Delivery device for a valve prosthesis and valve prosthesis system

Abstract

This application relates to the field of medical device technology, and particularly to a valve prosthesis delivery device, comprising: a sheath, a catheter assembly, and an inner core assembly; the sheath is sleeved on the distal end of the inner core assembly and fixedly connected to the inner core assembly, the sheath being used to restrain the valve prosthesis in a compressed state; the catheter assembly is movably sleeved on the inner core assembly, with the distal end of the catheter assembly located within the sheath, the distal end of the catheter assembly being used to load the valve prosthesis in a compressed state; the delivery device is configured such that: the inner core assembly is driven to move the sheath distally relative to the catheter assembly to release the compressed valve prosthesis. The valve prosthesis delivery device and valve prosthesis system provided in this application embodiment can deliver and release a valve prosthesis with a special structure to a target location in the human body.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a valve prosthesis delivery device and valve prosthesis system. Background Technology

[0002] Mitral regurgitation (MR) is the most common valvular disease, with an incidence rate of approximately 1.7% in the general population. Severe MR can seriously impair heart function, increase the risk of heart failure, and seriously threaten health and lifespan.

[0003] The traditional main treatment for severe MR patients is mitral valve repair / replacement under cardiopulmonary bypass, which involves open-heart surgery to repair the mitral valve or replacing the native mitral valve with a prosthetic valve. While mitral valve repair / replacement under cardiopulmonary bypass is a mature and effective technique, it carries significant risks and a high mortality rate for elderly patients, those with severe heart failure, or those with serious comorbidities, making it an unsuitable treatment option.

[0004] Transcatheter mitral valve replacement (TMVR) is a minimally invasive valve replacement technique that has emerged in recent years. This technique delivers a valve prosthesis to the target location via the apex of the heart or the femoral artery, and then releases the valve to replace the native mitral valve, thus avoiding invasive procedures such as sternal splitting and cardiopulmonary bypass. Therefore, TMVR is characterized by low risk, minimal trauma, and rapid recovery, providing elderly, high-risk MR patients with the opportunity for valve replacement, reducing regurgitation, and preventing heart failure, thereby benefiting elderly, high-risk MR patients.

[0005] However, existing valve prosthesis delivery devices have several problems, such as their inability to deliver valve prostheses with special structures (e.g., those with extended connectors or double-layer stent structures). Therefore, there is an urgent need to provide a new valve prosthesis delivery device and valve prosthesis system. Summary of the Invention

[0006] The purpose of this application is to provide a valve prosthesis delivery device and valve prosthesis system, which can deliver and release a valve prosthesis with a special structure to a target position in the human body.

[0007] To address the aforementioned problems, this application provides a valve prosthesis delivery device, comprising: a sheath, a catheter assembly, and an inner core assembly; the sheath is sleeved on the distal end of the inner core assembly and fixedly connected to the inner core assembly, the sheath being used to restrain a valve prosthesis in a compressed state; the catheter assembly is movably sleeved on the inner core assembly, the distal end of the catheter assembly being located within the sheath, the distal end of the catheter assembly being used to load the valve prosthesis in a compressed state; the delivery device is configured such that: the inner core assembly is driven to move the sheath distally relative to the catheter assembly to release the compressed valve prosthesis.

[0008] Furthermore, this application embodiment also provides a valve prosthesis system, including: a valve prosthesis and the above-mentioned delivery device, wherein the valve prosthesis in a compressed state is sleeved on the catheter assembly, and a portion of the valve prosthesis is located inside the sheath and another portion is located outside the sheath.

[0009] This application provides a valve prosthesis delivery device and valve prosthesis system, comprising: a sheath, a catheter assembly, and an inner core assembly; the sheath is sleeved on the distal end of the inner core assembly and fixedly connected to the inner core assembly, the sheath being used to restrain a valve prosthesis in a compressed state; the catheter assembly is movably sleeved on the inner core assembly, and the distal end of the catheter assembly is located within the sheath, the distal end of the catheter assembly being used to load the valve prosthesis in a compressed state; the delivery device is configured such that: the inner core assembly is driven to move the sheath distally relative to the catheter assembly to release the compressed valve prosthesis. Thus, after the valve prosthesis mounted on the distal end of the catheter assembly is delivered to the target location in the human body (i.e., the location in the human body where the valve prosthesis needs to be released) using the delivery device, the inner core assembly can be driven to move the sheath relative to the catheter assembly distally to release the compressed valve prosthesis. This avoids interference between the sheath and the special structure of the valve prosthesis (such as: the extended connector structure, the double-layer stent structure) during the release of the valve prosthesis by the delivery device, thereby realizing the delivery and release of the valve prosthesis with the special structure to the target location in the human body.

[0010] Additionally, the catheter assembly includes a cannula and a guide block fixed to the distal end of the cannula. Both the cannula and the guide block are fitted onto the inner core assembly. The distal end of the cannula is used to load a valve prosthesis in a compressed state. The guide block is accommodated in the sheath and used to guide the axial movement of the cannula.

