Valve apico-patch adjustment system

Abstract

The present application belongs to the technical field of medical devices, and particularly relates to a valve heart apex gasket adjusting system, which comprises a torque handle, and the torque handle comprises: an isolation mechanism, which has a torque transmission rod capable of driving a driving part of a valve heart apex gasket, the torque transmission rod is capable of rotating around an axis, and the torque transmission rod drives the driving part of the valve heart apex gasket to rotate when rotating; and a clamping mechanism, which is capable of clamping the valve heart apex gasket. The torque handle of the present application locks the shell of the valve heart apex gasket through the clamping structure, the torque transmission rod of the present application is detachably connected with the valve heart apex gasket, so as to transmit torque and drive the driving end of the valve heart apex gasket to rotate, thereby enabling the heart apex rope to be wound on the valve heart apex gasket to form a certain tension. Due to the arrangement of the isolation mechanism, the valve heart apex gasket can be operated externally through the arrangement of the torque transmission rod when being operated, the hands of the operator do not need to be inserted into the chest cavity of the human body, and the risk of surgical infection is greatly reduced.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to a valve apex pad adjustment system. Background Technology

[0002] Mitral / tricuspid regurgitation is a heart valve disease in which the valves between the two chambers of the heart cannot close properly, causing blood to leak backward and flow through the valves. Mitral / tricuspid regurgitation can cause harm to the body and even threaten life, and mitral / tricuspid valve replacement has become an effective treatment method.

[0003] In some heart valve replacement surgeries, an apical cord is required. One end of the cord is connected to the replacement valve, and the other end extends to the outside of the heart and is fixed to the lateral side of the heart by an apical spacer. The apical cord prevents the replacement valve from being squeezed into the atrium when it closes. The tension required by the apical cord is crucial. Different physiological valve annulus sizes and different systolic pressures result in different loads on the apical spacer. Traditionally, the surgeon's experience is the only reliable method. During the operation, repeated ultrasound examinations are used to check for paravalvular leakage and determine if the apical cord is tightened appropriately. This method requires a high level of experience from the surgeon, and due to the lack of guidance, if the tension of the apical cord is too low, it can cause paravalvular leakage of the replacement valve, resulting in valve regurgitation and surgical failure. On the other hand, if the tension is too high, the heart valve may be pulled out to the ventricular side, increasing surgical risks. It can even compress the size of the heart, causing excessive compression of the myocardium and preventing it from functioning properly. In severe cases, it can cause myocardial damage and heart failure.

[0004] At the same time, the operation of the apical patch can also affect the valve replacement surgery. The apical patch is generally limited in size and is close to the heart, so the operating space is limited. It is usually operated with forceps, which is not only difficult to operate, but also requires the hand to be inserted into the chest cavity, increasing the risk of surgical infection. Summary of the Invention

[0005] This invention addresses the technical problem that existing apical valvular ...

[0006] To address the aforementioned technical problems, a first aspect of the present invention provides a valve apex septum adjustment system, the valve apex septum adjustment system comprising a torque handle, the torque handle comprising:

[0007] An isolation mechanism having a torsion rod that can drive the drive portion of the apical valve inserter, the torsion rod being rotatable about an axial direction, the torsion rod rotating causing the drive portion of the apical valve inserter to rotate;

[0008] a clamping mechanism that can clamp the valve apical patch.

[0009] Optionally, in the valve apical patch adjusting system as described above, the clamping mechanism comprises:

[0010] a plurality of clamping members, the middle part of the clamping member is rotationally connected with the distal end of the isolation mechanism, the proximal end of the clamping member is provided with an elastic element, the elastic element is arranged between the clamping member and the isolation mechanism, by pressing the proximal end of the clamping member close to the isolation mechanism, the clamping member rotates, causing the distal end of the clamping member to open, when the force pressing the clamping member is released, the distal end of the clamping member is closed under the action of the elastic element, thereby clamping the valve apical patch.

[0011] Optionally, in the valve apical patch adjusting system as described above, the plurality of clamping members are arranged in pairs opposite to each other or uniformly arranged around the axis.

[0012] Optionally, in the valve apical patch adjusting system as described above, the proximal end of the clamping member and the isolation mechanism are respectively provided with built-in grooves, and the two ends of the elastic element are respectively arranged in the corresponding built-in grooves.

[0013] Optionally, in the valve apical patch adjusting system as described above, the proximal end of the clamping member and the isolation mechanism are respectively provided with built-in grooves that are nested with each other, and the elastic element is limited in the nested built-in grooves.

[0014] Optionally, in the valve apical patch adjusting system as described above, the distal end of the isolation mechanism is provided with a limiting part, the limiting part is located on the distal side of the rotation connection between the clamping member and the isolation mechanism, and on the inner side of the clamping member.

[0015] Optionally, in the valve apical patch adjusting system as described above, the distal end of the clamping member is provided with a stabilizing part, and the inner contour of the stabilizing part is used to match the contour of the valve apical patch.

[0016] Optionally, in the valve apical patch adjusting system as described above, the inner contour surface of the stabilizing part is provided with an enhancement layer that increases the friction of the inner contour of the stabilizing part, and the enhancement layer is at least one or a combination of a plurality of combinations of bosses, stripes, grooves, frosted treatment, rubber pieces, and silicone pieces.

