Forceps holder unit, curling mechanism, pressing and holding device, pressing and holding system and application method

Abstract

The invention discloses a forceps holder unit, a curling mechanism, a pressing and holding device, a pressing and holding system and an application method. The forceps holder unit comprises a first forceps body, a second forceps body, a limiting shaft, a first guide block, a first guide strip, a second guide block and a second guide strip. One ends of the first clamp body and the second clamp body are integrally connected, and the other ends are detachably connected through a limiting shaft; the first guide block and the first guide strip are located on the outer side face of the first clamp body. The second guide block and the second guide strip are located on the outer side face of the second clamp body. The first clamp body and the second clamp body are in mirror symmetry, and 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 second outer ridge, the second front side edge and the long axis center line of the first guide strip are parallel. The forceps holder units are small in surrounding diameter during application and suitable for small-diameter pressing and holding treatment, and the design cost and the manufacturing cost are reduced through the forceps holder units.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a clamping unit, a curling mechanism, a crimping device, a crimping system and an application method. Background Art

[0002] Heart valve disease is a common heart disease. In the past, for patients with aortic valve stenosis, the only option was traditional open-chest surgery. However, traditional open-chest surgery has the disadvantages of great trauma, long operation time (usually 3 to 4 hours), great postoperative pain, and slow patient recovery. With the aging of the population, the incidence of heart valve disease has increased, and the risk of open-chest surgery in the elderly is generally high. Transcatheter Aortic Valve Replacement (TAVR) is a minimally invasive surgery that implants an artificial bioprosthetic valve inside the original diseased aortic valve while retaining it. It can usually be performed through femoral artery puncture and under a catheter, similar to coronary artery stenting through femoral artery puncture.

[0003] The crimper (artificial bioprosthetic valve curling device) is an auxiliary tool for loading and releasing the artificial bioprosthetic valve. The artificial bioprosthetic valve needs to be installed in a curled state at the distal end of the catheter delivery assembly before implantation. The crimper needs to be used to crimp the artificial bioprosthetic valve carrying the artificial bioprosthetic valve to reduce the diameter of the artificial bioprosthetic valve, so that the artificial bioprosthetic valve carrying the artificial bioprosthetic valve can be delivered to the diseased position of the human heart valve through the catheter delivery assembly and the blood vessels.

[0004] The gripped bioprosthetic valve refers to a "stented valve" (the bioprosthetic valve in Example 3 in Application No. 201920458990.1), refer to Figure 1A As shown, the "stented valve" has a stent frame or stent, which provides the main structural support in the expanded state. The stent frame or stent (cobalt-chromium alloy material) is an expandable tubular structure, which can be expanded by a balloon or by free inherent elasticity. The valve structure installed on the stent frame or stent is formed by biomaterials. The biomaterials in this example are three bovine pericardial leaflets, which are made from healthy yellow cattle pericardium as raw materials and are prepared after chemical modification. The entire stented valve is composed of three bovine pericardial leaflets, sutures, outer skirts, inner skirts and stents. In order to maintain improved functions after installation in the human body, it is usually necessary to store this type of valve in a preservation solution in an expanded state. The stented valve needs to be crimped and curled by a crimper in the operating room a few minutes before transplantation.

[0005] The existing crimping device performs crimping and curling processing on the above-mentioned artificial biological valve during use, which has the disadvantages of low crimping yield rate and high failure rate of artificial biological valve. Summary of the invention

[0006] In order to improve the stability of force transmission of a crimper during the crimping process and reduce the cumulative error of each clamp so as to make the crimped bioprosthetic valve more round, thereby improving the crimping yield of the bioprosthetic valve, the present invention provides a clamping unit, a curling mechanism, a crimper, a crimping system and an application method.

[0007] In a first aspect, an embodiment of the present invention provides a clamp unit, which 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; one end of the first clamp body and the second clamp body are integrally connected, and the other end is detachably connected through 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;

[0008] The first pliers body and the second pliers body are mirror-symmetrical, and the second pliers body may include, 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 long axis center lines of the second outer ridge, the second front side and the first guide strip 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°.

[0009] In one embodiment, there is a rounded corner transition between the first outer ridge and the second outer ridge, a rounded corner transition between the second outer ridge and the third outer ridge, a rounded corner transition between the third outer ridge and the fourth outer ridge, a rounded corner transition between the first front side edge and the second front side edge, and a rounded corner transition between the second front side edge and the third front side edge.

[0010] In another embodiment, the limiting shaft passes through the first caliper body and the second caliper body respectively, and is connected to the first guide block and the second guide block respectively.

[0011] In a second aspect, an embodiment of the present invention provides a curling mechanism, which is used for a crimping device, and the curling mechanism may include: a clamp assembly, a rotating disk, a first shell and a second shell;

[0012] 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 close to the edge of the turntable, and the plurality of second travel tracks are in an inclined radial shape and are arranged close to the center of the turntable;

[0013] The clamp assembly comprises a plurality of clamp units as described in the first aspect, the number of the clamp units being equal to the number of the second travel tracks; the first clamp body and the second clamp body of the clamp unit are integrally connected at one end away from the second travel track, and the end close to the second travel track is slidably connected to the second travel track through the limiting shaft of the clamp unit;

[0014] The inner surface of the first shell is provided with a first positioning pin matching the first travel track, and a first track unit matching the first guide block and the first guide bar in the clamp assembly respectively; the inner surface of the second shell is provided with a second positioning pin matching the first travel track and the first positioning pin, and a second track unit matching the second guide block and the second guide bar in the clamp assembly respectively;

[0015] The first shell and the second shell are covered 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 limit shaft, respectively 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.

[0016] In one embodiment, the number of the first track units and the number of the second track units are respectively equal to the number of the clamp units;

[0017] The plurality of first track units are evenly distributed in a circular shape on the inner surface of the first shell, and each of the first track units may include: a first slide groove and a first partition plate; the first slide groove is located in the radial direction of the circle where the plurality of first track units are located, a second slide groove is formed between the first slide groove and the first partition plate, and the center line of the first slide groove is parallel to the center line 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;

[0018] Multiple second track units are evenly distributed in a circle on the inner surface of the second shell, and each second track unit may include: 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.

[0019] In one embodiment, the first sliding groove and the third sliding groove are respectively bar-shaped closed sliding grooves.

[0020] In one embodiment, the radius of the circle where several of the first positioning pins are located is greater than the radius of the circle where several of the first sliding grooves are located; and / or, the radius of the circle where several of the second positioning pins are located is greater than the radius of the circle where several of the third sliding grooves are located.

[0021] In one embodiment, the arc segment where the first travel track is located has an arc angle of 85° to 92°; the arc segment where the second travel track is located has an arc angle of 75° to 82°.

[0022] In a preferred embodiment, the arc segment where the first travel track is located has an arc angle of 87° to 89°; the arc segment where the second travel track is located has an arc angle of 78° to 79°.

[0023] In one embodiment, 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 smaller than the aperture of the first through hole, and the aperture of the middle hole is not smaller 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.

[0024] In a third aspect, an embodiment of the present invention provides a crimping device, the crimping device comprising: a handle and a curling mechanism as described in the second aspect;

[0025] 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 driving limit opening, and the driving limit opening is located on one side of the vertical center line of the crimping device; the handle extends out of the driving limit opening and can drive the turntable to swing in the driving limit opening; the handle drives the turntable to rotate to drive a plurality of the clamping units to radially gather or separate.