[0011] In addition, the above-mentioned delivery device further includes: a handle assembly, which is axially stationary with respect to the inner core assembly or fixed to the proximal end of the inner core assembly, and the handle assembly is used to drive the inner core assembly to move; the conduit assembly is located between the distal end of the inner core assembly and the handle assembly.

[0012] Additionally, the handle assembly includes a housing and a clamp fixed to the housing, the housing being for an operator to grip, and the clamp being for fixing the housing to the proximal end of the inner core assembly or keeping it axially relative to the core assembly stationary.

[0013] In addition, the housing is a hollow structure with a groove inside. The clamp is engaged in the groove and is sleeved and fixed to the near end of the inner core assembly.

[0014] Additionally, the catheter assembly includes: a central steel tube and a guidewire tube fixed to the proximal end of the central steel tube. Both the central steel tube and the guidewire tube are sleeved on the inner core assembly. The distal end of the central steel tube is used to load a valve prosthesis in a compressed state. The guidewire tube is located at the proximal end of the sheath. The guidewire tube has a first cavity that extends axially through the circumference and is used to accommodate the guidewire.

[0015] In addition, the guide wire tube is provided with a second cavity that extends axially, and the proximal portion of the middle steel tube is accommodated in the second cavity and fixed to the guide wire tube.

[0016] Additionally, the inner core assembly includes an inner core tube and an inner steel tube, the inner core tube being located at the distal end of the inner steel tube, at least a portion of the distal end of the inner core tube being accommodated in the sheath tube, and the diameter of the inner core tube being smaller than the diameter of the inner steel tube.

[0017] Additionally, the valve prosthesis includes: a main body portion and at least one connector fixed to the proximal end of the main body portion, the main body portion being located within the sheath, and the connector being located outside the sheath and extending from the proximal end of the main body portion to the distal end.

[0018] In addition, the valve prosthesis further includes: at least one support member, which is disposed outside the original leaflet or chordae tendon and constrains the radial expansion of the main body to clamp the original leaflet or chordae tendon together with the main body; the connector is connected to the support member to connect the support member to the main body.

[0019] In addition, the support member is a hollow elastic member and is arc-shaped in its natural state, forming a generally closed loop through the connector; the connector includes two hollow short rods and a connecting body that is connected to the main body and the two short rods; the number of the support members is the same as the number of the connectors, and the two ends of the support members are respectively sleeved on one of the short rods.

[0020] In addition, the valve prosthesis system further includes: a guidewire; the catheter assembly includes: a guidewire tube, the guidewire tube having at least two axially penetrating first lumens circumferentially, the first lumens being used to accommodate the guidewire; the guidewire cooperating with the two first lumens, the two short rods and the support member, the guidewire being used to guide the two short rods to engage with the support member. Attached Figure Description

[0021] Figure 1 A schematic diagram of the conveying device provided in Embodiment 1 of this application;

[0022] Figure 2 for Figure 1 A magnified view of part A in the middle section, with the sheath viewed through fluoroscopy.

[0023] Figure 3 This is a schematic diagram of the sheath and inner core assembly in accordance with Embodiment 1 of this application.

[0024] Figure 4 This is a schematic diagram of a partial structure of the catheter assembly provided in Embodiment 1 of this application;

[0025] Figure 5 This is an exploded cross-sectional view of the shell structure provided in Embodiment 1 of this application;

[0026] Figure 6 This is a schematic diagram of a partial structure of the guide wire tube provided in Embodiment 1 of this application;

[0027] Figure 7 This is a schematic diagram of the distal portion of the valve prosthesis system provided in Embodiment 2 of this application;

[0028] Figure 8 This is a cross-sectional view of the distal portion of the valve prosthesis system provided in Embodiment 2 of this application;

[0029] Figure 9 This is a schematic diagram of the main body and connector of the valve prosthesis provided in Embodiment 2 of this application;

[0030] Figure 10 This is a schematic diagram of the support component for the valve prosthesis provided in Embodiment 2 of this application. Detailed Implementation

[0031] Those skilled in the art will understand that many technical details have been presented in the various embodiments of this application to facilitate a better understanding of the application. However, the technical solutions claimed in this application can also be achieved based on various variations and modifications of the following embodiments.

[0032] In the various embodiments of this application, "proximal end" and "proximal side" refer to the end that is closer to the operator and further away from the patient; correspondingly, "distal end" and "distal side" refer to the end that is closer to the patient and further away from the operator.

[0033] This application provides a valve prosthesis delivery device and valve prosthesis system, including: a sheath, a catheter assembly, and an inner core assembly; the sheath is sleeved on the distal end of the inner core assembly and fixedly connected to the inner core assembly, the sheath being used to restrain the valve prosthesis in a compressed state; the catheter assembly is movably sleeved on the inner core assembly, and the distal end of the catheter assembly is located inside the sheath, the distal end of the catheter assembly being used to load the valve prosthesis in a compressed state; the delivery device is configured such that: the inner core assembly is driven to move the sheath distally relative to the catheter assembly to release the compressed valve prosthesis. In this way, after the valve prosthesis loaded on the distal end of the catheter assembly is delivered to the target position in the human body using the delivery device, the inner core assembly can be driven to move the sheath relative to the catheter assembly to the distal end, thereby releasing the compressed valve prosthesis. This avoids interference between the sheath and the special structure of the valve prosthesis (such as the extended connector structure and the double-layer stent structure) during the release of the valve prosthesis by the delivery device, thus realizing the delivery and release of the valve prosthesis with special structure to the target position in the human body.

