Disclosure of Invention
The utility model aims to provide a valve repairing device which aims to solve the problems that after the valve leaflet is captured by an instrument in the prior art, the clamping is not firm, and after the valve leaflet is closed by the instrument in the prior art, the valve leaflet is not tightly attached, so that recurrence is easy to cause.
To solve the above technical problems, the present utility model provides a valve repair device, which includes:
a spacer;
a joint assembly movably disposed with respect to the spacer in an axial direction of the spacer;
two repair assemblies disposed along radial symmetry of the spacer, the repair assemblies comprising:
an elastic spacer arm comprising a capturing section and a supporting section extending along the axial direction of the spacer body, wherein the spacer body, the capturing section and the supporting section are sequentially connected from the proximal end to the distal end; the distal end of the capturing section is connected with the proximal end of the supporting section to form a spacing part, and the distal end of the supporting section is connected with the joint assembly;
the clamping device is arranged on the capturing section and is used for clamping a preset position;
and the proximal end of the elastic pressing plate is connected with the spacing part, and the distal end of the elastic pressing plate is connected with the joint assembly.
Optionally, the elastic pressing plate is provided with a through hole area for the clamp to pass through, the through hole area is in a strip hole shape, and the short axis direction of the through hole area is perpendicular to the axial direction of the spacer body; the through hole area is close to one side opening of the joint component along the long axis direction of the through hole area.
Optionally, the elastic pressing plate is symmetrical about a long axis of the through hole region.
Optionally, a plurality of concave stripe grooves are formed in one surface, facing the spacer, of the elastic pressing plate, and/or a plurality of convex protruding points are formed in one surface, facing the spacer, of the elastic pressing plate.
Optionally, the proximal end of the elastic pressing plate has at least two through pressing holes.
Optionally, the connector assembly includes a distal connector having a first connection groove recessed radially outward of the spacer; the distal end of the elastic pressing plate is connected with a fixing piece, the fixing piece is provided with a second connecting groove recessed inwards along the radial direction of the spacer body, and the first connecting groove is matched with the second connecting groove.
Optionally, the binder comprises a binder plate and a support plate; the supporting plate is arranged on the capturing section, and one end of the clamping plate is elastically connected with the supporting plate, so that the clamping plate is applied with elastic force towards the supporting plate; the sandwich panel is adapted to pass through the through hole area under a force away from the support plate.
Optionally, the sandwich plate is provided with a plurality of through holes.
Optionally, be equipped with barb structure on the sandwich panel, barb structure includes long thorn and short thorn, long thorn's length dimension is greater than short thorn's length dimension, long thorn is including fixed part, connecting portion and the toper portion that connect gradually, fixed part connect in the sandwich panel.
Optionally, the valve repair device further comprises a proximal connector disposed at a proximal end of the spacer; the proximal joint has at least two first extensions protruding radially outward of the spacer; the proximal fitting has at least two second extensions protruding radially outward of the spacer, the second extensions having receptacles therethrough.
The valve repair device has at least the following technical effects:
in the first aspect, different forms can be changed under the combined action of the elastic pressing plate and the joint component by configuring the elastic spacing arm, and the position of the clamp is changed along with the change of the form of the elastic spacing arm when the clamp is arranged on the capturing section, so that implantation of the clamp, capturing and clamping of a valve and edge-to-edge repair of the valve are completed;
in the second aspect, the plate-shaped elastic pressing plate is designed, so that the contact area between the elastic pressing plate and the valve leaflet can be increased, the deformation angle of the elastic pressing plate is smaller due to the plate-shaped characteristic, the gap between the elastic pressing plate and the valve leaflet can be reduced, the anchoring effect of the elastic pressing plate on the valve leaflet is improved, the pulling acting force of the valve repairing device on the valve leaflet in the mitral valve pumping process is reduced, the problem of tearing of the valve leaflet caused by the attachment of the valve She Gangxing caused by a mechanical clamp can be avoided, the problem of poor clamping after the capture of the valve leaflet by the clamp is avoided, and the problem of recurrence or poor treatment effect of mitral regurgitation or tricuspid valve regurgitation caused by the loose attachment of the edge to edge after the closure of the implant are avoided.
