Pre-loading systems and methods for artificial heart valves

Abstract

This application relates to a pre-loading system and method for artificial heart valves. The pre-loading system includes: an artificial heart valve with a deformable structure and relative expansion and compression states; a first delivery device including a catheter assembly suitable for interventional delivery and a control handle connected to the proximal end of the catheter assembly, the catheter assembly having relative distal and proximal ends, the artificial heart valve being loaded in a compressed state at the distal end of the catheter assembly; and a second delivery device including a sheath slidably fitted around the periphery of the catheter assembly and a connector fixed to the proximal end of the sheath, the sheath enveloping the artificial heart valve and holding it in a compressed state. This application simplifies the on-site operation process for doctors or assistants during surgery, reduces the risk of errors, and improves operational efficiency.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a pre-loading system and method for an artificial heart valve. Background Technology

[0002] Cardiovascular interventional techniques are constantly evolving, especially transcatheter aortic valve replacement (TAVR) and related techniques, which have attracted much attention. During heart valve replacement surgery, physicians or assistants need to locate and install the artificial valve on-site. Current procedures require loading the artificial valve into the catheter assembly. Due to the lack of pre-planning and pre-loading mechanisms, a series of complex operations, including valve selection, pre-treatment, and loading into the catheter assembly, are often performed intraoperatively.

[0003] At any stage of the loading process, subjective judgment and operational proficiency can lead to connection deviations or excessively long loading times. This necessitates specialized training for medical personnel, resulting in high learning costs. More often, the manufacturer's technical personnel provide guidance or operate the equipment on-site during surgery, which not only increases costs but also significantly limits the product's widespread application. Summary of the Invention

[0004] This application provides a pre-installation system for an artificial heart valve that can further improve ease of operation.

[0005] This application discloses a pre-installed artificial heart valve system, comprising: An artificial heart valve, wherein the artificial heart valve has a deformable structure and has a relative expansion state and a compression state; A first delivery device includes a catheter assembly suitable for interventional delivery and a control handle connected to the proximal end of the catheter assembly, the catheter assembly having opposing distal and proximal ends, and the artificial heart valve being loaded in a compressed state at the distal end of the catheter assembly. The second delivery device includes a sheath that is slidably sleeved around the periphery of the catheter assembly and a connector fixed to the proximal end of the sheath. The sheath wraps around the artificial heart valve and holds the artificial heart valve in a compressed state.

[0006] Several alternative methods are provided below, but they are not intended as additional limitations on the overall solution above. They are merely further additions or optimizations. Provided there are no technical or logical contradictions, each alternative method can be combined individually with respect to the overall solution above, or multiple alternative methods can be combined with each other.

[0007] Optionally, the second conveying device has the following relative position to the first conveying device: In the combined state, the conduit assembly penetrates the second delivery device; In the separated state, relative to the combined state, the catheter assembly moves proximally and detaches from the second delivery device.

[0008] Optionally, the sheath has a length of 60cm to 120cm, and in the coupled state, the sheath has the following characteristics relative to the artificial heart valve: The sheath encloses the artificial heart valve at the loading position; The release position, relative to the loading position, further shifts the sheath proximally and exposes the artificial heart valve.

[0009] Optionally, the distal end of the catheter assembly has a guide head, which, in the coupled state, is located on the distal side of the sheath. The guide head is a deformable structure with the following characteristics: A preset shape is provided so that the distal end of the sheath abuts against and blocks the sheath along the axial direction; The shape is converging radially relative to a preset shape and is able to enter the sheath, allowing the second delivery device to tend towards a separation state.

[0010] Optionally, the guide head is made of an elastically deformable material, which can switch between a preset shape and a folded shape through elastic deformation.

[0011] The guide head has a core hole inside for the guide wire to extend, and the cross-section of the core hole is reduced in the folded shape compared to the preset state.

[0012] At least a portion of the core hole is an enlarged diameter region to absorb the deformation of the guide head.

[0013] Optionally, the guide head has a limiting step on its outer periphery, and the guide head, in a preset shape, prevents the sheath from moving relative to the distal end through the limiting step.

