Artificial bioprosthetic valve curling device and curling system

Abstract

The utility model discloses an artificial bioprosthetic valve curling device and a curling system. The device comprises a forceps holder assembly, a first shell, a second shell, a turntable and a gear assembly, a plurality of first travel rails and a plurality of second travel rails are arranged on the turntable; the first stroke tracks are in a regular sector shape and are arranged close to the edge of the rotary disc, and the second stroke tracks are in an inclined radial shape and are arranged close to the circle center of the rotary disc. The forceps clip assembly comprises a plurality of forceps clip units, and the number of the forceps clip units is the same as that of the second stroke rails; a first positioning pin and a first rail unit are arranged on the inner surface of the first shell; a second positioning pin and a second rail unit are arranged on the inner surface of the second shell; the first shell and the second shell are closed to form a containing cavity, the rotating disc and the forceps clip assembly are located in the containing cavity, and the first shell and the second shell are connected through a first positioning pin and a second positioning pin; and the gear assembly drives the turntable to rotate so as to drive the plurality of clamp units to radially gather or separate.

Description

TECHNICAL FIELD

[0001] The utility model relates to medical instrument technical field, especially a kind of artificial biological valve crimping device and crimping system. BACKGROUND

[0002] Heart valve disease is a common heart disease. Previously, the only option for patients with aortic valve stenosis was traditional open chest surgery. However, traditional open chest surgery has the disadvantages of large trauma, long operation time (usually 3-4 hours), severe postoperative pain, and slow recovery of patients. With the increasing aging of the population and the increasing incidence of heart valve disease, the risk of open chest surgery for the elderly population is generally high. Transcatheter aortic valve replacement (TAVR) is a minimally invasive surgery that implants an artificial biological valve inside the existing diseased aortic valve. It can usually be performed through femoral artery puncture under a catheter, similar to coronary stent surgery through femoral artery puncture.

[0003] The crimping device (artificial biological valve crimping device) is an auxiliary tool for loading and releasing the artificial biological valve. Before implantation, the artificial biological valve needs to be installed in a crimped state at the distal end of the catheter delivery assembly. The crimping device is used to crimp the artificial biological valve carrying the artificial biological valve, so that the diameter of the artificial biological valve is reduced, and the artificial biological valve carrying the artificial biological valve can be delivered to the diseased position of the heart valve through the catheter delivery assembly.

[0004] The crimped artificial biological valve refers to a "stented valve" (artificial biological valve in Example Three of Application No. 201920458990.1), as shown in Figure 1A The "stented valve" has a stent frame or stent that provides primary structural support in an expanded state. The stent frame or stent (made of cobalt-chromium alloy) is an expandable tubular structure that can be expanded by a balloon or by its own inherent elasticity. The valve structure mounted on the stent frame or stent is formed from a biological material. In this example, the biological material is three pieces of bovine pericardial leaflets, which are prepared from healthy bovine pericardium after chemical modification. The entire stented valve is composed of three pieces of bovine pericardial leaflets, sutures, outer skirts, inner skirts, and a stent. To maintain the improved function after installation in the human body, it is usually necessary to store such valves in an expanded state in a preservation solution, and the stented valve needs to be crimped and crimped by a crimping device in the operating room a few minutes before transplantation.

[0005] The existing crimping device has the disadvantages of low artificial biological valve crimping yield and high jump rate when crimping and crimping the artificial biological valve during use. The utility model discloses a content

[0006] In order to guarantee the stability in the process of force exertion, to reduce the jump piece probability, the utility model provides a kind of artificial biological valve curling device and curling system.

[0007] First, the utility model embodiment provides a kind of artificial biological valve curling device, can include: clamp assembly, first shell and second shell, the artificial biological valve curling device further includes: turntable, and gear assembly cooperation with the turntable;

[0008] The turntable is provided with a plurality of first stroke tracks and a plurality of second stroke tracks;A plurality of the first stroke track is regularly scalloped and is arranged close to the edge of the turntable, and a plurality of the second stroke track is arranged close to the center of the turntable in the form of inclined radiation;The clamp assembly includes a plurality of clamp units, and the number of the clamp unit is the same as the number of the second stroke track;

[0009] The inner surface of the first shell is provided with the first positioning pin matched with the first stroke track and the first track unit matched with the clamp unit respectively;The inner surface of the second shell is provided with the second positioning pin matched with the first stroke track and the first positioning pin respectively and the second track unit matched with the clamp unit respectively;The first shell and the second shell cover and form containing cavity, and the turntable and the clamp assembly are located in the containing cavity, and the first shell and the second shell are connected by the first positioning pin and the second positioning pin;

[0010] The gear assembly drives the turntable to rotate to drive a plurality of the clamp unit to gather or separate radially.

[0011] In an embodiment, the first shell or the second shell is provided with a mounting position, and the gear assembly can include: a knob, a shaft and a driving gear;The periphery of the turntable is provided with a gear tooth;The driving gear is engaged with the gear tooth of the periphery of the turntable;One end of the shaft is connected with the driving gear, and the other end extends out of the mounting position and is connected with the knob;The driving gear of the gear assembly drives the turntable to rotate to drive a plurality of the clamp unit to gather or separate radially.

[0012] In an embodiment, the first shell or the second shell is provided with a mounting position, and the gear assembly can include: a knob, a shaft, a driving gear and a gear ring;The gear ring is nested outside the turntable, and the driving gear is engaged with the gear ring;One end of the shaft is connected with the driving gear, and the other end extends out of the mounting position and is connected with the knob;The gear ring of the gear assembly drives the turntable to rotate to drive a plurality of the clamp unit to gather or separate radially.

[0013] In one embodiment, the rotating disc 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.

[0014] 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; in the state that the first shell and the second shell are closed, the first support seat and the second support seat form a support base to support the artificial biological valve crimping device.

