CN113040978A

CN113040978A - Transcatheter anchor implantation device and transcatheter anchor implantation system

Info

Publication number: CN113040978A
Application number: CN201911402229.7A
Authority: CN
Inventors: 郭荣辉; 谢琦宗; 张庭超
Original assignee: Hangzhou Valgen Medtech Co Ltd
Current assignee: Hangzhou Valgen Medtech Co Ltd
Priority date: 2019-12-27
Filing date: 2019-12-27
Publication date: 2021-06-29

Abstract

The invention provides a transcatheter anchor implantation device, which comprises a puncture assembly, wherein the puncture assembly comprises a hollow puncture needle and a puncture stop seat fixed outside 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 positioned at the proximal end of the puncture surface, the anchor is preassembled at the distal end of an inner cavity of the puncture needle and punctures along with the puncture needle, and the stop surface of the puncture stop seat is stopped at the proximal end of the puncture needle so as to limit the puncture depth of the puncture needle; the depth of the anchor implanted into the cardiac muscle is appropriate, the anchoring force is sufficient, the anchor is prevented from falling off, the tail end of the anchor can be prevented from penetrating the cardiac muscle, the injury to a human body is small, and the operation risk is reduced. The invention also relates to a transcatheter anchor implantation system.

Description

Transcatheter anchor implantation device and transcatheter anchor implantation system

Technical Field

The invention relates to the technical field of heart valve interventional therapy instruments, in particular to a transcatheter anchor implantation device and a transcatheter anchor implantation system.

Background

The heart is composed of four cavities, namely a left atrium, a left ventricle, a right atrium and a right ventricle, valves (atrioventricular valves) are arranged between the atria and the ventricles, and the valves enable blood to flow into the ventricles from the atria but not to flow backwards.

For heart valve diseases, drug therapy or surgical operation therapy is generally adopted, but the drug therapy is difficult to effectively eliminate the diseases, and the surgical operation therapy needs to adopt an invasive chest opening technology and implement general anesthesia and moderate low-temperature extracorporeal circulation as auxiliary support, so that the operation process is complex, the operation cost is high, the wound degree of a patient is high, the risk of complications is high, the hospitalization time is long, and the recovery process is painful.

The prior art can also treat the lesion position through a minimally invasive surgery, for example, the transcatheter ring-reducing surgery is a common minimally invasive surgery for treating the mitral valve and the tricuspid valve, specifically, a plurality of spaced anchors with spiral tail ends are implanted on the valve ring through a catheter, the anchors are connected through sutures, and finally the sutures are tensioned, so that the size of the valve orifice of the mitral valve or the tricuspid valve is reduced. The prior art also discloses a transcatheter artificial chordae implantation, in which a suture is implanted into the mitral valve or tricuspid valve leaflets as an artificial chordae, and the ends of the suture are fixed to papillary muscles or ventricular walls by anchors having helical ends. The defects of the anchor are that the connection between the spiral anchor and the cardiac muscle is reversible connection, after the implant is implanted, the spiral anchor can naturally reverse and screw out of the cardiac muscle in the long-term beating process of the heart, the anchor has the risk of fatigue and falling, and irreversible damage is caused to a postoperative patient; in addition, the external diameter of the spiral anchor determines the contact area with the cardiac muscle, and the larger the contact area is, the larger the anchoring force is, so in order to enhance the anchoring force, the external diameter of the anchor can be increased generally, but increasing the external diameter of the anchor can increase the external diameter of the whole conveying system, thereby increasing the conveying difficulty and increasing the injury to human bodies.

The prior art also discloses a self-expansion anchor, however, as the self-expansion anchor does not limit the puncture depth at the far end of the delivery system when the self-expansion anchor is punctured into the myocardium, if the puncture depth is insufficient, the depth of the anchor implanted into the myocardium is insufficient, the anchoring force is insufficient, and the risk of falling off exists; if the puncture depth is excessive, the myocardial wall becomes thin during diastole, and the risk of the tail end of the anchor penetrating the myocardial exists, thus causing injury to patients.

Disclosure of Invention

The technical problem to be solved by the present invention is to provide a transcatheter anchor implantation device, which can implant a self-expandable anchor in the heart by a purely interventional method and limit the penetration depth of the self-expandable anchor, thereby safely and effectively fixing a suture in the heart by the anchor.

In order to solve the technical problem, the invention provides a transcatheter anchor implantation device which comprises a puncture assembly, wherein the puncture assembly comprises a hollow puncture needle and a puncture stop seat fixed outside 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 positioned at the proximal end of the puncture surface, the anchor is preassembled at the distal end of an inner cavity of the puncture needle and punctures along with the puncture needle, and the stop surface of the puncture stop seat stops at the proximal end of the puncture needle so as to limit the puncture depth of the puncture needle.

The invention also provides a transcatheter anchor implantation system, which comprises a transcatheter anchor implantation device and a guiding device, wherein the transcatheter anchor implantation device is movably arranged in the guiding device in a penetrating way, the guiding device comprises an adjustable bent pipe and a bending adjusting mechanism arranged at the proximal end of the adjustable bent pipe, the puncture assembly extends out from the distal end of the adjustable bent pipe, the distal end of the adjustable bent pipe is provided with at least one adjustable bending section, and the bending adjusting mechanism adjusts the bending of the adjustable bending section so as to adjust the distal end position of the transcatheter anchor implantation device.

