Transcatheter anchor implantation device and transcatheter anchor implantation system

Abstract

The present invention provides a transcatheter anchor implantation device, including a puncture assembly, wherein the puncture assembly includes a hollow puncture needle and a puncture stop seat fixed to the outside of the puncture needle, the distal end of the puncture needle is provided with a puncture surface, the distal end of the puncture stop seat is provided with a stop surface, the stop surface is located at the proximal end of the puncture surface, the anchor is pre-installed at the distal end of the inner cavity of the puncture needle and punctures together with the puncture needle, the stop surface of the puncture stop seat stops at the proximal end of the puncture needle to limit the puncture depth of the puncture needle; not only can the anchor be implanted into the myocardium to a suitable depth, the anchoring force is sufficient to prevent the anchor from falling off, but also the end of the anchor can be prevented from penetrating the myocardium, causing less damage to the human body and reducing surgical risks. The present invention also relates to a transcatheter anchor implantation system.

Description

Technical Field

[0001] The present invention relates to the technical field of cardiac valve interventional treatment instruments, and in particular to a transcatheter anchor implantation device and a transcatheter anchor implantation system. Background Art

[0002] The heart is composed of four chambers: the left atrium, left ventricle, right atrium, and right ventricle. There are valves (atrioventricular valves) between the atria and ventricles. These valves prevent blood from flowing from the atria to the ventricles and not flowing back.

[0003] Heart valve disease is usually treated with medication or surgery, but medication is difficult to effectively eradicate the disease, and surgical treatment requires invasive thoracotomy techniques, general anesthesia, and moderate hypothermia extracorporeal circulation as auxiliary support. The operation is complicated and costly, and the patient is subjected to high trauma, high risk of complications, long hospitalization, and a painful recovery process.

[0004] The existing technology can also treat the lesion through minimally invasive surgery. For example, transcatheter ring reduction surgery is a common minimally invasive procedure for treating mitral valves and tricuspid valves. Specifically, it refers to implanting a number of anchors with spiral tails on the valve ring through a catheter. The anchors are connected by sutures, and finally the sutures are tightened to reduce the size of the mitral valve or tricuspid valve. The existing technology also discloses a transcatheter artificial chord implantation technique, which first implants sutures as artificial chords into the leaflets of the mitral valve or tricuspid valve, and then fixes the ends of the sutures to the papillary muscles or ventricular walls through anchors with spiral tails. The defect of this anchor is that the connection between the spiral anchor and the myocardium is reversible. After implantation, during the long-term beating of the heart, the spiral anchor may naturally reverse and rotate out of the myocardium. There is a risk of the anchor becoming fatigued and falling off, causing irreversible damage to the patient after surgery. In addition, the outer diameter of the spiral anchor determines its contact area with the myocardium. The larger the contact area, the greater the anchoring force. Therefore, in order to enhance the anchoring force, usually only the outer diameter of the anchor can be increased. Increasing the outer diameter of the anchor will increase the outer diameter of the overall delivery system, increasing the difficulty of delivery and increasing damage to the human body.

[0005] The prior art also discloses a self-expanding anchor, but since the puncture depth is not limited at the distal end of the delivery system when puncturing the myocardium, if the puncture depth is insufficient and the anchor is not implanted deep enough into the myocardium, the anchoring force is insufficient and there is a risk of falling off; if the puncture depth is excessive and the myocardial wall becomes thinner during diastole, there is a risk of the anchor end penetrating the myocardium, causing harm to the patient. Summary of the invention

[0006] The technical problem to be solved by the present invention is to provide a transcatheter anchor implantation device to address the defects of the prior art, implant a self-expanding anchor in the heart in a purely interventional manner, and limit the puncture depth of the self-expanding anchor, thereby safely and effectively fixing the suture in the heart through the anchor.

[0007] In order to solve the above technical problems, the present invention provides a transcatheter anchor implantation device, including a puncture assembly, the puncture assembly including a hollow puncture needle and a puncture stop seat fixed to the outside of the puncture needle, the distal end of the puncture needle is provided with a puncture surface, the distal end of the puncture stop seat is provided with a stop surface, the stop surface is located at the proximal end of the puncture surface, the anchor is pre-installed at the distal end of the inner cavity of the puncture needle and punctures together with the puncture needle, and the stop surface of the puncture stop seat stops at the proximal end of the puncture needle to limit the puncture depth of the puncture needle.

[0008] The present invention also provides a transcatheter anchor implantation system, comprising a transcatheter anchor implantation device and a guide device, wherein the transcatheter anchor implantation device is movably installed in the guide device, wherein the guide device comprises an adjustable bend tube and a bend adjustment mechanism arranged at the proximal end of the adjustable bend tube, wherein the puncture assembly extends from the distal end of the adjustable bend tube, wherein the distal end of the adjustable bend tube is provided with at least one adjustable bend segment, and the bend adjustment mechanism adjusts the bend of the adjustable bend segment to adjust the distal position of the transcatheter anchor implantation device.

[0009] The puncture component of the transcatheter anchor implantation device of the transcatheter anchor implantation system provided by the present invention extends from the distal end of the adjustable curved tube, and the adjustable curved section is driven to bend by operating the bending adjusting piece to pull the adjusting wire, so as to drive the puncture component to move to a suitable position, so as to adjust the distal end position of the anchor implantation device to reach the specified position; a stop surface is provided at the distal end of the puncture stop seat, and the puncture needle pierces the myocardium and other tissues. When the stop surface of the puncture stop seat is attached to the myocardium and other tissue parts, the distal end of the puncture needle cannot continue to move deeper into the tissue part. Since the anchor is pre-installed at the distal end of the inner cavity of the puncture needle and punctures together with the puncture needle, the anchor can be implanted into the myocardium at a suitable depth, which not only makes the anchoring force sufficient to prevent the anchor from falling off, but also prevents the end of the anchor from excessively puncturing the myocardium, causing less damage to the human body and reducing the risk of surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] In order to more clearly illustrate the technical solution of the embodiment of the present invention, the drawings required for use in the implementation are briefly introduced below.

