A curling mechanism, crimping device, crimping system and application method

Abstract

The present invention discloses a curling mechanism, a crimping device, a crimping system and an application method, comprising: a turntable, a clamping assembly, a first shell and a second shell; a plurality of first travel tracks and a second travel track are provided on the turntable; the first travel track is in a regular fan shape and is arranged close to the edge of the turntable, and the second travel track is in an inclined radial shape and is arranged close to the center of the turntable; the clamping assembly comprises a plurality of clamping units, wherein the first clamp body and the second clamp body are integrally connected at one end away from the second travel track, and are slidingly connected to the second travel track through a limiting shaft at one end close to the second travel track; 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; the inner surface of the first shell is provided with a first positioning pin and a first track unit; the inner surface of the second shell is provided with a second positioning pin and a second track unit; the turntable acts on the limiting shaft to drive the plurality of clamping units to radially gather or separate.

Description

Technical Field

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

[0007] In a first aspect, an embodiment of the present invention provides a curling mechanism for a crimper, the curling mechanism may include: a rotating disk, a clamping assembly, a first shell and a second shell;

[0008] 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;

[0009] The clamp assembly includes a plurality of clamp units, the number of which is equal to the number of the second travel tracks; the clamp units 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; the first clamp body and the second clamp body are integrally connected at one end away from the second travel track, and are slidably connected to the second travel track at one end close to the second travel track through 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;

[0010] The inner surface of the first housing 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 respectively; the inner surface of the second housing is provided with a second positioning pin matching the first travel track and the first positioning pin respectively, and a second track unit matching the second guide block and the second guide bar respectively;

[0011] 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.

[0012] 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;

[0013] 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;

[0014] 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.

[0015] In one embodiment, the first chute and the third chute are respectively bar-shaped closed chute.

[0016] In one embodiment, 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; 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.

[0017] In one 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.

[0018] 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°.

[0019] 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°.

[0020] 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 first through hole, the middle hole and the second through hole are located on the same center line and form a material processing channel.

[0021] In one embodiment, the aperture of the middle hole is not smaller than the aperture of the first through hole; the aperture of the middle hole is not smaller than the aperture of the second through hole.

[0022] In a second aspect, an embodiment of the present invention provides a crimper, which may include: a drive assembly, a base, and a curling mechanism as described in the first aspect;

[0023] The driving assembly is connected to the turntable and is used to drive the turntable to rotate;

[0024] The curling mechanism is located on the base.

[0025] In a third aspect, an embodiment of the present invention provides a crimping system, which may include: a catheter delivery assembly and a crimper as described in the second 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.

[0026] In a fourth aspect, an embodiment of the present invention provides a method for crimping and curling a bioprosthetic valve using the crimper as described in the second aspect.

[0027] The beneficial effects of the above technical solutions provided in the embodiments of the present invention include at least:

[0028] In an embodiment of the present invention, a curling mechanism, a crimping device, a crimping system and an application method are provided. The curling mechanism 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 smoother than the process of force transmission through the cam components on both sides.

[0029] 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.

[0030] The technical solution of the present invention is further described in detail below through the accompanying drawings and embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] 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:

[0032] Figure 1A Schematic diagram of the structure of a bioprosthetic valve in the prior art;

[0033] Figure 1B This is one of the structural diagrams of a prosthetic valve crimping device in the prior art;

[0034] Figure 1C for Figure 1B Exploded diagram;

[0035] Figure 1D for Figure 1B sectional view of

[0036] Figure 1E This is an exploded view of the second structural diagram of a prosthetic valve crimping device in the prior art;

[0037] Figure 2 This is an overall structural diagram of the curling mechanism provided in an embodiment of the present invention;

[0038] Figure 3 for Figure 2 Exploded diagram;

[0039] Figure 4 for Figure 2 A cross-sectional view in the vertical direction;

[0040] Figure 5 A schematic diagram of the turntable structure provided in an embodiment of the present invention;

[0041] Figure 6 A three-dimensional structural diagram of a clamp assembly provided in an embodiment of the present invention;

[0042] Figure 7 is an orthographic projection diagram of a clamping unit provided in an embodiment of the present invention;

[0043] Figure 8 A structural diagram of a clamping unit provided in an embodiment of the present invention;

[0044] Figure 9 A structural diagram of a first shell and a second shell provided in an embodiment of the present invention;

[0045] Figure 10 A structural diagram of a clamp assembly and a second housing provided in an embodiment of the present invention;

[0046] Figure 11 A structural diagram of an open state and a closed state provided in an embodiment of the present invention;

