CN115399917A - Artificial chordae tendineae implanting device - Google Patents

Abstract

The application provides an artificial chordae implantation device, which comprises a conveying mechanism, a chordae assembly, a clamping assembly and a puncture assembly, wherein the clamping assembly and the puncture assembly are fixed through a multi-cavity tube of the conveying mechanism; the first chuck of the clamping assembly is provided with a first embedded groove wound in an annular shape, the second chuck is provided with a second embedded groove communicated with the first embedded groove, the fastener is arranged in the second embedded groove, and the annular part of the artificial chordae tendineae folded in half is sleeved in the first embedded groove; the puncture assembly is provided with a buckling part, the puncture assembly sequentially penetrates through the annular part and the valve leaflets to enable the buckling part to be buckled with the buckling piece, and then the puncture assembly is pulled back to enable the buckling piece to penetrate through the annular part to finish the intra-cardiac knotting of the artificial chordae tendineae. The artificial chordae implantation device provided by the application can finish intracardiac suturing and knotting of the artificial chordae, so that the operation efficiency is improved; the artificial chordae tendineae can be fixed on the valve leaflet more firmly, and the success rate of the operation is improved.

Description

An artificial chord implantation device

technical field

The present application belongs to the technical field of medical devices, and more specifically relates to an artificial chord implantation device.

Background technique

The mitral valve is a complex tissue structure between the left atrium (LA) and the left ventricle (LV). cord and papillary muscle. The mitral valve acts as a gatekeeper, ensuring that blood can only flow from the left atrium to the left ventricle, and not in the opposite direction. Mitral valve insufficiency is one of the most common heart valve diseases today. The main causes are rheumatic heart disease, mitral valve myxoid degeneration, cardiac ischemic disease, cardiomyopathy, etc. Diseases of the valve leaflets, chordae and papillary muscles eventually lead to incomplete closure of the mitral valve leaflets. Among the many factors causing mitral valve insufficiency, lesions of the chordae or papillary muscles are common causes of incomplete closure of the mitral valve leaflets. A normal, healthy mitral valve has multiple chordae that connect at one end to the edge of the leaflet and at the other end to the papillary muscle in the wall of the ventricle. When the left ventricle is in diastole, the front and rear leaflets of the mitral valve are opened, the chordae are in a relaxed state, and blood flows from the left atrium to the left ventricle; Due to the pulling effect of the chordae tendineae, the valve leaflets will not flip to the atrium side due to blood pressure. Under the joint action of the leaflets and chordae tendineae, the blood flow channel between LA and LV is closed, and blood can only pass through the left ventricle. The aortic valve (Aortic valve, AV) flows to the aorta and sends it to various organs in the body. When the chordae or papillary muscles are pathologically affected, or are subjected to external shocks, part of the chordae tendineum is elongated or broken. When the left ventricle contracts, the valve leaflets are turned over to the atrium side under the action of blood pressure due to the loss of chordae tendinous traction. As a result, the valve leaflets cannot fit tightly, and then blood regurgitation occurs, that is, mitral valve regurgitation. Mild patients with mitral valve regurgitation manifest as dyspnea, chest tightness, and chest pain during exercise, and severe cases have symptoms such as lower extremity edema, gastrointestinal congestion, liver pain, nausea, and vomiting. It can be seen that the mitral valve regurgitation caused by the elongation or rupture of the mitral valve chordae has a great impact on human health and requires clinical intervention.

Surgery is an effective method for the treatment of mitral regurgitation. With the continuous improvement of medical level, minimally invasive interventional surgery is now a better choice for most heart diseases. The main interventional treatment method is artificial tendon implantation , mitral annuloplasty and mitral valve edge-to-edge repair. Among them, the implantation of artificial chordae on the valve leaflets can effectively treat mitral valve insufficiency caused by chordae tendon rupture and valve leaflet prolapse, while maintaining the integrity of the mitral valve's physiological structure.

In the existing artificial chord implantation operation, the artificial chord tendon is often sutured on the valve by an artificial chord tendon implantation device, and the artificial chord tendon is fixed by knotting. However, some of the existing artificial chord implantation devices need to be knotted outside the body, and then the tied knot is sent into the heart. This method is complicated to operate, difficult to operate and takes a long time; A group of sutures are sutured on the valve leaflet to pass through the valve as the artificial chord, without winding and knotting. This technique will easily lead to loose and unstable implanted artificial chord, and cannot obtain satisfactory clinical results.

Contents of the invention

The purpose of the embodiment of the present application is to provide an artificial chord tendon implantation device to solve the problem that the artificial chord tendon implantation device in the prior art can only be knotted outside the body or only sutured without knotting. Fixing with the valve leaflets brings technical problems such as complicated operation and poor implantation effect.

In order to achieve the above purpose, the technical solution adopted by the present application is to provide an artificial chord implantation device, comprising:

The delivery mechanism includes a multi-lumen tube, and the multi-lumen tube has multiple axially penetrating lumens;

The chord assembly includes a buckle and an artificial chord, the artificial chord is folded in half at least twice, the two free ends of the artificial chord are connected to the buckle, and the artificial chord The first folded end is configured as an annular portion;

The clamping assembly includes a first clamp disposed on the top end of the multi-lumen tube, and a second clamp capable of moving and engaging relative to the first clamp to clamp the leaflet, the first clamp has a first The embedded groove, the first embedded groove is annularly arranged on the first chuck, and the ring part is sleeved in the first embedded groove; the second chuck has a second embedded groove A buried groove, the second embedded groove communicates with the first embedded groove, and the buckle is placed in the second embedded groove;

The puncture component is movably mounted in the multi-lumen tube, and the puncture component has a buckle portion;

After the puncture component passes through the annular part and the valve leaflet in sequence, the buckle part and the buckle can be engaged; when the puncture component pulls back the buckle so that the two When the free end passes through the annular portion, the artificial chordae are knotted on the leaflet.

