CN119385722B

CN119385722B - A clamping unit, a crimping mechanism, a crimping device, a crimping system and an application method

Info

Publication number: CN119385722B
Application number: CN202411784597.3A
Authority: CN
Inventors: 罗健民; 金磊; 吴嘉; 万力; 陈云; 曲晓欢
Original assignee: Bairen Medical Jiangsu Co ltd
Current assignee: Bairen Medical Jiangsu Co ltd
Priority date: 2024-12-05
Filing date: 2024-12-05
Publication date: 2025-09-23
Anticipated expiration: 2044-12-05
Also published as: CN119385722A

Abstract

The invention discloses a clamping unit, a crimping mechanism, a pressing and holding device, a pressing and holding system and an application method, wherein the clamping unit comprises a first clamping body, a second clamping body, a limiting shaft, a first guide block, a first guide strip, a second guide block and a second guide strip; the first clamp body and the second clamp body are in mirror symmetry, the second clamp body sequentially comprises a first outer ridge, a second outer ridge, a third outer ridge, a fourth outer ridge, a first front side edge, a second front side edge and a third front side edge, the length of the second outer ridge is larger than that of the second front side edge, and the long axis center lines of the second outer ridge, the second front side edge and the first guide strip are parallel. The clamp unit has small surrounding diameter when in application, is suitable for small-diameter press holding treatment, and reduces design cost and manufacturing cost.

Description

Clamp unit, crimping mechanism, crimping device, crimping system and application method

Technical Field

The invention relates to the technical field of medical equipment, in particular to a clamping unit, a crimping mechanism, a crimping device, a crimping system and an application method.

Background

Heart valve disease is a common heart disease, and previously there was only one option for traditional open chest surgery for patients with aortic valve stenosis. However, the traditional open chest surgery has the defects of large wound, long surgery time (generally 3-4 hours), large postoperative pain, slow recovery of patients and the like. With the increasing aging of the population, the incidence rate of heart valve diseases increases, and the risk of the aged population to receive open chest surgery is generally higher. Transcatheter aortic valve replacement (TRANSCATHETER AORTIC VALVE REPLACEMENT, TAVR) is a minimally invasive procedure in which a prosthetic biological valve is implanted within the aortic valve while retaining the original diseased aortic valve, typically by a femoral puncture, optionally performed under a catheter, similar to a femoral puncture coronary stenting procedure.

A crimping device (artificial biological valve crimping device) and an auxiliary tool for loading and releasing the artificial biological valve. The prosthetic valve is required to be mounted at the distal end of the catheter delivery assembly in a crimped state prior to implantation, and the prosthetic valve bearing the prosthetic valve is required to be subjected to a crimping treatment by a crimping device so as to reduce the diameter of the prosthetic valve, thereby the prosthetic valve bearing the prosthetic valve can be delivered to the lesion position of the heart valve of the human body through the catheter delivery assembly via the blood vessel.

The crimped prosthetic valve is referred to as a "stented valve" (prosthetic valve in embodiment three of application 201920458990.1) and, referring to fig. 1A, the "stented valve" has a stent frame or stent that provides the primary structural support in an expanded state, the stent frame or stent (cobalt chrome alloy material) being an expandable tubular structure that can be expanded by a balloon or by free inherent elasticity. The valve structure arranged on the bracket frame or the bracket is formed by biological materials, the biological materials in the example are three bovine pericardium valve leaflets, the valve structure is prepared by taking healthy bovine pericardium as a raw material and carrying out chemical modification treatment, and the whole valve with the bracket consists of the three bovine pericardium valve leaflets, the suture, the outer skirt edge, the inner skirt edge, the bracket and the like. In order to maintain improved function after installation in the human body, it is often necessary to store such valves in an expanded state in a preservation solution, and several minutes before implantation, crimping of the stented valve by crimping devices in an operating room is required.

The existing pressing and holding device is used for pressing and holding the artificial biological valve in a curling process, and has the defects of low pressing and holding yield, high jump rate and the like of the artificial biological valve.

Disclosure of Invention

In order to improve the stability of force transmission of a press gripper in the press gripping process and reduce the accumulated error of each clamp, so that a pressed artificial biological valve is more round, and the press gripping yield of the artificial biological valve is improved, the invention provides a clamp unit, a crimping mechanism, the press gripper, a press gripping system and an application method.

In a first aspect, an embodiment of the present invention provides a clamping unit, where the clamping unit may include a first clamp body, a second clamp body, a limiting shaft, a first guide block, a first guide bar, a second guide block, and a second guide bar, where one end of the first clamp body is integrally connected with one end of the second clamp body, and the other end of the second clamp body is detachably connected with the other end of the first clamp body through the limiting shaft, where the first guide block and the first guide bar are located on an outer side surface of the first clamp body, and the second guide block and the second guide bar are located on an outer side surface of the second clamp body;

The first forceps body and the second forceps body are mirror symmetry, the second forceps body sequentially comprises a first outer ridge, a second outer ridge, a third outer ridge, a fourth outer ridge, a first front side edge, a second front side edge and a third front side edge, the length of the second outer ridge is larger than that of the second front side edge, long axis central lines of the second outer ridge, the second front side edge and the first guide strip are parallel, an included angle between the first outer ridge and the second outer ridge is 150 degrees, an included angle between the second outer ridge and the third outer ridge is 150 degrees, an included angle between the third outer ridge and the fourth outer ridge is 105 degrees, an included angle between the fourth outer ridge and the first front side edge is 30 degrees, an included angle between the first front side edge and the second front side edge is 105 degrees, and an included angle between the second front side edge and the third front side edge is 150 degrees.

In one embodiment, the rounded transition between the first outer ridge and the second outer ridge, the rounded transition between the second outer ridge and the third outer ridge, the rounded transition between the third outer ridge and the fourth outer ridge, the rounded transition between the first front side and the second front side, and the rounded transition between the second front side and the third front side.

In another embodiment, the limiting shaft penetrates through the first clamp body and the second clamp body respectively and is connected with the first guide block and the second guide block respectively.

In a second aspect, embodiments of the present invention provide a crimping mechanism for a crimping apparatus, the crimping mechanism may include a jaw assembly, a dial, a first housing, and a second housing;

the rotary table is provided with a plurality of first travel tracks and a plurality of second travel tracks, wherein the first travel tracks are in a regular fan shape and are arranged close to the edge of the rotary table, and the second travel tracks are in an inclined radial shape and are arranged close to the circle center of the rotary table;

The clamping assembly comprises a plurality of clamping units, wherein the number of the clamping units is equal to that of the second travel rails, the first clamping body and the second clamping body of the clamping units are integrally connected with one end, far away from the second travel rails, of the clamping units, and one end, close to the second travel rails, of the clamping units is in sliding connection with the second travel rails through a limiting shaft of the clamping units;

The inner surface of the first shell is provided with a first locating pin matched with the first travel track and a first track unit matched with a first guide block and a first guide strip in the clamping assembly respectively; the inner surface of the second shell is provided with a second locating pin matched with the first travel track and the first locating pin respectively, and a second track unit matched with a second guide block and a second guide bar in the clamping assembly respectively;

The first shell and the second shell are covered to form a containing cavity, the rotary disc and the clamping assembly are located in the containing cavity, the first shell and the second shell are connected through the first locating pin and the second locating pin, the rotary disc rotates to act on the limiting shaft to drive the first guide block and the first guide strip to slide on the first track unit respectively, and the second guide block and the second guide strip to slide on the second track unit so as to drive the plurality of clamping units to radially gather or separate.

In one embodiment, the number of the first rail units and the number of the second rail units are equal to the number of the jaw units, respectively;

The plurality of first track units are uniformly distributed in a circular shape on the inner surface of the first shell, and each first track unit can comprise a first chute and a first partition plate, wherein the first chute is positioned in the radial direction of the circle where the plurality of first track units are positioned, a second chute is formed between the first chute and the first partition plate, the center line of the first chute is parallel to the center line of the second chute, the first guide block is positioned in the first chute and can slide in the first chute, and the first guide bar is positioned in the second chute and can slide in the second chute;

The second track units are uniformly distributed on the inner surface of the second shell in a round shape, each second track unit can comprise a third sliding groove and a second partition plate, the third sliding grooves are located in the radial direction of the circles where the second track units are located, a fourth sliding groove is formed between the third sliding grooves and the second partition plates, the center line of the third sliding groove is parallel to the center line of the fourth sliding groove, the second guide blocks are located in the third sliding grooves and can slide in the third sliding grooves, and the second guide strips are located in the fourth sliding grooves and can slide in the fourth sliding grooves.

