CN115399917A

CN115399917A - Artificial chordae tendineae implanting device

Info

Publication number: CN115399917A
Application number: CN202111307032.2A
Authority: CN
Inventors: 黄辉
Original assignee: Hanxin Medical Technology Shenzhen Co ltd
Current assignee: Hanxin Medical Technology Shenzhen Co ltd
Priority date: 2021-11-05
Filing date: 2021-11-05
Publication date: 2022-11-29

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

Artificial chordae tendineae implanting device

Technical Field

The application belongs to the technical field of medical equipment, more specifically relates to an artificial chordae tendineae implantation device.

Background

The mitral valve is a complex tissue structure between the Left Atrium (LA) and the Left Ventricle (LV), and is composed of the mitral annulus, the anterior leaflet of the mitral valve, the posterior leaflet of the mitral valve, the chordae tendineae of the mitral valve, and papillary muscles. The mitral valve acts as a guard and ensures that blood can only flow from the left atrium to the left ventricle, but not vice versa. Mitral insufficiency is one of the most common heart valve diseases at present, and the main causes are rheumatic heart disease, mitral valve myxoid degeneration, ischemic heart disease, cardiomyopathy and the like, which cause the pathological changes of valve rings, valve leaflets, chordae tendineae and papillary muscles in the mitral valve structure, and finally cause the valve leaflets of the mitral valve to be not completely closed. Among the many factors that cause mitral insufficiency, lesions in the chordae tendineae or papillary muscles are common causes that lead to the inability of the leaflets of the mitral valve to close completely. A normal, healthy mitral valve has a plurality of chordae tendineae connected at one end to the leaflet edges and at the other end to papillary muscles located in the ventricular wall. When the left ventricle is in diastole, the anterior leaflet and the posterior leaflet of the mitral valve are opened, the chordae tendineae are in a relaxed state, and blood flows from the left atrium to the left ventricle; when the left ventricle is in the systolic phase, the anterior and posterior mitral valve coaptation is under the action of blood pressure, meanwhile, due to the pulling action of chordae tendinae, the valve leaflet can not overturn to the atrium side due to the blood pressure, and under the combined action of the valve leaflet and chordae tendineae, the blood flow channel between LA and LV is closed, and blood can only flow from the left ventricle to the aorta through the Aortic Valve (AV) and is sent to all organs of the whole body. When the chordae tendineae or papillary muscles are diseased or impacted by external force, part of the chordae tendineae is elongated or broken, and when the left ventricle contracts, the valve leaflets are overturned to one side of the atrium under the action of blood pressure due to the fact that the chordae tendineae is lost, so that the valve leaflets cannot be closely involuted, and blood backflow is generated, namely mitral regurgitation. Mild patients with mitral regurgitation have difficulty breathing or chest distress and chest pain during exercise, and severe patients have symptoms of edema of lower limbs, gastrointestinal congestion, liver pain, nausea, emesis, etc. It follows that mitral regurgitation caused by mitral chordae elongation or rupture has a significant impact on human health, requiring clinical intervention.

The surgery is an effective method for treating mitral insufficiency, and with the continuous improvement of medical level, the surgery is a more preferable choice for most heart diseases through minimally invasive intervention surgery at present, and the main intervention treatment modes comprise artificial chordae tendineae implantation, mitral valve annuloplasty, mitral valve edge-to-edge repair and the like. The artificial chordae tendineae implanted on the valve leaflets can effectively treat mitral insufficiency caused by chordae tendineae fracture, valve leaflet prolapse and the like, and meanwhile, the integrity of the physiological structure of the mitral valve can be kept.

The operation is implanted to current artifical chordae tendineae, often sews artifical chordae tendineae on the valve through artifical chordae tendineae implantation device, fixes artifical chordae tendineae through the mode of knoing. However, some of the existing artificial chordae tendineae implanting devices need to complete knotting in vitro and then send the knotted knots into the heart, and the method is complex in operation, high in operation difficulty and long in operation time; some methods suture a group of threads directly on the valve leaflets to pass through the valve as artificial chordae tendineae without winding and knotting, and the implanted artificial chordae tendineae are easy to loosen and unstable, so that satisfactory clinical effects cannot be obtained.

Disclosure of Invention

An object of the embodiment of the application is to provide a device is implanted to artifical chordae tendineae to solve the artifical chordae tendineae implantation device that exists among the prior art and can only fix artifical chordae tendineae and leaflet through the mode of knotting or only sewing up not knotting in vitro, thereby the operation that brings is complicated, implant the not good technical problem of effect.

In order to achieve the purpose, the technical scheme adopted by the application is as follows: there is provided an artificial chordae implantation device comprising:

the conveying mechanism comprises a multi-cavity tube, and a plurality of inner cavities which axially penetrate through the multi-cavity tube are formed in the multi-cavity tube;

the tendon assembly comprises a clamping piece and an artificial tendon, the artificial tendon is folded at least twice, two free ends of the artificial tendon are connected with the clamping piece, and a first folded end of the artificial tendon is arranged to be an annular part;

the clamping assembly comprises a first clamping head arranged at the top end of the multi-cavity tube and a second clamping head which can move and be engaged with the first clamping head to clamp the valve leaflets, the first clamping head is provided with a first embedded groove, the first embedded groove is annularly wound on the first clamping head, and the annular part is sleeved in the first embedded groove; the second chuck is provided with a second embedded groove, the second embedded groove is communicated with the first embedded groove, and the fastener is placed in the second embedded groove;

the puncture assembly is movably arranged in the multi-cavity tube in a penetrating manner and is provided with a buckling part;

after the puncture assembly sequentially penetrates through the annular part and the valve leaf, the buckling part and the buckling piece can be buckled; when the puncture component pulls back the fastener to enable the two free ends to pass through the annular part, the artificial chordae tendineae are knotted on the valve leaf.