[0011] Figure 1 It is a schematic structural diagram of a transcatheter anchor implantation system according to one embodiment of the present invention.

[0012] Figure 2 yes Figure 1 Schematic diagram of the transcatheter anchor implant system.

[0013] Figure 3 yes Figure 2 Schematic diagram of the three-dimensional structure of the transcatheter anchor implantation device.

[0014] Figure 4 yes Figure 3 Schematic diagram of a three-dimensional exploded view of the transcatheter anchor implantation device.

[0015] Figure 5 yes Figure 4 Schematic diagram of the three-dimensional structure of the push rod, guide wire tube, anchor and suture of the transcatheter anchor implantation device.

[0016] Figure 6 yes Figure 5 Schematic diagram of the three-dimensional structure of the puncture needle.

[0017] Figure 7 yes Figure 6 Side view of the puncture needle in the.

[0018] Figure 8 yes Figure 4 Schematic diagram of the three-dimensional structure of the puncture stop seat of the transcatheter anchor implantation device.

[0019] Fig. 9 yes Figure 8 Side view of the puncture stop in FIG.

[0020] Fig.10 yes Fig. 9 Schematic diagram of the end structure of the puncture stop seat.

[0021] Fig.11 yes Figure 5 A cross-sectional view of the push rod in FIG.

[0022] Fig.12 yes Figure 5 Side view of the push rod in FIG.

[0023] Fig.13 yes Fig.12 Magnified view of section XIII.

[0024] Fig.14 yes Figure 4 Side view of the connector of the transcatheter anchor implantation device.

[0025] Fig.15 yes Fig.14 Top view of the connector in the .

[0026] Fig.16 yes Figure 5 Cross-sectional view of the midline guide and suture.

[0027] Fig.17 yes Figure 4 Schematic diagram of the structure of the anchor of the transcatheter anchor implantation device.

[0028] Fig.18 yes Fig.17 A schematic diagram of the structure of the anchor from another perspective.

[0029] Fig.19 yes Fig.17 Schematic diagram of the end structure of the anchor.

[0030] Fig. 20 yes Fig.17 Schematic diagram of the anchoring state of the middle anchor.

[0031] Fig.21 yes Figure 4 Schematic diagram of the structure of the puncture stop seat, puncture needle and anchor assembly.

[0032] Fig. 22 yes Fig.21 Cross-sectional view along line XXII-XXII.

[0033] Fig.23 yes Figure 2 A schematic diagram of the cross-sectional structure of the guide device in FIG.

[0034] Fig.24 It is a schematic structural diagram of another embodiment of the guiding device.

[0035] Fig.25 yes Fig.24 Enlarged cross-sectional view of section XXV.

[0036] Fig.26 It is a structural schematic diagram of another embodiment of the guiding device.

[0037] Fig. 27 yes Fig.26 An enlarged cross-sectional view of part XXVII in FIG.

[0038] Figure 28 to Figure 32 is a schematic diagram of the use process of the transcatheter anchor implantation system of the present invention; wherein, Fig.29 yes Fig.28 Enlarged view of section XXIX; Fig.30 is a schematic diagram of the puncture needle puncture of the transcatheter anchor implantation system; Fig.31 is a schematic diagram of releasing an anchor of a transcatheter anchor implantation system; Fig.32 is a schematic diagram of the overall device for withdrawing the transcatheter anchor implant system.

[0039] Fig.33 It is a schematic diagram of another combination mode of the anchor and the suture of the transcatheter anchor implantation device of the present invention.

[0040] Fig.34 yes Fig.33 Diagram of the usage status of the transcatheter anchor implantation device.

[0041] Fig.35 yes Fig.33 Another usage state diagram of the transcatheter anchor implantation device. DETAILED DESCRIPTION

[0042] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0043] In addition, the following descriptions of the embodiments are made with reference to the attached diagrams to illustrate specific embodiments in which the present invention may be implemented. The directional terms mentioned in the present invention, such as "upper", "lower", "front", "back", "left", "right", "inner", "outer", "side", etc., are only with reference to the directions of the attached diagrams. Therefore, the directional terms used are for better and clearer description and understanding of the present invention, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore cannot be understood as limiting the present invention.

[0044] In order to more clearly describe the structure of the transcatheter suture implantation device and the transcatheter chord implantation system, the limiting terms "proximal end" and "distal end" described in the present invention are conventional terms in the field of interventional medicine. Specifically, the "distal end" refers to the end away from the operator during the surgical operation, and the "proximal end" refers to the end close to the operator during the surgical operation. It should be noted that when an element is referred to as "fixed to" or "disposed on" another element, the element can be directly connected to the other element, or it can be indirectly connected to the other element through one or more connecting elements. When an element is referred to as "connected to" another element, it can be directly connected to the other element, or it can be connected to the other element through one or more connecting elements. Unless otherwise defined, all technical and scientific terms used in the present invention have the same meaning as those generally understood by technicians in the technical field of the present invention. The conventional terms used in the specification of the present invention are only for the purpose of describing specific embodiments and cannot be understood as limitations on the present invention.