Optionally, the first chuck further includes a third embedded groove arranged axially along the multi-lumen tube, the third embedded groove communicates with the first embedded groove, and the artificial chord The second folded end of the second half is placed in the third embedded groove.

Optionally, the chordal tendon assembly further includes an auxiliary tensioning wire, the auxiliary tensioning wire is movably threaded in the first lumen of the multi-lumen tube, and the auxiliary tensioning wire is connected to the artificial tendon The second folded end of the cable is connected.

Optionally, the puncture assembly includes a puncture tube and a puncture needle movably mounted in the puncture tube, the puncture tube is movably mounted in the second lumen of the multi-lumen tube, the puncture tube has the The above buckle part.

Optionally, the clamping assembly further includes a push rod that is movably installed in the third lumen of the multi-lumen tube, and the first clamp and the second clamp are both passed through the push rod. On the rod, the push rod moves axially in the third inner cavity to drive the second chuck to engage or disengage from the first chuck.

Optionally, the clamping assembly further includes a detection rod movably installed in the fourth lumen of the multi-lumen tube, the top end of the detection rod elastically protrudes from the engaging surface of the first chuck, The corresponding position of the second chuck has an insertion hole matched with the detection rod, and the detection rod is inserted into the insertion hole to limit the rotation of the detection rod.

Optionally, the artificial tendon implantation device further includes an anchor, the anchor is detachably installed in the clamping assembly, the anchor has a mounting ring, and the mounting ring is passed through the puncture On the assembly, the anchor is used to anchor the artificial chord to the papillary muscle.

Optionally, the first chuck further has an accommodating cavity, and the anchor is embedded in the accommodating cavity.

Optionally, the artificial chord implantation device further includes a control handle and a control component installed in the control handle.

Optionally, the chordal assembly further includes spacers, and the spacers are used to fix the two free ends of the artificial chord outside the apex of the heart.

The beneficial effect of the artificial chord implantation device provided by the present application is that: compared with the prior art, the artificial chord implantation device of the present application includes a delivery mechanism, a tendon assembly, a clamping assembly and a puncture assembly. The lumen fixes the clamping component and the puncture component, and sets the chorda tendon component, wherein the artificial chordal tendon is folded in half at least twice, and the first folded end is set as a ring portion, and the two free ends of the artificial chordal tendon are buckled The parts are fixed; the first embedded groove is arranged on the first clamping head of the clamping assembly in a ring shape, and the second embedded groove is set on the second chuck, and the second embedded groove communicates with the first embedded groove , the annular portion of the artificial chord can be sleeved in the first pre-embedded groove, and the buckle is placed in the second pre-embedded groove, thereby forming a complete pre-embedded groove for the pre-embedded chord assembly; By setting the buckle part on the puncture component, the puncture component can be fastened with the buckle after moving axially along the multi-lumen tube through the annular part and the valve leaflet, and then pull the buckle back through the puncture component to make the two When the free end passes through the annular portion, the knotting of the artificial chord directly inside the viscera can be completed. The artificial chord implantation device of the present application can simultaneously complete the two-step operation of suturing and knotting the artificial chord in the heart. On the one hand, it saves the steps of knotting outside the body, reduces the difficulty of operation, and reduces the operation time; on the other hand The fixation of the artificial chord on the leaflet is more reliable, and the success rate of the operation is improved.

Description of drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present application, the accompanying drawings that need to be used in the descriptions of the embodiments or the prior art will be briefly introduced below. Obviously, the accompanying drawings in the following description are only for the present application For some embodiments, those of ordinary skill in the art can also obtain other drawings based on these drawings without paying creative efforts.

FIG. 1 is a schematic diagram of the overall structure of the artificial chord implantation device provided by the embodiment of the present application;

(a) and (b) in Fig. 2 are the side view and the cross-sectional view along the A-A direction of the multi-lumen tube of the embodiment of the present application respectively;

Fig. 3 is a schematic structural diagram of the chord assembly of the embodiment of the present application;

Fig. 4 is a schematic diagram of the structure of the first chuck of the embodiment of the present application;

(a) and (b) in FIG. 5 are schematic diagrams of different angles of the second chuck structure of the embodiment of the present application;

Fig. 6 is a schematic diagram of the assembly of the first collet and the second collet according to the embodiment of the present application;

Fig. 7 is a schematic diagram of the longitudinal section structure of the puncture component and the chorda tendon component when the valve leaflets are sutured according to the embodiment of the present application;

Fig. 8 is a schematic diagram of knotting in the heart of the artificial chordae according to the embodiment of the present application;

Fig. 9 is a partially enlarged schematic diagram of the puncture assembly of the embodiment of the present application;

(a) to (c) in Fig. 10 are schematic diagrams of the intracardiac knotting process of the artificial chord implantation device according to the embodiment of the present application; (a) is the device entering the heart; (b) is the device suturing the artificial chord tendon in the heart ; (c) Knotting the artificial chord tendon for installation in the heart;

Fig. 11 is a schematic diagram of the structure of the anchor in the embodiment of the present application;

(a) to (d) in Fig. 12 are the schematic diagrams of the process of anchoring the anchor in the embodiment of the present application on the papillary muscle; (a) is extending the anchor; (b) is anchoring the anchor in the papillary muscle; ( c) is to release the anchor and pull the free end of the artificial chord out of the body; (d) is to fix the free end of the artificial chord with a spacer outside the apex of the heart.

