An implant release device

Abstract

The present application relates to the technical field of medical devices, and discloses an implant releasing device, which comprises a first shell, a manipulating member passing through an inner cavity of the first shell, and a guide member arranged at least partially in the first shell, wherein the guide member is provided with a guide portion arranged along the axial direction of the inner cavity of the first shell, and the manipulating member cooperates with the guide portion and is radially constrained by the guide portion. According to the present application, the guide member is arranged to exert a radial constraint force on the manipulating member passing through the guide member, correct the bending tendency of the manipulating member, keep the manipulating member in a substantially straight state, eliminate the unilateral radial extrusion on the implant caused by the eccentric wall adhesion of the pre-shaped manipulating member, avoid the risk of axial movement or circumferential skewing of the implant during the release of the implant, and improve the success rate of surgery.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically to an implant release device. Background Technology

[0002] Transcatheter implantation technology is a rapidly developing minimally invasive interventional treatment method in recent years. During the procedure, implants (such as artificial valves, stents, etc.) are compressed and loaded within the restraints of the delivery system. After being delivered to the target location through blood vessels or natural cavities, the implant is unfolded and implanted into the body by a release mechanism.

[0003] Taking transcatheter aortic valve replacement (TAVR) as an example, TVR is an important treatment for valvular heart disease. Its core principle is to deliver an artificial heart valve, compressed on the delivery system, through a vascular puncture or a small incision, via a pre-established pathway (such as the femoral artery or apex of the heart) to the site of the heart lesion, then release and fix it in place, thereby replacing the function of the original heart valve. This technique has significant advantages such as minimal invasiveness, rapid recovery, and short hospital stay.

[0004] The heart valve release device is a crucial instrument for the success of heart valve replacement surgery. Current heart valve release devices include a hollow anterior nasal cone, a hollow posterior nasal cone, a nasal cone catheter, and a loading catheter. One end of the nasal cone catheter is connected to the distal end of the anterior nasal cone (the end furthest from the operator during surgery), while the loading catheter is connected to the proximal end of the posterior nasal cone (the end closest to the operator during surgery). In the delivery state, the artificial heart valve is compressed and fixed within the cavity between the anterior and posterior nasal cones by a deformable heart valve stent. During heart valve release, the loading catheter is pulled back proximally, separating the posterior nasal cone from the heart valve. The heart valve stent then gradually unfolds under its own expansion force, completing the release.

[0005] like Figure 1As shown, to facilitate the passage of the heart valve release device across the aortic root and to facilitate the alignment adjustment between the heart valve and the positioning element, both the nasal conus catheter 9 and the loading catheter are pre-shaped distally to bend towards the lesser curve. During the crucial step of releasing the heart valve, when the nasal conus catheter 9 remains extended while the loading catheter retracts the posterior nasal conus 8 proximally, the nasal conus catheter 9, due to its pre-bent shape, continuously and tightly adheres to the wall of the posterior nasal conus 8 near the lesser curve due to its pre-bending shape. This eccentric contact causes the proximal end of the heart valve, compressed between the anterior and posterior nasal conus 8, to experience abnormal radial clamping force on the lesser curve side, resulting in asymmetrical and asynchronous deployment of the heart valve stent during release. The portion farther from the lesser curve releases first due to less resistance, while the portion closer to the lesser curve is delayed in ejection due to being stuck, causing axial displacement or circumferential tilting of the heart valve during release. This can cause the heart valve to fail to anchor in the expected position that best matches the native valve annulus, directly affecting heart valve function, potentially leading to paravalvular leakage, impairing hemodynamics, and ultimately shortening the lifespan of the artificial heart valve and reducing the success rate of overall replacement surgery. Summary of the Invention

[0006] In view of the problem that implants are prone to shifting or tilting during release in the prior art, the present invention provides an implant release device that can prevent implants from shifting or tilting during release.

[0007] To address the aforementioned problems, the present invention provides an implant release device, comprising: a first housing; an actuating member passing through the inner cavity of the first housing; and a guiding member, at least partially disposed within the first housing, the guiding member having a guiding portion arranged along the axial direction of the inner cavity of the first housing, the actuating member cooperating with the guiding portion and being radially constrained by the guiding portion.

[0008] In use, the implant release device provided by this invention houses the implant within a first housing. Before releasing the implant, the manipulator, pre-shaped within the first housing, naturally tends to align to one side. During implant release, the first housing is retracted proximally, releasing the implant. During release, a guide member and its guide portion radially constrain the manipulator, effectively preventing lateral bending relative to the first housing. This radial constraint ensures stable movement of the manipulator along a predetermined axis within the first housing, preventing radial sway during implant release. This allows the implant to unfold and release uniformly and synchronously along a predetermined path, eliminating abnormal stress caused by asynchronous unfolding at different positions during the original release process. It effectively prevents axial movement or circumferential tilting of the implant during release, ensuring precise anchoring at the expected optimal matching position. This effectively reduces the risk of complications such as perivalvular leakage, thereby improving the overall success rate of implant replacement surgery.

[0009] The aforementioned implantable components include, but are not limited to, artificial heart valves, and components consisting of an artificial heart valve compressed into a stent and the stent.

[0010] In one alternative embodiment, the guide member includes a radial constraint kit, and the guide portion includes a constraint cavity disposed within the radial constraint kit. The axis of the constraint cavity is parallel to or coincides with the axis of the inner cavity of the first housing, and the actuating member passes through the constraint cavity. The axis of the constraint cavity is parallel to or coincides with the axis of the inner cavity of the first housing.

[0011] During the release of the implant, the inner wall of the constraint cavity applies a radial constraint force to the manipulator passing through it. This constraint force can correct the bending tendency of the manipulator and keep it in a basically straight state. Therefore, the manipulator cannot be eccentrically attached to or exert radial pressure on one side of the implant, thus avoiding the manipulator from tilting during the release process.

[0012] In one alternative embodiment, the guide portion includes a constraint groove disposed on the wall surface of the guide member, the actuating member being slidably adapted to the constraint groove, and the pre-bending direction of the actuating member being toward the constraint groove and radially constrained by the constraint groove.

[0013] After the second housing separates from the first housing, the constraint groove restricts and corrects the bending tendency of the manipulator, thus preventing lateral bending of the manipulator and preventing the manipulator from applying radial pressure to one side of the implant during implant release. This achieves the same technical effect as the constraint cavity in the embodiment, and can also solve the problem of asynchronous implant clamping and release caused by bending of the manipulator, reduce the risk of positional displacement during implant release, and improve the accuracy of implant positioning.

[0014] In one alternative embodiment, the guide portion includes a guide ring, the guide ring being provided with at least one, through which the actuating member passes; When multiple guide rings are provided, each guide ring is spaced apart on the operating member along the axial direction of the operating member.

[0015] Each guide ring limits the sidewall of the control component from different axial positions. Multi-point constraint can effectively prevent the middle section of the long control component from bending laterally during axial downward movement, and limit the radial displacement amplitude of the control component to the greatest extent.

[0016] In one alternative implementation, it further includes: A second housing is detachably fitted to the first housing, and the second housing has both a connected state and a separated state with the first housing; One end of the actuating member passes through the inner cavity of the first housing and connects to the second housing.

