Implanted prosthesis release device and delivery system

Abstract

The invention discloses an implanted prosthesis releasing device and a conveying system, and the implanted prosthesis releasing device comprises a loading assembly which comprises a first loading body and a second loading body, and the first loading body and the second loading body define a loading area; the driving assembly is connected with the first loading body and the second loading body; the axial limiting assembly is used for being in contact with the axial end part of the implanted prosthesis; the restraining assembly is connected with the loading assembly and the axial limiting assembly; when the first loading body and the second loading body move in the axial direction away from each other, the restraining assembly limits the axial displacement of the axial limiting assembly and the implanted prosthesis through a preset restraining relation. According to the restraining assembly, through the preset restraining relation and direct contact between the axial limiting assembly and the end of the implanted prosthesis, axial restraining on the implanted prosthesis is formed, it is ensured that the prosthesis is always located at the preset axis position before being released, when the first loading body and the second loading body move relatively, axial movement of the axial limiting assembly and the implanted prosthesis is limited, and the effect of restraining the implanted prosthesis is achieved. The operation risk is reduced.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to an implant prosthesis releasing device and a delivery system. BACKGROUND

[0002] The implant prosthesis releasing device is a key equipment in the field of minimally invasive intervention medicine, and is widely used in surgical scenarios such as heart valve replacement, vascular stent implantation, and ureteral stricture dilation. Its core function is to deliver the compressed implant prosthesis through the physiological channel of the human body (such as blood vessels and natural cavities) to the target lesion, and then release the radial constraint to make the implant prosthesis self-expand at the lesion site and complete fixation. With the intensification of population aging and the popularization of minimally invasive technology, high requirements are put forward for the release accuracy, delivery stability and operation convenience of the releasing device, especially in high-risk implantation scenarios such as heart valves. A release position deviation of more than 1mm may lead to perivalvular leakage, coronary artery obstruction and other serious complications.

[0003] The existing implant prosthesis releasing device mainly consists of a delivery device and an implant prosthesis, and its release accuracy directly affects the safety of the operation. The delivery device includes a first loading body and a second loading body, which load the implant prosthesis. When the delivery device moves to the target lesion position, the first loading body and the second loading body move to both sides at the same time to release the implant prosthesis, but there are the following defects: The implant prosthesis cannot be released in situ: the implant prosthesis is easy to deviate from the target position in the unconstrained state; High risk of operation: the implant prosthesis may move proximally or distally during the release process. SUMMARY

[0004] Therefore, the present application provides an implant prosthesis releasing device and a delivery system to solve the problems that the existing implant prosthesis releasing device cannot release the implant prosthesis in situ and has high risk of operation.

[0005] In a first aspect, the present application provides an implant prosthesis releasing device, comprising: a loading assembly, the loading assembly comprising a first loading body and a second loading body, the first loading body and the second loading body enclosing a loading area suitable for accommodating and radially constraining the implant prosthesis; a driving assembly, the driving assembly being connected to the first loading body and the second loading body respectively and controlling the movement of the first loading body and the second loading body; an axial limiting assembly, the axial limiting assembly being movably arranged in the loading area along the axial direction and being used to contact the two axial ends of the implant prosthesis; a constraint assembly, the constraint assembly connecting the loading assembly and the axial limiting assembly; When the first carrier and the second carrier move in an axial direction away from each other, the constraint assembly limits axial displacement of the axial limiting assembly and the implant prosthesis through a preset constraint relationship. When the implant prosthesis is released from the radial constraint of the loading area, the implant prosthesis expands radially to achieve release.

[0006] The implant prosthesis release device has the following advantages: the constraint assembly, the direct contact between the axial limiting assembly and the end of the implant prosthesis, and the axial constraint of the implant prosthesis form a preset axial position before release, limit the axial movement of the axial limiting assembly and the implant prosthesis during relative movement of the first carrier and the second carrier, avoid dysfunction of the implant prosthesis caused by release position deviation, and when the implant prosthesis is a heart valve prosthesis, the valve can be released in situ in the target area, increase the accuracy of the release position, eliminate the possibility of valve movement or flying during release, avoid problems such as blocking of coronary artery openings and perivalvular leakage, and reduce the risk of surgery.

[0007] In an alternative embodiment, the first carrier and the second carrier move in an axial direction away from each other, including: The first carrier and the second carrier simultaneously move in an axial direction away from each other; Or, the first carrier moves distally first, and then the second carrier moves proximally; Or, the second carrier moves proximally first, and then the first carrier moves distally.

[0008] In an alternative embodiment, the constraint assembly includes at least one flexible connector; The preset constraint relationship is that the flexible connector is connected between the first carrier and the axial limiting assembly, and the length of the flexible connector is configured to match the preset movement stroke of the first carrier; and / or, the flexible connector is connected between the second carrier and the axial limiting assembly, and the length of the flexible connector is configured to match the preset movement stroke of the second carrier.

[0009] The beneficial effects of the above technical solutions are: the matching design of the flexible connecting piece in the constraint assembly and the step-by-step moving stroke of the loading body, the flexible connecting piece is in a tension state after the first moving loading body (the first loading body or the second loading body) moves to the preset stroke and is fixed, which is converted into a rigid support fulcrum of the axial limiting assembly, when the second moving loading body moves, the support fulcrum can provide a reverse support force to offset the pulling tendency of the second moving loading body on the axial limiting assembly, realizing the axial zero displacement of the limiting assembly in the whole release process, thereby ensuring high-precision positioning of the implanted prosthesis, avoiding the cumulative error of step-by-step movement, and improving the operation fault tolerance and operation safety.

[0010] In an optional embodiment, the axial limiting assembly comprises: a first limiting piece, the first limiting piece is arranged in the loading area; a second limiting piece, the second limiting piece is arranged in the loading area; The first limiting piece and the second limiting piece form an implanted prosthesis limiting area for axially limiting the implanted prosthesis.