[0045] See also Figure 1 and Figure 2The present invention provides a transcatheter anchor implantation system, including a transcatheter anchor implantation device 100 and a guide device 500. The distal end of the transcatheter anchor implantation device 100 is movably installed in the guide device 500. The guide device 500 includes an adjustable curved tube 501 and a bending adjustment mechanism 503 provided at the proximal end of the adjustable curved tube 501. The distal end of the adjustable curved tube 501 is provided with at least one adjustable curved section 504. The bending adjustment mechanism 503 adjusts the bending of the adjustable curved section 504 to adjust the distal position of the transcatheter anchor implantation device 100. The transcatheter anchor implantation device 100 includes a puncture assembly 20. The puncture assembly 20 extends from the distal end of the adjustable curved tube 501. The adjustable curved section 504 is driven to bend by operating the bending adjustment member 505 to pull the adjustment wire 506, so as to drive the puncture assembly 20 to move to a suitable position, so as to adjust the distal end of the transcatheter anchor implantation device 100 to reach a designated position.

[0046] Specifically, the operator inserts the guide device 500 and the distal end of the transcatheter anchor implantation device 100 into the patient's body by intervention, and then adjusts the distal end of the transcatheter anchor implantation device 100 through the guide device 500 outside the patient's body so that the distal end of the transcatheter anchor implantation device 100 reaches a predetermined position, and then implants the anchor in the heart or other tissue parts through the transcatheter anchor implantation device 100. Before the transcatheter anchor implantation device 100 enters the human body or after the anchor is implanted, the operator can connect the transcatheter anchor implantation device 100 with other devices implanted in the human body (such as sutures) as needed, so as to fix the device in the patient's body. In this embodiment, the transcatheter anchor implantation device 100 is used to fix the suture 900 implanted on the heart valve leaflet to the ventricular wall or papillary muscle, so that the suture 900 acts as an artificial tendon to maintain the tension between the valve leaflet and the ventricular wall. The suture 900 is usually a PE suture or an e-PTFE suture.

[0047] like Figure 3 and Figure 5As shown, the puncture assembly 20 includes a hollow puncture needle 30, a puncture stopper 40 fixed to the outside of the puncture needle 30, a conveying assembly 60, an anchor 70 and a handle 80; the distal end of the puncture needle 30 is provided with a puncture surface 34, and the distal end of the puncture stopper 40 is provided with a stopper surface 42, and the stopper surface 42 is located at the proximal end of the puncture surface 34. When the anchor 70 is pre-installed at the distal end of the inner cavity of the puncture needle 30 and punctures together with the puncture needle 30, the stopper surface 42 of the puncture stopper 40 stops at the proximal end of the puncture needle 30 to limit the puncture depth of the puncture needle 30. The conveying assembly 60 includes a hollow push rod 62, a catheter 64 movably sleeved outside the push rod 62, a connector 65 connected between the distal end of the catheter 64 and the proximal end of the puncture needle 30, and a wire tube 67 accommodated in the inner cavity of the push rod 62. When in use, the suture 900 is inserted into the guide tube 67, the distal end of the suture 900 is connected to the heart valve leaflet, and the proximal end passes through the proximal end of the handle 80. The guide tube 67 is inserted into the wire hole on the anchor 70 and passes through the entire transcatheter anchor implantation device 100. When the guide tube 67 is withdrawn, the suture 900 passes through the wire hole on the anchor 600 and forms a connection with the anchor 600.

[0048] like Figure 6 and Figure 7 As shown, the puncture needle 30 includes a hollow puncture tube 32, and a puncture surface 34 is provided at the distal end of the puncture tube 32, and the puncture surface 34 is inclined to the axial extension of the puncture tube 32; preferably, the angle between the puncture surface 34 and the axial direction of the puncture tube 32 is in the range of 60 degrees to 70 degrees. At least one guide groove 35 is symmetrically provided on the distal side wall of the puncture tube 32 along the axial direction to limit the advancing direction of the anchor 70. The guide groove 35 passes through the distal surface of the puncture tube 32, that is, the distal end of the guide groove 35 passes through the puncture surface 34 of the puncture tube 32, and the proximal end of the guide groove 35 does not pass through the proximal end of the puncture tube 32. In this embodiment, the number of guide grooves 35 is two, that is, the puncture needle 30 includes a hollow puncture tube 32 with two guide grooves 35 on the side wall, that is, the distal end of the puncture needle 30 has two branches, each branch has a puncture surface 34 at the end, and the two branches enclose an inner cavity 36, which is used to accommodate the anchor 70. When the anchor 70 is pre-installed at the distal end of the inner cavity 36 of the puncture needle 30, the two puncture surfaces 34 and the distal end 607 of the anchor 70 are located in the same plane, thereby facilitating puncture. The puncture needle 30 is made of a rigid metal material, such as stainless steel SUS304.

[0049] Please also read Figure 3-Figure 4 and Figures 8 to 10The puncture stopper 40 is used to limit the forward direction of the anchor 70 and control the puncture depth of the puncture needle 30. The puncture stopper 40 includes a stopper strip fixedly attached to the outer peripheral surface of the puncture tube 30, and the stopper surface 42 is located at the distal end surface of the stopper strip. The stopper strip includes a proximal end surface 410 fixedly connected to the distal end surface of the connector 65, that is, the proximal end of the puncture stopper 40 is connected to the catheter 64 through the connector 65, so that the movement of the puncture stopper 40 can be controlled by the catheter 64. The inner surface of the proximal end of the stopper strip is fixed to the proximal end of the puncture needle 30, and the distal end of the puncture needle 30 extends from the distal end of the stopper strip, that is, the distal end of the puncture needle 30 extends from the stopper surface 42 of the puncture stopper 40 to the distal end. Therefore, when the stop surface 42 of the puncture stop seat 40 is attached to the myocardium and other tissue sites, the puncture surface 34 at the distal end of the puncture needle 30 cannot continue to move deeper into the tissue site, so that the stop surface 42 is used as a puncture depth limit surface to avoid excessive puncture and damage to the tissue.