[0034] A valve prosthesis exists in both a compressed and a released state. In the compressed state, at least a portion of the valve prosthesis's radial dimension is smaller than that in the released state. When the valve prosthesis needs to be delivered to the target location in the body, it must be in the compressed state. After delivery, the valve prosthesis must be converted from the compressed state to the released state using a balloon or self-inflation method to achieve fixation with the native valve.

[0035] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the various embodiments of this application will be described in detail below with reference to the accompanying drawings.

[0036] See Figure 1 and Figure 2 The valve prosthesis delivery device 100 provided in Embodiment 1 of this application includes: a sheath 110, a catheter assembly 120, and an inner core assembly 130; the sheath 110 is sleeved on the distal end of the inner core assembly 130 and is fixedly connected to the inner core assembly 130, and the sheath 110 is used to restrain the valve prosthesis in a compressed state; the catheter assembly 120 is movably sleeved on the inner core assembly 130, and the distal end of the catheter assembly 120 is located inside the sheath 110, and the distal end of the catheter assembly 120 is used to load the valve prosthesis in a compressed state; the delivery device 100 is configured such that: the inner core assembly 130 is driven to move the sheath 110 distally relative to the catheter assembly 120 to release the valve prosthesis in a compressed state.

[0037] During surgery, the valve prosthesis is compressed and loaded onto the distal end of the catheter assembly 120, with the sheath 110 restraining the compressed valve prosthesis. Then, the delivery device 100 provided in this embodiment delivers the valve prosthesis to the target location via the apex or atrial septum. After the valve prosthesis is delivered to the target location using the delivery device 100, the inner core assembly 130 drives the sheath 110 to move distally relative to the catheter assembly 120, thereby releasing the valve prosthesis from the sheath 110 and enabling the release of a valve prosthesis with a special structure. This special structured valve prosthesis may be, for example, a valve prosthesis with an extended connector and a double-layered stent.

[0038] See also Figure 1 and Figure 2 See also Figure 3 In this embodiment, the inner core assembly 130 includes an inner core member 131. The inner core member 131 is fixedly connected to the sheath tube 110 so that the inner core member 131 can drive the sheath tube 110 to move distally.

[0039] Furthermore, the inner core assembly 130 also includes a guide head 132, which is located at the distal end of the inner core 131 and is used to assist the sheath 110 and the valve prosthesis in reaching the target position for valve prosthesis release.

[0040] Specifically, the guide head 132 provided in this embodiment has an arc-shaped cross-section. It should be noted that in other embodiments, the cross-section of the guide head may not be arc-shaped. For example, in one alternative embodiment, the cross-section of the guide head is conical; in another alternative embodiment, the cross-section of the guide head is spindle-shaped.

[0041] In this embodiment, the guide head 132 is made of PEBAX material (PEBAX: polyether amide block copolymer) to prevent it from puncturing the heart or blood vessels during the delivery of the valve prosthesis to the target location on the human body using the delivery device 100. It should be noted that in other alternative embodiments, the guide head 132 may also be made of other materials, such as TPU material (TPU: thermoplastic polyurethane elastomer).

[0042] The guide head 132 is also used to secure the sheath 110 to the inner core assembly 130. In this embodiment, the distal end of the sheath 110 is secured to the guide head 132 of the inner core assembly 130.

[0043] Preferably, the sheath 110 is sleeved on the guide head 132, and the sheath 110 is fixed to the guide head 132. In this way, the guide head 132 can also support the inner lumen of the sheath 110. Specifically, the proximal end of the guide head 132 includes a fixing portion located inside the sheath 110 and fixed to it. The fixing portion and the sheath 110 can be an interference fit, or they can be bonded together using biocompatible adhesive to achieve a fixed connection. Furthermore, the outer diameter of the fixing portion is smaller than the outer diameter of the rest of the guide head 132, and the outer diameter of the sheath 110 is less than or equal to the outer diameter of the rest of the guide head 132, making the connection between the sheath 110 and the guide head 132 smoother and preventing the sheath 110 from scraping the blood vessel wall, ventricular wall, or atrial wall when entering human blood vessels, the heart, or other tissues and organs. In addition, the fixing portion and the rest of the guide head 132 form an abutment shoulder, which can prevent the sheath 110 from moving distally relative to the guide head 132.

[0044] In this embodiment, the sheath 110 is made of a thermoplastic material. Specifically, the sheath 110 provided in this embodiment is made of polypropylene. It should be noted that in other alternative embodiments, the sheath 110 may not be made of polypropylene; for example, in one alternative embodiment, the sheath 110 is made of polyvinyl chloride.