[0011] In an optional embodiment, the flexible connecting piece comprises at least two flexible connecting pieces, respectively: a first flexible connecting piece, the first flexible connecting piece connects the first loading body and the second limiting piece, and the axial length of the first flexible connecting piece is equal to the maximum forward stroke of the first loading body moving to the distal end; a second flexible connecting piece, the second flexible connecting piece connects the second limiting piece and the driving assembly or the second loading body, and the axial length of the second flexible connecting piece is equal to the maximum stroke of the second loading body moving to the proximal end.

[0012] The beneficial effects of the above technical solutions are: the independent length precise matching of the first flexible connecting piece and the second flexible connecting piece in the double flexible connecting piece design realizes the bidirectional constraint of the second limiting piece: When the first loading body moves to the preset stroke to the distal end, the first flexible connecting piece is tensioned, and when the second loading body moves to the proximal end, the first loading body is taken as a fulcrum to inhibit the second limiting piece from following; When the second loading body moves to the preset stroke to the proximal end, the second flexible connecting piece is tensioned and takes the driving assembly / second loading body as a fulcrum to offset the pulling tendency of the first loading body on the second limiting piece.

[0013] The first flexible connecting piece and the second flexible connecting piece cooperatively ensure the axial zero displacement of the second limiting piece in the whole moving process of the first loading body and the second loading body, and completely eliminate the cumulative error of step-by-step movement.

[0014] In an optional embodiment, the first flexible connecting piece and the second flexible connecting piece are located on both sides of the central axis of the loading assembly.

[0015] The beneficial effects of the above technical solution are as follows: when the carrier moves, the connecting parts on both sides transmit the supporting force from both sides of the axis, thereby avoiding the second limiting part of the axial limiting component from shifting laterally due to the force on one side.

[0016] In one alternative embodiment, the first limiting member and the second limiting member are rigidly connected; or, the first limiting member and the second limiting member are flexibly connected.

[0017] In one optional embodiment, when the first limiting member and the second limiting member are flexibly connected, the first limiting member and the second limiting member are connected by a third flexible connector, the axial length of which is equal to the axial length of the implanted prosthesis.

[0018] The beneficial effects of the above technical solution are as follows: When the implanted prosthesis is in the loading state, the axial length of the third flexible connector is precisely matched with the axial dimension of the implanted prosthesis, so that the first limiting member and the second limiting member are stably abutted against the two ends of the axial direction of the implanted prosthesis, forming a reliable axial limit and preventing the implanted prosthesis from axially moving within the loading assembly; when the implanted prosthesis gradually expands radially during the release process, the third flexible connector, due to its flexible characteristics, can adaptively deform synchronously with the expansion of the implanted prosthesis, allowing the first limiting member and the second limiting member to generate appropriate relative movement. This ensures that the radial expansion of the implanted prosthesis is not hindered due to the axial distance between the first limiting member and the second limiting member being too short, nor is it caused by the axial distance between the first limiting member and the second limiting member being too long, causing them to leave the constraint range of the implanted prosthesis, thus ensuring that the implanted prosthesis can smoothly detach from the position of the axial limiting assembly.

[0019] In one alternative implementation, the flexible connector is a single-strand or multi-strand connector.

[0020] In one alternative embodiment, the inner wall of the first loading body and / or the second loading body is provided with a wire groove along the axial direction, and the flexible connector is accommodated in the wire groove.

[0021] The beneficial effects of the above technical solution are as follows: The axial guide groove design on the inner wall of the first and / or second loading bodies accommodates the flexible connector, achieving precise guidance and spatial constraint of the flexible connector through physical limiting. The groove structure restricts the flexible connector within a preset axial path, preventing it from entangled, crossing, or squeezed with other components of the loading assembly due to radial offset during loading or release, thus avoiding interference and ensuring that the connector always moves linearly along the axial direction. Simultaneously, it avoids frictional damage caused by exposed flexible connectors and unintended contact with the implanted prosthesis, protecting its structural integrity. Furthermore, the directional accommodation design optimizes the internal spatial layout of the loading body, reducing the space occupied by the flexible connector in the loading area.

[0022] In one optional embodiment, the first limiting member is a stepped limiting member, and the outer diameter of the proximal end of the first limiting member is larger than the outer diameter of the distal end of the first limiting member. And / or, the second limiting member is a stepped limiting member, and the outer diameter of the distal end of the second limiting member is greater than the outer diameter of the proximal end of the second limiting member.

[0023] In one optional embodiment, both the first loading carrier and the second loading carrier are hollow tubes. The side of the first loading carrier closer to the second loading body is a first loading sub-region, and the side of the second loading carrier closer to the first loading body is a second loading sub-region. When the first loading carrier and the second loading carrier are docked, the first loading sub-region and the second loading sub-region enclose each other to form the loading area.

[0024] In one alternative embodiment, the inner diameters of the tubes of the first loading body and the second loading body are different.

[0025] The beneficial effects of the above technical solution are as follows: the constraint force between the loading carrier with a large inner diameter and the axial limiting component is small, while the constraint force between the loading carrier with a small inner diameter and the axial limiting component is large. Therefore, when the implanted prosthesis is released by moving the loading carriers separately, the loading carrier with a large inner diameter is moved first, and the axial limiting component is limited by the loading carrier with a small inner diameter. Then the loading carrier with a small inner diameter is moved, so that the implanted prosthesis can gradually leave the loading area in a preset axial sequence.

[0026] In one optional embodiment, the first loading carrier is located at the distal end of the second loading body, and the inner diameter of the tube of the first loading body is larger than the inner diameter of the tube of the second loading body; as the first loading carrier moves distally, the second loading carrier constrains the axial limiting component and the implanted prosthesis to limit the axial displacement of the axial limiting component and the implanted prosthesis.