Optionally, the first chuck further comprises a third pre-buried groove axially arranged along the multi-cavity tube, the third pre-buried groove is communicated with the first pre-buried groove, and the second folded end of the artificial chordae tendineae is placed in the third pre-buried groove.

Optionally, the tendon assembly further comprises an auxiliary tensioning line movably disposed through the first lumen of the multilumen tube, and the auxiliary tensioning line is connected with the second folded end of the artificial tendon.

Optionally, the puncture assembly includes puncture tube and activity dress in puncture needle in the puncture tube, puncture tube activity dress in the second inner chamber of multi-chamber pipe, puncture tube has the buckling part.

Optionally, the clamping assembly further comprises a push rod movably inserted into a third inner cavity of the multi-cavity tube, the first chuck and the second chuck are inserted into the push rod, and the push rod moves axially in the third inner cavity to drive the second chuck to engage with or separate from the first chuck.

Optionally, the clamping assembly further comprises a detection rod movably inserted into the fourth inner cavity of the multi-cavity tube, the top end of the detection rod elastically extends out of the engaging surface of the first chuck, an insertion hole matched with the detection rod is formed in the corresponding position of the second chuck, and the detection rod is inserted into the insertion hole to limit rotation of the detection rod.

Optionally, the artificial chordae implantation device further comprises an anchor member removably mounted within the clamping assembly, the anchor member having a mounting ring disposed through the penetrating assembly, the anchor member for anchoring the artificial chordae to the papillary muscle.

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

Optionally, the artificial chordae implantation device further comprises a manipulation handle and a manipulation assembly mounted within the manipulation handle.

Optionally, the tendon assembly further comprises a spacer for securing both of the free ends of the artificial tendon outside the apex of the heart.

The application provides a device is implanted to artifical chordae tendineae's beneficial effect lies in: compared with the prior art, the artificial chordae implantation device 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 chordae assembly is arranged, the artificial chordae is folded at least twice, a first folded end is arranged to be an annular part, and two free ends of the artificial chordae are fixed through a buckling part; the first pre-buried groove is arranged to annularly wind on a first chuck of the clamping assembly, a second pre-buried groove is formed in a second chuck, the second pre-buried groove is communicated with the first pre-buried groove, the annular part of the artificial tendon can be sleeved in the first pre-buried groove, and the buckling piece is placed in the second pre-buried groove, so that a complete pre-buried groove cavity channel is formed for pre-burying the tendon assembly; through set up buckle portion on the puncture subassembly for the puncture subassembly can with the buckle lock after passing annular portion and leaflet in proper order along multi-chamber pipe axial displacement, then when pulling back the buckle so that two free ends pass annular portion through the puncture subassembly, can accomplish the knotting of artifical chordae tendineae direct inside the viscera. The artificial chordae implantation device can simultaneously complete two steps of suturing and knotting of the artificial chordae inside the heart, on one hand, the step of knotting outside the body is saved, the operation difficulty is reduced, and the operation time is reduced; on the other hand, the artificial chordae tendineae are more firmly fixed on the valve leaflets, and the success rate of the operation is improved.

Drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings needed to be used in the embodiments or the prior art descriptions will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present application, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without inventive exercise.

Fig. 1 is a schematic view of the overall structure of an artificial chordae implantation device according to an embodiment of the present application;

FIGS. 2 (base:Sub>A) and (b) arebase:Sub>A side view,base:Sub>A sectional view taken along A-A, respectively, ofbase:Sub>A multi-lumen tube according to an embodiment of the present application;

figure 3 is a schematic view of the tendon assembly of an embodiment of the present application;

FIG. 4 is a schematic view of a first chuck according to an embodiment of the present disclosure;

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

FIG. 6 is a schematic view of the first and second jaws of an embodiment of the present application assembled together;

fig. 7 is a schematic longitudinal sectional view of a puncture assembly and chordae tendineae assembly of an embodiment of the present application as the leaflets are being sutured together;

fig. 8 is a schematic diagram of an artificial chordae tendineae intracardiac knot tying in accordance with an embodiment of the present application;

FIG. 9 is an enlarged partial schematic view of the spike assembly of the present embodiment of the application;

fig. 10 (a) to (c) are schematic views illustrating an intracardiac knotting process of the artificial chordae implantation device according to the embodiment of the present application; (a) accessing the heart for the device; (b) suturing the artificial chordae tendineae within the heart for the device; (c) tying the artificial chordae tendineae in the heart;

FIG. 11 is a schematic view of an anchor configuration according to an embodiment of the present application;

fig. 12 (a) to (d) are schematic views illustrating the anchoring process of the anchor member to the papillary muscle according to the embodiment of the present application; (a) extending the anchor; the anchoring piece is anchored on the papillary muscle; (c) In order to release the anchoring piece and pull the free end of the artificial chordae tendineae out of the body; (d) The free end of the artificial chordae tendineae is fixed outside the apex of the heart by a gasket.