Detailed Description
The utility model will be described in further detail with reference to the drawings and the specific embodiments thereof in order to make the objects, advantages and features of the utility model more apparent. It should be noted that the drawings are in a very simplified form and are not drawn to scale, merely for convenience and clarity in aiding in the description of embodiments of the utility model. Furthermore, the structures shown in the drawings are often part of actual structures. In particular, the drawings are shown with different emphasis instead being placed upon illustrating the various embodiments.
As used in this disclosure, the singular forms "a," "an," and "the" include plural referents, the term "or" are generally used in the sense of comprising "and/or" and the term "several" are generally used in the sense of comprising "at least one," the term "at least two" are generally used in the sense of comprising "two or more," and the term "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying any relative importance or number of features indicated. Thus, a feature defining "first," "second," "third," or "third" may explicitly or implicitly include one or at least two such features, with "one end" and "another end" and "proximal end" and "distal end" generally referring to the respective two portions, including not only the endpoints, but also the terms "mounted," "connected," "coupled," and "connected" are to be construed broadly, e.g., as being either a fixed connection, a removable connection, or as being integral therewith; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communicated with the inside of two elements or the interaction relationship of the two elements. Furthermore, as used in this disclosure, an element disposed on another element generally only refers to a connection, coupling, cooperation or transmission between two elements, and the connection, coupling, cooperation or transmission between two elements may be direct or indirect through intermediate elements, and should not be construed as indicating or implying any spatial positional relationship between the two elements, i.e., an element may be in any orientation, such as inside, outside, above, below, or on one side, of the other element unless the context clearly indicates otherwise. The specific meaning of the above terms in the present utility model can be understood by those of ordinary skill in the art according to the specific circumstances.
It should be noted that, the definition of "proximal" and "distal" in this document is: "proximal" generally refers to the end of the medical device that is closest to the operator during normal operation, and "distal" generally refers to the end of the medical device that first enters the patient during normal operation.
As shown in fig. 1 to 6, the present embodiment provides a valve repair device including a spacer 10, a joint assembly, and two repair assemblies 30. The spacer 10 has a space shape, the spacer 10 is generally braided into an ellipsoidal shape from a metal wire, for example, nickel titanium alloy wire is braided in advance, and then the shape fixing of the spacer 10 is realized through a heat setting process. The method for producing the spacer 10 is not limited to braiding, and may be laser cutting. The axial direction of the spacer 10 in this embodiment refers to the direction of the long axis of the ellipsoid. The joint assembly is located at a distal position of the spacer body 10 and is movably arranged with respect to the spacer body 10 in the axial direction of the spacer body 10. The two repair assemblies 30 are symmetrically arranged along the radial direction of the spacer 10, i.e. the two repair assemblies 30 are symmetrically arranged about the radial direction of the spacer 10, which is also understood to mean that the two repair assemblies 30 are located on both sides of the same radial direction of the spacer 10. Further, the repairing assembly 30 includes an elastic spacer 31, a clamp 32, and an elastic pressing plate 33 having a plate shape. The elastic spacer arm 31 includes a catching section 311 and a supporting section 312 extending along the axial direction of the spacer body 10, and the spacer body 10, the catching section 311 and the supporting section 312 are sequentially connected from the proximal end to the distal end, it being understood that the catching section 311 and the supporting section 312 extend along the axial direction of the spacer body 10 and are sequentially connected as illustrated in fig. 1; the distal end of the capturing section 311 and the proximal end of the supporting section 312 are connected to form a spacer 310, that is, the connection between the capturing section 311 and the supporting section 312 is defined as the spacer 310, in addition, the elastic spacer arm 31 is generally in a belt shape or a plate shape, the elastic spacer arm 31 has elastic force, that is, is made of an elastic material, and can change its shape under the action of external force, that is, change the presenting states of the capturing section 311 and the supporting section 322, for example, the capturing section 311 and the supporting section 322 can relatively present a folded state; the distal end of the support section 312 is connected to the connector assembly, and it should be noted that the elastic spacer arm 31 may be formed by braiding a metal wire (such as a nickel-titanium alloy wire), the elastic spacer arm 31 may be connected to the connector assembly by laser welding, and the elastic spacer arm 31 may be integrally formed with the spacer body 10, or may be formed separately and then connected. The clip 32 is disposed on the capturing section 311 (as illustrated in fig. 1, the clip 32 may be disposed on a side of the capturing section 311 that is radially outward of the spacer), and the clip 32 is used to clip a predetermined portion, where the predetermined portion is generally referred to as a mitral valve or a tricuspid valve, but may be any other natural valve, such as an aortic valve or a pulmonary valve, as determined according to the actual application scenario. The proximal end of the elastic pressing plate 33 is connected to the spacer 310, the distal end of the elastic pressing plate 33 is connected to the joint assembly, and the elastic pressing plate 33 is used for applying a force to the elastic spacer arm 31 and changing the direction of the force along with the movement of the joint assembly, so as to correspondingly change the shape of the elastic spacer arm 31. The elastic pressing plate 33 has a through hole region 333 (see fig. 9) therethrough, and the through hole region 333 is through which the clip 32 can pass, specifically, the clip 32 provided thereon can be passed in and out in the through hole region 333 when the elastic spacer arm 31 changes its own form. It should be noted that, the elastic pressing plate 33 and the clamp 32 may be formed by a nickel-titanium alloy laser cutting process and then a heat setting process.
