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

Abstract

The present invention discloses a clamping unit, a curling mechanism, a crimping device, a crimping system, and an application method. The clamping unit includes: 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 clamp body and the second clamp body are mirror-symmetrical, and the second clamp body includes: 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 in sequence; 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 bar are parallel. The clamping unit has a small enclosed diameter when in use and is suitable for small-diameter crimping processing. The clamping unit reduces design and manufacturing costs.

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 disadvantages such as large trauma, long operation time (usually 3 to 4 hours), severe 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 higher. Transcatheter Aortic Valve Replacement (TAVR) is a minimally invasive surgery that retains the original diseased aortic valve and implants an artificial bioprosthetic valve inside it. It can usually be performed through femoral artery puncture and under a catheter, similar to coronary artery stenting through femoral artery puncture.

[0003] A crimper (bioprosthetic valve crimping device) is an auxiliary tool used for loading and releasing a bioprosthetic valve. Prior to implantation, the bioprosthetic valve must be crimped and installed at the distal end of the catheter delivery assembly. The crimper is used to crimp the bioprosthetic valve, reducing its diameter. This allows it to be delivered through the catheter delivery assembly and blood vessels to the affected area of ​​the heart valve.

[0004] The gripped bioprosthetic valve refers to the "stent 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 (made of cobalt-chromium alloy) 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 and are prepared after chemical modification. The entire stented valve consists of three bovine pericardial leaflets, sutures, outer skirts, inner skirts and stents. In order to maintain improved functions after being installed in the human body, this type of valve usually needs to be stored in a preservation solution in an expanded state. A few minutes before transplantation, the stented valve needs to be crimped and curled by a crimper in the operating room.

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

[0006] In order to improve the stability of force transmission of the crimper during the crimping process, reduce the cumulative error of each clamp, make the crimped artificial bioprosthetic valve more round, and thus improve the crimping yield of the artificial 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 clamping 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 via the limiting shaft; the first guide block and the first guide bar are located on the outer side surface of the first clamp body, and the second guide block and the second guide bar are located on the outer side surface 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 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°.

[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 and the second front side, and a rounded corner transition between the second front side and the third front side.

[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 for a crimper, the curling mechanism may include: a clamping 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 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;

[0013] The clamp assembly includes a plurality of clamp units as described in the first aspect, 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;

[0014] 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;

[0015] 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.

[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 housing, 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 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;

[0018] Multiple second track units are evenly distributed in a circular shape 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 chute and the third chute are respectively bar-shaped closed chute.

[0020] In one embodiment, 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.

[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 crimper, 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 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.

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

[0027] In one embodiment, the crimper 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 crimper;

[0028] A limiting slot is provided on the base, and the first stopper is detachably inserted into the limiting slot.

[0029] In one embodiment, 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;

[0030] The crimping device may also include: two groups of support components; each group of support components includes: guide posts, guide grooves and pressure plates; the two guide posts are detachably inserted into the first slot and the second slot respectively; the two guide grooves are respectively connected to the two guide posts, 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 assembly 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 drive 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 the 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 is engaged with the turntable of the curling mechanism, and the other end extends out of the mounting position;

[0036] 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.

[0037] In one embodiment, the gear assembly may include: 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, 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 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 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 a bioprosthetic valve using the crimper as described in the third aspect or the fourth aspect.

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

[0043] In an embodiment of the present invention, a clamping unit, a curling mechanism, a crimper, a crimping system and an application method are provided. On the one 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 other hand, 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 production cost; on the other 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 bar, which reduces the cumulative error compared with the prior art in which the clamping unit is driven and limited by spiral tracks on both sides.

