Locking and Anchoring Device and Transcatheter Locking and Anchoring System

Abstract

The present application provides a locking and anchoring device and a transcatheter locking and anchoring system. The locking and anchoring device includes an adjustment assembly, a release assembly, and an anchor. The adjustment assembly includes a catheter and a stop seat protruding from the distal end of the catheter. The stop seat is provided with a wire groove for the suture to pass through. The anchor is accommodated at the distal end of the stop seat, and the distal end of the anchor protrudes from the stop seat. The release assembly passes through the catheter and the stop seat and is detachably connected to the anchor. During the intervention in the heart, the anchor can be retracted into the catheter in the present application, reducing the delivery difficulty and the damage to human tissues. Moreover, the depth of the anchor piercing into the myocardium is limited by the stop seat, reducing the damage to tissues while ensuring the anchoring force.

Description

Technical Field

[0001] This application relates to the technical field of medical devices, and particularly to a knot-locking and anchoring device and a transcatheter knot-locking and anchoring system. Background Art

[0002] The heart consists of four chambers: the left atrium, left ventricle, right atrium, and right ventricle. There are valves (atrioventricular valves) between the atria and ventricles, which allow blood to flow only from the atria into the ventricles and prevent backflow. When the heart valves in the human body are affected by various pathological reasons and cause blood reflux, it is called "mitral regurgitation" or "tricuspid regurgitation". For heart valve diseases such as mitral regurgitation or tricuspid regurgitation, drug treatment or surgical operations are usually adopted. Drug treatment is difficult to effectively eradicate the disease, while surgical treatment requires invasive thoracotomy techniques and general anesthesia and moderate hypothermic cardiopulmonary bypass as auxiliary support. The surgical process is complex, the surgical cost is high, and the patient has a high degree of trauma, a high risk of complications, a long hospital stay, and a painful recovery process.

[0003] The prior art can also treat the diseased location through minimally invasive surgery, such as treating mitral regurgitation and tricuspid regurgitation through transcatheter chordal repair. Specifically, it means implanting a suture on the valve leaf through a catheter and fixing the end of the suture on the papillary muscle or ventricular wall through a spiral anchor to use the suture as an artificial chord to maintain the tension between the valve leaf and the papillary muscle. However, since the connection between the spiral anchor and the myocardium is a reversible connection, after implantation, during the long-term beating of the heart, the spiral anchor may naturally reverse and screw out of the myocardium, posing a risk of anchor detachment and causing irreversible harm to the postoperative patient; 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, and increasing the outer diameter of the anchor will lead to an increase in the outer diameter of the overall delivery system, increasing the delivery difficulty and also increasing the harm to the human body. In addition, since the puncture depth cannot be limited when the anchor penetrates into the myocardium, if the puncture depth is insufficient and the depth of the anchor implanted into the myocardium is not enough, the anchoring force is insufficient and there is a risk of detachment; while if the puncture depth is excessive, the myocardial wall becomes thinner during diastole of the heart, and there is a risk of the end of the anchor penetrating through the myocardium, causing harm to the patient. That is, the current knot-locking and anchoring device is large in size, difficult to operate, and causes great harm to the human body. Summary of the Invention

[0004] The purpose of the present invention is to provide a knot-locking and anchoring device in view of the defects of the above-mentioned prior art. The device has a simple structure and is easy to operate. It can retract the anchor into the catheter, reducing the delivery difficulty and the harm to human tissues; and it can limit the puncture depth of the anchor, reducing myocardial damage while ensuring the anchoring force of the anchor, and the surgical risk is relatively low.

[0005] An embodiment of the present application provides a knot-locking and anchoring device for fixing a suture on a patient's tissue. The knot-locking and anchoring device includes an adjustment assembly, a release assembly, and an anchor. The adjustment assembly includes a catheter and a stop seat protruding from the distal end of the catheter. The stop seat is provided with a wire groove for the suture to pass through. The anchor is accommodated at the distal end of the stop seat, and the distal end of the anchor protrudes from the stop seat. The release assembly passes through the catheter and the stop seat and is detachably connected to the anchor.

[0006] An embodiment of the present application provides a transcatheter knot-locking and anchoring system. The transcatheter knot-locking and anchoring system includes the above-mentioned knot-locking and anchoring device. The transcatheter knot-locking and anchoring system further includes a guiding device, and the catheter is inserted into the guiding device.