[0050] In this embodiment, the puncture needle 30 is used to puncture the myocardial tissue, and the axial distance between the stop surface 42 and the puncture surface 34 of the puncture needle 30 is equal to the puncture depth of the puncture needle 30. The axial distance between the stop surface 42 and the puncture surface 34 ranges from 2mm to 6mm, preferably ranges from 2mm to 3mm, and more preferably ranges from 3mm. In order to ensure the stopping effect of the puncture stop seat 40, the radial dimension L of the stop surface 42 of the puncture stop seat 40 (i.e., the thickness at the farthest end of the stop strip) should be greater than 1mm, and the greater the thickness at the farthest end of the stop strip, the better the stopping effect. However, in order to take into account the overall outer diameter of the implant device, the radial dimension L of the stop surface 42 is preferably 1.5mm. The axial length D of the puncture stop seat 40 ranges from 5mm to 10mm, preferably 7mm, so as to ensure the effective restraint of the self-expanding hook of the anchor 70 and avoid affecting the instrument access.

[0051] In this embodiment, the stopper strip of the puncture stopper 40 includes a first stopper strip 41 and a second stopper strip 43 symmetrically arranged on the outer peripheral surface of the puncture tube 30. The first stopper strip 41 and the second stopper strip 43 are respectively opposite to the two guide grooves 35, and two limit grooves 46 corresponding to the two guide grooves 35 are formed between the first stopper strip 41 and the second stopper strip 43. The distal end surfaces of the first stopper strip 41 and the second stopper strip 43 together constitute the stopper surface 42 of the puncture stopper 40.

[0052] The first stop strip 41 and the second stop strip 43 have the same structure, and both are petal-shaped structures. The following only describes the structure of the first stop strip 41. The thickness of the distal end 41a of the first stop strip 41 is greater than the thickness of the proximal end 41b, and the distal end 41a and the proximal end 41b are smoothly transitioned through the transition section 41c. The radial dimension of the transition section 41c of the first stop strip 41 decreases from the distal end to the proximal end. Each stop strip has a receiving groove 44 axially disposed on the side facing the puncture tube 32. The two receiving grooves 44 enclose an inner cavity 45 for accommodating the puncture needle 30. Specifically, the outer peripheral surface of the puncture tube 32 is fixedly attached to the inner cavity 45. Figure 3 As shown, after the inner cavity 45 of the first stopper strip 41 and the second stopper strip 43 accommodates the puncture needle 30, the first stopper strip 41 and the second stopper strip 43 are not closed, that is, there is a gap between the sides of the first stopper strip 41 and the second stopper strip 43 with the receiving groove 44, so that the side of the puncture stopper 40 has an axial limit groove 46, and the two limit grooves 46 correspond to the two guide grooves 35 on the side of the puncture needle 30. The puncture stopper 40 can be made of metal or polymer material, such as stainless steel SUS304, POM, etc. When assembling the puncture assembly, the puncture needle 30 is assembled in the inner cavity 45 of the puncture stopper 40, and each limit groove 46 coincides with the corresponding guide groove 35, and the puncture stopper 40 is fixedly connected to the puncture needle 30.

[0053] like Figure 3-Figure 4 and Figures 11 to 13 As shown, the distal end of the push rod 62 can be movably inserted into the inner cavity of the puncture needle 30 along the axial direction, and the push rod 62 is installed in the catheter 64. The push rod 62 includes a hollow push rod body 621 and a push rod joint 623 provided at the distal end of the push rod body 621. The proximal end of the push rod body 621 is connected to the handle 80, and the distal end of the push rod body 621 is fixedly connected to the proximal end of the push rod joint 623. The push rod joint 623 is connected to the inside of the push rod 62 to form a cavity 625 extending along the axial direction. The cavity 625 is used to wear the wire tube 67. The distal end of the push rod joint 623 is in contact with the proximal end surface of the anchor 70, but not connected, so that the anchor 70 can be pushed by the push rod 62 to move axially toward the distal end. The push rod body 621 is a rigid tube with a certain flexibility, which can be made of metal material or polymer material, preferably stainless steel. The part near the distal end of the push rod body 621 is laser cut to cut a plurality of S-shaped grooves 626 along the axial direction to increase flexibility, and the length of the cut part ranges from 150 mm to 500 mm, preferably 200 mm, to avoid affecting the pushing performance of the push rod body 621. The push rod joint 623 is a hollow stainless steel sleeve, and the proximal end of the push rod joint 623 is welded or glued to the push rod body 621.

[0054] The catheter 64 is a hollow tube with a certain axial length. The proximal end of the catheter 64 is connected to the handle 80, and the handle 80 is used to control the movement of the catheter 64. The distal end of the catheter 64 is provided with a connector 65, and the connector 65 is used to connect to the puncture stop 40. A traction wire (not shown) is passed through the tube body of the catheter 64, and the proximal end of the traction wire is connected to the control knob on the handle 80 to achieve the bending function of the catheter 64. Specifically, the connector 65 is an annular perforated sleeve, and the material can be metal, such as SUS304, or plastic with a certain rigidity, such as POM, PEEK, etc.