[0014] Optionally, the guide head has a deformation absorption zone inside. When the guide head deforms, the limiting step collapses radially into the deformation absorption zone to prevent the sheath from moving relative to the distal end.

[0015] Optionally, the step surface of the limiting step is a conical surface, and it gradually converges towards the proximal end.

[0016] Optionally, the outer periphery of the guide head is provided with a deformation release groove.

[0017] Optionally, the deformation relief groove extends axially and / or circumferentially.

[0018] Optionally, the guide head can be controlled to deform.

[0019] Optionally, a transmission component is connected between the guide head and the control handle, and the guide head is driven to deform through the transmission component.

[0020] Optionally, the guide head is heated by an electrical signal to deform accordingly.

[0021] Optionally, the guide head has a hollow structure and includes, from the inside to the outside, a support frame made of shape memory alloy, an electric heating layer, and a heat insulation coating layer in the radial direction.

[0022] Optionally, the guide head is constructed as a radially deformable metal mesh cage.

[0023] Optionally, the guide head is double-conical, with its shape gradually converging at both ends along the axial direction.

[0024] Optionally, the metal mesh cage structure is made of woven metal wire or cut metal tubing.

[0025] Optionally, the catheter assembly includes: Core tube, the interior of which is a guide wire channel; A balloon body is located on the outer periphery of the core tube, and the distal end of the balloon body is sealed to the core tube. The artificial heart valve is sleeved on the outer periphery of the balloon body. An extension tube is located on the outer periphery of the core tube and is connected to the proximal end of the balloon body. The extension tube and the core tube form a fluid channel for delivering fluid into the balloon body.

[0026] Optionally, the interior of the balloon body is further provided with an axial limiting member connected to the core tube.

[0027] Optionally, the catheter assembly includes: Core tube, the interior of which is a guide wire channel; A balloon body is located on the outer periphery of the core tube, and the distal end of the balloon body is sealed to the core tube. An extension tube is located on the outer periphery of the core tube and is connected to the proximal end of the balloon body. The artificial heart valve is sleeved on the outer periphery of the extension tube and located on the proximal side of the balloon body. The extension tube and the core tube form a fluid channel for delivering fluid into the balloon body. The push tube is slidably sleeved on the outer periphery of the extension tube and located on the proximal side of the artificial heart valve, and is used to push the artificial heart valve to the outer periphery of the balloon body.

[0028] Optionally, the catheter assembly includes: Core tube, the interior of which is a guide wire channel; A connector is fixed to the core tube, and the artificial heart valve is sleeved on the outer periphery of the core tube and located on the distal side of the connector. A releasable positioning connection is formed between the artificial heart valve and the connector.

[0029] Optionally, the catheter assembly further includes: A loading tube is slidably disposed on the periphery of the artificial heart valve, and the distal end of the loading tube wraps around the artificial heart valve during interventional delivery.

[0030] Optionally, the length of the sheath may extend at least to carry the artificial heart valve to a predetermined implantation site, or the length of the sheath may extend to carry the artificial heart valve to an adjacent predetermined implantation site.

[0031] Optionally, the length of the sheath is 30cm to 120cm.

[0032] Optionally, the length of the sheath is 40cm to 90cm.

[0033] Optionally, the length of the sheath is 60cm to 100cm.

[0034] Optionally, the length of the sheath is 50cm to 70cm.

[0035] Optionally, the length of the sheath is 30cm to 50cm.

[0036] Optionally, the distal portion of the sheath has a structural reinforcement section.

[0037] Optionally, the structural reinforcement section is located at the distal end of the sheath.

[0038] Optionally, the sheath, in the loaded position, wraps around the artificial heart valve through the structural reinforcement section.

[0039] Optionally, the structural reinforcement section is constructed by embedding a layer of reinforcing material in the wall of the sheath.

[0040] Optionally, the distal end of the sheath has a deformable expansion structure.

[0041] Optionally, the expansion structure includes a plurality of elastic sheets arranged circumferentially, the distal ends of which can be turned outward or brought together relative to each other.

[0042] This application also provides a method for preloading an artificial heart valve, including: An artificial heart valve and a first delivery device with a catheter assembly are provided, the artificial heart valve having a deformable structure and having a relative expanded state and a compressed state. The artificial heart valve is fitted into the catheter assembly in a compressed state; A second delivery device with a sheath is provided to fit the sheath onto the catheter assembly and enclose the artificial heart valve.