[0007] For the knot-locking and anchoring device and the transcatheter knot-locking and anchoring system provided by the embodiment of the present application, the adjustment assembly includes a catheter and a stop seat protruding from the distal end of the catheter. The stop seat is provided with a wire groove for the suture to pass through. The anchor is accommodated at the distal end of the stop seat, and the distal end of the anchor protrudes from the stop seat. The release assembly passes through the catheter and the stop seat and is detachably connected to the anchor, making the overall volume of the knot-locking and anchoring device relatively small. During the intervention in the heart, the anchor can be retracted into the catheter, reducing the delivery difficulty and the harm to human tissue. And by restricting the puncture depth of the anchor with the stop seat, while ensuring the anchoring force of the anchor, myocardial injury is reduced, and the surgical risk is relatively low. Description of the Drawings

[0008] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following will briefly introduce the drawings required for the embodiments. Obviously, the drawings in the following description are only some embodiments of the present application. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0009] Figure 1 It is a schematic diagram of the transcatheter knot-locking and anchoring system provided by the embodiment of the present application;

[0010] Figure 2 It is a schematic diagram of the knot-locking and anchoring device provided by the embodiment of the present application;

[0011] Figure 3 It is a partial cross-sectional view of the knot-locking and anchoring device provided by the embodiment of the present application;

[0012] Figure 4 It is a partial cross-sectional view of the knot-locking and anchoring device provided by the embodiment of the present application;

[0013] Figure 5 It is a partial cross-sectional view of the knot-locking and anchoring device provided by the embodiment of the present application;

[0014] Figure 6 is a perspective view of the seat of the locking and anchoring device provided by an embodiment of the present application;

[0015] Figure 7 is a perspective view of the self-expanding member of the anchor of the locking and anchoring device provided by an embodiment of the present application;

[0016] Figure 8 is a perspective view of the self-expanding member of the anchor of the locking and anchoring device provided by an embodiment of the present application in a natural unfolded state;

[0017] Figure 9 is a cross-sectional view of the anchor of the locking and anchoring device provided by an embodiment of the present application in an expanded state;

[0018] Figure 10 is a partial cross-sectional view of the locking and anchoring device provided by an embodiment of the present application with a suture inserted;

[0019] Figure 11 is a partial cross-sectional view of the locking and anchoring device provided by an embodiment of the present application with a suture inserted;

[0020] Figure 12 is a perspective view of the lower seat of the anchor of the locking and anchoring device provided by an embodiment of the present application;

[0021] Figure 13 is a perspective view of the wire cutter of the anchor of the locking and anchoring device provided by an embodiment of the present application;

[0022] Figure 14 is a perspective view of the lower seat of the anchor of the locking and anchoring device provided by an embodiment of the present application from another angle;

[0023] Figure 15 is a perspective view of the distal ends of the push rod and the offset push rod of the locking and anchoring device provided by an embodiment of the present application;

[0024] Figure 16 and Figure 17 is a schematic diagram of the process of the offset push rod of the locking and anchoring device pushing the wire cutting part to cut the suture;

[0025] Figure 18 is a schematic diagram of the transcatheter locking and anchoring system intervening in the heart provided by an embodiment of the present application;

[0026] Figure 19 is a schematic diagram of the anchor tip of the locking and anchoring device about to pierce the heart provided by an embodiment of the present application;

[0027] Figure 20 is a schematic diagram of the locking and anchoring device provided by an embodiment of the present application with a suture inserted;

[0028] Figure 21Schematic diagram of the locking and anchoring device provided by the embodiment of the present application piercing the heart;

[0029] Figure 22 Cross-sectional view of the locking and anchoring device provided by the embodiment of the present application piercing the heart;

[0030] Figure 23 Schematic diagram of the natural expansion of the anchor of the locking and anchoring device provided by the embodiment of the present application after piercing the heart;

[0031] Figure 24 Schematic diagram of the completion of the implantation of the anchor of the locking and anchoring device provided by the embodiment of the present application;

[0032] Figure 25 and Figure 26 Schematic diagram of the transcatheter locking and anchoring system provided by the embodiment of the present application for mitral annuloplasty. Detailed implementation manners

[0033] In order to more clearly describe the structure of the transcatheter locking and anchoring device and the locking and anchoring system, the defined terms "proximal end" and "distal end" in the present invention are conventional terms in the field of interventional medicine. Specifically, the "distal end" refers to the end far from the operator during the surgical operation, and the "proximal end" refers to the end close to the operator during the surgical operation.

[0034] Please refer to Figure 1 , the transcatheter locking and anchoring system 1000 provided by the present invention includes a locking and anchoring device 900 and a guiding device 100. The locking and anchoring device 900 is partially inserted into the guiding device 100. The locking and anchoring device 900 is used to fix at least one suture X implanted in the patient's body to tissue sites such as papillary muscles, ventricular walls, and valve rings of the heart through an anchor 400. When in use, the distal end of the locking and anchoring device 900 is inserted into the guiding device 100, and the distal end of the locking and anchoring device 900 is provided with an anchor 400; the operator inserts the distal ends of the guiding device 100 and the locking and anchoring device 900 into the patient's body through an interventional method, and then adjusts the distal position of the locking and anchoring device 900 through the guiding device 100 outside the patient's body to make it reach the predetermined treatment site, and then fixes at least one suture to the tissue through the anchor 400 by the locking and anchoring device 900. The locking and anchoring device 900 includes an adjustment assembly 200, a release assembly 300, and an anchor 400. The adjustment assembly 200 includes a catheter 230 and a stop 240 protruding from the distal end of the catheter 230. The anchor 400 is accommodated at the distal end of the stop 240, and the distal end of the anchor 400 extends out of the stop 240. The release assembly 300 passes through the catheter 230 and the stop 240 and is detachably connected to the anchor 400.