[0055] like Fig.14 and Fig.15 As shown, the proximal end of the connector 65 is connected to the catheter 64 by mechanical connection or bonding, and the inner cavity 650 of the connector 65 is in communication with the inner cavity of the catheter 64 for inserting the push rod 62. The distal end surface of the connector 65 is fixedly connected to the proximal end of the puncture stop seat 40 by welding, mechanical connection or bonding, so that the catheter 64, the connector 65, the puncture needle 30 and the puncture stop seat 40 are fixedly connected to form an integrated structure, and the push rod 62 can move axially relative to the integrated structure.

[0056] Please also read Figure 5 and Fig.16 , the suture 900 is inserted into the inner cavity 670 of the wire tube 67. The wire tube 67 is inserted into the push rod 62, and the outer surface of the wire tube 67 is gap-matched with the inner surface of the push rod 62. After the distal end of the wire tube 67 passes through the distal end of the push rod joint 623, it continues to pass through the proximal surface of the anchor 70 that is in contact with the distal end of the push rod joint 623, and then continues to extend to the distal end of the transcatheter anchor implantation device 100, so as to facilitate the insertion of the suture 900. The proximal end of the wire tube 67 passes through the proximal end of the handle 80, so that the suture 900 can pass through the proximal end of the handle 80. The wire tube 67 is a hollow thin-walled flexible tube, and the material can be a polymer material such as PI, PEEK, PA, or a metal material such as nickel titanium or flexible stainless steel.

[0057] Please also read Figure 3-Figure 5 and Figure 17-Figure 20The anchor 70 includes a wire hanging portion 71, a needle 73 disposed at the distal end of the wire hanging portion 71, and a self-expanding hook 75 disposed between the wire hanging portion 71 and the needle 73. The needle 73 is a solid piece with a taper at the distal end, and the angle between the distal end surface 733 of the needle 73 and the axial direction is in the range of 60 degrees to 70 degrees. When assembling the anchor 70, the distal end of the wire hanging portion 71 passes through the inner cavity of the self-expanding hook 75 and is connected to the needle 73 by laser welding, and then the assembly is fixedly connected to the self-expanding hook 75 by a pin 77. The anchor 70 is pre-installed in the inner cavity 36 of the puncture needle 30. The outer surface of the anchor 70 is in contact with the inner surface of the puncture needle 30 but is not fixedly connected. It is assembled in the inner cavity 36 of the puncture needle 30 only by relying on the self-expanding performance of the self-expanding hook 75. The side wall of the anchor 70 is provided with a wire hole 731, which extends obliquely to the axial direction; the proximal end of the wire hole 731 passes through the proximal end surface of the anchor 70 to communicate with the inner cavity of the push rod 62, and the distal end of the wire hole 731 passes through the outer peripheral surface of the anchor 70 to communicate with the inner cavity 36 of the puncture needle 30. Specifically, the wire hole 731 is provided at the proximal end surface of the anchor 70, and the wire hole 731 is used for the wire tube 67 to pass through, so as to connect the suture 900 with the anchor 70. In this embodiment, the wire hole 731 is provided at the proximal end of the wire hanging portion 71, and the wire hole 731 extends along the axial direction oblique to the anchor 70, and the distal end of the wire hole 731 passes through the outer peripheral surface of the wire hanging portion 71.

[0058] The self-expanding hook 75 has a plurality of branches 752, which are arranged along the circumference of the anchor 70; in this embodiment, the self-expanding hook 75 has four branches 752, which are evenly arranged along the circumference of the anchor 70. When the anchor 70 is pre-installed in the inner cavity 36 of the puncture needle 30, the inner wall of the puncture needle 30 restricts the branches 752 of the self-expanding hook 75 to be in a contracted state, and each branch 752 has an outward radial expansion force to make the branch 752 press against the inner wall of the puncture needle 30, so as to fix the anchor 70 in the inner cavity 36 of the puncture needle 30. Specifically, as Fig.17 and Fig.18 As shown, the anchor 70 is in a restrained state, that is, when the anchor 70 is retracted into the inner cavity 36 of the puncture needle 30, the branch 752 of the self-expanding hook 75 is in a contracted state. At this time, the branch 752 has a tendency to expand radially outward, but is restricted by the inner wall of the puncture needle 30, thereby positioning the anchor 70 in the inner cavity 36 of the puncture needle 30.

[0059] When the push rod 62 pushes the anchor 70 axially to move distally until the branches 752 of the self-expanding hook 75 are free from the inner wall of the puncture needle 30, each branch 752 radiates radially outward to fix the anchor 70 in the tissue. Fig.19 The state of the anchor 70 after being released is shown, and each branch 752 of the self-expanding hook 75 expands outward, thereby fixing the anchor 70 in the human tissue.

[0060] The self-expanding hook 75 includes at least three branches 752, preferably 3 to 6. In the natural state, each branch 752 expands radially outward from the center. The self-expanding hook 75 is made of shape memory material and is processed through a shaping process so that each branch 752 expands radially in the natural state. Specifically, a nickel-titanium tube is first cut by laser, and then the cut nickel-titanium tube is placed in a mold and treated with a 300-650°C heat setting process so that each branch 752 of the self-expanding hook 75 expands radially outward from the center. The length of the self-expanding hook 75 ranges from 2-3mm, preferably 3mm. When it is completely pushed out of the puncture needle, the distance between its distal end and the inner surface of the tissue is 6mm. Except for the self-expanding hook 75, other components of the anchor 70 are made of biocompatible 316L stainless steel and other materials.