[0044] Other features and advantages of the present invention will be described in the following description, and in part will become apparent from the description, or will be 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 Schematic diagram of the structure of a bioprosthetic valve in the prior art;

[0048] Figure 1B This is one of the structural diagrams of a prosthetic valve crimping device in the prior art;

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

[0050] Figure 1D for Figure 1B sectional view of

[0051] Figure 1E This is an exploded view of the second structural diagram of a prosthetic valve crimping 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 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;

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

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

[0061] Figure 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] Figure 12 This is one of the structural diagrams of the crimping device provided in an embodiment of the present invention;

[0063] Figure 13 for Figure 12 Exploded diagram;

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

[0065] Figure 15 for Figure 14 Decomposition diagram of some areas;

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

[0067] Figure 17 This is the third structural diagram of the crimping device provided in an embodiment of the present invention;

[0068] Figure 18 for Figure 17 Exploded diagram;

[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-rotating disk; 13-first housing; 14-second housing; 15-accommodating cavity; 16-drive 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 bar; 117 - second guide block; 118 - second guide bar;

[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-rotating knob; 82-rotating shaft; 83-driving gear; 84-ring gear;

[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] Exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. Although 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. Rather, 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," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," "outer," "far," "near," "front," and "back" and the like, indicating positions or relationships, are based on the positions or relationships shown in the accompanying drawings and are intended solely to facilitate and simplify the description of the present invention. They are not intended to indicate or imply that the devices or components referred to must have, be constructed, or operate 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 should not be construed as indicating or implying relative importance.

[0082] In the description of the present invention, it should be noted that, unless otherwise expressly specified or limited, the terms "mounted," "connected," and "connected" should be understood in a broad sense. For example, they may refer to fixed, detachable, or integral connections; mechanical or electrical connections; direct or indirect connections through an intermediate medium; and internal communication between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on the specific circumstances.

[0083] Reference Figure 1B to Figure 1EAs shown, a conventional crimper jaw 1001 is configured about a central axis 1007, with housing assemblies 1002 on either side of the jaw 1001. Each portion of the housing assembly 1002 comprises a generally disk-shaped member (rotating disc 1003) having a radially oriented annular wall and an outer rim extending toward the opposing portion of the housing assembly 1002; the housing assemblies 1002, in turn, constrain each jaw 1001 to permit only radial movement. Each jaw 1001 preferably has a pair of guide plates 1012 oriented outwardly proximate the two radially outermost axes 1017 of the jaw 1001. The guide plates 1012 extend through and interact with guide slots 1010 within each stationary housing assembly 1002, thereby constraining 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 within each fixed housing assembly 1002. All four guide plates 1012 and guide ribs 1013 within each individual jaw 1001 are parallel, as are the four corresponding guide grooves 1010 and secondary grooves 1011. The resulting assembly constrains the jaw 1001 to move within the housing assembly 1002 along the guide grooves 1010 and secondary grooves 1011, which are generally oriented radially. In practice, the guide grooves 1010 lie on a radial line extending outward from the center of the crimping mechanism, while the secondary grooves 1011 are parallel but slightly spaced therefrom. The jaw gap 1015 is closed to a sufficient degree to crimp the stented valve 1014.

[0084] Both rotating disks 1003 have shafts 1017 necks so that they 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 that they rotate in coordination. Spiral cuts, grooves or rails in each rotating disk 1003 are provided on each side of the curling device to convert the rotational motion of the lever handle 1005 into linear motion of the clamp 1001. Ideally, spiral rails 1009 are formed between the spiral walls extending inward from the rotating disk 1003. The spiral rails 1009 act on an actuating pin-shaped cam member 1008, which is located on both sides of each clamp 1001, particularly extending outward 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 rotation handle 1016 connected to a shaft 1017 and a small gear 1018 to rotate a single rotating disk 1003. The small gear 1018 meshes with a large gear 1019 on the rotating disk 1003. An actuating cam member 1008 on only one side of the jaw 1001 is coupled to a single spiral rail 1009 and is guided by coupling a guide groove 1010 and a sub-groove 1011 to a guide plate 1012 and a 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 exhibited local deformation when crimping the bioprosthetic valve, and its yield rate was low, which would undoubtedly affect the preparations before surgery, cause meaningless loss of the bioprosthetic valve, and increase production costs. 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 the clamping structure design of the repairable valve curling device limits the final crimping size of the valve, and in the process of force transmission, the first and second outer rotating disks on both sides of the shell cooperate with the spiral rail (combined with the Figure 1D The invention utilizes a plurality of clamps (as shown) to transmit force, with each set of four clamps mated to a spiral track. This leads to unstable force transmission and increased cumulative error, reducing the yield rate of bioprosthetic valve crimping. Furthermore, designing clamps of varying specifications increases workpiece cost. In view of the aforementioned issues, the present invention provides a clamping unit, crimping mechanism, crimping device, crimping system, and application method that overcome or at least partially address these issues.