In one embodiment, the first chute and the third chute are each a bar-shaped closed chute.

In one embodiment, the radius of the circle where the plurality of first positioning pins are located is larger than the radius of the circle where the plurality of first sliding grooves are located, and/or the radius of the circle where the plurality of second positioning pins are located is larger than the radius of the circle where the plurality of third sliding grooves are located.

In one embodiment, the arc of the arc section of the first travel track is 85-92 degrees, and the arc of the arc section of the second travel track is 75-82 degrees.

In a preferred embodiment, the arc of the arc section of the first travel track is 87-89 degrees, and the arc of the arc section of the second travel track is 78-79 degrees.

In one embodiment, the turntable is provided with a middle hole, a first through hole matched with the middle hole is formed in the first shell, a second through hole matched with the middle hole is formed in the second shell, the aperture of the middle hole is not smaller than that of the first through hole, the aperture of the middle hole is not smaller than that of the second through hole, and the first through hole, the middle hole and the second through hole are located on the same central line and form a material processing channel.

In a third aspect, embodiments of the present invention provide a crimping apparatus comprising a handle and a crimping mechanism as described in the second aspect;

The handle is connected with the turntable of the crimping mechanism, a first limit opening is formed in the side face of a first shell of the crimping mechanism, a second limit opening is formed in the side face of a second shell of the crimping mechanism, a driving limit opening is formed by the first limit opening and the second limit opening, the driving limit opening is located at one side of the vertical center line of the press holder, the handle extends out of the driving limit opening and can drive the turntable to swing in the driving limit opening, and the handle drives the turntable to rotate so as to drive a plurality of jaw units to radially gather or separate.

In one embodiment, the press holder further comprises a base, wherein the base is provided with a mounting groove, and the first shell and the second shell in the crimping mechanism are detachably mounted in the mounting groove after being covered.

In one embodiment, the press grip may further comprise a first stop located at an end of the drive limiting opening away from the vertical centerline of the press grip;

The base is provided with a limiting slot, and the first stop piece is detachably inserted into the limiting slot.

In one embodiment, a first slot and a second slot are arranged on two sides of the mounting groove on the base, and the positions of the first slot and the second slot are matched with the positions of the middle hole on the turntable, the first through hole on the first shell and the second through hole on the second shell to form a material processing channel;

The pressing and holding device further comprises two groups of supporting components, each group of supporting components comprises a guide post, a guide groove and a pressing plate, the two guide posts are detachably inserted into the first slot and the second slot respectively, the two guide grooves are connected with the two guide posts respectively, the positions of the two guide grooves are matched with the positions of the material processing channels, the two pressing plates are respectively clamped with the two guide grooves, the pressing plates can slide on the guide grooves, and the shape surrounded by the clamping guide grooves is matched with the shape of a catheter conveying component connected with the crimped artificial biological valve.

In one embodiment, the pressing plate is provided with a limiting lug, and the size of the limiting lug is larger than the aperture of the first through hole in the first shell and the aperture of the second through hole in the second shell.

In one embodiment, the press holder further comprises a second stop piece, wherein the second stop piece is positioned in the accommodating cavity, is respectively connected with the first shell and the second shell, and is matched with the driving limit opening position;

The edge of the first shell extends to form a first supporting seat, the edge of the second shell extends to form a second supporting seat, and the first supporting seat and the second supporting seat form a supporting base to support the press holder in a state that the first shell and the second shell are covered.

In a fourth aspect, embodiments of the present invention provide a squeeze grip that may include a gear assembly and a crimping mechanism as described in the second aspect;

a mounting position is formed on the first shell or the second shell of the crimping mechanism, one end of the gear assembly is matched with the turntable of the crimping mechanism, and the other end extends out of the mounting position;

the gear assembly drives the turntable to rotate so as to drive a plurality of clamping units in the crimping mechanism to radially gather or separate.

In one embodiment, the gear assembly comprises a rotary knob, a rotating shaft, a driving gear and a gear ring, wherein the gear ring is nested outside a rotary disc in the crimping mechanism, the driving gear is meshed with the gear ring, one end of the rotating shaft is connected with the driving gear, the other end of the rotating shaft extends out of the mounting position to be connected with the rotary knob, and the gear ring of the gear assembly drives the rotary disc to rotate so as to drive a plurality of jaw units in the crimping mechanism to radially gather or separate.

In one embodiment, the gear assembly comprises a rotary knob, a rotary shaft and a driving gear, wherein gear teeth are arranged on the periphery of a rotary disc in the crimping mechanism, the driving gear is meshed with the gear teeth on the periphery of the rotary disc, one end of the rotary shaft is connected with the driving gear, the other end of the rotary shaft extends out of the mounting position to be connected with the rotary knob, and the driving gear of the gear assembly drives the rotary disc to rotate so as to drive a plurality of jaw units in the crimping mechanism to radially gather or separate.

In one embodiment, the edge of the first shell extends to form a first supporting seat, the edge of the second shell extends to form a second supporting seat, and the first supporting seat and the second supporting seat form a supporting base to support the press holder in a state that the first shell and the second shell are covered.

In a fifth aspect, an embodiment of the present invention provides a crimping system comprising a catheter delivery assembly and a grasper according to the third or fourth aspects, a crimped prosthetic valve for connection to one end of the catheter delivery assembly, the crimped prosthetic valve being crimped by the grasper.

In a sixth aspect, embodiments of the present invention provide a method of crimping a prosthetic biological valve using a crimping apparatus as described in the third or fourth aspects.

The technical scheme provided by the embodiment of the invention has the beneficial effects that at least the following steps are included:

The embodiment of the invention provides a clamping unit, a crimping mechanism, a press holder, a press holding system and an application method, wherein the clamping unit is smaller in surrounding diameter after being assembled into a clamping assembly and can be applied to small-diameter press holding treatment, the clamping unit is identical in structure when being assembled into the clamping assembly, compared with four groups of different clamping assemblies in the prior art, the clamping unit of the structure reduces design cost and manufacturing cost, and the clamping unit is independently operated in use, namely is driven by a limiting shaft and limited by a guide block and a guide strip, and compared with the clamping unit driven and limited by two-side spiral tracks in the prior art, the integrated error is reduced.

Additional features and advantages of the invention will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. The objectives and other advantages of the invention may be realized and attained by the structure particularly pointed out in the written description and drawings.

The technical scheme of the invention is further described in detail through the drawings and the embodiments.

Drawings

The accompanying drawings are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate the invention and together with the embodiments of the invention, serve to explain the invention. In the drawings:

FIG. 1A is a schematic diagram of a prior art prosthetic biological valve;

FIG. 1B is one of the structural diagrams of a prosthetic valve crimping device of the prior art;

FIG. 1C is an exploded view of FIG. 1B;

FIG. 1D is a cross-sectional view of FIG. 1B;

FIG. 1E is a diagram of a second exploded view of a prior art prosthetic valve crimping device;

FIG. 2 is a block diagram of a jaw unit provided in an embodiment of the present invention;

FIG. 3 is a perspective view of a jaw assembly provided in an embodiment of the invention;

FIG. 4 is an orthographic view of a jaw assembly provided in an embodiment of the invention;

FIG. 5 is a schematic view of the overall structure of a crimping mechanism provided in an embodiment of the present invention;

FIG. 6 is an exploded view of FIG. 5;

FIG. 7 is a cross-sectional view of FIG. 5 in a vertical direction;

FIG. 8 is a block diagram of a turntable provided in an embodiment of the present invention;

Fig. 9 is a structural view of a first housing and a second housing provided in an embodiment of the present invention;

FIG. 10 is a block diagram of a jaw assembly and a second housing provided in an embodiment of the invention;

FIG. 11 is a block diagram of the jaw assembly in an open and closed condition provided in an embodiment of the invention;

FIG. 12 is a diagram of one of the construction of a squeeze grip provided in an embodiment of the present invention;

FIG. 13 is an exploded view of FIG. 12;

FIG. 14 is a second embodiment of a press grip according to the present invention;

FIG. 15 is a partial area exploded view of FIG. 14;

FIG. 16 is a block diagram of a turntable, a handle and a second stop provided in an embodiment of the present invention;

FIG. 17 is a third view of a press grip structure according to an embodiment of the present invention;

