Cardiac anchors and cardiac anchoring systems

Abstract

This invention provides a cardiac anchor and a corresponding cardiac anchoring system. The cardiac anchor includes a locking assembly and an anchoring member extending distally from the locking assembly. The anchoring member has a connecting end for engagement with cardiac tissue. The locking assembly includes a base and a suture clamping member, the suture clamping member being movably connected to the proximal end of the base. The distal end of the base has a bearing portion, and the suture clamping member has a suture clamping portion. A suture is disposed between the bearing portion and the suture clamping portion. The suture clamping member moves relative to the base to drive the suture clamping portion to move the suture toward the bearing portion and clamp the suture to the bearing portion. This cardiac anchor and cardiac anchoring system not only ensure endothelial overgrafting after the cardiac anchor is anchored to cardiac tissue, but also further avoids damage to the native chordae tendineae, ultimately greatly ensuring and maintaining the therapeutic effect of the surgery.

Description

Technical Field

[0001] This invention relates to heart valve repair technology, and more particularly to a cardiac anchor and cardiac anchoring system. Background Technology

[0002] With the increasing aging of the population, valvular heart disease caused by mitral or tricuspid regurgitation is becoming more and more common. Currently, the mainstream interventional procedures for treating mitral or tricuspid regurgitation include annuloplasty and artificial chordae tendineae implantation. These procedures all require implants, such as intracardiac anchoring devices, to lock and anchor medical sutures to the target tissue area. Generally, after locking the sutures with an intracardiac anchoring device, an appropriate tail length needs to be left to ensure the effectiveness and stability of the locking. However, with existing intracardiac anchoring devices, the tail of the suture usually protrudes beyond the nearest end of the device. Therefore, the overall exposure height of the intracardiac anchoring device in the target tissue area is the axial length / height of the device plus the tail length. This inevitably leads to defects such as difficulty in endothelial lap or poor endothelial lap due to excessive implant exposure. At the same time, because the medical sutures protrude from the proximal end of the intracardiac anchoring device, they are more likely to come into contact with the native chordae tendineae, which may lead to the risk of damage to the native chordae tendineae due to entanglement or friction between the medical sutures and the native chordae tendineae, thus making it difficult to maintain the therapeutic effect of the surgery. Summary of the Invention

[0003] The purpose of this invention is to provide a cardiac anchor and cardiac anchoring system that not only ensures the endothelialization effect after anchoring, but also further avoids damage to the original chordae tendineae, ultimately greatly ensuring and maintaining the therapeutic effect of the surgery.

[0004] To achieve the above objectives, in a first aspect, the present invention provides a cardiac anchor, the cardiac anchor comprising:

[0005] A locking assembly includes a base and a pressure suture member, the pressure suture member being movably connected to the proximal end of the base; the distal end of the base has a support portion, the pressure suture member has a pressure suture portion, and a suture is disposed between the support portion and the pressure suture portion; the pressure suture member moves relative to the base to drive the pressure suture portion to move the suture toward the support portion and press the suture against the support portion; and

[0006] An anchoring element that extends distally from the locking assembly and has an engaging end for engaging with cardiac tissue.

[0007] Secondly, the present invention also provides a cardiac anchoring system, the system comprising:

[0008] Anchor pipe;

[0009] The aforementioned cardiac anchor is removably mounted within the anchor conduit;

[0010] An anchoring actuator, mounted within the anchoring conduit and detachably connected to the base or the anchoring element, the anchoring actuator being used to drive the cardiac anchor to extend from the distal end of the anchoring conduit so that the engagement end engages with the cardiac tissue; and

[0011] A thread-locking actuator, installed inside the anchor conduit and detachably connected to the pressure member, is used to drive the pressure member to rotate to press the suture.

[0012] The cardiac anchor and cardiac anchoring system provided by this invention utilizes the rotation of the suture clamp relative to the substrate to lock the suture to a position near the distal end of the locking assembly. At this point, the suture with a pre-existing tail suture will not extend beyond the locking assembly, thus effectively ensuring the endothelial overgraft effect of the cardiac anchor. This avoids the defects in existing technologies, such as difficulty in endothelial overgraft or poor endothelial overgraft effect due to excessive exposure of the entire implant to the target tissue. Simultaneously, because the suture tail does not extend beyond the locking assembly, there is no risk of contact with and damage to the native chordae tendineae, ultimately greatly ensuring and maintaining the therapeutic effect of the surgery. Attached Figure Description

[0013] To more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0014] Figure 1 The diagram illustrates the pathway for mitral valve repair via intravascular catheterization of cardiac anchors and cardiac anchoring systems in some embodiments.

[0015] Figure 2 A three-dimensional schematic diagram of a cardiac anchor is shown in some embodiments.

[0016] Figure 3 It shows Figure 2 Another angle of the cardiac anchor.

[0017] Figure 4 It shows Figure 2 Exploded 3D view of the central anchor.

[0018] Figure 5 a-5b shows Figure 4 A three-dimensional schematic diagram and a side sectional view of the medium-pressure line component.

[0019] Figure 6 It shows Figure 4 A three-dimensional schematic diagram of the central base.

[0020] Figure 7 It shows Figure 4 Side sectional view of the connection between the central base and the anchor.

[0021] Figure 8 It shows Figure 4 A three-dimensional schematic diagram of the central anchoring component.

[0022] Figure 9-10 A side sectional view of the base of another structure connected to different anchors is shown.

[0023] Figure 11 It shows Figure 4 A three-dimensional schematic diagram of the inner shell.

[0024] Figure 12 It shows Figure 2 A side sectional view of the medium-pressure line component in its initial position.

[0025] Figure 13 yes Figure 12 An enlarged schematic diagram of part V shown.

[0026] Figure 14 It shows Figure 12 Side sectional view of the medium pressure wire component rotated to the pressure wire position.

[0027] Figure 15-16 The side sectional views of the locking assembly without a second through space in different states are shown.

[0028] Figure 17 Schematic diagrams of cardiac anchoring systems in some embodiments are shown.

[0029] Figure 18 It shows Figure 17 A schematic diagram of the structure of the anchoring actuator and anchoring components.