The valve repair device configured as described above is configured such that the resilient spacer arm 31 is adapted to follow the movement of the connector assembly (either in the proximal direction or in the distal direction) under the force exerted by the resilient pressure plate 33 to switch between different configurations, typically between a first configuration and a second configuration, and between the second configuration and a third configuration, where the second configuration is understood to be a second configuration between the first configuration and the third configuration, and one of the second configurations is a second vertical configuration. Referring to fig. 1, when the elastic spacer arm 31 is in the first configuration, the capturing section 311 and the supporting section 312 are arranged substantially co-linearly and are substantially close to the central axis of the spacer body 10, and it should be understood that the co-linear arrangement is understood to be a co-linear arrangement in a broad sense, that is, substantially co-linear, and further that the spacer portion 310 is not bent, and that, when the elastic spacer arm 31 is in the first configuration, a projection of the spacer portion 310 along a radial inward direction of the spacer body 10 is out of the range of the spacer body 10, precisely, a projection is located on the central axis outside the spacer body 10, specifically, an axial position of the spacer portion 310 along the spacer body 10 is far away from the distal end of the spacer body 10. The resilient spacer arms 31 on both sides are shaped in front view (shown in fig. 1). Referring to fig. 2 and 3, when the elastic spacer arm 31 is in the second configuration, the elastic spacer arm 31 expands radially outwardly of the spacer body 10, and the spacer portion 310 is located away from the distal end of the spacer body 10 along the axial direction of the spacer body 10, i.e., the projection of the spacer portion 310 on the central axis of the spacer body 10 along the radial direction of the spacer body 10 is out of the range of the spacer body 10. The resilient spacer arms 31 switch from the first configuration to the second configuration and the spacer portions 310 gradually expand outwardly. In particular, referring to fig. 2 and 3, when the elastic spacer arms 31 are in the second vertical configuration as the joint assembly moves along the distal end toward the proximal end, the capturing section 311 is perpendicular to the central axis of the spacer body 10, and the elastic spacer arms 31 of the two repairing assemblies 30 are shaped like isosceles triangles, that is, the two elastic spacer arms 31 are stably triangular under the supporting action of the corresponding two elastic pressing plates 33, it should be understood that the capturing section 311 and the central axis of the spacer body 10 are perpendicular in a broad sense, such as that the capturing section 311 forms an angle with the central axis of the spacer body 10 in the range of [90 ° -5 °,90 ° +5 ° ], and the capturing section 311 is perpendicular to the central axis of the spacer body 10. As shown in fig. 4 and 5, when the elastic spacer arm 31 is in the third configuration, the elastic spacer arm 31 expands outwards along the radial direction of the spacer body 10, the projection of the spacer portion 310 inwards along the radial direction of the spacer body 10 is located on the spacer body 10, the axial position of the spacer portion 310 along the spacer body 10 is within the range of the spacer body 10, and the capturing section 311 and the supporting section 312 are folded and close to each other and are folded to the spacer body 10, that is, the capturing section 311 and the supporting section 312 are driven by the elastic pressing plate 33 to be drawn towards the spacer body 10. It should be noted that, in order to reduce the trauma of the valve repair device to the human tissue, at least one covering film is generally coated on the outer surface of the valve repair device, the covering film is generally a medical polymer material film, and the valve repair devices shown in fig. 1, 2, 3 and 5 are coated with the covering film, and the covering film is shown as a filler in the figures.