Wherein, in the figures, the respective reference numerals:

1. a conveying mechanism; 11. a multi-lumen tube; 111. a first lumen; 112. a second lumen; 113. a third lumen; 114. a fourth lumen; 2. a tendon assembly; 21. a fastener; 22. artificial chordae tendineae; 221. a free end; 222. an annular portion; 223. a second folded end; 23. auxiliary tensioning lines; 24. a gasket; 3. a clamping assembly; 31. a first chuck; 311. a first pre-buried groove; 312. a third pre-buried groove; 313. an accommodating cavity; 32. a second chuck; 321. a second pre-buried groove; 322. an accommodating chamber; 33. a mating surface; 34. a push rod; 35. a probe rod; 4. a puncture assembly; 41. puncturing needle; 42. a puncture tube; 421. a fastening part; 5. an anchoring member; 51. a mounting ring; 52. an anchoring end; 6. a control handle; 61. a housing; 7. a manipulation component; 8. a leaflet; 9. the papillary muscles.

Detailed Description

In order to make the technical problems, technical solutions and advantageous effects to be solved by the present application clearer, the present 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 merely illustrative of the present application and are not intended to limit the present application.

It will be understood that when an element is referred to as being "secured to" or "disposed on" another element, it can 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 be indirectly connected to the other element.

It will be understood that the terms "length," "width," "upper," "lower," "front," "rear," "left," "right," "top," "bottom," "inner," "outer," and the like, as used herein, refer to an orientation or positional relationship indicated in the drawings for convenience in describing the present application and to simplify description, and do not indicate or imply that the referenced device or element must have a particular orientation, be constructed and operated in a particular orientation, and thus should not be considered limiting of the present application.

Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the present application, "a plurality" means two or more unless specifically limited otherwise.

Referring to fig. 1, 2, 3 and 8 together, an artificial chordae implantation device according to an embodiment of the present application will now be described. The artificial chordae tendineae implanting device comprises a conveying mechanism 1, a chordae tendineae assembly 2, a clamping assembly 3 and a puncture assembly 4. The delivery mechanism 1 comprises a multilumen tube 11, the multilumen tube 11 having a plurality of axially extending lumens therein. Specifically, the plurality of axially penetrating lumens are not coaxially arranged, and the multi-lumen tube 11 may be a single tube having a plurality of axially penetrating lumens inside. The multi-cavity tube 11 may also be composed of a large tube and a plurality of non-coaxial small tubes sleeved inside the large tube, two cover bodies are arranged at two ends of the large tube, and holes matched with the small tubes are formed in the cover bodies to position the small tubes. Of course, in other embodiments, the multilumen tubing 11 may be of other similar configurations.

Specifically, referring to fig. 3, the tendon assembly 2 includes a fastener 21 and an artificial tendon 22, the artificial tendon 22 is folded at least twice, two free ends 221 of the artificial tendon 22 are both connected to the fastener 21, and a first folded end of the artificial tendon is provided as a ring portion 222. Preferably, the artificial chorda 22 are provided using conventional surgical sutures. Folding a single complete artificial chordae 22 at least twice, connecting the two folded free ends 221 to the buckle 21, and connecting the artificial chordae 22 and the buckle 21 together by gluing or pressing and fastening; the first folded end after being folded in half is provided as a ring-shaped portion 222, and the ring-shaped portion 222 may be in the shape of a circular ring, an elliptical ring, or the like. The tail end is decided into to the one end that buckle spare 21 and artifical chorda tendineae 22 are connected, and mounting hole or mounting groove have been seted up to the tail end, and two free ends 221 of artifical chorda tendineae 22 all insert the mounting hole or the mounting groove of buckle spare 21 tail end in, this moment, artifical chorda tendineae 22 is a complete circle. The front end of the buckling piece 21 opposite to the tail end is provided with a buckling head, the buckling head is provided with a convex barb step, the barb step is used for buckling, and the front end of the buckling piece 21 is in an inverted cone shape with a smooth top. In other embodiments, other shapes of the snap-in element 21 may be used.

Specifically, referring to fig. 4, 5 and 7, the clamping assembly 3 includes a first clamping head 31 disposed at the top end of the multi-lumen tube 11 and a second clamping head 32 capable of moving and engaging with the first clamping head 31 to clamp the valve leaflet 8, the first clamping head 31 has a first pre-embedding slot 311, the first pre-embedding slot 311 is annularly wound on the first clamping head 31, and the annular portion 222 of the artificial chordae 22 is sleeved in the first pre-embedding slot 311; the second chuck 32 has a second pre-embedded groove 321, the second pre-embedded groove 321 is communicated with the first pre-embedded groove 311, and the fastener 21 is placed in the second pre-embedded groove 321.

Referring to figures 6 and 7, a first collet 31 of the clamping assembly 3 is connected to the top end of the multilumen tubing 11, wherein the top end of the multilumen tubing 11 is the end of the multilumen tubing 11 which enters the heart of the human body, a second collet 32 of the clamping assembly 3 is coaxially arranged with the first collet 31, and the second collet 32 and the first collet 31 have mutually matching engagement surfaces 33 therebetween, the second collet 32 being movable relative to the first collet 31 to effect engagement and disengagement with the first collet 31. When the artificial chordae 22 is implanted, the clamping assembly 3 is used for clamping the heart valve leaflet 8, specifically, when the valve leaflet 8 is clamped, the valve leaflet 8 is positioned on the engaging surface 33 of the first chuck 31 and the second chuck 32, and the second chuck 32 is close to the first chuck 31 and then engaged, so that the valve leaflet 8 can be clamped. The first chuck 31 is provided with a first pre-buried groove 311, the first pre-buried groove 311 is annularly wound on the first chuck 31, that is, the first pre-buried groove 311 is wound along the circumferential direction of the first chuck 31, preferably, the first pre-buried groove 311 is annularly wound on the end portion of the first chuck 31 close to the engaging surface 33, that is, the plane where the first pre-buried groove 311 is located is parallel to the engaging surface 33. The annular part 222 of the artificial chorda tendineae 22 is sleeved in the first pre-buried slot 311. The second chuck 32 is provided with a second pre-buried groove 321, the second pre-buried groove 321 is smoothly communicated with the first pre-buried groove 311 in appearance to form an integral artificial tendon 22 pre-buried cavity channel, the fastener 21 is placed in the second pre-buried groove 321, and the artificial tendon 22 is pre-buried in the first pre-buried groove 311 and the second pre-buried groove 321 to form a complete closed loop.

