Implant conveying device and implant conveying system

Abstract

The invention relates to an implant conveying device and an implant conveying system. The implant delivery device includes: a handle portion; the conveying catheter is arranged at the far end of the handle part; the conveying catheter is arranged at the far end of the handle part; the conveying catheter comprises a catheter assembly, an inner core tube, a first fixing head and a second fixing head, the catheter assembly comprises an inner tube, a middle tube and an outer tube which are sleeved layer by layer, the inner core tube is movably arranged in the inner tube, the far end of the inner core tube extends out of the inner tube, the first fixing head is arranged at the far end of the middle tube, and the second fixing head is arranged at the far end of the inner tube. The hanging lug of the implant is detachably arranged on the second fixing head, and the first fixing head is movably arranged on the second fixing head in a sleeving mode so as to fix or release the hanging lug of the implant. Thus, when the inner core tube, the inner tube and the middle tube rotate, the first fixing head and the second fixing head can be driven to rotate, and then the implant is driven to rotate through the hanging lug, so that circumferential positioning of the implant is achieved, and the accuracy of implantation is guaranteed.

Description

Technical Field

[0001] This application relates to the technical field of medical devices, and particularly to an implant delivery device and an implant delivery system. Background Art

[0002] Transcatheter aortic valve replacement is a minimally invasive valve replacement surgery, which delivers an artificial valve prosthesis through a catheter to the diseased valve in the heart and implants it to replace the original aortic valve and complete the replacement. Currently, the artificial heart valve delivery system mainly consists of a handle part and a catheter part. The catheter part accommodates the artificial valve prosthesis inside. The distal end of the catheter part reaches the diseased valve in the heart through the femoral artery of the human body, and the artificial valve prosthesis is released by manipulating the handle part to deliver the valve prosthesis to the native annulus; then the catheter part is withdrawn from the body to complete the valve replacement surgery.

[0003] Generally, when the artificial valve prosthesis is implanted at the diseased valve in the heart, the artificial heart valve delivery system needs to be bent and extended into the diseased valve in the heart, and the artificial heart valve delivery system also needs to be circumferentially adjusted and positioned so that the artificial valve prosthesis can be aligned with the diseased valve in the heart to ensure the accuracy of implantation. However, most of the current artificial heart valve delivery systems have a bending function but cannot effectively achieve the circumferential positioning function in the bent state, which will cause the artificial valve prosthesis to be unable to accurately align with the diseased valve in the heart, affecting the accuracy of the implantation of the artificial valve prosthesis and posing a safety hazard. Summary of the Invention

[0004] Based on this, in view of the problem that the current artificial heart valve delivery system cannot achieve circumferential positioning in the bent state, it is necessary to provide an implant delivery device and an implant delivery system that can achieve circumferential positioning while bending to ensure that the implant can be aligned with the implantation site, thereby ensuring the accuracy of implant implantation.

[0005] An implant delivery device includes:

[0006] A handle part; and

[0007] A delivery catheter disposed at the distal end of the handle part; the delivery catheter includes a catheter assembly, an inner core tube, a first fixing head, and a second fixing head. The catheter assembly includes an inner tube, a middle tube, and an outer tube sleeved layer by layer. The inner core tube is movably disposed in the inner tube and its distal end extends out of the inner tube. The first fixing head is disposed at the distal end of the middle tube, and the second fixing head is disposed at the distal end of the inner tube. The hanging ear of the implant is detachably disposed on the second fixing head, and the first fixing head is movably sleeved on the second fixing head to fix or release the hanging ear of the implant.

[0008] In an embodiment of the present application, the second fixing head has a recess, and the lug is detachably installed in the recess. When the first fixing head moves, it can close or open the recess to fix or release the lug.

[0009] In an embodiment of the present application, the inner wall of the first fixing head has a first mating portion, and the outer wall of the second fixing head has a second mating portion, and the first mating portion and the second mating portion are movably mated.

[0010] In an embodiment of the present application, the inner tube, the middle tube, and the outer tube each include a first tube, a reinforcing portion, and a second tube. The second tube is sleeved on the first tube, and the reinforcing portion is disposed between the first tube and the second tube.

[0011] In an embodiment of the present application, the reinforcing portion is woven by at least five strands of braided wires in left-handed and right-handed directions;

[0012] Alternatively, the reinforcing portion is a woven mesh, the braided wires used for the woven mesh are at least seven strands, and the woven mesh is at least two layers.

[0013] In an embodiment of the present application, the delivery catheter further includes a first sheath and a tip. The distal end of the inner core tube is connected to the tip. The first sheath at least partially sleeves the catheter assembly and extends toward the tip. The first sheath covers the portion of the inner core tube that extends out, and the first sheath can cover the implant.

[0014] In an embodiment of the present application, the delivery catheter further includes a second sheath. The second sheath is disposed inside the distal end of the first sheath and covers the inflow channel of the implant. Operating the handle portion can drive the second sheath to move to release the inflow channel.

[0015] In an embodiment of the present application, the delivery catheter further includes a guiding head. The guiding head is disposed inside the distal end of the inner tube. The proximal end and the distal end of the guiding head have guiding surfaces for guiding the guiding head to move into or out of the second sheath.

[0016] In an embodiment of the present application, the guiding head and the second fixing head are an integral structure.

[0017] In an embodiment of the present application, the delivery catheter further includes a third fixing head. The third fixing head is disposed at the distal end of the inner core tube. The third fixing head is located in the second sheath and can abut against the tip.

[0018] An implant delivery system includes an implant and an implant delivery device as described in any of the above technical features. The distal end of the implant delivery device wraps the implant and delivers the implant to the implantation site.