[0015] In one embodiment, the clamp unit can include a first clamp body, a second clamp body, a limiting shaft, a first guide block, a first guide strip, a second guide block and a second guide strip; the first clamp body and the second clamp body are integrally connected away from one end of the second stroke track and are slidably connected with the second stroke track through the limiting shaft near one end of the second stroke track; the first guide block and the first guide strip are located on the outer side of the first clamp body, and the second guide block and the second guide strip are located on the outer side of the second clamp body; the rotating disc rotates to act on the limiting shaft, respectively drives the first guide block, the first guide strip to slide on the first track unit, and the second guide block and the second guide strip to slide on the second track unit, to drive a plurality of clamp body units to be radially gathered or separated.

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

[0017] A plurality of the first track units are uniformly distributed in a circular shape on the inner surface of the first shell, and each first track unit can include a first sliding groove and a first partition plate; the first sliding groove is located in the radial direction of the circle where the plurality of first track units are located, and a second sliding groove is formed between the first sliding groove and the first partition plate, and the center line of the first sliding groove is parallel to the center line of the second sliding groove; the first guide block is located in the first sliding groove and can slide in the first sliding groove; the first guide strip is located in the second sliding groove and can slide in the second sliding groove;

[0018] The second track units are evenly distributed in a circular shape on the inner surface of the second shell, each of the second track units can comprise: a third sliding groove and a second partition plate; the third sliding groove is located in the radial direction of the circle where the second track units are located, a fourth sliding groove is formed between the third sliding groove and the second partition plate, and the center line of the third sliding groove is parallel to the center line of the fourth sliding groove; the second guide block is located in the third sliding groove and can slide in the third sliding groove; and the second guide strip is located in the fourth sliding groove and can slide in the fourth sliding groove.

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

[0020] In one embodiment, the limiting shafts respectively pass through the first jaw body and the second jaw body and are respectively connected with the first guide block and the second guide block.

[0021] In one embodiment, the arc of the arc segment where the first stroke track is located is 85°-92°, and the arc of the arc segment where the second stroke track is located is 75°-82°.

[0022] In one embodiment, the arc of the arc segment where the first stroke track is located is 87°-89°, and the arc of the arc segment where the second stroke track is located is 78°-79°.

[0023] In a second aspect, the utility model embodiment provides a artificial biological valve curling system, include: catheter delivery assembly and the artificial biological valve curling device of as described in first aspect, the artificial biological valve that is pressed and held curling is used for connecting with one end of the catheter delivery assembly, the artificial biological valve that is pressed and held curling is handled by the artificial biological valve curling device and is pressed and held curling.

[0024] The above technical solution provided by the utility model embodiment has at least the following beneficial effects:

[0025] This utility model provides an artificial bio-valve curling device and curling system. Since the turntable 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 stroke 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 more smooth. Firstly, the gear assembly provides continuous and stable force to the central turntable. Secondly, the more continuous and stable force application effectively prevents force fluctuations at one end, thus avoiding valve jumping caused by changes in force (direction or magnitude). This prevents valve clamping or overlapping of the artificial bioprosthetic valve due to valve jumping, reducing the impact of human factors on the clamping yield. Thirdly, the gear assembly directly drives the turntable, which in turn moves the clamping components together or apart. Compared to existing technologies where the turntable is located on one side of the device's centerline, this avoids uneven force distribution at the clamping unit ends. Fourthly, its greater stability due to precision limitations prevents uneven force distribution at the ends, thus improving the yield of artificial bioprosthetic valve clamping.

[0026] Other features and advantages of this invention will be set forth in the description which follows, and will be apparent in part from the description, or may be learned by practicing the invention. The objects and other advantages of this invention can be realized and obtained by means of the structures particularly pointed out in the written description and the accompanying drawings.

[0027] The technical solution of this utility model will be further described in detail below with reference to the accompanying drawings and embodiments. Attached Figure Description

[0028] The accompanying drawings are provided to further illustrate the present invention and form part of the specification. They are used together with the embodiments of the present invention to explain the present invention, but do not constitute a limitation thereof. In the drawings:

[0029] Figure 1A This is a schematic diagram of an existing artificial bioprosthetic valve structure.

[0030] Figure 1B This is one of the structural diagrams of a reparative valve retraction device in the prior art;

[0031] Figure 1C for Figure 1B Exploded view;

[0032] Figure 1D for Figure 1B A sectional view;

[0033] Figure 1E This is the second exploded view of the structure of a reparative valve curling device in the prior art;

[0034] Figure 2 It is the overall structural drawing of the artificial biological valve curling device provided in the embodiment of the utility model;

[0035] Figure 3 It is Figure 2 The explosion map;

[0036] Figure 4 It is Figure 2 The cross-sectional view in the vertical direction;

[0037] Figure 5 It is the structure diagram of the turntable provided in the embodiment of the utility model;

[0038] Figure 6 It is the three-dimensional structure diagram of the clamp assembly provided in the embodiment of the utility model;

[0039] Figure 7 It is the front projection drawing of the clamp assembly provided in the embodiment of the utility model;

[0040] Figure 8 It is the structure diagram of the clamp unit provided in the embodiment of the utility model;

[0041] Figure 9 It is the structure diagram of the first shell and the second shell provided in the embodiment of the utility model;

[0042] Figure 10 It is the structure diagram of the clamp assembly and the second shell provided in the embodiment of the utility model;

[0043] Figure 11 It is the structure diagram of the open state and the closed state of the clamp assembly provided in the embodiment of the utility model;

[0044] Wherein, 1-artificial biological valve curling device; 2-artificial biological valve;

[0045] 11-clamp assembly; 12-first shell; 13-second shell; 14-turntable; 15-gear assembly; 16-containing cavity; 17-mounting position; 18-supporting base;

[0046] 111-clamp 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;

