Artificial chord tendon implant device

Abstract

The present application provides an artificial chord implantation device, comprising a conveying mechanism, a chord assembly, a clamping assembly, and a puncture assembly. The clamping assembly and the puncture assembly are fixed by a multi-lumen tube of the conveying mechanism. In the chord assembly, the two free ends of the artificial chord after being folded in half are connected to a fastener. The first clamp of the clamping assembly has a first pre-buried groove arranged in a ring shape, and the second clamp has a second pre-buried groove connected to the first pre-buried groove. The fastener is placed in the second pre-buried groove, and the annular portion of the artificial chord after being folded in half is sleeved in the first pre-buried groove. The puncture assembly has a fastener portion. After the puncture assembly passes through the annular portion and the leaflet in sequence, the fastener portion is engaged with the fastener. Then, the puncture assembly is pulled back to pass the fastener through the annular portion to complete the intracardiac knotting of the artificial chord. The artificial chord implantation device provided by the present application can simultaneously complete the intracardiac suturing and knotting of the artificial chord, thereby improving the efficiency of the operation. It also makes the artificial chord more securely fixed on the leaflet, thereby improving the success rate of the operation.

Description

Technical Field

[0001] The present application belongs to the field of medical device technology, and more specifically, relates to an artificial tendon implant device. Background Art

[0002] The mitral valve is a complex structure between the left atrium (LA) and left ventricle (LV), composed of the mitral annulus, anterior and posterior leaflets, chordae tendineae, and papillary muscles. The mitral valve acts as a gatekeeper, ensuring that blood flows only from the left atrium to the left ventricle and not vice versa. Mitral regurgitation is one of the most common heart valve diseases today. The main causes are rheumatic heart disease, myxomatous degeneration of the mitral valve, ischemic heart disease, and cardiomyopathy. These conditions lead to pathology in the annulus, leaflets, chordae tendineae, and papillary muscles of the mitral valve, ultimately preventing the leaflets from fully closing. Among the many factors that cause mitral regurgitation, pathology in the chordae tendineae or papillary muscles is a common cause of incomplete mitral leaflet closure. A healthy mitral valve has multiple chordae tendineae, one end of which connects to the leaflet margins and the other to the papillary muscles located in the ventricular wall. When the left ventricle is in diastole, the anterior and posterior leaflets of the mitral valve open, and the chordae tendineae relax, allowing blood to flow from the left atrium to the left ventricle. During systole, the anterior and posterior leaflets of the mitral valve close under the pressure of blood. However, due to the pull of the chordae tendineae, the leaflets cannot flip to the atrial side due to blood pressure. The combined action of the leaflets and chordae tendineae closes the blood flow path between the LA and LV, forcing blood to flow from the left ventricle through the aortic valve (AV) to the aorta and subsequently to the organs throughout the body. If the chordae tendineae or papillary muscles become diseased or are subjected to external force, causing some of the chordae tendineae to stretch or rupture, during LV contraction, the leaflets lose the pull of the chordae tendineae and flip to the atrial side under the pressure of blood, preventing them from closing tightly together. This results in blood backflow, a condition known as mitral regurgitation. Patients with mitral regurgitation may experience symptoms such as dyspnea during exercise or chest tightness and pain in mild cases, or lower limb edema, gastrointestinal congestion, pain in the liver area, nausea, and vomiting in severe cases. It can be seen that mitral regurgitation caused by elongation or rupture of mitral chordae tendineae has a great impact on human health and requires clinical intervention and treatment.

[0003] Surgery is an effective treatment for mitral regurgitation. With the continuous improvement of medical technology, minimally invasive interventional surgery is now a more preferred option for most heart diseases. The main interventional treatment methods include artificial chordal implantation, mitral annuloplasty, and mitral valve edge-to-edge repair. Among them, implanting artificial chords on the valve leaflets can effectively treat mitral regurgitation caused by chordal rupture and leaflet prolapse, while maintaining the integrity of the mitral valve's physiological structure.

[0004] Existing artificial chordal implantation procedures often involve suturing the artificial chordae to the valve using an artificial chordae implantation device and securing them by knotting. However, some existing artificial chordae implantation devices require tying the knot outside the body before inserting it into the heart, a complex, difficult, and time-consuming procedure. Others simply sew a set of threads through the valve leaflets to create the artificial chordae, without wrapping them around the threads and tying knots. This technique can easily lead to loose and unstable implanted artificial chordae, making them unsatisfactory clinical outcomes. Summary of the Invention

[0005] The purpose of the embodiments of the present application is to provide an artificial chordal implantation device to solve the technical problems in the prior art that the artificial chordal implantation device can only fix the artificial chords to the valve leaflets by tying knots in vitro or suturing without knotting, thereby causing complicated surgical operations and poor implantation effects.

[0006] To achieve the above objectives, the technical solution adopted in this application is to provide an artificial tendon implant device, comprising:

[0007] The delivery mechanism includes a multi-lumen tube having a plurality of axially penetrating lumens therein;

[0008] A tendon cord assembly includes a fastener and an artificial tendon cord, wherein the artificial tendon cord is folded at least twice, both free ends of the artificial tendon cord are connected to the fastener, and the first folded end of the artificial tendon cord is configured as a ring portion;

[0009] The clamping assembly includes a first clamp disposed at the top end of the multi-lumen tube, and a second clamp that can move relative to the first clamp to engage with the first clamp to clamp the leaflet, the first clamp having a first embedded groove, the first embedded groove being annularly arranged around the first clamp, the annular portion being sleeved within the first embedded groove; the second clamp having a second embedded groove, the second embedded groove being connected to the first embedded groove, and the fastener being placed within the second embedded groove;

[0010] a puncture assembly, movably mounted in the multi-lumen tube, the puncture assembly having a buckle portion;

[0011] After the puncture assembly passes through the annular portion and the leaflet in sequence, the buckle portion and the buckle can be buckled together; when the puncture assembly pulls back the buckle to allow the two free ends to pass through the annular portion, the artificial chordae are knotted on the leaflet.