[0027] The beneficial effects of the above technical solution are as follows: When the first loading body moves distally, the constraint on the axial limiting component from the second loading body is greater than the pulling force from the first loading body. Therefore, it will not slide distally synchronously with the first loading body, but will remain in a relatively fixed state with the second loading body. At the same time, the side of the implanted prosthesis closest to the second loading body is also restricted to its original loading position due to its fit with the axial limiting component, avoiding the situation where it is accidentally pulled away from the second loading body due to the movement of the first loading body, thus fundamentally eliminating the intraoperative risk of the implanted prosthesis being unable to be released.

[0028] In one optional embodiment, the inner cavity of the tube of the second loading body has a constant diameter and wall thickness structure; Alternatively, the inner cavity of the tube of the second loading body is a conical structure in which the inner diameter gradually decreases from the distal end to the proximal end.

[0029] In one alternative embodiment, the drive assembly includes a first catheter and a second catheter; the second catheter is connected to the proximal end of the second loading body; the first catheter passes through the second catheter, the axial limiting assembly and the implanted prosthesis, and is connected to the first loading body, and the first catheter is axially slidable relative to the second catheter.

[0030] In one alternative embodiment, the implanted prosthesis is a tubular implanted prosthesis.

[0031] In a second aspect, the present invention provides a conveying system, comprising: Implantable prosthesis release device; A sheath, the sheath being disposed around the implanted prosthesis release device; A control handle is connected to both the implanted prosthesis release device and the proximal end of the sheath.

[0032] In one optional embodiment, the movement of the first loading carrier and the second loading body is controlled by the control handle, which has a first state and a second state. When the control handle is in the first state, the first loading carrier and the second loading carrier can move synchronously along the axial direction. When the control handle is in the second state, the first loading carrier and the second loading carrier can move independently along the axial direction. Attached Figure Description

[0033] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0034] Figure 1 This is a schematic diagram of the structure of an implantable prosthesis release device provided by the present invention; Figure 2 A schematic diagram of the structure of the first and second carriers in the implantable prosthesis release device provided by the present invention during the closure process; Figure 3 This is a schematic diagram of the structure of an implantable prosthesis release device provided by the present invention when the first carrier is moved distally; Figure 4 This is a schematic diagram of the structure of the first carrier in the implantable prosthesis release device provided by the present invention when it is detached from the implantable prosthesis; Figure 5 A schematic diagram of the structure of an implantable prosthesis release device provided by the present invention when both the first carrier and the second carrier are detached from the implantable prosthesis; Figure 6 This is a schematic diagram of the structure of the second carrier in an implantable prosthesis release device provided by the present invention; Figure 7 This is a schematic diagram of the structure of an implanted prosthesis in an implanted prosthesis release device provided by the present invention; Figure 8 This is a schematic diagram of a conveying system provided by the present invention.

[0035] Explanation of reference numerals in the attached figures: 1. First mounting carrier; 2. Second mounting carrier; 3. First limiting member; 4. Second limiting member; 5. First catheter; 6. Second catheter; 7. First flexible connector; 8. Second flexible connector; 9. Third flexible connector; 10. Implanted prosthesis release device; 11. Sheath; 12. Control handle; 13. Spring; 14. Implanted prosthesis. Detailed Implementation

[0036] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0037] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the term "distal" generally refers to the end of the medical implant furthest from the operator; "proximal," the opposite of "distal," refers to the end of the medical implant closer to the operator; the term "radial" refers to a direction perpendicular to the axis of the medical implant; and the term "axial" refers to a direction along the axis of the medical implant. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0038] In the description of this invention, "implantable prosthesis" refers to a tubular or tubular prosthesis that is implanted into the body via a delivery system, has an extended structure, and requires end-capsulation for precise release. The implantable prosthesis can be a heart valve prosthesis or a vascular stent, such as a peripheral vascular stent or a neurointerventional stent.

[0039] The following is combined with Figures 1 to 8 The specific embodiments of the present invention will be described in detail with reference to the implantable prosthesis release device of the first aspect and the delivery system of the second aspect.

[0040] According to an embodiment of the present invention, in a first aspect, an implantable prosthesis release device is provided, combined with Figures 1 to 7 As shown, the device includes a loading assembly, a driving assembly, an axial limiting assembly, and a constraint assembly. The loading assembly includes a first loading carrier 1 and a second loading carrier 2, with the first loading carrier 1 located at the distal end of the second loading carrier 2. The first loading carrier 1 and the second loading carrier 2 together form a loading area suitable for accommodating and radially constraining the implanted prosthesis. The driving assembly is connected to and controls the movement of the first loading carrier 1 and the second loading carrier 2. The axial limiting assembly is axially movable within the loading area and is used to contact the two axial ends of the implanted prosthesis. The constraint assembly connects the loading assembly and the axial limiting assembly. When the first loading carrier 1 and the second loading carrier 2 move axially away from each other, the constraint assembly limits the axial displacement of the axial limiting assembly and the implanted prosthesis through a preset constraint relationship. When the implanted prosthesis is released from the radial constraint of the loading area, the implanted prosthesis expands radially to achieve release.

[0041] It should be noted that the movement of the first mounting carrier 1 and the second mounting carrier 2 in an axial direction away from each other means that: the first mounting carrier 1 and the second mounting carrier 2 move simultaneously in an axial direction away from each other; or the first mounting carrier 1 moves to the distal end first, and then the second mounting carrier 2 moves to the proximal end; or the second mounting carrier 2 moves to the proximal end first, and then the first mounting carrier 1 moves to the distal end.

[0042] Combination Figure 7As shown, the implant is a tubular implant with both a contracted and an expanded state. During delivery, the implant is in the contracted state and contained within the loading area of ​​the loading assembly. After release, the implant automatically expands under its own elasticity.