[0019] In an embodiment of the present application, the implant includes a hanging ear, a valve body, a positioning member, an inflow channel, and an outflow channel. The outflow channel is located at the proximal end of the valve body, the inflow channel is located at the distal end of the valve body, the positioning member is disposed on the side of the valve body, the hanging ear is disposed at the distal end of the outflow channel and is connected to the second fixed head of the implant delivery device. The outflow channel and the valve body are located in the first sheath of the implant delivery device, and the inflow channel is located in the second sheath of the implant delivery device.

[0020] After adopting the above technical solutions, the present application has at least the following technical effects:

[0021] In the implant delivery device and the implant delivery system of the present application, in the implant delivery device, the implant is accommodated in the delivery catheter, and the operation handle part drives the delivery catheter to push the implant to the implantation site. The operation handle part makes the inner core tube, the inner tube, and the middle tube drive the implant to rotate around its own axis through the hanging ear clamped by the first fixed head and the second fixed head, realizing the circumferential positioning of the implant, so that the positioning member of the implant can be aligned with the positioning part of the implantation site. Subsequently, the operation handle part separates the first fixed head from the second fixed head to release the hanging ear, and then releases the implant, releasing the implant at the implantation site. After the implant is implanted, the implant delivery device is withdrawn from the body to complete the replacement surgery. In this implant delivery device, the hanging ear of the implant is detachably arranged in the second fixed head and fixed or released by the first fixed head. When the inner core tube, the inner tube, and the middle tube rotate, they can drive the first fixed head and the second fixed head to rotate, and then drive the implant to rotate through the hanging ear to realize the circumferential positioning of the implant, ensuring that the implant can be aligned with the implantation site, ensuring the accuracy of implant positioning, and thus ensuring the accuracy of implantation. The same Description of the Drawings

[0022] Figure 1 Schematic diagram of loading an implant in the implant delivery device according to an embodiment of the present application.

[0023] Figure 2 For Figure 1 Schematic diagram of the distal end of the implant delivery device shown.

[0024] Figure 3 For Figure 2 Schematic diagram of the implant shown being delivered to the implantation site.

[0025] Figure 4 For Figure 1Schematic diagram of the distal end of the implant delivery catheter shown

[0026] Figure 5 is Figure 4 Schematic diagram of an embodiment at the connection between the first fixing head and the second fixing head shown

[0027] Figure 6 is Figure 4 Schematic diagram of another embodiment at the connection between the first fixing head and the second fixing head shown

[0028] Figure 7 is Figure 4 Schematic diagram of yet another embodiment at the connection between the first fixing head and the second fixing head shown

[0029] Figure 8 is Figure 2 Schematic diagram of an embodiment of the inner core tube at the distal end of the delivery catheter shown

[0030] Figure 9 is Figure 2 Schematic diagram of another embodiment of the inner core tube at the distal end of the delivery catheter shown

[0031] Figure 10 is Figure 2 Schematic diagram of the distal end of the delivery catheter when the implant delivery device is withdrawn shown

[0032] Figure 11 is Figure 2 Schematic diagram of the structure where the second fixing head and the guiding head at the distal end of the delivery catheter are integrated shown

[0033] Wherein: 10, implant delivery device; 100, handle part; 200, delivery catheter; 210, catheter assembly; 211, inner tube; 2111, first tube; 2112, second tube; 2113, strengthening part; 212, middle tube; 213, outer tube; 220, inner core tube; 230, first fixing head; 231, smooth surface; 232, first mating part; 240, second fixing head; 241, recessed part; 242, second mating part; 250, first sheath tube; 260, second sheath tube; 270, tip; 280, third fixing head; 290, guiding head; 291, guiding surface; 60, implant; 610, valve body; 620, positioning part; 630, inflow channel; 640, outflow channel; 70, implant site. Detailed implementation manners

[0034] To make the above objects, features, and advantages of the present application more apparent and understandable, the following provides a detailed description of the specific embodiments of the present application in conjunction with the accompanying drawings. Many specific details are set forth in the following description to facilitate a thorough understanding of the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without departing from the spirit of the present application. Therefore, the present application is not limited by the specific embodiments disclosed below.

[0035] In the description of the present application, it should be understood that if terms such as "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. appear, the orientation or positional relationship indicated by these terms is based on the orientation or positional relationship shown in the accompanying drawings. These are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, it should not be construed as a limitation to the present application.

[0036] In addition, if terms such as "first" and "second" appear, these terms are only for descriptive purposes and should not be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, features defined with "first" and "second" may explicitly or implicitly include at least one of such features. In the description of the present application, if the term "plurality" appears, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise specifically and clearly defined.

[0037] In the present application, unless otherwise clearly specified and limited, if terms such as "install", "connect", "join", "fix", etc. appear, these terms should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or integrated; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the communication inside two elements or the interaction relationship between two elements, unless otherwise clearly limited. For those of ordinary skill in the art, the specific meanings of the above terms in the present application can be understood according to specific circumstances.

[0038] In this application, unless otherwise clearly defined and limited, when a first feature is described as being "on" or "under" a second feature or the like, it may mean that the first and second features are in direct contact, or the first and second features are in indirect contact through an intermediate medium. Moreover, the first feature being "above", "over" and "on top of" the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature has a higher horizontal height than the second feature. The first feature being "under", "beneath" and "underneath" the second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature has a lower horizontal height than the second feature.