The puncture component of the transcatheter anchor implantation device of the transcatheter anchor implantation system provided by the invention extends out from the far end of the adjustable bent pipe, and the adjustable bent section is driven to be bent by operating the adjustable bent piece to pull the adjusting wire so as to drive the puncture component to move to a proper position, so that the far end position of the anchor implantation device is adjusted to reach a designated position; the distal end that the seat was stopped in the puncture is equipped with the backstop face, the pjncture needle pierces tissues such as cardiac muscle, when the backstop face laminating that the seat was stopped in the puncture to tissues positions such as cardiac muscle, the distal end of pjncture needle just can not continue to the more depths motion of tissues positions, because the anchor is adorned at the inner chamber distal end of pjncture needle and along with pjncture needle together puncture in advance, consequently, it is suitable to enable the depth that the anchor was implanted to cardiac muscle, not only make anchoring force enough, prevent that the anchor from droing, and can also prevent the terminal excessive puncture cardiac muscle of anchor, it is less.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the embodiments will be briefly described below.

Fig. 1 is a schematic structural view of a transcatheter anchor implantation system in accordance with one embodiment of the present invention.

Fig. 2 is an exploded schematic view of the transcatheter anchor implantation system of fig. 1.

Fig. 3 is a perspective view of the transcatheter anchor implantation device of fig. 2.

Fig. 4 is an exploded perspective view of the transcatheter anchor implantation device of fig. 3.

Fig. 5 is a schematic perspective view of the push rod, wire guide, anchor and suture of the transcatheter anchor implantation device of fig. 4.

Fig. 6 is a perspective view of the puncture needle of fig. 5.

Figure 7 is a side view of the needle of figure 6.

Fig. 8 is a perspective view of the puncture stop of the transcatheter anchor implantation device of fig. 4.

Fig. 9 is a side view of the puncture stop of fig. 8.

Fig. 10 is a schematic view of the end structure of the puncture stop of fig. 9.

Fig. 11 is a sectional view of the push rod of fig. 5.

Fig. 12 is a side view of the push rod of fig. 5.

Fig. 13 is an enlarged view of XIII in fig. 12.

Fig. 14 is a side view of the connector of the transcatheter anchor implantation device of fig. 4.

Fig. 15 is a top view of the connector of fig. 14.

Figure 16 is a cross-sectional view of the catheter and suture of figure 5.

Fig. 17 is a schematic view of the configuration of the anchor of the transcatheter anchor implantation device of fig. 4.

FIG. 18 is a schematic view of the anchor of FIG. 17 from another perspective.

Fig. 19 is an end configuration schematic view of the anchor of fig. 17.

Fig. 20 is a schematic view of the anchor of fig. 17 in an anchored state.

Fig. 21 is a schematic view of the combination of the puncture stop, the puncture needle, and the anchor shown in fig. 4.

Fig. 22 is a sectional view taken along line XXII-XXII in fig. 21.

Fig. 23 is a schematic cross-sectional view of the guide device of fig. 2.

Fig. 24 is a schematic structural view of another embodiment of the guide device.

Fig. 25 is a cross-sectional enlarged view of the XXV portion in fig. 24.

Fig. 26 is a schematic structural view of yet another embodiment of the guide device.

Fig. 27 is a cross-sectional enlarged view of the XXVII portion in fig. 26.

Fig. 28-32 are diagrammatic views of a procedure for using the transcatheter anchor implantation system of the present invention; wherein fig. 29 is an enlarged view of the XXIX portion of fig. 28; FIG. 30 is a schematic illustration of a needle penetration of the transcatheter anchor implantation system; FIG. 31 is a schematic view of a release anchor of the transcatheter anchor implantation system; fig. 32 is a schematic view of a retrieval ensemble of a transcatheter anchor implantation system.

Fig. 33 is a diagrammatic view of another anchor to suture combination for a transcatheter anchor implantation device of the present invention.

Fig. 34 is a view of the use of the transcatheter anchor implantation device of fig. 33.

Fig. 35 is another use condition view of the transcatheter anchor implantation device of fig. 33.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without any inventive step, are within the scope of the present invention.

Furthermore, the following description of the various embodiments refers to the accompanying drawings, which illustrate specific embodiments in which the invention may be practiced. Directional phrases used in this disclosure, such as "upper," "lower," "front," "rear," "left," "right," "inner," "outer," "side," and the like, refer only to the direction of the appended figures and, therefore, are used in order to better and more clearly illustrate and understand the present invention and are not intended to indicate or imply that the device or element so referred to must have a particular orientation, be constructed and operated in the particular orientation, and, therefore, should not be taken to be limiting of the present invention.