[0045] See also Figures 1 to 3 Preferably, the inner core 131 includes an inner core tube 133 and an inner steel tube 134, the inner core tube 133 is located at the distal end of the inner steel tube 134, at least a portion of the distal end of the inner core tube 133 is accommodated in the sheath tube 110, and the diameter of the inner core tube 133 is smaller than the diameter of the inner steel tube 134.

[0046] Thus, by using a larger diameter inner steel tube 134 as the proximal end of the inner core 131, it can be ensured that the proximal end of the inner core 131 will not deform when the inner core 131 or even the inner core assembly 130 is driven to move to the distal end.

[0047] In this embodiment, the proximal end of the inner core tube 133 is fixed to the distal end of the inner steel tube 134. In an alternative embodiment, the inner core tube 133 and the inner steel tube 134 are integrally formed.

[0048] See also Figure 1 and Figure 2 See also Figure 4 In this embodiment, the catheter assembly 120 includes a cannula 121 and a guide block 122 fixed to the distal end of the cannula 121. Both the cannula 121 and the guide block 122 are sleeved on the inner core assembly 130. The distal end of the cannula 121 is used to load a valve prosthesis in a compressed state. The guide block 122 is accommodated in the sheath 110 and is used to guide the axial movement of the cannula 121.

[0049] Specifically, in this embodiment, the proximal end of the guide block 122 is fixedly connected to the distal end of the sheath 121, and the distal end of the guide block 122 is a free end. The guide block 122 is axially movable and inserted into the sheath 110. Further, the guide block 122 includes a guide portion at the distal end and a support portion at the proximal end. The outer diameter of the guide portion increases from distal to proximal until it is comparable to the outer diameter of the support portion; the outer diameter of the support portion is slightly smaller than the inner diameter of the sheath 121, so as to allow the guide block 122 to move freely within the sheath 110. The guide portion can be frustum-shaped, spherical, hemispherical, etc. Thus, after the valve prosthesis is mounted on the distal end of the sheath 121, when the sheath 110 is needed to restrain the valve prosthesis, it is convenient to insert the guide block 122 into the sheath 110.

[0050] In addition, the catheter assembly 120 also includes a lug (not shown) located at the distal end of the cannula 121, which is used to detachably mount the valve prosthesis at the distal end of the cannula 121 to prevent undesirable axial movement of the valve prosthesis. This embodiment does not impose any particular limitation on the specific shape of the lug.

[0051] See further Figure 1 , Figure 4 and Figure 6 Preferably, the sheath 121 includes a central steel tube 123 and a guidewire tube 124 fixed to the proximal end of the central steel tube 123. Both the central steel tube 123 and the guidewire tube 124 are sleeved on the inner core assembly 130. The distal end of the central steel tube 123 is used to load the valve prosthesis in a compressed state. The guidewire tube 124 has a first cavity 125 axially penetrating in the circumferential direction, which is used to accommodate the guidewire. During delivery, the valve prosthesis in a compressed state is loaded on the distal end of the central steel tube 123, and the valve prosthesis is fixed to the central steel tube 123 without relative movement. When the valve prosthesis is released, the sheath 110 no longer restrains the valve prosthesis, and the valve prosthesis self-expands or is released from the fixation of the central steel tube 123 by balloon expansion. On the other hand, the guidewire tube 124 may have multiple axially penetrating first cavities 125 circumferentially to allow the guidewire to pass through. In this way, the problem of the guide wire being housed in the inner tube in the traditional conveying system, and the inner tube being unable to provide multiple channels for the guide wire due to size limitations, is solved, thus enabling the guide wire to perform more functions in addition to the functions of the traditional guiding and conveying device.

[0052] Furthermore, in this embodiment, before the inner core assembly 130 and the catheter assembly 120 in the delivery device 100 move in the human body, the guide wire passing through the first cavity 125 is guided by detection equipment such as X-ray, CT (computed tomography), and ultrasound to reach the target position along the natural cavity, blood vessel or planned path of the human organ, and then the inner core assembly 130 and the catheter assembly 120 are moved to the target position along the guide wire.

[0053] Furthermore, the guidewire tube 124 is provided with an axially penetrating second cavity 126, and the proximal portion of the central steel tube 123 is accommodated within the second cavity 126 and fixed to the guidewire tube 124. Since the proximal portion of the central steel tube 123 is accommodated within the second cavity 126, the outer diameter of the central steel tube 123 is smaller than the diameter of the second cavity 126, that is, the outer diameter of the central steel tube 123 is smaller than the outer diameter of the guidewire tube 124. Thus, by using the distal end of the smaller-diameter central steel tube 123 to load the valve prosthesis, when the distal end of the central steel tube 123 is placed within the sheath 110, the accommodating space between the central steel tube 123 and the sheath 110 is larger, facilitating the accommodation of larger-sized valve prostheses or reducing the difficulty of compressing the valve prosthesis. On the other hand, a slightly larger diameter guidewire tube 124 allows for the installation of more guidewires, enabling the delivery device to have more functions, realizing the release of valve prostheses with special structures, and reducing the types and number of instruments required during valve prosthesis delivery and release.