Wherein, each reference sign in the figure:

1. Delivery mechanism; 11. Multi-lumen tube; 111. First lumen; 112. Second lumen; 113. Third lumen; 114. Fourth lumen; 2. Chord component; 21. Buckle 22, artificial chord; 221, free end; 222, ring part; 223, second folded end; 23, auxiliary tension line; 24, spacer; 3, clamping assembly; 31, first chuck; 311 , the first embedded groove; 312, the third embedded groove; 313, the accommodation cavity; 32, the second chuck; 321, the second embedded groove; 322, the accommodation cavity; 33, the meshing surface; 34, the push rod ;35, detection rod; 4, puncture assembly; 41, puncture needle; 42, puncture tube; 421, buckle part; 5, anchor piece; 51, installation ring; 52, anchor end; 6, control handle; 61, shell ; 7, control components; 8, valve leaflets; 9, papillary muscles.

Detailed ways

In order to make the technical problems, technical solutions and beneficial effects to be solved by the present application clearer, the present application will be further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described here are only used to explain the present application, and are not intended to limit the present application.

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

It is to be understood that the terms "length", "width", "top", "bottom", "front", "rear", "left", "right", "top", "bottom", "inner", The orientation or positional relationship indicated by "outside" is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the application and simplifying the description, rather than indicating or implying that the referred device or element must have a specific orientation, constructed and operated in a particular orientation and therefore should not be construed as limiting the application.

In addition, the terms "first" and "second" are used for descriptive purposes only, and cannot be interpreted as indicating or implying relative importance or implicitly specifying the quantity of indicated technical features. Thus, a feature defined as "first" and "second" may explicitly or implicitly include one or more of these features. In the description of the present application, "plurality" means two or more, unless otherwise specifically defined.

Please refer to FIG. 1 , FIG. 2 , FIG. 3 and FIG. 8 together, and now the artificial chord implantation device provided by the embodiment of the present application will be described. The artificial chord implantation device includes a delivery mechanism 1 , a chord component 2 , a clamping component 3 and a puncture component 4 . The delivery mechanism 1 includes a multi-lumen tube 11, and the multi-lumen tube 11 has a plurality of axially penetrating lumens. Specifically, the multiple axially penetrating lumens are not arranged axially, and the multi-lumen tube 11 may be a tube with multiple axially penetrating lumens inside. The multi-cavity tube 11 can also be composed of a large tube and a plurality of small tubes with different shafts sleeved in the inside of the large tube. Two covers are arranged at the two ends of the large tube, and the cover is provided with a plurality of matching holes for each vial. Certainly, in other embodiments, the multi-lumen tube 11 may also have other similar structures.

Specifically, referring to FIG. 3 , the chord assembly 2 includes a buckle 21 and an artificial chord 22 , the artificial chord 22 is folded in half at least twice, and the two free ends 221 of the artificial chord 22 are connected to the buckle 21 , the first folded end of the artificial chord is set as the ring portion 222 . Preferably, the artificial chord 22 adopts common medical sutures. A single complete artificial chord 22 is folded in half at least twice, and the two free ends 221 folded in half are all connected to the buckle 21. Specifically, the artificial chord 22 and The buckles 21 are connected together; the first folded end after being folded in half is set as an annular portion 222 , and the annular portion 222 may be in the shape of a circular ring, an elliptical ring, or the like. One end of the buckle 21 connected to the artificial tendon 22 is defined as the tail end, and the tail end is provided with a mounting hole or a mounting groove. In the groove, at this moment, the artificial chord 22 is a complete circle. The front end of the buckle 21 opposite to the tail end has a buckle head with a protruding barb step for buckling. The front end of the buckle 21 is in the shape of an inverted cone with a smooth top. In other embodiments, buckle members 21 of other shapes may also be used.

Specifically, referring to FIG. 4 , FIG. 5 , and FIG. 7 , the clamping assembly 3 includes a first chuck 31 disposed on the top end of the multi-lumen tube 11 and a second chuck 31 that can move and engage with the first chuck 31 to clamp the leaflet 8 . The chuck 32, the first chuck 31 has a first embedded groove 311, the first embedded groove 311 is annularly arranged on the first chuck 31, and the annular part 222 of the artificial tendon 22 is sleeved on the first embedded In the groove 311 ; the second chuck 32 has a second embedded groove 321 , the second embedded groove 321 communicates with the first embedded groove 311 , and the buckle 21 is placed in the second embedded groove 321 .