[0047] 121-first positioning pin; 122-first track unit; 123-first through hole; 124-first supporting base; 125-first sliding groove; 126-first partition plate; 127-second sliding groove;

[0048] 131 - second positioning pin; 132 - second track unit; 133 - second through hole; 134 - second support seat; 135 - third sliding groove; 136 - second partition plate; 137 - fourth sliding groove;

[0049] 141 - first stroke track; 142 - second stroke track; 143 - tooth; 144 - middle hole;

[0050] 151 - turning knob; 152 - rotating shaft; 153 - driving gear; 154 - gear ring;

[0051] 1131 - first outer ridge; 1132 - second outer ridge; 1133 - third outer ridge; 1134 - fourth outer ridge; 1135 - first front side edge; 1136 - second front side edge; 1137 - third front side edge;

[0052] 1001 - clamp; 1002 - shell fitting; 1003 - rotating disc; 1004 - base fitting; 1005 - handle; 1006 - stop member; 1007 - central shaft; 1008 - cam member; 1009 - spiral track; 1010 - guide slot; 1011 - sub slot; 1012 - guide plate; 1013 - guide ridge; 1014 - valve; 1015 - clamp gap; 1016 - rotating handle; 1017 - shaft; 1018 - pinion; 1019 - gear wheel. DETAILED DESCRIPTION

[0053] Exemplary embodiments of the present disclosure will be described in greater detail below with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it is understood that the present disclosure can be embodied in various forms and should not be limited by the embodiments set forth herein. Rather, these embodiments are provided so that the present disclosure can be more thoroughly understood, and so that the scope of the present disclosure can be completely conveyed to those skilled in the art.

[0054] In the description of the present application, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", "far", "near", "front", "back", and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and therefore cannot be understood as indicating or implying that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application. In addition, the terms "first", "second", "third" are only for descriptive purposes and cannot be understood as indicating or implying relative importance.

[0055] In the description of the utility model, need explanation, unless another explicit provision and limitation, term "installation", "link", "connection" should do broad sense understanding, for example, can be fixed connection, also can be detachable connection, or integrally connected; can be mechanical connection, also can be electrical connection; can be direct connection, also can be indirectly connected through intermediate medium, can be two elements inside intercommunication. For ordinary skilled in the art, can understand the concrete meaning of the above-mentioned term in the utility model with specific circumstances.

[0056] Referring to Figures 1B-1E As shown in FIG. 1, the existing crimping forceps 1001 are configured to rotate about a central axis 1007, and the housing fittings 1002 are on both sides of the forceps 1001. Each portion of the housing fittings 1002 includes a substantially disc-shaped member (rotating disc 1003) having a radially oriented annular wall and an outer rim extending toward the opposite housing fitting 1002 portion; the housing fittings 1002 in turn constrain each forceps 1001 to allow only radial movement. Each forceps 1001 preferably has a pair of guide plates 1012 oriented outwardly on both sides of the two shafts 1017 radially outermost of the forceps 1001. The guide plates 1012 extend through and interact with guide slots 1010 in each stationary housing fitting 1002, thereby constraining linear sliding movement of the forceps 1001 toward and away from the central axis 1007. Elongated guide ridges 1013 extend from both sides of each forceps 1001, engaging parallel secondary slots 1011 in each stationary housing fitting 1002. All four guide plates 1012 and guide ridges 1013 in each individual forceps 1001 are parallel, as are the four corresponding guide slots 1010 and secondary slots 1011. The resulting assembly constrains movement of the forceps 1001 within the housing fittings 1002 along the guide slots 1010 and secondary slots 1011, which are generally radially oriented. In fact, the guide slots 1010 are on radial lines outward from the center of the crimping mechanism, while the secondary slots 1011 are parallel thereto but slightly offset. The forceps gap 1015 closes to the extent of the fully crimped band support valve 1014.

[0057] Both rotating discs 1003 have shafts 1017 necked so as to rotate about the central axis 1007 on the adjacent housing fitting 1002. A handle 1005 is connected to both rotating discs 1003 by a bracket structure so as to cause them to rotate in unison. Spiral cutouts, grooves or tracks in each rotating disc 1003 are provided on each side of the crimping device so as to convert the rotational motion of the lever handle 1005 into linear motion of the jaws 1001. Ideally, the spiral tracks 1009 are formed between spiral walls extending inwardly from the rotating discs 1003. The spiral tracks 1009 act on actuating cam members 1008 which are located on either side of each jaw 1001, particularly extending outwardly from each guide plate 1012. For each jaw 1001, there are four spiral tracks 1009 acting on four cam members 1008.

[0058] Referring to Figure 1E Instead of using the lever handle 1005, the actuator includes a rotating handle 1016 connected to the shaft 1017 and pinion 1018 so as to rotate one single rotating disc 1003. The pinion 1018 meshes with a large gear 1019 on the rotating disc 1003. The actuating cam members 1008 on only one side of the jaw 1001 are coupled to a single spiral track 1009 and guided by coupling the guide slot 1010 and secondary slot 1011 to the guide plate 1012 and guide cam 1013.