[0017] In use, the implant release device provided by this invention has the second housing connected to the first housing, with the implant simultaneously housed within both the second and first housings. Before releasing the implant, the manipulator, inserted within the first housing, naturally tends to laterally conform due to its pre-shaping. During implant release, the manipulator is pushed distally and / or the first housing is retracted proximally, separating the second and first housings and releasing the implant from both. During release, a guide member and its guide portion radially constrain the manipulator, effectively preventing lateral bending relative to the first housing. Therefore, the manipulator cannot eccentrically conform to the implant or exert radial pressure on one side, avoiding release jamming and improving release accuracy and stability. The guide member solves the problem of asynchronous implant release caused by bending of the manipulator, avoiding the risk of axial movement or circumferential tilting during release. This helps the implant to anchor more accurately at the target position, improving the fit between the implant and the original valve annulus and increasing the overall surgical success rate.

[0018] In one optional embodiment, a guide ring is provided on the outer periphery of the guide member, and the outer peripheral wall of the guide ring slides in engagement with the inner peripheral wall of the first housing. This ensures the straightness of the guide member's sliding and prevents it from swaying or getting stuck during sliding, thereby further limiting the radial movement of the control member.

[0019] In one alternative embodiment, the guide ring divides the inner cavity of the first housing into a first cavity and a second cavity from the proximal end to the distal end, and the second cavity and the inner cavity of the second housing enclose the implant loading area.

[0020] In one optional embodiment, the guide member is provided with an extension, which is arranged along the inner cavity axis of the first housing, and the guide is disposed on the extension. The extension extends the effective length of the guide, providing more sufficient radial constraint, ensuring that the second housing remains coaxial during the axial movement of the first housing cavity, preventing radial sway of the second housing due to uneven force, and ensuring that the positioning accuracy of the implant is not disturbed by the separation action.

[0021] In one optional embodiment, the extension includes a first extension with a first cylindrical surface on its outer periphery. The first extension is coaxial with and located within the inner cavity of the first housing. The first cylindrical surface supports one end of the implant in the loaded state. The first cylindrical surface and the inner wall of the inner cavity of the first housing work together to provide radial positioning for the implant and limit radial movement of the implant.

[0022] In one alternative implementation, the guide portion is coaxial with the inner cavity of the first housing. This ensures that the restraint kit aligns the manipulator with the centerline of the first housing, thereby maximizing the smoothness of implant release.

[0023] In one optional embodiment, the extension further includes a second extension disposed at the distal end of the first extension, the outer diameter of the second extension gradually decreasing from the proximal end to the distal end. This tapered diameter design of the second extension allows it to be inserted into the second housing, providing a longer radial constraint path for the actuating member, effectively preventing radial sway during axial pushing, and significantly improving the stability and coaxiality of the actuating member's movement. Simultaneously, the tapered outer edge can smoothly insert into the end of the second housing, reducing insertion resistance during insertion.

[0024] In one alternative embodiment, when the second housing is connected to the first housing, the guide member extends into the second housing. The guide member extending into the second housing ensures that unilateral compression of the implant is avoided after release, thereby further preventing the risk of the implant shifting or tilting during release.

[0025] In an optional embodiment, an elastic element is further included. The elastic element is disposed within the first housing, with one end connected to or abutting against the inner wall of the first housing, and the other end connected to or abutting against the end of the guide member facing away from the second housing. The guide member is at least partially slidably disposed within the first housing. The elastic element is compressed within the first housing, and during implant release, it can push the guide member and the implant to slide out, facilitating implant release and preventing jamming.

[0026] The elastic element can be either an elastic material block or a spring structure.

[0027] In one alternative embodiment, the elastic element is a spring structure, and the elastic element is sleeved outside the actuating member. The elastic force change and displacement of the spring structure are predictable, which is beneficial for accurately designing its initial compression, preload, and force-displacement curve throughout the release process, thereby ensuring smooth initiation and controllable deployment of the implant.

[0028] In one optional embodiment, the elastic element is made of a nickel-titanium alloy. Nickel-titanium alloys possess superelasticity and shape memory effect; when stored externally, the elastic element is highly compressed and stably maintains a pre-tensioned state without any decrease in pre-tension force. Upon insertion into the human body, body temperature activates its shape memory potential, enabling it to fully recover to its preset shape. During implantation, the elastic element instantly and completely recovers its deformation with the aid of body temperature, thereby precisely releasing the elastic force and providing controllable and accurate axial thrust to the guide component and the implant.

[0029] In one optional embodiment, when the second housing is connected to the first housing, the inner axis of the second housing is coaxial with the inner axis of the first housing. This ensures that the implant remains centered during compression and delivery, preventing misalignment and tilting during release.

[0030] Optionally, the second housing may or may not be in direct contact with the first housing. The second housing and the first housing can be detachably fitted together via connectors, or connected by snap-fit, plug-in, or other methods.

[0031] Furthermore, the second housing is nested, plugged into, or snapped into the first housing. These nesting, plugging into, or snapping connections are simple, reliable, easy to operate, and allow for quick separation.

[0032] In one optional embodiment, when the second housing is connected to the first housing, the end of the second housing facing the first housing extends into the inner cavity of the first housing. The outer sidewall of the second housing and the inner sidewall of the first housing fit and limit each other, which can stably ensure the coaxiality of the second housing and the first housing while achieving radial constraint, and facilitates the rapid separation of the second housing and the first housing during the operation, thus meeting the operational requirements for implant release.

[0033] In one optional embodiment, when the second housing is connected to the first housing, one end of the first housing facing the second housing extends into the inner cavity of the second housing, and the portion of the first housing located inside the second housing transitions into the inner cavity of the second housing. This avoids direct exposure of the implant to blood vessels during delivery within the human body, thereby preventing friction between the implant and the blood vessel wall, ensuring the safety of the implant delivery process, the integrity of the implant's function, and the overall success rate of the surgery.

[0034] In one alternative embodiment, the first housing is an expandable member having a folding configuration for loading the implant and an unfolding configuration for releasing the implant. When the second housing is connected to the first housing, the first housing is radially constrained by the second housing and is in a folded configuration. When the second housing is separated from the first housing, the first housing is in an unfolded configuration. This structural design, which achieves configuration switching of the first housing through the connection and separation of the second and first housings, eliminates the need for an additional independent expansion drive component, significantly simplifying the overall structure of the release device. After the second housing separates from the first housing, the first housing can automatically switch from a folded to an unfolded configuration using its own preset elastic expansion force, quickly completing the in-situ release of the implant without requiring additional release operations by the surgeon. This effectively avoids implant positioning deviation caused by manual intervention during the operation and significantly improves the accuracy of implant release.

[0035] In one optional embodiment, the first housing includes: a converging portion; and a plurality of extendable skeletons, one end of each of the plurality of extendable skeletons being connected to the converging portion and circumferentially distributed on the converging portion, and the other ends being close together within the inner cavity of the second housing. The plurality of extendable skeletons and the converging portion together form the inner cavity of the first housing. When releasing the implant, after pushing the manipulating member distally and / or retracting the first housing proximally, the second housing separates from the first housing, and the distal ends of the extendable skeletons, no longer constrained, move away from each other, allowing the implant to be released in place. This makes the release of the implant more uniform and synchronous, further improving the accuracy and reliability of the implant release. Moreover, the simultaneous arrangement of the first housing and the guiding member provides multiple safeguards, making the entire release device safer and more reliable, ultimately achieving faster, more coaxial, and more predictable precise anchoring of the implant, greatly improving the success rate of the surgery.