[0017] Optionally, in the valve apical patch adjusting system as described above, the inner contour of the stabilizing part is provided with a convex column, a concave groove, or a through hole.

[0018] Optionally, in the valve apical patch adjusting system as described above, the isolation mechanism further comprises:

[0019] An isolation rod, the length of which is axial, is rotatably connected to the middle of the clamping member at its distal end. The isolation rod is provided with a torsion transmission rod inside, and the isolation rod has through holes at its distal and proximal ends. The torsion transmission rod extends out from the through holes at the distal and proximal ends of the isolation rod.

[0020] Optionally, in the valve apical pad adjustment system as described above, the distal end of the torsion bar is provided with an operating end, and the distal end of the operating end is provided with a insert or slot.

[0021] Optionally, in the valve apical pad adjustment system described above, a limiting ring is provided at the proximal end of the torsion transmission rod. The limiting ring is located inside the isolation rod. A first elastic element is provided between the proximal end of the limiting ring and the isolation rod. When the torsion transmission rod is connected to the driving part of the valve apical pad, the first elastic element is in a compressed state. By the first elastic element pressing against the limiting ring, the distal end of the torsion transmission rod is pressed against the driving part of the valve apical pad.

[0022] Optionally, in the apical valve pad adjustment system described above, the apical valve pad adjustment system further includes:

[0023] A torque meter, the output end of which is connected to the proximal end of the torsion bar, drives the torsion bar to rotate axially within a preset torque range.

[0024] To address the aforementioned technical problems, a second aspect of the present invention provides a torque meter for a valve apical ventricular pad adjustment system, the torque meter comprising:

[0025] The distal end of the engagement disc is connected to the proximal end of the torsion bar, and the proximal end of the engagement disc is provided with engagement teeth.

[0026] A main meshing disc, wherein meshing teeth are provided at the distal end of the main meshing disc, and the meshing teeth of the main meshing disc can mesh with the meshing teeth of the slave meshing disc to transmit torque;

[0027] A second elastic element is used to apply a distal force to the main engagement disc, causing the engagement teeth of the main engagement disc to engage with the engagement teeth of the slave engagement disc initially.

[0028] Optionally, in the torque meter of the valve apex pad adjustment system as described above, the torque meter further includes:

[0029] The outer casing is rotatably connected to the slave meshing disc, and the master meshing disc is axially slidably connected inside the outer casing, with the outer casing driving the master meshing disc to rotate around the axial direction.

[0030] Optionally, in the torque instrument of the valve heart apex patch adjustment system as described above, the two ends of the second elastic member are abutted between the proximal end of the main engaging disc and the inner side of the shell, and the second elastic member is in compression at the beginning.

[0031] Optionally, in the torque instrument of the valve heart apex patch adjustment system as described above, the distal end of the slave engaging disc is provided with an output shaft, and the slave engaging disc is connected to the proximal end of the torque transmission rod through the output shaft.

[0032] Optionally, in the torque instrument of the valve heart apex patch adjustment system as described above, the slave engaging disc is rotationally connected to the shell through a bearing.

[0033] Optionally, in the torque instrument of the valve heart apex patch adjustment system as described above, a concentric shaft is arranged between the main engaging disc and the slave engaging disc, the proximal end of the concentric shaft is connected to the shaft center of the main engaging disc, and the distal end of the concentric shaft is axially slidably connected to the shaft center of the slave engaging disc, and when the concentric shaft is driven to rotate by the main engaging disc, the concentric shaft rotates relative to the slave engaging disc.

[0034] Optionally, in the torque instrument of the valve heart apex patch adjustment system as described above, a concentric shaft is arranged between the main engaging disc and the slave engaging disc, the distal end of the concentric shaft is connected to the shaft center of the slave engaging disc, and the proximal end of the concentric shaft is axially slidably connected to the shaft center of the main engaging disc, and when the main engaging disc rotates, the main engaging disc rotates relative to the concentric shaft.

[0035] Optionally, in the torque instrument of the valve heart apex patch adjustment system as described above, the torque instrument further comprises:

[0036] an adjustment shaft rotationally connected in the shell, the proximal end of the adjustment shaft extending out of the shell;

[0037] a stopper threadedly connected to the adjustment shaft, the stopper arranged in the shell and axially slidably connected to the shell, the stopper located above the main engaging disc, and the distal end of the stopper abutted by the second elastic member.

[0038] Optionally, in the torque instrument of the valve heart apex patch adjustment system as described above, the middle part of the adjustment shaft has an inner hole, and when the proximal end of the concentric shaft is connected to the shaft center of the main engaging disc, the concentric shaft penetrates the proximal end of the main engaging disc and extends into the inner hole of the adjustment shaft.

[0039] Optionally, in the torque instrument of the valve heart apex patch adjustment system as described above, a mark is arranged on the stopper, and an observation window and a scale for displaying the position of the mark are arranged on the shell.