[0043] This application also provides a method for deploying an artificial heart valve, including: Provides a pre-installed system for the artificial heart valve described in this application; The artificial heart valve is delivered via the first delivery device and the second delivery device; The first delivery device and the second delivery device are slid relative to each other, so that the artificial heart valve is exposed to the second delivery device; Drive the artificial heart valve to an expanded state and position it in the desired location.

[0044] This application also provides a method for deploying an artificial heart valve based on in vitro simulation, comprising: Provides a heart model and a pre-installed system for the artificial heart valve described in this application; The artificial heart valve is delivered into the heart model via the first delivery device and the second delivery device; The first delivery device and the second delivery device are slid relative to each other, so that the artificial heart valve is exposed to the second delivery device; Drive the artificial heart valve to an expanded state and position it at the intended location within the heart model.

[0045] Optionally, the deployment method further includes: While keeping the second conveying device in the engaged state, slide the first conveying device relative to it to separate the first conveying device from the second conveying device.

[0046] In the fully pre-installed system of this application, the interventional delivery and in vivo deployment of the artificial heart valve are achieved through the cooperation of the first delivery device and the second delivery device. This simplifies the on-site operation process for doctors or assistants during surgery, reduces the risk of errors, and improves operational efficiency. Attached Figure Description

[0047] To more clearly illustrate the technical solutions in the embodiments of this application or the conventional technology, the drawings used in the description of the embodiments or the conventional technology will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0048] Figure 1 This is a schematic diagram of the structure of a pre-installed system in one embodiment of this application; Figure 2 for Figure 1 Enlarged view of the mid-to-distal region; Figure 3 for Figure 1A schematic diagram showing the second delivery device moving proximally relative to the first delivery device, exposing the artificial heart valve. Figure 4 for Figure 3 Enlarged view of the mid-to-distal region; Figure 5 for Figure 4 A schematic diagram of an artificial heart valve in an expanded state; Figure 6 for Figure 3 A schematic diagram showing the first conveying device moving proximally relative to the second conveying device to close the distal end of the sheath. Figure 7 A schematic diagram of the internal structure of the head before deformation; Figure 8 for Figure 7 A schematic diagram showing the guide head deforming and entering the sheath. Figure 9 This is a schematic diagram of the guide head deforming and entering the sheath in another embodiment of this application; Figure 10 This is a schematic diagram of the sheath structure in another embodiment of this application; Figure 11 This is a partial schematic diagram of the first conveying device in another embodiment of this application; Figure 12 This is a partial schematic diagram of the first conveying device in another embodiment of this application; Figure 13 This is a schematic diagram of a transcatheter implantation of an artificial aortic valve using the pre-loaded system of this application; Figure 14 for Figure 13 A schematic diagram of an artificial heart valve in an expanded state; Figure 15 for Figure 14 A schematic diagram of the first conveyor retracting towards the near end; Figure 16 for Figure 15 A schematic diagram of the first conveyor device detaching from the second conveyor device; Figure 17 This is a schematic diagram of the pre-installed system in another embodiment of this application; Figure 18 for Figure 17 A schematic diagram showing the proximal movement of the sheath to expose the artificial heart valve; Figure 19 for Figure 18 A schematic diagram showing the loading tube moving proximally to expose the artificial heart valve; Figure 20 for Figure 17 A schematic diagram of the pre-installed system in use within the body; Figure 21This is a schematic diagram of the pre-installed system in another embodiment of this application.

[0049] The component labels are as follows: 100. Heart; 110. Aorta; 120. Native aortic valve; 200. Artificial heart valve; 210. Stent; 220. Positioning component; 300. First conveying device; 310. Core tube; 311. Guide head; 312. Core hole; 313. Diameter expansion zone; 314. Limiting step; 315. Deformation release groove; 320. Balloon body; 321. Axial limiting component; 330. Extension tube; 340. Pushing tube; 350. Loading tube; 351. Transmission component; 360. Guide wire; 370. Control handle; 400. Second conveying device; 410. Sheath; 411. Reinforcing section; 412. Elastic sheet; 420. Connecting seat; 421. Branch pipe. Detailed Implementation

[0050] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0051] It should be noted that when a component is referred to as being "fixed to" or "set on" another component, it can be directly on the other component or there may be an intermediate component. When a component is considered to be "connected to" another component, it can be directly connected to the other component or there may be an intermediate component present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used in this application's specification are for illustrative purposes only and do not represent the only possible implementation.