[0087] In an embodiment of the present invention, a clamping unit is provided, referring to Figures 2 to 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 bar 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 is radially limited 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 clamping 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. Figure 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; 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 used for 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 production cost, and is easy to replace after damage; third, 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 bar, which reduces the cumulative error compared with the prior art where the clamping unit is driven and limited by spiral tracks on both sides.

[0091] In an alternative embodiment, referring to Figures 2 to 4 As shown, there is 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 this embodiment, the edges of the jaws (the first jaw and the second jaw) are rounded to prevent adjacent jaws from being joined at right angles during use, making it difficult to retract and separate after being brought together. Furthermore, since the entire jaw unit is relatively small, the right-angled joints are relatively sharp, thus preventing injuries to the assembler during assembly.

[0092] In an alternative embodiment, referring to Figures 2 to 4 As shown, the limiting shaft 114 passes through the first clamp body 112 and the second clamp body 113 respectively, and is respectively connected to the first guide block 115 and the second guide block 117. In this embodiment, when assembling the clamp unit 111 or assembling the clamp unit 111 to the turntable, the limiting 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 limiting shaft 114 can pass through the first clamp body 112 and the second clamp body 113 respectively, and then the two ends are respectively connected to the first guide block 115 and the second guide block 117. The specific connection method can be a threaded connection, a riveted connection, a 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; a plurality of first travel rails 121 and a plurality of second travel rails 122 are provided on the turntable 12; the plurality of first travel rails 121 are in a regular fan shape and are arranged close to the edge of the turntable 12, and the plurality of second travel rails 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 rails 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 rail 122, and the end close to the second travel rail 122 is slidably connected to the second travel rail 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 rail 121, and a first positioning pin 131 respectively connected to the first travel rail 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 each other to form an accommodating cavity 15, the turntable 12 and the clamp assembly 11 are located in the accommodating cavity 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, 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 the 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 gather or separate radially synchronously. Compared with the prior art in which the clamps are driven to move radially by rotating disks on the shells on both sides, 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 embodiment of the present invention are described as follows: Figures 6 to 8As shown, the turntable 12 is generally disk-shaped and is located in the vertical middle portion of the entire crimping mechanism 1. 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 provided on the turntable 12. Since the turntable 12 is located in the middle portion of the entire crimping mechanism 1, and the crimping and pressing process of the crimping mechanism 1 is performed on a bioprosthetic valve 10 (see FIG. 1 ) measuring several millimeters, the precision requirements are very strict. The turntable 12 serves as the starting point for force transmission. This force transmission process is more stable than the prior art method of force transmission through the two side shells, avoiding the phenomenon of uneven force applied on both sides due to insufficient equipment precision during force transmission.

[0096] Reference Figure 8 and Figure 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 a relative rotation angle due to the limiting effect, thereby avoiding the disadvantages of limited gripping force and gripping size. It should be further explained that the first travel track 121 in this 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 the generation of 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 (usually medical staff) to normally squeeze and grip the curling mechanism 1 with less effort.

[0097] Reference Figure 8 and Figure 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 convergence or separation of several clamping units 111. Since each second-stroke track 122 can only drive one of the mutually matched clamping units 111 to transmit force, the force transmission errors between each clamping unit 111 are unrelated; compared with the prior art method of transmitting force through one spiral track with four groups of clamping units, the cumulative error caused by this is gradually increasing, and if a spiral track has a deviation in design or processing dimensions, it will cause the force transmission 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 respectively matched second-stroke tracks 112 and the same number of clamping units 111 are used, and since each second-stroke track 122 is matched with a limit shaft 114 of a clamping unit 111, the adjacent clamping units 111 do not affect each other during the force transmission process, and no cumulative error will be generated.