[0012] Optionally, the first chuck further comprises a third embedded groove arranged axially along the multi-lumen tube, the third embedded groove is communicated with the first embedded groove, and the second folded end of the artificial tendon is placed in the third embedded groove.

[0013] Optionally, the tendon assembly further includes an auxiliary tensioning line, which is movably arranged in the first inner cavity of the multi-lumen tube, and the auxiliary tensioning line is connected to the second folded end of the artificial tendon.

[0014] Optionally, the puncture assembly includes a puncture tube and a puncture needle movably installed in the puncture tube, the puncture tube is movably installed in the second inner cavity of the multi-lumen tube, and the puncture tube has the buckle portion.

[0015] Optionally, the clamping assembly further comprises a push rod movably mounted in the third inner cavity of the multi-lumen tube, the first chuck and the second chuck are both mounted on the push rod, and the push rod moves axially in the third inner cavity to drive the second chuck to engage or separate with the first chuck.

[0016] Optionally, the clamping assembly further includes a detection rod movably installed in the fourth inner cavity of the multi-lumen tube, the top end of the detection rod elastically extends out of the mating surface of the first chuck, and the corresponding position of the second chuck has a socket hole matching the detection rod, and the detection rod is plugged into the socket hole to limit the rotation of the detection rod.

[0017] Optionally, the artificial chord implant device further includes an anchor, which is detachably mounted in the clamping assembly. The anchor has a mounting ring, which is passed through the puncture assembly. The anchor is used to anchor the artificial chord to the papillary muscle.

[0018] Optionally, the first clamp further has a receiving cavity, and the anchor is embedded in the receiving cavity.

[0019] Optionally, the artificial chord implant device further includes a manipulation handle and a manipulation component installed in the manipulation handle.

[0020] Optionally, the chord assembly further comprises a gasket, and the gasket is used to fix the two free ends of the artificial chord to the outside of the apex.

[0021] The artificial chord implantation device provided by the present application has the following advantages: compared with the prior art, the artificial chord implantation device of the present application includes a conveying mechanism, a chord assembly, a clamping assembly, and a puncture assembly. The clamping assembly and the puncture assembly are fixed by a multi-lumen tube of the conveying mechanism, and the chord assembly is provided, wherein the artificial chord is folded at least twice, and the first folded end is provided as a ring portion, and the two free ends of the artificial chord are fixed by a fastener; a first pre-embedded groove is provided in an annular shape around the first clamp of the clamping assembly, and a second pre-embedded groove is provided on the second clamp, and the second pre-embedded groove is connected to the first pre-embedded groove, so that the ring portion of the artificial chord can be sleeved into the first pre-embedded groove, and the fastener is placed in the second pre-embedded groove, thereby forming a complete pre-embedded groove channel for pre-embedding the chord assembly; by providing the fastener on the puncture assembly, the puncture assembly can be moved axially along the multi-lumen tube and then sequentially pass through the ring portion and the leaflet, and then engage with the fastener. Then, when the fastener is pulled back by the puncture assembly to allow the two free ends to pass through the ring portion, the artificial chord can be directly knotted inside the internal organs. The artificial chordal implantation device of the present application can simultaneously complete the two-step operation of suturing and knotting the artificial chordae in the heart. On the one hand, it saves the step of knotting in vitro, reduces the difficulty of operation, and shortens the operation time; on the other hand, it makes the fixation of the artificial chordae on the valve leaflet more secure, thereby improving the success rate of the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the following briefly introduces the drawings required for use in the embodiments or descriptions of the prior art. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without any creative work.

[0023] Figure 1 A schematic diagram of the overall structure of the artificial chordal implant device provided in an embodiment of the present application;

[0024] Figure 2 (a) and (b) are respectively a side view and a cross-sectional view along the AA direction of the multi-lumen tube of an embodiment of the present application;

[0025] Figure 3 This is a schematic structural diagram of a tendon cable assembly according to an embodiment of the present application;

[0026] Figure 4 This is a schematic diagram of the first chuck structure of an embodiment of the present application;

[0027] Figure 5 (a) and (b) are schematic diagrams of the second chuck structure at different angles of an embodiment of the present application;

[0028] Figure 6This is a schematic diagram of the assembly of the first chuck and the second chuck in accordance with an embodiment of the present application;

[0029] Figure 7 This is a schematic diagram of the longitudinal cross-sectional structure of the puncture assembly and the tendon chord assembly during valve leaflet suturing according to an embodiment of the present application;

[0030] Figure 8 This is a schematic diagram of the principle of intracardiac knotting of artificial chordae tendineae according to an embodiment of the present application;

[0031] Figure 9 This is a partially enlarged schematic diagram of the puncture assembly according to an embodiment of the present application;

[0032] Figure 10 Figures (a) to (c) are schematic diagrams of the intracardiac knotting process of the artificial chordal implant device according to an embodiment of the present application; (a) shows the device entering the heart; (b) shows the device suturing the artificial chordal tendons in the heart; (c) shows the artificial chordal tendon knotting after being implanted in the heart;

[0033] Figure 11 This is a schematic diagram of the anchor structure of an embodiment of the present application;

[0034] Figure 12 (a) to (d) are schematic diagrams of the process of anchoring the anchor piece of an embodiment of the present application to the papillary muscle; (a) is the extension of the anchor piece; (b) is the anchor piece anchored to the papillary muscle; (c) is the release of the anchor piece and the free end of the artificial chord is pulled out of the body; (d) is the fixation of the free end of the artificial chord to the outside of the apex with a gasket.