It should be noted that, when the joint assembly moves so that the elastic pressing plate 33 drives the elastic spacer arm 31 to switch between the above three modes, the elastic pressing plate 33 does not always have a plate shape in absolute terms, and a small arc bending deformation is usually generated, for example, as shown in fig. 1, 2, 3 and 5. In other words, the shape of the elastic pressing plate 33 is not always a planar plate shape, but a curved plate shape with a small arc during the movement of the joint assembly.
With the above configuration, after the elastic spacer arm 31 in the first configuration is implanted in the ventricle of the patient along with the valve repair device, the elastic spacer arm 31 is then converted to the third configuration and is placed between the leaflets of the mitral valve or tricuspid valve along with the spacer body 10, the leaflets are captured and clamped by the clamping device 32 on the capturing section 311 after the elastic spacer arm 31 is converted to the second configuration (preferably the second vertical configuration) (the clamping device 32 passes through the through hole area 333 to capture the clamping operation), and when the clamping devices 32 of the two repair assemblies 30 are aligned with the corresponding leaflets She Gage, the elastic spacer arm 31 is finally converted to the third configuration, so that the edge-to-edge repair of the mitral valve or tricuspid valve can be realized. In practical applications, the elastic spacer arm 31 is generally in a form between the second vertical form and the third form, and it is understood that the elastic spacer arm 31 captures the leaflet when the elastic spacer arm 31 is just started to enter the third form, and the projection of the spacer 310 along the central axis of the spacer 10 is located at the distal end of the spacer 10. The spacer 10 has a space shape, reduces the gap between the spacer and the valve leaflet, and can avoid the situation that the valve leaflet is torn after being clamped and repaired. According to the utility model, the elastic spacer arm 31 is configured to change the shape under the combined action of the elastic pressing plate 33 and the distal joint 20, and the clamp 32 is arranged on the capturing section 311 to change the position of the clamp along with the change of the shape of the elastic spacer arm 31, so that the implantation of the clamp 32, the capturing and clamping of a valve and the edge-to-edge repair of the valve are completed, the success rate of instrument implantation is greatly improved, the risk of instrument implantation failure is reduced, the instrument implantation is safer, more reliable and more stable, the operation difficulty and operation time in the operation process are reduced, the safety and reliability in the operation process are improved, the risk caused by the instrument in the operation process is reduced, and the mitral regurgitation or tricuspid regurgitation of a patient can be effectively inhibited. In addition, when the elastic spacer arm 31 in the third form is driven by the elastic pressing plate 33 to close to the spacer body 10, the elastic pressing plate 33 also wraps the valve leaflet, and applies inward anchoring force, so that not only can the gap between the valve leaflet and the spacer body 10 be further reduced, but also the repair form of the mitral valve or tricuspid valve can be better, the repair effect is improved, and the risk of mitral regurgitation or tricuspid valve regurgitation recurrence is reduced. It will be appreciated that in the three mode conversions of the resilient spacer arms 31 described above, and after the clip 32 has clipped the leaflet, the resilient clip 33 acts as a resilient support.
In particular, the plate-shaped elastic pressing plate 33 is designed, on one hand, the contact area between the elastic pressing plate 33 and the valve leaflet can be increased, the elastic pressing plate 33 has smaller deformation angle due to the plate-shaped characteristic, the gap between the elastic pressing plate and the valve leaflet can be reduced, the trend that the elastic pressing plate 33 approaches to the spacer 10 to be folded is more obvious, the trend that the elastic pressing plate approaches to the spacer 10 to be folded is more greatly, the anchoring effect of the elastic pressing plate 33 on the valve leaflet is improved, the pulling acting force of the valve repair device on the valve is reduced in the mitral valve pumping process, the valve leaflet tearing problem caused by the attachment of the valve She Gangxing caused by a mechanical clamp can be avoided, and the problem of poor clamping after the clamp is completed on the valve leaflet and the problem of recurrence or poor treatment effect of the mitral regurgitation or tricuspid valve regurgitation caused by the attachment of the edge-to-edge attachment after the implant is closed are avoided.
Regarding the specific shape of the via region 333, in an exemplary embodiment, referring to fig. 9, the via region 333 is elongated in shape, such as rectangular, kidney-shaped, oval, etc. The short axis direction of the through hole region 333 is perpendicular to the axial direction of the spacer 10, and the through hole region is open at one side close to the joint assembly along the long axis direction thereof, that is, the through hole region 333 penetrates the elastic pressing plate 33 at one side close to the joint assembly along the long axis direction thereof. It can be understood that the major axis and the minor axis of the through hole area 333 are perpendicular to each other, and in this embodiment, the extending direction of the elastic pressing plate 33 is the major axis direction of the through hole area 333. Further, the long axis of the through-hole region 333 is always coplanar with the central axis of the spacer 10. Preferably, the elastic pressing plate 33 is symmetrical about the long axis of the through-hole region 333.