[0059] The inventor found that during the use of the crimping device (prosthetic valve crimping device) as shown in Figure 1E The inventor found that during the use of the crimping device (prosthetic valve crimping device) as shown in

[0060] The prosthetic valve crimping device is used for crimping a prosthetic biological valve, and the rotating disc is rotated by a gear to realize crimping. The inventor found that the overall structure of the rotating disc is located on one side of the center line of the device, which causes the end of the jaw to be stressed and the force to be transmitted, and the stability is poor during force application, and the probability of jumping is increased. For crimping a few millimeter prosthetic biological valve, the end of the jaw is unevenly stressed, and the cumulative error is increased due to the same track shared by the multiple jaws, and finally the yield of the crimped prosthetic biological valve is low. In view of the above problems, the present application is provided to overcome the above problems or at least partially solve the above problems. Figures 2-11As shown, the artificial biological valve curling device 1 can include: a clamp assembly 11, a first shell 12 and a second shell 13, and can further include: a turntable 14, and a gear assembly 15 cooperating with the turntable 14; the turntable 14 is provided with a plurality of first stroke tracks 141 and a plurality of second stroke tracks 142; the plurality of first stroke tracks 141 are regularly fan-shaped and arranged close to the edge of the turntable 14, and the plurality of second stroke tracks 142 are inclined and radially arranged close to the center of the turntable 14; the clamp assembly 11 includes a plurality of clamp units 111, and the number of the clamp units 111 is the same as that of the second stroke tracks 142; the inner surface of the first shell 12 is provided with a first positioning pin 121 matched with the first stroke track 141, and a first track unit 122 matched with the clamp unit 111 respectively; the inner surface of the second shell 13 is provided with a second positioning pin 131 matched with the first stroke track 141 and the first positioning pin 121 respectively, and a second track unit 132 matched with the clamp unit 111 respectively; the first shell 12 and the second shell 13 are combined to form a containing cavity 16, the turntable 14 and the clamp assembly 11 are located in the containing cavity 16, and the first shell 12 and the second shell 13 are connected through the first positioning pin 121 and the second positioning pin 131; the gear assembly 15 drives the turntable 14 to rotate, so as to drive the plurality of clamp units 111 to gather or separate radially (the radial direction of the plurality of clamp units 111 surrounding a circle).

[0061] The artificial biological valve curling device provided in the embodiment of the utility model has the following advantages: the turntable is the main body for driving the clamp assembly to move, the turntable cooperates with the clamp units in the clamp assembly through the second stroke track, and the turntable is directly driven through the gear assembly, so that the gear assembly is more stable when exerting force, and the force transmission process is also more stable.

[0062] The various devices in the embodiment of the utility model are introduced as follows: refer to Figure 3 and Figure 4As shown, the clamp assembly 11 as the force transmission and the device directly in contact with the crimped artificial biological valve of the entire device, it is driven by the turntable 14, and then a smaller circle is formed after the clamp assembly is closed to achieve the crimping process of the artificial biological valve.

[0063] Referring to Figures 2-4 , Figure 9 and Figure 10 , the first shell 12 and the second shell 13 in the embodiment are mirror-symmetric, the first positioning pin 121 on the inner surface of the first shell 12 matches the second positioning pin 131 on the inner surface of the second shell 13, and the first shell 12 and the second shell 13 are fixed to form the accommodating cavity 16 by covering the first positioning pin 121 and the second positioning pin 131. Wherein, the first positioning pin 121 and the second positioning pin 131 not only play a connecting role, but also can realize positioning and limiting effect. In the specific implementation of the embodiment of the utility model, the first positioning pin 121 and the second positioning pin 131 can be set to a nested structure, that is, one positioning pin is nested on the outside of the other positioning pin, to realize nested connection. Of course, as shown in Figure 4 , the outer diameters of the two positioning pins are consistent, and the positioning pins are hollow, and the first positioning pin 121 and the second positioning pin 131 match the positioning cylinder or the positioning column inside, for example, the end of the positioning cylinder matched in the first positioning pin 121 is located inside the first positioning pin 121, the end of the positioning cylinder matched in the second positioning pin 131 protrudes from the outer side wall of the second positioning pin 131 and is located inside the first positioning pin 121, and of course, the matching structure can also be set to be opposite. Further, the first positioning pin 121 and the second positioning pin 131 in the embodiment of the utility model can be set to any matching structure, as long as the connection, positioning and limiting functions can be realized, and the specific structure of the two is not limited in detail in the embodiment of the utility model.

[0064] Referring to Figure 9 and Figure 10 , the inner surfaces of the first shell 12 and the second shell 13 are respectively provided with the first rail unit 122 and the second rail unit 132 for limiting the clamp unit 111, the number of the first rail unit 122 and the second rail unit 132 is equal to the number of the clamp unit 111, and the first rail unit 122 and the second rail unit 132 are mirror-symmetric structures. The inventor sets such a one-to-one limiting structure on the shell, so that each clamp unit 111 can be operated independently, and the cumulative error between the clamp units 111 will not be generated.

[0065] Referring to Figures 3-5As shown, the rotating disc 14 is disc-shaped as a whole and is located in the middle of the artificial biological valve crimping device 1 in the vertical direction, has a certain thickness in the axial direction, and is provided with a first stroke track 141 and a second stroke track 142. In this embodiment, the first stroke track 141 and the second stroke track 142 are arc-shaped through grooves formed in the rotating disc 14. Since the rotating disc 14 is located in the middle of the artificial biological valve crimping device 1, and the artificial biological valve crimping device 1 is used to crimp and hold several millimeter artificial biological valves, the precision requirement is very strict. The rotating disc 14 is the starting point of force transmission, so the force transmission process is more stable than that of the prior art through the rotating disc located on one side, and the phenomenon that the force on both sides is not the same due to insufficient equipment precision when the rotating disc located on one side transmits force is avoided.

[0066] Referring to Figure 5 and Figure 10 As shown, the first stroke track 141 can be part of the limiting function component, and since it cooperates with the first positioning pin 121 on the first shell 12 and the second positioning pin 131 on the second shell 13, the first positioning pin 121 and the second positioning pin 131 can only slide within the stroke range of the first stroke track 141, so that the rotating angle range of the rotating disc 14 relative to the first shell 12 and the second shell 13 is limited. In this embodiment, three first stroke tracks 141 are arranged, so the first positioning pin 121 on the first shell 12 and the second positioning pin 131 on the second shell 13 are also three. The inventor designs in this way to ensure that the first shell 12 and the second shell 13 can be stably connected, achieve the purpose of limiting through the first stroke track 141, the first positioning pin 121 and the second positioning pin 131, and avoid the relative rotation angle being too small due to the limiting effect of more groups of design, and avoid the disadvantages of limited holding force and holding size. It should be further explained that the first stroke track 141 in this embodiment is regularly fan-shaped and arranged close to the edge of the rotating disc 14. The inventor designs in this way to avoid resistance in the radial direction when the first stroke track 141 respectively slides relative to the first positioning pin 121 and the second positioning pin 131, so that the user (usually medical staff) can normally hold the artificial biological valve crimping device 1 with less effort.