[0098] Reference Figure 8 and Figure 11 As shown, in the embodiment of the present invention, the number of the second travel rails 122 and the clamping units 111 are set to 12. Figures 2 to 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 the ends of the clamping units 121 near the center). When the diameter of the crimping hole is gradually reduced, the bioprosthetic valve placed in the crimping hole can be crimped and curled, and the ends (free ends) near the center of the 12 clamping units 111 can form a circle with a diameter no greater than 1 mm. When the diameter of the crimping hole is gradually increased, the crimped bioprosthetic valve can be removed or a bioprosthetic valve to be crimped can be placed.

[0099] Reference Figures 2 to 4 As shown, the clamping assembly 11 in the curling mechanism 1 is composed of a plurality of clamping units 111, and in a specific implementation, it is composed of 11 clamping units. Figure 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 、 Figure 9 and Figure 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 specifically 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 right-side positioning pin connection method, the two positioning pins have the same outer diameter and are hollow. The first positioning pin 131 and the second positioning pin 141 are matched with positioning cylinders or positioning columns. For example, the matching positioning cylinder end of the first positioning pin 131 is located inside the first positioning pin 131, and the matching positioning cylinder end of the second positioning pin 141 protrudes from the outer wall of the second positioning pin 141 and is located inside the first positioning pin 131. Of course, it can also be set to the opposite matching structure. Furthermore, 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 Figure 9 As shown, the inner surfaces of the first and second housings 13, 14 are respectively provided with first and second rail units 132, 142 for limiting the position of the clamping units 111. The number of first and second rail units 132, 142 is equal to the number of clamping units 111, and the first and second rail units 132, 142 are mirror-symmetrical structures. By providing such one-to-one limiting structures on the housings, the inventors can ensure that each clamping unit 111 operates independently, and there is no cumulative error between the clamping units 111.

[0102] Reference Figure 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 、 Figure 9 and Figure 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 plurality of 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 limit a clamping unit 111. Taking the first track unit 132 as an example, since the first slide 133 is located in the radial direction of the circle where the multiple first track units 132 are located, the center line of the first slide 133 is parallel to the center line of the second slide 135. Such a structure limits the moving trajectory of the clamping unit 111. Under the constraints of each group of the first track unit 132 and the second track unit 142, refer to Figure 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 gathering can be controlled to be as small as possible.

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

[0106] In another embodiment, referring to Figure 9 and Figure 10 As shown, the radius of the circle containing the plurality of first positioning pins 131 is greater than the radius of the circle containing the plurality of first chutes 133; and / or, the radius of the circle containing the plurality of second positioning pins 141 is greater than the radius of the circle containing the plurality of third chutes 143. In this embodiment, the first positioning pins 131 are located outside the first chutes 133, and the second positioning pins 141 are located outside the third chutes 143. In this way, the clamping unit 111 is not affected by the sliding travel of the first positioning pins 131 or the second positioning pins 141 during the process of converging or separating. The running paths of the components will not intersect, thus avoiding blocking or wear between the components.

[0107] In another embodiment, referring to Figure 8 As shown, the arc angle (α) of the arc segment where the first travel track 121 is located is 85°~92°; the arc angle (β) of the arc segment where the second travel track 122 is located is 75°~82°. Preferably, the arc angle (α) of the arc segment where the first travel track 121 is located is 87°~89°; the arc angle (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 Figure 10 and Figure 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 exceed 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 Figure 9As shown, the turntable 12 has a central hole 123; the first housing 13 has a first through-hole 136 that matches the central hole 123, and the second housing 14 has a second through-hole 146 that matches the central hole 123. The diameter of the central hole 123 is not less than that of the first through-hole 136, and the diameter of the central hole 123 is not less than that of the second through-hole 146. The first through-hole 136, the central hole 123, and the second through-hole 146 are located on the same centerline and form a material processing channel. In this embodiment, the through-holes provided in the middle of each component form a material processing channel. After the crimped bioprosthetic valve is processed in this material processing channel, it is removed from the channel and the next bioprosthetic valve to be crimped is placed in it. In this embodiment of the present invention, the first through-hole in the first housing and the second through-hole in the second housing preferably have the same diameter. This design allows the first through-hole to serve as both an inlet and an outlet, and similarly, the second through-hole can serve as both an inlet and an outlet, depending on the user's usage habits. 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, and avoid jamming when transporting the gripped artificial bioprosthetic valve.