[0026] In one embodiment, the crimping device may further include: 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.

[0027] In one embodiment, the crimping device may further include: a first stopper; the first stopper is located at an end of the drive limit opening away from the vertical center line of the crimping device;

[0028] The base is provided with a limit slot, and the first stopper is detachably inserted into the limit slot.

[0029] In one embodiment, a first slot and a second slot are provided on both sides of the mounting slot 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;

[0030] The crimping device may also include: 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 enclosed 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.

[0031] In one embodiment, a limiting ear is provided on the pressing plate, and a size of the limiting ear is larger than a diameter of the first through hole on the first shell and a diameter of the second through hole on the second shell.

[0032] In one embodiment, the crimping device may further include: 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 driving limit opening;

[0033] 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.

[0034] In a fourth aspect, an embodiment of the present invention provides a crimper, which may include: a gear assembly and a curling mechanism as described in the second aspect;

[0035] A mounting position is provided on the first housing or the second housing of the curling mechanism, one end of the gear assembly cooperates with the rotating disk of the curling mechanism, and the other end extends out of the mounting position;

[0036] The gear assembly drives the rotating disk to rotate, so as to drive a plurality of clamping units in the curling mechanism to radially gather or separate.

[0037] In one embodiment, the gear assembly may include: a turning button, 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 meshed 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 turning button; the ring gear of the gear assembly drives the turntable to rotate, so as to drive several of the clamping units in the curling mechanism to radially gather or separate.

[0038] In one embodiment, the gear assembly may include: a turning button, 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 meshed 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 turning button; the driving gear of the gear assembly drives the turntable to rotate, so as to drive a plurality of the clamping units in the curling mechanism to radially gather or separate.

[0039] In one embodiment, 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.

[0040] In the fifth aspect, an embodiment of the present invention provides a crimping system, comprising: a catheter delivery assembly and a crimper as described in the third aspect or the fourth aspect; 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.

[0041] In a sixth aspect, an embodiment of the present invention provides a method for crimping and curling an artificial biological valve using the crimper as described in the third aspect or the fourth aspect.

[0042] The beneficial effects of the above technical solution provided in the embodiments of the present invention include at least:

[0043] A clamping unit, a curling mechanism, a crimper, a crimping system and an application method are provided in the embodiment of the present invention. On the first hand, after the structure of the clamping unit is assembled into a clamping assembly, the enclosed diameter is smaller and can be applied to small-diameter crimping processing; on the second hand, when the clamping unit is assembled into a clamping assembly, the structure of each clamping unit is the same. Compared with four groups of different clamping assemblies in the prior art, the clamping unit with this structure reduces the design cost and the manufacturing cost; on the third hand, the clamping unit operates independently when in use, that is, the clamping unit is driven by a limit shaft and limited by a guide block and a guide strip. Compared with the prior art where the clamping unit is driven and limited by spiral tracks on both sides, the cumulative error is reduced.

[0044] Other features and advantages of the present invention will be described in the following description, and partly become apparent from the description, or understood by practicing the present invention. The purpose and other advantages of the present invention can be realized and obtained by the structures particularly pointed out in the written description and the accompanying drawings.

[0045] The technical solution of the present invention is further described in detail below through the accompanying drawings and embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0046] The accompanying drawings are used to provide a further understanding of the present invention and constitute a part of the specification. Together with the embodiments of the present invention, they are used to explain the present invention and do not constitute a limitation of the present invention. In the accompanying drawings:

[0047] Figure 1A It is a schematic diagram of the structure of a bioprosthetic valve in the prior art;

[0048] Figure 1B One of the structural diagrams of a prosthetic valve curling device in the prior art;

[0049] Figure 1C for Figure 1B Exploded diagram of

[0050] Figure 1D for Figure 1B A cross-sectional view of

[0051] Figure 1E This is an exploded view of the second structural diagram of a prosthetic valve curling device in the prior art;

[0052] Figure 2 A structural diagram of a clamping unit provided in an embodiment of the present invention;

[0053] Figure 3 A three-dimensional structural diagram of a clamp assembly provided in an embodiment of the present invention;

[0054] Figure 4 is an orthographic projection diagram of a clamp assembly provided in an embodiment of the present invention;

[0055] Figure 5 It is a schematic diagram of the overall structure of the curling mechanism provided in an embodiment of the present invention;

[0056] Figure 6 for Figure 5 Exploded diagram of

[0057] Figure 7 for Figure 5 A cross-sectional view in the vertical direction;

[0058] Figure 8 A structural diagram of a turntable provided in an embodiment of the present invention;

[0059] Fig. 9 A structural diagram of a first shell and a second shell provided in an embodiment of the present invention;

[0060] Fig.10 A structural diagram of a clamp assembly and a second housing provided in an embodiment of the present invention;

[0061] Fig.11 A structural diagram of the clamp assembly in an open state and a closed state provided in an embodiment of the present invention;

[0062] Fig.12 This is one of the structural diagrams of the crimping device provided in an embodiment of the present invention;

[0063] Fig.13 for Fig.12 Exploded diagram of

[0064] Fig.14 This is a second structural diagram of the crimping device provided in an embodiment of the present invention;

[0065] Fig.15 for Fig.14 Exploded diagram of some areas;

[0066] Fig.16 A structural diagram of a turntable, a handle and a second stopper provided in an embodiment of the present invention;

[0067] Fig.17 The third structural diagram of the crimping device provided in the embodiment of the present invention;

[0068] Fig.18 for Fig.17 Exploded diagram of

[0069] Among them, 1-curling mechanism; 2-handle; 3-base; 4-first stopper; 5-support assembly; 6-second stopper; 7-support base; 8-gear assembly; 10-artificial bioprosthetic valve;

[0070] 11-clamp assembly; 12-turntable; 13-first housing; 14-second housing; 15-accommodating cavity; 16-driving limit opening; 17-installation position;

[0071] 111-clamping unit; 112-first clamp body; 113-second clamp body; 114-limiting shaft; 115-first guide block; 116-first guide strip; 117-second guide block; 118-second guide strip;

[0072] 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;

[0073] 121-first travel track; 122-second travel track; 123-middle hole; 124-gear teeth;

[0074] 131 - first positioning pin; 132 - first track unit; 133 - first slide slot; 134 - first partition plate; 135 - second slide slot; 136 - first through hole; 137 - first limiting opening; 138 - first support seat;

[0075] 141 - second positioning pin; 142 - second track unit; 143 - third slide slot; 144 - second partition plate; 145 - fourth slide slot; 146 - second through hole; 147 - second limiting opening; 148 - second support seat;

[0076] 31-installation slot; 32-limiting slot; 33-first slot; 34-second slot;

[0077] 51-guide column; 52-guide groove; 53-pressing plate; 54-limiting ear;

[0078] 81-turn knob; 82-rotating shaft; 83-driving gear; 84-gear ring;

[0079] 1001-jaw; 1002-housing accessory; 1003-rotating disk; 1004-base accessory; 1005-handle; 1006-stop member; 1007-center axis; 1008-cam member; 1009-spiral rail; 1010-guide groove; 1011-auxiliary groove; 1012-guide plate; 1013-guide ridge; 1014-valve; 1015-jaw gap; 1016-rotating handle; 1017-axis; 1018-small gear; 1019-large gear. DETAILED DESCRIPTION

[0080] The exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. Although the exemplary embodiments of the present disclosure are shown in the accompanying drawings, it should be understood that the present disclosure can be implemented in various forms and should not be limited by the embodiments set forth herein. On the contrary, these embodiments are provided to enable a more thorough understanding of the present disclosure and to fully convey the scope of the present disclosure to those skilled in the art.