[0054] In this embodiment, the catheter assembly 120 is further provided with a sealing element (not shown in the figure). The sealing element is located between the proximal end of the central steel tube 123 and the guidewire tube 124 to seal and fix the proximal end of the central steel tube 123 to the guidewire tube 124. It should be noted that in other alternative embodiments, the sealing element may not be provided, as long as the proximal end of the central steel tube 123 can be fixed to the guidewire tube 124.

[0055] Furthermore, the guide wire tube 124 is made of a material with a low coefficient of surface friction. For example, the guide wire tube 124 is made of PEEK (polyether ether ketone) or PTFE (polytetrafluoroethylene). In this way, the frictional resistance experienced by the guide wire tube 124 can be reduced when moving the guide wire tube.

[0056] See also Figure 1 and Figure 3 In this embodiment, the above-mentioned delivery device 100 further includes: a handle assembly 140, which is axially stationary with respect to the inner core assembly 130 or fixed to the proximal end of the inner core assembly 130, and the handle assembly 140 is used to drive the inner core assembly 130 to move; the conduit assembly 120 is located between the distal end of the inner core assembly 130 and the handle assembly 140.

[0057] Thus, when the operator uses the delivery device 100 to deliver the valve prosthesis to the target position on the human body, the operator can operate the handle assembly 140 to move the handle assembly 140 distally, thereby driving the inner core assembly 130 to move distally, so as to drive the sheath 110 fixed to the distal end of the inner core assembly 130 to move distally relative to the catheter assembly 120, thereby realizing the release of the valve prosthesis in the compressed state.

[0058] More specifically, when the operator moves the inner core assembly 130 distally to release the valve prosthesis, to ensure that the sheath 110 moves distally relative to the catheter assembly 120 without displacement of the valve prosthesis mounted on the catheter assembly 120, the catheter assembly 120 can be kept stationary first. To keep the catheter assembly 120 stationary, it can be secured to another positioning device, or the operator can hold the catheter assembly 120 while operating the handle assembly 140, and keep the catheter assembly 120 stationary as the inner core assembly 130 moves distally.

[0059] In this embodiment, the handle assembly 140 is fixed to the proximal end of the inner core 131 of the inner core assembly 130. In an alternative embodiment, the handle assembly 140 is rotatably disposed on the inner core 131 circumferentially, and the handle assembly 140 and the inner core 131 of the inner core assembly 130 remain axially stationary. Thus, the relative rotation of the handle assembly 140 and the inner core 131 prevents the rotation from being transmitted to the sheath 110 when the handle assembly 140 is accidentally rotated, thereby avoiding kinking of the valve prosthesis.

[0060] See also Figure 1 and Figure 3 See also Figure 5 Furthermore, the handle assembly 140 includes a housing 141 and a clamp 142 fixed to the housing 141. The housing 141 is for an operator to hold in order to manipulate the inner core assembly 130, and the clamp 142 is for fixing the housing 141 to the proximal end of the inner core assembly 130 or keeping it axially relative to the proximal end.

[0061] Thus, when the operator uses the delivery device 100 to deliver the valve prosthesis to the target position on the human body, he holds the housing 141 and moves the housing 141 distally, so as to drive the inner core assembly 130 distally through the clamp 142, so as to drive the sheath 110 fixed to the distal end of the inner core assembly 130 to move distally relative to the catheter assembly 120, thereby releasing the valve prosthesis.

[0062] Specifically, the housing 141 has a hollow structure, and a groove 143 is provided inside the housing 141. The clamp 142 is engaged or rotatably disposed within the groove 143, and the clamp 142 is sleeved and fixed to the proximal end of the inner core 131. In this way, the housing 141 and the proximal end of the inner core 131 can be fixed together or kept axially relatively stationary by means of the clamp 142. In addition, since the housing 141 has a hollow structure, the volume of the housing 141 can be increased to increase the area for the operator to hold the housing 141, while ensuring that the weight of the housing 141 is light to facilitate the operator's surgical operations.

[0063] Furthermore, the groove 143 is an annular groove, and the outer edge of the chuck 142 is stepped. The chuck 142 has a first body 144 and a second body 145 connected to the first body 144. The outer diameter of the first body 144 is larger than the outer diameter of the second body 145. The first body 144 is engaged in the groove 143 so that the chuck 142 is at least axially fixed to the housing. Both the first body 144 and the second body 145 are sleeved on the proximal end of the inner core 131 and fixed to the inner core 131. In this way, the contact area between the chuck 142 and the inner core assembly 130 can be increased by the second body 145, thereby increasing the stability of the fixation between the chuck 142 and the inner core assembly 130. In another alternative embodiment, the chuck 142 is a bearing, the outer ring of the bearing is fixedly accommodated in the groove 143, and the inner ring of the bearing is fixedly connected to the proximal end of the inner core 131.

