square, or shaped. The number of the second through holes 242 is at least two. The plurality of second through holes 242 may be uniformly distributed at intervals in the circumferential direction; or may also be randomly distributed along the circumference. In this embodiment, 4 waist-shaped holes are uniformly distributed at intervals in the circumferential direction at the position where the proximal end of the driving member 21 is close to the limit boss 24.

The driving member 21 and the releasing member 11 are in clearance fit with the releasing rod 31, and the inner diameter d4 of the driving member 21 is equal to the inner diameter d1 of the releasing member 11 and slightly larger than the outer diameter of the releasing rod 31, so that the releasing rod 31 is arranged in the driving member 21 and the releasing member 11 in a penetrating manner. When the anchor assembly 10 is released, the guide surface 2201 of the second release structure 22 of the driving member 21 can move along the guide surface 1201 of the first release structure 12 of the release member 11 only by moving the release lever 31 from the distal end to the preset position from the proximal end, so that the driving member 21 is separated from the release member 11, and the driving assembly 20 and the anchor assembly 10 are released from the guide without sufficient radial displacement of the driving assembly 20 by an external force.

To ensure that the drive assembly 20 has sufficient relief, the outer diameter of the drive member 21 satisfies the following relationship: d1< D4 +.ltoreq.D3-2H, wherein D4 represents the outer diameter of the driving member 21 and D1 represents the inner diameter of the release member 11. Alternatively, considering that the overall size of the anchoring device 100 is as small as possible, while guaranteeing the function, the outer diameter of the driving member 21 satisfies the following relation: d4 =d2-2H-2 t2, where t2 represents a unilateral fit gap between the inner wall of the outer sleeve 41 and the screw, and the value range of t2 is 0.05-0.1 mm.

The inner diameter of the secondary flexible sheath 23 satisfies the following relationship: d4< d5<0.8 x d4, where d4 represents the inner diameter of the driver 21 and d5 represents the inner diameter of the secondary flexible sheath 23. The inner diameter D5 of the second flexible sheath 23 is substantially equal to the outer diameter D7 of the third flexible sheath 33 of the trip bar 31. Optionally, to ensure that the second flexible sheath 23 has sufficient torque control, d5 should not be too small, and d5 satisfies the following relationship: d5 =0.75×d4. The connection length L4 between the driving member 21 and the secondary flexible sheath 23 is: (1-1.5) d5. Preferably, the method comprises the steps of, l4=d5.

The structure and materials of the second flexible sheath 23 are suitable for the structure and materials of the first flexible sheath 43, and the embodiments of the present invention will not be described in detail. The driving member 21 may be made of a metallic material or a nonmetallic material. The metallic material is, for example, but not limited to, 304 stainless steel, 316 stainless steel, titanium alloy. The nonmetallic material is, for example, but not limited to, PC, etc. When the driving member 21 and the second flexible sheath 23 are both made of metal materials, the driving member 21 and the second flexible sheath 23 may be connected by glue or welded. When the driving member 21 and the second flexible sheath 23 are both made of non-metal materials, the driving member 21 and the second flexible sheath 23 may be connected by glue or fusion.

Referring to fig. 5 and 13, fig. 13 is a schematic view of a partially cut-away structure of the disengaging assembly 30. The trip assembly 30 further includes a third flexible sheath 33 attached to the proximal end of the trip bar 31. The release rod 31 and the third flexible sheath 33 are hollow. The outer diameter and the inner diameter of the third flexible sheath 33 are equal to the outer diameter and the inner diameter of the release rod 31, respectively.

As shown in fig. 7 and 13, the lumen of the third flexible sheath 33 and the release lever 31 is used for suture passing. Considering that the anchoring device 100 passes at least two sutures when threading the sutures, the inner diameter d7 of the third flexible sheath 33 and the inner diameter d6 of the release rod 31 are greater than or equal to 2 times the diameter of the suture. The outer diameter D7 of the third flexible sheath 33 and the outer diameter D6 of the release rod 31 are slightly smaller than the inner diameter D1 of the release member 11.

The effective axial length L5 of the release lever 31 satisfies the following relation: l5 is more than or equal to 2L1. In this way, it is ensured that the length of the release lever 31 is sufficient to penetrate into the release member 11 and the driving member 21 cooperatively connected by the first release structure 12 and the second release structure 22. Wherein the effective axial length L5 represents the axial length of the portion of the release rod 31 other than the portion connected to the third flexible sheath 33.