[0052] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0053] Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in this application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The term "and / or" as used in this application includes any and all combinations of one or more of the associated listed items.

[0054] See Figures 1-6 One embodiment of this application provides a pre-installation system for an artificial heart valve that can improve the ease of operation. The pre-installation system includes an artificial heart valve 200, a first delivery device 300, and a second delivery device 400.

[0055] The artificial heart valve 200 itself can incorporate existing technologies. For example, the artificial heart valve 200 includes a stent and leaflets connected to the stent. The stent is a radially deformable cylindrical structure, which can be made by cutting metal tubing or weaving metal wires. The interior of the stent is a blood flow channel. The leaflets are one or more pieces, which are used within the cylindrical structure to control the opening and closing of the blood flow channel. The leaflets can be made of biomaterials or polymer materials. When using biomaterials, they can be made into a dry membrane form to accommodate pre-loading.

[0056] The artificial heart valve 200 can be deployed in vivo via self-expansion or bulb expansion, with the material and actuation method chosen adaptively. Some embodiments described below use bulb expansion as an example, where the stent can be made of cobalt-chromium alloy or molybdenum-rhenium alloy. The artificial heart valve 200 has a relative expansion state and a compression state suitable for interventional delivery, depending on its diameter.

[0057] The pre-installed system and related components have a relatively distal end (away from the operator during use) and a proximal end (closer to the operator during use). The first delivery device 300 includes a catheter assembly suitable for interventional delivery and a control handle 370 connected to the proximal end of the catheter assembly. The artificial heart valve 200 is loaded in a compressed state at the distal end of the catheter assembly.

[0058] The second delivery device 400 includes a sheath 410 slidably sleeved around the periphery of the catheter assembly and a connector 420 fixed to the proximal end of the sheath 410. The sheath 410 encloses the artificial heart valve 200 and holds the artificial heart valve 200 in a compressed state. The connector 420 itself has no strict structural limitations, making it easy to hold and operate the sheath 410. The connector 420 itself has a channel communicating with the inner lumen of the sheath 410 for the catheter assembly to pass through, or the connector 420 is located on one side of the radial direction of the sheath 410 to avoid the catheter assembly.

[0059] When the catheter assembly passes through the channel inside the connector 420, a hemostatic valve can be provided inside the connector 420 to close the radial gap with the catheter assembly. The connector 420 can also be provided with a branch tube 421 for connecting to external equipment to perform perfusion, venting, or sampling, etc.

[0060] In this embodiment, the artificial heart valve 200 is pre-installed in a compressed state within the radial gap between the catheter assembly and the sheath 410, reducing cumbersome preparation work at the surgical site. During interventional surgery, the sheath 410 and the artificial heart valve 200 enter the body together, eliminating the need for separate delivery and deployment of a separate guide sheath. Overall, this reduces the number of times the outermost tubing (which is in direct contact with the blood vessel, i.e., the sheath 410 in this application) enters and exits the body during the procedure, while also reducing the number of surgical operations and auxiliary accessories required, thus improving surgical efficiency. The sheath 410 not only constructs a temporary channel within the body but also encapsulates and carries the artificial heart valve 200, relatively reducing the number of external tubing components around the artificial heart valve 200 and decreasing the size of the instruments that the blood vessel must tolerate, further improving safety. After the artificial heart valve 200 is deployed within the body, the first delivery device 300 can be separated from the second delivery device 400 while still maintaining the temporary channel within the body for subsequent operations, making the overall usage more flexible.