[0067] Referring to Figure 5 and Figure 10As shown, the second stroke track 142 on the turntable 14, serving as the starting point for force transmission, is arranged in an inclined radial pattern close to the center of the turntable 14. This structural design provides the limiting shaft 114 with the power for radial movement. Then, under the cooperating limiting action of the guide blocks (first guide block 115 and second guide block 117), guide bars (first guide bar 116 and second guide bar 118), and track units (first track unit 122 and second track unit 132), the clamping unit 111 achieves radial movement, thereby enabling several clamping units 111 to synchronously converge or separate radially. Since each second stroke track 142 can only drive one cooperating clamping unit 111 for force transmission, the force transmission error between each clamping unit 111 is independent; compared to the prior art using a spiral track (combined with...) Figure 1D As shown, the force transmission is achieved through four sets of clamping units. This results in a gradual increase in cumulative error. Furthermore, if a spiral track deviates in design or manufacturing dimensions, it will cause instability in the force transmission of the four matching clamping units, leading to non-rounded pieces or skipping during clamping. Moreover, due to the large changes in the spiral track angle, the user needs to exert more force to drive the clamps along the spiral track, making it more strenuous. In this embodiment, multiple sets of separately matched second-stroke tracks 142 and an equal number of clamping units 111 are used. Since each second-stroke track 142 is matched with a limiting shaft 114 of a clamping unit 111, adjacent clamping units 111 do not affect each other during force transmission, and no cumulative error occurs.

[0068] Reference Figure 5 and Figure 11 As shown, in the specific implementation of this utility model embodiment, the number of the second stroke track 142 and the clamping unit 111 are both set to 12, combined with Figures 6-8 As shown, the turntable 14 can move 12 clamping units 111, thereby changing the diameter of the gripping hole (the hole formed by the clamping unit 121 near the center). When the diameter of the gripping hole is gradually reduced, the artificial bioprosthetic valve placed in the gripping hole can be gripped and curled. The free ends of the 12 clamping units 111 near the center can form a circle with a diameter of no more than 1 mm. When the diameter of the gripping hole is gradually increased, the gripped artificial bioprosthetic valve can be removed, or an artificial bioprosthetic valve to be gripped can be placed.

[0069] Reference Figure 11As shown, the working process of the pressure holder 1 in the embodiment of the utility model is as follows: the gear assembly 15 drives the rotation of the rotating disc 14, the second stroke track 142 on the rotating disc 14 synchronously transmits force to each clamping unit 111 of the clamping assembly 11, and each clamping unit 111 is gathered or separated along the radial direction under the limiting action of the first track unit 122 on the first shell 12 and the second track unit 132 on the second shell 13, so as to realize the pressure holding treatment of the artificial biological valve.

[0070] The gear assembly in the embodiment of the utility model can have two structures, one structure is that the periphery of the rotating disc has gear teeth, and the other structure is that the gear assembly comprises a gear ring, and the gear ring is nested outside the rotating disc, and the two embodiments are specifically described as follows.

[0071] In one embodiment, referring to Figure 2 and Figure 3 As shown, the first shell 12 and / or the second shell 13 are provided with mounting positions 17, the gear assembly 15 can comprise a rotating knob 151, a rotating shaft 152 and a driving gear 153; the periphery of the rotating disc 14 is provided with gear teeth 143; the driving gear 153 is engaged with the gear teeth 143 on the periphery of the rotating disc 14; one end of the rotating shaft 152 is connected with the driving gear 153, and the other end extends out of the mounting position 17 and is connected with the rotating knob 151; the driving gear 153 of the gear assembly 15 drives the rotation of the rotating disc 14, so as to drive the radial gathering or separation of the plurality of clamping units 111. In the embodiment, the gear teeth on the periphery of the rotating disc are located at the vertical center position of the rotating disc, the driving gear and the gear teeth provided on the periphery of the rotating disc can be stably engaged, the rotating knob, the rotating shaft and the driving gear are rotated to drive the rotation of the rotating disc, and since the gear teeth and the rotating disc are located at the center position of the whole device, the force transmission process is more stable compared with the prior art.

[0072] Referring to Figure 3 As shown, the above mounting position 17 in the embodiment can be only a mounting hole provided on the first shell or the second shell; or can be a mounting hole provided on one shell (for example, the first shell) and a groove provided on the inner surface of the other shell (the second shell), the mounting hole is convenient for the extension of one end of the gear assembly, and the groove is convenient for the axial limiting of the other end of the gear assembly.

[0073] In another embodiment, a mounting position 17 is provided on the first housing 12 and / or the second housing 13. The gear assembly 15 may include: a rotating knob 151, a rotating shaft 152, a driving gear 153, and a gear ring 154. The gear ring 154 is nested on the outside of the turntable 14, and the driving gear 153 meshes with the gear ring 154. One end of the rotating shaft 152 is connected to the driving gear 153, and the other end extends out of the mounting position 17 and is connected to the rotating knob 151. The gear ring 154 of the gear assembly 15 drives the turntable 14 to rotate, thereby driving a plurality of clamping units 111 to radially converge or separate. This embodiment differs from the above embodiments in that the gear assembly includes a gear ring, and the gear ring is nested on the outside of the turntable. This structure serves the same function as the teeth on the periphery of the turntable. Correspondingly, since the gear ring and the turntable are located at the center of the entire device, the force application and transmission process is more stable than the force applied from a turntable located on one side in the prior art.