In the present embodiment, the hardness of the release rod 31 is greater than that of the third flexible sheath 33, so as to ensure that the release rod 31 sufficiently supports the release member 11 and the driving member 21, and simultaneously ensure that the third flexible sheath 33 has a flexible function, so as to achieve the purpose of delivering the anchoring device 100 to the target tissue and avoid damaging the operative path. The trip lever 31 may be made of a rigid material to enhance the torsional resistance of the trip lever 31. The rigid material comprises a metallic material or a nonmetallic material. The metallic material is, for example, but not limited to, 304 stainless steel, 316 stainless steel, titanium alloy. The nonmetallic material is, for example, but not limited to, PC, etc. The third flexible sheath 33 is made of a flexible material. The third flexible sheath 33 is, for example, but not limited to, a polyetheretherketone (peek) tube, a Polyimide (PI) tube, a stainless steel hose, or the like. When the release rod 31 and the third flexible sheath 33 are made of metal materials, the connection mode of the release rod 31 and the third flexible sheath 33 can be glue bonding or welding. When the release rod 31 and the third flexible sheath 33 are both made of non-metal materials, the release rod 31 and the third flexible sheath 33 may be connected by glue or fusion.

In some embodiments, the trip bar 31 is integrally formed with the third flexible sheath 33. Specifically, the release rod 31 and the third flexible sheath 33 are cut from a metal pipe, thereby greatly simplifying the assembly work and the connection strength.

Referring to fig. 5, 14 and 15, fig. 14 shows a cross-sectional view of the anchoring system 1000 along line XIV-XIV; fig. 15 shows an enlarged view of handle assembly 300 of anchor system 1000. In this embodiment, the handle assembly 300 includes a drive portion 301 and a release portion 303 disposed in sequence from the distal end to the proximal end. The release portion 303 is fixedly connected to the proximal end of the release assembly 30, and is configured to drive the release lever 31 to move proximally from the distal end of the anchoring device 100 to a predetermined position so that the driving member 21 can move along the guiding surface 1201 of the first release structure 12 to separate the second release structure 22 from the first release structure 11. The driving part 301 is fixedly connected to the proximal end of the driving assembly 20, and the driving part 301 is used for providing driving force to the driving member 21 so that the driving member 21 drives the anchor assembly 10 to axially move. In this manner, the axial movement of the trip assembly 30 is facilitated by the trip portion 303 of the handle assembly 300, and the anchor assembly 10 is driven to move axially by the drive portion 301.

Specifically, the handle assembly 300 further includes a connection 305. The connection portion 305 is disposed on a side of the driving portion 301 facing away from the releasing portion 303. The connecting portion 305 fixedly connects the proximal end of the outer sleeve assembly 40. The proximal end of the primary flexible sheath 43 is fixedly attached to the connector 305. The driving part 301 is connected to the proximal end of the second flexible sheath 23 in the driving assembly 20, and outputs driving force in a manner of rotating around the central axis P1 of the anchoring device 100, so as to drive the anchoring assembly 10 to advance or retract spirally, i.e. to realize screwing-out of the outer sleeve 41 or retracting-in of the anchoring assembly 10 into the outer sleeve 41. The disengaging portion 303 is connected to the proximal end of the third flexible tube 33 in the disengaging assembly 30, and slidably controls the advancing or retracting of the disengaging assembly 30 in the axial direction of the anchoring device 100, thereby enabling engagement and disengagement of the drive assembly 20 and the anchor assembly 10.

Referring to fig. 16-27 and 28, fig. 16-27 are schematic views of the anchoring system 1000 of fig. 3 in use, and fig. 28 is a schematic view of the driving member 21 in use. The following describes the use of the self-guiding and release anchoring system 1000 according to an embodiment of the present invention, using transcatheter mitral chordae repair as an example. The heart of the patient includes, among other things, the right atrium RA, tricuspid valve TV, atrial septum IAS, left atrium LA, mitral valve MV, and papillary muscle PM. Of course, the anchoring system 1000 may also be used in tricuspid valve repair and other situations where implantation of the anchor assembly 10 is desired.

The first step: as shown in fig. 16, one or more sutures 2 with elastic pad 1 are implanted on the left atrium LA side of the patient's anterior mitral valve A2 area, and the sutures 2 are led out of the body.