[0047] Figure 12 This is one of the structural diagrams of the crimping device provided in an embodiment of the present invention;

[0048] Figure 13 for Figure 12 Exploded diagram;

[0049] Figure 14 This is the second structural diagram of the crimping device provided in an embodiment of the present invention;

[0050] Figure 15 This is the third structural diagram of the crimping device provided in an embodiment of the present invention;

[0051] Among them, 1- curling mechanism; 2- driving assembly; 3- base; 4- artificial bioprosthetic valve;

[0052] 11-turntable; 12-clamp assembly; 13-first housing; 14-second housing; 15-accommodation chamber;

[0053] 111 - first travel track; 112 - second travel track; 113 - middle hole;

[0054] 121 - clamping unit; 122 - first clamp body; 123 - second clamp body; 124 - limiting shaft; 125 - first guide block; 126 - first guide bar; 127 - second guide block; 128 - second guide bar;

[0055] 131 - first positioning pin; 132 - first track unit; 133 - first slide groove; 134 - first partition plate; 135 - second slide groove; 136 - first through hole;

[0056] 141 - second positioning pin; 142 - second track unit; 143 - third slide slot; 144 - second partition plate; 145 - fourth slide slot; 146 - second through hole;

[0057] 1231-first outer ridge; 1232-second outer ridge; 1233-third outer ridge; 1234-fourth outer ridge; 1235-first front side; 1236-second front side; 1237-third front side;

[0058] 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

[0059] 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.

[0060] 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.

[0061] 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.

[0062] 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.

[0063] 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.

[0064] 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.

[0065] The inventors used Figure 1B to Figure 1E During the use 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. After studying its working process, the inventors found that, since the repairable valve curling device transmits force during the force transmission process through the first and second outer rotating disks on both sides of the shell in conjunction with the spiral rail and multiple groups of clamps, each clamp is matched with the first and second outer rotating disks through cam components on both sides, and every four groups of clamps are matched with a spiral rail, this leads to the disadvantages of unstable transmission and increased cumulative error during the force transmission process, thereby reducing the yield rate of crimping the bioprosthetic valve. In view of the above problems, the present invention is proposed to provide a curling mechanism, crimping device, crimping system and application method that overcome the above problems or at least partially solve the above problems.

[0066] In an embodiment of the present invention, a curling mechanism is provided. The curling mechanism 1 is used for a crimping device. Figures 2 to 11As shown, the curling mechanism 1 may include: a turntable 11, a clamping assembly 12, a first shell 13 and a second shell 14; a plurality of first travel rails 111 and a plurality of second travel rails 112 are provided on the turntable 11; the plurality of first travel rails 111 are in a regular fan shape and are arranged close to the edge of the turntable 11, and the plurality of second travel rails 112 are in an inclined radial shape and are arranged close to the center of the turntable 11; the clamping assembly 12 may include a plurality of clamping units 121, and the number of the clamping units 121 is equal to the number of the second travel rails 112 The clamping unit 121 may include: a first clamp body 122, a second clamp body 123, a limiting shaft 124, a first guide block 125, a first guide bar 126, a second guide block 127 and a second guide bar 128; the first clamp body 122 and the second clamp body 123 are integrally connected at one end away from the second travel track 112, and the end close to the second travel track 112 is slidably connected to the second travel track 112 through the limiting shaft 124; the first guide block 125 and the first guide bar 126 are located on the outer side of the first clamp body 122, and the second guide block 1 27 and the second guide bar 128 are located on the outer side of the second caliper body 123; the inner surface of the first housing 13 is provided with a first positioning pin 131 that matches the first travel track 111, and a first track unit 132 that matches the first guide block 125 and the first guide bar 126 respectively; the inner surface of the second housing 14 is provided with a second positioning pin 141 that matches the first travel track 111 and the first positioning pin 131 respectively, and a second track unit 142 that matches the second guide block 127 and the second guide bar 128 respectively; the first housing 13 and the second shell 14 cover to form an accommodating cavity 15, the turntable 11 and the clamp assembly 12 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 11 rotates to act on the limiting shaft 124, driving the first guide block 125 and the first guide bar 126 to slide on the first track unit 132, and the second guide block 127 and the second guide bar 128 to slide on the second track unit 142, so as to drive the plurality of clamp units 121 to radially gather or separate.

[0067] 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 gather or separate radially. 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.