[0030] Figure 19 Schematic diagrams show various connection methods between the first joint and the second joint.

[0031] Figure 20 The diagram shows the connection relationship between the first joint and the second joint, which is a snap-fit ​​connection.

[0032] Figure 21 It shows the way Figure 1 The diagram shows the path used to complete a transcatheter valve leaflet suturing procedure.

[0033] Figure 22 The cardiac anchoring system is shown along Figure 20 The diagram shows the path leading into the left ventricle of the mitral valve.

[0034] Figure 23 It shows Figure 22 A schematic diagram of using an anchoring actuator to anchor a cardiac anchor into the ventricular tissue.

[0035] Figure 24 A schematic diagram is shown showing the adjustment of sutures to appropriate tension outside the body.

[0036] Figure 25 A schematic diagram is shown of using a suture lock driver to lock a suture to a cardiac anchor.

[0037] Figure 26 This diagram shows the status of a completed cardiac anchor implantation. Detailed Implementation

[0038] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0039] Furthermore, the following descriptions of the embodiments are made with reference to the accompanying illustrations, which illustrate specific embodiments in which the invention can be implemented. Directional terms used in this invention, such as "up," "down," "front," "rear," "left," "right," "inner," "outer," and "side," are merely directional references to the accompanying illustrations. Therefore, the directional terms used are for better and clearer explanation and understanding of the invention, and are not intended to indicate or imply that the referred device or element must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as limiting the invention.

[0040] It should be noted that, in order to more clearly describe the cardiac anchor and cardiac anchoring system provided by this invention, the limiting terms "proximal" and "distal" used in the specification are conventional terms in the field of interventional medicine. Specifically, "distal" refers to the end away from the operator during the surgical procedure, and "proximal" refers to the end closer to the operator during the surgical procedure; the direction of the rotational axis of an object such as a cylinder or tube is defined as the axial direction; the circumferential direction is the direction around the axis of the object such as a cylinder or tube (perpendicular to the axis and also perpendicular to the cross-sectional radius); the radial direction is along the diameter or radius. It is worth noting that the term "end" appearing in terms such as "proximal," "distal," "one end," "the other end," "first end," "second end," "initial end," "end," "both ends," "free end," "upper end," and "lower end" is not limited to the tip, end point, or end face, but also includes a portion extending axially and / or radially from the tip, end point, or end face on the element to which the tip, end point, or end face belongs. Unless otherwise defined, all technical and scientific terms used in this invention have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The conventional terminology used in this specification is for the purpose of describing specific embodiments only and should not be construed as limiting the invention.

[0041] The present invention provides a cardiac anchor and a cardiac anchoring system that can obtain a path into the heart via the apex or via a catheter to anchor at least one suture to a target location in the heart tissue to perform mitral or tricuspid valve repair, thereby preventing mitral or tricuspid regurgitation.

[0042] Figure 1The diagram illustrates the pathway for cardiac anchors and systems to access the mitral valve for valve repair via intravascular catheterization in some embodiments. A guiding catheter 10 provides an extracorporeal pathway into the heart. Specifically, the guiding catheter 10 is a slender, flexible catheter inserted into the femoral vein in the patient's groin and advanced to the inferior vena cava 21 before entering the right atrium 22 within the heart. After puncturing the interatrial septum 23 using a suitable puncture tool, the guiding catheter 10 further passes through the interatrial septum 23 into the left atrium 24, positioning its distal opening within the left atrium 24. This provides the desired pathway for the cardiac anchor and system to enter the left atrium 24 or further into the left ventricle 25 to perform mitral valve repair, thereby preventing mitral regurgitation. Of course, if the heart valve being repaired is a tricuspid valve, after the guiding catheter 10 is pushed into the right atrium 22 inside the heart, its distal opening will be positioned within the right atrium 22, thereby providing the desired path for the cardiac anchor and cardiac anchoring system to enter the right atrium 22 or further into the right ventricle 26 to perform tricuspid valve repair, thereby preventing tricuspid regurgitation.

[0043] Figure 2-3A perspective view of a cardiac anchor 30 in some embodiments is shown, wherein the cardiac anchor 30 includes an anchor 40 and a locking assembly 50 connected to the anchor 40. The anchor 40 extends distally from the locking assembly 50 and has an engagement end 400 for engaging with cardiac tissue to embed the cardiac anchor 30 into the cardiac tissue of the human body. The locking assembly 50 is used to lock at least one suture 60 inserted therein; specifically, the locking assembly 50 includes a base 51 and a pressure suture 52, with the anchor 40 extending distally from the base 51. Further, the base 51 includes a distal end and a proximal end, and the pressure suture 52 is movably connected to the proximal end of the base 51, for example, by rotation or sliding connection. The distal end of the base 51 has a bearing portion 540, and the pressure suture 52 has a pressure suture portion 520, with the suture 60 disposed between the bearing portion 540 and the pressure suture portion 520. Therefore, under the action of external force, the suture clamping member 52 can move relative to the base 51, driving the suture clamping part 520 to move the suture 60 towards the support part 540 and press the suture 60 tightly against the support part 540. At this time, the locked position of the suture 60 will be located near the distal end of the locking assembly 50; therefore, even if the locked suture 60 needs to leave a certain tail line, the tail line will not protrude beyond the locking assembly 50, thus effectively ensuring the endothelial overlay effect of the cardiac anchor 30 and avoiding defects such as difficulty in endothelial overlay or poor endothelial overlay effect due to the overall implant being exposed too high in the heart tissue. Here, the exposure height of the implant refers to the longest axial distance between the implant (including the tail line of the suture) and the heart tissue after the implant is anchored into the heart tissue. At the same time, since the tail line of the suture 60 does not protrude beyond the locking assembly 50, there is no risk of contact with the native chordae tendineae and damage to the native chordae tendineae. In other words, the cardiac anchor 30 of the present invention can not only effectively ensure the endothelial overgraft effect after anchoring to the heart tissue, but also further avoid the risk of damaging the native chordae tendineae due to long-term contact, thus greatly ensuring and maintaining the therapeutic effect of the surgery.