[0081] In the description of the present invention, it should be noted that the terms "center", "up", "down", "left", "right", "vertical", "horizontal", "inside", "outside", "far", "near", "front", "back" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance.

[0082] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0083] Reference Figure 1B to Figure 1EAs shown, the prior art crimper jaw 1001 is configured around a central axis 1007 with housing components 1002 on either side of the jaw 1001. Each portion of the housing component 1002 includes a substantially disk-shaped member (rotating disk 1003) having a radially oriented annular wall and an outer rim extending toward the opposite portion of the housing component 1002; the housing components 1002 in turn constrain each jaw 1001 to allow only radial movement. Each jaw 1001 preferably has a pair of guide plates 1012 proximate to the radially outermost two axes 1017 sides of the jaw 1001 and oriented outwardly. The guide plates 1012 extend through and interact with guide slots 1010 in each fixed housing component 1002 to constrain linear sliding movement of the jaw 1001 toward and away from the central axis 1007. Extended guide ribs 1013 extend from both sides of each jaw 1001 and engage parallel secondary grooves 1011 located in each fixed housing assembly 1002. All four guide plates 1012 and guide ribs 1013 in each individual jaw 1001 are parallel, as are the four corresponding guide grooves 1010 and secondary grooves 1011. The resulting assembly constrains the movement of the jaw 1001 within the housing assembly 1002 to the guide grooves 1010 and secondary grooves 1011, which are generally radially oriented. In practice, the guide grooves 1010 are on a radial line outward from the center of the crimping mechanism, while the secondary grooves 1011 are parallel thereto but slightly spaced therefrom. The jaw gap 1015 is closed to a degree sufficient to crimp the stented valve 1014.

[0084] Both rotating disks 1003 have shafts 1017 necks so as to rotate around a central axis 1007 on adjacent housing accessories 1002. The handle 1005 is connected to the two rotating disks 1003 by a bracket structure so as to make them rotate in cooperation. The spiral cutouts, grooves or rails in each rotating disk 1003 are provided on each side of the crimping device so as to convert the rotary motion of the lever handle 1005 into the linear motion of the clamp 1001. Ideally, the spiral rails 1009 are formed between the spiral walls extending inwardly from the rotating disks 1003. The spiral rails 1009 act on the actuating pin-shaped cam members 1008, which are located on both sides of each clamp 1001, and in particular extend outwardly from each guide plate 1012. For each clamp 1001, there are four spiral rails 1009 acting on four cam members 1008.

[0085] Reference Figure 1EAs shown, instead of using a lever handle 1005, the actuator includes a rotating handle 1016 connected to a shaft 1017 and a pinion 1018 to rotate a single rotating disk 1003. The pinion 1018 meshes with a large gear 1019 on the rotating disk 1003. The actuating cam member 1008 on only one side of the jaw 1001 is coupled to a single spiral rail 1009 and guided by coupling the guide groove 1010 and the auxiliary groove 1011 to the guide plate 1012 and the guide ridge 1013.

[0086] The inventors used Figure 1B to Figure 1E During the manufacturing process of the crimping device (repairable valve curling device) shown in the figure, it was found that the repairable valve curling device often deformed locally when crimping the bioprosthetic valve, and its yield rate was low, which would undoubtedly affect the preparation before the operation, cause meaningless loss of the bioprosthetic valve, and increase the production cost. At the same time, due to the limitation of the clamping structure design of the repairable valve curling device, the valve size can be reduced to 6mm at most; after studying its working process, the inventor found that due to the clamping structure design of the repairable valve curling device, the final crimping size of the valve is limited, and during the force transmission process, the first and second outer rotating disks on both sides of the shell cooperate with the spiral rail (combined with the spiral rail) to transmit the force. Figure 1D As shown in the figure, the force is transmitted by using a plurality of groups of clamps, and each group of four clamps cooperates with a spiral track, which leads to the disadvantages of unstable transmission and increased cumulative error in the force transmission process, reducing the crimping yield of the artificial bioprosthetic valve; at the same time, designing clamps of different specifications increases the cost of the workpiece. In view of the above problems, the present invention is proposed to provide a clamp unit, a curling mechanism, a crimping device, a crimping system and an application method that overcome the above problems or at least partially solve the above problems.

[0087] In an embodiment of the present invention, a clamping unit is provided, referring to Figure 2 to Figure 4As shown, the clamp unit 111 may include: a first clamp body 112, a second clamp body 113, a limiting shaft 114, a first guide block 115, a first guide bar 116, a second guide block 117 and a second guide bar 118; one end of the first clamp body 112 and the second clamp body 113 are integrally connected, and the other end is detachably connected through the limiting shaft 114; the first guide block 115 and the first guide bar 116 are located on the outer side of the first clamp body 112, and the second guide block 117 and the second guide bar 118 are located on the outer side of the second clamp body 113; the first clamp body 112 and the second clamp body 113 are mirror-symmetrical, and the second clamp body 113 may include: 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, the second front side 1136 and the third front side 1137; the length of the second outer ridge 1132 is greater than the length of the second front side 1136, and the long axis center lines of the second outer ridge 1132, the second front side 1136 and the first guide strip 116 are parallel; the angle between the first outer ridge 1131 and the second outer ridge 1132 is 150°, the angle between the second outer ridge 1132 and the third outer ridge 1133 is 150°, the angle between the third outer ridge 1133 and the fourth outer ridge 1134 is 105°, the angle between the fourth outer ridge 1134 and the first front side 1135 is 30°, the angle between the first front side 1135 and the second front side 1136 is 105°, and the angle between the second front side 1136 and the third front side 1137 is 150°.

[0088] The above-mentioned clamping units provided in the embodiment of the present 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 (the external turntable provides driving power), and radial limiting is performed by guide blocks (first guide block 115 and second guide block 117) and guide bars (first guide bar 116 and second guide bar 118), so that each clamping unit in the clamping assembly can operate independently and synchronously to achieve gathering and separation.

[0089] In the embodiment of the present invention, the first jaw body 112 and the second jaw body 113 in the clamp unit 111 are mirror-symmetrical structures. According to the positional relationship between the first jaw body 112 and the second jaw body 113, they are divided into a front side, an outer side and an inner side. Taking the second jaw 113 as an example, the second jaw body 113 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 sequence. In this embodiment, a driving gap is formed between the first jaw body 112 and the second jaw body 113. Fig.11As shown, when the clamp assembly 11 is in a dispersed state, the fourth outer ridge and the first front side of two adjacent clamp units 111 are in a separated state, and when the clamp assembly 11 is in a gathered state, the fourth outer ridge and the first front side of two adjacent clamp units 111 are in a fitted state, so as to achieve a diameter of the enclosed circle of no more than 1 mm, thereby assisting doctors in performing small-diameter (less than 5 mm in diameter) compression and gripping of artificial biological valves during clinical applications.