[0061] In existing technologies, a temporary channel needs to be constructed within the blood vessel using a separate catheter sheath before the artificial heart valve 200 is delivered. This not only increases system complexity but also adds extra operational steps. In this embodiment, since the first delivery device 300 and the second delivery device 400 simultaneously carry the artificial heart valve 200 into the body, the channel construction and delivery are essentially synchronized, improving surgical efficiency and simplifying the entire interventional system. Furthermore, the maximum size of the system is reduced, improving interventional accessibility and reducing surgical difficulty.

[0062] The second delivery device 400 and the first delivery device 300 are axially slidingly engaged (extending between the distal and proximal ends), for example, they have opposing engaged and disengaged states. In the engaged state, the catheter assembly extends entirely through the second delivery device 400, for example, at least a portion of the catheter assembly in the first delivery device 300 is located on the distal side of the sheath 410, while the control handle 370 in the first delivery device 300 is located on the proximal side of the connector 420. In the disengaged state, the first delivery device 300 can detach from the second delivery device 400 after the catheter assembly moves proximally.

[0063] Since the second delivery device 400 and the first delivery device 300 are in sliding engagement, they have at least different relative positions when engaged due to changes in their relative positions. For example, the sheath 410 has a relative loading position and a release position relative to the artificial heart valve 200.

[0064] like Figure 1 , Figure 2 As shown, in the loading position, the sheath 410 wraps around the artificial heart valve 200, for example, during storage and transportation after the product has been manufactured and packaged, and during surgical delivery. The sheath 410 wraps around the artificial heart valve 200 and keeps the artificial heart valve 200 in a compressed state.

[0065] like Figure 3 , Figure 4 As shown, in the release position, relative to the loading position, the sheath 410 is further offset proximally and exposes the artificial heart valve 200. This exposure should be understood as the sheath 410 being misaligned with the artificial heart valve 200 in the axial position. When only the sheath 410 is outside the artificial heart valve 200, the artificial heart valve 200 is exposed to the environment. In some embodiments, there are other components outside the artificial heart valve 200 besides the sheath 410, so the artificial heart valve 200 is not exposed to the environment, but at least it is not wrapped or restrained by the sheath 410.

[0066] In this embodiment, the artificial heart valve 200 is released by a bulb expansion method. Based on its material characteristics, it can maintain itself in the compressed state. Therefore, in some cases, the second delivery device 400 and the first delivery device 300 can be stored and transported in a separate state, or in a combined state with the sheath 410 in the release position relative to the artificial heart valve 200. Only during the preoperative preparation work, the sheath 410 is slid to the loading position. This can avoid the artificial heart valve 200 being wrapped by the sheath 410 for a long time, which is conducive to maintaining the performance of the artificial heart valve 200 during long-term storage and transportation.

[0067] The catheter assembly includes one or more tubing components, and may also include solid rods or flexible leads as needed. Driven by the control handle 370, it is used for operations such as delivery, retrieval, or posture adjustment of the artificial heart valve 200. For example, the catheter assembly includes a core tube 310, a balloon body 320, and an extension tube 330.

[0068] The core tube 310 has a guidewire channel inside for the guidewire to pass through and guide the intervention path. A guide head 311 is fixed at the distal end of the core tube 310. The distal end of the guide head 311 has a converging shape to facilitate passage in the body. The balloon body 320 is located on the outer periphery of the core tube 310. The distal end of the balloon body 320 is sealed to the core tube 310. The extension tube 330 is located on the outer periphery of the core tube 310 and is connected to the proximal end of the balloon body 320. The proximal ends of both the extension tube 330 and the core tube 310 extend and are connected to the control handle 370. The space between the extension tube 330 and the core tube 310 is a fluid channel for delivering fluid into the balloon body 320.

[0069] During interventional delivery, the balloon body 320 is in a collapsed and folded state. The pre-loaded artificial heart valve 200 is compressed and fitted around the periphery of the balloon body 320. When the artificial heart valve 200 is expanded and released, the sheath 410 is switched to the release position relative to the artificial heart valve 200, and fluid is then delivered into the balloon body 320 via the fluid channel (see [reference]). Figure 5 (As indicated by the middle arrow), the inflated balloon 320 correspondingly drives the artificial heart valve 200 to expand radially.