To more clearly describe the structure of the transcatheter suture implantation device and the transcatheter chordae tendineae implantation system, the terms "proximal" and "distal" are used herein as terms customary in the field of interventional medicine. Specifically, "distal" refers to the end of the surgical procedure that is distal from the operator, and "proximal" refers to the end of the surgical procedure that is proximal to the operator. When an element is referred to as being "fixed" or "disposed" to another element, it can be directly connected to the other element or indirectly connected to the other element through one or more connecting elements. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or be connected to the other element through one or more connecting elements. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

Referring to fig. 1 and 2, the present invention provides a transcatheter anchor implantation system, which includes a transcatheter anchor implantation device 100 and a guiding device 500, wherein the transcatheter anchor implantation device 100 is movably inserted into the guiding device 500 through a distal end thereof, the guiding device 500 includes an adjustable bending tube 501 and a bending adjusting mechanism 503 disposed at a proximal end of the adjustable bending tube 501, the distal end of the adjustable bending tube 501 is provided with at least one adjustable bending section 504, and the bending adjusting mechanism 503 adjusts a bending of the adjustable bending section 504 to adjust a position of the distal end of the transcatheter anchor implantation device 100. The transcatheter anchor implantation device 100 includes a puncture assembly 20, wherein the puncture assembly 20 extends from the distal end of the adjustable bend 501, and wherein the adjustable bend section 504 is bent by operating the adjustable bend 505 to pull the adjustment wire 506, thereby moving the puncture assembly 20 to a desired position to adjust the distal end of the transcatheter anchor implantation device 100 to a desired position.

Specifically, the operator interventionally feeds the guiding device 500 and the distal end of the transcatheter anchor implantation device 100 into the patient, and then adjusts the distal end of the transcatheter anchor implantation device 100 through the guiding device 500 outside the patient to reach the predetermined site at the distal end of the transcatheter anchor implantation device 100, and finally implants the anchor at the tissue site such as the heart through the transcatheter anchor implantation device 100. Prior to entry of the transcatheter anchor implantation device 100 into the body or after the anchor implantation, the operator may attach the transcatheter anchor implantation device 100 to another device (e.g., a suture) implanted within the body as desired to secure the device within the patient. In this embodiment, the transcatheter anchor implantation device 100 is used to secure a suture 900 implanted on a heart leaflet to the ventricular wall or papillary muscle such that the suture 900 acts as an artificial chordae to maintain tension between the leaflet and the ventricular wall. Suture 900 is typically a PE suture or an e-PTFE suture.

As shown in fig. 3 and 5, the puncture assembly 20 includes a hollow puncture needle 30, a puncture stopper 40 fixed to the outside of the puncture needle 30, a delivery assembly 60, an anchor 70, and a handle 80; the puncture needle 30 is provided with a puncture surface 34 at the distal end, the puncture stop 40 is provided with a stop surface 42 at the distal end, the stop surface 42 is located at the proximal end of the puncture surface 34, and when the anchor 70 is preloaded at the distal end of the lumen of the puncture needle 30 and punctures with the puncture needle 30, the stop surface 42 of the puncture stop 40 stops at the proximal end of the puncture needle 30 to limit the puncture depth of the puncture needle 30. The delivery assembly 60 includes a hollow shaft 62, a catheter 64 movably disposed over the shaft 62, a connector 65 coupled between a distal end of the catheter 64 and a proximal end of the needle 30, and a catheter 67 received in the lumen of the shaft 62. In use, suture 900 is threaded through guidewire tube 67, with the distal end of suture 900 attached to the heart valve leaflets and the proximal end passing through the proximal end of handle 80. The guidewire tube 67 is disposed through the wire passing aperture in the anchor 70 and extends through the entire transcatheter anchor implantation device 100, and upon withdrawal of the guidewire tube 67, the suture 900 passes through the wire passing aperture in the anchor 600 to form a connection with the anchor 600.

As shown in fig. 6 and 7, the puncture needle 30 includes a hollow puncture cylinder 32, a puncture surface 34 is provided at a distal end of the puncture cylinder 32, and the puncture surface 34 extends obliquely to an axial direction of the puncture cylinder 32; preferably, the piercing face 34 is at an angle in the range of 60-70 degrees to the axial direction of the piercing cartridge 32. The distal sidewall of penetrating barrel 32 is axially symmetrically formed with at least one guide slot 35 to limit the direction of advancement of anchor 70. Guide slot 35 extends through the distal surface of lancing cartridge 32, i.e., the distal end of guide slot 35 extends through lancing surface 34 of lancing cartridge 32 and the proximal end of guide slot 35 extends through the proximal end of lancing cartridge 32. In this embodiment, the number of the guiding grooves 35 is two, that is, the puncture needle 30 includes a hollow puncture cylinder 32 with two guiding grooves 35 on the side wall, that is, the distal end of the puncture needle 30 has two branches, the end of each branch is provided with a puncture surface 34, the two branches enclose to form an inner cavity 36, the inner cavity 36 is used for accommodating the anchor 70, when the anchor 70 is preloaded 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 on the same plane, thereby facilitating the puncture. The puncture needle 30 is made of a metal material having rigidity, such as stainless SUS 304.

Referring to fig. 3-4 and 8-10, the penetration stop 40 is used to limit the advancing direction of the anchor 70 and control the penetration depth of the needle 30. The puncture stop 40 includes a stop bar fixedly attached to the outer peripheral surface of the puncture barrel 30, and a stop surface 42 is provided on the distal surface of the stop bar. The stop bar comprises a proximal face 410 fixedly connected to the distal face of the connecting element 65, i.e. the proximal end of the puncture stop 40 is connected to the catheter 64 via the connecting element 65, so that the movement of the puncture stop 40 can be controlled by the catheter 64. The proximal inner surface of the stop bar is affixed to the proximal portion of the needle 30 and the distal portion of the needle 30 extends distally from the stop bar, i.e., the distal end of the needle 30 extends distally from the stop surface 42 of the puncture stop 40. Therefore, when the stop surface 42 of the puncture stop 40 is attached to a tissue site such as a cardiac muscle, the puncture surface 34 at the distal end of the puncture needle 30 cannot move further into the tissue site, and the stop surface 42 serves as a puncture depth stop surface to prevent the tissue from being damaged by too deep puncture.