[0043] The aforementioned implant release device achieves zero-offset positioning of the implant through a dual constraint mechanism of axial limiting components and constraint components, thus solving the problem of implants failing to be released in situ. The axial limiting component is axially movable within the loading area and directly contacts the axial end of the implanted prosthesis, forming a mechanical limit that clamps both ends. When the first mounting carrier 1 and the second mounting carrier 2 move away from each other, the axial limiting component, through rigid contact with the end of the implanted prosthesis 14, prevents the implanted prosthesis 14 from axially shifting as it moves with the first mounting carrier 1 and the second mounting carrier 2. For example, when the second mounting carrier 2 moves proximally to release the radial constraint on the implanted prosthesis, the axial limiting component, under the action of the limiting component, remains in contact with the outlet end of the implanted prosthesis, ensuring that the implanted prosthesis only releases the radial constraint and does not undergo axial displacement, remaining in its initial positioning position even after completely leaving the loading area.

[0044] The constraint component connects the loading component and the axial limiting component. The length of the constraint component is precisely matched with the relative movement stroke of the first loading carrier 1 and / or the movement stroke of the second loading carrier 2 and / or the axial length of the implanted prosthesis, forming a preset constraint relationship. During the release of the implanted prosthesis, the constraint component limits the movement distance of the axial limiting component through the preset constraint relationship, ensuring that the axial position of the implanted prosthesis remains unchanged as the radial constraint is gradually released, thereby achieving in-situ release of the implanted prosthesis.

[0045] The aforementioned implant release device can prevent the implant from shifting during release, thus improving surgical safety. The drive assembly can independently and / or simultaneously control the movement of the first carrier 1 and the second carrier 2, and can adjust the release process according to surgical needs, making it particularly suitable for valve replacement scenarios with complex anatomical structures such as the aortic valve and mitral valve.

[0046] The aforementioned implant release device replaces the reliance on operator experience in traditional devices with a preset constraint relationship of the constraint component. The operator only needs to control the loading component to move to the preset stroke by driving the component, and then release the implant to accurately position the implant to the target location.

[0047] In addition to being used in heart valve prostheses, the aforementioned implantable prosthesis release device can also be adapted to tubular implantable prostheses such as vascular stents, peripheral vascular stents, neurointerventional stents, or ureteral stents by adjusting the size of each component.

[0048] In some embodiments, the constraint component includes at least one flexible connector, which can be precisely matched with the travel distance of the loading component by a preset length. The preset constraint relationship is as follows: A flexible connector is connected between the first mounting carrier 1 and the axial limiting component. The length of the flexible connector is configured to match the preset travel distance of the first mounting carrier 1. When the implanted prosthesis is released by moving the first mounting carrier 1 distally and then the second mounting carrier 2 proximally, after the first mounting carrier 1 moves distally to the preset travel distance and is fixed in position, the flexible connector is in a tensioned state. When the second mounting carrier 2 moves proximally, the second mounting carrier 2 tends to pull the axial limiting component proximally. At this time, the axial limiting component transmits this pulling force to the first mounting carrier 1 through the flexible connector. The first mounting carrier 1 can provide support force, thereby inhibiting the axial limiting component from following the second mounting carrier 2 proximally, so as to limit the axial displacement of the axial limiting component when the first mounting carrier 1 and the second mounting carrier 2 move away from each other.

[0049] And / or, a flexible connector is connected between the second mounting carrier 2 and the axial limiting component, and the length of the flexible connector is configured to match the preset travel distance of the second mounting carrier 2. When the implanted prosthesis is released by moving the second mounting carrier 2 proximally first and then the first mounting carrier 1 distally, the flexible connector is in a tensioned state after the second mounting carrier 2 moves proximally to the preset travel distance and is fixed in position. Similarly, when the first mounting carrier 1 moves distally, the second mounting carrier 2 can provide support force, thereby inhibiting the axial limiting component from following the first mounting carrier 1 proximally, so as to limit the axial displacement of the axial limiting component when the first mounting carrier 1 and the second mounting carrier 2 move away from each other.

[0050] In this embodiment, the matching design of the flexible connector and the step-by-step movement stroke of the restraint component allows the flexible connector to be tensioned after the first moving carrier (first carrier or second carrier) moves to the preset stroke and is fixed, thus transforming it into a rigid support fulcrum for the axial limiting component. When the subsequent moving carrier moves, this support fulcrum can provide a reverse support force to counteract the pulling tendency of the subsequent moving carrier on the axial limiting component, achieving zero axial displacement of the limiting component throughout the entire release process. This ensures high-precision positioning of the implanted prosthesis, avoids the cumulative error of step-by-step movement, and improves the surgical error tolerance and operational safety.

[0051] In some embodiments, the axial limiting component includes a first limiting member 3 and a second limiting member 4. The first limiting member 3 is disposed in the loading area, and the second limiting member 4 is disposed in the loading area. When the implanted prosthesis is in the loading state, the first limiting member 3 is located inside the first loading carrier 1, and the second limiting member 4 is located inside the second loading carrier 2; when the implanted prosthesis is in the release state, the first limiting member 3 disengages from the first loading carrier 1, and the second limiting member 4 disengages from the second loading carrier 2. The first limiting member 3 and the second limiting member 4 form an implanted prosthesis limiting area for axial limiting of the implanted prosthesis. Compared with the single-end limiting or no active limiting form in the prior art, the dual limiting members lock the implanted prosthesis on the central axis of the loading area through rigid contact with both ends of the implanted prosthesis, achieving zero axial displacement and reducing the positioning error before release.