[0044] Please see Figure 4 , Figure 4 An exploded perspective view of the cardiac anchor 30 is shown. The base 51 further includes a housing 53 and a base 54 fixedly housed within the housing 53. A pressure member 52 is movably connected to the proximal end of the housing 53, and a support portion 540 is disposed at the distal end of the base 54. An anchoring member 40 extends distally from the base 54 and is connected to the base 54; the connection can be either a fixed connection or a rotational connection.

[0045] Specifically, please also refer to Figure 5As shown, the stitching member 52 is generally rod-shaped, including a stitching portion 520 and a connecting portion 521 for movably connecting with the base 51. The stitching portion 520 and the connecting portion 521 are respectively disposed at opposite ends of the stitching member 52. The stitching portion 520 includes a stitching surface 5200. When the stitching member 52 is in the stitching position, the sewing thread 60 can be pressed between the stitching surface 5200 and the supporting portion 540. Simultaneously, to ensure the effective length of the locked sewing thread 60, the stitching portion 520 includes a stitching surface 5200 extending in at least two directions, such as a generally U-shaped stitching surface 5200 extending in three directions (see...). Figure 14 This is to provide sufficient locking force by having a good fit with the support portion 540 and forming a generally U-shaped locking length. In some embodiments, the crimping member 52 is rotatably connected to the base 51. The connecting portion 521 can be one of a shaft hole or a connecting shaft, thereby realizing the pivot connection between the crimping member 52 and the base 51. For example, in some embodiments, the locking assembly 50 further includes a pivot shaft 55, a first shaft hole 533 is provided at the proximal end of the base 51, and a through connecting portion 521, such as a second shaft hole 521, is provided at the end of the crimping member 52 away from the crimping portion 520. The pivot shaft 55 achieves the pivot connection between the two by passing through the first shaft hole 533 of the base 51 and the second shaft hole 521 of the crimping member 52, respectively. Of course, in other embodiments, the base 51 and the crimping member 52 are pivotally connected by having a connecting shaft protruding from both ends of one component and shaft holes provided at both ends of the other component.

[0046] Furthermore, the suture fastener 52 is also provided with a first thread guide space 522, so that the sewing thread 60 can be passed through and located between the support portion 540 and the suture fastener 520. The first thread guide space 522 is located between the suture fastener 520 and the connecting portion 521, and is disposed adjacent to the suture fastener 520. Simultaneously, the suture fastener 52 has an initial position and a suture fastening position. When the suture fastener 52 is in the initial position, the sewing thread 60 can pass through the first thread guide space 522 and be positioned between the support portion 540 and the suture fastener 520, and the sewing thread 60 can slide freely within the first thread guide space 522. In some embodiments, the first thread guide space 522 is a first thread guide hole penetrating the suture fastener 52. The diameter of the first thread guide space 522 is larger than the diameter of the sewing thread 60, so that the operator can quickly introduce the sewing thread 60 into the first thread guide space 522 for quick threading, and allow the sewing thread 60 to move freely within the first thread guide space 522.

[0047] To drive the crimping member 52 to rotate relative to the base 51, the crimping member 52 is further provided with a first driving part 523. The first driving part 523 is at least one of a traction hole or a driving surface, for engaging with a thread-locking driver 80 and rotating relative to the base 51 under the drive of the thread-locking driver 80. In some embodiments, the first driving part 523 is a first traction hole 523 formed on the crimping member 52. The first traction hole 523 is located on the crimping member 52 near the first thread passage space 522 for the thread-locking driver 80, such as a traction member, to pass through. The distal end of the traction member 80 passes through and connects to the first traction hole 523, and the proximal end of the traction member 80 extends out of the body. Pulling the proximal end of the traction member 80 drives the crimping member 52 to rotate relative to the base 51, thereby causing the crimping part 520 to rotate toward the support part 540 and press the thread 60. Understandably, to avoid the risk of the thread 60 and the traction member 80 becoming entangled during the locking process, the pressing part 520 and the first traction hole 523 are located on both sides of the first thread passage space 522. Of course, to ensure that the pressing member 52 can rotate effectively, the first traction hole 523 is further located between the first thread passage space 522 and the connecting part 521, such as the second shaft hole 521, and is spaced a certain distance from the second shaft hole 521. In some embodiments, there are two first traction holes 523, arranged side-by-side along an extension direction parallel to the second shaft hole 521; the axial center line of the first traction hole 523 is parallel to the axial center line of the first thread passage space 522 and perpendicular to the axial center line of the second shaft hole 521. Thus, the traction member 80 can be wound around through the two first traction holes 523 so that its distal end can be detachably connected to the pressure member 52. When the proximal end of the traction member 80 is pulled to drive the pressure member 52 to the pressure position and complete the locking of the line, pulling one of the proximal ends of the traction member 80 can remove the traction member 80 from the heart.

[0048] Understandably, to further ensure that the base 51 and the pressure member 52 remain locked after the suture is locked, so as to ensure that the cardiac anchor 30 can remain in the patient's body for a long time and maintain its effectiveness, in some embodiments, the base 51 and the pressure member 52 engage to restrict the pressure member 52 from rotating in the opposite direction away from the support portion 540, such as ratchet engagement or other similar engagement methods that can restrict the reverse rotation of the pressure member 52. The pressure member 52 can be provided with multiple ratchet teeth 524 on the outer periphery of the connecting portion 521 to engage with the ratchet 5411 on the base 54 (see...). Figure 6The meshing mechanism enables unidirectional stepped rotation, preventing reverse rotation. This not only ensures the stability of the wire pressing member 52 in its initial and pressing positions but also further fulfills the stepped control and unidirectional rotation requirements between the wire pressing member 52 and the base 54. Specifically, multiple ratchet teeth 524 are arranged in a semi-circular pattern around the connecting portion 521, with the wire pressing portion 520, the first wire passage space 522, and the first traction hole 523 located on the same side of the connecting portion 521, and the multiple ratchet teeth 524 located on the other side of the connecting portion 521.