In the present embodiment, the needle 30 is used to pierce myocardial tissue, and the axial distance between the stop surface 42 and the piercing surface 34 of the needle 30 is equal to the piercing depth of the needle 30. The distance between the stop surface 42 and the piercing surface 34 in the axial direction is in the range of 2mm to 6mm, preferably in the range of 2mm to 3mm, more preferably 3 mm. In order to ensure the stopping function 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 of the distal end of the stop strip) should be greater than 1mm, and the larger the thickness of the distal end of the stop strip, the better the stopping effect, but in order to take into account the overall outer diameter dimension of the implant device, the radial dimension L of the stop surface 42 is preferably 1.5 mm. The axial length D of the penetration stop 40 ranges from 5mm to 10mm, preferably 7mm, to ensure effective restraint of the self-expanding hook of anchor 70 and to avoid interfering with instrument access.

In this embodiment, the stop bar of the puncture stop base 40 includes a first stop bar 41 and a second stop bar 43 symmetrically disposed on the outer peripheral surface of the puncture barrel 30, the first stop bar 41 and the second stop bar 43 are respectively opposite to the two guide grooves 35, and two limit grooves 46 respectively corresponding to the two guide grooves 35 are formed between the first stop bar 41 and the second stop bar 43. The distal end surfaces of the first and second stop bars 41, 43 together form a stop surface 42 of the puncture stop 40.

The first stop bar 41 and the second stop bar 43 have the same structure, both of which are petal-shaped structures, and only the structure of the first stop bar 41 is described below, the thickness of the distal end portion 41a of the first stop bar 41 is greater than that of the proximal end portion 41b, and the distal end portion 41a and the proximal end portion 41b are smoothly transited through the transition section 41 c. The transition section 41c of the first stop bar 41 has a radial dimension that decreases from the distal end to the proximal end. Each stop bar is provided with a containing groove 44 along the axial direction facing the side surface of the puncture cylinder 32, the two containing grooves 44 enclose to form an inner cavity 45 for containing the puncture needle 30, and specifically, the outer peripheral surface of the puncture cylinder 32 is fixedly attached to the inner cavity 45. As shown in fig. 3, after the puncture needle 30 is received in the inner cavities 45 of the first and second stop bars 41 and 43, the first and second stop bars 41 and 43 are not closed, that is, a gap is formed between the side surfaces of the first and second stop bars 41 and 43, which are provided with the receiving groove 44, so that the side surface of the puncture stop seat 40 is provided with the axial limit grooves 46, and the two limit grooves 46 correspond to the two guide grooves 35 on the side surface of the puncture needle 30. The puncture stopper 40 may be made of metal or polymer material, such as stainless steel SUS304, POM, etc. When the puncture assembly is assembled, the puncture needle 30 is assembled in the inner cavity 45 of the puncture stop 40, each limit groove 46 is overlapped with the corresponding guide groove 35, and the puncture stop 40 is fixedly connected with the puncture needle 30.

As shown in fig. 3-4 and 11-13, the distal end of the push rod 62 is axially movably inserted into the lumen of the puncture needle 30, and the push rod 62 is inserted into the catheter 64. The plunger 62 includes a hollow plunger body 621 and a plunger connector 623 disposed at a distal end of the plunger body 621. The proximal end of the push rod main body 621 is connected with the handle 80, the distal end of the push rod main body 621 is fixedly connected with the proximal end of the push rod connector 623, the push rod connector 623 is communicated with the inside of the push rod 62 to form a cavity 625 extending along the axial direction, and the cavity 625 is used for threading the conduit 67. The distal end of the push rod connector 623 abuts the proximal surface of the anchor 70, but is not connected so that the anchor 70 can be pushed distally axially by the push rod 62. The main body 621 is a rigid tube with a certain flexibility, and may be made of metal material or polymer material, preferably stainless steel. The proximal portion of the pusher body 621 is laser cut to axially cut a plurality of S-shaped grooves 626 for increased compliance, the length of the cut portion being in the range of 150mm to 500mm, preferably 200mm, to avoid affecting the pushability of the pusher body 621. The push rod connector 623 is a hollow stainless steel sleeve, and the proximal end of the push rod connector 623 is welded or fixed to the push rod main body 621 in a cementing manner.

The catheter 64 is a hollow tube having an axial length, and the proximal end of the catheter 64 is connected to a handle 80, the handle 80 being used to control the movement of the catheter 64. The distal end of the catheter 64 is provided with a connector 65, the connector 65 being adapted to connect to the puncture stop 40. A pull wire (not shown) is inserted into the tube body of the catheter 64, and the proximal end of the pull wire is connected with a control knob on the handle 80 to realize the bending adjustment function of the catheter 64. Specifically, the connecting member 65 is an annular perforated sleeve made of metal, such as SUS304, or plastic with certain rigidity, such as POM, PEEK, or the like.