[0052] In some embodiments, the flexible connector includes at least two flexible connectors, namely a first flexible connector 7 and a second flexible connector 8. The first flexible connector 7 connects the first mounting carrier 1 and the second limiting member 4, and the axial length of the first flexible connector 7 is equal to the maximum forward travel of the first mounting carrier 1 towards the distal end. The second flexible connector 8 connects the second limiting member 4 and the drive assembly or the second mounting carrier 2, and the axial length of the second flexible connector 8 is equal to the maximum travel of the second mounting carrier 2 towards the proximal end.

[0053] In this embodiment, the dual flexible connector design achieves bidirectional constraint on the second limiting member by precisely matching the independent lengths of the first flexible connector 7 (matching the maximum forward stroke of the first mounting carrier) and the second flexible connector 8 (matching the maximum proximal stroke of the second mounting carrier). When the first mounting carrier 1 moves to the far end to the preset stroke, the first flexible connector 7 is tensioned. When the second mounting carrier 2 moves to the near end, the second limiting member 4 is suppressed to follow the movement by using the first mounting carrier 1 as the fulcrum. When the second mounting carrier 2 moves to the pre-set stroke, the second flexible connector 8 is tensioned and uses the drive assembly / second mounting carrier as a fulcrum to counteract the pulling tendency of the first mounting carrier 1 on the second limiting member 4.

[0054] The first flexible connector 7 and the second flexible connector 8 work together to ensure that the second limiting member 4 has zero axial displacement during the entire movement of the first mounting carrier 1 and the second mounting carrier 2, thus completely eliminating the cumulative error of step-by-step movement.

[0055] In some embodiments, the first flexible connector 7 and the second flexible connector 8 are located on both sides of the central axis of the loading assembly. They can apply a balanced bidirectional tensile force to the axial limiting assembly through a symmetrical or asymmetrical layout, forming a two-sided constraint mechanism: when the loading body moves, the two connectors transmit support force from both sides of the axis, preventing the second limiting member 4 of the axial limiting assembly from lateral displacement (such as radial tilting or rotation) due to unilateral force, and ensuring that it always remains axially stationary along the central axis.

[0056] In some embodiments, the first limiting member 3 and the second limiting member 4 are rigidly connected to form a stable integrated structure, ensuring that the bidirectional constraint force transmitted by the first flexible connector 7 and the second flexible connector 8 can act synchronously on the entire axial limiting assembly.

[0057] Alternatively, the first limiting member 3 and the second limiting member 4 can be flexibly connected.

[0058] Regardless of whether the first limiting member 3 and the second limiting member 4 are rigidly or flexibly connected, when the implanted prosthesis is in the loading state, the positions of the first limiting member 3 and the second limiting member 4 in the loading area remain unchanged.

[0059] When the first limiting member 3 and the second limiting member 4 are flexibly connected, the first limiting member 3 and the second limiting member 4 are connected by a third flexible connector 9, and the axial length of the third flexible connector 9 is equal to the axial length of the implanted prosthesis.

[0060] When the implanted prosthesis is in the loading state, the axial length of the third flexible connector 9 is precisely matched with the axial dimension of the implanted prosthesis, so that the first limiting member 3 and the second limiting member 4 are stably abutted against the two ends of the implanted prosthesis, forming a reliable axial limit and preventing the implanted prosthesis from axially moving within the loading assembly. When the implanted prosthesis gradually expands radially during the release process, the first limiting member 3 and the second limiting member 4 are allowed to have moderate relative movement. This ensures that the radial expansion of the implanted prosthesis is not hindered by the axial distance between the first limiting member 3 and the second limiting member 4 being too short, nor is it caused by the axial distance between the first limiting member 3 and the second limiting member 4 being too long, causing them to leave the constraint range of the implanted prosthesis. This ensures that the implanted prosthesis can smoothly detach from the position of the axial limiting assembly.

[0061] In some embodiments, the flexible connector is a single-strand or multi-strand connecting wire, achieving effective connection without increasing the outer diameter of the existing device. Single-strand connecting wires offer good flexibility and structural simplicity, making them suitable for scenarios with low constraint force requirements and frequent bending. Multi-strand connecting wires, through their twisted design, enhance overall strength and fracture resistance, making them more suitable for the first flexible connector 7 and the second flexible connector 8, which require the transmission of stable bidirectional constraint forces. This effectively addresses the complex mechanical environment during implant release, ensuring consistent force transmission.

[0062] In some embodiments, the inner wall of the first mounting carrier 1 and / or the second mounting carrier 2 is provided with a wire groove along the axial direction, and the flexible connector is accommodated in the wire groove.

[0063] In this embodiment, the axial guide groove design on the inner wall of the first mounting carrier 1 and / or the second mounting carrier 2 for accommodating the flexible connector can achieve precise guidance and spatial constraint of the flexible connector through physical limiting: the groove structure of the guide groove can restrict the flexible connector within a preset axial path, preventing it from getting entangled, crossing or squeezing with other parts of the loading assembly due to radial offset during loading or release, avoiding interference, and ensuring that the connector always moves linearly along the axial direction; at the same time, it can avoid friction damage caused by the exposure of the flexible connector and unexpected contact with the implanted prosthesis, protecting its structural integrity; in addition, the directional accommodating design can also optimize the internal space layout of the mounting carrier and reduce the occupation of the loading area by the flexible connector.

[0064] In some embodiments, the first loading carrier 1 and the second loading carrier 2 are both hollow tubes. The side of the first loading carrier 1 closest to the second loading carrier 2 is a first loading sub-region, and the side of the second loading carrier 2 closest to the first loading carrier 1 is a second loading sub-region. When the first loading carrier 1 and the second loading carrier 2 are docked, the first loading sub-region and the second loading sub-region enclose each other to form a loading area.