[0035] Among them, the reference numerals in the figures are:

[0036] 1. Conveying mechanism; 11. Multi-lumen tube; 111. First inner cavity; 112. Second inner cavity; 113. Third inner cavity; 114. Fourth inner cavity; 2. Tendon assembly; 21. Fastener; 22. Artificial tendon; 221. Free end; 222. Ring portion; 223. Second folded end; 23. Auxiliary tension line; 24. Gasket; 3. Clamping assembly; 31. First chuck; 311. First embedded groove; 312 , third embedded groove; 313, accommodating cavity; 32, second chuck; 321, second embedded groove; 322, accommodating cavity; 33, mating surface; 34, push rod; 35, detection rod; 4, puncture assembly; 41, puncture needle; 42, puncture tube; 421, buckle part; 5, anchoring piece; 51, mounting ring; 52, anchoring end; 6, control handle; 61, housing; 7, control assembly; 8, leaflet; 9, papillary muscle. DETAILED DESCRIPTION

[0037] In order to make the technical problems, technical solutions and beneficial effects to be solved by this application more clearly understood, this application is further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain this application and are not intended to limit this application.

[0038] It should be noted that when an element is referred to as being “fixed on” or “disposed on” another element, it may be directly on the other element or indirectly on the other element. When an element is referred to as being “connected to” another element, it may be directly connected to the other element or indirectly connected to the other element.

[0039] It should be understood that the terms "length", "width", "up", "down", "front", "back", "left", "right", "top", "bottom", "inside", "outside", etc., indicating the orientation or position relationship, are based on the orientation or position relationship shown in the accompanying drawings, and are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on this application.

[0040] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of the technical features being referred to. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. Throughout the description of this application, "plurality" means two or more, unless otherwise specifically defined.

[0041] Please also refer to Figure 1 、 Figure 2 、 Figure 3 as well as Figure 8 , the artificial chord implantation device provided in the embodiment of the present application is now described. The artificial chord implantation device includes a conveying mechanism 1, a chord assembly 2, a clamping assembly 3 and a puncture assembly 4. The conveying mechanism 1 includes a multi-lumen tube 11, and the multi-lumen tube 11 has a plurality of axially penetrating inner cavities. Specifically, the plurality of axially penetrating inner cavities are not arranged in the same axis, and the multi-lumen tube 11 can be a tube with a plurality of axially penetrating inner cavities inside. The multi-lumen tube 11 can also be composed of a large tube and a plurality of small tubes of different axes that are sleeved inside the large tube, and two cover bodies are provided at both ends of the large tube, and the cover bodies are provided with holes that match the plurality of small tubes to position each small tube. Of course, in other embodiments, the multi-lumen tube 11 can also be other similar structures.

[0042] Specifically, see Figure 3The tendon assembly 2 includes a fastener 21 and an artificial tendon 22. The artificial tendon 22 is folded at least twice, and both free ends 221 of the artificial tendon 22 are connected to the fastener 21. The first folded end of the artificial tendon is configured as a ring portion 222. Preferably, the artificial tendon 22 uses commonly used medical sutures. A single complete artificial tendon 22 is folded at least twice, and both free ends 221 after the fold are connected to the fastener 21. Specifically, the artificial tendon 22 and the fastener 21 can be connected together by gluing or pressing. The first folded end is configured as a ring portion 222, which can be in the shape of a circular ring, an elliptical ring, or the like. The end of the fastener 21 connected to the artificial tendon 22 is defined as the tail end, which is provided with a mounting hole or mounting groove. Both free ends 221 of the artificial tendon 22 are inserted into the mounting hole or mounting groove at the tail end of the fastener 21. At this time, the artificial tendon 22 forms a complete circle. The front end of the clip 21 opposite to the tail end has a clip head, the clip head has a protruding hook step, the hook step is used for clipping, and the front end of the clip 21 is an inverted cone with a smooth top. In other embodiments, other shapes of the clip 21 can also be used.

[0043] Specifically, see Figure 4 、 Figure 5 、 Figure 7 The clamping assembly 3 includes a first clamp 31 arranged at the top end of the multi-lumen tube 11 and a second clamp 32 that can move and engage relative to the first clamp 31 to clamp the leaflet 8. The first clamp 31 has a first embedded groove 311, and the first embedded groove 311 is annularly arranged on the first clamp 31. The annular portion 222 of the artificial tendon 22 is sleeved in the first embedded groove 311; the second clamp 32 has a second embedded groove 321, and the second embedded groove 321 is connected to the first embedded groove 311. The fastener 21 is placed in the second embedded groove 321.