Preferably, the top of the second collet 32 is ellipsoidal, and the second collet 32 is used as a component of the whole device which is firstly contacted with the heart tissue of the human body, and the damage to the human body tissue needs to be reduced as much as possible, so that the surface of the ellipsoidal second collet 32 is smooth, and when the ellipsoidal second collet 32 is contacted with the human body tissue in the operation process, the friction between the device and the human body organ can be reduced as much as possible, and the human body organ is prevented from being damaged. The second pre-buried grooves 321 extend from the end of the engaging surface 33 of the second collet 32, across the top of the ellipsoidal second collet 32, and reach the other end of the engaging surface 33, and the starting end and the tail end of the second pre-buried grooves 321 are both on the engaging surface 33. The second pre-embedded groove 321 is arranged at the top of the second chuck 32, so that when the device enters the heart of a human body, the artificial chordae tendineae 22 in the second pre-embedded groove 321 obtain the maximum tension, and the device is not easy to loosen. Of course, in other embodiments, the second pre-embedded groove 321 may be opened at other positions of the second chuck 32 to ensure smooth communication with the first pre-embedded groove 311 in appearance, and to ensure that the fastener 21 located in the second pre-embedded groove 321 can be fastened to the fastening 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 pre-embedded groove 321, and in order to facilitate placing the fastener 21, an accommodating cavity 322 may be disposed at the starting end of the second pre-embedded groove 321, and the fastener 21 is placed in the accommodating cavity 322.

Preferably, the engaging surface 33 between the first clip 31 and the second clip 32 has a corrugated step or a concave-convex step with other shapes, so as to increase the holding area when holding the valve leaflet 8 and increase the friction between the engaging surface 33 and the valve leaflet 8, thereby making the holding more stable and not easy to loosen.

Preferably, the engagement surface 33 between the first jaw 31 and the second jaw 32 is inclined, i.e. the normal to the engagement surface 33 is at an angle to the axis of the multilumen tubing 11, which angle is too small or too large for a secure gripping of the valve leaflets 8 by experimental comparison, and therefore is preferably selected to be an angle of typically 30 to 60 degrees. Correspondingly, the plane of the first embedded groove 311 is also an inclined plane, so that the artificial chordae tendineae 22 can be easily separated from the first embedded groove 311 when the artificial chordae tendineae 22 are pulled and knotted.

Specifically, referring to fig. 2, 7 and 9, the puncture assembly 4 is movably inserted into the multi-lumen tube 11, the puncture assembly 4 has a latch portion 421, and after the puncture assembly 4 sequentially passes through the annular portion 222 and the valve leaflet 8, the latch portion 421 and the latch 21 can be latched; when the puncture assembly 4 pulls back the catch 21 so that the two free ends 221 pass through the loop 222, the artificial chordae 22 are knotted over the leaflets 8. Specifically, the puncture assembly 4 can move axially in the multi-lumen tube 11, and when the artificial chordae tendineae 22 are sutured with the valve leaflet 8, the puncture assembly 4 moves axially and passes through a plane where the first pre-embedding slot 311 of the first clamping head 31 is located, that is, after passing through the artificial chordae tendineae 22 annularly sleeved on the first pre-embedding slot 311, so that the fastening part 421 of the puncture assembly 4 is fastened with the fastening part 21 of the chordae tendineae assembly 2, and the puncture assembly 4, the fastening part 21 and the artificial chordae tendineae 22 are connected into a whole. The puncture assembly 4 is pulled back again, the fastening part 421 pulls the fastening part 21 to pass through the annular part 222 on the first pre-buried groove 311, and the puncture assembly 4 is pulled back continuously, so that the knotting of the artificial chordae tendineae 22 on the valve leaflets 8 can be completed.

Compared with the prior art, the artificial chordae implantation device provided by the application comprises a conveying mechanism 1, a chordae assembly 2, a clamping assembly 3 and a puncture assembly 4, wherein the clamping assembly 3 and the puncture assembly 4 are fixed through a multi-cavity tube 11 of the conveying mechanism 1, the chordae assembly 2 is arranged, the artificial chordae 22 is folded at least twice, a first folded end is arranged to be an annular part 222, and two free ends 221 of the artificial chordae 22 are connected with a buckling part 21; a first embedded groove 311 annularly wound on the first chuck 31 of the clamping assembly 3 is arranged on the first chuck 31, a second embedded groove 321 is arranged on the second chuck 32, the second embedded groove 321 is communicated with the first embedded groove 311, the annular part 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, so that a complete embedded groove cavity is formed for embedding the tendon assembly 2; through setting up buckle portion 421 on puncture subassembly 4 for puncture subassembly 4 can buckle with buckle 21 after passing annular portion 222 and leaflet 8 in proper order along multilumen tube 11 axial displacement, then when pulling back buckle 21 through puncture subassembly 4 so that two free ends 221 pass annular portion 222, can accomplish the knotting of artifical chorda tendineae 22 directly inside the internal organ. The artificial chordae implantation device can complete two steps of suturing and knotting of the artificial chordae 22 in the heart at the same time, on one hand, the steps of knotting in vitro are saved, the operation difficulty is reduced, and the operation time is reduced; on the other hand, the artificial chordae 22 is more firmly fixed on the valve, and the success rate of the operation is improved.