[0070] After the artificial heart valve 200 is deployed in vivo, the first delivery device 300 can be retracted proximally relative to the second delivery device 400, as follows: Figure 6 As shown, after the guide head 311 has basically blocked the port of the sheath tube 410, the first delivery device 300 and the second delivery device 400 can be retracted proximally to the outside of the body.

[0071] See Figures 7-10 In some other embodiments of this application, after the artificial heart valve 200 is deployed in vivo, the second delivery device 400 is kept in its current position, i.e., at least a portion of the sheath 410 remains in the body to maintain the constructed interventional channel, while the first delivery device 300 is retracted only proximally until the first delivery device 300 is detached from the second delivery device 400, i.e., the two are in a separated state.

[0072] During product storage, transportation, and delivery, in order to position each other axially, the maximum diameter of the guide head 311 is greater than the inner diameter of the sheath 410. That is, in the combined state, the guide head 311 is located on the distal side of the sheath 410, which can prevent the sheath 410 from moving further to the distal end. In this embodiment, the guide head 311 is a deformable structure with a relatively preset shape and a retractable shape. In the preset shape, the maximum diameter of the guide head 311 is greater than the inner diameter of the sheath 410. The guide head 311 can be used to abut against the distal end of the sheath 410 and block the sheath 410 axially.

[0073] See Figure 7 After the artificial heart valve 200 is deployed in vivo, when the first delivery device 300 is withdrawn, the guide head 311 is blocked at the distal end of the sheath 410. Since the guide head 311 in this embodiment is a deformable structure, it can be radially retracted by further force or other driving methods, that is, switched to a retracted shape.

[0074] See Figure 8The guide head 311, in its retracted shape, can enter the sheath 410 to allow the second delivery device 400 to tend towards a separated state. The guide head 311 can be made of an elastically deformable material, switching between a preset shape and a retracted shape through elastic deformation. The interior of the guide head 311 has a core hole 312 (communicating with the guide wire channel within the core tube 310) for the guide wire 360 ​​to extend. In the retracted shape, the cross-section of the core hole 312 decreases. To further accommodate the deformation of the guide head 311 and to have sufficient deformation capacity, at least a portion of the core hole 312 is an enlarged diameter region 313, forming a larger cavity area inside the guide head 311 to absorb the deformation of the guide head 311.

[0075] The guide head 311 has a limiting step 314 on its outer periphery. The guide head 311, in a preset shape, prevents the sheath 410 from moving relative to the distal end through the limiting step 314. For example, the step surface of the limiting step 314 is a conical surface and gradually converges towards the proximal end.

[0076] See Figure 9 In another embodiment, the guide head 311 is provided with a deformation release groove 315 on its outer periphery. For example, the deformation release groove 315 extends along the axial and / or circumferential direction of the guide head 311. For example, the deformation release groove 315 is an annular groove extending along the circumferential direction of the guide head 311, and multiple deformation release grooves 315 may be arranged at intervals along the axial direction of the guide head 311. As another example, the deformation release groove 315 is a strip-shaped groove extending along the axial direction of the guide head 311, and multiple deformation release grooves 315 may be arranged at intervals along the circumferential direction of the guide head 311. In the folded shape, the adjacent parts of the deformation release groove 315 are correspondingly compressed and deformed, allowing the guide head 311 to enter the sheath tube 410.

[0077] In other embodiments, the guide head 311 is designed to be deformable. For example, a transmission component is connected between the guide head 311 and the control handle 370, and the guide head 311 is deformed by the transmission component.

[0078] In one embodiment, the guide head 311 can also be deformed by an electrical signal. For example, it can be deformed by heating with an electrical signal. In this embodiment, the guide head 311 adopts a composite structure of a shape memory alloy support frame, an electric heating layer, and a heat insulation coating layer. The support frame is made of medical nickel-titanium shape memory alloy and is made into a hollow mesh structure. The frame is pre-heat-set and is in a preset shape at body temperature. When it needs to be retracted to the proximal end, it can be energized to heat the electric heating layer (not exceeding 50 degrees Celsius to ensure safety), causing the guide head 311 to contract radially as a whole.

[0079] The heat insulation layer can be made of foam or membrane material to cover the heating wire and supporting frame inside the electric heating layer, with a thickness of 0.03~0.08mm. The heat insulation layer has a low thermal conductivity, which can concentrate the heat generated by the heating wire to the supporting frame, while preventing heat from diffusing to the surrounding human tissue and preventing heat damage.