[0074] In another embodiment, refer to Figure 3 and Figure 5 As shown, the turntable 14 of the artificial bioprosthetic valve curling device 1 has a central hole 144; the first housing 12 has a first through hole 123 matching the central hole 144, and the second housing 13 has a second through hole 133 matching the central hole 144; the first through hole 123, the central hole 144, and the second through hole 133 are located on the same center line and form a material processing channel. In this embodiment, the material processing channel is formed in the middle of each component. After the artificial bioprosthetic valve being pressed is processed in the material processing channel, it needs to be removed from the channel and the next artificial bioprosthetic valve to be pressed is placed in it.

[0075] In another embodiment, the edge of the first housing 12 extends to form a first support 124, and the edge of the second housing 13 extends to form a second support 134. When the first housing 12 and the second housing 13 are closed, the first support 124 and the second support 134 form a support base 18 to support the artificial bioprosthetic valve curling device 1. The structure of the support base in this embodiment makes the structure of the artificial bioprosthetic valve curling device more stable, and facilitates the device to be evenly stressed when the user uses the device.

[0076] The following are the pressure and gripping steps before performing TAVR surgery:

[0077] (1) Remove the artificial bio-valve curling device and correctly install the first stop and support components.

[0078] (2) Remove the label on the artificial bioprosthetic valve. Under sterile conditions, place the artificial bioprosthetic valve onto the balloon of the catheter delivery assembly in the correct direction of the procedure. Lift the handle of the artificial bioprosthetic valve curling device upwards, place the artificial bioprosthetic valve on the balloon of the catheter delivery assembly onto the guide groove, and then use the pressure plate to engage it. Push the pressure plate towards the material processing channel. The pressure plate will drive the artificial bioprosthetic valve to move radially and stably toward the material processing channel.

[0079] (3) Before pressing down, make sure that the opening direction of the artificial bioprosthetic valve leaflet is correct, and observe the accurate positioning of the artificial bioprosthetic valve before slowly pressing down the handle. After completing the pressing down operation, hold for 5 seconds and repeat pressing down the handle twice.

[0080] (4) Remove the protective sleeve of the balloon, rinse the loading sheath with heparin water, and then completely put the loaded balloon into the loader. The loader covers the balloon and the tip, and then pull out the protective wire.

[0081] (5) After pressing, push the artificial bio-valve into the guide groove on the guide post for later use.

[0082] It is important to note that the entire artificial bioprosthetic valve should not be left in place for more than 15 minutes after loading, in order to avoid damage to the valve leaflets and affecting the expected function after implantation.

[0083] Compared with existing devices that require two users (medical staff) to perform sample delivery and retrieval separately, the artificial bioprosthetic valve curling device provided in this embodiment only requires one user to complete the sample delivery, pressing and retrieval operations.

[0084] In another embodiment, refer to Figures 6-8 As shown, the clamping unit 111 of the artificial bioprosthetic valve curling device 1 may include: a first clamping body 112, a second clamping body 113, a limiting shaft 114, a first guide block 115, a first guide strip 116, a second guide block 117, and a second guide strip 118; the ends of the first clamping body 112 and the second clamping body 113 away from the second travel track 142 are integrally connected, and the ends close to the second travel track 142 are slidably connected to the second travel track 142 through the limiting shaft 114; the first guide block 115 and the first guide strip 116 are located on the outer side of the first clamping body 112, and the second guide block 117 and the second guide strip 118 are located on the outer side of the second clamping body 113; the turntable 14 rotates to act on the limiting shaft 114, thereby driving the first guide block 115 and the first guide strip 116 to slide on the first track unit 122, and the second guide block 117 and the second guide strip 118 to slide on the second track unit 132, so as to drive a plurality of clamping body units to radially converge or separate.

[0085] The embodiment in the specific implementation is composed of 12 clamping units 111. Due to the structure of the clamping unit 111, in combination with Figure 9 and Figure 10 , it moves radially under the limiting action of the first track unit 122 on the first shell 12 and the second track unit 132 on the second shell 13. In the embodiment, the first jaw body 112 and the second jaw body 113 in the clamping unit 111 are mirror-symmetric structures. According to the positional relationship of the first jaw body 112 and the second jaw body 113, they are divided into front, outer and inner sides, in combination with Figure 8 , the second jaw body 113 is taken as an example for description. The second jaw body 113 can sequentially 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, a second front side 1136 and a third front side 1137. The length of the second outer ridge 1132 in the second jaw body 113 is greater than the length of the second front side 1136, and the second outer ridge 1132, the second front side 1136 and the second guide strip 118 located on the second jaw body 113 are parallel. The included angle between the first outer ridge 1131 and the second outer ridge 1132 is 150°, and the two are circularly transitioned. The included angle between the second outer ridge 1132 and the third outer ridge 1133 is 150°, and the two are circularly transitioned. The included angle between the third outer ridge 1133 and the fourth outer ridge 1134 is 105°, and the two are circularly transitioned. The included angle between the fourth outer ridge 1134 and the first front side 1135 is 30°. The included angle between the first front side 1135 and the second front side 1136 is 105°, and the two are circularly transitioned. The included angle between the second front side 1136 and the third front side 1137 is 150°, and the two are circularly transitioned. In the embodiment, a driving gap is formed between the first jaw body 112 and the second jaw body 113, in combination with Figure 11 , in the dispersed state of the clamping assembly 11, the fourth outer ridge and the first front side of two adjacent clamping units 111 are in a separated state, and in the gathering state of the clamping assembly 11, the fourth outer ridge and the first front side of two adjacent clamping units 111 are in a fitted state, so as to realize that the diameter of the enclosed circle is not greater than 1 mm, and to assist the doctor in clinically applying the artificial biological valve to small-diameter (diameter less than 5 mm) pressing and holding processing.