FIG. 18 is an exploded view of FIG. 17;

Wherein, the device comprises a 1-crimping mechanism, a 2-handle, a 3-base, a 4-first stop piece, a 5-supporting component, a 6-second stop piece, a 7-supporting base, an 8-gear component and a 10-prosthetic biological valve;

11-jaw assembly, 12-turntable, 13-first shell, 14-second shell, 15-accommodating cavity, 16-driving limit opening and 17-installation position;

111-jaw unit, 112-first jaw body, 113-second jaw body, 114-limit shaft, 115-first guide block, 116-first guide bar, 117-second guide block, 118-second guide bar;

1131-first outer ridge, 1132-second outer ridge, 1133-third outer ridge, 1134-fourth outer ridge, 1135-first front side, 1136-second front side, 1137-third front side;

121-first travel track, 122-second travel track, 123-intermediate hole, 124-gear teeth;

131-a first locating pin, 132-a first rail unit, 133-a first chute, 134-a first partition plate, 135-a second chute, 136-a first through hole, 137-a first limit opening, 138-a first supporting seat;

141-a second locating pin, 142-a second track unit, 143-a third chute, 144-a second partition plate, 145-a fourth chute, 146-a second through hole, 147-a second limit opening, 148-a second supporting seat;

31-mounting slot, 32-limit slot, 33-first slot, 34-second slot;

51-guide posts, 52-guide grooves, 53-pressing plates and 54-limit lugs;

81-rotation button, 82-rotation shaft, 83-driving gear, 84-gear ring;

1001-jaws, 1002-housing fittings, 1003-rotating disks, 1004-base fittings, 1005-handles, 1006-stop members, 1007-central shaft, 1008-cam members, 1009-helical tracks, 1010-guide slots, 1011-secondary slots, 1012-guide plates, 1013-guide ribs, 1014-valves, 1015-jaw gaps, 1016-rotating handles, 1017-shafts, 1018-pinions, 1019-large gears.

Detailed Description

Exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.

In the description of the present invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," "outer," "far," "near," "front," "rear," and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, merely to facilitate description of the present invention and simplify the description, and do not indicate or imply that the device or element being referred to must have a specific orientation, be configured and operated in a specific orientation, and therefore should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

In the description of the present invention, unless explicitly stated or limited otherwise, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected, mechanically connected, electrically connected, directly connected, indirectly connected via an intervening medium, or in communication between two elements. The specific meaning of the above terms in the present invention will be understood in specific cases by those of ordinary skill in the art.

Referring to fig. 1B-1E, a conventional press-grasper jaw 1001 is arranged around a central axis 1007, and a housing fitting 1002 is provided on both sides of the jaw 1001. Each portion of the housing fitting 1002 includes a substantially disk-shaped member (rotating disk 1003) having a radially oriented annular wall and an outer rim extending toward the opposite housing fitting 1002 portion, the housing fitting 1002 numbered to constrain each jaw 1001 in turn to permit only radial movement. Each jaw 1001 preferably has a pair of guide plates 1012, the guide plates 1012 being oriented outwardly on the sides of the two axes 1017 proximate the radially outermost portions of the jaw 1001. A guide plate 1012 extends through and interacts with guide slots 1010 in each fixed housing fitting 1002 to constrain the jaw 1001 to linear sliding movement toward and away from the central axis 1007. Extending from both sides of each jaw 1001 are elongated guide ribs 1013 that engage parallel secondary slots 1011 in each fixed housing fitting 1002. All four guide plates 1012 and guide ribs 1013 are parallel in each individual jaw 1001, as are four corresponding guide slots 1010 and secondary slots 1011. The resulting assembly constrains movement of the jaws 1001 within the housing assembly 1002 with the guide slots 1010 and the secondary slots 1011, the guide slots 1010 and the secondary slots 1011 being generally radially oriented. In effect, the guide slot 1010 is on a radial line outward from the center of the crimping mechanism, while the secondary slot 1011 is parallel thereto but slightly spaced therefrom. The jaw gap 1015 is closed to the point of fully crimping the stented valve 1014.

Both rotating disks 1003 have a shaft 1017 neck to rotate about a central axis 1007 on an adjacent housing fitting 1002. The handle 1005 is connected to the two rotating disks 1003 by a bracket structure so as to rotate them cooperatively. A spiral cut, groove or track in each rotating disc 1003 is provided on each side of the crimping device to convert rotational movement of the lever handle 1005 into linear movement of the jaws 1001. Desirably, the helical track 1009 is formed between helical walls extending inwardly from the rotating disk 1003. The helical track 1009 acts on an actuating pin-like camming member 1008, which camming member 1008 is located on either side of each jaw 1001, and in particular extends outwardly from each guide plate 1012. For each jaw 1001, there are four helical tracks 1009 acting on four camming members 1008.

Referring to fig. 1E, instead of using a lever handle 1005, the actuator includes a rotary handle 1016 coupled to a shaft 1017 and a pinion 1018 to rotate a single rotary disk 1003. Pinion 1018 meshes with a large gear 1019 on the rotating disk 1003. The actuation cam member 1008 on only one side of the jaw 1001 is coupled to a single helical track 1009 and is guided by coupling the guide slot 1010 and the secondary slot 1011 to the guide plate 1012 and the guide rib 1013.

The inventor found that in the process of using the grasper (prosthetic valve crimping device) shown in fig. 1B to 1E, the prosthetic valve crimping device often has a local deformation phenomenon when grasping the prosthetic valve, and the yield is low, which can undoubtedly affect the preparation before the operation, cause meaningless loss of the prosthetic valve, and increase the production cost. The inventor researches the working process of the prosthetic valve crimping device to find that the prosthetic valve crimping device limits the final crimping size of the valve because of the limitation of the clamping structure design, and force is transmitted through the first outer rotating disk and the second outer rotating disk on two sides of the shell in the force transmission process, which are matched with the spiral rail (shown in combination with figure 1D) and the multiple groups of clamping jaws, and each four groups of clamping jaws are matched with one spiral rail, so that the defects of unstable transmission and increased accumulated error in the force transmission process are caused, the crimping yield of the prosthetic biological valve is reduced, and meanwhile, the clamping jaws with different specifications are designed to increase the cost of workpieces. The present invention has been made in view of the above problems, and has as its object to provide a jaw unit, crimping mechanism, crimping device, crimping system and method of application which overcome or at least partially solve the above problems.

In the embodiment of the invention, as shown in fig. 2-4, the clamping unit 111 may include a first clamping body 112, a second clamping body 113, a limiting shaft 114, a first guide block 115, a first guide strip 116, a second guide block 117 and a second guide strip 118, one end of the first clamping body 112 is integrally connected with one end of the second clamping body 113, the other end of the second clamping body is detachably connected through the limiting shaft 114, the first guide block 115 and the first guide strip 116 are located on the outer side surface of the first clamping body 112, the second guide block 117 and the second guide strip 118 are located on the outer side surface of the second clamping body 113, the first clamping body 112 and the second clamping body 113 are in mirror symmetry, the second clamping body 113 sequentially includes a first outer ridge 1131, a second outer ridge 1132, a third outer ridge 1133, a fourth outer ridge 1134, a first front side 1135, a second front side 1136 and a third front side 1137, the length of the second outer ridge 1132 is larger than the second front side 1136, an included angle 1135 is formed between the second front side 1136 and the second front side 1135, an included angle 113150 is formed between the second front side 1132 and the second front side 1135 and the second front side 1136, and the second front side 1135 is 150 ° and the second front side 1135, and an included angle 1135 is formed between the second front 1132 and the second front 1135 and the second front side 1135.

The above-mentioned clamping units provided in the embodiment of the invention can be assembled into a circular clamping assembly, and the structure of each clamping unit is the same, each clamping unit is driven by a limiting shaft 114 (an external rotating disc provides driving power), and radial limiting is performed by guide blocks (a first guide block 115 and a second guide block 117) and guide strips (a first guide strip 116 and a second guide strip 118), so that each clamping unit in the clamping assembly can independently and synchronously operate to realize gathering and separation.