[0065] In some embodiments, the inner diameters of the first mounting carrier 1 and the second mounting carrier 2 are different. The mounting carrier with a larger inner diameter has a smaller constraint force with the axial limiting component, while the mounting carrier with a smaller inner diameter has a larger constraint force with the axial limiting component. Thus, when the implanted prosthesis is released by moving the mounting carriers separately, the mounting carrier with a larger inner diameter is moved first, and the axial limiting component is limited by the mounting carrier with a smaller inner diameter. Then, the mounting carrier with a smaller inner diameter is moved, so that the implanted prosthesis can gradually leave the loading area in a preset axial sequence.

[0066] Specifically, when the first mounting carrier 1 (assuming the first mounting carrier 1 is a large-diameter tube) is moved away from the second mounting carrier 2, the first mounting carrier 1 can slide smoothly relative to the axial limiting component due to the small constraint force between it and the axial limiting component. However, the second mounting carrier 2 (a small-diameter tube) can stably restrict the axial position of the axial limiting component due to the high constraint force between it and the axial limiting component. At this time, the side of the implanted prosthesis closest to the first mounting carrier 1 will be released from the constraint of the first mounting carrier 1 first. After the first mounting carrier 1 moves to the preset initial release position, the second mounting carrier 2 is moved away from the first mounting carrier 1. At this time, the axial limiting component loses the strong constraint from the second mounting carrier 2 and can gradually release the restriction on the side of the implanted prosthesis closest to the second mounting carrier 2 as the second mounting carrier 2 moves, so that the remaining part of the implanted prosthesis can be smoothly removed from the loading area. This step-by-step release sequence design utilizes the constraint force gradient caused by the difference in the inner diameter of the tube to ensure the controllability of the implanted prosthesis release, prevent the flexible connector from undergoing unexpected displacement or pulling due to the step-by-step release of the implanted prosthesis, and further ensure the structural integrity and functional reliability of the flexible connector.

[0067] If the first carrier 1 moves distally, it may cause the implanted prosthesis to move distally away from the second carrier 2, resulting in the implanted prosthesis being unable to be released and causing significant intraoperative risks. To solve this technical problem, as a preferred embodiment, the inner diameter of the tube of the first carrier 1 is larger than the inner diameter of the tube of the second carrier 2; when the first carrier 1 moves distally, the second carrier 2 constrains the axial limiting component and the implanted prosthesis to limit their axial displacement.

[0068] Specifically, the smaller inner diameter of the second mounting carrier 2 allows for a tighter interference fit or contact compression with the outer circumferential surface of the axial limiting component. The axial constraint force between them is significantly higher than that between the first mounting carrier 1 and the axial limiting component. This difference in constraint force creates a stable constraint gradient. When the first mounting carrier 1 moves distally, the constraint on the axial limiting component from the second mounting carrier 2 is greater than the pulling force from the first mounting carrier 1. Therefore, it does not slide distally with the first mounting carrier 1 but remains relatively fixed with the second mounting carrier 2. Simultaneously, the side of the implanted prosthesis closest to the second mounting carrier 2 is also confined to its original loading position due to its close contact with the axial limiting component. This prevents the implanted prosthesis from being accidentally pulled away from the second mounting carrier 2 due to the movement of the first mounting carrier 1, fundamentally eliminating the intraoperative risk of the implanted prosthesis being unable to be released.

[0069] In some embodiments, the inner cavity of the second mounting carrier 2 is a constant diameter and wall thickness structure. For a constant diameter and wall thickness structure, the diameter and wall thickness of the inner cavity remain constant along the axial direction, so that the constraint strength of the second mounting carrier 2 on the axial limiting component is uniform and consistent. When the second mounting carrier 2 moves away from the first mounting carrier 1, the contact state between the axial limiting component and the inner wall of the second mounting carrier 2 is stable, and the constraint release process is uniform and controllable. This avoids the impact caused by the sudden change in constraint when the remaining part of the implanted prosthesis is dislodged, ensuring the smoothness of the release. The inner cavity of the second mounting carrier 2 can be cylindrical, polygonal, or conical. When the inner cavity of the second mounting carrier 2 is polygonal, it is preferably rhomboid.

[0070] As an alternative embodiment, the inner cavity of the tube of the second carrier 2 is a tapered structure with an inner diameter that gradually decreases from the distal end to the proximal end. The tapered structure creates a predictable constraint force gradient through the gradual change in inner diameter from the distal end to the proximal end. When the second carrier 2 moves towards the proximal end, the axial limiting component slides out gradually along the inner wall of the tapered structure. The constraint force decreases linearly as the inner diameter decreases, and the release force at each step meets the design expectations, further improving the accuracy of step-by-step release.

[0071] In some embodiments, the inner cavity of the tube of the first mounting carrier 1 is a structure with equal diameter and wall thickness. The inner cavity of the tube of the first mounting carrier 1 can be cylindrical, polygonal or conical. When the inner cavity of the tube of the first mounting carrier 1 is polygonal, it is preferably rhomboid.

[0072] As an alternative embodiment, the inner cavity of the tube of the first carrier 1 may also be conical.

[0073] In some embodiments, the outer diameter of the distal end of the first carrier 1 gradually increases from the distal end to the proximal end. More specifically, the distal end of the first carrier 1 is configured as a cone shape to facilitate movement within the blood vessel. The first limiting member 3 is a stepped limiting member, and the outer diameter of the proximal end of the first limiting member 3 is larger than the outer diameter of the distal end of the first limiting member 3, so that the distal end of the first limiting member 3 can match the first limiting groove of the distal end of the first carrier 1.

[0074] The outer diameter of the proximal end of the second mounting carrier 2 gradually decreases from the distal end to the proximal end. More specifically, the proximal end of the second mounting carrier 2 is set in a conical shape. The second limiting member 4 is a stepped limiting member. The outer diameter of the distal end of the second limiting member 4 is larger than the outer diameter of the proximal end of the second limiting member 4, so that the proximal end of the second limiting member 4 can match the second limiting groove of the proximal end of the second mounting carrier 2.