In another embodiment of the present application, referring to fig. 4, the first collet 31 further includes a third pre-embedding slot 312 axially disposed along the multi-lumen tube 11, the third pre-embedding slot 312 is communicated with the first pre-embedding slot 311, and the second folded end 223 of the artificial chorda tendineae 22 is placed in the third pre-embedding slot 312.

Specifically, in the present embodiment, since the multilumen tube 11 of the artificial chordae implantation device enters the inside of the heart from a small incision at the apex of the heart when the artificial chordae 22 is implanted, and the small incision is spaced from the valve leaflet 8 of the artificial chordae 22 to be implanted, a longer medical suture is usually used for the artificial chordae 22, and in the present embodiment, the length of the folded artificial chordae 22 is still greater than the distance between the small incision and the valve leaflet 8. Therefore, when the artificial chordae 22 is sutured with the leaflet 8, the length of the middle segment will be received by the third embedding slot 312 of the first clamp 31. The third pre-buried groove 312 is opened on the surface of the first chuck 31 and is axially arranged along the multi-cavity tube 11, and the third pre-buried groove 312 is communicated with the first pre-buried groove 311. After the artificial chordae tendineae 22 are sleeved in the first pre-buried groove 311, the redundant part is in a double-folded state, namely, the second folded end 223 has four artificial chordae tendineae 22 in total, and the second folded end 223 is placed in the third pre-buried groove 312. At this time, the first embedding slot 311, the second embedding slot 321 and the third embedding slot 312 are smoothly communicated in appearance, so that an integral artificial tendon 22 embedding slot is formed, in this state, the artificial tendon 22 is embedded in the annular first embedding slot 311 in a single state, the artificial tendon 22 is embedded in the second embedding slot 321 in two states, and the artificial tendon 22 is embedded in the third embedding slot 312 in four states. When the artificial chordae implantation device extends into the heart, the artificial chordae 22 are all in the pre-buried grooves, so that the surface of the multilumen tubing 11 is smooth, the friction between the device and the human organ is reduced, and the damage of the device to the human organ is avoided.

In another embodiment of the present application, referring to fig. 8, the tendon assembly 2 further includes an auxiliary tension line 23, the auxiliary tension line 23 is movably disposed in the first lumen 111 of the multi-lumen tube 11, and the auxiliary tension line 23 is connected to the second folded end 223 of the artificial tendon 22.

Specifically, in order to prevent the artificial chordae tendineae 22 from loosening in the first pre-buried groove 311, the second pre-buried groove 321 and the third pre-buried groove 312, and thus cause a surgical failure due to the inability to tie a knot, an auxiliary tension line 23 is provided in the first lumen 111 of the multilumen tube 11 for tensioning the artificial chordae tendineae 22. The auxiliary tension line 23 has one end fixed to the trailing end (the end opposite to the tip end) of the multilumen tubing 11 and the other end detachably connected to the second folded end 223 of the artificial chordae 22. The tensioning degree of the artificial chorda tendineae 22 in the embedded grooves can be adjusted by adjusting the length of the auxiliary tensioning line 23, and finally the artificial chorda tendineae 22 are adjusted to be tightly attached to the embedded grooves in the embedded grooves and not to loosen.

In another embodiment of the present application, referring to fig. 8 and 9, the puncture assembly 4 comprises a puncture tube 42 and a puncture needle 41 movably inserted into the puncture tube 42, the puncture tube 42 is movably inserted into the second lumen 112 of the multilumen tubing 11, and the puncture tube 42 has a latch 421.

Specifically, referring to fig. 2, in the present embodiment, the puncture assembly 4 includes a puncture tube 42 and a puncture needle 41, the puncture tube 42 is movably inserted into the second lumen 112 of the multi-lumen tube 11, the puncture needle 41 is movably inserted into the puncture tube 42, the puncture tube 42 is axially movable in the second lumen 112, the puncture needle 41 is axially movable in the puncture tube 42, and the tip of the puncture tube 42 has a fastening portion 421 that can be fastened to the fastening member 21. Specifically, the tip of the puncture tube 42 is formed in a pointed taper shape without a tip, and a hole is formed in the side wall of the tip of the puncture tube 42, and the hole is used as a locking portion 421 that can be locked to the locking member 21. When the puncture suture is performed, the puncture needle 41 firstly moves in the puncture tube 42 and penetrates a small hole on the valve leaflet 8, then the puncture tube 42 axially moves in the second inner cavity 112, and passes through the small hole on the valve leaflet 8 along with the puncture needle 41, the puncture tube 42 is continuously moved, so that the head part of the buckling piece 21 is inserted into the puncture tube 42, and the buckling part 421 at the top end of the puncture tube 42 is buckled with the buckling piece 21 of the chordae component 2.