[0090] The above-mentioned clamping unit provided in the embodiment of the present invention has the following effects: first, after the structure of the clamping unit is assembled into a clamping assembly, the enclosed diameter is smaller and can be applied to small-diameter crimping processing; second, when the clamping unit is assembled into a clamping assembly, the structure of each clamping unit is the same. Compared with the four groups of different clamping assemblies in the prior art, the clamping unit with this structure reduces the design cost and the manufacturing cost, and is easy to replace after damage; third, the clamping unit is independently operated during use, that is, the clamping unit is driven by a limit shaft and limited by a guide block and a guide strip. Compared with the prior art in which the clamping unit is driven and limited by spiral tracks on both sides, the cumulative error is reduced.

[0091] In an alternative embodiment, referring to Figure 2 to Figure 4 As shown, the first outer ridge 1131 and the second outer ridge 1132 have a rounded transition, the second outer ridge 1132 and the third outer ridge 1133 have a rounded transition, the third outer ridge 1133 and the fourth outer ridge 1134 have a rounded transition, the first front side 1135 and the second front side 1136 have a rounded transition, and the second front side 1136 and the third front side 1137 have a rounded transition. In this embodiment, the edges of the clamp body (the first clamp body and the second clamp body) are set to have rounded transitions. On the one hand, it is to prevent the adjacent clamp units from being right-angled during the use of the clamp unit, which is not convenient for retraction and separation after being gathered; on the other hand, since the entire clamp unit component is small, the right-angle connection is relatively sharp, which avoids injuries to the assembler during the assembly process.

[0092] In an alternative embodiment, referring to Figure 2 to Figure 4 As shown, the limit shaft 114 passes through the first clamp body 112 and the second clamp body 113 respectively, and is connected to the first guide block 115 and the second guide block 117 respectively. In this embodiment, when the clamp unit 111 is assembled or the clamp unit 111 is assembled on the turntable, the limit shaft 114 needs to be disassembled from one end of the first clamp body 112 or the second clamp body 113, and then passed through the second travel track 122 on the turntable 12 and then installed. Therefore, the limit shaft 114 can pass through the first clamp body 112 and the second clamp body 113 respectively, and then the two ends are connected to the first guide block 115 and the second guide block 117 respectively. The specific connection method can be threaded connection, riveting or snap connection, etc., which is not specifically limited in this embodiment.

[0093] Based on the same inventive concept, a curling mechanism is provided in an embodiment of the present invention. The curling mechanism 1 is used for a crimping device. Figures 5 to 11 As shown, the curling mechanism 1 may include: a clamping assembly 11, a turntable 12, a first shell 13 and a second shell 14; the turntable 12 is provided with a plurality of first travel tracks 121 and a plurality of second travel tracks 122; the plurality of first travel tracks 121 are in a regular fan shape and are arranged close to the edge of the turntable 12, and the plurality of second travel tracks 122 are in an inclined radial shape and are arranged close to the center of the turntable 12; the clamping assembly 11 includes a plurality of the above-mentioned clamping units 111, and the number of the clamping units 111 is equal to the number of the second travel tracks 122; the first clamp body 112 and the second clamp body 113 of the clamping unit 111 are integrally connected at one end away from the second travel track 122, and the end close to the second travel track 122 is slidably connected to the second travel track 122 through the limiting shaft 114 of the clamping unit 111; the inner surface of the first shell 13 is provided with a first positioning pin 131 matching the first travel track 121, and a first positioning pin 131 respectively connected to the first travel track 121 in the clamping assembly 11 A first track unit 132 that matches the guide block 115 and the first guide bar 116; the inner surface of the second shell 14 is provided with a second positioning pin 141 that matches the first travel track 121 and the first positioning pin 131 respectively, and a second track unit 142 that matches the second guide block 117 and the second guide bar 118 in the clamp assembly 11 respectively; the first shell 13 and the second shell 14 cover to form a accommodating chamber 15, the turntable 12 and the clamp assembly 11 are located in the accommodating chamber 15, and the first shell 13 and the second shell 14 are connected by the first positioning pin 131 and the second positioning pin 141; the turntable 12 rotates to act on the limiting shaft 114, respectively driving the first guide block 115 and the first guide bar 116 to slide on the first track unit 132, and the second guide block 117 and the second guide bar 118 to slide on the second track unit 142, so as to drive the plurality of clamp units 111 to radially gather (radially of a circle formed by the plurality of clamp units 111) or separate.

[0094] The above-mentioned curling mechanism in the embodiment of the present invention drives the limit shaft to move through the second travel track on the turntable, so as to drive several groups of clamping units to synchronously radially gather or separate. Compared with the prior art in which the clamps are driven to move radially by rotating disks on the shells on both sides, since the prior art requires higher precision in the manufacturing of the cam components due to the force applied on both sides, and the uneven force applied on both sides leads to force errors, the turntable in the embodiment of the present invention is in direct contact with the limit shaft, which is more stable than the process of force transmission through the cam components on both sides, so that the artificial biological valve being clamped is rounder, thereby improving the yield rate of the artificial biological valve clamping.

[0095] The various components in the embodiments of the present invention are described as follows: Figure 6 to Figure 8As shown, the turntable 12 is disk-shaped as a whole and is located in the middle part of the entire curling mechanism 1 in the vertical direction. It has a certain thickness in the axial direction. The turntable 12 is provided with a first travel track 121 and a second travel track 122. In this embodiment, the first travel track 121 and the second travel track 122 are arc-shaped through grooves opened on the turntable 12. Since the turntable 12 is located in the middle part of the entire curling mechanism 1, and the curling mechanism 1 is used to curl and press the artificial bioprosthetic valve 10 (see FIG. 1 ) of several millimeters, the precision requirement is very strict. The turntable 12 is used as the starting point of force transmission. In this way, the force transmission process is more stable than the force transmission through the two side shells in the prior art, and the phenomenon of different forces on both sides due to insufficient equipment precision during force transmission on the two side shells is avoided.

[0096] Reference Figure 8 and Fig.10 As shown, the first travel track 121 can be used as a part of the limiting functional component. Since it cooperates with the first positioning pin 131 on the first shell 13 and the second positioning pin 141 on the second shell 14, the first positioning pin 131 and the second positioning pin 141 can only slide within the travel range of the first travel track 111, thereby limiting the rotation angle range of the turntable 12 relative to the first shell 13 and the second shell 14; in this embodiment, three first travel tracks 121 are specifically arranged, so the first positioning pin 131 on the first shell 13 and the second positioning pin 141 on the second shell 14 are also three. Through such a design, the inventor can ensure that the first shell 13 and the second shell 14 can be stably connected, and achieve the purpose of limiting by the first travel track 111, the first positioning pin 131 and the second positioning pin 141, while also avoiding the design of more groups resulting in too small relative rotation angle due to the limiting effect, and avoiding the disadvantages of limited gripping force and gripping size. It should be further explained that the first travel track 121 in the present embodiment is in a regular fan shape and is arranged close to the edge of the turntable 12. The inventor designed it in this way to avoid resistance in the radial direction when the first travel track 121 slides relative to the first positioning pin 131 and the second positioning pin 141 respectively, which enables the user (generally medical staff) to normally squeeze and grip the curling mechanism 1 with less effort.