[0109] Based on the same inventive concept, a crimping device is provided in an embodiment of the present invention, referring to Figure 12 and Figure 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 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). In this way, 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 swing 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 applying force; on the other 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 (direction or magnitude), thereby avoiding the occurrence of phenomena such as the valve frame of the artificial biological valve clamping the leaflets and the valve frame overlapping due to jumping parts, reducing the influence of human factors on the crimping qualification rate; 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 generation of force errors caused by uneven force on both sides, and improving the crimping qualification rate of artificial biological valves.

[0111] In another embodiment, referring to Figure 13 As shown, the crimping device may further include a base 3 having a mounting slot 31 defined therein. The first housing 13 and the second housing 14 of the crimping mechanism 1 are removably mounted within the mounting slot 31 after being closed. The structure of the base 3 in this embodiment is intended to stabilize the overall structure of the crimping device during installation, ensuring uniform force distribution during use. The base 3 provides effective support.

[0112] In another embodiment, referring to Figure 13 As shown, the crimping device may further include: a first stopper 4; the first stopper 4 is located at the end of the drive limit opening 16 that is away from the vertical centerline of the crimping device; and a limit slot 32 is defined on the base 3, into which the first stopper 4 is removably inserted. In this embodiment, the first stopper 4 is used to prevent the user from applying excessive force or excessive pressure, thereby causing deformation, damage, or puncture of the bioprosthetic valve, etc. As long as the stopper 4 is located at the end of the drive limit opening 16 that is away from the vertical centerline of the crimping device, it can achieve a blocking and limiting function. In this embodiment, the first stopper 4 is specifically disposed on the base 3 via the limit slot 32. It should be noted that the bottom of the first stopper 4 in this embodiment can be in the shape of a "cross" or "T", 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 pressed.

[0113] In another embodiment, referring to Figure 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 into 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 channels; 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] During use, the support assembly 5 of this embodiment places the catheter delivery assembly, connected to the bioprosthetic valve, in the guide groove 52 of one support assembly 5. The pressure plate 53 is then engaged, and the pressure plate 53 is pushed to move the catheter delivery assembly radially and stably toward the material processing channel. This support assembly 5 facilitates accurate positioning of the bioprosthetic valve prior to crimping. In this embodiment, two sets of support assemblies 5 can be provided, one at each end of the material processing channel, to facilitate crimping and curling operations from different directions, depending on the user's hand.

[0115] In another embodiment, referring to Figure 13 As shown, the pressure plate 53 is provided with a limiting ear 54. The size of the limiting ear 54 is larger than the diameter of the first through hole 136 in the first housing 13 and the second through hole 146 in the second housing 14. In this embodiment, the limiting ear 54 can serve as a limiter, thereby controlling the sliding stroke of the pressure plate 53 on the guide groove 52, thereby accurately positioning the bioprosthetic valve.

[0116] Before TAVR surgery, the following steps should be taken:

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

[0118] (2) Remove the label on the artificial bioprosthetic valve, and in a sterile environment, put the artificial bioprosthetic 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 bioprosthetic 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 bioprosthetic valve to move radially and stably toward the material processing channel.

[0119] (3) Before squeezing, be sure to confirm that the leaflet opening direction of the artificial bioprosthetic valve is correct, and pay attention to the accurate positioning of the squeezing handle before slowly pressing down the handle. After completing the squeezing operation, hold it 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 post and set 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 stop member 6; the second stop member 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 embodiment is that the second stop member in this embodiment has a different structure from the first stop member in the above embodiment. The second stop member in this embodiment matches the position of the drive limit opening, and 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. The arc-shaped opening angle of the second stop member can control the rotation of the handle within 90°, and 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. Figure 17 and Figure 18 As shown, the crimper may include: a gear assembly 8 and the above-mentioned curling mechanism 1; a mounting position 17 is provided 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 to drive the plurality of clamping units 111 in the curling mechanism 1 to radially gather or separate.