[0039] It should be noted that if an element is referred to as being "fixed to" or "disposed on" another element, it can be directly on the other element or there may also be an intermediate element. If an element is considered to be "connected" to another element, it can be directly connected to the other element or there may be an intermediate element at the same time. If so, the terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used in this application are only for the purpose of illustration and do not represent the only implementation.

[0040] See Figures 1 to 3 , this application provides an implant delivery device 10. The implant delivery device 10 can accommodate an implant 60 to form an implant delivery system for delivering the implant 60 to an implantation site 70. After the implant 60 is released at the implantation site 70, the implant delivery device 10 is withdrawn from the body to complete the replacement and achieve the therapeutic purpose. Figure 1 It is a schematic diagram of loading the implant 60 in the implant delivery device 10 according to an embodiment of this application. Figure 2 is Figure 1 a schematic diagram of the distal end of the implant delivery device 10 shown. Figure 3 is Figure 2 a schematic diagram of delivering the implant 60 shown to the implantation site 70.

[0041] It is worth noting that the implant 60 in this application is an artificial heart valve prosthesis, and the corresponding implantation site 70 is the diseased heart valve. Of course, in other embodiments of this application, the implant 60 can also be other components that need to be delivered into the patient's body. Only the implant 60 being an artificial heart valve prosthesis is taken as an example for illustration hereinafter.

[0042] It can be understood that most of the current artificial heart valve delivery systems have a bending function but cannot effectively achieve the circumferential positioning function in the bent state, which affects the accuracy of the implantation of the artificial valve prosthesis. For this reason, the present application provides a novel implant delivery device 10, which can achieve circumferential positioning while bending, ensure the coaxiality of the implant 60 and the implantation site 70, and further ensure that the implant 60 can be aligned with the implantation site 70, so as to further ensure the accuracy and service performance of the implantation. The following describes the specific structure of the implant delivery device 10 in an embodiment.

[0043] Referring to Figures 1 to 3 , in an embodiment, the implant delivery device 10 includes a handle portion 100 and a delivery catheter 200. The delivery catheter 200 is disposed at the distal end of the handle portion 100; the delivery catheter 200 includes a catheter assembly 210, an inner core tube 220, a first fixing head 230, a second fixing head 240, a first sheath tube 250, and a tip 270. The catheter assembly 210 includes an inner tube 211, a middle tube 212, and an outer tube 213 that are sleeved layer by layer. The inner core tube 220 is movably disposed in the inner tube 211, and its distal end extends out of the inner tube 211 and is connected to the tip 270. The proximal end of the first sheath tube 250 is located at the distal end of the catheter assembly 210 and covers the part of the inner core tube 220 that extends out, and the distal end is located at the proximal end of the tip 270. The first sheath tube 250 can cover the implant 60. The first fixing head 230 is disposed at the distal end of the middle tube 212, and the second fixing head 240 is disposed at the distal end of the inner tube 211. The lug of the implant 60 is detachably disposed on the second fixing head 240. The first fixing head 230 is movably sleeved on the second fixing head 240 and fixes or releases the lug of the implant 60.

[0044] The delivery catheter 200 has a proximal end and a distal end that are oppositely disposed along its axial direction. The proximal end of the delivery catheter 200 refers to the end of the delivery catheter 200 close to the operator, and the distal end of the delivery catheter 200 refers to the end of the delivery catheter 200 far from the operator. It should be noted that the concepts of the proximal end and the distal end here are applicable to each component in the implant delivery device 10 and the implant 60, and will not be described in detail later. Moreover, the axial direction in the present application is the length direction of the delivery catheter 200, which refers to the direction of the delivery catheter 200 from the proximal end to the distal end.

[0045] To better describe the process of the implant delivery device 10 delivering the implant 60 to the implantation site 70, the specific structure of the implant 60 is introduced here first and will be described in combination during the description of the specific structure of the delivery catheter 200. The implant 60 includes ear hooks, a valve body 610, a positioning member 620, an inflow channel 630, and an outflow channel 640. The handle portion 100 is provided at the proximal end of the delivery catheter 200. The implant 60 is located in the delivery catheter 200 and at the distal end of the delivery catheter 200. The structure of the handle portion 100 is prior art, and how the handle portion 100 controls various movements of the delivery catheter 200 will not be elaborated here.

[0046] When the operator operates the handle portion 100, the delivery catheter 200 can be controlled to move to the implantation site 70 in the patient's body. Then, the operator operates the handle portion 100 to control the delivery catheter 200 to drive the implant 60 to rotate, so as to axially position the implant 60, making the implant 60 align with the implantation site 70, that is, the diseased heart valve. Furthermore, the positioning member 620 can align with the sinus bottom at the diseased heart valve. Subsequently, the operator operates the handle portion 100 to control the delivery catheter 200 to release the implant 60, realizing the implantation of the implant 60 at the diseased heart valve. After the replacement is completed, the operator withdraws the implant delivery device 10 from the body.

[0047] The inner core tube 220 is located at the innermost side of the delivery catheter 200. The inner tube 211 sleevs the inner core tube 220 at the proximal end, and the part of the inner core tube 220 at the distal end extends and exposes from the inner tube 211, that is, the inner core tube 220 is partially covered by the inner tube 211, as Figure 2 and Figure 4 shown, Figure 4 is Figure 1 a schematic diagram of the distal end of the implant 60 delivery catheter 200 shown. The middle tube 212 is sleeved on the outer wall of the inner tube 211, the outer tube 213 is sleeved on the outer wall of the middle tube 212, and the implant 60 is sleeved on the part of the inner core tube 220 that exposes from the inner tube 211. The inner core tube 220 can move relative to the inner tube 211, the inner core tube 220, the inner tube 211, and the middle tube 212 can also move relative to the outer tube 213, and the middle tube 212 can move relative to the inner core tube 220.