[0097] Reference Figure 8 and Fig.10As shown, the second travel track 122 on the turntable 12, which serves as the starting point of force transmission, is arranged in an inclined radial shape and close to the center of the turntable 12. Such a structural design can provide radial movement power for the limiting shaft 114, and then under the cooperative limiting action of the guide blocks (the first guide block 115 and the second guide block 117), the guide bars (the first guide bar 116 and the second guide bar 118) and the track units on the shell (the first track unit 132 and the second track unit 142), the clamping unit 111 realizes radial movement to achieve synchronous radial gathering or separation of several clamping units 111. Since each second travel track 122 can only drive one of the mutually matched clamping units 111 to transfer force, the force transfer errors between each clamping unit 111 are unrelated; compared with the prior art that uses one spiral track to match four groups of clamping units for force transfer, the cumulative error caused by this is gradually increasing, and if a spiral track has a design or processing size offset, it will cause the force transfer of the four groups of clamping units matched with it to be unstable and the clamping will not be round or there will be a phenomenon of jumping parts during the clamping process; further, due to the large angle change of the spiral track, the user needs to exert greater force to drive the clamp to slide along the spiral track during use, which is more laborious. In the embodiment of the present invention, multiple groups of second travel tracks 112 and the same number of clamping units 111 are used, and since each second travel track 122 is matched with a limit shaft 114 of a clamping unit 111, the adjacent clamping units 111 will not affect each other during the force transfer process, and no cumulative error will be generated.

[0098] Reference Figure 8 and Fig.11 As shown, in the specific implementation of the embodiment of the present invention, the number of the second travel rail 122 and the clamping unit 111 are both set to 12. Figure 2 to Figure 4 As shown, the turntable 12 can drive the 12 clamping units 111 to move, thereby changing the diameter of the crimping hole (the hole formed by one end of the clamping unit 121 close to the center). When the diameter of the crimping hole is controlled to gradually become smaller, the artificial bioprosthetic valve placed in the crimping hole can be crimped and curled, and one end (free end) of the 12 clamping units 111 close to the center can enclose a circle with a diameter not greater than 1 mm. When the diameter of the crimping hole is controlled to gradually become larger, the crimped artificial bioprosthetic valve can be taken out, or the artificial bioprosthetic valve to be crimped can be placed.

[0099] Reference Figure 2 to Figure 4 As shown, the clamp assembly 11 in the curling mechanism 1 is composed of a plurality of clamp units 111, and in a specific implementation, is composed of 11 clamp units. Fig. 9 As shown, it moves radially under the limiting action of the first track unit 132 on the first shell 13 and the second track unit 142 on the second shell 14.

[0100] Reference Figure 6 , Figure 7 , Fig. 9 and Fig.10 As shown, the first shell 13 and the second shell 14 in this embodiment are mirror-symmetrical, and the first positioning pin 131 on the inner surface of the first shell 13 matches the second positioning pin 141 on the inner surface of the second shell 14. The first shell 13 and the second shell 14 are fixed together by the first positioning pin 131 and the second positioning pin 141 to form an accommodating cavity 15, wherein the first positioning pin 131 and the second positioning pin 141 not only play a connecting role, but also can achieve positioning and limiting functions. When the embodiment of the present invention is implemented, the first positioning pin 131 and the second positioning pin 141 can be set to a nested structure, that is, one of the positioning pins is nested on the outside of the other positioning pin to achieve a nested connection. Of course, you can also refer to Figure 7 As shown in the connection mode of the right positioning pin, the outer diameters of the two positioning pins are consistent, and the positioning pins are hollow. The first positioning pin 131 and the second positioning pin 141 are matched with positioning tubes or positioning columns. For example, the matching positioning tube end of the first positioning pin 131 is located in the first positioning pin 131, and the matching positioning tube end of the second positioning pin 141 protrudes from the outer wall of the second positioning pin 141 and is located in the first positioning pin 131. Of course, it can also be set to an opposite matching structure. Further, in the embodiment of the present invention, the first positioning pin 131 and the second positioning pin 141 can be set to any matching structure as long as they can achieve the connection, positioning and limiting functions. The embodiment of the present invention does not make detailed restrictions on the specific structures of the two.

[0101] Reference Fig. 9 As shown, the inner surfaces of the first shell 13 and the second shell 14 are respectively provided with a first rail unit 132 and a second rail unit 142 for limiting the clamping unit 111, and the number of the first rail unit 132 and the second rail unit 142 is equal to the number of the clamping units 111, and the first rail unit 132 and the second rail unit 142 are mirror-symmetrical structures. By providing such a one-to-one corresponding limiting structure on the shell, the inventor can realize that each clamping unit 111 is operated independently, and no cumulative error will be generated between the clamping units 111.

[0102] Reference Fig.11 As shown, the above-mentioned curling mechanism provided in the embodiment of the present invention works as follows: the turntable 12 rotates, and the second travel track 122 on the turntable 12 synchronously transmits force to the limiting shaft 114 on each clamping unit 111, and each clamping unit 111 is gathered or separated radially under the limiting action of the first track unit 132 on the first shell 13 and the second track unit 142 on the second shell 14, so as to realize the compression and gripping of the artificial biological valve.

[0103] In an alternative embodiment, referring to Figure 6 , Fig. 9 and Fig.10 As shown, the number of the first track units 132 and the number of the second track units 142 are respectively equal to the number of the clamping units 111; the multiple first track units 132 are evenly distributed in a circular shape on the inner surface of the first shell 13, and each first track unit 132 may include: a first slide groove 133 and a first partition plate 134; the first slide groove 133 is located in the radial direction of the circle where the multiple first track units 132 are located, and a second slide groove 135 is formed between the first slide groove 133 and the first partition plate 134, and the center line of the first slide groove 133 is parallel to the center line of the second slide groove 135; the first guide block 115 is located in the first slide groove 133 and can slide in the first slide groove 133; the first guide bar 116 is located in the first slide groove 133 The second guide block 117 is located in the third guide groove 143 and can slide in the third guide groove 143; the second track units 142 are evenly distributed in a circle on the inner surface of the second shell 14, and each second track unit 142 may include: a third guide groove 143 and a second partition plate 144; the third guide groove 143 is located in the radial direction of the circle where the plurality of second track units 142 are located, and a fourth guide groove 145 is formed between the third guide groove 143 and the second partition plate 144, and the center line of the third guide groove 143 is parallel to the center line of the fourth guide groove 145; the second guide block 117 is located in the third guide groove 143 and can slide in the third guide groove 143; the second guide bar 118 is located in the fourth guide groove 145 and can slide in the fourth guide groove 145.

[0104] In this embodiment, a first track unit 132 and another second track unit 142 are mirror-symmetrical, and together they limit a clamp unit 111. Taking the first track unit 132 as an example, since the first slide groove 133 is located in the radial direction of the circle where the first track units 132 are located, the center line of the first slide groove 133 is parallel to the center line of the second slide groove 135, such a structure limits the moving track of the clamp unit 111. Under the constraints of each group of the first track unit 132 and the second track unit 142, refer to Fig.11 As shown, the multiple groups of clamping units 111 can only move in the radial direction of the circle they are in, so that the diameter of the circle formed by the multiple groups of clamping units 111 after being gathered together can be controlled to be as small as possible.