[0061] Please also read Figure 3 and Fig. 20 , the side wall of the anchor 70 is provided with a guide member 712, which can be slidably accommodated in the guide groove 35 of the puncture cylinder 32 and the corresponding limit groove 46 of the puncture stop seat 40 to control the axial movement of the anchor 70. Preferably, the side wall of the anchor 70 is provided with a guide member 712 respectively accommodated in the two guide grooves 35 and the corresponding limit groove 46. In this embodiment, the guide member 712 is a protrusion convexly arranged at the proximal end of the anchor 70, and the protrusion is used to limit the forward direction of the anchor 70, so that the anchor 70 can only move toward the distal end along the limit groove 46 of the puncture stop seat 40.

[0062] like Figure 3-Figure 4 and Figure 21-22 As shown, before use, the transcatheter anchor implantation device 100 pre-installs the anchor 70 in the inner cavity 36 of the puncture needle 30, and the anchor 70 is in a contracted state in the inner cavity 36. In the absence of external force, the anchor 70 can be positioned in the inner cavity 36; at this time, the distal surface 733 of the anchor 70 is coplanar with the puncture surface 34 of the puncture needle 30, that is, the puncture surface 34 and the distal surface 733 are both inclined to the axial setting; the guide member 712 can be slidably accommodated in the guide groove 35 and the corresponding limit groove 46 of the puncture needle 30, and the distal surface of the push rod 62 is used to abut the anchor 70 in the inner cavity 36 of the puncture needle 30, that is, the distal surface of the push rod joint 623 abuts against the proximal surface of the anchor 70, thereby limiting the anchor 70 to move only in the axial direction.

[0063] like Figure 1-Figure 3As shown, the handle 80 is fixedly connected to the proximal end of the catheter 64, which is convenient for the operator to grasp. Through its forward and backward movement and rotational movement, the catheter 64 is driven to make corresponding movements, thereby adjusting the position and spatial angle of the device in the heart. The handle 80 is provided with a push knob 82, which is connected to the proximal end of the push rod 62. The push knob 82 controls the push rod 62 to move axially toward the distal end relative to the catheter 64 to drive the anchor 70 to be released from the inner cavity 36 of the puncture needle 30, thereby achieving the implantation of the anchor 70. The handle 80 is also provided with a control knob 84, which is connected to the proximal end of the traction wire of the catheter 64, and can be used to adjust the catheter 64 to more effectively find the spatial position where anchoring is required.

[0064] See also Fig.23 The guide device 500 includes an adjustable curved tube 501 with a certain axial length and a bending adjustment mechanism 503. The distal end of the adjustable curved tube 501 is provided with at least one adjustable curved section 504. The bending adjustment mechanism 503 includes a bending adjustment member 505 provided at the proximal end of the adjustable curved tube 501 and an adjustment wire 506 passing through the adjustable curved tube 501. The distal end of the adjustment wire 506 is connected to the distal end of the adjustable curved section 504. The bending adjustment member 505 pulls the adjustment wire 506 to bend the adjustable curved section 504 to adjust the distal end position of the transcatheter anchor implantation device 100. For ease of operation, a bending adjustment handle 507 is also provided at the proximal end of the adjustable curved tube 501, and the bending adjustment member 505 is arranged on the bending adjustment handle 507.

[0065] At least one adjusting wire channel 5011 is provided in the wall of the adjustable bend tube 501 along its axial direction, and an adjusting wire 506 is inserted in the adjusting wire channel 5011. The distal end of the adjusting wire 506 is connected to the distal end of the adjustable bend section 504, and the proximal end of the adjusting wire 506 is connected to the bending adjusting member 505. By pulling the adjusting wire 506 toward the proximal end through the bending adjusting member 505, the adjustable bend section 504 can bend toward the side of the pulled adjusting wire 506; when the pulling force on the adjusting wire 506 is released, the adjustable bend section 504 automatically resets. Preferably, a plurality of mutually spaced adjustment wire channels 5011 are opened in the tube wall of the adjustable bend tube 501 along its axial direction, and the plurality of adjustment wire channels 5011 are arranged along the circumference of the adjustable bend tube 501. An adjustment wire 506 is inserted into each adjustment wire channel 5011, and an adjustment piece 505 is provided at the proximal end of each adjustment wire 506. By pulling each adjustment wire 506 toward the proximal end through each adjustment piece 505, the adjustable bend section 504 can bend toward the side of the pulled adjustment wire 506, so that the adjustable bend section 504 can bend in different directions to adapt to the requirements of the curved human tubular cavity structure.

[0066] An adjusting ring 508 is embedded in the adjustable curved section 504, and the distal end of the adjusting wire 506 is connected to the adjustable curved section 504 through the adjusting ring 508. The adjusting ring 508 can be made of a metal material or a polymer material. In this embodiment, the adjusting ring 508 is made of 304 stainless steel. The way of connecting the adjusting wire 506 to the adjusting ring 508 includes but is not limited to bonding, welding, hot melting, knotting, etc., which are not limited here.

[0067] The outer cover of the adjusting wire 506 is provided with a wire wrapping tube 5061, and the part of the adjusting wire 506 located in the tube body is movably arranged in the wire wrapping tube 5061. The wire wrapping tube 5061 limits the pulling direction of the adjusting wire 506 and protects the adjusting wire 506. The hardness of the part of the wire wrapping tube 5061 corresponding to the adjustable curved section 504 should be less than the hardness of other parts, that is, the part of the wire wrapping tube 5061 corresponding to the adjustable curved section 504 is flexible, so as not to affect the bending of the adjustable curved section 504. For example, the part of the wire wrapping tube 5061 embedded in the adjustable curved section 504 can be made of a softer PTFE thin tube, while the other parts can be made of a PI thin tube or a stainless steel thin tube.