[0044] See Figure 6 、 Figure 7The first clamp 31 of the clamping assembly 3 is connected to the top end of the multi-lumen tube 11, wherein the top end of the multi-lumen tube 11 refers to the end of the multi-lumen tube 11 that enters the human heart. The second clamp 32 of the clamping assembly 3 is coaxially arranged with the first clamp 31, and a mating surface 33 is provided between the second clamp 32 and the first clamp 31. The second clamp 32 can move relative to the first clamp 31 to achieve engagement and separation with the first clamp 31. When the artificial chordae tendineae 22 are implanted, the clamping assembly 3 is used to clamp the heart valve leaflets 8. Specifically, when clamping the leaflets 8, the leaflets 8 are located on the mating surface 33 between the first clamp 31 and the second clamp 32. The second clamp 32 approaches the first clamp 31 and then engages, thereby clamping the leaflets 8. The first chuck 31 defines a first embedded groove 311, which is annularly arranged around the first chuck 31, i.e., the first embedded groove 311 is arranged along the circumference of the first chuck 31. Preferably, the first embedded groove 311 is annularly arranged around the end of the first chuck 31 near the meshing surface 33, i.e., the plane of the first embedded groove 311 is parallel to the meshing surface 33. The annular portion 222 of the artificial tendon 22 is sleeved within the first embedded groove 311. The second chuck 32 defines a second embedded groove 321, which is smoothly connected to the first embedded groove 311 in appearance, forming an integral embedded cavity for the artificial tendon 22. The fastener 21 is placed in the second embedded groove 321, and the artificial tendon 22 is embedded in the first embedded groove 311 and the second embedded groove 321, forming a complete closed loop.

[0045] Preferably, the top of the second clamp 32 is ellipsoidal in shape. As the first component of the entire device to contact human heart tissue, the second clamp 32 needs to minimize damage to human tissue. Therefore, the ellipsoidal second clamp 32 has a smooth surface, which can minimize friction between the device and human organs when in contact with human tissue during surgery, thereby preventing damage to human organs. The second embedded groove 321 begins at the end of the meshing surface 33 of the second clamp 32, spans the top of the ellipsoidal second clamp 32, and reaches the other end of the meshing surface 33. The starting and ending points of the second embedded groove 321 are both on the meshing surface 33. The second embedded groove 321 is located at the top of the second clamp 32, so that when the device enters the human heart, the artificial chord 22 located in the second embedded groove 321 receives maximum tension, thereby preventing it from loosening. Of course, in other embodiments, the second embedded groove 321 can also be provided at other locations of the second clamp 32 to ensure that it is in smooth external communication with the first embedded groove 311, and to ensure that the fastener 21 located in the second embedded groove 321 can be fastened to the fastener portion 421 of the puncture assembly 4 after the puncture assembly 4 punctures the leaflet 8. Preferably, the fastener 21 of the tendon assembly 2 is placed at the starting end of the second embedded groove 321. To facilitate the placement of the fastener 21, a receiving cavity 322 can be provided at the starting end of the second embedded groove 321, and the fastener 21 is placed in the receiving cavity 322.

[0046] Preferably, the engaging surface 33 between the first clamp 31 and the second clamp 32 has corrugated steps, or concave-convex steps of other shapes, so as to increase the clamping area when clamping the leaflet 8 and increase the friction between the engaging surface 33 and the leaflet 8, thereby making the clamping more stable and not easy to loosen.

[0047] Preferably, the meshing surface 33 between the first clamp 31 and the second clamp 32 is an inclined surface, that is, a certain angle is formed between the normal of the meshing surface 33 and the axis of the multi-lumen tube 11. Through experimental comparison, it has been found that an angle that is too small or too large is not conducive to firmly clamping the leaflets 8. Therefore, an angle of 30 to 60 degrees is generally suitable. Correspondingly, the plane in which the first embedded groove 311 is located is also an inclined surface, so that the artificial chord 22 can be easily disengaged from the first embedded groove 311 during traction and knotting.

[0048] Specifically, see Figure 2 、 Figure 7 、 Figure 9The puncture assembly 4 is movably installed in the multi-lumen tube 11. The puncture assembly 4 has a snap portion 421. After the puncture assembly 4 passes through the annular portion 222 and the leaflet 8 in sequence, the snap portion 421 can be snapped with the snap member 21. When the puncture assembly 4 pulls back the snap member 21 to allow the two free ends 221 to pass through the annular portion 222, the artificial chord 22 is knotted on the leaflet 8. Specifically, the puncture assembly 4 can move axially in the multi-lumen tube 11. When suturing the artificial chord 22 and the leaflet 8, the puncture assembly 4 moves axially and passes through the plane of the first embedded groove 311 of the first clamp 31, that is, after passing through the artificial chord 22 annularly sleeved on the first embedded groove 311, the snap portion 421 of the puncture assembly 4 is snapped with the snap member 21 of the chord assembly 2, thereby connecting the puncture assembly 4, the snap member 21 and the artificial chord 22 into one body. Then pull back the puncture assembly 4, the buckle portion 421 pulls the buckle 21 through the annular portion 222 on the first embedded groove 311, and continue to pull back the puncture assembly 4 to complete the knotting of the artificial chordae 22 on the leaflet 8.

[0049] Compared with the prior art, the artificial tendon implantation device provided by the present application includes a conveying mechanism 1, a tendon assembly 2, a clamping assembly 3 and a puncture assembly 4. The clamping assembly 3 and the puncture assembly 4 are fixed by the multi-lumen tube 11 of the conveying mechanism 1, and the tendon assembly 2 is provided, wherein the artificial tendon 22 is folded in half at least twice, and the first folded end is provided as a ring portion 222, and the two free ends 221 of the artificial tendon 22 are both connected to the fastener 21; a first pre-buried groove 311 is provided on the first clamp 31 in a ring shape around the first clamp 31, a second pre-buried groove 321 is provided on the second clamp 32, and the second pre-buried groove 321 is provided on the second clamp 32. The embedded groove 321 is connected to the first embedded groove 311, and the annular portion 222 of the artificial tendon 22 can be sleeved in the first embedded groove 311, and the fastener 21 is placed in the second embedded groove 321, thereby forming a complete embedded groove cavity for the embedded tendon assembly 2; by arranging the fastener portion 421 on the puncture assembly 4, the puncture assembly 4 can be moved axially along the multi-lumen tube 11 and pass through the annular portion 222 and the leaflet 8 in turn, and then the fastener 21 is pulled back by the puncture assembly 4 to allow the two free ends 221 to pass through the annular portion 222, and the artificial tendon 22 can be directly knotted inside the internal organs. The artificial tendon implantation device of the present application can simultaneously complete the two-step operation of suturing and knotting the artificial tendon 22 in the heart. On the one hand, it saves the step of knotting in vitro, reduces the difficulty of operation, and reduces the operation time; on the other hand, it makes the fixation of the artificial tendon 22 on the valve more secure, and improves the success rate of the operation.