[0048] The first fixing head 230 is a fixing head sleeved on the distal end of the middle tube 212, and the second fixing head 240 is a fixing head of the inner tube 211 and is arranged at the distal end of the inner tube 211. Moreover, the proximal part of the second fixing head 240 is located in the first fixing head 230, and the first fixing head 230 and the second fixing head 240 can move relative to each other. The lug of the implant 60 is releasably arranged on the second fixing head 240. The delivery catheter 200 further includes a first sheath tube 250 and a second sheath tube 260. The first sheath tube 250 is at least partially at the distal end of the catheter assembly 210. The implant 60 is located in the first sheath tube 250. The distal end of the first sheath tube 250 is at the proximal side of the tip 270. The second sheath tube 260 is arranged in the first sheath tube 250 and is located at the distal position of the first sheath tube 250. The inflow channel 630 of the implant 60 is located in the second sheath tube 260, and the outflow channel 640 of the implant 60 and the valve body 610 are located in the first sheath tube 250. It can be understood that the first sheath tube 250 is a long sheath tube, and the second sheath tube 260 is a short sheath tube. The second sheath tube 260 is arranged in the first sheath tube 250. Here, the first sheath tube 250 and the second sheath tube 260 are briefly described first to facilitate the description of the input process of the implant 60. The specific structure will be described later.

[0049] When pushing the delivery catheter 200 and circumferentially positioning the implant 60, the lug is fixed on the second fixing head 240, and the first fixing head 230 can play a role in fixing and releasing the lug. When the first fixing head 230 fixes the lug, the first fixing head 230 is sleeved on the second fixing head 240. When the first fixing head 230 releases the lug, the first fixing head 230 disengages from the second fixing head 240. When releasing the implant 60, the first fixing head 230 disengages from the second fixing head 240 to release the lug, and the lug can disengage from the second fixing head 240. When installing the lug, the operation handle part 100 drives the middle tube 212 to move proximally relative to the inner tube 211. At this time, the middle tube 212 drives the first fixing head 230 to disengage from the second fixing head 240. After installing the lug on the second fixing head 240, the operation handle part 100 drives the middle tube 212 to move distally so that the lug is fixed on the second fixing head 24 and is fixed by the first fixing head 230. The process of releasing the lug is opposite to the installation process and will not be elaborated here.

[0050] That is to say, the fixation and release of the implant 60 are achieved through the cooperation of the first fixed head 230 and the second fixed head 240. When the implant 60 is fixed to the second fixed head 240 and locked by the first fixed head 230, the inner core tube 220, the inner tube 211, and the middle tube 212 can drive the implant 60 to rotate to adjust the circumferential position of the implant 60 and ensure that the implant 60 is aligned with the sinus floor. When it is necessary to release the implant 60, the first fixed head 230 is disengaged from the second fixed head 240 to release the lug. In this way, through the cooperation of the first fixed head 230 and the second fixed head 240, the delivery catheter 200 can achieve the axial positioning of the implant 60 while meeting the bending performance, so as to ensure the reliability of the implant 60 implantation.

[0051] During the operation, the operator operates the handle portion 100 to control the distal end of the delivery catheter 200 to enter the implantation site 70 (i.e., the diseased heart valve, which will not be mentioned later) through the femoral artery puncture approach. The operator operates the handle portion 100 to control the first sheath 250 to move proximally to release the positioning member 620 of the implant 60. At this time, the operator operates the handle portion 100 to control the distal end of the delivery catheter 200 to bend to adjust the coaxiality between the implant 60 (artificial heart valve prosthesis) and the native annulus. Subsequently, the operator operates the handle portion 100 to control the inner core tube 220, the inner tube 211, and the middle tube 212 to rotate around their own axes. The inner tube 211 drives the first fixed head 230, and the middle tube 212 drives the second fixed head 240 to rotate simultaneously. Since the lug is fixed in the second fixed head 240 and locked by the first fixed head 230, when the first fixed head 230 and the second fixed head 240 rotate, they can drive the lug to rotate, and then the lug can drive the implant 60 to rotate when it rotates.

[0052] Moreover, when the inner core tube 220, the inner tube 211, and the middle tube 212 drive the implant 60 to rotate, the implant 60 can rotate clockwise or counterclockwise so that the positioning member 620 can be aligned with the sinus floor to achieve the circumferential positioning of the implant 60. After the circumferential positioning, the operator operates the handle portion 100 to push the whole or part of the delivery catheter 200 to make the implant 60 enter the implantation site 70. The operator operates the handle portion 100 to move the second sheath 260 in the ventricular direction (i.e., the distal direction of the delivery catheter 200) to release the inflow tract 630 of the implant 60. Subsequently, the operator operates the handle portion 100 to move the middle tube 212 proximally to release the outflow tract 640 of the implant 60. At this time, the implant 60 is implanted into the implantation site 70 to complete the replacement operation. After the implantation is completed, the operator operates the handle portion 100 to move the inner core tube 220 and the inner tube 211 proximally to the ascending aorta, and the operator operates the handle portion 100 to move the outer tube 213 in the ventricular direction (i.e., the distal direction of the delivery catheter 200) to complete the closure of the implant delivery device 10 and withdraw it from the body to complete the replacement operation.