[0049] Please continue reading. Figure 6 , Figure 6 A perspective view of the base 54 is shown. The base 54 includes a body 541 extending axially, and a support portion 540 extending radially from the distal end of the body 541. In some embodiments, a generally L-shaped smooth inner surface is formed between the support portion 540 and the body 541, including a first surface 540a and a second surface 541b. An acute angle is formed between the first surface 540a and the second surface 541b, ranging from 30 degrees to 90 degrees, preferably 60 degrees in this invention. The first surface 540a is an arcuate surface inside the support portion 540, and the second surface 541b is disposed above the body 541 and is a stepped surface. The surface of the second surface 541b adjacent to the support portion 540 is higher than the surface away from the support portion 540. Further, a protrusion 5410 is provided on the surface of the second surface 541b adjacent to the support portion 540, forming a gap between the protrusion 5410 and the support portion 540 to accommodate at least a portion of the pressure line portion 520. Naturally, the cross-section of the protrusion 5410 is smaller than the aperture of the first thread-passing space 522 of the pressure member 52. When the pressure member 52 is in the pressure position, the protrusion 5410 will be accommodated within the first thread-passing space 522, and the pressure part 520 will also be accommodated in the gap formed between the protrusion 5410 and the support part 540. At this time, the thread 60 is pressed by the U-shaped pressure surface 5200 of the pressure part 520 onto the first surface 540a, the second surface 541b, and the inner surface of the protrusion 5410 to complete the locking of the thread 60. In addition, a plurality of ratchet teeth 5411 are provided on the surface of the second surface 541b away from the support part 540 for engaging with a plurality of ratchet teeth 524 of the pressure member 52 to achieve unidirectional stepped rotation and prevent the thread 60 from loosening.

[0050] In some embodiments, both the first surface 540a and the suture surface 5200 are arc-shaped. When the suture member 52 rotates from its initial position toward the base 54 to the suture position, a uniform gap is formed between the first surface 540a and the suture surface 5200. That is, at this time, the gap between all points between the first surface 540a and the suture surface 5200 is equal and uniform, and the suture 60 can be uniformly locked between the first surface 540a and the suture surface 5200. The risk of suture breakage is greatly reduced, further ensuring the therapeutic effect of the surgery.

[0051] Furthermore, a second thread-passing space 5400 is provided at a position away from the main body 541 in the support part 540 for the suture 60 to pass through. The second thread-passing space 5400 is an axially penetrating through hole located above the support part 540. The suture 60 passes through the second thread-passing space 5400 and the first thread-passing space 522 sequentially before exiting the locking assembly 50. The diameter of the second thread-passing space 5400 is larger than the diameter of the suture 60, allowing the operator to quickly introduce the suture 60 into the second thread-passing space 5400 and quickly exit the first thread-passing space 522, enabling rapid threading of the suture 60 at the end of the cardiac anchor 30. At this time, the suture 60 can slide freely within the second thread-passing space 5400 and the first thread-passing space 522. Of course, in some other embodiments, the base 54 does not include the second thread passage space 5400, and the stitch 60 only needs to be introduced into and pass through the first thread passage space 522 of the pressure thread member 52 before exiting the locking assembly 50 (see...). Figure 15-16 ).

[0052] To ensure that the base 54 can be aligned and securely positioned within the housing 53, the base 54 further includes positioning portions 542 disposed at both ends of the body 541. These positioning portions 542 extend circumferentially around both ends of the body 541 to form a disc or semi-disc shape, respectively, for fixed connection to both ends of the housing 53. Furthermore, the proximal positioning portion 542 has an axially penetrating second traction hole 543, through which the proximal end of the locking wire actuator 80 passes.

[0053] In addition, to ensure that the anchor 40 can be disposed at the distal end of the locking assembly 50 and that the two are not axially separated, the base 51 also has an axially extending receiving channel 544 for receiving the proximal end of the anchor 40 within the receiving channel 544. The anchor 40 can be rotatably or fixedly connected relative to the locking assembly 50. In some embodiments, the receiving channel 544 is located approximately at the center of the base 54, passing through the axial center of the body 541 and the positioning part 542 to form a through cavity. The second traction hole 543 is disposed adjacent to the receiving channel 544 and located below the receiving channel 544.

[0054] In some embodiments, such as Figure 7-8As shown, the proximal end of the anchor 40 is connected within the receiving channel 544, and the engaging end 400 protrudes from the receiving channel 544 and extends distally. Specifically, the anchor 40 includes a helical coil 41 and a connector 42 connected to the proximal end of the helical coil 41. The engaging end 400 is a helical segment of the helical coil 41 for engaging with cardiac tissue and has a sharp distal end with at least one bevel to ensure that the force-bearing area of ​​the sharp distal end as the first contact point for the anchor 40 to anchor into the cardiac tissue is small and the puncture resistance is small, thus making it easier to puncture the target tissue. The connecting end 410 is a cylindrical segment formed by the transition of the proximal helical segment. This cylindrical segment is concentrically arranged with the helical segment to ensure that the anchor 40 does not experience radial jump during anchoring. The connector 42 is generally hollow tubular, including a hollow inner cavity 421 extending along its axis. The connecting end 410 of the helical coil 41 is housed in the distal end of the hollow inner cavity 421 and axially fixedly connected to the hollow inner cavity. The connection can be achieved through laser welding, adhesive bonding, or other methods. During assembly, the entire connector 42 of the anchor 40 is assembled as follows: Figure 7 The anchor 40 is inserted into the distal end of the receiving channel 544 of the base 54 and laser-welded into the receiving channel 544 to achieve a fixed connection between the anchor 40 and the base 54. At this time, the engaging end 400 of the spiral coil 41 will protrude from the receiving channel 544 and extend distally, and be positioned at the distal end of the base 54. That is to say, only the engaging end 400 of the anchor 40 is exposed outside the base 54, and all other components, such as the connector 42, are completely housed within the receiving channel 544. This not only ensures the stability of the cardiac anchor 30, but also reduces the implantation height of the cardiac anchor 30 after implantation into the heart tissue, further reducing the defect of endothelial overgrowth.