Puncture tube 42 and pjncture needle 41 cooperate and form puncture subassembly 4, can make buckle joint position of buckle portion 421 and buckle 21 be in puncture tube 42 inside, and the surface after the two buckles is smooth, has reduced puncture subassembly 4 and has penetrated in the heart tissue, has worn out the damage to the tissue when wearing out for the wound area is littleer, changes the recovery.

Alternatively, in other embodiments, the puncture assembly 4 may also be a single puncture needle 41, and the tip of the puncture needle 41 has a latch 421 that can be latched with the latch 21. If the tip of the puncture needle 41 has a barb-like latch 421, the latch 21 has an opening corresponding to the barb-like latch 421.

In another embodiment of the present application, referring to fig. 2 and 6, the clamping assembly 3 further includes a push rod 34 movably inserted into a third inner cavity 113 of the multi-cavity tube 11, the first collet 31 and the second collet 32 are both inserted into the push rod 34, and the push rod 34 axially moves in the third inner cavity 113 to drive the second collet 32 to engage with or disengage from the first collet 31.

Specifically, in the present embodiment, the first collet 31 and the second collet 32 of the clamping assembly 3 are inserted into the third inner cavity 113 of the multi-lumen tube 11 through the push rod 34, and the second collet 32 is engaged with or disengaged from the first collet 31 by pushing the push rod 34 to move axially in the third inner cavity 113. Preferably, the push rod 34 is a smooth round rod, the number of the push rods 34 is two, and the first chuck 31 and the second chuck 32 are both provided with penetrating holes matched with the push rods 34. When actually holding the valve leaflet 8, the first collet 31 is fixedly connected to the top end of the multi-lumen tube 11, the valve leaflet 8 captured by the holding assembly 3 is positioned on the engagement surface 33 between the first collet 31 and the second collet 32, and the second collet 32 is driven by the push rod 34 to approach the first collet 31 and engage with the first collet 31, thereby clamping the valve leaflet 8; the second jaw 32 is moved away from the first jaw 31 by the pusher 34, thereby disengaging and releasing the clamped leaflet 8. The second chuck 32 is engaged with or separated from the first chuck 31 by pushing the push rod 34, so that the device is compact, simple and reliable.

In another embodiment of the present application, referring to fig. 2 and 6, the clamping assembly 3 further includes a detection rod 35 movably inserted into the fourth inner cavity 114 of the multi-cavity tube 11, a top end of the detection rod 35 elastically extends out of the engaging surface 33 of the first chuck 31, a corresponding position of the second chuck 32 has an insertion hole matching with the detection rod 35, and the detection rod 35 is inserted into the insertion hole to limit the rotation of the detection rod 35.

Specifically, in this embodiment, preferably, the number of the detection rods 35 is two, two detection rods 35 are movably inserted into the fourth inner cavity 114 of the multi-cavity tube 11, and the detection rods 35 can axially move relative to the fourth inner cavity 114 or rotate in the fourth inner cavity 114. The tip end of the detection rod 35 passes through the first chuck 31 and protrudes from the end surface of the engagement surface 33 of the first chuck 31, and the tip end of the detection rod 35 has elasticity to be retractable and extendable with respect to the engagement surface 33 of the first chuck 31. The second chuck 32 has a plug hole into which the detection rod 35 is inserted at a position corresponding to the end surface of the engagement surface 33. Specifically, the top part of the detecting rod 35 is a polygonal rod structure, such as a triangular rod, a square rod, a hexagonal rod, etc., correspondingly, the second chuck 32 also has an insertion hole matched with the top part of the detecting rod 35 in shape, the part of the detecting rod 35 located in the fourth inner cavity 114 is a round rod, and in an embodiment, the detecting rod 35 can be realized by sleeving a section of polygonal pipe on a round rod.

The detection rod 35 mainly serves to detect whether the leaflet 8 is successfully captured or not during the process of capturing and holding the leaflet 8 by the first clip 31 and the second clip 32 in cooperation. The top ends of the second chuck 32 and the detection rod 35 are respectively arranged at two sides of the valve leaflet 8, and whether the valve leaflet 8 is captured is judged by judging whether the insertion hole on the second chuck 32 and the detection rod 35 can be inserted. When fully captured, the second collet 32 and the probe rod 35 are blocked by the valve leaflet 8 and cannot be inserted into each other, and the probe rod 35 can rotate in the fourth lumen 114, indicating that the valve leaflet 8 is captured. When no valve leaflet 8 is clamped or the clamping is incomplete, the second chuck 32 and the detection rod 35 can be mutually inserted, after the insertion, the detection rod 35 is radially limited and cannot rotate due to the multi-edge structure, and when the detection rod 35 cannot rotate, the valve leaflet 8 is not captured successfully, and the position needs to be adjusted again to capture and clamp the valve leaflet 8.

The top end of the detection rod 35 has elasticity, and can retract and extend relative to the engagement surface 33 of the first chuck 31, specifically, the detection rod 35 can be sleeved with a spring to realize elastic extension and retraction, when the valve leaflet 8 is clamped, the spring is compressed under the action of the clamping force, the top of the detection rod 35 retracts into the engagement surface 33 of the first chuck 31, and the first chuck 31 is engaged with the second chuck 32 to firmly clamp the valve leaflet 8.

In another embodiment of the present application, referring to fig. 11 and 12, the artificial chordae tendineae implantation device further comprises an anchoring member 5, the anchoring member 5 is detachably mounted in the holding assembly 3, the anchoring member 5 has a mounting ring 51, the mounting ring 51 is arranged on the puncture assembly 4 in a penetrating manner, and the anchoring member 5 is used for anchoring the artificial chordae tendineae 22 to the papillary muscles 9.