As shown in Figs. 14 and 15, the proximal end of the connector 65 is connected to the catheter 64 by mechanical connection or gluing, and the lumen 650 of the connector 65 is in communication with the lumen of the catheter 64 for insertion of the push rod 62. The distal end surface of the connecting member 65 is fixedly connected to the proximal end of the puncture stop 40 by welding, mechanical connection, or gluing, so that the catheter 64, the connecting member 65, the puncture needle 30, and the puncture stop 40 are fixedly connected to form an integral structure, and the push rod 62 can move axially relative to the integral structure.

Referring to both fig. 5 and 16, a suture 900 is threaded through the lumen 670 of the guidewire tube 67. The conduit 67 is inserted into the push rod 62, and the outer surface of the conduit 67 is in clearance fit with the inner surface of the push rod 62. The distal end of the wire conduit 67, after exiting the distal end of the pusher connector 623, continues through the proximal face of the anchor 70 engaging the distal end of the pusher connector 623 and then continues out the distal end of the transcatheter anchor implant device 100 to facilitate threading of a suture 900. The proximal end of the guidewire tube 67 exits the proximal end of the handle 80 such that the suture 900 may exit through the proximal end of the handle 80. The conduit 67 is a hollow thin-wall flexible tube, and can be made of polymer materials such as PI, PEEK, and PA, or metal materials such as nickel titanium or flexible stainless steel.

Referring to fig. 3-5 and 17-20, anchor 70 includes a wire-hanging portion 71, a needle 73 disposed at a distal end of wire-hanging portion 71, and a self-expanding hook 75 disposed between wire-hanging portion 71 and needle 73, needle 73 is a solid member having a taper at a distal end, and an angle between a distal end face 733 of needle 73 and an axial direction is in a range of 60 degrees to 70 degrees. When assembling anchor 70, the distal end of the wire hanging portion 71 is connected to the needle 73 through the lumen of the self-expanding hook 75 by laser welding, and then this assembly is fixedly connected to the self-expanding hook 75 by the pin 77. The anchor 70 is preloaded into the lumen 36 of the needle 30, and the outer surface of the anchor 70 is in abutting but loose connection with the inner surface of the needle 30, relying only on the self-expanding nature of the self-expanding hook 75 to fit within the lumen 36 of the needle 30. A thread passing hole 731 is formed in the side wall of the anchor 70, and the thread passing hole 731 extends obliquely to the axial direction; the proximal end of the wire passing hole 731 passes through the proximal end face of the anchor 70 and is communicated with the inner cavity of the push rod 62, and the distal end of the wire passing hole 731 passes through the outer peripheral surface of the anchor 70 and is communicated with the inner cavity 36 of the puncture needle 30. Specifically, a wire passing hole 731 is opened at a proximal end surface of the anchor 70, and the wire passing hole 731 is used for passing the wire guide 67 therethrough, thereby connecting the suture 900 with the anchor 70. In this embodiment, the wire passing hole 731 is opened at a proximal end of the wire hanging portion 71, the wire passing hole 731 extends along an axial direction oblique to the anchor bolt 70, and a distal end of the wire passing hole 731 passes through an outer peripheral surface of the wire hanging portion 71.

Self-expanding hook 75 has a plurality of legs 752, the plurality of legs 752 being spaced apart in a circumferential direction of anchor 70; in this embodiment, the self-expanding hook 75 has four branches 752, and the four branches 752 are uniformly arranged along the circumferential direction of the anchor 70. When the anchor 70 is preloaded into the lumen 36 of the needle 30, the inner wall of the needle 30 constrains the legs 752 of the self-expanding hook 75 in a contracted state, each leg 752 having an outward radial deployment force that urges the leg 752 against the inner wall of the needle 30 to secure the anchor 70 within the lumen 36 of the needle 30. Specifically, as shown in fig. 17 and 18, the anchor 70 is in a captive state, i.e., when the anchor 70 is retracted into the lumen 36 of the needle 30, the limbs 752 of the self-expanding hook 75 are in a collapsed state, wherein the limbs 752 have a tendency to expand radially outward but are restrained by the inner wall of the needle 30, thereby positioning the anchor 70 within the lumen 36 of the needle 30.

When the push rod 62 axially pushes the anchor 70 distally to the point where the limbs 752 of the self-expanding hook 75 disengage from the limits of the inner wall of the needle 30, each limb 752 radially expands outwardly to anchor the anchor 70 in tissue. Specifically, as shown in fig. 19, after the anchor 70 is released, each leg 752 of the self-expanding hook 75 expands outwardly to anchor the anchor 70 in the tissue of the human body.

The self-expanding hook 75 includes at least three branches 752, preferably 3-6. In the natural state, each branch 752 is radially spread from the center to the outside. The self-expanding hook 75 is made of a shape memory material and is treated through a sizing process such that each branch 752 is radially expanded in a natural state. Specifically, a nickel-titanium tube is firstly cut by laser, and then the cut nickel-titanium tube is placed in a mold and is treated by a 300-650 ℃ heat setting process, so that each branch 752 of the self-expansion hook 75 is unfolded outwards in the radial direction from the center. The self-expanding hook 75 has a length in the range of 2-3mm, preferably 3mm, and a distal end thereof is 6mm from the inner surface of the tissue when completely pushed out of the puncture needle. Other components of anchor 70, except for self-expanding hook 75, are made of biocompatible 316L stainless steel.