[0055] Furthermore, the proximal end of the connector 42 is provided with a first engagement portion 422 for use with the anchoring actuator 90 of the driving cardiac anchor 30 (see... Figure 16 The connection is detachable. Therefore, when the cardiac anchor 30 is embedded into the heart tissue using the anchoring actuator 90, the distal end of the base 54 is flush against the heart tissue to enhance the stability of the cardiac anchor 30 while reducing its overall height. Once the cardiac anchor 30 is anchored, the anchoring actuator 90 can detach from the first joint 422 and be withdrawn from the body, leaving the cardiac anchor 30 inside the body.

[0056] It is understandable that the anchor 40 can be as follows: Figure 7-9 The spiral coil type anchor shown can also be used for, for example Figure 10 The radially expandable expandable implant shown can be a structure such as a barb or umbrella-shaped element. Of course, the anchor 40 can be configured as follows: Figure 7-8 It can be connected to the base 54 in the manner shown, and can also be connected in the manner shown. Figure 9-10It is connected to the base 54 in the manner shown. Specifically, as... Figure 9-10 As shown, at this time, the anchor 40 includes a connecting end 400 and a connecting end 410, but does not include a connecting member 42; the receiving channel 544 of the base 54 is provided at the distal end of the base 54, and the anchor 40 is connected to the base 54 by fixing the connecting end 410 to the receiving channel 544. In addition, the base 54 is further provided with a first connecting portion 545 for detachable connection with the anchoring actuator 90 that drives the cardiac anchor 30 to be helically or axially advanced distally.

[0057] Please also refer to Figure 4 and Figure 11 As shown, the outer casing 53 is a hollow cylinder open at both ends, including a hollow cavity 531 for accommodating the base 54, which extends axially to both ends. An axial channel 532 communicating with the hollow cavity 531 is formed on the side wall of the outer casing 53, providing a rotational and oscillating movement channel for the wire pressing member 52; thus, when the wire pressing member 52 rotates relative to the base 54, the wire pressing portion 520 can be driven and pass through the axial channel 532 to move towards the support portion 540. In some embodiments, the channel 532 can be a U-shaped groove extending from the distal end to the proximal end of the side wall of the outer casing 53, or it can be a through groove passing through both ends of the side wall of the outer casing 53. A first shaft hole 533 is provided on the side wall near the proximal end of the outer casing 53 and symmetrically arranged on opposite sides of the channel 532 for the pivot shaft 55 to pass through. Furthermore, to ensure smooth pulling of the traction member 80, the locking assembly 50 is further provided with a traction shaft 56 for the traction member 80 to wind around. Specifically, two third shaft holes 534 are provided on the side wall of the housing 53 for positioning the traction shaft 56 within the two third shaft holes 534. When the distal end of the traction member 80 is detachably connected to the pressure wire member 52, the proximal end of the traction member 80 can bypass the traction shaft 56 and further pass through the second traction hole 543 to exit the locking assembly 50. In some embodiments, the two third shaft holes 534 are symmetrically arranged on opposite sides of the channel 532 and disposed away from the channel 532, for example, disposed below the housing 53. During assembly, the base 54 is inserted into the hollow cavity 531 of the housing 53 so that the bearing part 540 is placed at the far end of the axial channel 532 of the housing 53. At the same time, the two ends of the base 54 are aligned with the two ends of the hollow cavity 531 of the housing 53 and the base 54 is fixed by laser welding or glue bonding.

[0058] like Figure 12The diagram shows the initial state of the locking assembly 50. At this point, the base 54 is fixedly housed within the housing 53. The wire clamping member 52 enters from the axial channel 532 of the housing to align the second shaft hole 521 of the wire clamping member 52 with the first shaft hole 533 of the housing 53. A pivot shaft 55 is then inserted through and fixed into both the first shaft hole 533 and the second shaft hole 521 to complete the rotational connection. Simultaneously, the ratchet teeth 524 of the wire clamping member 52 need to engage with the ratchet 5411 of the base 54 to ensure that the wire clamping member 52 remains in the initial state. Figure 12 The initial position is shown. Of course, the two ends of the pivot shaft 55 can be fixed to the two first shaft holes 533 of the housing 53 by welding or gluing to avoid the risk of the pivot shaft 55 detaching from the housing 53 and the pressure member 52, which would cause the locking assembly 50 to fail. Specifically, the pressure member 52 is positioned generally vertically above the body 541 of the base 54, and the bearing portion 540 extends from the far end of the body 541 in the direction toward the axial channel 532. The first thread passage space 522 and the second thread passage space 5400 are both located above the axial channel 532 of the housing 53, that is, they both protrude from the axial channel 532 to expose the locking assembly 50, which facilitates the operator to perform a quick threading operation on the sewing thread 60. Of course, in other embodiments, the first thread passage space 522 and the second thread passage space 5400 may both be located below the axial channel 532 of the housing 53 in the initial state, for example, without exposing the locking assembly 50. In this case, although it makes the thread-leading operation of the suture 60 more difficult, it can effectively avoid the risk of the pressure member 52 touching and damaging the heart tissue during the locking operation. In some embodiments, the support portion 540 and the pressure member 52 are both located above the central axis of the base 54 and / or the housing 53. Thus, when the pressure member 52 is in the initial position, the free end of the suture 60 can pass through the first thread passage space 522 and the second thread passage space 5400 to extend through the locking assembly 50 in one direction, thereby realizing the quick thread lead of the locking assembly 50; at this time, the suture 60 can slide freely relative to the first thread passage space 522 and the second thread passage space 5400.