[0036] In one optional embodiment, the deployable skeleton is made of shape memory material. When the second shell releases its radial constraint on the first shell, the deployable skeleton automatically unfolds under the shape memory effect, causing the first shell to switch from a folded configuration to an unfolded configuration. The application of shape memory material allows the unfolding process of the first shell to be driven entirely by the physical properties of the material itself, without the need for an additional driving mechanism, making the unfolding process smooth and controllable.

[0037] In one optional embodiment, both the converging portion and the expandable skeleton are made of nickel-titanium alloy. Nickel-titanium alloy exhibits superelasticity and shape memory effect. After undergoing plastic deformation at low temperatures, the nickel-titanium alloy can completely recover its pre-set shape when the ambient temperature reaches above the phase transition temperature. When the first shell enters the human body, the body temperature allows the expandable skeleton to return to its original shape, thus enabling immediate deployment after the second shell detaches from the first shell. Compared to other elastic materials, the nickel-titanium alloy converging portion and expandable skeleton allow for more efficient and reliable implant release.

[0038] In one alternative embodiment, a suture cavity is formed between two adjacent expandable skeletons, and the inner cavity of the first housing is connected to the external space of the first housing through the suture cavity. The suture cavity is used for the connection wires on the implant to pass through, avoiding release jamming.

[0039] In one alternative embodiment, the inner wall of the second housing is provided with a guide cone surface at the proximal end, the inner diameter of which gradually decreases from the proximal end to the distal end.

[0040] In one optional embodiment, the inner wall of the second housing is further provided with a second cylindrical surface, which is connected to the distal end of the guide cone surface. The second cylindrical surface is used to store the high secondary peak segment of the valve during loading, and the guide cone surface is used to store the low secondary peak segment of the valve during loading, reducing the external elastic force during valve release, which is beneficial for the release of the implant to the distal end and avoids jamming.

[0041] In one optional embodiment, the manipulation member is located within the inner cavity of the second housing, and this portion is coaxially connected to the inner cavity of the second housing. This not only improves the efficiency of surgical force transmission but also prevents the second housing from tilting during implant release, allowing for more precise implant release.

[0042] In one alternative embodiment, the distal end of the actuating member is located within the inner cavity of the second housing, and this end is connected to the distal wall of the second housing. This prevents relative axial movement or radial misalignment between the actuating member and the second housing during the delivery of the device to the target lesion location.

[0043] In an optional embodiment, an outer tube is further included, one end of which is connected to the end of the first housing facing away from the second housing. One end of the actuating member passes sequentially through the inner cavity of the outer tube, the inner cavity of the first housing, and the guide portion before connecting to the second housing. The outer tube provides axial guidance for the actuating member, enabling precise control of the axial movement of the second housing. Furthermore, the outer tube allows the surgeon to apply operating force directly and efficiently to the first housing.

[0044] In one alternative embodiment, the distal end of the first housing is a polygonal structure with a constant inner diameter but a gradually decreasing outer diameter; or The distal end of the first housing is a columnar structure with a constant inner diameter.

[0045] In one alternative embodiment, the inner diameter of the first housing gradually increases from the proximal end to the distal end.

[0046] The beneficial effects of this invention are: 1. By incorporating a guide member, a radial constraint force can be applied to the manipulator traveling within it, correcting its bending tendency and maintaining it in a basically straight state. This eliminates unilateral radial compression of the implant caused by the manipulator's pre-shaping and eccentric adherence to the wall, resolving the issue of asynchronous implant clamping and release due to manipulator bending, and avoiding the risk of axial movement or circumferential tilting during implant release. This helps the implant to anchor more accurately at the target location, improves the fit between the implant and the original valve annulus, and increases the overall success rate of the surgery.

[0047] 2. The first housing adopts a deployable structure. When releasing the implant, pushing the manipulator distally allows the implant to be released in place. This makes the release of the implant more uniform and synchronous, further improving the accuracy and reliability of the implant release. Moreover, it provides multiple safeguards, making the entire release device safer and more reliable, ultimately achieving faster, more coaxial, and more predictable precise anchoring of the implant, greatly improving the success rate of the surgery. Attached Figure Description

[0048] 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.

[0049] Figure 1 This is a schematic diagram of the manipulation component pressing against the first housing in the prior art; Figure 2 A perspective view of an implant release device provided by the present invention; Figure 3 This is a schematic diagram of the structure of an implant release device before releasing the implant, provided by the present invention; Figure 4 This is a schematic diagram of the structure of an implant release device after the implant is released, provided by the present invention. Figure 5 A schematic diagram of the first housing closed state of an implant release device provided by the present invention; Figure 6 A schematic diagram of the first housing of an implant release device provided by the present invention in an unfolded state; Figure 7 A schematic diagram of the state of the implant after the first housing of the implant release device is deployed, as provided by the present invention. Figure 8 A cross-sectional view of a first guide member of an implant release device provided by the present invention; Figure 9 A cross-sectional view of the main body of the second housing of an implant release device provided by the present invention; Figure 10 A schematic diagram of the external structure of the main body and end of the second housing of an implant release device provided by the present invention; Figure 11 This is a schematic diagram of the structure of a second guide member of an implant release device provided by the present invention; Figure 12An assembly diagram of a second guide member and actuating member for an implant release device provided by the present invention; Figure 13 This is a structural schematic diagram of a third type of guide member for an implant release device provided by the present invention; Figure 14 This is an assembly diagram of a third type of guide member and manipulation member for an implant release device provided by the present invention.

[0050] Explanation of reference numerals in the attached figures: 1. Second shell; 101. First inner cavity; 1011. Guide cone surface; 1012. Second cylindrical surface; 102. Main body; 103. End; 2. First shell; 201. Gathering part; 202. Outwardly expandable skeleton; 2021. Second inner cavity; 2022. Threading cavity; 3. Outer tube; 4. Guide member; 401. Restraint cavity; 402. Guide ring; 403. First extension; 404. Second extension; 405. Restraint groove; 406. Guide ring; 5. Manipulation member; 6. Elastic element; 7. Implant; 701. Valve high secondary peak segment; 702. Valve low secondary peak segment; 8. Posterior nasal cone; 9. Nasal cone catheter. Detailed Implementation

[0051] 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.

[0052] 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 implant that is furthest from the operator; the term "proximal," in contrast to "distal," refers to the end of the implant that is closest to the operator; the term "radial" refers to the direction perpendicular to the axis of the implant; and the term "axial" refers to the direction along the axis of the implant. The term "implant" refers to a tubular or tubular prosthesis with an extended structure that is implanted into the body via an implant release device. The implant can be a heart valve or a vascular stent. Those skilled in the art will understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0053] The following is combined Figures 2 to 10 The following describes embodiments of the present invention.

[0054] Example 1 According to an embodiment of the present invention, an implant release device is provided, combined with Figures 2 to 4As shown, it includes: a first housing 2, an actuating member 5, and a guiding member 4. The inner cavity of the first housing 2 is used to accommodate the implant; the actuating member 5 passes through the inner cavity of the first housing 2; the guiding member 4 is at least partially disposed within the first housing 2, and the guiding member 4 is provided with a guiding portion, which is arranged along the axial direction of the inner cavity of the first housing 2. The actuating member 5 cooperates with the guiding portion and is radially constrained by the guiding portion.