Referring to Fig. 6 and Fig. 7, the first chuck 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 into the heart of the human body. The second chuck 32 of the assembly 3 is arranged coaxially with the first chuck 31, and there is a mating surface 33 between the second chuck 32 and the first chuck 31, and the second chuck 32 can be opposite to the first The collet 31 moves so as to achieve engagement and disengagement with the first collet 31 . When the artificial chord 22 is implanted, the clamping assembly 3 is used to clamp the heart valve leaflet 8, specifically, when the valve leaflet 8 is clamped, the valve leaflet 8 is located between the first clamping head 31 and the second clamping head 32 On the engaging surface 33 of the valve leaflet 8, the second clip 32 is close to the first clip 31 and then engaged, so that the valve leaflet 8 can be clamped. The first embedded groove 311 is opened on the first chuck 31, and the first embedded groove 311 is arranged on the first chuck 31 in a ring shape, that is, the first embedded groove 311 is wound along the circumferential direction of the first chuck 31. Suppose, preferably, the first pre-embedded groove 311 is annularly arranged at the end of the first chuck 31 close to the engaging surface 33 , that is, the plane where the first embedded groove 311 is located is parallel to the engaging surface 33 . The annular portion 222 of the artificial chord 22 is sheathed in the first pre-embedded groove 311 . The second chuck 32 is provided with a second pre-embedded groove 321, and the second pre-embedded groove 321 is smoothly connected with the first pre-embedded groove 311 in appearance, forming an integral artificial chorda 22 pre-embedded cavity, and the buckle 21 Placed in the second embedded groove 321, the artificial chord 22 is embedded in the first embedded groove 311 and the second embedded groove 321, forming a complete closed loop.

Preferably, the top of the second clip 32 is in the shape of an ellipsoid. The second clip 32, as the first part of the whole device that contacts the human heart tissue, needs to minimize its damage to the human tissue. Therefore, the ellipsoid-shaped first The surface of the second chuck 32 is smooth, and when in contact with human tissues during the operation, the friction between the device and human organs can be reduced as much as possible to avoid damage to human organs. The second embedded groove 321 starts from the engaging surface 33 end of the second chuck 32, crosses the top of the second elliptical chuck 32, reaches the other end of the engaging surface 33, the starting end and the end of the second embedded groove 321 All on the mating surface 33. The second pre-embedded groove 321 is opened on the top of the second chuck 32, so that when the device enters the human heart, the artificial chord 22 located in the second pre-embedded groove 321 can obtain the maximum tension, so that it is not easy to loose. Of course, in other embodiments, the second embedded groove 321 can also be opened in other parts of the second chuck 32 to ensure that it communicates smoothly with the first embedded groove 311 in appearance, and can ensure that it is located in the second embedded groove 311 . The buckle 21 in the slot 321 can form a fastening connection with the buckle part 421 of the puncture component 4 after the puncture component 4 punctures through the leaflet 8 . Preferably, the buckle 21 of the tendon assembly 2 is placed at the starting end of the second embedded groove 321. In order to facilitate the placement of the buckle 21, a receiving cavity 322 can be provided at the starting end of the second embedded groove 321. , place the buckle 21 in the accommodating cavity 322 .

Preferably, the meshing surface 33 between the first clip 31 and the second clip 32 has corrugated steps, or has other shapes of concave-convex steps, so as to increase the clamping area when clamping the leaflet 8 and increase the meshing surface The friction between 33 and leaflet 8 makes the clamping more stable and not easy to loosen.

Preferably, the engaging surface 33 between the first chuck 31 and the second chuck 32 is an inclined surface, that is, there is a certain angle between the normal line of the engaging surface 33 and the axis of the multi-lumen tube 11, and the experimental comparison , if the included angle is too small or too large, it is not conducive to firmly clamping the valve leaflet 8, therefore, the included angle is generally selected as an included angle of 30 degrees to 60 degrees. Correspondingly, the plane where the first embedded groove 311 is located is also an inclined surface, so that when the artificial chord 22 is pulled and knotted, the artificial chord 22 can be easily moved from the first embedded groove 311. break away.

Specifically, referring to FIG. 2, FIG. 7, and FIG. 9, the puncture assembly 4 is movably installed in the multi-lumen tube 11, and the puncture assembly 4 has a buckle portion 421. After the puncture assembly 4 passes through the annular portion 222 and the leaflet 8 in sequence , the buckle part 421 can be buckled with the buckle part 21; when the puncture assembly 4 pulls the buckle part 21 back so that the two free ends 221 pass through the ring part 222, the artificial chordae 22 are knotted on the leaflet 8. Specifically, the puncture assembly 4 can move axially in the multi-lumen tube 11, and when the artificial chordae 22 and the valve leaflet 8 are sutured, the puncture assembly 4 can move axially and pass through the first embedded part of the first clip 31. The plane where the groove 311 is located, that is, after passing through the artificial chord 22 annularly sleeved on the first pre-embedded groove 311, the buckle part 421 of the puncture component 4 is buckled with the buckle part 21 of the chord component 2, so that The puncture assembly 4, the buckle 21 and the artificial chord 22 are connected as a whole. Then pull the puncture assembly 4 back, the buckle part 421 pulls the buckle 21 through the annular part 222 on the first pre-embedded groove 311, and continues to pull the puncture assembly 4 back, and the artificial chordae 22 are placed on the valve leaflet 8 the knotted.