Specifically, referring to fig. 12 (a) to (c), in the present embodiment, the anchor member 5 may be a conventional screw anchor, a barb anchor, an expansion anchor, or the like, which is not limited herein. The anchoring member 5 has a mounting ring 51 at one end, the puncture assembly 4 is pre-passed through the mounting ring 51, when the fastening portion 421 of the puncture assembly 4 is fastened to the fastening member 21 of the tendon assembly 2, the artificial tendon 22 is pulled by the puncture assembly 4 to be gradually pulled out of the heart, the artificial tendon 22 is passed through the mounting ring 51, when the device is withdrawn to the vicinity of the papillary muscle 9, the anchoring member 5 can be anchored on the papillary muscle 9 by adjusting the angular position of the device and the papillary muscle 9, and then the device is moved away from the papillary muscle 9, so that the anchoring member 5 can be separated from the holding assembly 3, and the anchoring is completed. Anchoring the artificial chordae 22 to the papillary muscles 9 by means of the anchors 5 allows the implanted artificial chordae 22 to be closer to the stress and movement of the native chordae, making the procedure more effective and safe.

In another embodiment of the present application, referring to fig. 4, the first collet 31 has a receiving cavity 313, and the anchor 5 is embedded in the receiving cavity 313.

Specifically, in the present embodiment, the first chuck 31 is provided with a receiving cavity 313 for embedding the anchor 5. The anchoring member 5 is embedded in the receiving cavity 313, and the anchoring end 52 thereof is exposed out of the receiving cavity 313, so that the puncture assembly 4 can pass through the mounting ring 51 when performing puncture suturing. The anchoring member 5 is detachably embedded in the accommodating cavity 313, and after the anchoring member 5 is anchored on the papillary muscle 9, the anchoring member 5 can fall off from the accommodating cavity 313 by moving the device away from the papillary muscle 9, so that anchoring is completed. The receiving cavity 313 provides a mounting cavity for the anchor 5, which avoids traumatic damage to the tissue of the leaflet 8 caused by the anchor 5 being completely exposed to the outside of the first collet 31 during implantation of the artificial chordae 22.

In another embodiment of the present application, referring to fig. 1, the artificial chordae tendineae implantation device further comprises a manipulation handle 6 and a manipulation assembly 7 mounted within the manipulation handle 6.

In particular, in this embodiment, the steering handle 6 is mounted to the rear end of the multilumen tubing 11. The control handle 6 is designed according to human engineering and is provided with a shell 61 convenient for holding by hand, and a pushing module matched with the push rod 34, a pull line slide block matched with the auxiliary tightening line 23, a rotation control module matched with the detection rod 35 and a puncture push block matched with the puncture assembly 4 are respectively arranged in the shell 61. The pushing module controls the push-pull push rod 34 to realize the axial movement of the push rod 34 in the third inner cavity 113; the tensioning and releasing of the auxiliary tensioning line 23 can be realized by controlling the pulling of the auxiliary tensioning line 23 by the wire pulling slider, so that the tensioning and releasing of the artificial chordae tendineae 22 in the first inner cavity 111 are controlled; the rotation control module controls the rotation of the detection rod 35, and can judge whether the detection rod 35 is inserted into the second chuck 32, so as to judge whether the valve leaflet 8 is successfully captured; the puncture push block controls the push-pull puncture needle 41 and the puncture tube 42 in the puncture assembly 4, and the puncture assembly 4 can axially move in the second inner cavity 112.

The integration of the control assemblies 7 into the housing 61 of the handle makes the whole device compact and more suitable for minimally invasive surgery of implantation of the artificial chordae 22.

In another embodiment of the present application, referring to fig. 12 (d), the tendon assembly 2 further comprises a spacer 24, the spacer 24 being used to fix the two free ends 221 of the artificial tendon 22 to the outside of the apex of the heart.

Specifically, in this embodiment, after suturing and knotting the artificial chordae 22 inside the heart, the artificial chordae 22 is pulled by the puncture assembly 4 to extend out of the body, the locking member 21 is removed, both free ends 221 of the artificial chordae 22 extend out of the body, after anchoring the artificial chordae 22 on the papillary muscle 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 outside the apex of the heart by the spacer 24, thereby completing implantation of the whole artificial chordae 22, and the spacer 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 outside the apex of the heart, thereby reducing the risk that the free ends 221 are loosened due to loose fixation, and further reducing the immune reaction between the artificial chordae 22 and the body tissue of the human body.