[0055] It should be noted that the manipulating member 5 in this embodiment allows the guide wire to pass through, thus guiding the guide wire. Furthermore, before the guide member 4 is provided, the implant can be gripped on the manipulating member 5 to facilitate smooth release of the implant when the first housing 2 is retracted proximally without retracting the manipulating member 5. After the guide member 4 is provided, the implant is gripped on the guide member 4, or simultaneously on both the guide member 4 and the manipulating member 5, with the periphery of the implant radially limited by the first housing 2. When the implant is gripped on the guide member 4, the guide member 4 can be relatively fixed in position relative to the manipulating member 5, facilitating smooth release of the implant when the first housing 2 is retracted proximally without retracting the manipulating member 5. When the implant is gripped on both the guide member 4 and the manipulating member 5, the positions of the guide member 4 and the manipulating member 5 can be relatively fixed or relatively movable, facilitating smooth release of the implant when the first housing 2 is retracted proximally without retracting the manipulating member 5.

[0056] In this embodiment, the implant release device is used such that the implant is housed inside the first housing 2. Before releasing the implant, the manipulator 5, which is inserted into the first housing 2, has a natural tendency to bend to one side due to its pre-shaping. When releasing the implant, the first housing 2 is retracted proximally, so that the implant is released from the first housing 2. During the release of the implant, the manipulator 5 is radially constrained by the guide member 4 and its guide portion, which effectively prevents the manipulator 5 from bending laterally relative to the first housing 2. The radial constraint on the manipulator 5 ensures that the manipulator 5 always moves stably along the preset axis direction of the inner cavity of the first housing 2, avoiding radial swaying of the manipulator 5 during the release of the implant. This allows the implant to be uniformly and synchronously unfolded and released along the preset path, eliminating the abnormal force problem caused by the asynchronous unfolding of different positions of the implant during the original release process. It effectively avoids axial movement or circumferential tilting of the implant during the release stage, ensuring that the implant can be accurately anchored in the expected optimal matching position, effectively reducing the risk of adverse problems such as paravalvular leakage, and thus improving the overall success rate of implant replacement surgery.

[0057] The guide member 4 and its guide portion radially constrain the operating member 5. This means that the guide member 4 is disposed in the inner cavity of the first housing 2, and the guide portion extends along the axial direction of the first housing 2 to form a limiting structure on the radially outer side of the operating member 5. This restricts the range of motion of the operating member 5 within the preset area enclosed by the guide portion, thus limiting the radial displacement of the operating member 5 under its pre-bending configuration and keeping the operating member 5 as a whole in the posture of extending along the axial direction of the first housing 2.

[0058] This embodiment, by setting the guide member 4, can solve the problem of asynchronous clamping and release of the implant caused by the bending of the manipulation member 5, avoid the risk of axial movement or circumferential tilt during the release of the implant, help the implant to be anchored more accurately at the target position, improve the fit between the implant and the original valve annulus, and improve the overall success rate of the surgery.

[0059] The aforementioned implantable components include, but are not limited to, artificial heart valves, and components consisting of an artificial heart valve compressed into a stent and the stent.

[0060] The manipulation component 5 can be a manipulation tube with a hollow tubular structure inside to facilitate the delivery of the guidewire. The guidewire can be pre-guided along the blood vessel path to the target location, providing navigation support for the delivery of the entire implant release device.

[0061] In some embodiments, the guide member 4 includes a radial constraint kit, the guide portion includes a constraint cavity 401, the constraint cavity 401 is disposed within the radial constraint kit, the axis of the constraint cavity 401 is parallel to or coincides with the axis of the inner cavity of the first housing 2, and the operating member 5 passes through the constraint cavity 401.

[0062] In this embodiment, the radial displacement of the control member 5 is always limited by the constraint cavity 401 during the entire push-pull action. Even if the control member 5 itself has pre-bending stress, it cannot be offset in the radial direction and always maintains the coaxial motion posture with the first housing 2.

[0063] During the release of the implant, the inner wall of the constraint cavity 401 applies a radial constraint force to the manipulator 5 passing through it. This constraint force can correct the bending tendency of the manipulator 5 and keep the manipulator 5 in a basically straight state. Therefore, the manipulator 5 cannot be eccentrically attached to or exert radial pressure on one side of the implant, thus avoiding the manipulator 5 from tilting during the release process.

[0064] In addition, the constraint cavity 401 can be smoothed and made low-friction by treating the inner wall, which reduces the operating resistance during the pushing and pulling process of the manipulating component 5, further improves the operating feel, and makes it easier for the operator to accurately control the release rhythm of the implant.

[0065] For ease of description and understanding, the inner cavity of the second shell 1 is referred to as the first inner cavity 101, and the inner cavity of the first shell 2 is referred to as the second inner cavity 2021.

[0066] Furthermore, the constraint cavity 401 is coaxial with the second inner cavity 2021. This ensures that the constraint kit aligns the manipulator 5 with the centerline of the first housing 2, thereby maximizing the smoothness of implant release.

[0067] In some embodiments, the implant release device further includes a second housing 1, which is detachably coupled to the first housing 2, and the second housing 1 and the first housing 2 have a connected state and a separated state. One end of the actuating member 5 is connected to the second housing 1 after passing through the inner cavity of the first housing 2.

[0068] Combination Figure 3 and Figure 4 As shown, in use, the implant release device provided in this embodiment has the second housing 1 connected to the first housing 2, and the implant is simultaneously housed inside both the second housing 1 and the first housing 2. Before releasing the implant, the actuating member 5, which is inserted into the first housing 2, has a natural tendency to be biased to one side due to its pre-shaping. When releasing the implant, the actuating member 5 is pushed distally and / or the outer tube 3 is retracted proximally, so that the implant is released from the second housing 1 and the first housing 2. During the release of the implant, the actuating member 5 is radially constrained by the guide member 4 and its guide portion, which effectively prevents the actuating member 5 from bending laterally relative to the first housing 2. Therefore, the actuating member 5 cannot be biased against or exert radial pressure on one side of the implant, avoiding release jamming and improving release accuracy and stability.

[0069] Furthermore, a guide ring 402 is provided on the outer periphery of the guide member 4, and the outer peripheral wall of the guide ring 402 slides in engagement with the inner peripheral wall of the first housing 2. This ensures the straightness of the sliding of the guide member 4 and prevents it from swaying or getting stuck during the sliding process, thereby further limiting the radial movement of the control member 5.

[0070] The guide ring 402 divides the inner cavity of the first housing 2 into a first cavity and a second cavity from the proximal end to the distal end. The second cavity and the inner cavity of the second housing 1 enclose the implant loading area, and the implant can be loaded in the implant loading area.

[0071] Furthermore, combined Figure 2 and Figure 8As shown, the guide member 4 is provided with an extension, which is arranged along the inner cavity axis of the first housing 2, and the guide is disposed on the extension. The extension provided in this embodiment can extend the axial length of the guide, providing a longer radial constraint for the operating member 5. Even if the overall length of the operating member 5 is long and its own bending stress is large, it can maintain the constraint posture of the operating member 5 throughout the entire push-pull stroke and will not lose its corrective effect at the end of the stroke.

[0072] The extension includes a first extension 403, the outer periphery of which is provided with a first cylindrical surface. The first extension 403 is coaxial with the inner cavity of the first housing 2 and is located within the inner cavity of the first housing 2. The first cylindrical surface is used to support one end of the implant 7 in the loaded state. The first cylindrical surface and the inner wall of the second inner cavity 2021 work together on the implant 7 to provide radial positioning for the implant 7 and limit the radial sway of the implant 7.