[0035] Since the overall volume of the locking anchor device 900 is relatively small, during cardiac intervention, the anchor 400 can be retracted into the catheter, reducing the difficulty of delivery and damage to human tissue; and the puncture depth of the anchor 400 is limited by the stop seat 240, which reduces myocardial damage while ensuring the anchoring force of the anchor 400, and the surgical risk is relatively low.

[0036] See also Figure 2 and Figure 3 The guide device 100 includes a guide handle 110 and a guide tube 120 connected to the guide handle 110. The interior of the guide tube 120 is connected to the interior of the guide handle 110. The distal end portion of the locking anchor device 900 passes through the guide handle 110 and is installed in the guide tube 120. Specifically, the distal ends of the anchor 400 and the adjustment assembly 200 are installed in the guide tube 120 of the guide device 100. The guide tube 120 is an adjustable curved sheath tube or a pre-shaped sheath tube. In this embodiment, an adjustable curved sheath tube is used.

[0037] The distal end of the adjustment component 200 is connected to the anchor 400 to adjust the position and locking state of the anchor 400 in the heart. The adjustment component 200 includes a catheter 230, a stopper 240 protruding from the distal end of the catheter 230, and a handle 220 provided at the proximal end of the catheter 230. The anchor 400 is installed at the distal end of the catheter 230 and driven to a predetermined treatment point by the catheter 230. The catheter 230 is an adjustable bending sheath tube or a pre-shaped sheath tube. In this embodiment, an adjustable bending sheath tube is used, and a traction wire is passed through the tube wall of the adjustable bending sheath tube. The catheter 230 can be bent arbitrarily as needed. The handle 220 facilitates pushing and controlling the rotation of the catheter 230. The handle 220 is provided with an adjustment knob 210 connected to the traction wire, and the adjustment knob 210 is used to adjust the bending state of the distal end tube body of the catheter 230 through the traction wire. The adjustment knob 210 and the handle 220 are preferably made of polymer materials, such as ABS, PC, etc.

[0038] like Figure 3As shown, the stop seat 240 is arranged on the outer surface of the catheter 230 near the distal end, and is used for threading the anchor 400 and restricting the depth of the anchor 400 entering tissues such as myocardium. The proximal end of the stop seat 240 is sleeved and fixed on the distal end of the catheter 230. The stop seat 240 is hollow, and its interior is communicated with the interior of the catheter 230. The distal end of the release assembly 300 is connected to the anchor 400 through the catheter 230 and the stop seat 240. The distal end of the stop seat 240 is circumferentially provided with a boss 241 that expands in a trumpet shape. There is a certain distance between the distal end surface of the boss 241 and the distal end surface of the stop seat 240, and this distance generally determines the depth of the anchor 400 entering the myocardium. Preferably, the range of the distance L between the distal end surface of the boss 241 and the distal end surface of the stop seat 240 is 2-8 mm, so that the puncture depth can neither damage the myocardium nor ensure the anchoring force of the anchor 400. Specifically, the anchor 400 is accommodated at the distal end of the stop seat 240, and the distal end of the anchor 400 extends out of the stop seat 240, that is, the anchor 400 is threaded inside the distal end of the stop seat 240, and the anchor tip 410 of the anchor 400 exposes the stop seat 240. When the anchor tip 410 of the anchor 400 penetrates into the myocardium and the distal end surface of the boss 241 of the stop seat 240 fits against the myocardial surface, the anchor tip 410 cannot move deeper, thus avoiding the risk of the anchor tip 410 piercing too deep into the tissue. The interior of the stop seat 240, the interior of the catheter 230, and the interior of the anchor 400 are communicated with each other to facilitate the suture to pass through the catheter 230, the stop seat 240, and the anchor 400. A wire groove 242 communicating with the interior of the anchor 400 is provided near the boss 241 of the stop seat 240 for the suture to penetrate into the anchor 400 and the catheter 230. The stop seat 240 is preferably made of stainless steel material. The boss 241 of the stop seat 240 has a certain thickness, and the thickness gradually increases from the proximal end to the distal end to enhance the abutting force of the boss 241 against the tissue surface and prevent the anchor 400 from shifting, sliding, or piercing too deep due to insufficient abutting force.