And a second step of: as shown in fig. 17 to 19, the suture 2 withdrawn in the first step is passed through the internal passage of the release assembly 30 in the anchoring device 100 of the embodiment of the present invention, and the anchoring device 100 is fed into the patient along the suture 2, with the help of the guiding device adjustable curved sheath, the distal end of the anchoring device 100 (i.e., the distal end of the outer sleeve 41) is directed toward and conforms to the papillary muscle PM on the top surface thereof. At this time, the screw 13 is received in the outer sleeve 41 and is engaged with the screw section 411 of the outer sleeve 41. The first release structure 12 of the release member 11 cooperates with the second release structure 22 of the driving member 21.

And a third step of: as shown in fig. 14, 20-21, rotating the drive portion 301 of the handle assembly 300 counterclockwise causes the spikes 13 to extend the pointed structure 131 of the spikes 13 out of the outer sleeve 41 and into the papillary muscle PM with the engagement of the threaded surface of the threaded section 411 of the outer sleeve 41. At this time, whether the anchoring depth and the anchoring form of the screw 13 are correct or not can be judged by means of the ultrasonic image, otherwise, the driving part 301 is rotated clockwise, the screw 13 is retracted, and the anchoring operation is repeated after repositioning until the anchoring state meets the requirement. It is foreseeable that the suture 2 will automatically rise or rest along the screw surface under the influence of the papillary muscle PM surface tissue during the screw 13 screwing in, until the anchoring is completed, at which point the suture 2 will be at the weld of the distal surface of the release member 11 with the inner surface of the screw 13. At this time, the release member 11 is received in the unthreaded section 413 of the outer sleeve 41, and the screw 13 cannot continue to be screwed into the papillary muscle PM.

Fourth step: as shown in fig. 22-26 and 28. Continued counterclockwise rotation of the drive portion 301 of the handle assembly 300 drives the body 111 of the release member 11 fully exposed and then withdraws the release assembly 30. After the release rod 31 is separated from the mating connection region of the first release structure 12 of the release member 11 and the second release structure 22 of the driving member 21, the driving assembly 20 is retracted, and the second release structure 22 on the driving member 21 is guided by the two guide surfaces 1201 of the first release structure 12 of the release member 11 to perform a predetermined release displacement in the radial direction. To ensure smooth disengagement, it is desirable to ensure that the tangential component F1 on the guide surface 2201 is greater than the product of the normal component F2 and the coefficient of friction. The coefficient of friction is generally less than 1 for different materials. In this embodiment, the guide surface 1201 forms an angle β of 30 ° with the central axis of the anchoring device 100, and the drive member 21 is acted upon by a proximally directed axial force F, which is a component of force in the tangential direction on the guide surface 2201Greater than component in normal directionIt is possible to ensure that the release is smooth, complete the implantation of the anchor assembly 10, and then withdraw the remaining elements of the anchoring device 100 and withdraw the suture 2 to the outside of the body.

Fifth step: as shown in fig. 27, the existing locking device 3 is used to enter the anchoring assembly 10 along the suture 2, the suture 2 is cinched to adjust the length of the suture 2 from the anterior leaflet A2 area of the mitral valve to the anchoring assembly 10 until the requirement is met, the locking device 3 is tightly attached to the anchoring assembly 10 and after the suture 2 is locked, the suture 2 is cut, the locking device 3 is withdrawn, and the tendon repair is completed.

In the anchoring device 100 and the anchoring system 1000 provided by the embodiments of the present invention, the release member 11 of the anchoring assembly 10 and the driving member 21 of the driving assembly 20 are cooperatively connected by the first release structure 12 and the second release structure 22, and the release rod 31 axially penetrates the driving member 21 and the release member 11. Because the guide surfaces 1201, 2201 of the release structures 12, 22 form a certain included angle β, β' with the central axis P1 of the anchoring device 100, the driving member 21 can be moved along the guide surface 1201 of the first release structure 12 and separated from the release member 11 only by moving the release rod 31 from the distal end to the proximal end to the preset position during release, so that the driving assembly 20 and the anchoring assembly 10 are self-guided and released, and no external force is required to cause the driving assembly 20 to perform sufficient radial displacement. In addition, the drive member 21 requires less radial disengagement space to disengage from the disengagement member 11, facilitating disengagement and reducing surgical trauma and risk.

In the present invention, the retraction means a distal movement.