[0064] More specifically, in this embodiment, the housing 141 is an axially through hollow structure, and the inner core assembly 130 passes through the housing 141 and continues to extend towards the proximal end of the conveying device 100. That is, part of the proximal end of the inner core assembly 130 is located inside the hollow structure of the housing 141, and part is located outside the proximal end of the housing 141.

[0065] See also Figures 1 to 6 See also Figures 7 to 10 Embodiment 2 of this application provides a valve prosthesis system, including: a delivery device 100 and a valve prosthesis 200. The delivery device 100 includes a sheath 110, a catheter assembly 120, and an inner core assembly 130. The sheath 110 is sleeved on the distal end of the inner core assembly 130 and is fixedly connected to the inner core assembly 130. The sheath 110 is used to restrain the valve prosthesis 200 in a compressed state. The catheter assembly 120 is movably sleeved on the inner core assembly 130, and the distal end of the catheter assembly 120 is located inside the sheath 110. The distal end of the catheter assembly 120 is loaded with the valve prosthesis 200 in a compressed state. The delivery device 100 is configured such that the inner core assembly 130 is driven to move the sheath 110 distally relative to the catheter assembly 120 to release the valve prosthesis 200 in a compressed state. The valve prosthesis 200 in a compressed state is sleeved on the catheter assembly 120, with a portion of the valve prosthesis 200 located inside the sheath 110 and another portion located outside the sheath 110.

[0066] In fact, the valve prosthesis system provided in Embodiment 2 of this application includes the same delivery device 100 as the delivery device provided in Embodiment 1 above. Therefore, the valve prosthesis system provided in Embodiment 2 of this application includes the same beneficial effects as the delivery device provided in Embodiment 1 above, and will not be described again here.

[0067] Preferably, the valve prosthesis 200 includes a main body 210 and at least one connector 220 fixed to the proximal end of the main body 210. The main body 210 is located inside the sheath 110, and the connector 220 is located outside the sheath 110 and extends from the proximal end of the main body 210 to the distal end.

[0068] Specifically, after the valve prosthesis 200 is implanted, its distal end is closer to the atrium, and its proximal end is closer to the ventricle. During loading, the valve prosthesis 200 is positioned proximal to the sheath 110, with the main body 210 inside the sheath 110 and the connector 220 outside. Thus, after the valve prosthesis 200 is delivered to the target position using the delivery device 100, the inner core assembly 130 drives the sheath 110 to move distally relative to the catheter assembly 120, allowing the valve prosthesis 200 to gradually release until it is completely released from the sheath 110. During this process, since the connector 220 is located outside the sheath 110 and at the proximal end of the sheath 110, if a conventional delivery device is used, the sheath fixedly connected to the outer tube assembly (similar to the catheter assembly in this embodiment) will interfere with the connector 220 of the valve prosthesis 200, causing the valve prosthesis to undergo undesirable displacement. However, in the delivery device of this embodiment, the sheath 110 fixed to the inner core assembly moves distally relative to the catheter assembly 120, and the sheath 110 will not interfere with the connector 220 of the valve prosthesis 200, ensuring that the valve prosthesis will not undergo undesirable displacement during release.

[0069] Furthermore, the valve prosthesis 200 also includes at least one support member 230, which is positioned outside the original leaflet or chordae tendon and constrains the radial expansion of the main body 210 to clamp the original leaflet or chordae tendon together with the main body 210. A connector 220 is connected to the support member 230 to connect the support member 230 to the main body 210.

[0070] Furthermore, the support member 230 is a hollow elastic member, and is arc-shaped in its natural state, forming a generally closed loop through the connector 220. This "generally closed loop" should be understood broadly, meaning that the arrangement of the multiple support members 230 around the main body 210 is sufficient to restrain the radial expansion of the main body 210, rather than narrowly implying that the multiple support members 230 must extend a full circle in the circumference.

[0071] Accordingly, the connector 220 includes two hollow short rods 221 and a connecting body 222 connected to both the main body 210 and the two short rods 221. The number of support members 230 is the same as the number of connectors 220. Each end of the support member 230 is fitted onto a short rod 221. This fitting can be done by fitting each end of the support member 230 onto a short rod 221 of a different connector 220, or by fitting each end of the support member 230 onto a short rod 221 of the same connector 220. This allows the support member 230 to be connected to the main body 210 and restricts the radial expansion of the main body 210. Obviously, the outer diameter of the short rod 221 must be smaller than the inner diameter of the support member 230. To reinforce the relative positional relationship between the two short rods 221 of each connector 220, the connector 220 also includes a reinforcing body 223, the two ends of which are fixedly connected to a short rod 221 respectively.

[0072] In this embodiment, there are two support members 230. The support members 230 are semi-circular in their natural state, and the two support members 230 form a generally circular shape. After the valve prosthesis is implanted, the support member 230 is located outside the original leaflet or chordal tendon, and the main body 210 is located inside the original leaflet or chordal tendon, with the main body 210 subjected to radial force from the support member 230. In other alternative embodiments, there is one support member 230, which forms a generally circular shape in its natural state. In further alternative embodiments, there are three, four, or more support members 230, which are semi-circles with a smaller curvature in their natural state.