Preferably, with continued reference to fig. 4 and 9, in an embodiment, a surface of the elastic pressing plate 33 facing the spacer 10 is provided with a plurality of concave stripe grooves 332, and the extending direction of the stripe grooves 332 may be parallel to the short axis direction of the through hole area 333, for example, and the stripe grooves 332 may be designed to enhance the anchoring effect of the elastic pressing plate 33 on the valve leaflet. In another embodiment, the side of the elastic pressing plate 33 facing the spacer 10 is provided with a plurality of raised bumps (not shown), for example, the raised bumps may be arranged in an array, and the design of the raised bumps may also enhance the anchoring effect of the elastic pressing plate 33 on the valve leaflet.
Typically, the physician controls the operating state of the valve repair device through an external delivery system, including but not limited to driving the valve repair device into the patient's heart chamber, controlling the resilient spacer arms 31 to switch between the three configurations, controlling the operating state of the clamp 32, and, after the valve repair device has completed repair of the mitral or tricuspid valve, controlling the delivery system to disengage from the valve repair device and withdraw from the patient. In particular, the delivery system includes a guidewire 90 and a control wire 100, the guidewire 90 being used to control movement of the connector assembly and delivery of the valve repair device to the interior of the human body, and the control wire 100 being used to control the clamping or working state of the clamp 32.
Further, referring to fig. 1, 6 and 7, the valve repair device includes a proximal connector 40, the proximal connector 40 being connected to the proximal end of the spacer 10, the valve repair device being configured to connect to an external delivery system via the proximal connector 40. Specifically, the delivery system is detachably connected with the proximal connector 40, so that the delivery system is conveniently separated from the proximal connector 40, and the valve repair device is separated. Typically, the delivery system includes a connector 110 through which the connector 110 is detachably connected to the proximal hub 40. The connecting piece 110 makes the proximal joint 40 of the valve repair device fixed to the delivery system, the guide wire 90 is threaded through the connecting piece 110, the distal end of the guide wire 90 is fixed to the distal end of the valve repair device, and then when the proximal joint 40 is fixed to the distal end of the delivery system, the guide wire 90 is pushed to move back and forth along the axial direction of the spacer 10 by the delivery system, so that the valve repair device is switched among the first configuration, the second configuration and the third configuration. Also during delivery, the delivery system implants the valve repair device (shown in fig. 1) into the patient with the resilient spacer arms 31 in the first configuration.
Still further, referring to fig. 15, the proximal fitting 40 has at least two first extensions 41 (fig. 15 shows two symmetrically disposed first extensions 41) protruding radially outward of the spacer body 10 (i.e., in a direction away from the central axis of the spacer body 10), the first extensions 41 for snap-fit connection with a delivery system. Specifically, referring to fig. 20, the connecting piece 110 has first connecting pieces 111 corresponding to the number and positions of the first extending portions 41, the connecting pieces have through holes 1110, when assembled, the first connecting pieces 111 expand outwards along the radial direction of the spacer body 10, the expansion process of the plurality of first connecting pieces 111 is similar to the spreading of petals, then the holes 1110 are inserted into the corresponding first extending portions 41, and the first connecting pieces 111 shrink inwards again to realize the snap connection between the first extending portions 41 and the holes 1110.
Still further, the proximal fitting 40 has at least two second extensions 42 protruding radially outward of the spacer body 10, the second extensions 42 having a through receptacle 420 located therein, the receptacle 420 for a snap-fit connection with the delivery system. Specifically, the connecting member 110 has second connecting pieces 112 corresponding to the number and positions of the first extending portions 41, and the second connecting pieces 112 are connected to the insertion holes 420 in a plugging manner.