[0050] In another embodiment of this application, please refer to Figure 4The first chuck 31 further includes a third embedded groove 312 axially arranged along the multi-lumen tube 11 . The third embedded groove 312 is connected to the first embedded groove 311 . The second folded end 223 of the artificial tendon 22 is placed in the third embedded groove 312 .

[0051] Specifically, in this embodiment, during the artificial chord 22 implantation procedure, the multi-lumen tube 11 of the artificial chord implantation device enters the heart through a small incision at the apex of the heart. There is a certain distance between the small incision and the valve leaflets 8 where the artificial chords 22 are to be implanted. Therefore, the artificial chords 22 are typically implanted using longer medical sutures. In this embodiment, the folded length of the artificial chord 22 is still greater than the distance between the small incision and the valve leaflets 8. Therefore, when the artificial chord 22 is sutured to the valve leaflets 8, the middle length of the artificial chord 22 is received by the third pre-buried groove 312 on the first clamp 31. The third pre-buried groove 312 is defined on the surface of the first clamp 31 and is arranged axially along the multi-lumen tube 11. The third pre-buried groove 312 is connected to the first pre-buried groove 311. After the artificial chord 22 is inserted into the first pre-embedded groove 311, the excess portion is doubled in half, forming the second folded end 223. The second folded end 223 contains four artificial chords 22, which are then placed in the third pre-embedded groove 312. At this point, the first, second, and third pre-embedded grooves 311, 321, and 312 are seamlessly connected, forming a single artificial chord 22 pre-embedded groove. In this state, a single artificial chord 22 is pre-embedded in the annular first pre-embedded groove 311, two artificial chords 22 are pre-embedded in the second pre-embedded groove 321, and four artificial chords 22 are pre-embedded in the third pre-embedded groove 312. When the artificial chord implant device is inserted into the heart, all artificial chords 22 are located in the pre-embedded grooves, making the surface of the multi-lumen tube 11 smooth, reducing friction between the device and the human organ and preventing damage to the organ.

[0052] In another embodiment of this application, please refer to Figure 8 The tendon assembly 2 also includes an auxiliary tensioning line 23, which is movably arranged in the first inner cavity 111 of the multi-lumen tube 11 and is connected to the second folded end 223 of the artificial tendon 22.

[0053] Specifically, to prevent the artificial chords 22 from loosening in the first, second, and third pre-buried grooves 311, 321, and 312, which could lead to surgical failure due to inability to tie a knot, an auxiliary tensioning wire 23 is provided within the first lumen 111 of the multi-lumen tube 11 for tightening the artificial chords 22. One end of the auxiliary tensioning wire 23 is fixed to the rear end (opposite the top end) of the multi-lumen tube 11, and the other end is detachably connected to the second folded end 223 of the artificial chord 22. By adjusting the length of the auxiliary tensioning wire 23, the tension of the artificial chords 22 in the pre-buried grooves can be adjusted, ultimately ensuring that the artificial chords 22 adhere tightly to each pre-buried groove and do not loosen.

[0054] In another embodiment of this application, please refer to Figure 8 、 Figure 9 The puncture assembly 4 includes a puncture tube 42 and a puncture needle 41 movably mounted in the puncture tube 42 . The puncture tube 42 is movably mounted in the second inner cavity 112 of the multi-lumen tube 11 . The puncture tube 42 has a buckle portion 421 .

[0055] Specifically, see Figure 2 In this embodiment, the puncture assembly 4 includes a puncture tube 42 and a puncture needle 41. The puncture tube 42 is movably mounted in the second lumen 112 of the multi-lumen tube 11, and the puncture needle 41 is movably mounted in the puncture tube 42. The puncture tube 42 can move axially in the second lumen 112, and the puncture needle 41 can move axially in the puncture tube 42. The top end of the puncture tube 42 has a snap-on portion 421 that can be snapped into the snap member 21. Specifically, the top end of the puncture tube 42 is in the shape of a sharp cone without a top. A hole is opened in the side wall of the top end of the puncture tube 42, and the opened hole serves as the snap-on portion 421 that can be snapped into the snap member 21. During puncture and suturing, the puncture needle 41 first moves in the puncture tube 42 and makes a small hole on the leaflet 8. Then, the puncture tube 42 moves axially in the second inner cavity 112, and passes through the small hole on the leaflet 8 together with the puncture needle 41. The puncture tube 42 continues to move so that the head of the fastener 21 is inserted into the puncture tube 42, and the fastener part 421 at the top of the puncture tube 42 is fastened together with the fastener 21 of the tendon assembly 2.

[0056] The puncture tube 42 and the puncture needle 41 cooperate to form the puncture assembly 4, so that the buckle portion 421 and the buckle 21 are buckled inside the puncture tube 42. The outer surface of the two after buckling is smooth, which reduces the damage to the tissue when the puncture assembly 4 penetrates into and out of the heart tissue, making the wound area smaller and easier to recover.