[0040] The positive progress effect of the application is that:

[0041] 1、The torque handle of the application is connected with the valve apical pad through the clamping structure and the locking valve apical pad shell, the torque transmission rod of the application is detachably connected with the valve apical pad, so that the torque can be transmitted to drive the driving end of the valve apical pad, such as the rotating disc, to rotate, so that the apical cord is wound on the valve apical pad to form a certain tension. Due to the arrangement of the isolation mechanism, the valve apical pad can be operated externally through the arrangement of the torque transmission rod during operation, and the hands of the operator do not need to be inserted into the chest cavity of the human body, thereby greatly reducing the risk of surgical infection.

[0042] 2、In order to prevent the elastic element from falling off, especially the device operated in the chest cavity, the falling off of any part of the device is risky, therefore, the built-in groove is arranged at the position of the clamping piece corresponding to the elastic element and the isolation mechanism, and the elastic element is arranged in the built-in groove. In particular, the built-in grooves are nested with each other, the elastic element is hidden in the built-in grooves, and the elastic element is prevented from being separated from the system, the nested built-in grooves can move relative to each other, and the compression and elongation of the elastic element are not affected.

[0043] 3、The limiting part is arranged at the distal end of the isolation mechanism, which can prevent the built-in groove from being invalid, that is, prevent the built-in groove from being opened too large to lose the function of the built-in groove, and can limit the closing degree of the distal end of the clamping piece to prevent excessive clamping force on the valve apical pad.

[0044] 4、The stabilizing part at the distal end of the clamping piece can be attached to the contour of the valve apical pad; the reinforcing layer is arranged to increase the friction force of the contour in the stabilizing part, thereby increasing the stability of the stabilizing part and the valve apical pad.

[0045] 5、In order to prevent the torque transmission rod from being separated from the valve apical pad during rotation, the limiting ring and the first elastic element are arranged at the proximal end of the torque transmission rod, the first elastic element is in a compressed state when the torque transmission rod is connected with the valve apical pad, the distal end of the torque transmission rod is abutted on the valve apical pad by abutting against the limiting ring, and the separation of the torque transmission rod during driving the valve apical pad is prevented, when separation is needed, the proximal end of the torque transmission rod is pulled to further compress the first elastic element, so that the torque transmission rod and the valve apical pad can be separated.

[0046] 6、The torque handle is operated by the torque instrument, so as to prevent the torque handle from generating excessive torque on the valve apical pad to cause excessive tension of the apical cord, that is, the tension of the apical cord can be effectively controlled by operating the torque handle by the torque instrument.

[0047] 7. Since sterilization processes can easily damage electronic components, the torque meter of this invention differs from traditional torque meters that use electronic components. The torque meter of this invention employs a purely mechanical design to limit the torque of the torque handle. Furthermore, this purely mechanical torque meter differs from industrial-grade products; existing industrial-grade torque meters are not suitable for the medical industry and lack suitable interfaces for direct connection to medical devices. Therefore, this invention designs a torque meter adapted for implantable devices.

[0048] The torque meter of the present invention drives the torque handle to operate the valve apex pad by rotating the main engagement disc and the slave engagement disc. When the torque fed back by the torque handle to the valve apex pad increases to a certain level, the main engagement disc will be pushed up. At this time, the main engagement disc will be unable to provide driving force to the slave engagement disc, thereby preventing the valve apex pad cord from being over-tightened.

[0049] 8. The outer casing is designed to protect both the main and slave meshing discs, and the main meshing disc can be rotated directly by rotating the outer casing.

[0050] 9. To ensure the coaxial rotational stability of the main and driven meshing discs, a concentric shaft is provided between them. Furthermore, when the concentric shaft extends into the inner hole of the adjusting shaft, multiple components can be sequentially connected via a single central shaft, thus making the entire torque meter more stable.

[0051] 10. In order to adjust the torque of the torque meter, the torque meter also includes an adjusting shaft and a stop. By rotating the adjusting shaft, the stop connected to it by threads can move up or down under the action of thread engagement, thereby further adjusting the elastic force of the second elastic element, thus achieving the function of adjusting the torque of the torque meter.

[0052] 11. The present invention allows the operator to observe the positional relationship between the scale and the markings on the stop through the observation window, thereby determining the torque corresponding to the torque meter and providing the operator with a more intuitive view of the current torque status. Attached Figure Description

[0053] The disclosure of this invention will become more apparent from the accompanying drawings. It should be understood that these drawings are for illustrative purposes only and are not intended to limit the scope of protection of this invention. In the drawings:

[0054] Figure 1 This is a front view of the present invention;

[0055] Figure 2(a) shows Figure 1 A sectional view;

[0056] Figure 2(b) is a partial schematic diagram of point A in Figure 2(a);

[0057] Fig. 2(c) is a partial view of Fig. 2(a) at B;

[0058] Figure 3 Fig. 3 is a perspective view of the present application;

[0059] Fig. 4(a) is a partial exploded view of Figure 3 Fig. 4(b) is another perspective view of Fig. 4(a);

[0060] Fig. 4(c) is a partial view of Fig. 4(b) at C;

[0061] Fig. 5(a) is another perspective view of the present application;

[0062] Fig. 5(b) is a partial view of Fig. 5(a) at D;

[0063] Fig. 6(a) is another perspective view of the present application;

[0064] Fig. 6(b) is a partial view of Fig. 6(a) at E;

[0065] Fig. 7(a) is a sectional view of a torque meter of the present application;

[0066] Fig. 7(b) is a partial view of Fig. 7(a) at F;