[0059] Furthermore, after the distal end of the traction member 80 is wound back and passed through the first pulling hole 523 of the pressure member 52, the traction member 80 further passes around the traction shaft 56 and exits through the second traction hole 543 to the outside. Of course, in order to change the pulling direction of the traction member 80 to ensure the stability of the pulling, the traction shaft 56 is located on the distal side of the pressure member 52, that is, the traction shaft 56 is located on the distal side of the connecting part 521, for example, positioned at the lower left of the outer casing 53 parallel to the second traction hole 543. Figure 13As shown, during wire locking, the traction member 80 drives the wire pressing member 52 to rotate around the pivot shaft 55 in the X direction, for example, counterclockwise. The ratchet teeth 524 of the wire pressing member 52 engage with the ratchet 5411 of the base 54. When the wire pressing member 52 rotates to the wire pressing position, as... Figure 14 As shown, the suture 60 is locked to the bearing portion 540 by the pressing portion 520 of the pressing member 52. That is, the suture 60 is pressed against the inner surface of the first surface 540a, the second surface 541b, and the protrusion 5410 by the U-shaped pressing surface 5200 of the pressing portion 520 to complete the locking of the suture 60. In some embodiments, when the pressing member 52 is in the pressing position, the axial distance between the nearest end of the first thread passage space 522 and the farthest end of the base 51 is 0.5 to 0.8 times the total length of the base 51, where the total length of the base 51 refers to the axial length of the base 51. In other embodiments, the rotation angle of the pressing member 52 from the initial position to the pressing position ranges from 0 degrees to 90 degrees, and 60 degrees is preferred in this invention. Of course, since the ratchet tooth 524 is engaged with the ratchet bar 5411 and cannot be reversed, the pressing member 52 will be held in the pressing position to ensure the long-term stability of the locking assembly 50. It should be noted that the locked shape of the suture 60 is roughly U-shaped, and the locked length of the suture 60 is the sum of three segments, namely two vertical lengths and one horizontal length. Therefore, the effective length of the suture 60 is increased, which not only effectively improves the locking force of the locking component 50, but also further increases the reliability of the suture 60 locking.

[0060] In other embodiments, such as Figure 15-16 As shown, the base 54 does not include a second thread passage space 5400. Specifically, the second thread passage space 5400 is not provided on the support portion 540, and the locking assembly 50 is not exposed on the support portion 540. At this time, the thread 60 only needs to be introduced from the first thread passage space 522 of the pressure member 52, pass through it, and exit the locking assembly 50, and can slide freely within the first thread passage space 522. When the pressure member 52 is driven by the traction member 80 to rotate around the pivot axis 55, for example, counterclockwise, to the pressure position, the thread 60 is locked to the support portion 540 by the pressure portion 520 of the pressure member 52, that is, the thread 60 is pressed by the U-shaped pressure surface 5200 of the pressure portion 520 to the first surface 540a, the second surface 541b, and the inner surface of the protrusion 5410 to complete the locking of the thread 60. Given that the other structures of the base 54, the pressure member 52, and the housing 53 are all related to Figure 12-14 The structure is the same as that in the previous section, so it will not be repeated here.

[0061] It is understood that the present invention also provides a cardiac anchoring system 100 for delivering and anchoring a cardiac anchor 30 to a target location inside the heart. Specifically, as Figure 17As shown, the cardiac anchoring system 100 includes a cardiac anchor 30, an anchor conduit 12, a suture 60, a suture lock actuator 80, and an anchoring actuator 90. The anchor conduit 12 is a hollow, flexible, elongated tube, within which the cardiac anchor 30, suture lock actuator 80, and anchoring actuator 90 are all housed. The cardiac anchor 30 is pre-removably mounted on the distal end of the anchor conduit 12 so that other components can be withdrawn after the cardiac anchor 30 is anchored to the cardiac tissue. The anchoring actuator 90 is detachably connected to the proximal end of the base 51 or the proximal end of the anchor 40, and can be helically or axially advanced distally along the anchor conduit 12 to extend the cardiac anchor 30 from the distal end of the anchor conduit 12, allowing the engaging end 400 of the anchor 40 to engage with the cardiac tissue, thereby achieving anchoring of the cardiac anchor 30. Specifically, if the anchor 40 is a helical coil, the anchoring actuator 90 is used to drive the cardiac anchor 30 to advance helically; if the anchor 40 is an expandable implant, the anchoring actuator 90 is used to drive the cardiac anchor 30 to advance axially. The suture driver 80 is detachably connected to the suture clamping member 52. The free end of the suture 60 is introduced from the distal end of the anchor conduit 12, passes through the locking assembly 50, and then extends out of the body from the proximal end of the anchor conduit 12 for operator manipulation. The suture driver 80 can apply rotational power to the suture clamping member 52 within the anchor conduit 12 to drive the suture clamping member 52 to rotate and lock the suture 60. The rotational power can be one of traction, thrust, torque, etc.

[0062] In some embodiments, the distal end of the anchoring actuator 90 is detachably connected to the proximal end of the cardiac anchor 30, for example, detachably connected to the first engagement 422 of the anchoring member 40 within the receiving channel 544 of the base 54, or detachably connected to the first engagement 545 of the base 51 within the proximal end of the base 51. The proximal end of the anchoring actuator 90 passes through the anchor conduit 12 and is connected to the proximal handle (not shown). The distal end of the locking wire actuator 80 is detachably connected to the crimping member 52. The proximal end of the locking wire actuator 80 passes through the anchor conduit 12 and is connected to the proximal handle. In some embodiments, the locking wire actuator 80 is a flexible traction member. After the distal end of the flexible traction member 80 wraps around the two first traction holes 523 of the crimping member 52, the proximal end of the flexible traction member 80 will further wrap around the traction shaft 56 and pass through the second traction hole 543, and then pass through the anchor conduit 12 to the proximal handle for fixed connection to the handle. In use, the operating handle drives the anchoring actuator 90 to advance the cardiac anchor 30 distally, anchoring the anchor 40 into the heart tissue. Further operation of the handle drives the suture locking actuator 80 to rotate the suture pressing member 52, which in turn causes the suture pressing member 520 to rotate the suture 60 toward the support member 540, pressing the suture 60 tightly against the support member 540 to complete the suture locking.