[0057] Alternatively, in other embodiments, the puncture assembly 4 may be a single puncture needle 41, the top of which may have a snap portion 421 that may be snapped into engagement with the snap member 21. For example, if the top of the puncture needle 41 has a barbed snap portion 421, the snap member 21 may have a corresponding opening that may be snapped into engagement with the barbed snap portion 421.

[0058] In another embodiment of this application, please refer to Figure 2 、 Figure 6 The clamping assembly 3 also includes a push rod 34 that is movably installed in the third inner cavity 113 of the multi-lumen tube 11. The first chuck 31 and the second chuck 32 are both installed on the push rod 34. The push rod 34 moves axially in the third inner cavity 113 to drive the second chuck 32 to engage or separate with the first chuck 31.

[0059] Specifically, in this embodiment, the first chuck 31 and the second chuck 32 of the clamping assembly 3 are inserted into the third inner cavity 113 of the multi-lumen tube 11 via a push rod 34. The second chuck 32 can be engaged or disengaged with the first chuck 31 by pushing the push rod 34 to move axially within the third inner cavity 113. Preferably, the push rod 34 is a smooth round rod, and there are two push rods 34. Both the first chuck 31 and the second chuck 32 have insertion holes that match the push rods 34. When actually clamping the leaflet 8, the first clamp 31 is fixedly connected to the top end of the multi-lumen tube 11 and remains stationary. The leaflet 8 captured by the clamping assembly 3 is located on the engagement surface 33 between the first clamp 31 and the second clamp 32. Driven by the push rod 34, the second clamp 32 approaches the first clamp 31 and engages with the first clamp 31, thereby clamping the leaflet 8. Driven by the push rod 34, the second clamp 32 moves away from the first clamp 31, thereby disengaging and releasing the clamped leaflet 8. The engagement and separation of the second clamp 32 and the first clamp 31 by the push rod 34 makes the device compact, simple, and highly reliable.

[0060] In another embodiment of this application, please refer to Figure 2 、 Figure 6 The clamping assembly 3 also includes a detection rod 35 that is movably installed in the fourth inner cavity 114 of the multi-lumen tube 11. The top end of the detection rod 35 elastically extends from the mating surface 33 of the first clamp 31. The corresponding position of the second clamp 32 has a socket matching the detection rod 35. The detection rod 35 is plugged into the socket to limit the rotation of the detection rod 35.

[0061] Specifically, in this embodiment, preferably, the number of the detection rods 35 is two, and the two detection rods 35 are movably installed in the fourth inner cavity 114 of the multi-lumen tube 11. The detection rods 35 can move axially relative to the fourth inner cavity 114, and can also rotate in the fourth inner cavity 114. The top end of the detection rod 35 passes through the first chuck 31 and extends out of the end face of the mating surface 33 of the first chuck 31. The top end of the detection rod 35 is elastic and can be retracted and extended relative to the mating surface 33 of the first chuck 31. A plug hole for inserting the detection rod 35 is provided at a position corresponding to the end face of the mating surface 33 of the second chuck 32. Specifically, the top portion of the detection rod 35 is a polygonal rod structure, such as a triangular rod, a quadrangular rod, a hexagonal rod, etc. Correspondingly, the second chuck 32 also has a plug hole that matches the shape of the top portion of the detection rod 35. The portion of the detection rod 35 located in the fourth inner cavity 114 is a round rod. In one embodiment, the detection rod 35 can be implemented by sleeved a section of polygonal tube on a round rod.

[0062] In the process of the first chuck 31 and the second chuck 32 cooperating to capture and clamp the leaflet 8, the function of the detection rod 35 is mainly to detect whether the leaflet 8 has been successfully captured. Among them, the top ends of the second chuck 32 and the detection rod 35 are respectively arranged on both sides of the leaflet 8, and whether the leaflet 8 has been captured is determined by judging whether the plug-in hole on the second chuck 32 and the detection rod 35 can be plugged in. When fully captured, the second chuck 32 and the detection rod 35 are blocked by the leaflet 8 and cannot be plugged in to each other. The detection rod 35 can rotate in the fourth inner cavity 114, indicating that the leaflet 8 has been captured. When the leaflet 8 is not clamped or the clamping is incomplete, the second chuck 32 and the detection rod 35 can be plugged in to each other. After plugging in, due to the multi-faceted structure, the detection rod 35 is radially limited and cannot be rotated. When the detection rod 35 cannot rotate, it indicates that the leaflet 8 has not been captured successfully and the position needs to be readjusted to capture and clamp the leaflet 8.

[0063] The top end of the detection rod 35 is elastic and can be retracted and extended relative to the mating surface 33 of the first clamp 31. Specifically, the elastic extension and retraction can be achieved by arranging a spring on the detection rod 35. When clamping the leaflet 8, under the action of the clamping force, the spring is compressed and the top end of the detection rod 35 is retracted into the mating surface 33 of the first clamp 31. The first clamp 31 and the second clamp 32 are engaged to firmly clamp the leaflet 8.

[0064] In another embodiment of this application, please refer to Figure 11 、 Figure 12 The artificial chord tendon implantation device also includes an anchor 5, which is detachably mounted in the clamping assembly 3. The anchor 5 has a mounting ring 51, which is passed through the puncture assembly 4. The anchor 5 is used to anchor the artificial chord tendon 22 to the papillary muscle 9.