[0067] Fig. 8 is a schematic view of the working principle of the master engaging disc and the slave engaging disc of the present application;

[0068] Figure 8 Fig. 9(a) is an exploded view of a torque meter of the present application;

[0069] Fig. 9(b) is another perspective view of Fig. 9(a);

[0070] Fig. 10 is a schematic view of the connection relationship between the master engaging disc and the concentric shaft of the present application;

[0071] Figure 10 Fig. 11 is a schematic view of the connection relationship between the master engaging disc and the concentric shaft of the present application;

[0072] Figure 11 Fig. 12 is a schematic view of the structure of a valve heart apex patch;

[0073] Figure 12 Fig. 13 is a schematic view of the application of the present application. DETAILED DESCRIPTION

[0074] The present application is described in detail by specific examples, and those skilled in the art can easily understand other advantages and effects of the present application from the disclosure. The present application can also be implemented or applied by different specific embodiments, and the details in the specification can be modified or changed based on different views and applications without departing from the spirit of the present application.

[0075] It should be noted that the following embodiments and features in the embodiments can be combined with each other in the case of no conflict.

[0076] In the description of the present application, it should be noted that, for the orientation words, such as the terms "outer side", "middle section", "inner", "outer", etc. indicate the orientation and positional relationship based on the orientation or positional relationship shown in the drawings, which is only for the convenience of describing the present application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and cannot be understood as limiting the specific protection scope of the present application.

[0077] In addition, if the terms "first", "second" are used for description purposes only, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features. Therefore, the "first", "second" features defined can explicitly or implicitly include one or more features, and in the description of the present application, the meaning of "several", "several" is two or more, unless otherwise explicitly and specifically limited.

[0078] It should be noted that "distal", "proximal", "distal section", "proximal section" are used as orientation words in the present application, which are common terms in the field of interventional medical devices, wherein "distal", "distal section" means that the distal end or section of the valve apical patch adjustment system or torque instrument is away from the operator during the operation, and "proximal", "proximal section" means that the proximal end or section of the valve apical patch adjustment system or torque instrument is close to the operator during the operation. "Axial" refers to the direction parallel to the center line connecting the distal center and the proximal center of the valve apical patch adjustment system or torque instrument; "radial" refers to the direction perpendicular to the "axial" direction.

[0079] Referring to Figure 1 The embodiment of the present application provides a valve apical patch adjustment system, which comprises a torque handle, and the torque handle comprises an isolation mechanism 100 and a clamping mechanism 200.

[0080] The isolation mechanism 100 comprises a torque transmission rod 110, the torque transmission rod 110 can rotate around the axial direction, the torque transmission rod 110 can drive the driving part of the valve apical patch, and the torque transmission rod 110 drives the driving part of the valve apical patch to rotate when rotating. The clamping mechanism 200 can clamp the valve apical patch, so that when the torque transmission rod 110 drives the driving part of the valve apical patch to rotate, the valve apical patch is fixed and kept stationary by the clamping mechanism 200, and only the driving part rotates.

[0081] When the transmission torque rod 110 drives the driving part of the valve apex pad, the transmission torque rod 110 can be detachably connected with the valve apex pad, so as to transmit the torque and drive the driving end of the valve apex pad to rotate, so as to make the apex rope wrap around the valve apex pad to form a certain tension. The axial length of the transmission torque rod 110 can be set according to actual needs. Due to the arrangement of the isolation mechanism 100, the valve apex pad can be operated outside the body when being operated, and the hands of the operator do not need to be deep into the chest cavity of the human body, thereby greatly reducing the risk of surgical infection.

[0082] In some embodiments, the clamping mechanism 200 of the present application can adopt the structure capable of clamping the valve apex pad in the prior art. Preferably, the clamping mechanism 200 is designed as follows.

[0083] Referring to Figures 2(a) to 6(b) , the clamping mechanism 200 comprises a plurality of clamping members 210 and a plurality of elastic elements 220. The middle part of the clamping member 210 is rotationally connected with the distal end of the isolation mechanism 100, and the proximal end of the clamping member 210 is provided with the elastic element 220. The elastic element 220 is arranged between the clamping member 210 and the isolation mechanism 100. By pressing the proximal end of the clamping member 210 close to the isolation mechanism 100, the clamping member 210 rotates, so that the distal end of the clamping member 210 is opened. When the pressing force of the clamping member 210 is released, the distal end of the clamping member 210 is closed under the action of the elastic element 220, so as to clamp the valve apex pad.

[0084] In some embodiments, the plurality of clamping members 210 are arranged in pairs opposite to each other or uniformly arranged around the axial direction.

[0085] The number of clamping members 210 can be determined according to the size of the valve apex pad to be clamped and / or the tightening force requirement. For example, as Figure 3 shown, the clamping mechanism 200 has two clamping members 210, which are arranged opposite to each other on the distal end side of the isolation mechanism 100.

[0086] In some embodiments, referring to FIG. 2(b) and FIG. 4(a), in order to prevent the elastic element 220 from falling off, especially for the equipment operated in the chest cavity, the falling off of any part of the equipment is risky. Therefore, the built-in slot 211 is arranged at the proximal end of the clamping member 210, and the built-in slot 111 is arranged on the isolation mechanism 100. The built-in slot 111 and the built-in slot 211 are arranged opposite to each other inside and outside, the inner end of the elastic element 220 is arranged in the built-in slot 111, and the outer end of the elastic element 220 is arranged in the built-in slot 211.