[0068] The various components in the embodiment of the present invention are described as follows: Figures 3 to 5As shown, the turntable 11 is generally disk-shaped and located in the vertical middle portion of the entire crimping mechanism 1. It has a certain thickness in the axial direction. A first travel track 111 and a second travel track 112 are provided on the turntable 11. In this embodiment, the first travel track 111 and the second travel track 112 are arcuate through-slots provided on the turntable 11. Because the turntable 11 is located in the middle of the entire crimping mechanism 1, and this crimping mechanism 1 performs crimping and compression on a bioprosthetic valve 4 measuring several millimeters, which places very strict precision requirements, the turntable 11 serves as the starting point for force transmission. This allows for a smoother force transmission process than in the prior art, where force is transmitted from both sides. This avoids the phenomenon of uneven force applied on both sides due to insufficient equipment precision.

[0069] Reference Figure 5 and Figure 10 As shown, the first travel track 111 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 11 relative to the first shell 13 and the second shell 14; in this embodiment, three first travel tracks 111 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 111 in this embodiment is in a regular fan shape and is arranged close to the edge of the turntable 11. The inventor designed it in this way to avoid the generation of resistance in the radial direction when the first travel track 111 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.

[0070] Reference Figure 5 and Figure 10As shown, the second travel track 112 on the turntable 11, which serves as the starting point of force transmission, is arranged in an inclined radial shape and close to the center of the turntable 11. Such a structural design can provide radial movement power for the limiting shaft 124, and then under the cooperation and limiting action of the guide blocks (the first guide block 125 and the second guide block 127), the guide bars (the first guide bar 126 and the second guide bar 128) and the track units (the first track unit 132 and the second track unit 142), the clamping unit 121 realizes radial movement to realize the synchronous radial (radial of the circle formed by the multiple clamping units 121) gathering or separation. Since each second travel track 112 can only drive one clamping unit 121 that cooperates with each other to transmit force, the force transmission error between each clamping unit 121 is unrelated; compared with the prior art which uses a spiral track (combined with Figure 1D As shown in the figure, the four sets of clamping units are used to transmit force, and the cumulative error caused by this is gradually increasing. If a spiral track has an offset in design or processing size, it will cause the four sets of clamping units matched with it to transmit force unstably and the clamping will not be round or there will be a jumping phenomenon during the clamping process. Furthermore, 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 sets of respectively matched second travel tracks 112 and the same number of clamping units 121 are used. Since each second travel track 112 is matched with a limit shaft 124 of a clamping unit 121, the adjacent clamping units 121 do not affect each other during the force transmission process, and no cumulative error will be generated.

[0071] Reference Figure 5 and Figure 11 As shown, in the embodiment of the present invention, the number of the second travel rails 112 and the clamping units 121 are set to 12. Figures 6 to 8 As shown, the turntable 11 can drive the movement of the 12 clamping units 121, 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 121 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.

[0072] Reference Figures 6 to 8 As shown, the clamping assembly 12 in the curling mechanism 1 is composed of a plurality of clamping units 121, and in a specific implementation, it is composed of 12 clamping units 121. Due to the structural setting of the clamping unit 121, combined with Figure 9As 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. In the embodiment of the present invention, the first jaw body 122 and the second jaw body 123 in the clamping unit 121 are mirror-symmetrical structures. According to the positional relationship between the first jaw body 122 and the second jaw body 123, they are divided into the front side, the outer side and the inner side. Taking the second jaw body 123 as an example, the second jaw body 123 may include a first outer ridge 1231, a second outer ridge 1232, a third outer ridge 1233, a fourth outer ridge 1234, a first front side 1235, a second front side 1236 and a third front side 1237 in sequence. The length of the second outer ridge 1232 in the second jaw body 123 is greater than the length of the second front side 1236, and the second outer ridge 1232, the second front side 1236 and the third front side 1237 located at the second jaw body The second guide strip 128 on 123 is parallel; the angle between the first outer ridge 1231 and the second outer ridge 1232 is 150 degrees, and the angle between the two is rounded; the angle between the second outer ridge 1232 and the third outer ridge 1233 is 150 degrees, and the angle between the two is rounded; the angle between the third outer ridge 1233 and the fourth outer ridge 1234 is 105 degrees, and the angle between the two is rounded; the angle between the fourth outer ridge 1234 and the first front side 1235 is 30 degrees; the angle between the first front side 1235 and the second front side 1236 is 105 degrees, and the angle between the two is rounded; the angle between the second front side 1236 and the third front side 1237 is 150 degrees, and the angle between the two is rounded. In this embodiment, a driving gap is formed between the first pliers body 122 and the second pliers body 123, combined with Figure 11 As shown, when the clamp assembly 12 is in a dispersed state, the fourth outer ridge and the first front side of two adjacent clamp units 121 are in a separated state; when the clamp assembly 12 is in a gathered state, the fourth outer ridge and the first front side of two adjacent clamp units 121 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.