[0063] In some embodiments, such as Figure 18-20As shown, the anchoring actuator 90 includes a support member 91 and a release rod 92. The support member 91 is a hollow tube of a certain length. The distal end of the support member 91 is detachably connected to the proximal end of the cardiac anchor 30. The proximal end of the support member 91 passes through the anchor conduit 12 and is fixed to the handle. Specifically, the distal end of the support member 91 is provided with a second engagement portion 910 that is removably engaged with the first engagement portion 422 / 545 to cooperate with the first engagement portion 422 / 545. The release rod 92 is generally elongated and is placed in the hollow cavity of the support member 91, and can be pulled and slid relative to the support member 91. The support member 91 achieves the connection between the two by limiting the release rod 92 in the first engagement portion 422 / 545. After connection, both the cardiac anchor 30 and the anchoring actuator 90 are pre-loaded in the anchor conduit 12. After the suture locking driver 80 is operated to drive the cardiac anchor 30 to complete the suture locking, the release lever 92 is disengaged from the first joint 422 / 545 to achieve separation. It is understood that the support member 91 can be made of stainless steel cut tube, stainless steel wound tube, nickel-titanium cut tube, polymer tube, etc., with stainless steel wound tube being preferred in this invention; the release lever 92 can be made of stainless steel rod, nickel-titanium rod, or polymer rod. Since polymer rods are prone to breakage under stress and stainless steel rods are difficult to recover after deformation, nickel-titanium rod is preferred in this invention.

[0064] In some embodiments, the first engagement portion 422 / 545 and the second engagement portion 910 are connected by a snap-fit ​​connection, for example, as shown in the figure. Figure 19 As shown in Figure a, the S-shaped buckle, as... Figure 19 The diagonal buckle shown in b, or as... Figure 19 The toothed buckle shown in c, and other similar fasteners, can also be made as follows: Figure 20 The elastic buckle shown. (As illustrated) Figure 20 As shown, the first joint 422 / 545 consists of at least two snap-fit ​​slots, which are arranged opposite each other and each communicates with the hollow inner cavity; the second joint 910 consists of at least two snaps made of shape memory material such as nickel-titanium alloy. Specifically, the at least two snaps 910 can be inserted into the hollow inner cavity in their natural state to be aligned with the at least two snap-fit ​​slots 422 / 545; simultaneously, the release lever 92 is pushed distally along the hollow cavity of the support member 91 into the gap between the at least two snaps 910 to compress the at least two snaps 910 into the at least two snap-fit ​​slots 422 / 545 to achieve a fixed connection. However, once the release lever 92 is withdrawn proximally, the at least two snaps 910 can disengage from the at least two snap-fit ​​slots 422 / 545 under the action of elastic restoring force to complete the release. Of course, in other embodiments, the first joint 422 / 545 and the second joint 910 can also be threaded, such as a removable joint of internal and external threads, or a removable joint such as magnetic attraction.

[0065] Understandably, the cardiac anchoring system 100 provided by this invention integrates anchoring and suture locking, eliminating the need for frequent changes and introduction of different instruments during the entire surgical process. This simplifies the surgical procedure, significantly shortens the surgical time, and further ensures the therapeutic effect of the surgery.

[0066] The following example of chordae tendineae repair illustrates how the cardiac anchoring system 100 delivers and anchors the cardiac anchor 30 to the ventricular tissue of the mitral valve, such as the papillary muscle or free wall, via a catheter to complete the chordae tendineae repair of the mitral valve and thereby prevent mitral regurgitation. Figure 21-26 The cardiac anchoring system 100 is shown through Figure 1 The diagram illustrates multiple states of pathways leading to the mitral valve for chordae tendineae repair. The cardiac anchoring system 100 further includes a guiding catheter 10, such as... Figure 21 As shown, after the transcatheter leaflet suturing operation is completed (i.e., one end of the suture 60 is implanted onto the leaflet), the suture 60 extends out of the body along the path of the guiding catheter 10. Next, the free end of the suture 60 is introduced into the cardiac anchor 30 outside the body and led out from the proximal end of the anchor catheter 12, at which point the cardiac anchor 30 has been pre-loaded onto the distal end of the anchor catheter 12. The anchor catheter 12 is advanced at a constant speed along the direction of the suture 60 through the path provided by the guiding catheter 10 into the left ventricle 25 of the mitral valve, so that its distal opening is abutted against the target location of ventricular tissue, such as the papillary muscle. At this point, the proximal end of the suture 60 is outside the body, such as... Figure 22 As shown. Therefore, as Figure 23 As shown, the cardiac anchor 30 mounted on the distal end of the anchor catheter 12 can be driven by the proximal-connected anchoring actuator 90 to helically or axially advance distally and extend from the distal end of the anchor catheter 12, thereby anchoring the anchor 40 to the target position, wherein the anchor 40 can be inserted along the inner surface of the ventricular tissue substantially perpendicular to it. Further, the tension of the suture 60 can be adjusted by pulling the proximal end of the suture 60 externally to adjust the distance of the suture 60 between the mitral valve leaflets and the ventricular tissue; once the tension of the suture 60 is adjusted to such a position... Figure 24 The appropriate tension is shown to achieve optimal heart valve function. The proximal handle is operated to drive the suture locking actuator 80, causing the suture clamping member 52 to rotate relative to the base 51 to press the suture 60 against the base 51, thereby holding the suture 60 under this tension to complete the suture locking operation. Figure 25As shown. Once the suture locking is complete, the proximal handle is operated to force the cardiac anchor 30 to disengage from the anchoring actuator 90, and the anchoring catheter 12, suture locking actuator 80, and anchoring actuator 90 are withdrawn, leaving the cardiac anchor 30 inside the body. Finally, the suture 60 needs to be cut near the cardiac anchor 30 to leave the suture 60 between the leaflet of the heart valve and the ventricular tissue as an artificial chordae tendineae. The cutting can be done by further introducing a suture cutting device (not shown), or by setting additional cutting elements on devices such as the anchoring catheter 12, suture locking actuator 80, and / or anchoring actuator 90. If a suture cutting device is used, it can be considered as part of the cardiac anchoring system 100 of this application. The suture cutting device can be advanced along the suture 60 and the guide catheter 10 to the vicinity of the cardiac anchor 30, and the cutting element in the suture cutting device cuts the suture 60 near the suture clamp 52. After the suture is cut, the suture cutting device and the remaining cut sutures are removed, and the guiding catheter 10 is further removed to complete the implantation of the cardiac anchor 30, as shown in the implantation status. Figure 26 As shown; at this point, the cut suture 60 will form between the heart valve leaflet and the ventricular tissue to create an artificial chordae tendineae, thereby replacing or supplementing the natural chordae tendineae inside the heart. Additionally, commonly used materials for the suture 60 include PTFE, e-PTFE, PET, and UHMWPE.