[0075] In some embodiments, a spring 13 is provided at the distal end of the inner cavity of the first mounting carrier 1. When the first mounting carrier 1 and the second mounting carrier 2 abut against each other, the axial limiting component and the implanted prosthesis are housed within the loading area. The axial limiting component compresses the spring 13, and the spring 13, under the action of elastic force, presses against the first limiting member 3 of the axial limiting component. Consequently, the first limiting member 3 generates an axial compressive force on the implanted prosthesis, clamping the implanted prosthesis axially. Simultaneously, when the first mounting carrier 1 moves distally, the arranged spring 13 expands, still generating a certain compressive force on the first limiting member 3 of the axial limiting component, thus ensuring that the axial limiting component and the implanted prosthesis remain in the same position. When the spring 13 no longer contacts the first limiting member 3 of the axial limiting component, it no longer generates a compressive force on the first limiting member 3 of the axial limiting component.

[0076] In some embodiments, the driving assembly includes a first catheter 5 and a second catheter 6, which can be tubes of equal diameter. The second catheter 6 is connected to the proximal end of the second carrier 2. The first catheter 5 passes through the second catheter 6, the axial limiting assembly, and the implanted prosthesis, and is connected to the first carrier 1. The first catheter 5 can slide axially relative to the second catheter 6. The first catheter 5 has a first guidewire hole inside, and correspondingly, the distal end of the first carrier 1 has a second guidewire hole. The guidewire can pass through the first guidewire hole and the second guidewire hole and extend out from the second guidewire hole. The guidewire can drive the entire implanted prosthesis release device to move within the blood vessel.

[0077] The following example, using a device with three flexible connectors (a first flexible connector 7, a second flexible connector 8, and a third flexible connector 9), illustrates the process of releasing the implanted prosthesis 14 using the aforementioned implant release device: The implanted prosthesis 14 is compressed and installed in the loading area of ​​the loading assembly in ice water, and the first loading carrier 1 and the second loading carrier 2 are closed, specifically as follows: Figure 2 As shown. At this time, the first flexible connector 7 and the second flexible connector 8 are completely relaxed, and the third flexible connector 9 is straightened due to the axial support of the implanted prosthesis.

[0078] After the implanted prosthesis is loaded, the delivery system moves along the guidewire to the target area, ready to release the implanted prosthesis: keeping the second carrier 2 stationary, the first carrier 1 is moved distally via the first catheter 5, specifically as follows: Figure 3As shown, when the first mounting carrier 1 moves distally, if the implanted prosthesis and the first limiting member 3 tend to move distally due to the movement of the first mounting carrier 1, the third flexible connector 9 will pull the proximal second limiting member 4, causing it to move distally. At this time, the smaller inner cavity of the second mounting carrier 2 generates greater friction on the implanted prosthesis, further restricting the second limiting member 4 from moving distally. Ultimately, this indirectly tightens the first limiting member 3, preventing it from moving distally with the first mounting carrier 1. Simultaneously, as the first mounting carrier 1 gradually moves distally, the first flexible connector 7 gradually straightens from a relaxed state. At this point, the implanted prosthesis is positioned by the first limiting member 3 and the second limiting member 4, remaining stationary.

[0079] After the first carrier 1 moves to its maximum stroke at the distal end, it remains stationary. At this time, the first flexible connector 7 is straightened. Specifically... Figure 4 As shown.

[0080] The second implantation carrier 2 moves proximally under the traction of the second catheter 6. At this time, the second limiting member 4 is fixedly connected to the first implantation carrier 1 through the first flexible connector 7, thus remaining stationary and restricting the implanted prosthesis from moving proximally with the second implantation carrier 2. As the second implantation carrier 2 moves proximally, the implanted prosthesis is gradually released. When the second implantation carrier 2 reaches its maximum proximal position, the third flexible connector 9 is straightened, completing the release of the implanted prosthesis, as detailed below. Figure 5 As shown.

[0081] The aforementioned implant release device offers the following overall advantages: It enables in-situ release of the implant within the target area, increasing the accuracy of the release location. It eliminates the possibility of the implant shifting towards or proximally during release, reducing surgical risks. It achieves its design goals without increasing the distal diameter of existing devices. It achieves its design goals without adding any additional operational requirements based on existing release procedures. It eliminates the risk of the implant failing to open, ensuring that the implant can definitely be released.

[0082] According to an embodiment of the present invention, in a second aspect, a conveying system is provided, in conjunction with Figure 8 As shown, the device includes an implantable prosthesis release device 10, a sheath 11, and a control handle 12. The sheath 11 is located around the implantable prosthesis release device. The control handle 12 is connected to the proximal ends of both the implantable prosthesis release device 10 and the sheath 11.

[0083] The movement of the first carrier 1 and the second carrier 2 is controlled by the control handle 12, which has a first state and a second state. When the control handle 12 is in the first state, the first conduit 5 is connected to the second conduit 6 so that the first carrier 1 and the second carrier 2 can move synchronously along the axial direction. When the control handle 12 is in the second state, the first conduit 5 is separated from the second conduit 6 so that the first carrier 1 and the second carrier 2 can move relative to each other along the axial direction.

[0084] Although embodiments of the invention have been described in conjunction with the accompanying drawings, those skilled in the art can make various modifications and variations without departing from the spirit and scope of the invention, and such modifications and variations all fall within the scope defined by the appended claims.