The application provides a device is implanted to artifical chordae tendineae's theory of operation does: referring to fig. 10 (a) to (c) and fig. 12 (a) to (d), when the artificial chordae 22 is implanted, 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 assembly 3, and then punctured and sutured by the puncturing assembly 4. Specifically, whether the valve leaflet 8 is successfully captured and clamped is judged through the detection rod 35, when the clamping assembly 3 firmly clamps the valve leaflet 8, the puncture needle 41 in the puncture assembly 4 is pushed towards the target valve leaflet 8, so that the puncture needle 41 sequentially passes through the annular portion 222 and the target valve leaflet 8, a small hole is formed in the target valve leaflet 8, then the puncture tube 42 is pushed towards the target valve leaflet 8 along the puncture needle 41, so that the puncture tube 42 also sequentially passes through the annular portion 222 and the target valve leaflet 8, the puncture tube 42 passes through the target valve leaflet 8 along the small hole formed by the puncture needle 41, until the buckling portion 421 on the puncture tube 42 is buckled with the buckling member 21 of the chordae assembly 2, and at this time, the puncture tube 42 is connected with the buckling member 21 and the artificial chordae 22 into a whole. The puncture tube 42 and the puncture needle 41 are pulled back together, i.e., pulled in the direction outside the heart, so that the fastening member 21 and the artificial chorda tendineae 22 are pulled out through the small hole on the target valve leaflet 8, at this time, one end (i.e., the free end 221) of the artificial chorda tendineae 22 connected with the fastening member 21 just passes through the annular portion 222 of the first pre-buried slot 311 where the artificial chorda tendineae 22 is sleeved, the artificial chorda tendineae 22 is pulled to the end of the control handle 6 and cut short, the artificial chorda tendineae 22 is pulled continuously, and the auxiliary tightening wire 23 is released at the same time, so that the second folded end 223 of the artificial chorda tendineae 22 in the third pre-buried slot 312 is shortened continuously until the second folded end 223 disappears, and the fastening and knotting of the artificial chorda tendineae 22 on the valve leaflet 8 can be completed. While the artificial chordae 22 is pulled by the puncture assembly 4 to extend out of the body and complete the intracardiac knotting, the artificial chordae 22 is pulled by the puncture assembly 4 to pass through the mounting ring 51 of the anchor 5, the holding 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, the anchor 5 extending out of the accommodating cavity 313 is fixed on the papillary muscle 9 under the guidance of the surgical image, the device is moved away from the papillary muscle 9, the anchor 5 can be separated from the accommodating cavity 313, the end of the holding assembly 3 of the device is withdrawn out of the heart, the free end 221 of the artificial chordae 22 is also kept out of the body, and the artificial chordae 22 is fixed on the outer side of the apex of the heart by using the gasket 24. In this way, the suturing, knotting and anchoring of the entire artificial chordae tendineae 22 on the heart valve leaflets 8 are completed, and the suturing and knotting are completed simultaneously in the heart, reducing the operation time; tying the artificial chordae 22 to the heart valve leaflets 8 to make the artificial chordae 22 more firmly fixed to the valve leaflets 8, closer to the standard of surgery; meanwhile, one side of the artificial chordae 22 is fixed on the papillary muscle 9 through the anchoring piece 5, so that the artificially implanted chordae are closer to the stress and motion state of the primary chordae, and the operation has higher effectiveness and safety.

The above description is only exemplary of the present application and should not be taken as limiting the present application, as any modification, equivalent replacement, or improvement made within the spirit and principle of the present application should be included in the protection scope of the present application.

Claims

1. An artificial chordae tendineae implantation device, comprising: comprises that

the puncture assembly is movably arranged in the multi-cavity tube in a penetrating mode and is provided with a buckling part;

after the puncture assembly sequentially penetrates through the annular part and the valve leaf, the buckling part and the buckling piece can be buckled; when the puncture assembly pulls back the fastener so that the two free ends pass through the annular part, the artificial chordae tendineae are knotted on the valve leaf.

2. The artificial chordae implantation device of claim 1, wherein: the first chuck further comprises a third embedded groove axially arranged on the multi-cavity pipe, the third embedded groove is communicated with the first embedded groove, and the second opposite folding end of the artificial chordae tendineae is placed in the third embedded groove.

3. The artificial chordae implantation device of claim 2, wherein: the tendon assembly further comprises an auxiliary tensioning line, the auxiliary tensioning line is movably arranged in the first inner cavity of the multi-cavity tube in a penetrating mode, and the auxiliary tensioning line is connected with the second folded end of the artificial tendon.

4. The artificial chordae implantation device of claim 1, wherein: the puncture assembly comprises a puncture tube and a puncture needle movably arranged in the puncture tube, the puncture tube is movably arranged in the second inner cavity of the multi-cavity tube in a penetrating mode, and the puncture tube is provided with the buckling part.

5. The artificial chordae implantation device of claim 1, wherein: the clamping assembly further comprises a push rod movably arranged in a third inner cavity of the multi-cavity tube in a penetrating mode, the first chuck and the second chuck are arranged on the push rod in a penetrating mode, and the push rod moves axially in the third inner cavity to drive the second chuck to be meshed with or separated from the first chuck.

6. The artificial chordae implantation device of claim 5, wherein: the clamping assembly further comprises a detection rod movably arranged in a fourth inner cavity of the multi-cavity tube in a penetrating mode, the top end of the detection rod elastically extends out of the meshing surface of the first chuck, a plug-in hole matched with the detection rod is formed in the corresponding position of the second chuck, and the detection rod is plugged with the plug-in hole to limit rotation of the detection rod.

7. The artificial chordae implantation device of any one of claims 1 to 6, wherein: the artificial chordae tendineae implantation device further comprises an anchoring piece, wherein the anchoring piece is detachably arranged in the clamping component and is provided with a mounting ring, the mounting ring penetrates through the puncture component, and the anchoring piece is used for anchoring the artificial chordae tendineae on papillary muscles.

8. The artificial chordae implantation device of claim 7, wherein: the first chuck is provided with an accommodating cavity, and the anchoring piece is embedded in the accommodating cavity.

9. The artificial chordae implantation device of claim 8, wherein: the artificial chordae implantation device further comprises a control handle and a control assembly arranged in the control handle.

10. The artificial chordae implantation device of claim 9, wherein: the chordae assembly further comprises a spacer for securing the two free ends of the artificial chordae outside the apex of the heart.