[0068] like Fig.24 and Fig.25 As shown, in another embodiment of the guide device, the guide device 500a includes a pre-shaped shaping catheter. Specifically, the guide device 500a includes a handle 507a and a shaping tube body 501a, which are rigidly connected. The shaping tube body 501a is formed using a shaping process, and its shape is close to the physiological shape of the heart to be delivered to the position. When it is delivered to the designated position through a blood vessel, the shaping tube body 501a can automatically fit the shape of the heart. The shaping tube body 501a can be a single-layer tube, such as a nickel-titanium tube, a Peek tube, a PE tube, etc., which has a certain rigidity; it can also be a multi-layer tube, such as an inner membrane PTFE, an intermediate metal braided mesh tube, and an outer layer PEBAX tube that is melted into a multi-layer flexible pipe. During shaping, the tube body is first placed in a shaping mold, and then shaped by heat setting or other shaping processes to obtain a shaping tube body 501a close to the physiological shape of the heart.

[0069] like Fig.26 and Fig. 27 As shown, the structure of another embodiment of the guiding device 500b is similar to Fig.26 The structure of the guide device 500 shown in the figure is similar, except that the guide device 500b is a shaped adjustable bending sheath tube, thereby increasing the bending angle of the tube body, reducing the bending force, and making it easier for the distal end of the tube body to reach the designated position.

[0070] The use process of the transcatheter anchor implantation system of this embodiment is described below with reference to the accompanying drawings.

[0071] Taking the mitral valve repair surgery as an example, a suture 900 is first implanted on the leaflet of the mitral valve, and then the transcatheter anchor implantation system of the present invention is used to fix the suture 900 connected to the leaflet to the papillary muscle through the anchor 70. The suture 900 is connected between the leaflet and the papillary muscle as an artificial tendon to pull the leaflet.

[0072] The first step, such as Fig.28 and Fig.29 As shown, the proximal end of the suture 900 is inserted into the guide tube 67 outside the patient's body, and through the bending of the guide device 500 and the bending of the catheter 64, the distal end of the transcatheter anchor implantation system is introduced through the femoral vein-inferior vena cava-atrial septum-mitral valve orifice-papillary muscle approach and reaches the designated position.

[0073] The second step is, Fig.30 , the catheter 64 is pushed to the distal end to drive the puncture stopper 40 and the puncture needle 30 to puncture the papillary muscle. When the puncture reaches a certain depth, the distal surface 204 of the puncture stopper 40 fits to the surface of the papillary muscle, blocking the further puncture of the puncture needle 30, so that the puncture depth can be controlled. At this time, the distal end of the anchor 70 enters the papillary muscle, but the self-expanding hook 75 is still restricted by the inner wall of the puncture needle 30.

[0074] The third step is Fig.31 By pushing the push rod 62 to the distal end through the push knob 82, the anchor 70 is pushed. When the anchor 70 extends from the distal end of the puncture needle 30, the three branches 752 of the self-expanding hook 75 are naturally unfolded and penetrate into the papillary muscle to achieve the anchoring effect.

[0075] The fourth step is Fig.32 , withdraw the entire transcatheter anchor implantation device 100, at which time the anchor 70 remains in the patient's body, connect the suture 900 implanted on the valve leaflet to the papillary muscle, and the suture 900 remains in the patient's body as an artificial chordae, completing the surgical operation.

[0076] See also Fig.33 and Fig.34 In other embodiments, the anchor 70 is not directly connected to the suture 900, but the distal end of the suture 900 is knotted to form a knot 901, and the size of the knot 901 is larger than the size of the thread hole 731 on the anchor 70, to ensure that when the anchor 70 is implanted in the tissue, the knot 901 will not detach from the anchor 70 during the stretching process.

[0077] It is understandable that the transcatheter anchor implantation device 100 of the present invention can also be used to anchor the sutures implanted in the valve ring or other heart tissues. For example, the transcatheter anchor implantation device 100 of the present invention can be used for mitral valve ring reduction surgery. Fig.35As shown, when in use, a plurality of anchors 70 are first connected via sutures 900 or adjustment wires, and then the anchor implantation device 100 of the present invention is inserted through the valve ring in an interventional manner, and a plurality of connected anchors 70 are implanted in the valve ring in sequence, and finally, by pulling the sutures 900, locking the sutures 900 in pairs or all together, the size of the valve ring can be reduced to achieve a therapeutic effect.

[0078] The above is an implementation of the embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the embodiment of the present invention. These improvements and modifications are also considered to be within the scope of protection of the present invention.

Claims

1. A transcatheter anchor implantation device, characterized in that: The invention comprises a puncture assembly, wherein the puncture assembly comprises a hollow puncture needle and a puncture stop seat fixed to the outside of the puncture needle, a puncture surface is provided at the distal end of the puncture needle, the puncture needle comprises a hollow puncture tube, the puncture surface is provided at the distal end of the puncture tube, a stop surface is provided at the distal end of the puncture stop seat, the puncture stop seat comprises a stop strip fixedly attached to the outer peripheral surface of the puncture tube, the stop surface is located at the distal end of the stop strip, the stop surface is located at the proximal end of the puncture surface, an anchor is pre-installed at the distal end of the inner cavity of the puncture needle and punctures together with the puncture needle, the distal end surface of the anchor is coplanar with the puncture surface, and the stop surface of the puncture stop seat stops at the proximal end of the puncture needle to limit the puncture depth of the puncture needle.