[0073] Reference Figure 3 、 Figure 4 、 Figure 9 and Figure 10As 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 4 As shown, 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 end of the matching positioning cylinder in the first positioning pin 131 is located inside the first positioning pin 131, and the end of the matching positioning cylinder in 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, the opposite matching structure can also be set. 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.

[0074] Reference Figure 9 As shown, the inner surfaces of the first and second housings 13 and 14 are respectively provided with first and second rail units 132 and 142 for limiting the position of the clamping units 121. The number of first and second rail units 132 and 142 is equal to the number of clamping units 121, and the first and second rail units 132 and 142 are mirror-symmetrical structures. By providing such one-to-one limiting structures on the housings, the inventors can ensure that each clamping unit 121 operates independently, and there is no cumulative error between the clamping units 121.

[0075] Reference Figure 11 As shown, the above-mentioned curling mechanism provided in the embodiment of the present invention works as follows: the turntable 11 rotates, and the second travel track 112 on the turntable 11 synchronously transmits force to the limiting shaft 124 on each clamping unit 121, and each clamping unit 121 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.

[0076] In one embodiment, referring to Figure 3 、 Figure 9 and Figure 10As 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 121; the plurality of 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 plurality of 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 125 is located in the first slide groove 133 and can slide in the first slide groove 133; the first guide bar 126 is located in the second slide groove The second guide block 127 is located in the third groove 143 and can slide in the third groove 143; accordingly, 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 groove 143 and a second partition plate 144; the third groove 143 is located in the radial direction of the circle where the plurality of second track units 142 are located, and a fourth groove 145 is formed between the third groove 143 and the second partition plate 144, and the center line of the third groove 143 is parallel to the center line of the fourth groove 145; the second guide block 127 is located in the third groove 143 and can slide in the third groove 143; the second guide bar 128 is located in the fourth groove 145 and can slide in the fourth groove 145.

[0077] In this embodiment, a first track unit 132 and another second track unit 142 are mirror-symmetrical and together limit a clamping unit 121. 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. This structure limits the moving trajectory of the clamping unit 121. Under the constraints of each group of first track units 132 and second track units 142, refer to Figure 11 As shown, the multiple groups of clamping units 121 can only move in the radial direction of the circle in which they are located, so that the diameter of the circle formed by the multiple groups of clamping units 121 after gathering can be controlled to be as small as possible.

[0078] In another embodiment, referring to Figure 3 、 Figure 4 、 Figure 9 and Figure 10 As shown, the first slide groove 133 and the third slide groove 143 in this embodiment are respectively bar-shaped closed slide grooves. The closed slide grooves help to limit the radial sliding stroke of the first guide block 125 and the second guide block 127 adapted thereto, thereby limiting the stroke range of the clamping unit 121.

[0079] In another embodiment, referring to Figure 4 、 Figure 9 and Figure 10As 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 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 121 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.

[0080] In another embodiment, in order to facilitate the installation of the limit shaft, refer to Figure 4 and Figure 8 As shown, the limiting shaft 124 passes through the first caliper body 122 and the second caliper body 123 respectively, and is connected to the first guide block 125 and the second guide block 127 respectively. In this embodiment, when assembling the curling mechanism, the limiting shaft 124 needs to be disassembled from one end of the first caliper body 122 or the second caliper body 123, and then passed through the second travel track 112 on the turntable 11 and then installed. Therefore, the limiting shaft 124 can pass through the first caliper body 122 and the second caliper body 123 respectively, and then the two ends are connected to the first guide block 125 and the second guide block 127 respectively. The specific connection method can be a threaded connection, a riveted connection, a snap connection, etc., which is not specifically limited in the embodiment of the present invention.

[0081] In another embodiment, referring to Figure 5 As shown, the arc angle (α) of the arc segment where the first travel track 111 is located is 85°~92°; the arc angle (β) of the arc segment where the second travel track 112 is located is 75°~82°. Preferably, the arc angle (α) of the arc segment where the first travel track 111 is located is 87°~89°; the arc angle (β) of the arc segment where the second travel track 112 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 111 have a certain thickness, their actual sliding range must be smaller than the curvature range of the arc segment where the first travel track 111 is located. The inventor has limited the curvature of the arc segment where the first travel track 111 is located, so that the relative rotation angle of the turntable 11 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 112 is located also avoids large angle changes in the direction of the force when the second travel track 112 applies force to the limit shaft 124, making the user's use process more labor-saving.