[0053] For the implant delivery device 10 of the above embodiments, the lug of the implant 60 is located in the second fixing head 240 and locked by the first fixing head 230. When the inner core tube 220, the inner tube 211, and the middle tube 212 rotate, they can drive the first fixing head 230 and the second fixing head 240 to rotate, and then drive the implant 60 to rotate through the lug, so as to realize the circumferential positioning of the implant 60, ensure that the implant 60 can be aligned with the implant site 70, ensure the accuracy of the positioning of the implant 60, and further ensure the accuracy of the implantation.

[0054] See Figures 1 to 3 , in one embodiment, the delivery catheter 200 further includes a first sheath 250 and a tip 270. The inner core tube 220 is movably disposed in the inner tube 211, and its distal end extends out of the inner tube 211 and is connected to the tip 270. At least a part of the first sheath 250 is sleeved on the distal end of the catheter assembly 210 and extends toward the tip 270. The first sheath 250 can cover the part of the inner core tube 220 that extends out, and the first sheath 250 can cover the implant 60.

[0055] The tip 270 is the tip head, which is arranged at the distal end of the inner core tube 220. When the operator pushes the delivery catheter 200 into the patient's body, the tip 270 can play a guiding role and facilitate the movement of the delivery catheter 200 in the patient's body. At least a part of the first sheath 250 is sleeved on the catheter assembly 210, and the distal end of the first sheath 250 is located at the proximal end of the tip 270. Specifically, the proximal end of the first sheath 250 abuts against the distal end of the outer tube 213, the distal end of the first sheath 250 abuts against the proximal end of the tip 270, and the distal end of the inner tube 211 is located in the first sheath 250. At this time, the first sheath 250 covers the part of the inner core tube 220 that extends out of the inner tube 211, and the implant 60 is located in the first sheath 250. The first sheath 250 has good bending performance, so that the implant delivery device 10 can realize circumferential positioning while bending, so as to ensure the coaxiality of the implant 60 and the implant site 70, ensure the accuracy of the implantation of the implant 60, and ensure the use performance of the implant delivery device 10.

[0056] See Figures 5 to 7 , in one embodiment, the outer wall of the second fixing head 240 has a recess 241, and the lug is detachably arranged in the recess 241. When the first fixing head 230 moves, its inner wall can close or open the recess 241 to fix or release the lug. Figure 5 For Figure 4 a schematic diagram of an embodiment of the connection between the first fixing head 230 and the second fixing head 240 shown in Figure 6 For Figure 4 a schematic diagram of another embodiment of the connection between the first fixing head 230 and the second fixing head 240 shown in Figure 7 For Figure 4Schematic diagram of another embodiment at the connection between the first fixed head 230 and the second fixed head 240 shown.

[0057] The second fixed head 240 is generally cylindrical in shape. The first fixed head 230 has a cylindrical hole, and the second fixed head 240 is movably disposed in the cylindrical hole of the first fixed head 230. The outer wall of the second fixed head 240 has a recess 241, and the recess 241 is provided on the outer wall of the second fixed head 240. In this way, the lug of the implant 60 can be fitted and fixed with the recess 241. The inner wall of the first fixed head 230 has a smooth surface 231, and the smooth surface 231 corresponds to the recess 241. Here, the smooth surface 231 means that the surface of the inner wall of the first fixed head 230 at this position has no recess or other settings.

[0058] When the first fixed head 230 is sleeved on the second fixed head 240, the smooth surface 231 on the inner wall of the first fixed head 230 can cover the recess 241 on the outer wall of the second fixed head 240. By limiting the lug in the recess 241 through the smooth surface 231, the lug is locked in the recess 241 of the second fixed head 240. When the first fixed head 230 moves proximally, the smooth surface 231 will gradually move away from the recess 241. At this time, the lug can be disengaged from the recess 241 to achieve the release of the lug.

[0059] Optionally, the number of the recesses 241 is multiple, and the multiple recesses 241 are evenly arranged. By respectively fitting the multiple recesses 241 with the lugs of the implant 60, it is ensured that the proximal end of the implant 60 is reliably fixed and can rotate synchronously with the middle tube 212. Optionally, the number of the recesses 241 is equal to the number of the lugs, and one lug is installed in each recess 241, or the number of the recesses 241 is more than the number of the lugs, and lugs are installed in some of the recesses 241.

[0060] See Figures 5 to 7 , in an embodiment, the inner wall of the first fixed head 230 has a first mating portion 232, and the outer wall of the second fixed head 240 has a second mating portion 242. The first mating portion 232 and the second mating portion 242 are movably mated. The first fixed head 230 is sleeved on the outer surface of the second fixed head 240 and moves relative to the second fixed head 240. The first fixed head 230 and the second fixed head 240 cooperate with each other, and the first fixed head 230 can move along the second mating portion 242 through the first mating portion 232 so that the smooth surface 231 can accurately cover or disengage from the recess 241.

[0061] Optionally, the first engaging portion 232 and the second engaging portion 242 are a mating structure of a guiding boss and a guiding groove. Optionally, the first engaging portion 232 is a guiding groove, and the second engaging portion 242 is a guiding protrusion. The guiding protrusion is installed in the guiding groove. When the first fixing head 230 moves proximally, the guiding groove can slide along the guiding protrusion. Optionally, the first engaging portion 232 can also be a guiding protrusion, and the second engaging portion 242 is a guiding groove. Optionally, the numbers of the first engaging portion 232 and the second engaging portion 242 are both multiple and correspond to each other, which can ensure the accuracy of the movement of the first fixing head 230 along the second fixing head 240.