[0126] It should be noted that, referring to Figure 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 the extension of one end of the gear assembly, 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 that is the main body that drives the clamping assembly to move, and the turntable cooperates with the clamping unit in the clamping assembly through the second travel track. The turntable is directly driven by the gear assembly. This structural setting makes the gear assembly more stable when applying force and the force transmission process is also smoother. First, the gear assembly acts on the turntable in the middle to apply force continuously and stably; second, since the force application process is more continuous and stable, the force on one end is avoided, which effectively prevents the occurrence of jumping parts due to changes in the applied force (direction or magnitude), thereby avoiding the occurrence of phenomena such as the valve frame of the artificial biological valve clamping the 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, thereby avoiding the occurrence of force errors caused by uneven force on the end, thereby improving the qualified rate of crimping of artificial biological valves.

[0128] In another embodiment, referring to Figure 17 and Figure 18 As shown, the gear assembly 8 may include: a knob 81, a rotating shaft 82, and a driving gear 83; gear teeth 124 are provided on the periphery of the turntable 12 in the curling mechanism 1; the driving gear 83 meshes with the gear teeth 124 on the periphery of the turntable 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 knob 81; the driving gear 83 of the gear assembly 8 drives the turntable 12 to rotate, thereby driving the plurality of clamping units 111 in the curling mechanism 1 to radially converge or separate. The gear teeth on the periphery of the turntable in this embodiment are located at the vertical center of the turntable, and the driving gear can stably mesh with the gear teeth provided on the periphery of the turntable. The turntable is driven to rotate by the rotation of the knob, the rotating shaft, and the driving gear. Since the gear teeth and the turntable 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 turntable located on one side.

[0129] In another embodiment, referring to Figure 17 and Figure 18As shown, the gear assembly 8 may include: a rotating button 81, a rotating shaft 82, a driving gear 83 and a ring gear 84; the ring gear 84 is nested on the outside of the turntable 12 in the curling mechanism 1, and the driving gear 83 is meshed with the ring gear 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 ring gear 84 of the gear assembly 8 drives the turntable 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 ring gear, and the ring gear is nested on the outside of the turntable. Such a structure plays the same role as the gear teeth on the periphery of the turntable. Accordingly, since the ring gear and the turntable 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 turntable on one side.

[0130] In another embodiment, referring to Figures 5 to 11 As shown, the edge of the first housing 13 extends to form a first support base 138, and the edge of the second housing 14 extends to form a second support base 148. When the first and second housings 13 and 14 are closed, the first and second support bases 138 and 148 form a support base 7 to support the crimper. The structure of the support base in this embodiment can make the crimper structure more stable, facilitating uniform force distribution 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 with application number 201920458990.1. The artificial biological valve did not have problems such as clamping of the leaflets and overlapping of the valve frame. 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, an embodiment of the present invention also provides a crimping system, 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 a bioprosthetic valve using the 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, those skilled in the art may make various changes and modifications to the present invention 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 modifications and variations may be made without departing from the scope of the present disclosure. The scope of the present disclosure is limited solely by the appended claims. Thus, to the extent such modifications and variations fall within the scope of the claims and their equivalents, the present disclosure is intended to include such modifications and variations.

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, 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 and the second front side, and a rounded corner transition between the second front side and the third front side.

3. The clamping unit 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 crimper, and the curling mechanism comprises: 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, 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 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, 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 section where the first travel track is located has an arc angle of 85° to 92°; the arc section 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 section where the first travel track is located has an arc angle of 87° to 89°; the arc section 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 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.

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 crimping device according to claim 11, wherein: 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, wherein: 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; A limiting slot is provided on the base, and the first stopper is detachably inserted into the limiting 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 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 crimping device according to claim 14, wherein: 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 crimper according to claim 11, wherein: 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 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 crimping device, characterized in that: The crimping device 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 crimping device according to claim 17, wherein: The gear assembly includes: a rotating knob, a rotating shaft, a driving gear and a ring gear; the ring gear is nested outside the rotating disk 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 rotating knob; the ring gear of the gear assembly drives the rotating disk to rotate, thereby driving the plurality of clamping units in the curling mechanism to radially converge or separate.

19. The crimping device according to claim 17, wherein: 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 engaged 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, thereby driving the plurality of 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: 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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