[0082] In another embodiment, referring to Figure 2、 Figure 5 and Figure 9 As shown, the turntable 11 defines a central hole 113; the first housing 13 defines a first through-hole 136 that matches the central hole 113; and the second housing 14 defines a second through-hole 146 that matches the central hole 113. The first through-hole 136, the central hole 113, and the second through-hole 146 are located on the same centerline and form a material processing channel. The channels formed in the middle of the various components in this embodiment form the material processing channel. After the crimped bioprosthetic valve is processed, it is removed from the channel and the next bioprosthetic valve to be crimped is placed in it.

[0083] In another embodiment, in order to prevent the squeezed artificial bioprosthetic valve from getting stuck or scratched during transportation, the aperture of the middle hole 113 in this embodiment is not less than the aperture of the first through hole 136; the aperture of the middle hole 113 is not less than the aperture of the second through hole 146. In the embodiment of the present invention, preferably, the aperture of the first through hole on the first shell is consistent with the aperture of the second through hole on the second shell. This design is based on the user's usage habits. The first through hole can be used as both an inlet and an outlet. 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 less than the aperture of the first through hole and the second through hole, it can effectively prevent the inner diameter of the material processing channel from becoming smaller from the outside to the inside, thereby avoiding the jamming phenomenon when transporting the squeezed artificial bioprosthetic valve.

[0084] Based on the same inventive concept, a crimping device is provided in an embodiment of the present invention, referring to Figures 12 to 15 As shown, the crimper may include a drive assembly 2 , a base 3 and the above-mentioned curling mechanism 1 ; the drive assembly 2 is connected to the turntable 11 for driving the turntable 11 to rotate; the curling mechanism 1 is located on the base 3 .

[0085] The above-mentioned crimping device in the embodiment of the present invention is referred to Figures 12 to 15 As shown, the driving assembly 2 can be a driving handle or a driving knob (with built-in gear), and the base 3 can be a separate component or a part of the extension of the shell (first shell and second shell) in the curling mechanism 1. The first shell and the second shell of the curling mechanism 1 are covered and installed on the base.

[0086] The above-mentioned crimper 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 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.

[0087] Based on the same inventive concept, an embodiment of the present invention further provides a crimping system, which may include: a catheter delivery assembly (not shown) and the above-mentioned crimping device; a crimped and curled artificial bioprosthetic valve 4 (refer to Figure 1A As shown) is used to connect with one end of the catheter delivery assembly; the crimped and curled artificial bioprosthetic valve 4 is crimped and curled by a crimper.

[0088] 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.

[0089] The specific implementation and detailed effects of the above-mentioned crimping device, crimping system and application method in the embodiments of the present invention can refer to the relevant description of the above-mentioned curling mechanism, and the embodiments of the present invention will not be repeated here.

[0090] 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 curling mechanism, characterized in that: The curling mechanism is used for a crimping device, and the curling mechanism includes: a rotating disk, a clamping assembly, 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 includes a plurality of clamp units, the number of which is equal to the number of the second travel tracks; the clamp units 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; the first clamp body and the second clamp body are integrally connected at one end away from the second travel track, and are slidably connected to the second travel track at one end close to the second travel track through 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; The inner surface of the first housing 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 respectively; the inner surface of the second housing is provided with a second positioning pin matching the first travel track and the first positioning pin respectively, and a second track unit matching the second guide block and the second guide bar 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.

2. The curling mechanism according to claim 1, 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.

3. The curling mechanism according to claim 2, characterized in that: The first chute and the third chute are respectively bar-shaped closed chute.

4. The curling mechanism according to claim 2, wherein: 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; 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.

5. The curling mechanism according to claim 1, wherein: The limiting shaft passes through the first clamp body and the second clamp body respectively, and is connected to the first guide block and the second guide block respectively.

6. The curling mechanism according to claim 1, wherein: 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°.

7. The curling mechanism according to claim 6, 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°.

8. The curling mechanism according to any one of claims 1 to 7, 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 first through hole, the middle hole and the second through hole are located on the same center line and form a material processing channel.

9. The curling mechanism according to claim 8, characterized in that: The aperture of the middle hole is not smaller than the aperture of the first through hole; the aperture of the middle hole is not smaller than the aperture of the second through hole.

10. A crimping device, characterized in that: The crimper comprises a drive assembly, a base, and a curling mechanism as claimed in any one of claims 1 to 9; The driving assembly is connected to the turntable and is used to drive the turntable to rotate; The curling mechanism is located on the base.

11. A crimping system, characterized in that: include: A catheter delivery assembly and a crimping device as described in claim 10; 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.

12. A method for crimping and curling a bioprosthetic valve using the crimper according to claim 10.

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