In the embodiment of the present invention, the first jaw 112 and the second jaw 113 in the jaw unit 111 are in mirror symmetry, and are divided into a front side, an outer side and an inner side according to the positional relationship between the first jaw 112 and the second jaw 113, and the second jaw 113 is taken as an example for illustration, the second jaw 113 sequentially includes a first outer ridge 1131, a second outer ridge 1132, a third outer ridge 1133, a fourth outer ridge 1134, a first front side 1135, a second front side 1136 and a third front side 1137, in which a driving gap is formed between the first jaw 112 and the second jaw 113, and in the embodiment, in combination with fig. 11, in the dispersed state of the jaw assembly 11, the fourth outer ridge and the first front side of two adjacent jaw units 111 are in a separated state, and in the gathered state of the jaw assembly 11, the fourth outer ridge and the first front side of two adjacent jaw units 111 are in a fitting state, so as to achieve a diameter of a circle after being rounded not greater than 1mm, and to assist in holding a diameter of an artificial biological valve in clinical application to be smaller than 5 mm.

The clamping unit provided by the embodiment of the invention has the advantages that the clamping unit is smaller in surrounding diameter after being assembled into the clamping assembly and can be applied to small-diameter press holding treatment, the clamping unit is identical in structure when being assembled into the clamping assembly, compared with four different clamping assemblies in the prior art, the clamping unit is low in design cost and manufacturing cost and easy to replace after being damaged, and the clamping unit is independently operated in use, namely, the clamping unit is driven by a limiting shaft and limited by a guide block and a guide strip, and compared with the clamping unit driven and limited by two-side spiral tracks in the prior art, the accumulated error is reduced.

In an alternative embodiment, referring to fig. 2-4, a rounded transition between the first outer ridge 1131 and the second outer ridge 1132, a rounded transition between the second outer ridge 1132 and the third outer ridge 1133, a rounded transition between the third outer ridge 1133 and the fourth outer ridge 1134, a rounded transition between the first front side 1135 and the second front side 1136, and a rounded transition between the second front side 1136 and the third front side 1137. In the embodiment, the edges of the clamp bodies (the first clamp body and the second clamp body) are set to be in rounded transition, so that the adjacent clamp units are prevented from being attached at right angles in the process of using the clamp units and inconvenient to retract and separate after gathering, and on the other hand, the right angle connection parts are sharp due to the fact that the whole clamp unit parts are small, and damage to assembly personnel in the assembly process is avoided.

In an alternative embodiment, referring to fig. 2 to 4, a limiting shaft 114 penetrates the first clamp body 112 and the second clamp body 113, and is connected to the first guide block 115 and the second guide block 117, respectively. In this embodiment, when the clamping unit 111 is assembled or the clamping unit 111 is assembled to the turntable, the limiting shaft 114 needs to be detached from one end of the first clamping body 112 or the second clamping body 113 and then installed through the second travel rail 122 on the turntable 12, so that the limiting shaft 114 may penetrate through the first clamping body 112 and the second clamping body 113 respectively, and then the two ends of the limiting shaft are connected with the first guiding block 115 and the second guiding block 117 respectively, and the specific connection manner may be threaded connection, riveting connection or snap connection, etc., which is not limited in this embodiment.

Based on the same inventive concept, in the embodiment of the present invention, a crimping mechanism 1 is provided for a press grip, and referring to fig. 5 to 11, the crimping mechanism 1 may include a jaw assembly 11, a turntable 12, a first housing 13, and a second housing 14; the rotary table 12 is provided with a plurality of first travel tracks 121 and a plurality of second travel tracks 122, the first travel tracks 121 are in a regular fan shape and are arranged close to the edge of the rotary table 12, the second travel tracks 122 are in an inclined radial shape and are arranged close to the circle center of the rotary table 12, the clamping assembly 11 comprises a plurality of clamping units 111, the number of the clamping units 111 is equal to that of the second travel tracks 122, one ends of a first clamping body 112 and a second clamping body 113 of the clamping units 111, which are far away from the second travel tracks 122, are integrally connected, one end close to the second travel tracks 122 is in sliding connection with the second travel tracks 122 through a limiting shaft 114 of the clamping units 111, a first locating pin 131 matched with the first travel tracks 121 is arranged on the inner surface of the first shell 13, and a first track unit 132 matched with a first guide block 115 and a first guide strip 116 in the clamping assembly 11 are respectively arranged on the inner surface of the second shell 14, a second locating pin 141 matched with the first travel tracks 121 and the first locating pin 131 respectively, and a first locating pin 142 in the second shell 14 are respectively arranged on the inner surface of the second shell 14, and the first shell 14 is respectively contacted with the first guide block 115 and the first guide strip 116 in the first shell 13 and the first shell 13, the first shell 13 and the first guide block 15 and the first guide block 13 are respectively contacted with the first guide block 13 and the first guide strip 116 in a rotary table 13, the first shell 13 and the first locating pin 13 is formed by the first locating pin and the first locating pin 13 and the first guide block 15 and the first guide block 13 are respectively, and the second guide block 117 and the second guide bar 118 slide on the second rail unit 142 to drive the plurality of jaw units 111 to radially gather (the plurality of jaw units 111 are rounded in the radial direction) or to separate.

Compared with the prior art that the clamping jaws are driven to move radially by the rotating disc on the two side shells to move radially, the crimping mechanism in the embodiment of the invention drives the limiting shaft to move through the second travel track on the rotating disc, and compared with the prior art that the clamping jaws are driven to move radially by the rotating disc on the two side shells, the crimping mechanism in the embodiment of the invention has the advantages that the requirements on the manufacturing precision of the cam members are higher due to the force application on the two sides, and the force application errors are caused by the uneven force application on the two sides.

Referring to fig. 6-8, the rotary table 12 is disc-shaped as a whole, the rotary table 12 is located at the middle part of the whole curling mechanism 1 in the vertical direction, and has a certain thickness in the axial direction, the rotary table 12 is provided with a first travel track 121 and a second travel track 122, and in this embodiment, the first travel track 121 and the second travel track 122 are arc-shaped through grooves formed in the rotary table 12. Because the turntable 12 is positioned in the middle of the whole crimping mechanism 1, and the crimping mechanism 1 is used for crimping and holding the prosthetic biological valve 10 (shown in reference to fig. 1) with a few millimeters, the precision requirement is very strict, and the turntable 12 serves as a starting point of force transmission, so that the force transmission process is more stable compared with the force transmission process carried out by two side shells in the prior art, and the phenomenon that the force transmission of the two side shells is different in force application size due to insufficient equipment precision is avoided.

Referring to fig. 8 and 10, the first travel rail 121 may be used as a part of a limiting functional component, and due to the fact that the first travel rail 121 is matched with the first positioning pin 131 on the first housing 13 and the second positioning pin 141 on the second housing 14, the first positioning pin 131 and the second positioning pin 141 can only slide within the travel range of the first travel rail 111, so that the rotation angle range of the turntable 12 relative to the first housing 13 and the second housing 14 is limited, in this embodiment, 3 first rows Cheng Guidao 121 are specifically arranged, therefore, the number of the first positioning pin 131 on the first housing 13 and the number of the second positioning pin 141 on the second housing 14 are also three, and by adopting such a design, the inventor can ensure that the first housing 13 and the second housing 14 can be stably connected, and also achieve the purpose of limiting through the first row Cheng Guidao 111, the first positioning pin 131 and the second positioning pin 141, and meanwhile, the defects of excessively small relative rotation angle and limited holding force and limited holding size caused by the limiting effect are avoided. It should be further noted that, in the present embodiment, the first travel track 121 is in a regular fan shape and is disposed near the edge of the turntable 12, so that the inventor designs the first travel track 121 to avoid resistance generated in the radial direction when sliding relative to the first positioning pin 131 and the second positioning pin 141, respectively, so that the user (typically, a medical staff) can hold the curling mechanism 1 under normal pressure with more effort.

Referring to fig. 8 and 10, the second travel rail 122 on the turntable 12, which is used as a starting point of force transmission, is inclined and radial and is arranged near the center of the turntable 12, and such a structural design can provide radial movement power for the limiting shaft 114, so that under the cooperation limiting action of the guide blocks (the first guide block 115 and the second guide block 117), the guide strips (the first guide strip 116 and the second guide strip 118) and the rail units (the first rail unit 132 and the second rail unit 142) on the shell, the jaw units 111 realize radial movement, so as to realize synchronous radial gathering or separation of a plurality of jaw units 111. Because each second stroke track 122 can only drive one jaw unit 111 matched with each other to transmit force, the force transmission error between each jaw unit 111 is irrelevant, compared with the prior art that the force transmission is carried out by matching four groups of jaw units through one spiral track, the accumulated error caused by the force transmission is gradually increased, if one spiral track deviates in design or processing size, the force transmission of the four groups of jaw units matched with the spiral track is unstable, the clamping is out of round in piece or the clamping process is jumped, and further, because the angle of the spiral track is changed greatly, a user is required to apply more force to drive the jaws to slide along the spiral track, and more effort is required. In the embodiment of the invention, through the plurality of groups of second travel tracks 112 which are respectively matched and the same number of jaw units 111, each second travel track 122 is matched with the limiting shaft 114 of one jaw unit 111, so that adjacent jaw units 111 are not mutually affected in the force transmission process, and accumulated errors are not generated.