[0062] In the implant delivery device 10 of the present application, the fixing of the lug is achieved through the cooperation of the recessed portion 241 and the smooth surface 231, ensuring that the implant 60 is reliably fixed, so that the implant 60 can rotate synchronously with the middle tube 212, the inner tube 211, and the inner core tube 220, facilitating the subsequent adjustment of the circumferential position of the implant 60. Moreover, the cooperation of the first engaging portion 232 and the second engaging portion 242 can ensure the consistent rotation of the middle tube 212 and the inner tube 211, improving the stability and reliability of the circumferential rotation.

[0063] See Figures 5 to 7 , in an embodiment, the proximal end of the first fixing head 230 is cylindrical or conical, and / or the distal end of the second fixing head 240 is cylindrical or conical. The conical shape here refers to a gradually inclined structural form to reduce the longitudinal cross-sectional area of the conical end, thereby facilitating movement. The cylindrical shape refers to a structural form similar to a column.

[0064] See Figure 5 , optionally, both the proximal end of the first fixing head 230 and the distal end of the second fixing head 240 are cylindrical. See Figure 6 , optionally, the proximal end of the first fixing head 230 is conical, and the distal end of the second fixing head 240 is cylindrical. When the function of the first fixing head 230 is satisfied, the recessed portion 241 is axially penetrated, so that the size of the first fixing head 230 can be reduced, the interference between the implant 60 and the distal end of the delivery catheter 200 can be reduced, and the cross-sectional size of the distal end of the catheter can be reduced. Optionally, the proximal end of the first fixing head 230 is conical, and the distal end of the second fixing head 240 is conical. See Figure 7 , optionally, both the proximal end and the distal end of the second fixing head 240 are conical, that is, both ends of the second fixing head 240 are double-conical, reducing the interference between the implant 60 and the distal end of the delivery catheter 200 after the implant 60 is released, which is beneficial to the operation after the surgical withdrawal.

[0065] See Figure 2 , Figure 8 and Figure 9In one embodiment, the inner tube 211 , the middle tube 212 and the outer tube 213 all include a first tube 2111 , a reinforcement portion 2113 and a second tube 2112 , the second tube 2112 is sleeved on the first tube 2111 , and the reinforcement portion 2113 is disposed between the first tube 2111 and the second tube 2112 . Figure 8 for Figure 2 The schematic diagram of an embodiment of the inner tube 211 in the distal end of the delivery catheter 200 is shown. Figure 9 for Figure 2 A schematic diagram of another embodiment of the inner tube 211 in the distal end of the delivery catheter 200 is shown.

[0066] It is worth noting that the structures of the inner tube 211, the middle tube 212 and the inner tube 211 are the same, and only the structure of the inner tube 211 is used as an example for description. The first tube 2111 and the second tube 2112 are the main tubes of the inner tube 211, and the second tube 2112 is sleeved on the outside of the first tube 2111. The reinforcement part 2113 is arranged between the first tube 2111 and the second tube 2112, and strengthens the connection between the first tube 2111 and the second tube 2112 to improve the structural strength of the inner tube 211. At the same time, the reinforcement part 2113 can also realize the bidirectional torsion resistance of the catheter assembly 210, increase its damping, and improve the rotation response time and stability.

[0067] See also Figure 8 Optionally, the reinforcement portion 2113 is formed by at least five strands of braided wires woven in a left-handed and right-handed manner. That is to say, in this embodiment, the reinforcement portion 2113 is a spirally wound structure, and the braided wires are respectively arranged in a left-handed and a right-handed manner, and the left-handed braided wires and the right-handed braided wires are staggered on the outer wall of the first tube 2111, which can achieve bidirectional torsion resistance of the catheter assembly 210, increase its damping, and improve the rotation response time and stability. Optionally, the number of braided wires is at least five strands to ensure the structural strength of the reinforcement portion 2113. Optionally, the longitudinal cross-sectional shape of the braided wire includes but is not limited to circular, square, annular, etc. The longitudinal cross-sectional direction here is Figure 8 The directions shown are reference only.

[0068] See also Figure 9 Optionally, the reinforcement portion 2113 is a braided mesh, the braided mesh uses at least seven braided wires, and the braided mesh has at least two layers. The braided wires are bidirectionally interlaced to form a mesh structure, and are sleeved on the outer wall of the first tube 2111 to ensure the structural strength of the reinforcement portion 2113. At the same time, the bidirectional torsion resistance of the catheter assembly 210 can be achieved, thereby increasing its damping and improving the rotation response time and stability. Optionally, the braided mesh has at least two layers. Optionally, the number of braided wires in the braided mesh is at least seven strands. Optionally, the longitudinal cross-sectional shape of the braided wire includes but is not limited to circular, square, trapezoidal, annular, etc. The longitudinal cross-sectional direction here is Figure 9 The directions shown are reference only.

[0069] Optionally, the first tube 2111 is made of PTFE (tetrafluoroethylene) or other materials that can be delivered into the patient's body and ensure structural strength. Optionally, the second tube 2112 is made of a super-elastic molecular material, such as Pebax (polyether block polyamide), Pa (polyamide), etc.

[0070] See Figure 2 and Figure 4 , in one embodiment, the delivery catheter 200 further includes a second sheath 260. The second sheath 260 is disposed inside the distal end of the first sheath 250 and covers the inflow channel 630 of the implant 60. The operating handle portion 100 drives the second sheath 260 to move to release the inflow channel 630 and reset the second sheath 260. The second sheath 260 can limit the inflow channel 630 of the implant 60, facilitating the delivery of the implant 60.