Compared with the prior art, the artificial chord implantation device provided by the present application includes a delivery mechanism 1, a tendon component 2, a clamping component 3, and a puncture component 4, and the clamping component is paired by the multi-lumen tube 11 of the delivery mechanism 1. 3 and the puncture assembly 4 are fixed, and the chord tendon assembly 2 is set, wherein the artificial chord 22 is folded in half at least twice, and the first folded end is set as a ring portion 222, and the two free ends 221 of the artificial chord 22 are all connected to the The buckle 21 is connected; on the first chuck 31 of the clamping assembly 3, a first pre-embedded groove 311 is arranged in a ring around the first chuck 31, and a second embedded groove is opened on the second chuck 32 321, and the second embedded groove 321 communicates with the first embedded groove 311, the annular part 222 of the artificial chord 22 can be set in the first embedded groove 311, and the buckle 21 is placed in the second embedded groove 311. In the embedded groove 321, thereby forming a complete pre-embedded groove channel for pre-embedding the chorda tendon assembly 2; by setting the buckle part 421 on the puncture assembly 4, the puncture assembly 4 is moved axially along the multi-lumen tube 11 sequentially After passing through the annular part 222 and the valve leaflet 8, it can be fastened with the buckle 21, and then the buckle 21 is pulled back through the puncture assembly 4 so that the two free ends 221 pass through the annular part 222, and the artificial chordae can be completed. 22 knots directly inside the viscera. The artificial chord implantation device of the present application can simultaneously complete the two-step operation of suturing and knotting the artificial chord 22 in the heart. On the one hand, it saves the steps of knotting outside the body, reduces the difficulty of operation, and reduces the operation time; On the one hand, the fixation of the artificial chord 22 on the valve is more firm, and the success rate of the operation is improved.

In another embodiment of the present application, please refer to FIG. 4 , the first chuck 31 further includes a third embedded groove 312 arranged axially 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 chord 22 is placed in the third pre-embedded groove 312 .

Specifically, in this embodiment, since the multi-lumen tube 11 of the artificial chord implantation device enters the heart from a small incision at the apex of the heart during the implantation operation of the artificial chord 22, the small incision and the implanted There is a certain distance between the leaflets 8 of the artificial chordae 22. Therefore, the artificial chordae 22 usually use longer medical sutures. The distance between 8. Therefore, when the artificial chordae 22 and the valve leaflet 8 are sutured, the length of the middle section thereof will be accommodated through the third pre-embedded groove 312 on the first clip 31 . The third pre-embedded groove 312 is opened on the surface of the first chuck 31 and is arranged along the axial direction of the multi-lumen tube 11 . The third pre-embedded groove 312 communicates with the first pre-embedded groove 311 . After the artificial tendons 22 are sleeved in the first pre-embedded groove 311, the redundant part will be double-folded, which is the second folded end 223. The second folded end 223 has four artificial tendons 22. The second folded end 223 has four artificial tendons 22. 223 is placed in the third embedded groove 312. At this time, the first embedded groove 311, the second embedded groove 321, and the third embedded groove 312 are smoothly connected in appearance, forming an integral artificial chord 22 embedded groove. In this state, the artificial chord tendon 22 is pre-embedded in a single state in the first annular pre-embedded groove 311, the artificial chord 22 is pre-embedded in a state of two in the second pre-embedded groove 321, and the artificial chord 22 is pre-embedded in the third pre-embedded groove 312, Embedded in four states. When the artificial chord implantation device is inserted into the heart, all the artificial chord 22 is in the pre-embedded groove, making the surface of the multi-lumen tube 11 smooth, reducing the friction between the device and human organs, and avoiding the damage of the device to human organs .

In another embodiment of the present application, please refer to FIG. 8 , the chord assembly 2 further includes an auxiliary tension wire 23, which is movably threaded in the first lumen 111 of the multi-lumen tube 11, and assists in pulling The tight wire 23 is connected with the second folded end 223 of the artificial chord 22 .

Specifically, in order to prevent the artificial chord 22 from getting loose in the first embedded groove 311, the second embedded groove 321, and the third embedded groove 312, thereby causing the failure of the operation due to the inability to tie a knot, in the first embedded groove 311 of the multi-lumen tube 11, An auxiliary tensioning wire 23 is provided in an inner cavity 111 for tensioning the artificial chord 22 . One end of the auxiliary tension wire 23 is fixed to the tail end (the end opposite to 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 degree of the artificial tendon 22 in the embedded groove can be adjusted, and it is finally adjusted so that the artificial tendon 22 is close to each embedded groove in the embedded groove and does not loosen. .

In another embodiment of the present application, please refer to FIG. 8 and FIG. 9 , the puncture assembly 4 includes a puncture tube 42 and a puncture needle 41 movably mounted in the puncture tube 42 , and the puncture tube 42 is movably mounted in the multi-lumen tube 11 In the second lumen 112 , the puncture tube 42 has a buckle portion 421 .

Specifically, please refer to FIG. 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, the puncture needle 41 can move axially in the puncture tube 42, and the top end of the puncture tube 42 has a button that can be fastened with the buckle 21. buckle part 421 . Specifically, the top of the puncture tube 42 is in the shape of a pointed cone without a top, and a hole is opened on the side wall of the top end of the puncture tube 42 , and the opened hole is used as a buckle portion 421 that can be buckled with the buckle 21 . When performing puncture and suturing, the puncture needle 41 first moves in the puncture tube 42 and pierces a small hole on the valve leaflet 8, then the puncture tube 42 moves axially in the second lumen 112, and passes through the valve leaflet 41 together with the puncture needle 41. Continue to move the puncture tube 42 so that the head of the buckle 21 is inserted into the puncture tube 42, and the buckle part 421 at the top of the puncture tube 42 is buckled with the buckle 21 of the tendon assembly 2 together.

The puncture tube 42 cooperates with the puncture needle 41 to form the puncture assembly 4, so that the fastening position of the buckle part 421 and the buckle part 21 is inside the puncture tube 42. The damage to the tissue when it penetrates into and out of the heart tissue makes the trauma area smaller and easier to recover.