[0105] In another embodiment, referring to Fig. 9 and Fig.10 As shown, the first slide groove 133 and the third slide groove 143 are respectively bar-shaped closed slide grooves. The closed slide grooves help to limit the radial sliding stroke of the first guide block 115 and the second guide block 117 adapted thereto, so as to limit the stroke range of the clamping unit 111.

[0106] In another embodiment, referring to Fig. 9 and Fig.10 As shown, the radius of the circle where the first positioning pins 131 are located is greater than the radius of the circle where the first slide grooves 133 are located; and / or, the radius of the circle where the second positioning pins 141 are located is greater than the radius of the circle where the third slide grooves 143 are located. In this embodiment, the first positioning pins 131 are located outside the first slide grooves 133, and the second positioning pins 141 are located outside the third slide grooves 143, so that the clamping unit 111 will not be affected by the sliding stroke of the first positioning pins 131 or the second positioning pins 141 during the process of gathering or separating, and there will be no intersection of the running tracks between the components, thereby avoiding blocking or wear between the components.

[0107] In another embodiment, referring to Figure 8 As shown, the arc (α) of the arc segment where the first travel track 121 is located is 85°~92°; the arc (β) of the arc segment where the second travel track 122 is located is 75°~82°. Preferably, the arc (α) of the arc segment where the first travel track 121 is located is 87°~89°; the arc (β) of the arc segment where the second travel track 122 is located is 78°~79°. In the embodiment of the present invention, combined with Fig.10 and Fig.11 As shown, since the first positioning pin 131 and the second positioning pin 141 sliding in the first travel track 121 have a certain thickness, their actual sliding range must be smaller than the curvature range of the arc segment where the first travel track 121 is located. The inventor has limited the curvature of the arc segment 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 shell 13 and the second shell 14 will not be greater than 90°, avoiding large-angle changes in direction during the application and transmission of force. Furthermore, the curvature setting range of the arc segment where the second travel track 122 is located also avoids large-angle changes in the direction of the force when the second travel track 122 applies force to the limit shaft 114, making the user's use process more labor-saving.

[0108] In another embodiment, referring to Figure 6 , Figure 8 and Fig. 9As shown, the turntable 12 is provided with a middle hole 123; the first shell 13 is provided with a first through hole 136 matching the middle hole 123, and the second shell 14 is provided with a second through hole 146 matching the middle hole 123; the aperture of the middle hole 123 is not less than the aperture of the first through hole 136, and the aperture of the middle hole 123 is not less than the aperture of the second through hole 146; the first through hole 136, the middle hole 123 and the second through hole 146 are located on the same center line and form a material processing channel. In this embodiment, the passages arranged in the middle of each component form a material processing channel. After the material processing channel is processed, the artificial bioprosthetic valve to be pressed needs to be taken out of the channel and placed in the next artificial bioprosthetic valve to be pressed. In the embodiment of the present invention, preferably, the aperture size of the first through hole on the first shell is consistent with that of the second through hole on the second shell. In this design, according to the user's usage habits, the first through hole can be used as both an inlet and an outlet, and similarly, the second through hole can be used as both an inlet and an 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, this can effectively prevent the inner diameter of the material processing channel from becoming smaller from the outside to the inside, thereby avoiding jamming when transporting the compressed bioprosthetic valve.

[0109] Based on the same inventive concept, a crimping device is provided in an embodiment of the present invention, referring to Fig.12 and Fig.13 As shown, the crimping device may include: a handle 2 and the above-mentioned curling mechanism 1; the handle 2 is connected to the turntable 12 of the curling mechanism 1; a first limit opening 137 is opened on the side of the first shell 13 of the curling mechanism 1, and a second limit opening 147 is opened on the side of the second shell 14 of the curling mechanism 1, the first limit opening 137 and the second limit opening 147 form a drive limit opening 16, and the drive limit opening 16 is located on one side of the vertical center line of the crimping device; the handle 2 extends out of the drive limit opening 16, and can drive the turntable 12 to swing in the drive limit opening 16; the handle 2 drives the turntable 12 to rotate, so as to drive a plurality of clamping units 111 to radially gather or separate.

[0110] The above-mentioned crimping device provided in the embodiment of the present invention has a driving limit opening 16 formed by the first limit opening 137 on the first shell 13 and the second limit opening 147 on the second shell 14, which is located on one side of the vertical center line of the crimping device (curling mechanism 1). When the user uses the crimping device, the handle 2 can only be swung downward from one side of the vertical center line of the entire crimping device to the horizontal direction, and the swinging angle can be controlled within 90°. Compared with the crimping device in the prior art whose handle can swing within a range of 180°, on the one hand, the user does not need to change hands or turn hands near the vertical center line during use, which is more in line with the direction of human force and effectively ensures the continuous and stable output of force when crimping and gripping. On the second hand, since the force application process is more continuous and stable, it effectively prevents the occurrence of jumping parts due to changes in the applied force (changes in direction or size), thereby avoiding the occurrence of phenomena such as the valve frame of the artificial biological valve clamping the valve leaflets and the valve frame overlapping due to jumping parts, thereby reducing the influence of human factors on the qualified rate of crimping. On the third hand, since the handle is directly connected to the turntable located in the middle of the crimping device, the clamping assembly is driven to gather or separate through the turntable in the middle. Compared with the method of driving the clamping assembly to move from the two side shells in the prior art, it is more stable due to precision limitations, avoiding the occurrence of force errors caused by uneven force on both sides, and improving the crimping yield of artificial biological valves.

[0111] In another embodiment, referring to Fig.13 As shown, the crimping device may further include: a base 3; a mounting groove 31 is provided on the base 3, and the first shell 13 and the second shell 14 in the curling 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 overall structure of the crimping device, so that the crimping device can be evenly stressed when used by the user, and the base 3 can play an effective supporting role.

[0112] In another embodiment, referring to Fig.13 As shown, the crimping device may further include: a first stopper 4; the first stopper 4 is located at one end of the driving limit opening 16 away from the vertical center line of the crimping device; a limit slot 32 is provided on the base 3, and the first stopper 4 is detachably inserted into the limit slot 32. In this embodiment, the first stopper 4 is used to prevent the user from deforming, damaging, or puncturing the balloon due to excessive force or excessive gripping of the artificial bioprosthetic valve. As long as the blocking and limiting function is achieved at one end of the driving limit opening 16 away from the vertical center line of the crimping device, the first stopper 4 in this embodiment is specifically arranged on the base 3 through the limit slot 32. It should be noted that the bottom of the first stopper 4 in this embodiment can be in a "cross" shape or a "T" shape, and the corresponding limit slot 32 is also in a matching shape. In this embodiment, the first stopper 4 can prevent the handle 2 from swinging downward at an excessive angle when gripping.

[0113] In another embodiment, referring to Fig.13 As shown, a first slot 33 and a second slot 34 are provided on both sides of the mounting groove 31 on the base 3, and the positions of the first slot 33 and the second slot 34 match the position of the material processing channel formed by the middle hole 123 on the turntable 12, the first through hole 136 on the first shell 13 and the second through hole 146 on the second shell 14; the crimper may also include: two groups of support components 5; each group of support components 5 may include: guide columns 51, guide grooves 52 and pressure plates 53; the two guide columns 51 are detachably inserted in the first slot 33 and the second slot 34 respectively; the two guide grooves 52 are respectively connected to the two guide columns 51, and the positions of the two guide grooves 52 match the positions of the material processing channel; the two pressure plates 53 are respectively engaged with the two guide grooves 52, and the pressure plates 53 can slide on the guide grooves 52; the shape surrounded by the pressure plate 53 engaging the guide grooves 52 matches the shape of the catheter delivery component connected to the crimped and curled artificial biological valve 10 (refer to Figure 1).