Referring to fig. 8 and 11, in the embodiment of the present invention, the number of the second travel tracks 122 and the number of the jaw units 111 are all set to 12, and, as shown in fig. 2 to 4, the turntable 12 may drive the 12 jaw units 111 to move, so as to change the diameter of the pressure holding hole (a hole surrounded by the end of the jaw unit 121 near the center), when the diameter of the pressure holding hole is controlled to be gradually reduced, the pressure holding curl can be performed on the prosthetic biological valve placed in the pressure holding hole, and the end (the free end) of the 12 jaw units 111 near the center can be surrounded into a circle with a diameter not greater than 1mm. When the diameter of the controlled press-holding hole gradually becomes larger, the pressed-held artificial biological valve can be taken out or the artificial biological valve to be pressed-held can be placed.

Referring to fig. 2 to 4, the jaw assembly 11 of the crimping mechanism 1 is composed of a plurality of jaw units 111, and in practice, is composed of 11 jaw units. Due to the structural arrangement of the clamping unit 111, it is moved in the radial direction by the limiting action of the first rail unit 132 on the first housing 13 and the second rail unit 142 on the second housing 14, as shown in connection with fig. 9.

Referring to fig. 6, 7, 9 and 10, the first housing 13 and the second housing 14 in this embodiment are mirror symmetry, the first positioning pin 131 on the inner surface of the first housing 13 and the second positioning pin 141 on the inner surface of the second housing 14 are matched with each other, and the first housing 13 and the second housing 14 are covered and fixed by the first positioning pin 131 and the second positioning pin 141 to form the accommodating cavity 15, wherein the first positioning pin 131 and the second positioning pin 141 not only play a role in connection, but also can realize a positioning and a limiting role. In the embodiment of the present invention, the first positioning pin 131 and the second positioning pin 141 may be provided in a nested structure, that is, one positioning pin is nested outside the other positioning pin, so as to realize nested connection. Of course, as shown in the right-side dowel connection mode of fig. 7, the outer diameters of the two dowel pins are identical, the dowel pins are hollow, and the first dowel pin 131 and the second dowel pin 141 are internally matched with a dowel cylinder or a dowel column, for example, the end part of the dowel cylinder matched in the first dowel pin 131 is located in the first dowel pin 131, and the end part of the dowel cylinder matched in the second dowel pin 141 is protruding from the outer side wall of the second dowel pin 141 and located in the first dowel pin 131, and of course, the two dowel pins may be provided in opposite matching structures. Further, in the embodiment of the present invention, the first positioning pin 131 and the second positioning pin 141 may be provided with any matching structure, so long as the connection, positioning and limiting functions can be achieved, and the specific structures of the two structures are not limited in detail in the embodiment of the present invention.

Referring to fig. 9, the inner surfaces of the first and second cases 13 and 14 are provided with first and second rail units 132 and 142, respectively, limiting the jaw units 111, the number of the first and second rail units 132 and 142 is equal to that of the jaw units 111, and the first and second rail units 132 and 142 are of a mirror-symmetrical structure. The inventor can realize that each jaw unit 111 operates independently by providing such one-to-one limiting structure on the housing, and no accumulated error is generated between the jaw units 111.

Referring to fig. 11, the above-mentioned crimping mechanism provided in the embodiment of the present invention has a working process that the turntable 12 rotates, the second travel rail 122 on the turntable 12 synchronously transmits the force to the limiting shaft 114 on each of the jaw units 111, and each of the jaw units 111 gathers or separates in a radial direction under the limiting action of the first rail unit 132 on the first housing 13 and the second rail unit 142 on the second housing 14, so as to implement the crimping process on the prosthetic valve.

In an alternative embodiment, referring to fig. 6, 9 and 10, the number of the first rail units 132 and the number of the second rail units 142 are equal to the number of the jaw units 111, respectively, the plurality of first rail units 132 are uniformly distributed in a circular shape on the inner surface of the first housing 13, each of the first rail units 132 may include a first chute 133 and a first partition plate 134, the first chute 133 is located in a radial direction of a circle in which the plurality of first rail units 132 are located, a second chute 135 is formed between the first chute 133 and the first partition plate 134, a center line of the first chute 133 is parallel to a center line of the second chute 135, the first guide block 115 is located in the first chute 133 and is slidable in the first chute 133, the first guide bar 116 is located in the second chute 135 and is slidable in the second chute 135, the plurality of second rail units 142 are uniformly distributed in a circular shape on the inner surface of the second housing 14, each of the second rail units 142 may include a third chute 143 and a second partition plate 143, the third chute 133 is located in a radial direction of a circle in which the plurality of first chute 133 is located, a center line of the first chute 133 is parallel to a center line of the second chute 135, the third chute 133 is located in the third chute 145 and a center line of the fourth chute 145 is located in the third chute 145 and a center line of the fourth chute 143 is slidable in the third chute 145 is located in the third chute line 145.

In this embodiment, the first rail unit 132 and the second rail unit 142 are mirror symmetrical, and together limit the clamping unit 111. Taking the first track units 132 as an example, since the first sliding groove 133 is located in the radial direction of the circle where the plurality of first track units 132 are located, the center line of the first sliding groove 133 is parallel to the center line of the second sliding groove 135, and this structure limits the moving track of the jaw units 111, under the constraint of each group of the first track units 132 and the second track units 142, the plurality of groups of jaw units 111 can only move in the radial direction of the circle where they are located, so as to control the diameters of the circles where the plurality of groups of jaw units 111 are enclosed after gathering to be as small as possible, as shown in fig. 11.

In another embodiment, referring to fig. 9 and 10, the first chute 133 and the third chute 143 are bar-shaped closed chutes, respectively. The closed chute helps to limit the radial sliding travel of the first and second guide blocks 115, 117 adapted thereto, so as to achieve a limit on the range of travel of the jaw unit 111.

In another embodiment, referring to fig. 9 and 10, the radius of the circle where the plurality of first positioning pins 131 is located is larger than the radius of the circle where the plurality of first sliding grooves 133 is located, and/or the radius of the circle where the plurality of second positioning pins 141 is located is larger than the radius of the circle where the plurality of third sliding grooves 143 is located. In this embodiment, the first positioning pin 131 is located at the outer side of the first chute 133, and the second positioning pin 141 is located at the outer side of the third chute 143, so that the jaw unit 111 is not affected by the sliding stroke of the first positioning pin 131 or the second positioning pin 141 in the gathering or separating process, and running track crossing between components is avoided, thereby avoiding blocking or wearing of components.

In another embodiment, referring to fig. 8, the arc (α) of the arc section of the first travel track 121 is 85 ° -92 °, and the arc (β) of the arc section of the second travel track 122 is 75 ° -82 °. Preferably, the arc (alpha) of the arc section where the first travel track 121 is located is 87-89 degrees, and the arc (beta) of the arc section where the second travel track 122 is located is 78-79 degrees. In the embodiment of the present invention, as shown in fig. 10 and 11, since the first positioning pin 131 and the second positioning pin 141 sliding in the first travel track 121 have a certain thickness, the actual sliding range must be smaller than the arc range of the arc section where the first travel track 121 is located, and the inventor limits the arc of the arc section where the first travel track 121 is located, so that the relative rotation angle of the turntable 12 located in the middle relative to the first housing 13 and the second housing 14 is not greater than 90 °, and large angle change of the direction of the force during the application and transmission process is avoided. Further, the radian setting range of the arc section where the second travel rail 122 is located also avoids the large angle change of the force direction of the second travel rail 122 in the process of applying the force to the limiting shaft 114, so that the use process of the user is more labor-saving.