[0039] The release assembly 300 is connected to the proximal end of the adjustment assembly 200 and is connected to the anchor 400 via the adjustment assembly 200 for releasing the anchor 400 onto the heart. The release assembly 300 passes through the catheter 230 and the stop 240 and is detachably connected to the anchor 400. The release assembly 300 includes a lock 310, a knob 320, a push rod 330, and a biasing push rod 340. The push rod 330 is inserted into the adjustment assembly 200. Specifically, the push rod 330 sequentially passes through the handle 220 and the catheter 230. The proximal end of the push rod 330 is fixedly connected to the knob 320, and the distal end of the push rod 330 is fixedly connected to the biasing push rod 340. The biasing push rod 340 is coaxially arranged with the push rod 330. The distal end of the biasing push rod 340 extends to the distal end of the catheter 230 and is detachably connected to the anchor 400, so as to drive the biasing push rod 340 to push the anchor 400 forward through the push rod 330. By rotating the knob 320 relative to the handle 220, the push rod 330 and the biasing push rod 340 can be driven to rotate, and further the biasing push rod 340 can rotate relative to the anchor 400, facilitating the connection or disconnection between the biasing push rod 340 and the anchor 400. When the operator pushes or pulls the knob 320, the knob 320 can also drive the push rod 330 and the biasing push rod 340 to move forward or backward.

[0040] The lock 310 is used to lock or release the fixed connection between the knob 320 and the handle 220. Specifically, the lock 310 includes a lock rod 311 and a lock head 312 fixedly connected to the proximal end of the lock rod 311. The lock rod 311 sequentially passes through the knob 320 and the handle 220. The distal end of the lock rod 311 is inserted into the handle 220, and the proximal end is inserted into the knob 320, thereby synchronously and fixedly connecting the knob 320 and the handle 220. At this time, the synchronous movement of the adjustment assembly 200 and the release assembly 300 can be controlled. The distal end of the lock rod 311 where it is inserted into the handle 220 is offset from the position where the push rod 330 passes through the handle 220, ensuring that the lock rod 311 can lock the knob 320 and the handle 220 in synchronous fixation. When it is necessary to twist and control the rotation or forward and backward sliding of the push rod 330 and the biasing push rod 340, the lock head 312 of the lock 310 is pulled out, and the lock rod 311 is retracted so that the distal end of the lock rod 311 is separated from the handle 220, thereby releasing the fixed connection between the knob 320 and the handle 220. Then, the push rod 330 can be driven by the knob 320 to rotate or slide forward and backward relative to the handle 220 alone.

[0041] See also Figure 15, the push rod 330 can be made of metal materials such as nickel-titanium or stainless steel, or can be made of polymer materials with a certain strength such as PE, etc.; it can be a solid rod or bar, or can be a hollow tube with an inner cavity. The push rod 330 is preferably a tube with a circular cross-section. The offset push rod 340 is preferably made of metal materials such as nickel-titanium or stainless steel. The lock 310 and the knob 320 are preferably made of polymer materials such as ABS, PC, etc. The offset push rod 340 is preferably a flat rod with a rectangular cross-section.

[0042] Please refer to Figure 4 , Figure 5 and Figure 6 , the anchor 400 includes an anchoring portion 401, and the anchoring portion 401 includes an anchor tip 410 with a certain taper, a connecting rod 430 fixedly connected to the proximal end of the anchor tip 410, and a self-expanding member 490 disposed outside the distal end of the connecting rod 430. The proximal end of the connecting rod 430 and the self-expanding member 490 are both inserted into the stop 240, and the inner wall of the stop 240 restricts the radial expansion of the self-expanding member 490. The proximal end of the connecting rod 430 can receive the thrust of the offset push rod 340, so as to drive the self-expanding member 490 to extend out of the stop 240, so that the self-expanding member 490 expands radially and is fixed in the tissue. The connecting rod 430 and the self-expanding member 490 are connected to each other through a fixing pin 420. A wire passing hole 431 is provided in the proximal portion of the connecting rod 430, and the wire passing hole 431 corresponds to the wire groove 242 on the stop 240. The wire passing hole 431 penetrates from the outer wall of the connecting rod 430 to the inner cavity of the connecting rod 430 for accommodating and passing the suture X, that is, the suture X passes through the wire passing hole 431 into the anchor 400 and the catheter 230. The anchor tip 410 is located outside the distal end of the stop 240, that is, the anchor tip is fixed to the distal end of the connecting rod and extends out of the stop. The anchor tip 410 is used to pierce the tissue. When assembled, the proximal shoulder 411 of the anchor tip 410 is attached to the distal end face of the stop 240. At this time, the self-expanding member 490 shrinks into the stop 240 and abuts against the stop 240 of the adjustment assembly 200 by virtue of its self-expansion force. The anchor 400 is pushed into the tissue by the release assembly 300 and the adjustment assembly 200. The lock 310 is used to fix the knob 320 and the handle 220 synchronously, and the push rod 330 and the offset push rod 340 are rotated and pushed, so that the offset push rod 340 drives the self-expanding member 490 of the anchor 400 to extend out of the stop 240. The self-expanding member 490 naturally expands after being implanted into the tissue due to its self-expansion performance. Using the irreversible retraction property of the self-expanding member 490, the anchor 400 is fixed in the tissue, and then the release assembly 300 is separated from the anchor 400 by rotating the push rod 330 and the offset push rod 340, so that the anchor 400 is left alone in the tissue.