[0087] In some embodiments, the built-in slot 111 and the built-in slot 211 are mutually nested built-in slots, and the elastic element 220 is limited in the mutually nested built-in slots. By using the mutually nested built-in slots, the elastic element 220 is hidden inside, preventing it from being separated from the system, and the nested built-in slots can move relative to each other without affecting the compression and elongation of the elastic element 220.

[0088] In some embodiments, the elastic element 220 is a spring or a spring piece.

[0089] In some embodiments, the elastic element 200 and the space for its movement are provided between the clamping member 210 and the isolation mechanism 100. The space can be formed by expanding the outer contour of the clamping member 210 or by reducing the inner dimension of the outer contour of the isolation mechanism 100.

[0090] In some embodiments, referring to FIG. 2(b) and FIG. 4(c), the distal end of the isolation mechanism 100 is provided with a limiting portion 120, which is located on the distal side of the rotating connection between the clamping member 210 and the isolation mechanism 100, and is located on the inner side of the clamping member 210. By providing the limiting portion 120 at the distal end of the isolation mechanism 100, firstly, the built-in slot is prevented from being ineffective, i.e., the built-in slot is prevented from opening too wide and losing its function; secondly, the closing degree of the distal end of the clamping member 210 is limited, preventing excessive clamping force on the valve heart apex pad.

[0091] In some embodiments, referring to FIG. 2(b) and Figure 3 , the distal end of the clamping member 210 is provided with a stabilizing portion 212, and the inner contour of the stabilizing portion 212 is used to fit the contour of the valve heart apex pad.

[0092] For example, if the contour of the valve heart apex pad is circular, then the inner contour of the stabilizing portion 212 is also circular or arc-shaped.

[0093] In some embodiments, the inner contour surface of the stabilizing portion 212 is provided with an enhancement layer 213 that increases the friction of the inner contour of the stabilizing portion 212. The enhancement layer 213 is at least one or a combination of a plurality of combinations of protrusions, stripes, grooves, frosted treatment, rubber pieces, and silicone pieces. By providing the enhancement layer 213, the friction of the inner contour of the stabilizing portion 212 is increased, thereby increasing the stability of the stabilizing portion 212 in gripping the valve heart apex pad.

[0094] As shown in FIG. 5(a) and FIG. 5(b), a plurality of protrusions are provided on the inner contour surface of the stabilizing portion 212 to form the enhancement layer 213.

[0095] In some embodiments, the inner contour of the stabilizing portion 212 is provided with protrusions, grooves, or through holes. The grooves, through holes, or protrusions are provided at the positions of the corresponding valve heart apex pads, thereby increasing the stability of the valve heart apex pad in clamping.

[0096] As shown in FIG. 6(a) and FIG. 6(b), the convex column 214 is arranged on the inner contour of the stabilizing part 212, and the recess or through hole is arranged at the position of the corresponding valve apex pad.

[0097] In some embodiments, referring to Figure 1 and FIG. 2(a), the isolation mechanism 100 further comprises an isolation rod 130, which forms the outer part of the isolation mechanism 100, the length direction of the isolation rod 130 is axial, and the axial length of the isolation rod 130 can be set according to actual needs. The distal end surface of the isolation rod 130 is rotationally connected to the middle part of the clamping part 210, the inside of the isolation rod 130 is provided with the torque rod 110, and the distal end and the proximal end of the isolation rod 130 are provided with isolation rod through holes, and the torque rod 110 extends out of the isolation rod through holes at the distal end and the proximal end of the isolation rod 130. The arrangement of the isolation rod through holes at the distal end and the proximal end can simultaneously limit the position of the torque rod 110, so that the torque rod 110 cannot shake in the radial direction during rotation, but can move in the axial direction.

[0098] In some embodiments, the isolation rod 130 is integrally made with the limiting part 120 on the distal end side thereof.

[0099] In some embodiments, referring to FIG. 2(b), Figure 3 and FIG. 4(a), the distal end of the torque rod 110 is provided with an operation end 112, and the distal end of the operation end 112 is provided with an insertion piece or a clamping groove. Correspondingly, the valve apex pad is provided with a clamping groove or an insertion piece, the insertion piece is inserted into the clamping groove, the torque rod 110 is rotated to drive the valve apex pad to tighten the apex cord.

[0100] As shown in FIG. 2(b), the insertion piece 113 is arranged at the distal end of the operation end 112.

[0101] In some embodiments, referring to FIG. 2(c), in order to prevent the torque rod 110 from being separated from the valve apex pad during rotation, the proximal end of the torque rod 110 is provided with a limiting ring 114, the limiting ring 114 is located in the inside of the isolation rod 130, and a first elastic member 140 is arranged between the proximal end of the limiting ring 114 and the isolation rod 130. When the torque rod 110 is connected with the driving part of the valve apex pad, the first elastic member 140 is in a compressed state, the first elastic member 140 abuts against the limiting ring 114, the distal end of the torque rod 110 abuts against the driving part of the valve apex pad, and separation of the torque rod 110 from the valve apex pad during driving of the valve apex pad is prevented. When separation is needed, the proximal end of the torque rod 110 is pulled to further compress the first elastic member 140, so that the torque rod 110 can be separated from the valve apex pad.