In another embodiment, referring to fig. 6, 8 and 9, the turntable 12 is provided with a middle hole 123, the first housing 13 is provided with a first through hole 136 matched with the middle hole 123, the second housing 14 is provided with a second through hole 146 matched with the middle hole 123, the aperture of the middle hole 123 is not smaller than the aperture of the first through hole 136, the aperture of the middle hole 123 is not smaller than the aperture of the second through hole 146, and the first through hole 136, the middle hole 123 and the second through hole 146 are positioned on the same central line and form a material processing channel. In this embodiment, the middle part of each component is provided with a material processing channel, and after the material processing channel is processed, the pressed prosthetic biological valve needs to be taken out of the channel and put into the next prosthetic biological valve to be pressed. In the embodiment of the invention, the aperture sizes of the first through hole on the first shell and the second through hole on the second shell are preferably consistent, so that the first through hole can be used as a sample inlet or a sample outlet according to the use habit of a user, and the second through hole can be used as a sample inlet or a sample outlet. In this embodiment, since the aperture of the middle hole is not smaller than the apertures of the first through hole and the second through hole, the inner diameter of the material processing channel from outside to inside can be effectively prevented from being reduced, and the phenomenon of shell blockage during conveying the pressed and held prosthetic biological valve is avoided.

Based on the same inventive concept, the embodiment of the invention provides a press-and-hold device, which is shown in fig. 12 and 13, and can comprise a handle 2 and the crimping mechanism 1, wherein the handle 2 is connected with a turntable 12 of the crimping mechanism 1, a first limiting opening 137 is formed on the side surface of a first shell 13 of the crimping mechanism 1, a second limiting opening 147 is formed on the side surface of a second shell 14 of the crimping mechanism 1, the first limiting opening 137 and the second limiting opening 147 form a driving limiting opening 16, the driving limiting opening 16 is positioned on one side of the vertical center line of the press-and-hold device, the handle 2 extends out of the driving limiting opening 16 and can drive the turntable 12 to swing in the driving limiting opening 16, and the handle 2 drives the turntable 12 to rotate so as to drive a plurality of clamping units 111 to radially gather together or separate.

In the above-mentioned press grip according to the embodiment of the present invention, since the driving limit opening 16 formed by the first limit opening 137 on the first housing 13 and the second limit opening 147 on the second housing 14 is located at one side of the vertical center line of the press grip (crimping mechanism 1), the handle 2 can only swing downward to the horizontal direction from one side of the vertical center line of the entire press grip when the user uses the press grip, and the swing angle can be controlled within 90 °. Compared with the prior art, the pressure grasping device has the advantages that a handle can swing within the range of 180 degrees, on the first hand, a user does not need to change hands or rotate hands near a vertical center line in the use process, the pressure grasping device is more in line with the force application direction of a human body, the continuous and stable output of force in the pressure grasping force application process is effectively guaranteed, on the second hand, the pressure grasping device is more stable in the force application process, the phenomenon of jumping parts caused by the change (direction or size change) of the force application is effectively prevented, the phenomenon that a valve holder of an artificial biological valve clamps valve leaves, the valve holder is overlapped and the like caused by jumping parts is further avoided, the influence of artificial factors on the pressure grasping qualification rate is reduced, and on the third hand, the clamp assembly is driven to gather or separate through the turntable in the middle, compared with the mode that the clamp assembly is driven to move from two side shells in the prior art, the pressure grasping device is more stable due to the fact that the force application errors are limited by precision, the generation of uneven force application on two sides is avoided, and the pressure grasping qualification rate of the artificial biological valve is improved.

In another embodiment, referring to fig. 13, the press grip may further include a base 3, where the base 3 is provided with a mounting groove 31, and the first housing 13 and the second housing 14 in the crimping mechanism 1 are detachably mounted in the mounting groove 31 after being covered. The structure of the base 3 in this embodiment is to stably install the whole structure of the press-holding device, so that the press-holding device can be uniformly stressed when a user uses the press-holding device, and the base 3 can play an effective supporting role.

In another embodiment, referring to fig. 13, the press holder may further include a first stopper 4, the first stopper 4 is located at an end of the driving limiting opening 16 away from a vertical center line of the press holder, a limiting slot 32 is formed on the base 3, and the first stopper 4 is detachably inserted into the limiting slot 32. The first stopper 4 is used for preventing the prosthetic biological valve from being deformed, damaged, or puncturing the balloon due to excessive force or excessive pressure of the user. As long as the stop limiting function is achieved at one end of the driving limiting opening 16 away from the vertical center line of the press grip, the first stop member 4 in this embodiment is specifically disposed on the base 3 through the limiting slot 32. It should be noted that, in this embodiment, the bottom of the first stop member 4 may be in a cross shape or a T shape, and the corresponding limiting slot 32 is also in a shape matching with the cross shape, so that the first stop member 4 in this embodiment can prevent the handle 2 from being pressed down to swing too much.

In another embodiment, referring to fig. 13, the mounting groove 31 on the base 3 is provided with a first slot 33 and a second slot 34 on both sides, the positions of the first slot 33 and the second slot 34 are matched with the positions of a middle hole 123 on the turntable 12, a first through hole 136 on the first housing 13 and a second through hole 146 on the second housing 14 forming a material processing channel, the holder may further comprise two groups of support components 5, each group of support components 5 may comprise a guide post 51, a guide groove 52 and a pressing plate 53, the two guide posts 51 are detachably inserted in the first slot 33 and the second slot 34 respectively, the two guide grooves 52 are connected with the two guide posts 51 respectively, the positions of the two guide grooves 52 are matched with the positions of the material processing channel, the two pressing plates 53 are respectively engaged with the two guide grooves 52, the pressing plates 53 can slide on the guide grooves 52, and the shape enclosed by the pressing plates 53 engaged with the guide grooves 52 is matched with the shape of a catheter delivery component connected with the crimped prosthetic valve 10 (referring to fig. 1).

In use, the support assembly 5 of the present embodiment places the catheter delivery assembly with the prosthetic valve attached thereto on the guide groove 52 of one support assembly 5, then engages the pressure plate 53, and drives the catheter delivery assembly to move radially and stably toward the material processing channel by pushing the pressure plate 53, and the support assembly 5 helps to accurately position the prosthetic valve before crimping. In this embodiment, the support assembly 5 may be provided with two sets of support assemblies respectively located at two ends of the material processing channel, so that a user who uses different hands to perform pressing and crimping operations can conveniently perform pressing and crimping operations from different directions.

In another embodiment, referring to fig. 13, a limiting lug 54 is provided on the pressing plate 53, and the size of the limiting lug 54 is larger than the aperture of the first through hole 136 on the first housing 13 and the second through hole 146 on the second housing 14. In this embodiment, the limiting lug 54 can perform a limiting function, so that the sliding travel of the pressing plate 53 on the guide groove 52 is controlled, and the position of the prosthetic biological valve can be accurately positioned.

Before performing a TAVR procedure, the crimping procedure was as follows:

(1) The press is removed and the first stop and support assembly are properly installed.

(2) The method comprises the steps of removing labels on a prosthetic valve, sleeving the prosthetic valve on a balloon on a catheter conveying assembly according to the correct operation implementation direction in a sterile environment, lifting a handle of a press gripper upwards, clamping the prosthetic valve on the balloon of the catheter conveying assembly on a guide groove by using a pressing plate, pushing the pressing plate in the direction close to a material processing channel, and driving the prosthetic valve to move towards the material processing channel radially and stably by the pressing plate.

(3) Before the pressing and holding, the opening direction of the valve leaflet of the prosthetic biological valve is required to be confirmed to be correct, and before the handle is slowly pressed down, the accurate positioning of the pressing and holding of the prosthetic biological valve is observed, the valve is kept for 5 seconds after the pressing and holding operation is finished, and the handle is repeatedly pressed down for 2 times.

(4) Removing the balloon protecting sleeve, flushing the loading sheath with heparin water, completely sleeving the loaded balloon into a loader, covering the balloon and the tip by the loader, and extracting the protecting steel wire.

(5) After the artificial biological valve is pressed and held, the artificial biological valve is deduced into a guide groove on the guide post for standby.

It should be noted that the entire prosthetic valve should not be placed for more than 15 minutes after loading, so as not to cause leaflet damage to the intended function after implantation.

In another embodiment, referring to fig. 5-11, the press-grip device may further include a second stop member 6, wherein the second stop member 6 is located in the accommodating cavity 15, and is respectively connected with the first housing 13 and the second housing 14 and is matched with the driving limiting opening 16 in position, the edge of the first housing 13 extends to form a first supporting seat 138, the edge of the second housing 14 extends to form a second supporting seat 148, and the first supporting seat 138 and the second supporting seat 148 form a supporting base 7 in a state that the first housing 13 and the second housing 14 are covered, so as to support the press-grip device.