Claims

1. An implantable prosthesis release device, characterized in that, include: The loading assembly includes a first loading carrier (1) and a second loading carrier (2), wherein the first loading carrier (1) and the second loading carrier (2) enclose a loading area suitable for accommodating the implanted prosthesis and radially constraining the implanted prosthesis; A drive assembly is connected to the first mounting carrier (1) and the second mounting carrier (2) respectively and controls the movement of the first mounting carrier (1) and the second mounting carrier (2); An axial limiting component is axially movable within the loading area and is used to contact the two axial ends of the implanted prosthesis. A constraint assembly, wherein the constraint assembly connects the loading assembly and the axial limiting assembly; When the first mounting carrier (1) and the second mounting carrier (2) move away from each other in an axial direction, the constraint component limits the axial displacement of the axial limiting component and the implanted prosthesis through a preset constraint relationship; When the implanted prosthesis is released from the radial constraint of the loading region, the implanted prosthesis expands radially to achieve release.

2. The implantable prosthesis release device according to claim 1, characterized in that, The constraint component includes at least one flexible connector; The preset constraint relationship is as follows: the flexible connector is connected between the first mounting carrier (1) and the axial limiting component, and the length of the flexible connector is configured to match the preset travel of the first mounting carrier (1); and / or, the flexible connector is connected between the second mounting carrier (2) and the axial limiting component, and the length of the flexible connector is configured to match the preset travel of the second mounting carrier (2).

3. The implantable prosthesis release device according to claim 2, characterized in that, The axial limiting component includes: The first limiting member (3) is disposed in the loading area; The second limiting member (4) is disposed in the loading area; The first limiting member (3) and the second limiting member (4) form an implantable prosthesis limiting area for axial limiting of the implanted prosthesis.

4. The implantable prosthesis release device according to claim 3, characterized in that, The flexible connector includes at least two flexible connectors, namely: The first flexible connector (7) connects the first mounting carrier (1) and the second limiting member (4). The axial length of the first flexible connector (7) is equal to the maximum forward stroke of the first mounting carrier (1) moving to the far end. The second flexible connector (8) connects the second limiting member (4) to the drive assembly or the second mounting carrier (2), and the axial length of the second flexible connector (8) is equal to the maximum stroke of the second mounting carrier (2) moving proximally.

5. The implantable prosthesis release device according to claim 4, characterized in that, The first flexible connector (7) and the second flexible connector (8) are located on both sides of the central axis of the loading assembly.

6. The implantable prosthesis release device according to claim 4, characterized in that, The first limiting member (3) and the second limiting member (4) are rigidly connected; or the first limiting member (3) and the second limiting member (4) are flexibly connected.

7. The implantable prosthesis release device according to claim 6, characterized in that, When the first limiting member (3) and the second limiting member (4) are flexibly connected, the first limiting member (3) and the second limiting member (4) are connected by a third flexible connector (9), the axial length of the third flexible connector (9) being equal to the axial length of the implanted prosthesis.

8. The implantable prosthesis release device according to claim 2, characterized in that, The flexible connector is a single-strand or multi-strand connector.

9. The implantable prosthesis release device according to claim 2, characterized in that, The inner wall of the first mounting carrier (1) and / or the second mounting carrier (2) is provided with a wire groove along the axial direction, and the flexible connector is accommodated in the wire groove.

10. The implantable prosthesis release device according to claim 3, characterized in that, The first limiting member (3) is a stepped limiting member, and the outer diameter of the proximal end of the first limiting member (3) is greater than the outer diameter of the distal end of the first limiting member (3); And / or, the second limiting member (4) is a stepped limiting member, and the outer diameter of the distal end of the second limiting member (4) is greater than the outer diameter of the proximal end of the second limiting member (4).

11. The implantable prosthesis release device according to any one of claims 1-10, characterized in that, Both the first loading carrier (1) and the second loading carrier (2) are hollow tubes. The side of the first loading carrier (1) closest to the second loading carrier (2) is the first loading sub-region, and the side of the second loading carrier (2) closest to the first loading carrier (1) is the second loading sub-region. When the first loading carrier (1) and the second loading carrier (2) are docked, the first loading sub-region and the second loading sub-region enclose each other to form the loading area.

12. The implantable prosthesis release device according to claim 11, characterized in that, The inner diameters of the tubes of the first carrier (1) and the second carrier (2) are different.

13. The implantable prosthesis release device according to claim 12, characterized in that, The first mounting carrier (1) is located at the distal end of the second mounting carrier (2), and the inner diameter of the tube of the first mounting carrier (1) is greater than the inner diameter of the tube of the second mounting carrier (2). When the first mounting carrier (1) moves to the distal end, the second mounting carrier (2) constrains the axial limiting component and the implanted prosthesis to limit the axial displacement of the axial limiting component and the implanted prosthesis.

14. The implantable prosthesis release device according to claim 1, characterized in that, The inner cavity of the tube of the second carrier (2) is a structure with equal diameter and wall thickness; Alternatively, the inner cavity of the tube of the second carrier (2) is a conical structure with the inner diameter gradually decreasing from the distal end to the proximal end.

15. The implantable prosthesis release device according to any one of claims 1-10, characterized in that, The drive assembly includes a first catheter (5) and a second catheter (6); the second catheter (6) is connected to the proximal end of the second implantation carrier (2); the first catheter (5) passes through the second catheter (6), the axial limiting assembly and the implanted prosthesis, and is connected to the first implantation carrier (1), and the first catheter (5) can slide axially relative to the second catheter (6).

16. A conveying system, characterized in that, include: The implantable prosthesis release device according to any one of claims 1-15; Sheath (11), the sheath (11) being disposed around the implanted prosthesis release device; A control handle (12) is connected to the proximal end of the implanted prosthesis release device and the sheath (11), respectively.

17. The conveying system according to claim 16, characterized in that, The movement of the first mounting carrier (1) and the second mounting carrier (2) is controlled by the control handle (12). The control handle (12) has a first state and a second state. When the control handle (12) is in the first state, the first mounting carrier (1) and the second mounting carrier (2) can move synchronously along the axial direction. When the control handle (12) is in the second state, the first mounting carrier (1) and the second mounting carrier (2) can move independently along the axial direction.

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