[0102] In some embodiments, referring to FIG. 2(c), the first elastic member 140 is a spring, the spring is sleeved on the proximal end of the torque rod 110, the distal end of the spring abuts against the proximal end of the limiting ring 114, and the proximal end of the spring abuts against the inner wall of the isolation rod 130.

[0103] In some embodiments, the torque transmission rod 110, the isolation rod 130, the clamping piece 210, etc. can be designed in parts according to assembly needs and then assembled, which can be assembled by means of gluing, welding, threaded connection, etc. How to design in parts is obtained by those skilled in the art without creative labor according to assembly needs.

[0104] In some embodiments, referring to Figure 1 , the valve apex pad adjusting system further comprises a torque instrument 300, the output end of the torque instrument 300 is connected to the proximal end of the torque transmission rod 110, and the torque instrument 300 drives the torque transmission rod 110 to rotate around the axis within a preset torque range. The torque instrument 300 of the present application operates the torque handle, prevents the torque handle from generating excessive torque on the valve apex pad, and causes the apex rope to generate excessive tension, that is, the torque instrument 300 can effectively control the tension of the apex rope by operating the torque handle.

[0105] Since sterilization treatment is easy to cause damage to electronic components, the torque instrument 300 of the present application is different from the conventional existing torque instrument 300 using electronic components. The torque instrument 300 of the present application is a pure mechanical torque instrument 300 to limit the torque of the torque handle. The pure mechanical torque instrument 300 of the present application is different from an industrial-grade product, and the existing industrial-grade torque instrument 300 is not suitable for the medical industry and lacks a suitable interface to directly connect with medical devices.

[0106] Therefore, the present application also provides a torque instrument 300 adapted to an implanted device.

[0107] Referring to Figures 7(a) to 9(b) , the torque instrument 300 comprises a slave engaging disc 310, a master engaging disc 320, and a second elastic member 330.

[0108] The proximal end of the torque transmission rod 110 is connected to the distal end of the slave engaging disc 310, and the slave engaging disc 310 drives the torque transmission rod 110 to rotate around the axis. The slave engaging disc 310 is provided with engaging teeth 311 at the proximal end. The master engaging disc 320 is provided with engaging teeth 321 at the distal end, and the engaging teeth 321 of the master engaging disc 320 can be engaged with the engaging teeth 311 of the slave engaging disc 310 to transmit torque. That is, the master engaging disc 320 drives the slave engaging disc 310 to rotate around the axis. The second elastic member 330 is used to apply a force to the distal end of the master engaging disc 320, so that the engaging teeth 321 of the master engaging disc 320 are engaged with the engaging teeth 311 of the slave engaging disc 310 at the initial time.

[0109] The torque meter 300 of the present invention drives the torque handle to operate the valve apex pad by rotating the main engagement disk 320 and the slave engagement disk 310. When the torque fed back by the torque handle to the valve apex pad increases to a certain level, the main engagement disk 320 will be pushed up. At this time, the main engagement disk 320 will be unable to provide driving force to the slave engagement disk 310, thereby preventing the valve apex pad cord from being over-tightened.

[0110] Reference Figure 8 Let M be the torque fed back from the valve apex shim via the torque handle. As the torque M increases, the primary engagement disc 320 and the secondary engagement disc 310 rotate coaxially. The engagement teeth 321 and 311 have the same radius. Assuming the radius of the engagement teeth is R, the engagement tooth 321 will be subjected to the feedback force F from the engagement tooth 311. 合力 =M / (Rcosα), its component force F 轴 Then it is F 合力 sinα=F 周 tanα = M / R * tanα, when F 轴 When the pressure exceeds that of the second elastic element 330, the main engagement disc 320 will be pushed up. At this time, the main engagement disc 320 will be unable to provide driving force to the slave engagement disc 310, thereby preventing the apical cord of the valve apical pad from being over-tightened.

[0111] Among them, the tension F of the heart rope 心尖绳 Preoperative screening of the patient's valvular annulus, defining the annular area as A and the patient's systolic blood pressure as P, allows for the assessment of the ventricular systolic cycle. The force exerted by blood on the valve towards the atrium is: F. 心尖绳 =P*A*μ (μ is the evaluation adjustment coefficient).

[0112] For example, using, Figure 11 The apical valve insert 400 shown has a drive end of a turntable 410. The apical valve insert 400 is an operating lever for winding the apical cord around the insert. Assuming the radius of the operating lever is r, when the turntable 410 rotates, the operating lever rotates accordingly, causing the apical cord to reach a predetermined tension F. 心尖绳 The required torque is F. 心尖绳 r, and the maximum torque M can be obtained. max At this time, the elastic force of the second elastic element 330 should be set to M. max / R*tanα, when the tension in the center rope reaches F 心尖绳 At this time, the torque meter 300 continues to rotate. At this time, the main engagement disc 320 compresses the second elastic element 330 and pushes it up. The main engagement disc 320 and the slave engagement disc 310 have a "slippage" effect, so that the core rope cannot be further tightened, thus preventing damage caused by further tightening of the core rope.