[0073] Furthermore, the extension also includes a second extension 404, which is located at the distal end of the first extension 403. The outer diameter of the second extension 404 gradually decreases from the proximal end to the distal end. This tapered diameter design of the second extension allows it to be inserted into the second housing, providing a longer radial constraint path for the manipulator and effectively preventing radial sway during axial pushing, thus significantly improving the stability and coaxiality of the manipulator's movement. Simultaneously, the tapered outer edge can smoothly insert into the end 103 of the second housing, reducing insertion resistance during insertion. Another purpose of the second extension 404 is to optimize the implant loading process. Specifically, the structural design of the second extension 404 significantly simplifies the operation, allowing operators to easily place the implant 7 around it. During compression by the implant compression mechanism, the implant can be held firmly against the second extension 404, improving loading efficiency and ensuring stable radial support and centering of the implant during the initial loading stage.

[0074] When the implant 7 is in a compressed state, the inner ring of the implant 7 can grip the periphery of the second extension 404. Of course, the outer peripheral surface of the second extension 404 can also be a cylindrical surface.

[0075] The guide member 4 has a sufficiently long axial extension distance, so that the operating member 5 is always wrapped and constrained by the guide member 4 along most of the path through the first housing 2 and the second housing 1. This long-span constraint configuration can significantly increase the straightening length of the pre-bending section of the operating member 5, eliminating the risk of the operating member 5 bending locally or eccentrically sticking to the wall again.

[0076] Furthermore, when the second housing 1 is connected to the first housing 2, the guide member 4 extends into the second housing 1. The extension of the guide member 4 into the second housing 1 ensures that unilateral compression of the implant is avoided after the implant is released, thereby further reducing the risk of the implant shifting or tilting during release.

[0077] Furthermore, it also includes an elastic element 6, which is disposed within the first housing 2. One end of the elastic element 6 is connected to or abuts against the inner wall of the first housing 2, and the connection method includes, but is not limited to, bonding, snap-fitting, etc. The other end of the elastic element 6 is connected to or abuts against the end of the guide member 4 facing away from the second housing 1, and the connection method therein also includes, but is not limited to, bonding, snap-fitting, etc. The guide member 4 is at least partially slidably disposed within the first housing 2. The elastic element 6 is compressed within the first housing 2. When the implant is released, the elastic element 6 can push the guide member 4 and the implant to slide out, facilitating the release of the implant and preventing jamming.

[0078] The first cavity is an elastic element receiving cavity, in which the elastic element can be placed. When the implant is loaded into the implant loading area, the elastic element can push the guide ring 402 to move distally, and the guide ring 402 and the distal wall of the second housing 1 achieve axial restraint of the implant. During implant release, after the second housing 1 separates from the first housing 2, the elastic element can push the guide ring 402 to move distally, thereby pushing the implant out of the second cavity.

[0079] Among them, the elastic element 6 can be one of the following: an elastic material block or a spring structure.

[0080] Furthermore, the elastic element 6 is a spring structure, and the elastic element 6 is sleeved outside the actuating member 5. The elastic force change and displacement of the spring structure can be predicted, which is conducive to the precise design of its initial compression, preload, and force-displacement curve throughout the release process, thereby ensuring smooth initiation and controllable deployment of the implant.

[0081] Furthermore, the elastic element 6 is made of nickel-titanium alloy. Nickel-titanium alloy possesses superelasticity and shape memory effect. When stored externally, the elastic element 6 is compressed and stably maintained in a pre-tightened state, during which the pre-tightening force does not decay. Upon insertion into the human body, body temperature activates its shape memory potential, enabling it to fully recover to its preset shape. When the implant is released, the elastic element 6 instantly and completely recovers its deformation with the assistance of body temperature, thereby precisely releasing the elastic force and providing controllable and accurate axial thrust to the guide member 4 and the implant.

[0082] Furthermore, when the second housing 1 is connected to the first housing 2, the axis of the first inner cavity 101 is coaxial with the axis of the second inner cavity 2021. This ensures that the implant remains centered during compression and delivery, preventing misalignment and tilting during release.

[0083] Optionally, the second housing 1 and the first housing 2 may or may not be in direct contact. The second housing 1 and the first housing 2 may be detachably connected via a connector.

[0084] Currently, when the second housing 1 and the first housing 2 are being transported, there is a gap between the second housing 1 and the first housing 2. This causes some implants to be directly exposed in the blood vessels during the transport process. The exposed implants expand outward from the gap due to their own expansion properties, increasing the risk during the transport process.

[0085] To address this issue, in some embodiments, the second housing 1 and the first housing 2 are interlocked, plugged into, or snapped together. These interlocking, plugging, or snapping connections are simple, reliable, easy to operate, and facilitate rapid separation. By using these interlocking, plugging, or snapping connections, the second housing 1 and the first housing 2 form a tight fit in the connected state, eliminating gaps between them during delivery. This ensures the implant is completely enclosed within the closed cavity, avoiding the risk of direct exposure of the implant to blood vessels during delivery. It also enhances the stability and reliability of the connection, ensuring the implant remains protected throughout the delivery process and reducing the risk of tissue damage.

[0086] Furthermore, when the second housing 1 and the first housing 2 are connected, the end of the first housing 2 facing the second housing 1 extends into the first inner cavity 101, and the portion of the first housing 2 located within the first inner cavity 101 transitionally engages with the first inner cavity 101. This avoids direct exposure of the implant to blood vessels during delivery within the human body, thereby preventing friction between the implant and the inner wall of the blood vessels, ensuring the safety of the implant delivery process, the integrity of the implant's function, and the overall success rate of the surgery.

[0087] As an alternative embodiment, when the second housing 1 is connected to the first housing 2, the end of the second housing 1 facing the first housing 2 extends into the second inner cavity 2021. The outer sidewall of the second housing 1 and the inner sidewall of the first housing 2 fit and limit each other, which can stably ensure the coaxiality of the second housing 1 and the first housing 2 while achieving radial constraint, and facilitates the quick separation of the second housing 1 and the first housing 2 during the operation, thus meeting the operation requirements for the release of the implant 7.

[0088] In some embodiments, the distal end of the first housing 2 is a polygonal structure with a constant inner diameter but a gradually decreasing outer diameter. The polygonal structure can be a rhombus structure, which not only facilitates the assembly of the first housing 2 and the second housing 1, but also prevents relative rotation between the first housing 2 and the second housing 1. On the one hand, the tapered transition section formed by the gradually decreasing outer diameter acts as a guide during assembly, allowing the first housing to slide smoothly into the inner cavity of the second housing, reducing the assembly difficulty and the alignment accuracy requirements during assembly, and improving assembly efficiency and reliability. On the other hand, the non-circular cross-sectional profile of the rhombus structure forms a shape fit with the inner cavity of the second housing, effectively restricting the relative rotation between the first housing 2 and the second housing 1 in the connected state, avoiding displacement of the implant position or deviation of the release angle due to torsion or rotation during transportation, and ensuring the overall stability of the device during implant transportation and release.