Referring to fig. 8 and 16, the valve repair device further comprises a sealing gasket 50 connected to the proximal connector 40, the sealing gasket 50 having at least two third extensions 51 extending radially outwardly of the spacer body 10, the third extensions 51 having first clamping slots 510 therethrough, the first clamping slots 510 for insertion connection with the delivery system. By providing a sealing gasket 50, blood can be prevented from entering the valve repair device and delivery system, reducing the risk of surgery. The sealing gasket 50 may be made of silicone, i.e., a silicone gasket. In addition, compared with the prior art, the first slot 510 on the sealing gasket 50 is beneficial for separating the delivery system from the valve repair device, specifically, the second connecting piece 112 of the connecting piece 110 is connected to the proximal connector 40 by inserting the first slot 510 and the insertion hole 420 in sequence, and when the second connecting piece 11 withdraws from the proximal connector 40 and is separated from the sealing gasket 50, the friction between the second connecting piece 112 and the sealing gasket 50 can be reduced by the arrangement of the first slot 510, so that the second connecting piece 112 can be withdrawn conveniently.
Further, the sealing gasket 50 has a second slot 52 formed therethrough, and the second slot 52 is used for passing a guide wire 90 of the delivery system therethrough. The second clamping groove hole 52 is not only beneficial to pushing or withdrawing the guide wire 90, but also beneficial to realizing the sealing effect of the sealing gasket 50 and the guide wire 90, so that the guide wire 90 is prevented from bringing blood into the valve repair device in the working process. Preferably, the first slot hole 510 and the second slot hole 52 are in a slit shape, and the shape enables the sealing gasket 50 at the first slot hole 510 and the second slot hole 52 to be completely attached to the outer surface of the insert, so that the sealing performance of the sealing gasket 50 is further improved compared with a hole-shaped structure.
Referring to fig. 7 and 13, the valve repair device further includes a support body 60, the support body 60 is located inside the spacer body 10 and is fixed inside the spacer body 10 near the distal end of the spacer body 10, the support body 60 has a first guide hole 61 penetrating along the axial direction of the spacer body 10, the first guide hole 61 is used for passing a guide wire 90 of an external delivery system, and typically, the guide wire 90 sequentially passes through the sealing gasket 50, the proximal end connector 40, the spacer body 10 and the support body 60, and finally is connected to the connector assembly. With respect to a specific fixing form of the supporting body 60, a through supporting hole 62 is provided on the supporting body 60 for allowing a suture thread to pass through to achieve suture connection of the supporting body 60 and the spacer body 10.
Preferably, referring to fig. 14, the first guide hole 61 includes a first hole segment 611, a second hole segment 612 and a third hole segment 613 sequentially connected from the proximal end to the distal end, the radial dimension of the first hole segment 611 and the radial dimension of the third hole segment 613 are both greater than the radial dimension of the second hole segment 612, the radial dimension of the first hole segment 611 gradually decreases from the proximal end to the distal end, and the radial dimension of the third hole segment 613 gradually increases from the proximal end to the distal end. The radial dimension herein refers to the largest dimension of the first guide hole 61 in the radial direction thereof, and when the first guide hole 61 is a circular hole, the diameter thereof is referred to. Thus, the first hole segment 611 corresponds to an inverted circular truncated cone, and the third hole segment 613 corresponds to an upright circular truncated cone. In fact, when the valve repair device is delivered to the ventricle, the valve repair device needs to be diverted and delivered between the valve leaflets of the mitral valve or tricuspid valve, and the valve repair device is diverted by controlling the guide wire 90 of the delivery system, while the present embodiment can enable the guide wire 90 to have a greater degree of freedom in the first guide hole 61 by configuring the first guide hole 61 with the first hole segment 611, the second hole segment 612 and the third hole segment 613, so that the navigation diverting function can be better implemented on the valve repair device.
Referring to fig. 2 and 4, the connector assembly of the present embodiment includes a guide wire connector 70, a distal connector 20 and a cover connector 80 arranged in a distal direction from a proximal end, wherein the guide wire connector 70 and the distal connector 20 are fastened and fixed, and the cover connector 80 is screwed and fixed with the guide wire connector 70.
Further, referring to fig. 18 and 19, the guide wire joint 70 has a second guide hole 710, and the axial direction of the second guide hole 710 is parallel to the axial direction of the spacer 10; the cover joint 80 has a fifth extension 81 protruding toward the support body 10, and the fifth extension 81 is configured to be screwed with the second guide hole 710 so as to achieve the screw-fastening of the guide wire joint 70 and the cover joint 80. The second via 710 may be a through hole or a blind hole, and if the blind hole is formed, the proximal end of the second via 710 is closed. In addition, the guidewire 90 of the delivery system is secured to the guidewire hub 70, such as by securing the guidewire 90 in a proximal position of the second guide opening 710.