[0113] In some embodiments, refer toFigures 7(a) to 9(b) The torque instrument 300 further comprises a housing 340, the housing 340 is rotationally connected to the slave engaging disc 310, the master engaging disc 320 is axially slidably connected in the housing 340, but the master engaging disc 320 cannot rotate relative to the housing 340, and the master engaging disc 320 is driven to rotate around the axis by the housing 340. The housing 340 is arranged to protect the master engaging disc 320 and the slave engaging disc 310, and the master engaging disc 320 can be directly driven to rotate by rotating the housing 340.

[0114] In some embodiments, the distal end of the second elastic member 330 abuts against one side of the master engaging disc 320 away from the engaging teeth 321, and the distal end of the second elastic member 330 abuts against the inner side of the housing 340. The second elastic member 330 is in a compressed state at the beginning, so that the second elastic member 330 maintains a certain pressure at the beginning, and the master engaging disc 320 is abutted against the slave engaging disc 310 under the action of the second elastic member 330. At this time, rotating the housing 340 drives the master engaging disc 320 to rotate, and the slave engaging disc 310 also rotates to drive the torque handle to operate the valve heart apex patch.

[0115] In some embodiments, referring to FIGS. 7(a), 9(a) and 9(b), the output shaft 350 is arranged at the distal end of the slave engaging disc 310, and at this time, the output shaft 350 is connected to the proximal end of the transmission lever 110 as the output end of the torque instrument 300.

[0116] In some embodiments, referring to FIGS. 7(a), 9(a) and 9(b), since the slave engaging disc 310 is rotationally connected to the housing 340, but the slave engaging disc 310 cannot move axially relative to the housing 340, the slave engaging disc 310 is rotationally connected to the housing 340 through the bearing 360.

[0117] In some embodiments, referring to FIGS. 7(b), 9(a) and 9(b), in order to ensure the coaxial rotation stability of the master engaging disc 320 and the slave engaging disc 310, a concentric shaft 370 is arranged between the master engaging disc 320 and the slave engaging disc 310, the proximal end of the concentric shaft 370 is connected to the axis of the master engaging disc 320, and the distal end of the concentric shaft 370 is axially slidably connected to the axis of the slave engaging disc 310. When the master engaging disc 320 drives the concentric shaft 370 to rotate, the concentric shaft 370 rotates relative to the slave engaging disc 310.

[0118] In some embodiments, the concentric shaft can also be arranged reversely: a concentric shaft is arranged between the master engaging disc 320 and the slave engaging disc 310, the distal end of the concentric shaft is connected to the axis of the slave engaging disc 310, and the proximal end of the concentric shaft is axially slidably connected to the axis of the master engaging disc 320. When the master engaging disc 320 rotates, the master engaging disc 320 rotates relative to the concentric shaft.

[0119] In some embodiments, referring to FIG. 7(a), FIG. 9(a) and FIG. 9(b), in order to adjust the torque of the torque meter 300, the torque meter 300 further comprises an adjusting shaft 380 and a stopper 390. The adjusting shaft 380 is connected to the housing 340 in axial rotation, and the proximal end of the adjusting shaft 380 extends out of the housing 340. The stopper 390 is threadedly connected to the adjusting shaft 380, and the stopper 390 is arranged in the housing 340 and is in axial sliding connection with the housing 340. The stopper 390 is located above the main engagement disc 320, and the distal end of the stopper 390 is abutted by the second elastic member 330, i.e. the distal end of the second elastic member 330 abuts the proximal end of the main engagement disc 320, and the proximal end of the second elastic member 330 abuts the distal end of the stopper 390. By rotating the adjusting shaft 380, the stopper 390 threadedly connected thereto can be moved upward or downward under the action of the threaded engagement, thereby further adjusting the elastic force of the second elastic member 330, and thereby adjusting the torque of the torque meter 300.

[0120] In some embodiments, the second elastic member 330 is a spring, and the spring is sleeved outside the adjusting shaft 380 directly between the main engagement disc 320 and the stopper 390, with the distal end of the spring abutting the proximal end of the main engagement disc 320 and the proximal end of the spring abutting the distal end of the stopper 390.

[0121] In some embodiments, referring to FIG. 7(a), FIG. 9(b) and Figure 10 The middle part of the adjusting shaft 380 has an inner hole, and when the proximal end of the concentric shaft 370 is connected to the shaft center of the main engagement disc 320, the concentric shaft 370 penetrates the proximal end of the main engagement disc 320 and extends into the inner hole of the adjusting shaft 380, so that multiple components are sequentially connected by one central shaft, thereby making the entire torque meter 300 more stable.

[0122] In some embodiments, referring to FIG. 9(a) and FIG. 9(b), the stopper 390 is provided with a mark 391, and the housing 340 is provided with a viewing window 341 and a scale 342 for displaying the position of the mark 391. By observing the positional relationship between the scale 342 and the mark 391 on the stopper 390 through the viewing window 341, the corresponding torque of the torque meter 300 can be determined, thereby providing the operator with a more intuitive current torque condition.

[0123] In some embodiments, the housing 340 of the torque meter 300 and the like can be designed in a split body according to assembly needs and then assembled, which can be assembled by means of gluing, welding, threaded connection, etc. How to design in a split body is obtainable by a person of ordinary skill in the art without creative labor according to assembly needs.