[0086] In another embodiment, refer to Figure 3 , Figures 9-11As shown, the number of first track units 122 and the number of second track units 132 are equal to the number of jaw units respectively; the plurality of first track units 122 are evenly distributed in a circular shape on the inner surface of the first shell 12, each first track unit 122 can include: a first sliding groove 125 and a first partition plate 126; the first sliding groove 125 is located in the radial direction of the circle where the plurality of first track units 122 are located, and the first sliding groove 125 and the first partition plate 126 form a second sliding groove 127, the center line of the first sliding groove 125 is parallel to the center line of the second sliding groove 127; the first guide block 115 is located in the first sliding groove 125 and can slide in the first sliding groove 125; the first guide strip 116 is located in the second sliding groove 127 and can slide in the second sliding groove 127; the plurality of second track units 132 are evenly distributed in a circular shape on the inner surface of the second shell 13, each second track unit 132 can include: a third sliding groove 135 and a second partition plate 136; the third sliding groove 135 is located in the radial direction of the circle where the plurality of second track units 132 are located, and the third sliding groove 135 and the second partition plate 136 form a fourth sliding groove 137, the center line of the third sliding groove 135 is parallel to the center line of the fourth sliding groove 137; the second guide block 117 is located in the third sliding groove 135 and can slide in the third sliding groove 135; the second guide strip 118 is located in the fourth sliding groove 137 and can slide in the fourth sliding groove 137.

[0087] In this embodiment, one first track unit 122 and one second track unit 132 are mirror-symmetric and jointly limit one jaw unit 111. Taking the first track unit 122 as an example, since the first sliding groove 125 is located in the radial direction of the circle where the plurality of first track units 122 are located, and the center line of the first sliding groove 125 is parallel to the center line of the second sliding groove 127, such a structure limits the moving track of the jaw unit 111. Under the constraint of each group of first track units 122 and second track units 132, the plurality of jaw units 111 can only move in the radial direction of the circle where they are located, so as to control the diameter of the circle formed by the plurality of jaw units 111 after gathering to be as small as possible. Figure 11 As shown, the plurality of jaw units 111 can only move in the radial direction of the circle where they are located, so as to control the diameter of the circle formed by the plurality of jaw units 111 after gathering to be as small as possible.

[0088] In another embodiment, as shown in Figure 3 , Figure 9 and Figure 10 , the first sliding groove 125 and the third sliding groove 135 are respectively strip-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 matched therewith, so as to limit the stroke range of the jaw unit 111.

[0089] In another embodiment, as shown in Figure 3 , Figure 9 and Figure 10As shown, the radius of the circle on which the first positioning pins 121 are located is greater than the radius of the circle on which the first sliding grooves 125 are located; and / or, the radius of the circle on which the second positioning pins 131 are located is greater than the radius of the circle on which the third sliding grooves 135 are located. In the embodiment, the first positioning pins 121 are located outside the first sliding grooves 125, and the second positioning pins 131 are located outside the third sliding grooves 135, so that the clamping unit 111 is not affected by the sliding stroke of the first positioning pins 121 or the second positioning pins 131 during the process of gathering or separating, and the operating tracks of the components do not cross each other, thereby avoiding interference or wear between the components.

[0090] In another embodiment, in order to facilitate the installation of the limiting shaft, referring to Figure 6 and Figure 8 As shown, the limiting shaft 114 penetrates the first jaw body 112 and the second jaw body 113 respectively, and is connected with the first guide block 115 and the second guide block 117 respectively. In the embodiment, when the artificial biological valve crimping device is assembled, the limiting shaft 114 needs to be disassembled from one end of the first jaw body 112 or the second jaw body 113, and then installed by penetrating the second stroke track 142 on the rotating disc 14, so that the limiting shaft 114 can penetrate the first jaw body 112 and the second jaw body 113 respectively, and then be connected with the first guide block 115 and the second guide block 117 at both ends. The specific connection mode can be threaded connection, riveting or buckle connection, etc., which is not limited in the embodiment.

[0091] In another embodiment, referring to Figure 5 As shown, the arc (a) of the arc segment on which the first stroke track 141 is located is 85°-92°; and the arc (b) of the arc segment on which the second stroke track 142 is located is 75°-82°. Preferably, the arc (a) of the arc segment on which the first stroke track 141 is located is 87°-89°; and the arc (b) of the arc segment on which the second stroke track 142 is located is 78°-79°.

[0092] In the embodiment, as shown in Figure 11 Since the first positioning pins 121 and the second positioning pins 131 sliding in the first stroke track 141 have a certain thickness, the actual sliding range must be less than the arc range of the arc segment on which the first stroke track 141 is located. The inventor limits the arc of the arc segment on which the first stroke track 141 is located, so that the relative rotation angle of the rotating disc 14 located in the middle relative to the first shell 12 and the second shell 13 is not greater than 90°, thereby avoiding large-angle change of the force direction during the process of applying and transmitting the force. Further, the arc of the arc segment on which the second stroke track 142 is located is also set in a range, thereby avoiding large-angle change of the force direction during the process of applying the force to the limiting shaft 114 by the second stroke track 142, so that the user can use it more easily.

[0093] The artificial biological valve is subjected to the pressing and crimping treatment by the artificial biological valve crimping device in the embodiment of the utility model, and the artificial biological valve does not have problems such as clamping the valve leaf, overlapping the valve frame and the like; the artificial biological valve is round in the pressing process and after the pressing, the overall good product rate is high and there is no jumping part phenomenon through the caliper measurement and the columnar mold comparison.

[0094] Based on the same inventive concept, the utility model embodiment further provides an artificial biological valve crimping system, comprising: a catheter conveying assembly and the artificial biological valve crimping device; the artificial biological valve subjected to the pressing and crimping is used for being connected with one end of the catheter conveying assembly; the artificial biological valve subjected to the pressing and crimping is subjected to the pressing and crimping treatment by the artificial biological valve crimping device.