[0073] In this embodiment, the valve prosthesis system further includes a guidewire 300; the catheter assembly 120 of the delivery device 100 includes a guidewire tube 124, which has at least two axially penetrating first channels 125 circumferentially, the first channels 125 for accommodating the guidewire 300; the guidewire 300 cooperates with the two first channels 125, two short rods 221, and a support member 230, and the guidewire 300 guides the two short rods 221 to engage with the support member 230. The guidewire 300, as described in the above embodiment, is used to deliver the valve prosthesis 200 along the path of the guidewire 300 to the target position, and also cooperates with the two first channels 125, the two short rods 221, and the support member 230 so that both ends of the support member 230 are respectively engaged with a short rod 221.

[0074] The following example illustrates the operation of the valve prosthesis delivery system of this embodiment, using a valve prosthesis delivery system formed by a valve prosthesis 200 having two guide wires 300, two support members 230, and a delivery device 100 having four first cavities 125 as an example.

[0075] When performing surgery using a valve prosthesis system, a guide wire 300 is first delivered to the human body through a first cavity 125 until the end of the guide wire 300 reaches the vicinity of the mitral valve and the guide wire 300 is arranged to surround the native leaflet of the mitral valve from one side; then a capture device (not shown in the figure) is delivered to the human body through another first cavity 125 and the end of the guide wire 300 is captured, and the guide wire 300 is extended out of the human body through another first cavity 125 where the capture device is located; according to the previous steps, another guide wire 300 is entered into the human body through a first cavity 125 and surrounds the native leaflet of the mitral valve from the other side, and then extends out of the human body through another first cavity 125.

[0076] Then, a support member 230 is fitted onto a guide wire 300, and the support member 230 is delivered to the outer side of the mitral valve's original leaflet along the path of the guide wire 300. For example, the support member 230 can be pushed to the outer side of the mitral valve's original leaflet using a pushing device (not shown in the figure). The delivery device 100 is then removed, leaving the support member 230 and part of the guide wire 300 inside the body. The main body 210 of the valve prosthesis 200 is compressed and loaded onto the distal end of the catheter assembly 120, and the inner core assembly... The component 130 moves the proximal end of the sheath 110 close to and binds the main body 210 of the valve prosthesis 200. The connector 220 of the valve prosthesis 200 is located outside the sheath 110. The two ends of the guide wire 300 are passed through the short rods 221 of the different connectors 220 respectively. The valve prosthesis 200 is delivered to the vicinity of the mitral valve, and the end of the support 230 is sleeved with the short rods 221 of the connector 220. Then the guide wire 300 is withdrawn, and the support 230 returns to its natural state, forming a roughly closed loop. When the end of the support member 230 is sleeved with the short rod 221 of the connector 220, since one end of the guide wire 300 is located in a first cavity 125 and a short rod 221, and the other end is located in another first cavity 125 and another short rod 221, and the two ends of the guide wire 300 are located within the support member 230, when the short rod 221 is moved to the far end by the conveying device 100, the two short rods 221 can move along the path of the guide wire 300 to ensure that the two short rods 221 can be aligned with one end of the support member 230 respectively, thereby facilitating the sleeve of the end of the support member 230 with the short rod 221 of the connector 220.

[0077] Finally, the position and orientation of the valve prosthesis 200 are adjusted to a suitable position. Then, the inner core assembly 130 moves the sheath 110 distally, releasing the main body 210 of the valve prosthesis 200. The main body 210 expands and is constrained by the support member 230. At this time, the valve prosthesis 200 and the original leaflet are better fixed and connected under the combined action of the support member 230 and the expanded main body 210.

[0078] In this embodiment, when the inner core assembly 130 moves the sheath 110 distally to release the main body 210 of the valve prosthesis 200, the sheath 110 moves distally relative to the catheter assembly 120, while the connector 220 of the valve prosthesis 200 is located proximally to the valve prosthesis 200 and extends from the proximal end of the main body 210 to the distal end. Therefore, interference between the sheath 110 and the connector 220 of the valve prosthesis 200 can be avoided during the release of the valve prosthesis by the delivery device 100. After the valve prosthesis 200 is released from the sheath 110, the valve prosthesis 200 loaded at the distal end of the catheter assembly 120 can be changed from a compressed state to a released state by means of balloon or self-inflation. When the valve prosthesis 200, in its compressed state, is mounted on the distal end of the catheter assembly 120, the valve prosthesis 200 and the catheter assembly 120 are fixed together and do not move relative to each other. However, when the valve prosthesis 200 is in its released state, it is released from the fixation of the catheter assembly 120. At this time, the catheter assembly 120 can move relative to the valve prosthesis. Furthermore, throughout the delivery process, the guidewire tube 124 has multiple axially penetrating first cavities 125 circumferentially for the guidewire 300 to pass through. This solves the problem in traditional delivery systems where the guidewire 300 is housed in an inner tube, and the inner tube, due to size limitations, cannot provide multiple channels for the guidewire 300 to pass through. This allows the guidewire 300 to perform more functions than those of traditional delivery devices.