2. The transcatheter anchor implantation device according to claim 1, characterized in that: The puncture surface and the distal end surface of the anchor are both arranged obliquely to the axial direction.

3. The transcatheter anchor implantation device according to claim 2, characterized in that: The angles between the puncture surface and the distal end surface of the anchor and the axial direction are both in the range of 60 degrees to 70 degrees.

4. The transcatheter anchor implantation device according to claim 1, characterized in that: The axial distance between the stop surface and the puncture surface is equal to the puncture depth of the puncture needle.

5. The transcatheter anchor implantation device according to claim 2, characterized in that: The axial distance between the stop surface and the puncture surface ranges from 2 mm to 6 mm.

6. The transcatheter anchor implantation device according to claim 1, characterized in that: The distal side wall of the puncture tube is provided with a guide groove along the axial direction, and the guide groove passes through the distal end surface of the puncture tube. The side wall of the anchor is provided with a guide member, and the guide member is slidably accommodated in the guide groove to control the axial movement of the anchor.

7. The transcatheter anchor implantation device according to claim 6, characterized in that: The distal side wall of the puncture tube is provided with two symmetrical guide grooves, and the anchor nail is provided with guide members respectively accommodated in the two guide grooves.

8. The transcatheter anchor implantation device according to claim 7, characterized in that: The stop bar includes a first stop bar and a second stop bar symmetrically arranged on the outer circumferential surface of the puncture tube, the first stop bar and the second stop bar are respectively opposite to the two guide grooves, and two limit grooves corresponding to the two guide grooves are formed between the first stop bar and the second stop bar.

9. The transcatheter anchor implantation device according to claim 6, characterized in that: The side surface of the stop strip facing the puncture tube is provided with a receiving groove along the axial direction, and the outer peripheral surface of the puncture tube is fixedly attached to the receiving groove of the stop strip.

10. The transcatheter anchor implantation device according to claim 6, characterized in that: The radial thickness of the distal end portion of the stop strip is greater than the radial thickness of the proximal end portion.

11. The transcatheter anchor implantation device according to any one of claims 1 to 10, characterized in that: It also includes a conveying assembly, which includes a push rod movably inserted into the inner cavity of the puncture needle along the axial direction, and the distal end surface of the push rod abuts against the anchor pin in the inner cavity of the puncture needle.

12. The transcatheter anchor implantation device according to claim 11, characterized in that: The push rod is hollow, and a wire hole is formed on the side wall of the anchor. The wire hole extends obliquely to the axial direction, the proximal end of the wire hole passes through the proximal end surface of the anchor to connect to the inner cavity of the push rod, and the distal end of the wire hole passes through the outer peripheral surface of the anchor to connect to the puncture needle.

13. The transcatheter anchor implantation device according to claim 12, characterized in that: The anchor also includes a self-expanding hook arranged at the distal end, and the self-expanding hook includes a plurality of branches arranged along the circumference of the anchor. When the anchor is pre-installed in the inner cavity of the puncture needle, the inner wall of the puncture needle limits the branches of the self-expanding hook to be in a contracted state, and each branch has an outward radial expansion force to make the branch press against the inner wall of the puncture needle to fix the anchor in the inner cavity of the puncture needle.

14. The transcatheter anchor implantation device according to claim 13, characterized in that: When the push rod pushes the anchor axially toward the distal end until the branches of the self-expanding hook are separated from the restrictions of the inner wall of the puncture needle, each branch radiates radially outward to fix the anchor in the tissue.

15. The transcatheter anchor implantation device according to claim 12, characterized in that: The conveying assembly also includes a guide wire tube accommodated in the push rod, the guide wire tube is used for threading sutures, and the distal end of the guide wire tube is detachably inserted into the wire-passing hole.

16. The transcatheter anchor implantation device according to claim 11, characterized in that: The conveying assembly also includes a sheath tube sleeved outside the push rod, the proximal end of the puncture needle is fixedly connected to the distal end of the sheath tube, and the push rod can move axially relative to the sheath tube.

17. The transcatheter anchor implantation device according to claim 16, characterized in that: It also includes an operating handle, the push rod and the proximal end of the sheath are connected to the operating handle, the operating handle is provided with a push knob, and the push knob controls the push rod to move axially toward the distal end relative to the sheath to drive the anchor to be released from the inner cavity of the puncture needle.

18. A transcatheter anchor implantation system, characterized in that: It comprises the transcatheter anchor implantation device and the guide device as described in any one of claims 1-17, wherein the transcatheter anchor implantation device is movably installed in the guide device, the guide device comprises an adjustable bend tube and a bend adjustment mechanism arranged at the proximal end of the adjustable bend tube, the puncture assembly extends from the distal end of the adjustable bend tube, the distal end of the adjustable bend tube is provided with at least one adjustable bend section, and the bend adjustment mechanism adjusts the bending of the adjustable bend section to adjust the distal position of the transcatheter anchor implantation device.

19. The transcatheter anchor implantation system according to claim 18, characterized in that: The bending adjustment mechanism includes a bending adjustment piece arranged at the proximal end of the adjustable bending tube and an adjustment wire connected to the bending adjustment piece, the distal end of the adjustment wire is connected to the adjustable bending section, and the bending adjustment piece pulls the adjustment wire to bend the adjustable bending section.

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