Further, referring to fig. 17 and 18, the guide wire connector 70 has a sixth extension 72 protruding away from the spacer body 10, and the distal connector 20 has a connector groove 21 recessed in a proximal-to-distal direction, and the connector groove 21 is adapted to the sixth extension 72. The sixth extension 72 is engaged in the joint groove 21 to achieve the engagement fixation of the distal joint 20 and the guide wire joint 70. Regarding the arrangement form of the second guide hole 710, it may be that the wire joint 70 has a fourth extension 71 protruding toward the spacer 10, and one portion of the second guide hole 710 is in the fourth extension 71 and the other portion is in the sixth extension 72. In addition, the fourth extension 71 is also used to follow the movement of the joint assembly into or out of the first guide hole 61 of the support body 60.
In this embodiment, the connection manner of the elastic pressing plate 33 and the elastic spacer arm 31 and the joint assembly is not particularly limited, and in an exemplary embodiment, referring to fig. 9 and 10, at least two through pressing holes 331 are provided at the proximal end of the elastic pressing plate 33, and the pressing holes 331 are used to cooperate with a suture thread to enable the elastic pressing plate 33 to be in suture connection with the spacer 310. In another exemplary embodiment, referring to fig. 9 and 19, the present embodiment configures the elastic pressing plate 33 to be connected to the distal joint 20 in the joint assembly, the distal joint 20 has a first connection groove 22, the first connection groove 22 is recessed radially outward of the spacer body 10, the distal end of the elastic pressing plate 33 is connected to the fixing member 34, the fixing member 34 has a second connection groove 340 recessed radially inward of the spacer body 10, the first connection groove 22 is matched with the second connection groove 340, the connection between the elastic pressing plate 33 and the distal joint 20 is achieved by the cooperation of the first connection groove 22 and the second connection groove 340, further referring to fig. 17 and 18, and during the assembly process of the elastic pressing plate 33 and the distal joint 20, the fixing member 34 at the distal end of the elastic pressing plate 33 passes through the groove 73 of the wire guide joint 70 and is finally fixed in the first connection groove 22. The fixing member 34 may be integrally formed with the elastic pressing plate 33, or may be separately formed and then assembled together.
Referring to fig. 10, the clutch 32 includes a clutch plate 321 and a support plate 322; the supporting plate 322 is fixedly arranged on the capturing section 311, and the supporting plate 322 is close to the attaching capturing section 311, preferably the supporting plate 322 is parallel to the capturing section 311; one end of the clamping plate 321 is elastically coupled to the support plate 322 such that the clamping plate 321 is applied with an elastic force toward the support plate 322. It should be noted that, in this embodiment, the clutch 32 passes through the through hole region 333, and specifically, the clutch plate 321 is configured to pass through the through hole region 333 under a force (as understood, the force is applied by the control wire 100) away from the support plate 322. The position of the gripper 32 changes accordingly with the change in form of the elastic spacer arm 31, and the elastic spacer arm 31 is in the second form, preferably the second vertical form, or the elastic spacer arm 31 is initially brought into the third form, at which time the gripper 32 is operated to catch and grip the leaflet. Specifically, the elastic connection between the support plate 322 and the support plate 321 makes the support plate 321 apply an elastic force towards the support plate 322, and the support plate 322 is fixed on the capturing section 311, so that an external force substantially away from the support plate 322 can be applied to the support plate 321, so that the support plate 322 and the support plate 321 are in an open shape, substantially in a ">" shape, thereby capturing the valve leaflet, and after the external force is removed, the support plate 321 is restored and the valve She Gage is between the support plate 322 and the support plate 321 under the action of the elastic force. It can be understood that the opening and closing degree of the clamping plate 321 and the supporting plate 322 can be controlled by controlling the magnitude of the external force, i.e., the opening degree of ">" can be controlled by the magnitude of the external force.
As a further embodiment, the support plate 322 includes a transverse portion 3221 and a vertical portion 3222 connected in a T-shape, the transverse portion 3221 is perpendicular to the extending direction of the clamping plate 321, the transverse portion 3221 is used to abut against the clamping plate 321, and one end of the vertical portion 3222 away from the transverse portion 3221 is elastically connected with the clamping plate 321.