The difference between the present embodiment and the above embodiment is that the second stop member in the present embodiment is different from the first stop member in the above embodiment in structure, and the second stop member in the present embodiment is matched with the position of the driving limiting opening, is located in the accommodating cavity formed by the first housing and the second housing, and is mounted on the first housing and the second housing, and the second stop member is integrally arc-shaped, and the arc-shaped opening angle of the second stop member can control the handle to rotate within 90 ° for further limiting the position of the handle, so that the handle can only rotate to the horizontal position.

Based on the same inventive concept, the embodiment of the invention also provides a press-and-hold device, which can comprise a gear assembly 8 and the crimping mechanism 1, wherein a mounting position 17 is arranged on the first shell 13 and/or the second shell 14 of the crimping mechanism 1, one end of the gear assembly 8 is matched with the rotary table 12 of the crimping mechanism 1, the other end extends out of the mounting position 17, and the gear assembly 8 drives the rotary table 12 to rotate so as to drive a plurality of clamping units 111 in the crimping mechanism 1 to radially gather or separate.

It should be noted that, referring to fig. 18, the mounting position 17 in this embodiment may be a mounting hole formed in the first housing or the second housing, or may be a mounting hole formed in one housing (for example, the first housing), and a groove formed in an inner surface of the other housing (for example, the second housing), where the mounting hole is convenient for one end of the gear assembly to extend out, and the groove is convenient for the other end of the gear assembly to axially limit.

The press grasping device provided in this embodiment, because the carousel is the main part that drives the jaw subassembly and remove, and the carousel passes through the second travel track and the jaw unit cooperation in the jaw subassembly, and the carousel passes through gear assembly direct drive, and such structure setting makes gear assembly force application time more stable, and force transmission in-process is also more steady. In the first aspect, the gear assembly acts on the turntable in the middle to continuously and stably apply force; in the second aspect, the force is applied more continuously and stably, the phenomenon that the part is jumped due to the change (direction or size change) of the applied force is effectively prevented from being caused by the stress at one side end part, the phenomenon that the valve frame of the artificial biological valve clamps the valve leaves, the valve frame is overlapped and the like due to the fact that the jumped part is prevented from being caused, the influence of artificial factors on the press-holding qualification rate is reduced, in the third aspect, the gear assembly directly drives the turntable to rotate, the clamp assembly is driven to gather or separate through the turntable in the middle, compared with the prior art, the turntable is positioned at one side of the center line of the whole device, in the embodiment, the turntable is positioned at the center line of the whole device, the limiting shaft is stressed, the phenomenon that the stress at the end part of the clamp unit is uneven is prevented, in the fourth aspect, the phenomenon that the stress is limited by precision is more stable, the phenomenon that the stress application error is caused by uneven force application at the end part is avoided, and the press-holding qualification rate of the artificial biological valve is improved.

In another embodiment, referring to fig. 17 and 18, the gear assembly 8 may include a knob 81, a rotating shaft 82 and a driving gear 83, wherein the periphery of the turntable 12 in the curling mechanism 1 is provided with gear teeth 124, the driving gear 83 is meshed with the gear teeth 124 on the periphery of the turntable 12, one end of the rotating shaft 82 is connected with the driving gear 83, the other end extends out of the mounting position 17 to be connected with the knob 81, and the driving gear 83 of the gear assembly 8 drives the turntable 12 to rotate so as to drive a plurality of jaw units 111 in the curling mechanism 1 to radially gather or separate. The gear teeth on the periphery of the turntable are positioned at the center position in the vertical direction of the turntable, the gear teeth arranged on the periphery of the driving gear and the turntable can be stably meshed, the turntable is driven to rotate through rotation of the rotary knob, the rotary shaft and the driving gear, and the gear teeth and the turntable are positioned at the center position of the whole device, so that force application and force transmission are more stable compared with the turntable positioned at one side in the prior art.

In another embodiment, referring to fig. 17 and 18, the gear assembly 8 may include a rotary knob 81, a rotary shaft 82, a driving gear 83 and a gear ring 84, wherein the gear ring 84 is nested outside the rotary table 12 in the curling mechanism 1, the driving gear 83 is meshed with the gear ring 84, one end of the rotary shaft 82 is connected with the driving gear 83, the other end extends out of the mounting position 17 to be connected with the rotary knob 81, and the gear ring 84 of the gear assembly 8 drives the rotary table 12 to rotate so as to drive a plurality of jaw units 111 in the curling mechanism 1 to radially gather or separate. The present embodiment differs from the above embodiment in that the gear assembly includes a gear ring, and the gear ring is nested outside the turntable, and such a structure plays the same role as the gear teeth on the periphery of the turntable, and accordingly, since the gear ring and the turntable are located at the center of the whole device, the force is more smoothly applied from the turntable located at one side in the process of applying force and transferring force than in the prior art.

In another embodiment, referring to fig. 5 to 11, the edge of the first housing 13 extends to form a first supporting seat 138, the edge of the second housing 14 extends to form a second supporting seat 148, and the first supporting seat 138 and the second supporting seat 148 form a supporting base 7 for supporting the press-grip in a state that the first housing 13 and the second housing 14 are covered. The structure of the supporting base in the embodiment can enable the structure of the pressing and holding device to be more stable, and the device can be uniformly stressed when a user uses the device.

Compared with the prior device which needs two users (medical staff) to send samples and take samples respectively, the three pressure grasping devices provided in the embodiment can finish the operations of sending samples, pressing grasping, taking samples and the like by only one user.

The artificial biological valve in the third embodiment with the application number 201920458990.1 is subjected to press-holding crimping treatment by using the press-holding device in the embodiment of the invention, the artificial biological valve does not have the problems of clamping the valve leaflet, overlapping the valve frame and the like, and the artificial biological valve is round in the press-holding process and after the press-holding process through caliper measurement and columnar die comparison, so that the overall yield is high and no jump piece phenomenon exists.

Based on the same conception, the embodiment of the invention also provides a crimping system which can comprise a catheter conveying assembly and the crimping device, wherein the crimped prosthetic valve is used for being connected with one end of the catheter conveying assembly, and the crimped prosthetic valve is subjected to crimping treatment through the crimping device.

Based on the same inventive concept, the embodiment of the invention also provides a method for performing crimping treatment on the artificial biological valve by using the crimping device.

The embodiment of the present invention may refer to the detailed description of the crimping mechanism for the implementation of the press grip and the application method, and the embodiment of the present invention is not described herein.

It will be apparent to those skilled in the art that various modifications and variations can be made to the present invention without departing from the spirit or scope of the invention. The present disclosure is not limited to the precise construction that has been described above and shown in the drawings, and various modifications and changes may be made without departing from the scope thereof. The scope of the present disclosure is limited only by the appended claims. Thus, it is intended that the present invention also include such modifications and alterations insofar as they come within the scope of the appended claims or the equivalents thereof.

Claims

1. A clamping unit, characterized in that the clamping unit comprises: a first clamp body, a second clamp body, a limiting shaft, a first guide block, a first guide bar, a second guide block, and a second guide bar; one end of the first clamp body and the second clamp body are integrally connected, and the other end is detachably connected via the limiting shaft; the first guide block and the first guide bar are located on the outer side of the first clamp body, and the second guide block and the second guide bar are located on the outer side of the second clamp body;

The first pliers body and the second pliers body are mirror-symmetrical, and the second pliers body includes, in sequence: a first outer ridge, a second outer ridge, a third outer ridge, a fourth outer ridge, a first front side, a second front side and a third front side; the length of the second outer ridge is greater than the length of the second front side, and the second outer ridge, the second front side and the long axis center line of the first guide bar are parallel; the angle between the first outer ridge and the second outer ridge is 150°, the angle between the second outer ridge and the third outer ridge is 150°, the angle between the third outer ridge and the fourth outer ridge is 105°, the angle between the fourth outer ridge and the first front side is 30°, the angle between the first front side and the second front side is 105°, and the angle between the second front side and the third front side is 150°.

2. The clamping unit according to claim 1 is characterized in that there is a rounded transition between the first outer ridge and the second outer ridge, a rounded transition between the second outer ridge and the third outer ridge, a rounded transition between the third outer ridge and the fourth outer ridge, a rounded transition between the first front side and the second front side, and a rounded transition between the second front side and the third front side.