[0071] See Figure 4 , in one embodiment, the delivery catheter 200 further includes a third fixing head 280. The third fixing head 280 is disposed at the distal end of the inner core tube 220. The third fixing head 280 is located in the second sheath 260 and can abut against the tip 270. The third fixing head 280 can fix the inner core tube 220 to fix the inner core tube 220 and the second sheath 260 to the tip 270. In this way, when the inner core tube 220 moves, it can drive the second sheath 260 and the tip 270 to move synchronously through the third fixing head 280.

[0072] See Figure 2 , Figure 4 and Figure 10 , in one embodiment, the delivery catheter 200 further includes a guide head 290. The guide head 290 is disposed on the inner tube 211. The proximal end and the distal end of the guide head 290 have guide surfaces 291 for guiding the guide head 290 to move into or out of the second sheath 260. Figure 10 For Figure 2 a schematic diagram of the distal end of the delivery catheter 200 when the implant delivery device 10 shown is withdrawn.

[0073] The guide surfaces 291 at the proximal end and the distal end of the guide head 290 can play a guiding role. When the operating handle portion 100 drives the second sheath 260 to move in the ventricular direction (i.e., the distal direction of the delivery catheter 200), the second sheath 260 will move along the guide surface 291 of the proximal guide, reducing the friction between the guide head 290 and the second sheath 260 and facilitating the movement of the second sheath 260 in the ventricular direction (i.e., the distal direction of the delivery catheter 200). After the second sheath 260 releases the outflow channel 640 of the implant 60, the guide head 290 is located outside the second sheath 260. By cooperating the guide surface 291 at the distal end of the guide head 290 with the second sheath 260, it can facilitate the movement of the guide head 290 into the second sheath 260.

[0074] When the delivery catheter 200 is withdrawn, the inner core tube 220 drives the second sheath tube 260 to move in the distal direction, causing the guiding head 290 to close the end of the second sheath tube 260 near the ventricle. Then, the entire implant delivery device 10 is withdrawn to the ascending aorta. The operating handle portion 100 causes the outer tube 213 to drive the first sheath tube 250 to move in the ventricular direction to the proximal end of the tip 270 and then stop, so as to complete the overall closure before withdrawal. Subsequently, the entire implant delivery device 10 is withdrawn from the body. Optionally, the guiding head 290 is in a double streamline structure form. Optionally, the longitudinal cross-sectional shape of the guiding head 290 is not limited to a conical shape, a spherical shape, an ellipsoidal shape, etc.

[0075] See Figure 11 , in one embodiment, the guiding head 290 and the second fixing head 240 are of an integral structure. Figure 11 For Figure 2 a schematic diagram showing that the second fixing head 240 and the guiding head 290 are of an integral structure in the distal end of the delivery catheter 200 shown. That is to say, the second fixing head 240 and the guiding head 290 are formed into an integral structure, so that the inner tube 211 at one end can be reduced, and the outer diameter of the part in contact with the implant 60 can be reduced, effectively reducing the size of the distal end of the delivery catheter 200.

[0076] The implant delivery device 10 of the above embodiment takes into account the two performance requirements of bending and circumferential positioning, and can control the rotation of the implant 60 while controlling the bending of the delivery catheter 200 to achieve the axial positioning of the implant 60 and ensure the accuracy of implanting the implant 60. Moreover, the bending performance of the first sheath tube 250 and the second sheath tube 260 can well meet the release of the implant 60, ensuring that the implant 60 can maintain good coaxiality with the implantation site 70 (the diseased heart valve), and solving the requirement for the implant 60 to accurately enter the sinus.

[0077] See Figure 1 , the present application further provides an implant delivery system, including an implant 60 and the implant delivery device 10 according to any one of the above embodiments. The distal end of the implant delivery device 10 wraps the implant 60 and transports the implant 60 to the implantation site 70. The implant delivery system of the present application uses the above implant delivery device 10 to transport the implant 60, which can ensure the use performance of the implant delivery system. Optionally, the implant 60 can be assembled into the implant delivery device 10 before leaving the factory, or can be assembled to the implant delivery device 10 after leaving the factory.

[0078] In one embodiment, the implant 60 includes lugs, a valve body 610, a positioning member 620, an inflow channel 630, and an outflow channel 640. The outflow channel 640 is located at the proximal end of the valve body 610, the inflow channel 630 is located at the distal end of the valve body 610, the positioning member 620 is disposed on the side surface of the valve body 610, the lugs are disposed at the distal end of the outflow channel 640 and are connected to the second fixing head 240 of the implant delivery device 10. The outflow channel 640 and the valve body 610 are located in the first sheath 250 of the implant delivery device 10, and the inflow channel 630 is located in the second sheath 260 of the implant delivery device 10.

[0079] After the implant 60 is installed in the first sheath 250, the positioning member 620 is limited in the first sheath 250. When the first sheath 250 moves proximally, the positioning member 620 will protrude from the first sheath 250, forming a claw-shaped structure. At this time, the positioning member 620 protrudes obliquely relative to the first sheath 250. When the inner core tube 220, the inner tube 211, and the middle tube 212 are rotated, the implant 60 will rotate synchronously, and then the positioning member 620 will abut against the sinus floor to achieve circumferential positioning of the implant 60. Other structures of the implant 60 have been mentioned above and will not be elaborated here.