[0089] As an alternative embodiment, the distal end of the first housing 2 is a columnar structure with a constant inner diameter. The columnar structure can be a cylindrical structure, which simplifies the processing technology, reduces manufacturing costs and processing difficulty. At the same time, the cylindrical surface can form a uniform circumferential contact with the inner wall of the second housing, providing a balanced and stable radial constraint force in the connected state. This ensures that the first housing 2 is subjected to uniform force in all circumferential directions, avoiding local stress concentration or deformation caused by structural asymmetry. This is beneficial for the implant to maintain a stable compression shape during delivery, ensuring the uniformity and consistency of the implant's unfolding during release.

[0090] As an alternative embodiment, the inner diameter of the first housing 2 is designed as a gradually expanding structure that increases from the proximal end to the distal end, which serves as a guide when loading the implant 7, making it easier for the implant to enter from the distal inlet and effectively reducing the operational difficulty of the loading process.

[0091] In some embodiments, the second housing 1 is provided with a first inner cavity 101, and a portion of the actuating member 5 is located within the first inner cavity 101 and is coaxially connected to the first inner cavity 101. This allows the actuating member 5 to maintain more precise alignment throughout the release of the implant 7.

[0092] Furthermore, the distal end of the actuating member 5 is located within the first inner cavity 101, and this end is connected to the distal wall of the second housing 1. During the process of pushing the device to the target position, relative axial movement or radial misalignment between the actuating member 5 and the second housing 1 can be avoided.

[0093] Specifically, one end of the operating component 5 is connected to the second housing 1 by adhesive dispensing. This connection method is relatively simple, and the adhesive layer between the operating component 5 and the second housing 1 can evenly fill the mating gap between the operating component 5 and the second housing 1 and form a continuous seal, which can prevent bodily fluids from seeping into the interior of the second housing. Of course, the connection method between the operating component 5 and the second housing 1 is not limited to adhesive bonding; it can also be a threaded connection or a snap-fit ​​connection.

[0094] In some embodiments, combined with Figure 2 , Figure 9 and Figure 10 As shown, a guide cone surface 1011 is provided near the wall of the first inner cavity 101. The inner diameter of the guide cone surface 1011 near the first housing 2 is larger than the inner diameter of the other end, and its diameter gradually decreases from the proximal end to the distal end. The guide cone surface 1011 can be trumpet-shaped or trapezoidal, and the angle between the generatrix of the guide cone surface 1011 and the axis of the first inner cavity 101 is between 45° and 90°.

[0095] When the end of the first housing 2 is inserted into the first inner cavity 101, the guide cone surface 1011 can guide the end of the first housing 2 to slide smoothly into the first inner cavity 101, which helps to reduce assembly difficulty and improve assembly efficiency.

[0096] Furthermore, the wall of the first inner cavity 101 is also provided with a second cylindrical surface 1012, which is connected to the distal end of the guide cone surface 1011. The second cylindrical surface 1012 is used to store the high secondary peak segment 701 of the valve during loading, and the guide cone surface 1011 is used to store the low secondary peak segment 702 of the valve during loading, reducing the external elastic force during valve release, which is conducive to the release of the implant 7 to the distal end and avoids jamming.

[0097] The proximal inner wall of the first inner cavity 101 is jointly formed by the guide cone surface 1011 and the second cylindrical surface 1012. When the implant 7 is a heart valve and its stent, the space enclosed by the second cylindrical surface 1012 is used to accommodate the high secondary peak segment of the stent in the loaded state, while the space enclosed by the guide cone surface 1011 is used to accommodate the low secondary peak segment of the stent. This helps to reduce the external elastic force of the stent at the moment of heart valve release, making its release process more stable.

[0098] Specifically, the second housing 1 includes a main body 102 and an end 103. The outer peripheral surface of the end 103 is conical, and the end 103 is detachably connected to the main body 102. Optionally, the end 103 is threadedly connected to the main body 102. The proximal outer peripheral surface of the main body 102 is cylindrical, and the distal outer peripheral surface of the main body 102 is conical and smoothly connected to the outer peripheral surface of the end 103. The first inner cavity 101 extends through the main body 102 and the end 103. A guide cone surface 1011 is disposed on the main body 102. The distal end of the end 103 is provided with a distal wall, and an opening is provided on the distal wall of the end 103 to facilitate the passage of a guide wire. The distal end of the operating tube is connected to the distal wall of the end 103.

[0099] The distal end of the control tube and the distal wall of the end 103 can be connected by adhesive bonding, for example by dispensing glue; or, the distal end of the control tube and the distal wall of the end 103 can be connected by welding.

[0100] The outer peripheral surface of the tip 103 is conical, smoothly connecting with the conical surface near the proximal end of the main body 102. This effectively reduces the pushing resistance of the second housing 1, preventing scratching and damage to the inner wall of the blood vessel, and improving the overall passability and safety of the release device within the blood vessel. The distal end of the tip 103 also features a smooth transition design to avoid scratching and damage to the inner wall of the blood vessel. The main body 102 and the tip 103 are connected by threads, facilitating the replacement of the tip 103.

[0101] Furthermore, such as Figure 3 As shown, when the second housing 1 and the first housing 2 are connected, the distal end of the guide member 4 extends into the end head 103, ensuring the coaxiality of the second housing and the first housing after connection. This effectively reduces blood flow resistance during the pushing process, improves the accuracy of the implant release position, and helps increase the success rate of the surgery. Furthermore, the distal end of the guide member is housed inside the end head and will not protrude from the outer surface of the end head, thus preventing it from scraping the inner wall of the blood vessel and further enhancing the safety of the device.

[0102] In some embodiments, such as Figures 2 to 5 As shown, it also includes an outer tube 3, one end of which is connected to the end of the first housing 2 facing away from the second housing 1. One end of the manipulating member 5 passes sequentially through the inner cavity of the outer tube 3, the second inner cavity 2021, and the constraint passage 401 before connecting to the second housing 1. The outer tube 3 provides axial guidance for the manipulating member 5, enabling precise control of the axial movement of the second housing 1. Furthermore, the outer tube 3 allows the surgeon to apply operating force directly and efficiently to the first housing 2.

[0103] The following describes in detail the implant loading process, implant transport process, and implant release process of the implant release device, taking the implant release device including the second housing 1 and the first housing 2 as an example.

[0104] In the loaded state, the second housing 1 is separated from the first housing 2. In an ice-water environment, the guide member 4 is squeezed proximally, compressing the elastic member 6 and simultaneously loading the implant into the implant loading area of ​​the first housing 2. The proximal end of the implant is located within the inner cavity of the first housing 2, and the distal end is located within the inner cavity of the second housing 1. The connecting line between the implant and the positioning member passes through a slide rail on the side wall of the first housing 2. Subsequently, the second housing 1 and the first housing 2 are interlocked, with the distal portion of the first housing 2 fitting into the proximal inner cavity of the second housing 1, forming a connection. At this point, the implant is completely enclosed within the implant loading area formed by the second housing 1 and the first housing 2.

[0105] During delivery, the guidewire passes through the manipulator 5 and the second housing 1, extending from the distal end of the second housing 1 to the target location on the blood vessel. Simultaneously, the outer tube 3 and the manipulator 5 are driven, propelling the second housing 1, the first housing 2, and the loaded implant along the distal end of the blood vessel. The second housing 1 remains connected to the first housing 2, and the implant is completely enclosed within the implant loading area formed by the second housing 1 and the first housing 2, isolating it from the external vascular environment. The guide member 4 radially constrains the manipulator 5, ensuring that the manipulator 5 remains concentric with the first housing 2 and preventing the manipulator 5 from tilting due to device bending during delivery.