[0114] When the support assembly 5 in this embodiment is used, the catheter delivery assembly connected with the artificial bioprosthetic valve is placed on the guide groove 52 of one support assembly 5, and then the pressing plate 53 is engaged, and the catheter delivery assembly is driven to move radially and stably toward the material processing channel by pushing the pressing plate 53. The support assembly 5 helps to accurately locate the position of the artificial bioprosthetic valve before crimping. In this embodiment, the support assembly 5 can be provided with two groups, which are respectively located at the two ends of the material processing channel, so that users who use different hands for crimping can perform crimping and curling operations from different directions.

[0115] In another embodiment, referring to Fig.13 As shown, the pressing plate 53 is provided with a limiting ear 54, and the size of the limiting ear 54 is larger than the aperture of the first through hole 136 on the first shell 13 and the second through hole 146 on the second shell 14. In this embodiment, the limiting ear 54 can play a limiting role, thereby controlling the sliding stroke of the pressing plate 53 on the guide groove 52, and the position of the artificial bioprosthetic valve can be accurately positioned.

[0116] Before TAVR surgery, the compression steps are as follows:

[0117] (1) Remove the crimping device and correctly install the first stopper and the support assembly.

[0118] (2) Remove the label on the artificial biological valve, and in a sterile environment, put the artificial biological valve on the balloon on the catheter delivery assembly in the correct direction of the operation; lift the handle of the crimping device upwards, place the artificial biological valve on the balloon of the catheter delivery assembly on the guide groove, use the pressure plate to engage it, and then push the pressure plate in the direction close to the material processing channel. The pressure plate drives the artificial biological valve to move radially and stably toward the material processing channel.

[0119] (3) Before crimping and gripping, be sure to confirm that the leaflet opening direction of the prosthetic valve is correct, and pay attention to the accurate positioning of the crimping and gripping of the prosthetic valve before slowly pressing down the handle. After completing the crimping and gripping operation, hold for 5 seconds and repeat pressing the handle down twice.

[0120] (4) Remove the balloon protective cover, rinse the loading sheath with heparin water, and then completely insert the loaded balloon into the loader. The loader covers the balloon and the tip, and remove the protective wire.

[0121] (5) After pressing and gripping, push the artificial bioprosthetic valve into the guide groove on the guide column and set it aside for use.

[0122] It should be noted that the entire artificial bioprosthetic valve should not be placed in place for more than 15 minutes after loading, so as to avoid damage to the valve leaflets and affect the expected function after implantation.

[0123] In another embodiment, referring to Figures 5 to 11 As shown, the crimping device may also include: a second stopper 6; the second stopper 6 is located in the accommodating cavity 15, and is respectively connected to the first shell 13 and the second shell 14, and matches the position of the drive limit opening 16; the edge of the first shell 13 extends to form a first support seat 138, and the edge of the second shell 14 extends to form a second support seat 148; when the first shell 13 and the second shell 14 are covered, the first support seat 138 and the second support seat 148 form a support base 7 to support the crimping device.

[0124] The difference between this embodiment and the above-mentioned embodiment lies in that the second stop member in this embodiment has a different structure from the first stop member in the above-mentioned embodiment. The second stop member in this embodiment matches the position of the drive limit opening, is located in the accommodating cavity formed by the first shell and the second shell, and is installed on the first shell and the second shell. The second stop member is arc-shaped as a whole, and the arc-shaped opening angle of the second stop member can control the rotation of the handle within 90°, which is used to further limit the position of the handle so that the handle can only be rotated to a horizontal position.

[0125] Based on the same inventive concept, a crimping device is also provided in the embodiment of the present invention. Fig.17 and Fig.18 As shown, the crimping device may include: a gear assembly 8 and the above-mentioned curling mechanism 1; a mounting position 17 is opened on the first shell 13 and / or the second shell 14 of the curling mechanism 1, one end of the gear assembly 8 cooperates with the turntable 12 of the curling mechanism 1, and the other end extends out of the mounting position 17; the gear assembly 8 drives the turntable 12 to rotate, so as to drive several clamping units 111 in the curling mechanism 1 to radially gather or separate.

[0126] It should be noted that, refer to Fig.18As shown, the above-mentioned mounting position 17 in this embodiment can be just a mounting hole opened on the first shell or the second shell; or it can be a mounting hole starting from one shell (for example, the first shell), and a groove opened on the inner surface of the other shell (the second shell), the mounting hole facilitates one end of the gear assembly to extend out, and the groove facilitates the axial limitation of the other end of the gear assembly.

[0127] The crimping device provided in this embodiment has a turntable which is the main body driving the clamp assembly to move, and the turntable cooperates with the clamp unit in the clamp assembly through the second travel track. The turntable is directly driven by the gear assembly. Such a structural setting makes the gear assembly more stable when applying force and the force transmission process is also smoother. First, the gear assembly can apply force continuously and stably on the turntable in the middle; second, since the force application process is more continuous and stable, force is avoided on one end, which effectively prevents the occurrence of jumping parts due to changes in the applied force (direction or size), thereby avoiding the occurrence of phenomena such as the valve frame of the artificial biological valve clamping the valve leaflets and the valve frame overlapping due to jumping parts, thereby reducing the influence of human factors on the qualified rate of crimping; third, since the gear assembly directly drives the turntable to rotate, the turntable in the middle drives the clamping assembly to gather or separate, compared with the prior art, because the turntable is located on one side of the center line of the entire device, the turntable of this embodiment is located on the center line and the limit axis in the middle of the clamping unit is subjected to force, thereby avoiding the occurrence of uneven force on the end of the clamping unit; fourth, due to the precision limitation, it is more stable, avoiding the occurrence of force errors caused by uneven force on the end, and improving the qualified rate of crimping of artificial biological valves.

[0128] In another embodiment, referring to Fig.17 and Fig.18 As shown, the gear assembly 8 may include: a turn button 81, a rotating shaft 82 and a driving gear 83; the periphery of the rotating disk 12 in the curling mechanism 1 is provided with gear teeth 124; the driving gear 83 meshes with the gear teeth 124 on the periphery of the rotating disk 12; one end of the rotating shaft 82 is connected to the driving gear 83, and the other end extends out of the mounting position 17 and is connected to the turn button 81; the driving gear 83 of the gear assembly 8 drives the rotating disk 12 to rotate, so as to drive the plurality of clamping units 111 in the curling mechanism 1 to radially gather or separate. The gear teeth on the periphery of the rotating disk in this embodiment are located at the vertical center of the rotating disk, and the driving gear can stably mesh with the gear teeth set on the periphery of the rotating disk, and the rotating disk is driven to rotate by rotating the turn button, the rotating shaft and the driving gear. Since the gear teeth and the rotating disk are located at the center of the entire device, the force application and force transmission process is more stable than the force application from the rotating disk located on one side in the prior art.