[0080] When using the implant delivery device 10 of the present application to push the implant 60, the operator operates the handle portion 100 to control the distal end of the delivery catheter 200 to enter the implant site 70, i.e., the diseased heart valve, through the femoral artery puncture approach. The operator operates the handle portion 100 to control the first sheath 250 to move proximally, releasing the positioning member 620 of the implant 60. At this time, the operator operates the handle portion 100 to control the distal end of the delivery catheter 200 to bend to adjust the coaxiality between the implant 60 and the native valve annulus. Subsequently, the operator controls the inner core tube 220, the inner tube 211, and the middle tube 212 to rotate around their own axes. The inner tube 211 drives the first fixing head 230, and the middle tube 212 drives the second fixing head 240 to rotate simultaneously. Since the lugs are fixed in the recess 241, when the first fixing head 230 and the second fixing head 240 rotate, they can drive the lugs to rotate, and then when the lugs rotate, they can drive the implant 60 to rotate.

[0081] Moreover, when the inner core tube 220, the inner tube 211, and the middle tube 212 drive the implant 60 to rotate, the implant 60 can rotate in the clockwise or counterclockwise direction so that the positioning member 620 can be aligned with the sinus floor to achieve the circumferential positioning of the implant 60. After the circumferential positioning, the entire operating handle portion 100 is pushed or a part of the delivery catheter 200 is pushed so that the implant 60 enters the implantation site 70. The operating handle portion 100 causes the inner core tube 220 to drive the second sheath tube 260 to move in the ventricular direction (i.e., the distal direction of the delivery catheter 200) to release the inflow tract 630 of the implant 60. Subsequently, the operating handle portion 100 causes the middle tube 212 to move proximally to release the outflow tract 640 of the implant 60. At this time, the implant 60 is implanted into the implantation site 70 to complete the replacement surgery. After the implantation is completed, the operating handle portion 100 causes the inner core tube 220 and the inner tube 211 to move proximally to the ascending aorta, and then the operating handle portion 100 causes the outer tube 213 to move in the ventricular direction (i.e., the distal direction of the delivery catheter 200) to complete the closure of the implant delivery device 10 and withdraw it from the body to complete the replacement surgery.

[0082] The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered to be within the scope described in this specification.

[0083] The above-described embodiments merely represent several implementation manners of the present application. The description is relatively specific and detailed, but it should not be construed as a limitation on the scope of the patent application. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present application, several modifications and improvements can still be made, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent of the present application shall be subject to the appended claims.

Claims

1. An implant delivery device, characterized in that, Comprising: A handle portion; And A delivery catheter disposed at the distal end of the handle portion; the delivery catheter includes a catheter assembly, an inner core tube, a first fixing head, and a second fixing head. The catheter assembly includes an inner tube, a middle tube, and an outer tube sleeved layer by layer. The inner core tube is movably disposed within the inner tube and its distal end extends out of the inner tube. The first fixing head is disposed at the distal end of the middle tube, and the second fixing head is disposed at the distal end of the inner tube. The ear of the implant is detachably disposed on the second fixing head, and the first fixing head is movably sleeved on the second fixing head to fix or release the ear of the implant.

2. The implant delivery device according to claim 1, characterized in that, The second fixing head has a recess portion, and the ear is detachably installed in the recess portion. When the first fixing head moves, it can close or open the recess portion to fix or release the ear.

3. The implant delivery device according to claim 1, characterized in that, The inner wall of the first fixing head has a first mating portion, and the outer wall of the second fixing head has a second mating portion, and the first mating portion and the second mating portion are movably mated.

4. The implant delivery device according to claim 1, characterized in that, The inner tube, the middle tube, and the outer tube each include a first tube, a reinforcing portion, and a second tube. The second tube is sleeved on the first tube, and the reinforcing portion is disposed between the first tube and the second tube.

5. The implant delivery device according to claim 4, characterized in that, The reinforcing portion is formed by left-handed and right-handed braiding of at least five strands of braided wire; Alternatively, the reinforcing portion is a braided mesh, the braided wire used for the braided mesh is at least seven strands, and the braided mesh is at least two layers.

6. The implant delivery device according to any one of claims 1 to 5, characterized in that, The delivery catheter further includes a first sheath tube and a tip. The distal end of the inner core tube is connected to the tip. The first sheath tube at least partially sleeves the catheter assembly and extends towards the tip. The first sheath tube covers the part of the inner core tube that extends out, and the first sheath tube can cover the implant.

7. The implant delivery device according to claim 6, characterized in that, The delivery catheter further includes a second sheath tube. The second sheath tube is disposed inside the distal end of the first sheath tube and covers the inflow path of the implant. Operating the handle portion can drive the second sheath tube to move to release the inflow path.

8. The implant delivery device according to claim 7, characterized in that, The delivery catheter further includes a guiding head. The guiding head is disposed inside the distal end of the inner tube. The proximal end and the distal end of the guiding head have guiding surfaces for guiding the guiding head to move into or out of the second sheath tube.

9. The implant delivery device according to claim 8, characterized in that, The guiding head and the second fixing head are of an integral structure.

10. The implant delivery device according to claim 7, characterized in that, The delivery catheter further includes a third fixing head. The third fixing head is disposed at the distal end of the inner core tube. The third fixing head is located in the second sheath tube and can abut against the tip.

11. An implant delivery system, characterized in that, Including an implant and an implant delivery device according to any one of claims 1 to 10. The distal end of the implant delivery device covers the implant and delivers the implant to the implantation site.

12. The implant delivery system according to claim 11, characterized in that, The implant includes ear hooks, a valve body, a positioning member, an inflow channel, and an outflow channel. The outflow channel is located at the proximal end of the valve body, the inflow channel is located at the distal end of the valve body, the positioning member is disposed on the side surface of the valve body, the ear hooks are disposed at the distal end of the outflow channel and connected to the second fixed head of the implant delivery device. The outflow channel and the valve body are located in the first sheath of the implant delivery device, and the inflow channel is located in the second sheath of the implant delivery device.

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