[0106] Once the device is delivered to the target location, the release operation begins. The outer tube 3 moves proximally and / or the actuating member 5 moves distally, causing the second housing 1 to move distally and / or the first housing 2 to move proximally, gradually separating the second housing 1 from the first housing 2. During the proximal movement of the first housing 2, the elastic member 6 gradually recovers its natural shape from a compressed state under normal body temperature. The elastic restoring force of the elastic member 6 drives the guide member 4 to move distally along the inner cavity of the first housing 2, pushing the implant distally. As the guide member 4 moves distally along the inner cavity of the first housing 2, its distal end continuously acts on the actuating member 5, ensuring that the actuating member 5 remains concentric with the first housing 2 during release. This prevents the actuating member 5 from bending towards the small bend relative to the first housing 2 during release, thus preventing the implant from being clamped on the proximal small bend side and avoiding jamming.

[0107] After the outer tube 3 moves a preset distance proximally and / or the manipulator 5 moves a preset distance distally, the second housing 1 is completely separated from the first housing 2, and the implant is fully released to the target position. After release, the device is withdrawn, completing the implantation surgery.

[0108] Example 2 Based on Example 1, this example discloses an implant release device. The difference between this example and Example 1 lies in the specific structure of the guide portion.

[0109] Reference Figure 11 and Figure 12 In this embodiment, the guide portion includes a constraint groove 405, meaning the constraint cavity 401 can be replaced by the constraint groove 405. The pre-bending direction of the operating member 5 faces the constraint groove 405 and is radially constrained by it. The operating member 5 abuts against the constraint groove 405. After the second housing 1 separates from the first housing 2, the constraint groove 405 restricts and corrects the bending tendency of the operating member 5, thus preventing lateral bending of the operating member 5 and preventing radial compression of the implant on one side during implant release. This achieves the same technical effect as the constraint cavity in Embodiment 1, and also solves the problem of asynchronous implant clamping and release caused by bending of the operating member, reducing the risk of positional displacement during implant release and improving the accuracy of implant positioning.

[0110] Example 3 Based on Example 1, this example discloses an implant release device. The difference between this example and Example 1 lies in the specific structure of the guide portion.

[0111] Reference Figure 13 and Figure 14 In this embodiment, the guide portion includes a guide ring 406, and at least one guide ring 406 is provided, through which the operating member 5 passes. When multiple guide rings 406 are provided, each guide ring 406 is spaced apart on the operating member 5 along the axial direction of the operating member 5.

[0112] Each guide ring limits the sidewall of the manipulator 5 from different axial positions. This multi-point constraint effectively prevents lateral bending of the middle section of the long manipulator 5 during axial downward movement, maximizing the limitation of the radial displacement of the manipulator 5. Even when releasing large implants with long strokes of the manipulator 5, the movement direction of the manipulator 5 can be stably maintained, preventing the manipulator 5 from tilting and squeezing the implant on one side. This ensures uniform force on both sides of the implant, making the implant release process synchronous and controllable. It further reduces the risk of positional deviation during implant release, steadily improves the accuracy of implant positioning, and can adapt to the release needs of more implants of different sizes.

[0113] Example 4 Based on Embodiment 1, Embodiment 2, or Embodiment 3, this embodiment discloses an implant release device. The difference between this embodiment and Embodiment 1 lies in the specific structure of the first housing 2.

[0114] In this embodiment, the first housing 2 is an expandable component. The first housing 2 has a folded configuration for loading the implant 7 and an unfolded configuration for releasing the implant 7. When the second housing 1 is connected to the first housing 2, the first housing 2 is radially constrained by the second housing 1 and is in the folded configuration. When the second housing 1 is separated from the first housing 2, the first housing 2 is in the unfolded configuration. This structural design, which achieves configuration switching of the first housing 2 through the connection and separation of the second housing 1 and the first housing 2, eliminates the need for an additional independent expansion drive component, significantly simplifying the overall structure of the release device. After the second housing 1 separates from the first housing 2, the first housing 2 can automatically switch from the folded configuration to the unfolded configuration using its own preset elastic expansion force, quickly completing the in-situ release of the implant 7 without requiring additional release operations by the surgeon. This effectively avoids implant 7 positioning deviation caused by manual intervention during the operation, significantly improving the accuracy of the implant 7 release position.

[0115] Furthermore, such as Figures 5 to 7 As shown, the first housing 2 includes: a converging portion 201; and multiple extendable skeletons 202, one end of each of the multiple extendable skeletons 202 being connected to the converging portion 201 and circumferentially distributed on the converging portion 201, and the other ends being close together within the first inner cavity 101. The multiple extendable skeletons 202 and the converging portion 201 together form a second inner cavity 2021. When releasing the implant 7, after pushing the manipulating member 5 distally and / or retracting the first housing 2 proximally, the second housing 1 separates from the first housing 2, and the distal ends of the extendable skeletons 202 move away from each other due to the lack of constraint, allowing the implant 7 to be released in place. This makes the release of the implant 7 more uniform and synchronous, further improving the accuracy and reliability of the release of the implant 7. Moreover, the simultaneous arrangement of the first housing 2 and the guiding member 4 provides multiple safeguards, making the entire release device safer and more reliable, ultimately achieving faster, more coaxial, and more predictable precise anchoring of the implant 7, greatly improving the success rate of the surgery. Of course, the expandable frame 202 can also be replaced with other non-expandable structures, but expandable is better.

[0116] Furthermore, the deployable skeleton 202 is made of shape memory material. When the second shell 1 releases the radial constraint on the first shell 2, the deployable skeleton 202 automatically unfolds under the shape memory effect, causing the first shell 2 to switch from a folded configuration to an unfolded configuration. The application of shape memory material allows the unfolding process of the first shell 2 to be driven entirely by the physical properties of the material itself, without the need for an additional driving mechanism, making the unfolding process smooth and controllable.

[0117] Furthermore, both the collection section 201 and the expandable skeleton 202 are made of nickel-titanium alloy. Nickel-titanium alloy exhibits superelasticity and shape memory effect. After undergoing plastic deformation at low temperatures, the nickel-titanium alloy can completely recover to the pre-set shape at high temperatures when the ambient temperature reaches above the phase transition temperature. When the first shell 2 enters the human body environment, the body temperature allows the expandable skeleton 202 to return to its original shape, thus allowing it to unfold immediately after the second shell 1 detaches from the first shell 2. Compared to other elastic materials, the nickel-titanium alloy collection section 201 and expandable skeleton 202 enable higher efficiency and reliability in the release of the implant 7.

[0118] Furthermore, a suture cavity 2022 is formed between two adjacent extendable skeletons 202, and the second inner cavity 2021 is connected to the external space of the first housing 2 through the suture cavity 2022. The suture cavity 2022 is used for the connecting wires on the implant 7 to pass through, so as to avoid release jamming.

[0119] Optionally, three threading cavities 2022 are provided and distributed at 120° intervals. Of course, the number of threading cavities 2022 is not limited to three; it can also be two, four, etc., and the specific number can be set according to actual needs.

[0120] Additionally, it should be noted that this embodiment may retain the guide member 4 and the elastic member 6, or it may omit the guide member 4 and the elastic member 6. When the guide member 4 and the elastic member 6 are omitted, when the implant is delivered to the target position, the outer tube 3 and the first shell 2 are retracted proximally, while the second shell 1 is pushed distally, which allows each of the extendable skeletons 202 to unfold, thereby achieving in-situ release of the implant.