3 . The clamping unit according to claim 1 , wherein the limiting shaft passes through the first clamp body and the second clamp body respectively, and is connected to the first guide block and the second guide block respectively.

4. A curling mechanism, characterized in that the curling mechanism is used for a crimper, the curling mechanism comprising: a clamping assembly, a rotating disk, a first shell and a second shell;

The turntable is provided with a plurality of first travel tracks and a plurality of second travel tracks; the plurality of first travel tracks are in a regular fan shape and are arranged near the edge of the turntable, and the plurality of second travel tracks are in an inclined radial shape and are arranged near the center of the turntable;

The clamp assembly comprises a plurality of clamp units according to any one of claims 1 to 3, wherein the number of the clamp units is equal to the number of the second travel rails; the first and second clamp bodies of the clamp units are integrally connected at one end away from the second travel rail, and the ends close to the second travel rail are slidably connected to the second travel rail via a limiting shaft of the clamp unit;

The inner surface of the first housing is provided with a first positioning pin that matches the first travel track, and a first track unit that matches the first guide block and the first guide bar in the clamp assembly respectively; the inner surface of the second housing is provided with a second positioning pin that matches the first travel track and the first positioning pin, and a second track unit that matches the second guide block and the second guide bar in the clamp assembly respectively;

The first shell and the second shell cover each other to form an accommodating cavity, the turntable and the clamp assembly are located in the accommodating cavity, and the first shell and the second shell are connected by the first positioning pin and the second positioning pin; the turntable rotates to act on the limiting shaft, driving the first guide block and the first guide bar to slide on the first track unit, and the second guide block and the second guide bar to slide on the second track unit, so as to drive the plurality of clamp units to radially gather or separate.

5. The curling mechanism according to claim 4, wherein the number of the first track units and the number of the second track units are respectively equal to the number of the clamping units;

The plurality of first track units are evenly distributed in a circular shape on the inner surface of the first housing, and each of the first track units includes: a first slide groove and a first partition plate; the first slide groove is located in a radial direction of the circle in which the plurality of first track units are located; a second slide groove is formed between the first slide groove and the first partition plate; a centerline of the first slide groove is parallel to a centerline of the second slide groove; the first guide block is located in the first slide groove and can slide in the first slide groove; the first guide bar is located in the second slide groove and can slide in the second slide groove;

Multiple second track units are evenly distributed in a circular shape on the inner surface of the second shell, and each second track unit includes: a third slide groove and a second partition plate; the third slide groove is located in the radial direction of the circle where the multiple second track units are located, and a fourth slide groove is formed between the third slide groove and the second partition plate, and the center line of the third slide groove is parallel to the center line of the fourth slide groove; the second guide block is located in the third slide groove and can slide in the third slide groove; the second guide bar is located in the fourth slide groove and can slide in the fourth slide groove.

6 . The curling mechanism according to claim 5 , wherein the first chute and the third chute are respectively bar-shaped closed chute.

7. The curling mechanism according to claim 5 is characterized in that the radius of the circle where several first positioning pins are located is greater than the radius of the circle where several first sliding grooves are located; and/or the radius of the circle where several second positioning pins are located is greater than the radius of the circle where several third sliding grooves are located.

8. The curling mechanism according to claim 4, wherein the arc angle of the arc segment where the first travel track is located is 85° to 92°; the arc angle of the arc segment where the second travel track is located is 75° to 82°.

9. The curling mechanism according to claim 8, wherein the arc angle of the arc segment where the first travel track is located is 87° to 89°; the arc angle of the arc segment where the second travel track is located is 78° to 79°.

10. The curling mechanism according to any one of claims 4 to 9 is characterized in that the turntable is provided with a middle hole; the first shell is provided with a first through hole matching the middle hole, and the second shell is provided with a second through hole matching the middle hole; the aperture of the middle hole is not less than the aperture of the first through hole, and the aperture of the middle hole is not less than the aperture of the second through hole; the first through hole, the middle hole and the second through hole are located on the same center line and form a material processing channel.

11. A crimping device, characterized in that the crimping device comprises: a handle and a curling mechanism according to any one of claims 4 to 10;

The handle is connected to the turntable of the curling mechanism; a first limit opening is provided on the side of the first shell of the curling mechanism, and a second limit opening is provided on the side of the second shell of the curling mechanism, and the first limit opening and the second limit opening form a drive limit opening, and the drive limit opening is located on one side of the vertical center line of the crimping device; the handle extends out of the drive limit opening and can drive the turntable to swing in the drive limit opening; the handle drives the turntable to rotate to drive a plurality of the clamping units to radially gather or separate.

12. The crimper according to claim 11, characterized in that the crimper further comprises: a base; a mounting groove is provided on the base, and the first shell and the second shell in the curling mechanism are detachably mounted in the mounting groove after being covered.

13. The crimper according to claim 12, further comprising: a first stopper; the first stopper being located at an end of the drive limit opening away from the vertical centerline of the crimper;

A limiting slot is provided on the base, and the first stopper is detachably inserted into the limiting slot.

14. The crimper according to claim 12 or 13, wherein a first slot and a second slot are provided on both sides of the mounting groove on the base, and the positions of the first slot and the second slot match the positions of the material processing channel formed by the middle hole on the turntable, the first through hole on the first shell, and the second through hole on the second shell;

The crimping device also includes: two groups of support components; each group of support components includes: guide columns, guide grooves and pressure plates; the two guide columns are detachably inserted into the first slot and the second slot respectively; the two guide grooves are respectively connected to the two guide columns, and the positions of the two guide grooves match the positions of the material processing channels; the two pressure plates are respectively engaged with the two guide grooves, and the pressure plates can slide on the guide grooves; the shape formed by the pressure plates engaging the guide grooves matches the shape of the catheter delivery component connected to the crimped and curled artificial biological valve.

15 . The crimper according to claim 14 , wherein the pressing plate is provided with a limiting ear, and the size of the limiting ear is larger than the aperture of the first through hole on the first shell and the second through hole on the second shell.

16. The crimper according to claim 11, further comprising: a second stopper; the second stopper is located in the accommodating cavity, connected to the first shell and the second shell respectively, and matches the position of the drive limit opening;

The edge of the first shell extends to form a first support seat, and the edge of the second shell extends to form a second support seat; when the first shell and the second shell are covered, the first support seat and the second support seat form a support base to support the crimping device.

17. A crimper, characterized in that it comprises: a gear assembly and a crimping mechanism according to any one of claims 4 to 10;

A mounting position is provided on the first housing and/or the second housing of the curling mechanism, one end of the gear assembly engages with the turntable of the curling mechanism, and the other end extends out of the mounting position;

The gear assembly drives the turntable to rotate, so as to drive a plurality of clamping units in the curling mechanism to radially gather or separate.

18. The crimper according to claim 17 is characterized in that the gear assembly includes: a rotating knob, a rotating shaft, a driving gear and a ring gear; the ring gear is nested on the outside of the turntable in the curling mechanism, and the driving gear is engaged with the ring gear; one end of the rotating shaft is connected to the driving gear, and the other end extends out of the mounting position and is connected to the rotating knob; the ring gear of the gear assembly drives the turntable to rotate, thereby driving the plurality of clamping units in the curling mechanism to radially converge or separate.

19. The crimper according to claim 17 is characterized in that the gear assembly includes: a rotating knob, a rotating shaft and a driving gear; the periphery of the turntable in the curling mechanism is provided with gear teeth; the driving gear is engaged with the gear teeth on the periphery of the turntable; one end of the rotating shaft is connected to the driving gear, and the other end extends out of the mounting position and is connected to the rotating knob; the driving gear of the gear assembly drives the turntable to rotate, so as to drive the plurality of the clamping units in the curling mechanism to radially converge or separate.

20. The crimping device according to any one of claims 17 to 19, characterized in that the edge of the first shell extends to form a first support seat, and the edge of the second shell extends to form a second support seat; when the first shell and the second shell are covered, the first support seat and the second support seat form a support base to support the crimping device.

21. A crimping system, characterized in that it comprises: a catheter delivery assembly and a crimper as described in any one of claims 11 to 20; the crimped and curled artificial biological valve is used to be connected to one end of the catheter delivery assembly; the crimped and curled artificial biological valve is crimped and curled by the crimper.

22. A method for crimping and curling a bioprosthetic valve using the crimper according to any one of claims 11 to 20.