[0079] Those skilled in the art will understand that the above-described embodiments are specific examples of implementing this application, and in practical applications, various changes in form and detail may be made without departing from the spirit and scope of this application. Any person skilled in the art can make their own modifications and alterations without departing from the spirit and scope of this application; therefore, the scope of protection of this application should be determined by the scope defined in the claims.

Claims

1. A valve prosthesis delivery device, characterized in that, include: Sheath, catheter assembly, and inner core assembly; The sheath is sleeved on the distal end of the inner core assembly and is fixedly connected to the inner core assembly. The sheath is used to restrain the valve prosthesis in a compressed state. The catheter assembly is movably fitted onto the inner core assembly, and the distal end of the catheter assembly is located within the sheath. The distal end of the catheter assembly is used to load a valve prosthesis in a compressed state. The delivery device is configured such that the inner core assembly drives the sheath to move distally relative to the catheter assembly to release the compressed valve prosthesis; The valve prosthesis includes: a main body and at least one connector fixed to the proximal end of the main body, the main body being located inside the sheath, and the connector being located outside the sheath and extending from the proximal end of the main body to the distal end; The valve prosthesis further includes: at least one support member, which is disposed outside the original leaflet or chordae tendon and constrains the radial expansion of the main body to clamp the original leaflet or chordae tendon together with the main body; the connector is connected to the support member to connect the support member to the main body. The support member is a hollow elastic member and is arc-shaped in its natural state, forming a generally closed loop through the connector; the connector includes two hollow short rods and a connecting body that is connected to the main body and the two short rods; the number of the support members is the same as the number of the connectors, and the two ends of the support members are respectively sleeved on one of the short rods; The catheter assembly includes: a guidewire tube, the guidewire tube having at least two axially penetrating first cavities circumferentially, the first cavities being used to accommodate a guidewire; a guidewire cooperating with the two first cavities, the two short rods and a support member, the guidewire being used to guide the two short rods to engage with the support member.

2. The conveying device according to claim 1, characterized in that, The catheter assembly includes a cannula and a guide block fixed to the distal end of the cannula. Both the cannula and the guide block are fitted onto the inner core assembly. The distal end of the cannula is used to load a valve prosthesis in a compressed state. The guide block is accommodated in the sheath and used to guide the axial movement of the cannula.

3. The conveying device according to claim 1, characterized in that, Also includes: A handle assembly is provided, which is axially stationary relative to the inner core assembly or fixed to the proximal end of the inner core assembly, and is used to drive the inner core assembly to move; the catheter assembly is located between the distal end of the inner core assembly and the handle assembly.

4. The conveying device according to claim 3, characterized in that, The handle assembly includes: a housing and a clamp fixed to the housing, the housing being for an operator to hold, and the clamp being for fixing the housing to the proximal end of the inner core assembly or keeping it axially relative to the core assembly stationary.

5. The conveying device according to claim 4, characterized in that, The housing is a hollow structure with a groove inside. The clamp is engaged in the groove and is sleeved and fixed to the near end of the inner core assembly.

6. The conveying device according to claim 1, characterized in that, The catheter assembly includes: a central steel tube, a guidewire fixed to the proximal end of the central steel tube, both the central steel tube and the guidewire being sleeved on the inner core assembly, the distal end of the central steel tube being used to load a valve prosthesis in a compressed state, and the guidewire being located at the proximal end of the sheath.

7. The conveying device according to claim 6, characterized in that, The guide wire tube has an axially penetrating second cavity, and the proximal portion of the middle steel tube is accommodated in the second cavity and fixed to the guide wire tube.

8. The conveying device according to claim 1, characterized in that, The inner core assembly includes an inner core tube and an inner steel tube, the inner core tube being located at the distal end of the inner steel tube, at least a portion of the distal end of the inner core tube being accommodated in the sheath tube, and the diameter of the inner core tube being smaller than the diameter of the inner steel tube.

9. A valve prosthesis system, characterized in that, include: The valve prosthesis and the delivery device as described in claim 1, wherein the valve prosthesis in a compressed state is fitted onto the catheter assembly, and a portion of the valve prosthesis is located inside the sheath and another portion is located outside the sheath; The valve prosthesis includes: a main body and at least one connector fixed to the proximal end of the main body, the main body being located inside the sheath, and the connector being located outside the sheath and extending from the proximal end of the main body to the distal end; The valve prosthesis further includes: at least one support member, which is disposed outside the original leaflet or chordae tendon and constrains the radial expansion of the main body to clamp the original leaflet or chordae tendon together with the main body; the connector is connected to the support member to connect the support member to the main body. The support member is a hollow elastic member and is arc-shaped in its natural state, forming a generally closed loop through the connector; the connector includes two hollow short rods and a connecting body that is connected to the main body and the two short rods; the number of the support members is the same as the number of the connectors, and the two ends of the support members are respectively sleeved on one of the short rods; The valve prosthesis system further includes: a guide wire; one of the guide wires cooperates with two first cavities, two short rods and a support member, the guide wire being used to guide the two short rods to engage with the support member.

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