Preferably, referring to fig. 11, the laminated plate 321 is provided with a plurality of through holes 3211, and the plurality of through holes 3211 may be, for example, linearly arranged along the extending direction of the laminated plate 321. The design of the plurality of through holes 3211 can ensure that after the clamping device 32 clamps the valve leaflet, part of tissues of the valve leaflet are embedded into the through holes to be buckled, so that the anchoring stability of the valve leaflet is improved, and the valve leaflet is not easy to fall off.
Preferably, referring to fig. 10, 11 and 12, the clamping plate 321 is provided with a barb structure 323, the barb structure 323 includes a long thorn 3231 and a short thorn 3232, the length dimension of the long thorn 3231 is greater than that of the short thorn 3232, the long thorn 3231 includes a fixing portion 3233, a connecting portion 3234 and a taper portion 3235 connected in sequence, the fixing portion 3233 is connected to the clamping plate 321, the short thorn 3232 plays a role in supporting and stabilizing the long thorn 3231, and the long thorn 3231 pierces the valve leaflet through the taper portion 3235. The penetration of the long thorns 3231 into the leaflet can improve the capture of the leaflet by the clip 32 and the stability and reliability of the clip. In practical implementation, the length of the long thorn 3231 can be adaptively lengthened within an allowable range, so as to improve the puncture effect and the puncture depth.
Referring to fig. 14, the present embodiment is not limited to the specific form of the cone 3235, including but not limited to a cone, a pyramid (such as the rectangular pyramid shown in fig. 12). Compared with the prior art, the cone part of the barb structure 323 is triangular on the plane, the cone part 3235 of the barb structure 323 is conical in space three-dimensional, so that the long thorn 3231 of the barb structure can puncture the valve leaflet more easily, the barb structure is uniformly stressed on the valve leaflet tissue in the circumferential direction, the damage to the valve leaflet is reduced, and the stabilizing effect is better.
Based on the valve repair device described above, the present embodiment further provides a medical repair instrument assembly including the valve repair device described above and a delivery system including a guide wire 90, a control wire 100, and a connector 110, wherein the guide wire 90 is connected to a joint assembly through the spacer 10 for driving the joint assembly to move in the axial direction of the spacer 10; the control wire 100 is connected to the clamp 32, and is used for controlling the clamping state of the clamp 32, that is, controlling the clamp 32 to capture and clamp the valve leaflet, and controlling the clamp 32 to capture and clamp the valve leaflet again when the clamping effect of the clamp 32 on the valve leaflet is not ideal, and the connecting piece 110 is detachably connected with the valve repair device through the proximal end connector 40. The guidewire 90 is passed through the connector 110 of the delivery system, the sealing gasket 50 of the valve repair device, the proximal hub 40, the spacer 10, the support 60, and finally connected to the guidewire hub 70.
In one embodiment, referring to fig. 1, 3 and 10, the clamping plate 321 has a control hole 3212, the clamping plate 321 is connected to the control wires 100 through the control hole 3212, and the two control wires 100 are respectively connected to the clamping plate 321. During the operation, the elastic spacer arm 31 is in the second configuration, preferably the second vertical configuration, under the combined action of the guide wire 90, the joint assembly and the elastic pressing plate 33, or when the elastic spacer arm 31 is just started to enter the third configuration, the control wire 100 is manipulated to control the clamping plate 321 and the supporting plate 322 to be opened so as to capture and clamp the valve leaflet, specifically, the clamping state of the clamping device 32 on the valve leaflet is observed through the external ultrasonic imaging device, and if the clamping state does not achieve the ideal effect, the valve leaflet can be captured and clamped again under the action of the control wire 100. It should be noted that, the two control wires 100 do not interfere with each other, so that the respective corresponding clampers 32 can be operated simultaneously, or the respective corresponding clampers 32 can be operated separately, so as to realize the function of separately opening and capturing the two clamping plates 321, thereby meeting the operation requirement of the single clamping device 32 possibly occurring in the operation process.
It should be noted that this example only focuses on the implementation of the delivery system to control the valve repair device, and that other ancillary components in the delivery system's working principles and other structural components, as well as the medical repair instrument aggregate, are not described here, as will be appreciated by those skilled in the art from the prior art.
The foregoing description is only illustrative of the preferred embodiments of the present utility model, and is not intended to limit the scope of the present utility model in any way, and any changes and modifications made by those skilled in the art in light of the foregoing disclosure will be deemed to fall within the scope and spirit of the present utility model.