[0121] 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 implant release device, characterized in that, include: First shell (2); A control member (5) passes through the inner cavity of the first housing (2); A guide member (4) is at least partially disposed within the first housing (2). The guide member (4) is provided with a guide portion, which is arranged along the axial direction of the inner cavity of the first housing (2). The operating member (5) cooperates with the guide portion and is radially constrained by the guide portion.

2. The implant release device according to claim 1, characterized in that, The guide member (4) includes a radial constraint kit, and the guide portion includes a constraint cavity (401). The constraint cavity (401) is disposed within the radial constraint kit. The axis of the constraint cavity (401) is parallel to or coincides with the axis of the inner cavity of the first housing (2). The operating member (5) passes through the constraint cavity (401).

3. The implant release device according to claim 1, characterized in that, The guide portion includes a constraint groove (405) disposed on the wall surface of the guide member (4). The operating member (5) is slidably adapted to the constraint groove (405). The pre-bending direction of the operating member (5) is toward the constraint groove (405) and is radially constrained by the constraint groove (405).

4. The implant release device according to claim 1, characterized in that, The guide portion includes a guide ring (406), the guide ring (406) is provided with at least one, and the operating member (5) passes through the guide ring (406); When multiple guide rings (406) are provided, each guide ring (406) is spaced apart on the operating member (5) along the axial direction of the operating member (5).

5. The implant release device according to claim 1, characterized in that, Also includes: The second housing (1) is detachably fitted with the first housing (2), and the second housing (1) and the first housing (2) have a connected state and a separated state; One end of the operating member (5) passes through the inner cavity of the first housing (2) and is connected to the second housing (1).

6. The implant release device according to claim 5, characterized in that, The outer periphery of the guide member (4) is provided with a guide ring (402), and the outer peripheral wall of the guide ring (402) slides in cooperation with the inner peripheral wall of the first housing (2).

7. The implant release device according to claim 6, characterized in that, The guide ring (402) divides the inner cavity of the first housing (2) from the proximal end to the distal end into a first cavity and a second cavity, and the second cavity and the inner cavity of the second housing (1) enclose the implant loading area.

8. The implant release device according to claim 1, characterized in that, The guide member (4) is provided with an extension, which is arranged along the inner cavity axis of the first housing (2), and the guide is provided on the extension.

9. The implant release device according to claim 8, characterized in that, The extension includes a first extension (403), the outer periphery of which is provided with a first cylindrical surface. The first extension (403) is coaxial with the inner cavity of the first housing (2) and is located inside the inner cavity of the first housing (2).

10. The implant release device according to claim 9, characterized in that, The extension also includes a second extension (404), which is disposed at the distal end of the first extension (403), and the outer diameter of the second extension (404) gradually decreases from the proximal end to the distal end.

11. The implant release device according to claim 1, characterized in that, The guide portion is coaxial with the inner cavity of the first housing (2).

12. The implant release device according to claim 5, characterized in that, When the second housing (1) is connected to the first housing (2), the guide member (4) extends into the second housing (1).

13. The implant release device according to claim 5, characterized in that, It also includes an elastic element (6), which is disposed inside the first housing (2). One end of the elastic element (6) is connected to or abuts against the inner wall of the first housing (2), and the other end is connected to or abuts against the end of the guide member (4) facing away from the second housing (1). The guide member (4) is at least partially slidably disposed inside the first housing (2).

14. The implant release device according to claim 13, characterized in that, The elastic element (6) is a spring structure, and the elastic element (6) is sleeved on the outer periphery of the operating member (5).

15. The implant release device according to claim 14, characterized in that, The elastic element (6) is made of nickel-titanium alloy.

16. The implant release device according to claim 5, characterized in that, When the second housing (1) is connected to the first housing (2), the inner cavity axis of the second housing (1) is coaxial with the inner cavity axis of the first housing (2).

17. The implant release device according to claim 5, characterized in that, The second housing (1) is sleeved, plugged into, or snapped into the first housing (2).

18. The implant release device according to claim 5, characterized in that, When the second housing (1) is connected to the first housing (2), the end of the second housing (1) facing the first housing (2) extends into the inner cavity of the first housing (2).

19. The implant release device according to claim 5, characterized in that, When the second housing (1) is connected to the first housing (2), one end of the first housing (2) facing the second housing (1) extends into the inner cavity of the second housing (1).

20. The implant release device according to claim 19, characterized in that, The first housing (2) is an expandable member, and the first housing (2) has a folding configuration for loading the implant and an unfolding configuration for releasing the implant; When the second housing (1) and the first housing (2) are connected, the first housing (2) is radially constrained by the second housing (1) and the first housing (2) is in a folded configuration; when the second housing (1) and the first housing (2) are separated, the first housing (2) is in an unfolded configuration.

21. The implant release device according to claim 20, characterized in that, The first housing (2) includes: Collection Department (201); Multiple extendable skeletons (202) are provided. One end of each of the multiple extendable skeletons (202) is connected to the gathering part (201) and is distributed circumferentially on the gathering part (201). The other end is close to each other in the inner cavity of the second shell (1). The multiple extendable skeletons (202) and the gathering part (201) together form the inner cavity of the first shell (2).

22. The implant release device according to claim 21, characterized in that, The expandable skeleton (202) is made of shape memory material. When the second shell (1) releases the radial constraint on the first shell (2), the expandable skeleton (202) automatically unfolds under the shape memory effect, causing the first shell (2) to switch from a folded configuration to an unfolded configuration.

23. The implant release device according to claim 22, characterized in that, Both the collection section (201) and the extendable frame (202) are made of nickel-titanium alloy.

24. The implant release device according to claim 21, characterized in that, A threading cavity (2022) is formed between two adjacent outwardly extendable skeletons (202), and the inner cavity of the first housing (2) is connected to the external space of the first housing (2) through the threading cavity (2022).

25. The implant release device according to claim 5, characterized in that, The inner wall of the second housing (1) is provided with a guide cone surface (1011) at the proximal end, and the inner diameter of the guide cone surface (1011) gradually decreases from the proximal end to the distal end.

26. The implant release device according to claim 25, characterized in that, The inner wall of the second housing (1) is also provided with a second cylindrical surface (1012), which is connected to the far end of the guide cone surface (1011).

27. The implant release device according to claim 5, characterized in that, The operating member (5) is located within the inner cavity of the second housing (1) and is coaxially connected to the inner cavity of the second housing (1).

28. The implant release device according to claim 27, characterized in that, The distal end of the operating member (5) is located inside the cavity of the second housing (1), and this end is connected to the distal wall of the second housing (1).

29. The implant release device according to claim 5, characterized in that, It also includes an outer tube (3), one end of which is connected to the end of the first housing (2) facing away from the second housing (1). One end of the operating member (5) passes through the inner cavity of the outer tube (3), the inner cavity of the first housing (2) and the guide portion in sequence, and then connects to the second housing (1).

30. The implant release device according to any one of claims 1 to 29, characterized in that, The distal end of the first housing (2) is a polygonal structure with a constant inner diameter but a gradually decreasing outer diameter; or The distal end of the first housing (2) is a columnar structure with a constant inner diameter.

31. The implant release device according to any one of claims 1 to 29, characterized in that, The inner diameter of the first housing (2) gradually increases from the proximal end to the distal end.

Images