[0043] It can be understood that the outer diameter of the catheter 230 of the locking and anchoring device 900 is relatively small. During the transportation process, the proximal end of the anchor 400 can be received into the stop 240, and only the anchor tip 410 of the anchor 400 is outside the distal end of the stop 240. Moreover, the anchor 400, the catheter 230, and the stop 240 are all received in the guiding tube 120. The caliber of the guiding tube 120 is approximately the same as the outer diameter of the stop 240, reducing the transportation resistance of the guiding tube 120 and lowering the transportation difficulty of the anchor 400 and the harm to human tissues.

[0044] As Figure 7 , Figure 8 and Figure 9 shown, the self-expanding member 490 has a fixed end 491 and an expandable end 492 fixedly connected to the fixed end 491. The expandable end 492 includes at least three blades that can be freely bent and unfolded. A plurality of blades are arranged along the circumferential side of the connecting rod 430, and the plurality of blades radially expand outward in the natural state. In this embodiment, there are three blades. When the fixed end 491 is fixed to the distal end of the connecting rod 430 and the self-expanding member 490 is located inside the stop 240, the expandable end 492 fits against the outer peripheral side wall of the distal end of the connecting rod 430 and is located between the inner wall of the stop 240 and the connecting rod 430. When the fixed end 491 gradually extends out of the stop 240 and moves away from the stop 240 along with the distal end of the connecting rod 430 until the expandable end 492 is completely outside the stop 240, the plurality of blades of the expandable end 492 bend and open automatically and are fixed in the tissue. Moreover, the expandable end 492 of the self-expanding member 490 is a barbed structure, and the direction of its tendency to break away from the myocardium is exactly opposite to the direction of the force acting on it in the myocardium. And the force exerted by the myocardium on the expandable end 492 will further enhance its connection reliability with the myocardium, preventing the anchor 400 from retrograde withdrawal from the tissue and avoiding the risk of fatigue shedding. The self-expanding member 490 is made of a shape memory material, preferably made of a metal material with shape memory function, and is placed in a mold for heat setting treatment to obtain Figure 8 the natural state shown, so that it can be anchored in the tissue relying on the natural characteristics of its material after expansion. The shape memory material includes but is not limited to nickel-titanium alloy, cobalt-chromium alloy, etc., and nickel-titanium alloy is preferred.

[0045] Except for the self-expanding member 490, the remaining parts of the anchor 400 are preferably made of metal materials such as stainless steel with good biocompatibility, or other polymer materials with good biocompatibility can also be selected, such as PEEK, etc.

[0046] In order to cut the suture threaded through the anchor 400, the anchor 400 further includes a suture cutting part 402. As Figure 4As shown, the wire cutting part 402 is arranged at the proximal end of the connecting rod 430. The wire cutting part 402 includes a mating upper seat 470 and a lower seat 480, a pressing head 450 movably installed in the upper seat 470 and the lower seat 480, a locking spring 440 elastically abutting against the pressing head 450, and a wire cutter 460. The release assembly 300 is connected to the wire cutting part 402 through a catheter 230, and the release assembly 300 pushes the wire cutter 460 through the catheter 230 to cut the suture between the upper seat 470 and the lower seat 480.

[0047] Specifically, please refer to Figure 4 , Figure 12 , Figure 13 , Figure 14 and Figure 15 , after the upper seat 470 and the lower seat 480 are mated, they are fixedly connected to the proximal end of the connecting rod 430. The proximal end of the lower seat 480 is provided with a jack 471 inserted with the biasing push rod 340 and a narrow groove 472 communicating with the jack 471. The biasing push rod 340 is inserted into the jack 471 of the lower seat 480 and abuts against the outer wall of the narrow groove 472, connecting the release assembly 300 with the anchor 400, so as to push the anchor 400 to move distally. The outer peripheral side wall of the biasing push rod 340 and the inner peripheral side wall of the jack 471 are in clearance fit, so that the biasing push rod 340 can rotate in the jack 471. When the release assembly 300 controls the biasing push rod 340 to rotate and then inserts into the narrow groove 472, the wire cutter 460 can be pushed to move to cut the suture.