[0065] Specifically, see Figure 12In (a) to (c), in this embodiment, the anchor 5 can be a commonly used spiral anchor, or a barb anchor, an expansion anchor, etc., which is not limited here. One end of the anchor 5 has a mounting ring 51, and the puncture assembly 4 is pre-pierced through the mounting ring 51. When the buckle portion 421 of the puncture assembly 4 is engaged with the buckle 21 of the tendon assembly 2, the artificial tendon 22 is pulled out of the heart by the puncture assembly 4. The artificial tendon 22 will pass through the mounting ring 51. When the device is withdrawn to the vicinity of the papillary muscle 9, the anchor 5 can be anchored to the papillary muscle 9 by adjusting the angular position of the device and the papillary muscle 9. Then, by moving the device away from the papillary muscle 9, the anchor 5 can be dropped from the clamping assembly 3, completing the anchoring. Anchoring the artificial tendon 22 to the papillary muscle 9 through the anchor 5 can make the implanted artificial tendon 22 closer to the stress and motion state of the native tendon, making the surgery more effective and safe.

[0066] In another embodiment of this application, please refer to Figure 4 The first clamp 31 has a receiving cavity 313 , and the anchor 5 is embedded in the receiving cavity 313 .

[0067] Specifically, in this embodiment, a receiving cavity 313 is provided on the first clamp 31 for embedding the anchor 5. The anchor 5 is embedded in the receiving cavity 313, with its anchoring end 52 exposed outside the receiving cavity 313, and enables the puncture assembly 4 to pass through the mounting ring 51 during puncture and suturing. The anchor 5 is embedded in the receiving cavity 313 in a detachable form. After the anchor 5 is anchored to the papillary muscle 9, the anchor 5 can be removed from the receiving cavity 313 by moving the device away from the papillary muscle 9, thereby completing the anchoring. The receiving cavity 313 provides an installation chamber for the anchor 5, thereby preventing the anchor 5 from being completely exposed outside the first clamp 31 during the implantation of the artificial tendon 22, thereby preventing the leaflet 8 tissue from being traumatically damaged by the anchor 5.

[0068] In another embodiment of this application, please refer to Figure 1 The artificial chord tendon implant device also includes a control handle 6 and a control component 7 installed in the control handle 6.

[0069] Specifically, in this embodiment, the control handle 6 is mounted at the rear end of the multi-lumen tube 11. The control handle 6 is ergonomically designed and has a housing 61 that is easy to hold. Within the housing 61, a push module that matches the push rod 34, a pull wire slider that matches the auxiliary tension wire 23, a rotation control module that matches the probe rod 35, and a puncture push block that matches the puncture assembly 4 are respectively provided. The push module controls the pushing and pulling of the push rod 34 to achieve axial movement of the push rod 34 in the third inner cavity 113; the pull wire slider controls the pulling of the auxiliary tension wire 23 to achieve tensioning and loosening of the auxiliary tension wire 23, thereby controlling the tensioning and loosening of the artificial tendon 22 in the first inner cavity 111; the rotation control module controls the rotation of the probe rod 35 to determine whether the probe rod 35 is plugged into the second clamp 32, thereby determining whether the leaflet 8 has been successfully captured; and the puncture push block controls the pushing and pulling of the puncture needle 41 and puncture tube 42 in the puncture assembly 4 to achieve axial movement of the puncture assembly 4 in the second inner cavity 112.

[0070] Integrating the control components 7 into the housing 61 of the handle makes the entire device small and compact, which better meets the requirements of minimally invasive surgery for implanting artificial chordae tendineae 22 .

[0071] In another embodiment of this application, please refer to Figure 12 (d) The chord assembly 2 further includes a gasket 24, which is used to fix the two free ends 221 of the artificial chord 22 to the outside of the apex.

[0072] Specifically, in this embodiment, after the suturing and knotting of the artificial chordae 22 inside the heart are completed, the artificial chordae 22 are extended out of the body under the traction of the puncture component 4, the fastener 21 is removed, and the two free ends 221 of the artificial chordae 22 are extended out of the body. After the anchoring of the artificial chordae 22 on the papillary muscles 9 is completed, the artificial chordae implantation device is moved out of the body, and then the free ends 221 of the artificial chordae 22 are knotted and fixed on the outside of the apex through the gasket 24, thereby completing the implantation of the entire artificial chordae 22. The gasket 24 fixes the free ends 221 of the artificial chordae 22, so that the free ends 221 of the artificial chordae 22 can be firmly fixed on the outside of the apex, reducing the risk of the free ends 221 loosening due to loose fixation, thereby reducing the immune response of the artificial chordae 22 and the human body's main tissues.