Optionally, in other embodiments, the puncture assembly 4 can also be a single puncture needle 41 , and the top end of the puncture needle 41 has a buckle portion 421 that can be buckled with the buckle 21 . For example, the tip of the puncture needle 41 has a barb-shaped buckle 421 , and the buckle 21 correspondingly has an opening that can be buckled with the barb-shaped buckle 421 .

In another embodiment of the present application, please refer to FIG. 2 and FIG. 6 , the clamping assembly 3 further includes a push rod 34 movably mounted in the third lumen 113 of the multi-lumen tube 11 , the first chuck 31 and the second The two clamps 32 are both mounted on the push rod 34 , and the push rod 34 moves axially in the third inner chamber 113 to drive the second clamp 32 to engage or separate from the first clamp 31 .

Specifically, in this embodiment, the first chuck 31 and the second chuck 32 of the clamping assembly 3 are inserted into the third lumen 113 of the multi-lumen tube 11 through the push rod 34 , and by pushing the push rod 34 The axial movement in the three inner cavities 113 can realize the engagement or separation of the second chuck 32 and the first chuck 31 . Preferably, the push rod 34 is a smooth round rod, and the number of the push rod 34 is two. Both the first chuck 31 and the second chuck 32 are provided with through holes matching the push rod 34 . When the leaflet 8 is actually clamped, the first chuck 31 is fixedly connected to the top end of the multi-lumen tube 11 and does not move, and the leaflet 8 captured by the clamping assembly 3 is located between the first chuck 31 and the second chuck 32 On the meshing surface 33 of the push rod 34, the second chuck 32 approaches the first chuck 31 and engages with the first chuck 31, thereby clamping the leaflet 8; the second chuck 32 is on the push rod 34 Driven away from the first clamping head 31, the engagement is released, and the clamped leaflet 8 is released. The engagement or separation of the second chuck 32 from the first chuck 31 is achieved by pushing the push rod 34 , which can make the whole device compact, simple and reliable.

In another embodiment of the present application, please refer to FIG. 2 and FIG. 6 , the clamping assembly 3 further includes a detection rod 35 movably mounted in the fourth inner cavity 114 of the multi-lumen tube 11 , and the top end of the detection rod 35 is elastically extended. Out of the engaging surface 33 of the first chuck 31 , the corresponding position of the second chuck 32 has an insertion hole matched with the detection rod 35 , and the detection rod 35 is plugged into the insertion hole to limit the rotation of the detection rod 35 .

Specifically, in this embodiment, preferably, the number of detection rods 35 is two, and the two detection rods 35 are movably worn in the fourth inner cavity 114 of the multi-lumen tube 11, and the detection rods 35 can be moved relative to the fourth inner cavity. 114 to move axially, and also to rotate in the fourth inner cavity 114 . The top end of the detection rod 35 passes through the first chuck 31 and stretches out from the end face of the engaging 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 engaging surface 33 of the first chuck 31. out. At the position corresponding to the end surface of the engaging surface 33 of the second chuck 32 , there is an insertion hole for inserting the detection rod 35 . Specifically, the top part of the detection rod 35 is a polygonal rod structure, such as a triangular rod, a square rod, a hexagonal rod, etc. The connecting hole, the part 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 realized by sheathing a section of polygonal tube on a round rod.

During the process of the first clamp 31 and the second clamp 32 cooperating to capture and clamp the leaflet 8 , the function of the detection rod 35 is mainly to detect whether the leaflet 8 is successfully captured. Wherein, the top ends of the second chuck 32 and the detection rod 35 are arranged on both sides of the leaflet 8, and it is judged whether the leaflet 8 is inserted by judging whether the insertion hole on the second chuck 32 and the detection rod 35 can be inserted. capture. When fully captured, the second chuck 32 and the detection rod 35 are blocked by the leaflet 8 and cannot be inserted into each other, and the detection rod 35 can rotate in the fourth inner chamber 114, which indicates that the leaflet 8 is captured. When the leaflet 8 is not clamped or the clamping is incomplete, the second chuck 32 and the detection rod 35 can be inserted into each other. After the insertion, due to the multi-edge structure, the detection rod 35 is radially limited and cannot rotate. , when the detection rod 35 cannot be rotated, it indicates that the leaflet 8 is not captured successfully, and the position needs to be readjusted to capture and clamp the leaflet 8 .

The top end of the detection rod 35 has elasticity, and can be retracted and extended relative to the engaging surface 33 of the first chuck 31. Specifically, the elastic extension and retraction can be realized by covering the detection rod 35 with a spring. At 8 o'clock, under the action of the clamping force, the spring is compressed, and the top of the detection rod 35 is retracted into the engaging surface 33 of the first chuck 31, and the engagement of the first chuck 31 and the second chuck 32 is used to firmly clamp the flap. leaf 8.

In another embodiment of the present application, please refer to Fig. 11 and Fig. 12, the artificial chord implantation device further includes an anchor 5, the anchor 5 is detachably installed in the clamping assembly 3, the anchor 5 has a mounting ring 51, The installation ring 51 is passed through the puncture assembly 4 , and the anchor 5 is used to anchor the artificial chord 22 to the papillary muscle 9 .