Referring to fig. 3 and 20, the side wall of the anchor 70 is provided with a guiding element 712, and the guiding element 712 is slidably received in the guiding slot 35 of the penetration barrel 32 and the corresponding limiting slot 46 of the penetration stop 40 to control the axial movement of the anchor 70. Preferably, the side wall of anchor 70 is provided with guiding elements 712 received in two guiding slots 35 and corresponding retaining slots 46, respectively. In this embodiment, guiding element 712 is a protrusion protruding from the proximal end of anchor 70 for limiting the direction of advancement of anchor 70, such that anchor 70 can only move distally along limiting slot 46 of penetration stop 40.

As shown in fig. 3-4 and 21-22, prior to use of the transcatheter anchor implantation device 100, the anchor 70 is preloaded into the lumen 36 of the needle 30, the anchor 70 being in a collapsed configuration within the lumen 36, the anchor 70 being positionable within the lumen 36 in the absence of external forces; at this time, the distal end surface 733 of the anchor 70 is coplanar with the piercing surface 34 of the piercing needle 30, i.e., both the piercing surface 34 and the distal end surface 733 are disposed obliquely to the axial direction; the guide element 712 is slidably received in the guide slot 35 and the corresponding retaining slot 46 of the needle 30, and the distal surface of the push rod 62 is adapted to abut the anchor 70 in the lumen 36 of the needle 30, i.e., the distal surface of the push rod connector 623 abuts the proximal surface of the anchor 70, thereby limiting axial movement of the anchor 70.

As shown in fig. 1-3, the handle 80 is fixedly connected to the proximal end of the catheter 64, so as to facilitate grasping by the operator, and the operator can move the catheter 64 back and forth and rotate the catheter, thereby adjusting the position and spatial angle of the device in the heart. The handle 80 is provided with a push knob 82, the push knob 82 being coupled to the proximal end of the push rod 62, and the push rod 62 being controlled by the push knob 82 to move axially distally relative to the catheter 64 to actuate release of the anchor 70 from the lumen 36 of the needle 30 to effect implantation of the anchor 70. The handle 80 is further provided with a regulating knob 84, and the regulating knob 84 is connected with the proximal end of the traction wire of the catheter 64, so that the catheter 64 can be subjected to bending regulation operation, and the spatial position needing anchoring can be found more effectively.

Referring to fig. 23, the guiding device 500 includes an adjustable bending tube 501 having a certain axial length and a bending adjusting mechanism 503, and the distal end of the adjustable bending tube 501 is provided with at least one adjustable bending section 504. The bending adjusting mechanism 503 comprises a bending adjusting member 505 disposed at the proximal end of the adjustable bent tube 501 and an adjusting wire 506 disposed through the adjustable bent tube 501, the distal end of the adjusting wire 506 is connected to the distal end of the adjustable bending section 504, and the bending adjusting member 505 pulls the adjusting wire 506 to bend the adjustable bending section 504, so as to adjust the distal end position of the transcatheter anchor implantation device 100. For the convenience of operation, the proximal end of the adjustable elbow 501 is further provided with a bending adjusting handle 507, and the bending adjusting member 505 is disposed on the bending adjusting handle 507.

At least one adjusting wire channel 5011 is formed in the pipe wall of the adjustable bent pipe 501 along the axial direction of the pipe wall, an adjusting wire 506 is inserted into the adjusting wire channel 5011, the far end of the adjusting wire 506 is connected to the far end of the adjustable bent section 504, the near end of the adjusting wire 506 is connected to the bending adjusting piece 505, and the adjustable bent section 504 can be bent towards one side of the pulled adjusting wire 506 by pulling the adjusting wire 506 towards the near end through the bending adjusting piece 505; the tension on the adjustment wire 506 is released and the adjustable bend section 504 automatically resets. Preferably, a plurality of adjusting wire channels 5011 are formed in the tube wall of the adjustable bent tube 501 along the axial direction thereof, the plurality of adjusting wire channels 5011 are arranged along the circumferential direction of the adjustable bent tube 501, an adjusting wire 506 is inserted into each adjusting wire channel 5011, a bending adjusting member 505 is respectively disposed at the proximal end of each adjusting wire 506, and the adjustable bending section 504 can be bent towards one side of the pulled adjusting wire 506 by pulling each adjusting wire 506 towards the proximal end through each bending adjusting member 505, so that the adjustable bending section 504 can be bent towards different directions to meet the requirement of the lumen structure of a bent human body.

An adjusting ring 508 is embedded in the adjustable bending section 504, and the distal end of the adjusting wire 506 is connected with the adjustable bending section 504 through the adjusting ring 508. The adjustment ring 508 may be made of a metallic material or a polymeric material. In this embodiment, the adjustment ring 508 is made of 304 stainless steel. The adjusting wire 506 is connected to the adjusting ring 508 by means of, but not limited to, bonding, welding, heat fusing, knotting, etc., and is not limited thereto.

The adjusting wire 506 is sleeved with a wire wrapping tube 5061, the part of the adjusting wire 506 positioned in the tube body is movably arranged in the wire wrapping tube 5061 in a penetrating way, and the wire wrapping tube 5061 limits the traction direction of the adjusting wire 506 and protects the adjusting wire 506. The hardness of the filament-wrapped tube 5061 in the portion corresponding to the adjustable bending section 504 should be less than the hardness of the other portions, i.e., the portion of the filament-wrapped tube 5061 corresponding to the adjustable bending section 504 is flexible so as not to affect the bending of the adjustable bending section 504. For example, the portion of the filament-covered tube 5061 embedded in the adjustable bend section 504 may be a relatively flexible thin tube of PTFE, while the other portion may be a thin tube of PI or stainless steel.