The foregoing has outlined rather broadly the more detailed description of embodiments of the invention, wherein the principles and embodiments of the invention are explained in detail using specific examples, the above examples being provided solely to facilitate the understanding of the method and core concepts of the invention; meanwhile, as those skilled in the art will appreciate, modifications will be made in the specific embodiments and application scope in accordance with the idea of the present invention, and the present disclosure should not be construed as limiting the present invention.

Claims

1. The anchoring device is characterized by comprising an anchoring assembly, a driving assembly and a releasing assembly, wherein the anchoring assembly comprises a releasing piece, the driving assembly comprises a driving piece, the releasing assembly comprises a releasing rod, a first releasing structure is arranged at the proximal end of the releasing piece, a second releasing structure is arranged at the distal end of the driving piece, the releasing piece and the driving piece are connected in a matched mode through the first releasing structure and the second releasing structure, the releasing rod axially penetrates through the driving piece and the releasing piece, the first releasing structure and the second releasing structure comprise two opposite and parallel guide surfaces, and an included angle between each guide surface and the central axis of the anchoring device is larger than 0 degree and smaller than 90 degrees; one of the first release structure and the second release structure is configured as a protrusion, the other one of the first release structure and the second release structure is configured as a groove, the protrusion comprises two release blocks which are opposite and are arranged at intervals, the two release blocks are symmetrically distributed along the central axis of the anchoring device, and the release piece or the driving piece comprises a main body and two release blocks which are convexly arranged at one end of the main body.

2. An anchoring device according to claim 1, wherein two of said release blocks divide an end face of said body into a first region and a second region, said first region having an area greater than an area of said second region, projections of two of said release blocks onto said end face of said body partially overlapping said first region and contiguous and non-overlapping said second region.

3. The anchor of claim 1, further comprising an outer sleeve assembly, the outer sleeve assembly comprising an outer sleeve, the anchor assembly further comprising an anchor, the proximal end of the anchor fixedly attached to the release member, the distal end of the anchor being a free end having a pointed configuration, the anchor being movably attached to the outer sleeve.

4. An anchoring device according to claim 3 wherein said anchor is configured as a hollow screw, the distal end of said release member being embedded within the interior of said screw.

5. The anchoring device of claim 4, wherein a mating length between said release member and said screw is greater than or equal to a pitch of said screw, said mating length being an axial length of a portion of said release member embedded within said screw.

6. The anchoring device according to claim 5, wherein an inner wall of the outer sleeve is provided with a thread section screwed with the screw, a pitch of the thread section is equal to a pitch of the screw, and a direction of rotation of the thread section is the same as a direction of rotation of the screw.

7. The anchor device of claim 6, wherein a distal end of the inner wall of the outer sleeve is provided with a non-threaded section contiguous with the threaded section, the non-threaded section having an axial length greater than or equal to the mating length.

8. The anchor device of claim 7, wherein the outer sleeve comprises a first barrel and a second barrel fixedly connected to a proximal end of the first barrel, the threaded section is disposed at the proximal end of the first barrel, the non-threaded section is disposed at a distal end of the first barrel, the outer sleeve assembly further comprises a first flexible sheath connected to the second barrel, the first flexible sheath being of hollow construction.

9. The anchoring device of claim 1, wherein said first relief is a protrusion and said second relief is a recess, and wherein the length of said protrusion along the axial direction of said relief satisfies the relationship: Wherein L1 represents the length of the protrusion along the axial direction of the release member, D1 represents the outer diameter of the release member, and alpha represents the complementary angle of the included angle.

10. An anchoring device according to claim 9 wherein the distance between two of said guide surfaces of said projection is:。

11. an anchoring device according to claim 9 wherein the radial displacement required to disengage said groove from said projection satisfies the relationship: Wherein H represents the radial displacement required for the groove to separate from the protrusion.

12. The anchoring device of claim 1, wherein the proximal end of the driver is provided with a spacing boss, the driver assembly further comprises a second flexible sheath fixedly connected to the spacing boss, the second flexible sheath is of hollow structure, and the connection length of the driver and the second flexible sheath is less than or equal to the axial length between the spacing boss and the proximal end face of the driver.

13. The anchoring device of claim 1, wherein said trip assembly further comprises a third flexible sheath connected to a proximal end of said trip rod, said trip rod and said third flexible sheath each being hollow, an outer diameter and an inner diameter of said third flexible sheath being equal to an outer diameter and an inner diameter of said trip rod, respectively.

14. An anchoring system comprising the anchoring device of any one of claims 1-13 and a handle assembly comprising a drive portion and a release portion disposed in sequence from a distal end to a proximal end;