Specifically, please refer to (a) to (c) in FIG. 12 . In this embodiment, the anchor 5 can be a commonly used helical anchor, or a barb anchor, an expansion anchor, etc., and there is no unique limitation here. One end of the anchor 5 has a mounting ring 51, and the puncture assembly 4 passes through the mounting ring 51 in advance. When the buckle part 421 of the puncture assembly 4 is engaged with the buckle 21 of the tendon assembly 2, the artificial tendon is pulled by the puncture assembly 4. When the cable 22 gradually pulls it out of the heart, the artificial chord 22 will pass through the installation ring 51. When the device is withdrawn to the vicinity of the papillary muscle 9, the anchor 5 can be anchored by adjusting the angle between the device and the papillary muscle 9. On the papillary muscle 9, and then move the device away from the papillary muscle 9, the anchor 5 can fall off from the clamping component 3 to complete the anchoring. Anchoring the artificial chord 22 to the papillary muscle 9 through the anchor 5 can make the implanted artificial chord 22 closer to the stress and movement state of the original chord, making the operation more effective and safe.

In another embodiment of the present application, please refer to FIG. 4 , the first chuck 31 has an accommodating cavity 313 , and the anchor piece 5 is embedded in the accommodating cavity 313 .

Specifically, in this embodiment, an accommodating cavity 313 is opened on the first chuck 31 for embedding the anchor piece 5 . The anchor piece 5 is embedded in the accommodating cavity 313 , and its anchoring end 52 is exposed outside the accommodating cavity 313 , and enables the puncture assembly 4 to pass through the installation ring 51 when performing puncture and suture. The anchor piece 5 is embedded in the accommodating cavity 313 in a detachable form. After the anchor piece 5 is anchored on the papillary muscle 9, the anchor piece 5 can be removed from the accommodating cavity 313 by moving the device away from the papillary muscle 9. Come off to complete the anchoring. The accommodating cavity 313 provides an installation chamber for the anchor piece 5, avoiding that the anchor piece 5 is completely exposed outside the first clip 31 during the implantation process of the artificial chord 22, which would cause damage to the valve leaflet 8 tissue. Trauma damage.

In another embodiment of the present application, please refer to FIG. 1 , the artificial chord implantation device further includes a control handle 6 and a control component 7 installed in the control handle 6 .

Specifically, in this embodiment, the control handle 6 is installed at the tail end of the multi-lumen tube 11 . The control handle 6 conforms to the ergonomic design and has a housing 61 that is easy to hold. Inside the housing 61, a pushing module matching the push rod 34, a pull wire slider matching the auxiliary tensioning wire 23, and a detection module are arranged respectively. The rotation control module matched with the rod 35 and the puncture pushing block matched with the puncture assembly 4 . The pushing module controls the pushing and pulling of the push rod 34 to realize the 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 realize the tension and loosening of the auxiliary tension wire 23, Thereby controlling the tension and loosening of the artificial chordae 22 in the first inner cavity 111; the rotation control module controls the rotation of the detection rod 35 to determine whether the detection rod 35 is inserted into the second chuck 32, thereby judging whether the valve leaflet 8 Whether it is successfully captured; the puncture push block controls the push and pull of the puncture needle 41 and the puncture tube 42 in the puncture assembly 4 to realize the axial movement of the puncture assembly 4 in the second lumen 112 .

The control components 7 are integrated into the outer shell 61 of the handle, so that the whole device is small and compact, which is more in line with the requirements of minimally invasive surgery for implanting the artificial chordae 22 .

In another embodiment of the present application, please refer to FIG. 12( d ), the chord assembly 2 further includes a spacer 24 for fixing the two free ends 221 of the artificial chord 22 outside the apex of the heart.

Specifically, in this embodiment, after the artificial chord 22 is sutured and knotted inside the heart, the artificial chord 22 protrudes out of the body under the pull of the puncture assembly 4, and the buckle 21 is removed, and the artificial tendon Both free ends 221 of the cord 22 protrude outside the body. After the anchorage of the artificial cord 22 on the papillary muscle 9 is completed, the artificial cord implantation device is moved out of the body. The end 221 is knotted and fixed on the outside of the apex of the heart, thereby completing the implantation of the entire artificial chord 22. The gasket 24 fixes the free end 221 of the artificial chord 22, so that the free end 221 of the artificial chord 22 can be firmly fixed on the outside of the apex. The risk of loosening of the free end 221 due to loose fixation is reduced, thereby reducing the immune reaction between the artificial chord 22 and the body tissue of the human body.