In another embodiment of the guide device, as shown in fig. 24 and 25, the guide device 500a comprises a pre-shaped catheter. Specifically, the guiding device 500a comprises a handle 507a and a shaped tube 501a, rigidly connected therebetween. The shaping tube 501a is shaped by a shaping process, the shape of the shaping tube is close to the physiological shape of the heart to be delivered to the position, and when the shaping tube 501a is delivered to the designated position through a blood vessel, the shaping tube 501a can automatically fit the shape of the heart. The shaping tube 501a may be a single-layer tube, such as a flexible tube with certain rigidity, such as a nickel-titanium tube, a Peek tube, or a PE tube; or a multi-layer pipe, such as inner film PTFE, middle metal braided net pipe and outer layer PEBAX pipe, which are thermally fused into a multi-layer flexible pipe. During shaping, the tube body is placed in a shaping mold, and then is shaped by heat shaping or other shaping processes, so that a shaped tube body 501a similar to the physiological shape of the heart is obtained.

As shown in fig. 26 and 27, the structure of the further embodiment of the guide device 500b is similar to that of the guide device 500 shown in fig. 26, except that: the guiding device 500b is a shaped adjustable bending sheath tube, so that the bending angle of the tube body is increased, the bending strength is reduced, and the distal end of the tube body can reach the designated position more favorably.

The following describes the use of the transcatheter anchor implantation system of the present embodiment with reference to the drawings.

Taking mitral valve repair surgery as an example, firstly, a suture 900 is implanted on a valve leaflet of a mitral valve, then the suture 900 connected with the valve leaflet is fixed on papillary muscles through the anchor 70 by adopting the transcatheter anchor implantation system of the invention, and the suture 900 is connected between the valve leaflet and the papillary muscles to be used as an artificial chordae tendineae to pull the valve leaflet.

First, as shown in fig. 28 and 29, the proximal end of the suture 900 is threaded into the guidewire 67 outside the patient, and the distal end of the transcatheter anchor implantation system is routed through the femoral vein, inferior vena cava, atrial septum, mitral valve orifice, papillary muscles to the desired location by bending the guide device 500 and bending the catheter 64.

In a second step, as shown in FIG. 30, the catheter 64 is pushed distally to drive the puncture stop 40 and the puncture needle 30 to puncture the papillary muscles. When the penetration reaches a certain depth, the distal face 204 of the penetration stop 40 abuts against the surface of the papillary muscle, blocking further penetration of the penetration needle 30, and allowing the penetration depth to be controlled, at which time the distal portion of the anchor 70 enters the papillary muscle, but the self-expanding hook 75 is still restrained by the inner wall of the penetration needle 30.

Thirdly, as shown in fig. 31, the push rod 62 is pushed to the distal end by the push knob 82, so as to push the anchor 70, and after the anchor 70 extends out from the distal end of the puncture needle 30, the three branches 752 of the self-expanding hook 75 naturally expand and pierce into the papillary muscle, thereby achieving the anchoring effect.

Fourth, as shown in fig. 32, the entire transcatheter anchor implantation device 100 is withdrawn, with the anchors 70 remaining in the patient, and the suture 900 implanted on the leaflets is connected to the papillary muscles, leaving the suture 900 as an artificial chordae tendineae in the patient, completing the surgical procedure.

Referring to fig. 33 and 34, in other embodiments, anchor 70 is not directly connected to suture 900, but rather, a distal end of suture 900 is knotted to form knot 901, and the size of knot 901 is larger than the size of hole 731 in anchor 70, so that when anchor 70 is implanted in tissue, knot 901 does not detach from anchor 70 during the pulling process.

It will be appreciated that sutures implanted on the annulus or other tissue of the heart may also be anchored by the transcatheter anchor implantation device 100 of the present invention. For example, the transcatheter anchor implantation device 100 of the present invention may be used in a mitral valve reduction procedure. As shown in fig. 35, when in use, the plurality of anchor bolts 70 are connected through the suture 900 or the adjusting wire, then the anchor bolt implanting device 100 of the present invention is inserted through the valve annulus through an intervention manner, the plurality of connected anchor bolts 70 are sequentially implanted on the valve annulus, and finally the size of the valve annulus can be reduced by pulling the suture 900 and locking the suture 900 two by two or locking all the suture bolts together, thereby realizing the treatment effect.

The foregoing is illustrative of embodiments of the present invention, and it should be noted that modifications and adaptations to those skilled in the art may be made without departing from the principles of the embodiments of the present invention and are intended to be within the scope of the present invention.

Claims

1. The utility model provides a device is implanted through pipe anchor, its characterized in that, includes puncture assembly, puncture assembly includes hollow pjncture needle and is fixed in the outside seat is ended in puncture of pjncture needle, the distal end of pjncture needle is equipped with the puncture face, the distal end of seat is ended in puncture is equipped with the backstop face, the backstop face is located the near-end of puncture face, the anchor pre-installation is in the inner chamber distal end of pjncture needle and along with the together puncture of pjncture needle, the backstop face of seat is ended in the near-end of pjncture needle is stopped in the restriction the depth of puncture of pjncture needle.