[0073] The working principle of the artificial tendon implant device provided in this application is as follows: Figure 10 (a) to (c) and Figure 12In (a) to (d), when performing the artificial chordae tendineae 22 implantation surgery, the device enters the heart through a small incision at the apex of the heart, captures and clamps the leaflets 8 through the clamping component 3, and then punctures and sutures through the puncture component 4. Specifically, the detection rod 35 is used to determine whether the leaflet 8 is successfully captured and clamped. When the clamping assembly 3 firmly clamps the leaflet 8, the puncture needle 41 in the puncture assembly 4 is first pushed toward the target leaflet 8, so that the puncture needle 41 passes through the annular portion 222 and the target leaflet 8 in turn, and makes a small hole in the target leaflet 8. Then, the puncture tube 42 is pushed toward the target leaflet 8 along the puncture needle 41, so that the puncture tube 42 also passes through the annular portion 222 and the target leaflet 8 in turn. The puncture tube 42 passes through the target leaflet 8 along the small hole made by the puncture needle 41 until the buckle portion 421 on the puncture tube 42 is buckled with the buckle 21 of the tendon assembly 2. At this time, the puncture tube 42 is connected to the buckle 21 and the artificial tendon 22 as a whole. Then pull the puncture tube 42 and the puncture needle 41 back together, that is, pull them toward the outside of the heart, so that the fastener 21 and the artificial chord 22 are pulled out through the small hole on the target leaflet 8. At this time, the end of the artificial chord 22 connected to the fastener 21 (that is, the free end 221) just passes through the annular portion 222 of the artificial chord 22 in the first embedded groove 311. Pull the artificial chord 22 to the end of the control handle 6 and cut it short. Continue to pull the artificial chord 22, and release the auxiliary tension line 23 at the same time, so that the second folded end 223 of the artificial chord 22 in the third embedded groove 312 is continuously shortened until the second folded end 223 disappears, and the artificial chord 22 is fastened and knotted on the leaflet 8. While the artificial chordae tendineae 22 is extended out of the body and knotted intracardiacally under the traction of the puncture component 4, the artificial chordae tendineae 22 passes through the mounting ring 51 of the anchor 5 under the traction of the puncture component 4, and the clamping end of the device is withdrawn to the vicinity of the papillary muscle 9. The angle between the delivery mechanism 1 of the device and the free wall of the left ventricle is adjusted. Under the guidance of the surgical image, the anchor 5 extending out of the accommodating cavity 313 is fixed to the papillary muscle 9, and then the device is moved away from the papillary muscle 9, so that the anchor 5 can be separated from the accommodating cavity 313, and then the clamping component 3 end of the device is withdrawn from the heart. At the same time, the free end 221 of the artificial chordae tendineae 22 is also retained outside the body, and the gasket 24 is used to fix the artificial chordae tendineae 22 to the outside of the apex. In this way, the suturing, knotting and anchoring of the entire artificial chordae 22 on the heart valve leaflet 8 are completed, and the suturing and knotting are completed simultaneously in the heart, which reduces the operation time; the artificial chordae 22 are tied with a knot on the heart valve leaflet 8, so that the artificial chordae 22 are fixed on the leaflet 8 more firmly and closer to the surgical standard; at the same time, one side of the artificial chordae 22 is fixed to the papillary muscle 9 through the anchor 5, so that the artificially implanted chordae are closer to the stress and movement state of the native chordae, making the operation more effective and safe.

[0074] The above description is only a preferred embodiment of the present application and is not intended to limit the present application. Any modifications, equivalent replacements and improvements made within the spirit and principles of the present application should be included in the scope of protection of the present application.

Claims

1. An artificial chordal implant device, characterized in that: include The delivery mechanism includes a multi-lumen tube having a plurality of axially penetrating lumens therein; A tendon cord assembly includes a fastener and an artificial tendon cord, wherein the artificial tendon cord is folded at least twice, both free ends of the artificial tendon cord are connected to the fastener, and the first folded end of the artificial tendon cord is configured as a ring portion; The clamping assembly includes a first clamp disposed at the top end of the multi-lumen tube, and a second clamp that can move relative to the first clamp to engage with the first clamp to clamp the leaflet, the first clamp having a first embedded groove, the first embedded groove being annularly arranged around the first clamp, the annular portion being sleeved within the first embedded groove; the second clamp having a second embedded groove, the second embedded groove being connected to the first embedded groove, and the fastener being placed within the second embedded groove; a puncture assembly, movably mounted in the multi-lumen tube, the puncture assembly having a buckle portion; After the puncture assembly passes through the annular portion and the leaflet in sequence, the buckle portion and the buckle member can be buckled together; when the puncture assembly pulls back the buckle member to allow the two free ends to pass through the annular portion, the artificial chordae are knotted on the leaflet; The puncture assembly includes a puncture tube and a puncture needle movably installed in the puncture tube. The puncture tube is movably installed in the second inner cavity of the multi-lumen tube. The puncture tube can move axially in the second inner cavity. The puncture needle can move axially in the puncture tube. The top end of the puncture tube has the buckle part that is buckled with the buckle.

2. The artificial chordal implant device according to claim 1, wherein: The first chuck further includes a third embedded groove arranged axially along the multi-lumen tube, the third embedded groove is communicated with the first embedded groove, and the second folded end of the artificial tendon is placed in the third embedded groove.

3. The artificial chordal implant device according to claim 2, wherein: The tendon assembly further includes an auxiliary tensioning line, which is movably arranged in the first inner cavity of the multi-lumen tube and is connected to the second folded end of the artificial tendon.

4. The artificial chordal implant device according to claim 1, wherein: The clamping assembly also includes a push rod movably installed in the third inner cavity of the multi-lumen tube, the first chuck and the second chuck are both installed on the push rod, and the push rod moves axially in the third inner cavity to drive the second chuck to engage or separate with the first chuck.

5. The artificial chordal implant device according to claim 4, wherein: The clamping assembly also includes a detection rod movably installed in the fourth inner cavity of the multi-lumen tube, the top end of the detection rod elastically extends out of the mating surface of the first chuck, and the corresponding position of the second chuck has a plug hole matching the detection rod, and the detection rod is plugged into the plug hole to limit the rotation of the detection rod.

6. The artificial chordal implant device according to any one of claims 1 to 5, characterized in that: The artificial chord tendon implantation device also includes an anchor, which is detachably mounted in the clamping assembly. The anchor has a mounting ring that is passed through the puncture assembly. The anchor is used to anchor the artificial chord tendon to the papillary muscle.

7. The artificial chordal implant device according to claim 6, wherein: The first clamp has a receiving cavity, and the anchor is embedded in the receiving cavity.

8. The artificial chordal implant device according to claim 7, wherein: The artificial chord implant device further includes a control handle and a control component installed in the control handle.

9. The artificial chordal implant device according to claim 8, wherein: The chord assembly further includes a gasket, which is used to fix the two free ends of the artificial chord to the outside of the apex.

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