[0067] It is understood that the above illustrations are merely examples of mitral valve chordae tendineae implantation, where one end of the suture 60 is implanted from the left atrium to the left ventricle, and the other end of the suture 60 is anchored to the papillary muscle. The cardiac anchor 30 and cardiac anchoring system 100 of this application can also be used via a guiding path through the right ventricle-interventricular septum-left ventricle-mitral valve, or via a guiding path through the apex-left ventricle-mitral valve, for mitral valve repair. Of course, the cardiac anchor 30 and cardiac anchoring system 100 can also be used for anchoring after tricuspid valve suture implantation, or for suture anchoring after mitral / tricuspid valve annulusoplasty.

[0068] The above describes the embodiments of the present invention. It should be noted that those skilled in the art can make various improvements and modifications without departing from the principles of the embodiments of the present invention, and these improvements and modifications are also considered within the scope of protection of the present invention.

Claims

1. A cardiac anchor, characterized in that, The cardiac anchor includes: A locking assembly includes a base and a pressure suture member, the pressure suture member being movably connected to the proximal end of the base; the distal end of the base has a support portion, the pressure suture member has a pressure suture portion, and a suture is disposed between the support portion and the pressure suture portion; the pressure suture member moves relative to the base to drive the pressure suture portion to move the suture toward the support portion and press the suture against the support portion; and An anchoring element extending distally from the locking assembly and having an engaging end for engaging with cardiac tissue to embed the cardiac anchoring device into the cardiac tissue.

2. The cardiac anchor as described in claim 1, characterized in that, The pressure piece is rotatably connected to the base and can rotate relative to the base.

3. The cardiac anchor as described in claim 2, characterized in that, The pressing part is provided with a first thread passage space, and the sewing thread passes through the first thread passage space and is located between the bearing part and the pressing part.

4. The cardiac anchor as described in claim 3, characterized in that, The pressure member has a connecting portion that is rotatably connected to the base, and the first wire passage space is located between the pressure portion and the connecting portion.

5. The cardiac anchor as described in claim 3, characterized in that, The pressure member has an initial position and a pressure position. At the pressure position, the axial distance between the nearest end of the first thread passage space and the farthest end of the substrate is 0.5 to 0.8 times the total length of the substrate.

6. The cardiac anchor as claimed in claim 1, characterized in that, The wire clamping member is provided with a first driving part, which is used to engage with a wire locking driver and move relative to the base under the drive of the wire locking driver.

7. The cardiac anchor as described in claim 4, characterized in that, The pressure member has a first traction hole located between the first wire passage space and the connecting part. The distal end of a traction member passes through and is connected to the first traction hole to pull the pressure member to move.

8. The cardiac anchor as described in claim 7, characterized in that, A traction shaft is provided on the base, the traction shaft is located on the far end side of the connecting part, and a second traction hole is opened at the proximal end of the base. The proximal end of the traction member passes around the traction shaft and exits the base through the second traction hole.

9. The cardiac anchor as claimed in claim 1, characterized in that, The substrate engages with the pressure member to restrict the pressure member from moving away from the support portion.

10. The cardiac anchor as claimed in claim 9, characterized in that, The surface of the substrate away from the bearing portion is provided with a ratchet, and the outer periphery of the pressure piece is provided with ratchet teeth that mesh with the ratchet.

11. The cardiac anchor as claimed in claim 1, characterized in that, The base includes an outer shell and a base fixedly housed within the outer shell. The bearing portion is disposed at the distal end of the base, and the crimping member is rotatably connected to the proximal end of the outer shell. An axial channel is formed on the side wall of the outer shell. The crimping member rotates relative to the base and can drive the crimping portion through the axial channel to move toward the bearing portion.

12. The cardiac anchor as claimed in claim 11, characterized in that, The base includes a body, the support portion extends from the distal end of the body in a direction toward the axial channel, a protrusion is provided on the surface of the body adjacent to the support portion, and a gap is formed between the support portion and the protrusion to accommodate at least a portion of the pressure line portion.

13. The cardiac anchor as claimed in claim 11, characterized in that, The base is also provided with a second wire passage space, which is located on the bearing part at a position protruding from the axial channel.

14. The cardiac anchor as claimed in claim 1, characterized in that, The substrate has an axially extending receiving channel, the proximal end of the anchor is received in the receiving channel, and the engaging end protrudes from the receiving channel and extends distally.

15. The cardiac anchor as claimed in claim 14, characterized in that, The anchoring element includes a helical coil and a connector disposed near the proximal end of the helical coil. The receiving channel extends axially through the base body so that an anchoring actuator can be detachably connected to the connector within the receiving channel.

16. The cardiac anchor as claimed in claim 14, characterized in that, The receiving channel is disposed on the distal side of the substrate, and the proximal side of the substrate is provided with a first engagement portion for removable engagement with an anchoring driver.

17. A cardiac anchoring system, characterized in that, The system includes: Anchor pipe; The cardiac anchor as described in any one of claims 1-16, wherein the cardiac anchor is removably mounted within the anchor conduit; An anchoring actuator, mounted within the anchoring conduit and detachably connected to the base or the anchoring element, the anchoring actuator being used to drive the cardiac anchor to extend from the distal end of the anchoring conduit so that the engagement end engages with the cardiac tissue; and A thread-locking actuator, installed inside the anchor conduit and detachably connected to the pressure member, is used to drive the pressure member to rotate to press the suture.

18. The cardiac anchoring system as claimed in claim 17, characterized in that, The locking wire driver is a flexible traction component.

19. The cardiac anchoring system as claimed in claim 17, characterized in that, The substrate or the anchoring member includes a first engagement portion, and the anchoring driver includes a second engagement portion that is removably engaged with the first engagement portion.

Images