[0129] In another embodiment, referring to Fig.17 and Fig.18As shown, the gear assembly 8 may include: a rotating button 81, a rotating shaft 82, a driving gear 83 and a gear ring 84; the gear ring 84 is nested on the outside of the rotating disk 12 in the curling mechanism 1, and the driving gear 83 is meshed with the gear ring 84; one end of the rotating shaft 82 is connected to the driving gear 83, and the other end extends out of the mounting position 17 and is connected to the rotating button 81; the gear ring 84 of the gear assembly 8 drives the rotating disk 12 to rotate, so as to drive the plurality of clamping units 111 in the curling mechanism 1 to radially gather or separate. The difference between this embodiment and the above embodiment is that the gear assembly includes a gear ring, and the gear ring is nested on the outside of the rotating disk. Such a structure plays the same role as the gear teeth on the periphery of the rotating disk. Accordingly, since the gear ring and the rotating disk are located at the center of the entire device, the force application and force transmission process is more stable than the prior art in which the force is applied from the rotating disk on one side.

[0130] In another embodiment, referring to Figures 5 to 11 As shown, the edge of the first shell 13 extends to form a first support seat 138, and the edge of the second shell 14 extends to form a second support seat 148; when the first shell 13 and the second shell 14 are covered, the first support seat 138 and the second support seat 148 form a support base 7 to support the crimping device. The structure of the support base in this embodiment can make the crimping device structure more stable, so that the device can be evenly stressed when the user uses the device.

[0131] Compared with the existing devices that require two users (medical staff) to deliver samples and take samples respectively, the above three types of crimpers provided in this embodiment only require one user to complete operations such as sample delivery, crimping and sampling.

[0132] The crimping device in the embodiment of the present invention was used to crimp and curl the artificial biological valve in Example 3 of Application No. 201920458990.1, and the artificial biological valve did not have problems such as clamping of valve leaflets and overlapping of valve frames. Through caliper measurement and cylindrical mold comparison, the artificial biological valve was relatively round during and after the crimping process, with a high overall yield and no jumping phenomenon.

[0133] Based on the same inventive concept, a crimping system is also provided in an embodiment of the present invention, which may include: a catheter delivery assembly and the above-mentioned crimping device; 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 crimping device.

[0134] Based on the same inventive concept, an embodiment of the present invention further provides a method for crimping and curling an artificial biological valve using the above-mentioned crimper.

[0135] The specific implementation of the above-mentioned crimping device and application method in the embodiment of the present invention can refer to the detailed description of the above-mentioned curling mechanism, and the embodiment of the present invention will not be repeated here.

[0136] Obviously, various changes and modifications may be made to the present invention by those skilled in the art without departing from the spirit and scope of the present invention. The present disclosure is not limited to the precise structure described above and shown in the accompanying drawings, and various changes and modifications may be made without departing from the scope thereof. The scope of the present disclosure is limited only by the appended claims. Thus, if these changes and modifications of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these changes and modifications.

Claims

1. A clamping unit, characterized in that: The clamp 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 through 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 comprises 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 long axis center lines of the second outer ridge, the second front side and the first guide strip 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 clamp unit according to claim 1, characterized in that: There is a rounded corner transition between the first outer ridge and the second outer ridge, a rounded corner transition between the second outer ridge and the third outer ridge, a rounded corner transition between the third outer ridge and the fourth outer ridge, a rounded corner transition between the first front side edge and the second front side edge, and a rounded corner transition between the second front side edge and the third front side edge.

3. The clamp assembly according to claim 1 or 2, characterized in that: 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 crimping device, and the curling mechanism comprises: a clamp 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 close to the edge of the turntable, and the plurality of second travel tracks are in an inclined radial shape and are arranged close to the center of the turntable; The clamp assembly comprises a plurality of clamp units as claimed in any one of claims 1 to 3, the number of the clamp units being equal to the number of the second travel tracks; the first clamp body and the second clamp body of the clamp unit are integrally connected at one end away from the second travel track, and the end close to the second travel track is slidably connected to the second travel track through the limit shaft of the clamp unit; The inner surface of the first shell is provided with a first positioning pin matching the first travel track, and a first track unit matching the first guide block and the first guide bar in the clamp assembly respectively; the inner surface of the second shell is provided with a second positioning pin matching the first travel track and the first positioning pin, and a second track unit matching the second guide block and the second guide bar in the clamp assembly respectively; The first shell and the second shell are covered 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 limit shaft, respectively 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, characterized in that: The number of the first track units and the number of the second track units are respectively equal to the number of the clamp units; The plurality of first track units are evenly distributed in a circular shape on the inner surface of the first shell, and each of the first track units comprises: a first slide groove and a first partition plate; the first slide groove is located in the radial direction of the circle where the plurality of first track units are located, a second slide groove is formed between the first slide groove and the first partition plate, and the center line of the first slide groove is parallel to the center line 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; A plurality of second track units are evenly distributed in a circle 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 plurality of second track units are located, 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, characterized in that: The first chute and the third chute are respectively bar-shaped closed chute.

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

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

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

10. The curling mechanism according to any one of claims 4 to 9, 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 as claimed in 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 driving limit opening, and the driving limit opening is located on one side of the vertical center line of the crimping device; the handle extends out of the driving limit opening and can drive the turntable to swing in the driving limit opening; the handle drives the turntable to rotate to drive a plurality of the clamping units to radially gather or separate.

12. The crimping device according to claim 11, characterized in that: The crimping device further comprises: a base; a mounting groove is formed 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 crimping device according to claim 12, characterized in that: Also includes: A first stopper; the first stopper is located at an end of the drive limit opening away from the vertical center line of the crimping device; The base is provided with a limit slot, and the first stopper is detachably inserted into the limit slot.

14. The crimping device according to claim 12 or 13, characterized in that: 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 enclosed 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 crimping device according to claim 14, characterized in that: The pressure 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 crimping device according to claim 11, characterized in that: The crimping device further includes: 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 driving 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 crimping device, characterized in that: The crimping device comprises: a gear assembly and a crimping mechanism as claimed in 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 cooperates with the rotating disk of the curling mechanism, and the other end extends out of the mounting position; The gear assembly drives the rotating disk to rotate, so as to drive a plurality of clamping units in the curling mechanism to radially gather or separate.

18. The crimping device according to claim 17, characterized in that: The gear assembly includes: a rotating knob, a rotating shaft, a driving gear and a gear ring; the gear ring is embedded in the outer side of the rotating disk in the curling mechanism, and the driving gear is meshed with the gear ring; 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 gear ring of the gear assembly drives the rotating disk to rotate, so as to drive the plurality of clamping units in the curling mechanism to radially gather or separate.

19. The crimping device according to claim 17, characterized in that: The gear assembly includes: a rotating knob, a rotating shaft and a driving gear; the periphery of the rotating disk in the curling mechanism is provided with gear teeth; the driving gear is meshed with the gear teeth on the periphery of the rotating disk; 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 rotating disk to rotate, so as to drive a plurality of the clamping units in the curling mechanism to radially gather 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: include: A catheter delivery assembly and a crimping device as described in any one of claims 11 to 20; the crimped and curled artificial bioprosthetic valve is used to be connected to one end of the catheter delivery assembly; the crimped and curled artificial bioprosthetic valve is crimped and curled by the crimping device.

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

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