[0048] After the upper seat 470 and the lower seat 480 are matched, a cavity 474 is formed at the distal end, and the cavity 474 is used to accommodate the pressure head 450 and the locking spring 440. The wire hole 431 of the connecting rod 430 extends from the inner cavity of the connecting rod 430 to the cavity 474, and the pressure head 450 blocks the wire hole 431 of the connecting rod 430 in the radial direction. After the upper seat 470 and the lower seat 480 are connected, a wire cutting cavity 475 connected to the narrow groove 472 and a threading groove 476 connected to the wire cutting cavity 475 and separated from the insertion hole 471 are formed at the proximal end. The wire cutting cavity 475 is also connected to the cavity 474, so that the suture X can pass through the cavity 474, the threading groove 476 and the wire cutting cavity 475 via the wire hole 431. The thread cutting cavity 475 is used to accommodate the thread cutter 460, and the thread cutter 460 receives the thrust of the distal end of the biasing push rod 340 after passing through the narrow groove 472, so that the thread cutter 460 cuts the suture X passing through the thread cutting cavity 475. Therefore, the suture X can be cut by the catheter while fixing the suture X, avoiding the use of a separate thread cutting device or thread cutting step, saving operation time, and reducing surgical risks. The lower end of the locking spring 440 is fixed on the inner wall of the lower seat 480, and the upper end of the locking spring 440 abuts the lower end of the pressure head 450. Since the locking spring 440 has elastic force, the pressure head 450 can be pushed to the limit position, so that the upper end of the pressure head 450 fits with the inner wall of the upper seat 470, that is, the pressure head 450 pushes the suture X between the inner walls of the upper seat 470 and the lower seat 480 under the elastic force of the locking spring 440. When a suture X passes between the upper end of the pressure head 450 and the inner wall of the upper seat 470, the locking spring 440 presses against the pressure head 450, thereby fixing the suture X; and when the suture X needs to be pulled, the pressure head 450 is subjected to the pressure of the suture, thereby compressing the locking spring 440, and the locking spring 440 can be appropriately compressed and deformed to ensure that the suture X can be pulled. Specifically, one end of the pressure head 450 that presses against the suture X is tapered, which facilitates pulling the suture X and prevents the suture X from being cut, and ensures that when the suture X is pulled, the locking spring 440 can be compressed and deformed backward by the tension of the suture X.

[0049] It should be noted that if Figure 4 , Figure 10 and Figure 11 As shown, since the locking spring 440 abuts against the pressure head 450 in the initial state, the pressure head 450 is attached to the inner wall of the upper seat 470 in the initial state. In order to allow the suture X to pass smoothly from the upper end of the pressure head 450, it is necessary to pre-install a wire tube 01 between the pressure head 450 and the inner wall of the upper seat 470 before the instrument is used. This wire tube 01 is an auxiliary tool and is not an important structural description of the instrument. This wire tube 01 is pre-buried and passes through the wire cutting cavity 475 and the cavity 474. The distal end of the wire tube 01 extends out of the wire hole 431 of the connecting rod 430, and the proximal end extends to the proximal end of the operation. After the suture X passes through the wire tube 01, the wire tube 01 is removed. This wire tube 01 can use a PI tube, PA tube or other flexible polymer material tube that can be bent.

[0050] As Figure 16 shown, this is the initial state of the locking and anchoring device 900. At this time, the distal end face of the biasing push rod 340 is in contact with the proximal end face of the narrow groove 472 of the lower seat 480. The narrow groove 472 is a rectangular groove. The long side of the cross-section of the biasing push rod 340 forms a 90-degree angle with the long side of the narrow groove 472 of the lower seat 480, that is, the biasing push rod 340 intersects the narrow groove 472 at right angles. And the outer surface of the biasing push rod 340 cooperates with the cylindrical cavity at the proximal end of the lower seat 480 to ensure the coaxiality of the biasing push rod 340 and the lower seat 480 when they rotate relative to each other. At this time, the biasing push rod 340 is located outside the narrow groove 472, and the biasing push rod 340 is separated from the wire cutter 460. The wire cutter 460 abuts against the lower seat 480 in the wire cutting cavity 475 to facilitate the suture X to pass through the wire cutting cavity 475 and the cavity 474. The pressing head 450 abuts against the suture X under the elastic force of the locking spring 440, so that the suture X is firmly clamped between the pressing head 450 and the inner wall of the upper seat 470, and the suture X is locked. Since before fixing the suture X, the length and tightness of the suture can be adjusted by pulling the suture X, and then the repair state of the tissue can be adjusted until the suture X is fixed when the symptoms disappear or are the mildest, thereby improving the surgical effect.

[0051] Figure 17 shown, the wire cutter 460 has a blade end 461 and a slope end 462 opposite to the blade end 461. The blade end 461 has a blade that can cut the suture X, and the slope end 462 has an inclined slope 4621 that can receive the thrust of the biasing push rod 340. When the knob 320 is rotated so that the biasing push rod 340 rotates 90 degrees, the distal end of the biasing push rod 340 can pass through the narrow groove 472 on the lower seat 480 and be pushed into the wire cutting cavity 475 to contact and cooperate with the slope 4621 of the wire cutter 460. When the biasing push rod 340 acts on the inclined slope 4621 of the slope end 462, the thrust of the biasing push rod 340 has a force to push the wire cutter 460 to slide against the upper seat 470. By continuously pushing the push rod 330, as the biasing push rod 340 moves forward, it will push the wire cutter 460 to move radially against the inner wall of the upper seat 470, that is, the wire cutter 460 moves towards the suture X.