2. The transcatheter anchor implantation device of claim 1, wherein when the anchor is preloaded at the distal end of the lumen of the puncture needle, the distal surface of the anchor is coplanar with the puncture surface.

3. The transcatheter anchor implantation device of claim 2, wherein the puncture surface and the distal end surface of the anchor are both disposed obliquely to the axial direction.

4. The transcatheter anchor implantation device of claim 3, wherein the puncture surface and the distal surface of the anchor each have an angle in a range of 60-70 degrees from an axial direction.

5. The transcatheter anchor implantation device of claim 2, wherein an axial distance between the stop surface and the puncture surface is equal to a puncture depth of the puncture needle.

6. The transcatheter anchor implantation device of claim 3, wherein the stop surface is axially spaced from the puncture surface by a distance in a range of 2mm to 6 mm.

7. The transcatheter anchor implantation device of claim 1, wherein the puncture needle comprises a hollow puncture barrel, the puncture surface is disposed at a distal end of the puncture barrel, and the puncture stop seat comprises a stop strip fixedly attached to an outer circumferential surface of the puncture barrel, the stop surface being disposed at a distal end of the stop strip.

8. The transcatheter anchor implantation device of claim 7, wherein a distal sidewall of the penetrating barrel is axially slotted with a guide slot extending through a distal surface of the penetrating barrel, the sidewall of the anchor having a guide member slidably received in the guide slot to control axial movement of the anchor.

9. The transcatheter anchor implantation device of claim 8, wherein the distal sidewall of the penetrating barrel defines two symmetrical guiding slots, the anchor having guiding elements received in the two guiding slots, respectively.

10. The transcatheter anchor implantation device according to claim 9, wherein the stop strip includes a first stop strip and a second stop strip symmetrically disposed on an outer circumferential surface of the penetration barrel, the first stop strip and the second stop strip are respectively opposite to the two guide grooves, and two limit grooves respectively corresponding to the two guide grooves are formed between the first stop strip and the second stop strip.

11. The transcatheter anchor implantation device of claim 8, wherein a side of the stop strip facing the penetrating barrel is axially slotted with a receiving groove, and an outer circumferential surface of the penetrating barrel is fixedly attached to the receiving groove of the stop strip.

12. The transcatheter anchor implantation device of claim 8, wherein a radial thickness of the distal portion of the stop bar is greater than a radial thickness of the proximal portion.

13. The transcatheter anchor implantation device of any one of claims 1-12, further comprising a delivery assembly including a push rod movably axially inserted within the lumen of the puncture needle, a distal surface of the push rod abutting the anchor within the lumen of the puncture needle.

14. The transcatheter anchor implantation device according to claim 13, wherein the push rod is hollow, a thread passing hole is formed in a side wall of the anchor, the thread passing hole extends obliquely to an axial direction, a proximal end of the thread passing hole passes through a proximal end surface of the anchor and is communicated with an inner cavity of the push rod, and a distal end of the thread passing hole passes through an outer peripheral surface of the anchor and is communicated with the puncture needle.

15. The transcatheter anchor implantation device of claim 14, wherein the anchor further comprises a self-expanding hook disposed at the distal end, the self-expanding hook including a plurality of legs circumferentially aligned with the anchor, the inner wall of the puncture needle limiting the legs of the self-expanding hook from a collapsed configuration when the anchor is preloaded in the lumen of the puncture needle, each leg having an outward radial deployment force causing the leg to bear against the inner wall of the puncture needle to secure the anchor within the lumen of the puncture needle.

16. The transcatheter anchor implantation device of claim 15, wherein when the pushrod axially urges the anchor distally to move the limbs of the self-expanding hook out of the confines of the inner wall of the piercing needle, each limb radially expands outwardly to anchor the anchor in tissue.

17. The transcatheter anchor implantation device of claim 14, wherein the delivery assembly further comprises a wire conduit received in the push rod, the wire conduit adapted to receive a suture therethrough, a distal end of the wire conduit being removably insertable into the wire passage hole.

18. The transcatheter anchor implantation device of claim 13, wherein the delivery assembly further includes a sheath disposed over the pushrod, the puncture needle having a proximal end fixedly attached to a distal end of the sheath, the pushrod being axially movable relative to the sheath.

19. The transcatheter anchor implantation device of claim 18, further comprising an operating handle to which the proximal ends of the push rod and the sheath are connected, the operating handle providing a push knob that controls the push rod to move axially distally relative to the sheath to drive the release of the anchor from the lumen of the puncture needle.

20. A transcatheter anchor implantation system comprising the transcatheter anchor implantation device according to any one of claims 1-19 and a guide device, the transcatheter anchor implantation device being movably disposed in the guide device, the guide device comprising an adjustable elbow and a bend adjustment mechanism disposed at a proximal end of the adjustable elbow, the penetration assembly extending from a distal end of the adjustable elbow, the adjustable elbow having at least one adjustable bend segment at a distal end thereof, the bend adjustment mechanism adjusting the bend of the adjustable bend segment to adjust a position of the distal end of the transcatheter anchor implantation device.

21. The transcatheter anchor implantation system of claim 20, wherein the bend adjustment mechanism includes a bend adjustment member disposed at a proximal end of the adjustable elbow and an adjustment wire coupled to the bend adjustment member, a distal end of the adjustment wire coupled to the adjustable bend segment, the bend adjustment member pulling the adjustment wire to bend the adjustable bend segment.