[0124] In some embodiments, the valve heart apex gasket adjustment system is used for Figure 11When the apex cord of the valve apex patch 400 shown in the figure is adjusted, the distal end of the clamping mechanism 200 of the valve apex patch adjustment system is opened, the distal end of the transmission rod 110 of the isolation mechanism 100 is inserted into the rotating disc 410 of the valve apex patch 400, the force exerted by the clamping mechanism 200 is released, and the valve apex patch 400 is clamped by the clamping mechanism 200 as shown in the figure. Turn the outer shell 340 until the main engagement disc 320 and the slave engagement disc 310 have the "slip" effect, it is considered that the apex cord reaches the preset tension, and the adjustment of the valve apex patch 400 is completed. The distal end of the clamping mechanism 200 is opened again, the outer shell 340 is pulled to the proximal end, and then the transmission rod 110 is pulled to the proximal end, and the distal end of the transmission rod 110 is separated from the rotating disc 410 of the valve apex patch 400. Figure 12

[0125] The above embodiments of the application are described in detail in combination with the drawings, and those of ordinary skill in the art can make various changes to the application according to the above description. Therefore, some details in the embodiments should not constitute a limitation on the application, and the scope of protection of the application will be defined by the appended claims.​

Claims

1. A valve apex pad adjustment system, characterized in that, The valve apical pad adjustment system includes a torque handle, the torque handle comprising: An isolation mechanism having a torsion bar that can drive a drive portion of a valve apical ventricular pad, the torsion bar being rotatable about an axial direction; A clamping mechanism, which can clamp a valve apical spacer, and the clamping mechanism includes a plurality of clamping elements; The isolation mechanism further includes an isolation rod, the length of which is axial. The distal end of the isolation rod is rotatably connected to the middle of the clamping member. The torsion transmission rod is provided inside the isolation rod. The distal and proximal ends of the isolation rod are provided with isolation rod through holes. The torsion transmission rod extends out from the isolation rod through holes at the distal and proximal ends of the isolation rod. The distal end of the torsion transmission rod is provided with an operating end, and the distal end of the operating end is provided with a insert or slot. The proximal end of the torsion transmission rod is provided with a limiting ring, which is located inside the isolation rod. A first elastic element is provided between the proximal end of the limiting ring and the isolation rod. When the torsion transmission rod is connected to the driving part of the valvular apical spacer, the first elastic element is in a compressed state. By the first elastic element pressing against the limiting ring, the distal end of the torsion transmission rod is pressed against the driving part of the valvular apical spacer. The apical valve pad adjustment system also includes: A torque meter, the output end of which is connected to the proximal end of the torsion transmission rod, the torque meter driving the torsion transmission rod to rotate axially within a preset torque range; The torque meter includes: The distal end of the engagement disc is connected to the proximal end of the torsion bar, and the proximal end of the engagement disc is provided with engagement teeth. A main meshing disc, wherein meshing teeth are provided at the distal end of the main meshing disc, and the meshing teeth of the main meshing disc can mesh with the meshing teeth of the slave meshing disc to transmit torque; A second elastic element is used to apply a distal force to the main engagement disc, causing the engagement teeth of the main engagement disc to engage with the engagement teeth of the slave engagement disc initially.

2. The valve apex pad adjustment system as described in claim 1, characterized in that, The middle part of the clamping member is rotatably connected to the distal end of the isolation mechanism. An elastic element is provided at the proximal end of the clamping member, which is located between the clamping member and the isolation mechanism. By pressing the proximal end of the clamping member close to the isolation mechanism, the clamping member rotates, causing the distal end of the clamping member to open. When the force pressing the clamping member is released, the distal end of the clamping member closes under the action of the elastic element, thereby clamping the apical valvular spacer.

3. The apical valve pad adjustment system as described in claim 2, characterized in that, Several of the clamping elements are arranged in pairs opposite each other or evenly arranged around the axial direction.

4. The apical valve pad adjustment system as described in claim 2, characterized in that, The clamping member and the isolation mechanism are respectively provided with built-in grooves, and the two ends of the elastic element are respectively provided in the corresponding built-in grooves; Alternatively, the proximal end of the clamping member and the isolation mechanism are respectively provided with mutually nested built-in grooves, and the elastic element is confined within the mutually nested built-in grooves.

5. The valve apex pad adjustment system as described in claim 2, characterized in that, The isolation mechanism has a limiting part at its distal end, which is located on the distal side of the rotatable connection between the clamping member and the isolation mechanism, and is located on the inner side of the clamping member.

6. The apical valve pad adjustment system as described in claim 2, characterized in that, The clamping member has a stabilizing part at its distal end, and the inner contour of the stabilizing part is used to conform to the contour of the valvular apical pad.

7. The apical valve pad adjustment system as described in claim 6, characterized in that, The inner contour surface is provided with a reinforcing layer to increase the friction of the inner contour of the stabilizing part. The reinforcing layer is a combination of at least one or more of the following: bosses, stripes, grooves, frosted finish, rubber sheet or silicone sheet.

8. The apical valve pad adjustment system as described in claim 6, characterized in that, The inner contour of the stabilizing part is provided with protrusions, grooves or through holes.

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