[0052] When the offset push rod 340 moves to a certain extent (extreme position) distally, that is, when the thread cutter 460 is in contact with the inner cavity surface of the upper seat 470, the blade on the thread cutter 460 is in contact with the suture X and squeezes the suture X between the blade end 461 and the inner cavity of the upper seat 470, and the offset push rod 340 is continuously pushed to apply force to the thread cutter 460, so that the pressure and cutting force applied by the blade end 461 of the thread cutter 460 on the suture X increase, and the squeezing and cutting force of the blade end 461 on the suture X reaches a certain extent, and the suture X will be cut, so that the offset push rod 340 pushes the thread cutter 460 to cut the suture X. Therefore, the anchor 400 and the thread cutter 460 are integrated in the locking anchor device 900 at the same time, and the suture X can be cut while fixing the suture X, avoiding the use of a separate thread cutting device or thread cutting steps, saving operation time, and reducing surgical risks.

[0053] The following describes the use of this embodiment during surgery in conjunction with the accompanying drawings.

[0054] In this embodiment, the suture X connected to the leaflet of the mitral valve is fixed to the papillary muscle by the anchor 400, and the suture X is cut, so that the suture serves as an artificial tendon to maintain the tension between the papillary muscle and the leaflet.

[0055] The first step, such as Figure 18 and Figure 19 As shown, a suture X is implanted in the posterior leaflet of the mitral valve, and the guide device 100 of the transcatheter locking knot anchoring system 1000 is manipulated to adjust the bending angle of the guide tube 120 of the guide device 100 and the catheter 230 of the locking knot anchoring device 900, so that the distal ends of the guide tube 120 and the catheter 230 sequentially reach the vicinity of the papillary muscle via the femoral vein-inferior vena cava-atrial septum-mitral valve orifice-papillary muscle. The free end of the suture X is passed through the auxiliary wire tube 01 and the wire entry groove 242 on the stop seat 240 into the anchor 400.

[0056] The second step is, Figure 20 As shown, the suture X passes through the anchor 400 and the catheter 230, passes out from the proximal end of the handle 220, and the wire tube 01 is removed. The suture X passes through the wire hole 431 of the anchor 400 and passes over the upper end surface of the pressure head 450. At this time, the locking spring 440 locks the suture X due to its own elasticity, and the distal end of the suture X passes through the catheter 230 and the handle 220 and is retained outside the handle 220.

[0057] The third step is Figure 21 and Figure 22 As shown, the papillary muscle is punctured by simultaneously pushing the adjustment component 200 and the release component 300. When the puncture reaches a certain depth, the distal end surface of the boss 241 of the stopper 240 fits with the surface of the papillary muscle, preventing the anchor tip 410 from further puncturing, thereby achieving controllable puncture depth. At this time, the distal end of the anchor 400 enters the papillary muscle.

[0058] The fourth step is Figure 23 As shown, by pushing the knob 320, the anchor 400 is pushed, and the proximal end of the anchor 400 extends out of the stop seat 240, so that the anchor 400 is released from the stop seat 240, and the expandable end 492 of the self-expandable member 490 expands and unfolds to form a barb, thereby achieving an anchoring effect.

[0059] Step 5: Figure 24 As shown, the suture X is pulled to adjust the distance between the valve leaflet and the papillary muscle, and observed by medical imaging equipment such as ultrasound. When the mitral regurgitation is observed to disappear or reach the lightest amount, it means that the ideal treatment effect is achieved. At this time, the locker 310 can be removed from the knob 320, the synchronization state of the knob 320 and the handle 220 is released, and the connection between the adjustment component 200 and the release component 300 is released; then the knob 320 is rotated clockwise or counterclockwise by 90 degrees; then the knob 320 is pushed to the distal end, which drives the push rod 330 and the offset push rod 340 to move to the distal end, and the distal end of the offset push rod 340 passes through the narrow groove 472 on the lower seat 480 and acts on the slope 4621 of the thread cutter 460; as the offset push rod 340 moves forward, the thread cutter 460 moves toward the suture X; when the thread cutter 460 moves to the extreme position, that is, when it fits with the inner cavity surface of the upper seat 470, the suture X is cut, as shown in FIG. Figure 22 As shown, at this time, a suture X of appropriate length can be connected between the posterior leaflet of the mitral valve and the papillary muscle to maintain tension as an artificial tendon to treat or alleviate mitral valve regurgitation, and finally the device is withdrawn to complete the operation.