[0095] Obviously, those skilled in the art can make various modifications and variations to the utility model without departing from the spirit and scope of the utility model. The disclosure is not limited to the precise structures described above and shown in the drawings, and various modifications and changes can be made without departing from the scope thereof. The scope of the disclosure is limited only by the appended claims. Thus, if these modifications and variations of the utility model fall within the scope of the claims of the utility model and their equivalents, the utility model also intends to include these modifications and variations.

Claims

1. An artificial bioprosthetic valve retraction device, comprising: The clamping assembly, the first housing, and the second housing are characterized in that the artificial bio-valve curling device further includes: a turntable and a gear assembly that cooperates with the turntable; 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 arranged in a regular fan shape and close to the edge of the turntable, and the plurality of second travel tracks are arranged in an inclined radial shape and close to the center of the turntable; the clamping assembly includes a plurality of clamping units, the number of clamping units being the same as the number of second travel tracks; 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 clamping unit; 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 clamping unit; the first housing and the second housing are closed to form a receiving cavity, the turntable and the clamping assembly are located in the receiving cavity, and the first housing and the second housing are connected by the first positioning pin and the second positioning pin; The gear assembly drives the turntable to rotate, thereby driving the plurality of clamping units to radially converge or separate.

2. The artificial bioprosthetic valve curling device according to claim 1, characterized in that, The first housing and / or the second housing are provided with mounting positions. The gear assembly includes: a knob, a shaft, and a drive gear. The circumference of the turntable is provided with gear teeth. The drive gear meshes with the gear teeth on the circumference of the turntable. One end of the shaft is connected to the drive gear, and the other end extends out of the mounting position and connects to the knob. The drive gear of the gear assembly drives the turntable to rotate, thereby driving a plurality of clamping units to radially converge or separate.

3. The artificial bioprosthetic valve curling device according to claim 1, characterized in that, The first housing and / or the second housing are provided with mounting positions. The gear assembly includes: a knob, a shaft, a drive gear, and a gear ring. The gear ring is nested on the outside of the turntable, and the drive gear meshes with the gear ring. One end of the shaft is connected to the drive gear, and the other end extends out of the mounting position and connects to the knob. The gear ring of the gear assembly drives the turntable to rotate, thereby driving a plurality of clamping units to radially converge or separate.

4. The artificial bioprosthetic valve curling device according to claim 3, characterized in that, The turntable has a central hole; the first housing has a first through hole that matches the central hole, and the second housing has a second through hole that matches the central hole; the first through hole, the central hole, and the second through hole are located on the same center line and form a material processing channel.

5. The artificial bioprosthetic valve curling device according to any one of claims 1 to 4, characterized in that, The edge of the first housing extends to form a first support base, and the edge of the second housing extends to form a second support base; when the first housing and the second housing are closed, the first support base and the second support base form a support base to support the artificial bio-valve curling device.

6. The artificial bioprosthetic valve curling device according to any one of claims 1 to 4, characterized in that, The clamping unit includes: a first clamping body, a second clamping body, a limiting shaft, a first guide block, a first guide strip, a second guide block, and a second guide strip; the first clamping body and the second clamping body are integrally connected at their ends away from the second travel track, and their ends close to the second travel track are slidably connected to the second travel track via the limiting shaft; the first guide block and the first guide strip are located on the outer side of the first clamping body, and the second guide block and the second guide strip are located on the outer side of the second clamping body; the turntable rotates to act on the limiting shaft, thereby driving the first guide block and the first guide strip to slide on the first track unit, and the second guide block and the second guide strip to slide on the second track unit, so as to drive the plurality of clamping body units to radially converge or separate.

7. The artificial bioprosthetic valve curling device according to claim 6, characterized in that, The number of the first track units and the number of the second track units are each equal to the number of the clamp units; Multiple first track units are evenly distributed in a circular shape on the inner surface of the first housing. Each first track unit includes: a first groove and a first partition plate; the first groove is located radially in the circle containing the multiple first track units, and a second groove is formed between the first groove and the first partition plate, with the center line of the first groove parallel to the center line of the second groove; the first guide block is located in the first groove and can slide in the first groove; the first guide strip is located in the second groove and can slide in the second groove. Multiple second track units are evenly distributed in a circular shape on the inner surface of the second housing. Each second track unit includes: a third slide groove and a second partition plate; the third slide groove is located radially in the circle containing the multiple second track units, and a fourth slide groove is formed between the third slide groove and the second partition plate, with the center line of the third slide groove being 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 strip is located in the fourth slide groove and can slide in the fourth slide groove.

8. The artificial bioprosthetic valve curling device according to claim 7, characterized in that, The first slide and the third slide are both strip-shaped closed slides; the radius of the circle containing the first positioning pins is greater than the radius of the circle containing the first slide; and / or, the radius of the circle containing the second positioning pins is greater than the radius of the circle containing the third slide.

9. The artificial bioprosthetic valve curling device according to claim 6, characterized in that, The limiting shafts pass through the first clamp body and the second clamp body respectively, and are connected to the first guide block and the second guide block respectively.

10. The artificial bioprosthetic valve curling device according to claim 6, characterized in that, The arc of the first travel track is 85° to 92°; the arc of the second travel track is 75° to 82°.

11. The artificial bioprosthetic valve curling device according to claim 10, characterized in that, The arc of the first travel track is 87° to 89°; the arc of the second travel track is 78° to 79°.

12. An artificial biological valve curling system, characterized in that, include: The catheter delivery assembly and the artificial bioprosthetic valve curling device as described in any one of claims 1 to 11; the compressed and curled artificial bioprosthetic valve is used to connect to one end of the catheter delivery assembly; the compressed and curled artificial bioprosthetic valve is compressed and curled by the artificial bioprosthetic valve curling device.

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