The working principle of the artificial chord implantation device provided by the present application is as follows: please refer to (a) to (c) in FIG. 10 and (a) to (d) in FIG. , the device enters the heart through a small incision at the apex of the heart, the valve leaflet 8 is captured and clamped by the clamping component 3 , and then punctured and sutured by the puncture component 4 . Specifically, it is judged by the detection rod 35 whether the valve leaflet 8 has been successfully captured and clamped. When the clamping assembly 3 firmly clamps the valve leaflet 8, firstly, the puncture needle 41 in the puncture assembly 4 is directed toward the target leaflet 8. Pushing, so that the puncture needle 41 passes through the ring portion 222, the target leaflet 8 in sequence, and pierces a small hole on the target leaflet 8, and then pushes the puncture tube 42 along the puncture needle 41 toward the direction of the target leaflet 8, so that The puncture tube 42 also passes through the annular portion 222 and the target valve leaflet 8 sequentially. The puncture tube 42 passes through the target valve leaflet 8 along the small hole pierced by the puncture needle 41 until the buckle part 421 on the puncture tube 42 and the chorda tendon assembly The buckle 21 of 2 is buckled together, and at this moment, the puncture tube 42 is connected with the buckle 21 and the artificial chord 22 as a whole. Then the puncture tube 42 and the puncture needle 41 are pulled back together, that is, pulled in the direction outside the heart, so that the buckle 21 and the artificial chord 22 are pulled out through the small hole on the target leaflet 8. At this time, the artificial chord 22. One end (that is, the free end 221) connected to the buckle 21 just passes through the annular part 222 where the artificial chord 22 is set in the first embedded groove 311, and pulls 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 wire 23 at the same time, so that the second folded end 223 of the artificial chord 22 in the third pre-embedded groove 312 is continuously shortened until the second folded end 223 disappears, that is, The fastening and knotting of the artificial chordae 22 on the leaflet 8 can be completed. While the artificial chord 22 stretches out of the body under the traction of the puncture assembly 4 and completes the knotting in the heart, the artificial chord 22 passes through the installation ring 51 of the anchor 5 under the traction of the puncture assembly 4, and the clamping end of the device Withdraw back to the vicinity of the papillary muscle 9, adjust the angle between the delivery mechanism 1 of the device and the left ventricular free wall, and under the guidance of the surgical image, fix the anchor 5 protruding outside the accommodation cavity 313 to the papillary muscle 9, and then move The device is far away from the papillary muscle 9, so that the anchor 5 can be separated from the accommodating cavity 313, and then the 3 ends of the clamping component of the device are withdrawn from the heart, while the free end 221 of the artificial chord 22 is also kept outside the body, and the artificial chord 22 is kept in place by using the spacer 24. 22 fixed on 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 in the heart at the same time, which reduces the operation time; A knot makes the artificial chord 22 fixed on the valve leaflet 8 more firmly, closer to the surgical standard; at the same time, one side of the artificial chord 22 is fixed on the papillary muscle 9 through the anchor 5, so that the artificially implanted tendon The stress and motion state of the cord is closer to that of the original tendon, which makes the operation more effective and safe.

The above descriptions are only preferred embodiments of the application, and are not intended to limit the application. Any modifications, equivalent replacements and improvements made within the spirit and principles of the application should be included in the protection of the application. within range.

Claims (10)

1. An artificial chord implantation device, characterized in that: comprising The delivery mechanism includes a multi-lumen tube, and the multi-lumen tube has multiple axially penetrating lumens; The chord assembly includes a buckle and an artificial chord, the artificial chord is folded in half at least twice, the two free ends of the artificial chord are connected to the buckle, and the artificial chord The first folded end is configured as an annular portion; The clamping assembly includes a first clamp disposed on the top end of the multi-lumen tube, and a second clamp capable of moving and engaging relative to the first clamp to clamp the leaflet, the first clamp has a first The embedded groove, the first embedded groove is annularly arranged on the first chuck, and the ring part is sleeved in the first embedded groove; the second chuck has a second embedded groove A buried groove, the second embedded groove communicates with the first embedded groove, and the buckle is placed in the second embedded groove; The puncture component is movably mounted in the multi-lumen tube, and the puncture component has a buckle portion; After the puncture component passes through the annular part and the valve leaflet in sequence, the buckle part and the buckle can be engaged; when the puncture component pulls back the buckle so that the two When the free end passes through the annular portion, the artificial chordae are knotted on the leaflet. 2. The artificial chord implantation device according to claim 1, characterized in that: said first chuck further comprises a third pre-embedded groove arranged axially along said multi-lumen tube, said third pre-embedded groove The groove communicates with the first embedded groove, and the second folded end of the artificial chord is placed in the third embedded groove. 3. The artificial chord implantation device according to claim 2, characterized in that: the chord assembly further includes an auxiliary tension wire, and the auxiliary tension wire is movably threaded through the first part of the multi-lumen tube. In the inner cavity, and the auxiliary tension wire is connected with the second folded end of the artificial chord. 4. The artificial chord implantation device according to claim 1, characterized in that: the puncture assembly includes a puncture tube and a puncture needle movably mounted in the puncture tube, and the puncture tube is movably mounted in the puncture tube. In the second lumen of the multi-lumen tube, the puncture tube has the buckle portion. 5. The artificial chord implantation device according to claim 1, characterized in that: the clamping assembly further comprises a push rod movably mounted in the third lumen of the multi-lumen tube, the first Both the chuck and the second chuck are passed through the push rod, and the push rod moves axially in the third inner cavity to drive the second chuck to engage with the first chuck or separation. 6. The artificial chord implantation device according to claim 5, characterized in that: the clamping assembly further comprises a detection rod movably worn in the fourth inner cavity of the multi-lumen tube, and the detection rod The top end elastically protrudes from the meshing surface of the first chuck, and the corresponding position of the second chuck has an insertion hole matching the detection rod, and the detection rod is inserted into the insertion hole to The rotation of the detection rod is restricted. 7. The artificial chord implantation device according to any one of claims 1 to 6, characterized in that: the artificial chord implantation device further comprises an anchor, and the anchor is detachably mounted on the clamping In the component, the anchor has a mounting ring, the mounting ring is passed through the puncture component, and the anchor is used to anchor the artificial chord to the papillary muscle. 8 . The artificial chord implantation device according to claim 7 , wherein the first clip has an accommodating cavity, and the anchor is embedded in the accommodating cavity. 9 . 9. The artificial chord implantation device according to claim 8, wherein the artificial chord implantation device further comprises a control handle and a control component installed in the control handle. 10. The artificial chord implantation device according to claim 9, characterized in that: the chord tendon assembly further comprises a spacer, and the spacer is used to fix the two free ends of the artificial chord tendon outside the apex of the heart.

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