[0060] The above-mentioned use process is more suitable for treating organic mitral regurgitation caused by chordal rupture and the like by chordal repair. The transcatheter locking knot anchoring system 1000 of the present invention can also be used to treat functional mitral regurgitation. Functional mitral regurgitation is usually repaired by ring reduction surgery. Specifically, Figure 25 As shown, a plurality of spiral nails 02 are implanted on the mitral valve ring through a catheter, and the other end of each spiral nail 02 is sequentially connected by a suture X, and then the free end of the suture X is inserted into the locking knot anchoring system 1000 of the present invention, and then the suture X is tightened and cut in the heart and fixed to the myocardial wall by the anchor 400, so that the ring shrinking effect can be achieved. The state after the ring shrinking is as shown in FIG. Figure 26 shown.

[0061] The embodiments of the present invention are described above in conjunction with the accompanying drawings, but the present invention is not limited to the above-mentioned specific implementation modes, which are merely illustrative rather than restrictive. Under the guidance of the present invention, ordinary technicians in this field can also make many forms without departing from the scope of protection of the present invention and the claims, all of which are within the protection of the present invention.

[0062] In summary, although the present application has been disclosed above with preferred embodiments, the preferred embodiments are not intended to limit the present application. Those of ordinary skill in the art can make various modifications and refinements without departing from the spirit and scope of the present application. Therefore, the protection scope of the present application shall be subject to the scope defined by the claims.

Claims

1. A locking and anchoring device for fixing a suture to a patient's tissue, characterized in that, the locking and anchoring device comprises an adjustment assembly, a release assembly and an anchor. The adjustment assembly includes a catheter and a stop convexly provided at the distal end of the catheter. The stop is provided with a wire inlet groove for the suture to pass through. The anchor is accommodated at the distal end of the stop and the distal end of the anchor protrudes from the stop. The release assembly passes through the catheter and the stop and is detachably connected to the anchor; wherein, a convex platform that flares out in a trumpet shape is provided circumferentially at the distal end of the stop; the anchor is provided with an anchoring portion, the anchoring portion includes a connecting rod, an anchor tip and a self-expanding member. The connecting rod is inserted into the stop. The anchor tip is fixed to the distal end of the connecting rod and protrudes from the stop. The self-expanding member is fixed to the outside of the connecting rod and is made of a shape memory material.

2. The locking and anchoring device according to claim 1, characterized in that, the distance between the distal end face of the convex platform and the distal end face of the stop ranges from 2 mm to 8 mm.

3. The locking and anchoring device according to claim 2, characterized in that, the thickness of the convex platform gradually increases from the proximal end to the distal end.

4. The locking and anchoring device according to claim 1, characterized in that, the self-expanding member is provided with at least three blades arranged on the circumferential side of the connecting rod, and the at least three blades radially expand outwards in a natural state.

5. The locking and anchoring device according to claim 4, characterized in that, the connecting rod is provided with a wire passing hole corresponding to the wire inlet groove, and the suture passes through the wire passing hole into the anchor and the catheter.

6. The locking and anchoring device according to claim 5, characterized in that, the anchor is further provided with a wire cutting portion, the wire cutting portion is arranged at the proximal end of the connecting rod for cutting the suture passing through the anchor, and the release assembly is connected to the wire cutting portion through the catheter.

7. The locking and anchoring device according to claim 6, characterized in that, the wire cutting portion includes an upper seat, a lower seat that mates with the upper seat, and a wire cutter accommodated between the upper seat and the lower seat. After the upper seat and the lower seat are butted, they are fixedly connected to the connecting rod, and the release assembly pushes the wire cutter through the catheter to cut the suture passing between the upper seat and the lower seat.

8. The locking and anchoring device according to claim 7, characterized in that, the wire cutting portion further includes a pressing head movably installed between the upper seat and the lower seat and a locking spring that elastically abuts against the pressing head. The pressing head presses the suture against the inner walls of the upper seat and the lower seat under the elastic action of the locking spring.

9. The locking and anchoring device according to claim 7, characterized in that, the release assembly includes a push rod inserted into the catheter and a biasing push rod fixed to the distal end of the push rod. The biasing push rod pushes the wire cutter to cut the suture.

10. The locking and anchoring device according to claim 9, characterized in that, The lower seat is provided with a socket connected to the offset push rod, and a narrow slot connected to the socket. The offset push rod is inserted into the socket and abuts against the outer wall of the narrow slot to push the anchor to move toward the distal end. The release assembly controls the offset push rod to rotate and then insert it into the narrow slot to push the thread cutter to move to cut the suture.

11. The knot anchoring device according to claim 1, It is characterized in that The adjustment component also includes a traction wire penetrating through the tube wall of the catheter and a handle arranged at the proximal end of the catheter, and the traction wire is pulled to adjust the bending state of the catheter.

12. The knot anchoring device according to claim 11, It is characterized in that The release assembly further includes a locker and a knob, wherein the locker passes through the knob and the handle so that the knob is fixedly connected to the handle.

13. A transcatheter locking knot anchoring system, It is characterized in that The transcatheter knot-locking anchoring system comprises the knot-locking anchoring device according to any one of claims 1 to 12, and the transcatheter knot-locking anchoring system further comprises a guiding device, and the catheter is inserted into the guiding device.

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