[0080] In one embodiment, the guide head 311 is an overall radially deformable metal mesh cage structure. The metal mesh cage structure is made of woven metal wire or cut metal tubing and can be adaptively deformed under the action of the sheath tube 410 until it is pulled into the interior of the sheath tube 410 and moves towards the proximal side.

[0081] The metal mesh cage structure can be made by weaving medical-grade nickel-titanium shape memory alloy wire with a diameter of 0.1~0.2mm, or by laser cutting medical-grade nickel-titanium shape memory alloy tubing with an outer diameter of 3~5mm and a wall thickness of 0.15~0.25mm. Its mesh units are rhomboid in shape, with side lengths of 1~2mm. This allows the mesh cage to shrink in diameter by changing the angle of the mesh units as it contracts radially. The metal mesh cage structure is simple and reliable, requiring no additional drive components and relying solely on mechanical extrusion to achieve deformation, thus reducing the complexity and failure risk of the interventional system.

[0082] The total length of the sheath 410 in this application is 30cm to 120cm. For example, 40cm to 90cm, 60cm to 100cm, 50cm to 70cm, or 30cm to 50cm.

[0083] In some embodiments, the sheath 410 is at least long enough to extend and carry the artificial heart valve 200 to a predetermined implantation site, for example, after the artificial heart valve 200 has completed its transvalvular crossing, it is retracted proximally to expose the artificial heart valve 200. In other embodiments, the sheath 410 is long enough to extend and carry the artificial heart valve 200 to an adjacent predetermined implantation site, for example, the length of the sheath 410 is only enough to wrap around the artificial heart valve 200 and extend across the aortic arch, in which case the first delivery device 300 is pushed further distally to expose the artificial heart valve 200. The sheath 410 has sufficient length to assist in the delivery of the catheter assembly in vivo and to be close to the lesion. In some embodiments, the sheath 410 itself may also have a bending function or be pre-shaped according to physiological structural characteristics, which is more conducive to interventional delivery to improve surgical efficiency, and can also reduce the force with surrounding tissues, improve safety, and reduce potential risks.

[0084] To facilitate the positioning of the artificial heart valve 200 in the body, taking the artificial aortic valve as an example, a positioning component (such as a strip-shaped or U-shaped component connected to the stent) that can expand radially can be provided on the periphery of the stent. The positioning component can extend into the bottom of the valve sinus to perform positioning. The positioning component can also cooperate with the stent to clamp the original valve leaflet to optimize the positioning effect. When the sheath 410 has sufficient length, it can always wrap the positioning component before the pre-set implantation position to prevent it from expanding outward and interfering with the interventional delivery. The positioning component is only exposed through relative axial movement when it is near or reaches the pre-set implantation position. The positioning component can expand outward by self-expansion and enter the bottom of the corresponding valve sinus to perform positioning.

[0085] See Figure 8 To accommodate the deformation of the guide head 311, a structural reinforcement section 411 is provided at the distal end of the sheath 410. For example, a reinforcing material layer, such as a metal ring or fiber mesh, is embedded in the wall of the distal end of the sheath 410. The distal end of the sheath 410 can act on the limiting step 314 of the guide head 311, driving the guide head 311 to deform. In other embodiments, the structural reinforcement section 411 may be further distributed in a region corresponding to the circumferential position of the artificial heart valve 200, so that the sheath 410, in the loading position, wraps around the artificial heart valve 200 through the structural reinforcement section 411 to ensure a restraint effect.

[0086] See Figure 10 In other embodiments, the distal end of the sheath 410 has a deformable expansion structure to accommodate the deformation of the guide head 311. For example, the expansion structure includes a plurality of elastic sheets 412 arranged circumferentially, the distal ends of which can be turned outward or brought together relative to each other.

[0087] See Figure 11 In other embodiments, the catheter assembly includes: The core tube 310 has a guide wire channel inside, and the distal end of the core tube 310 has a guide head 311. The proximal end of the core tube 310 is connected to the control handle 370. The balloon body 320 is located on the outer periphery of the core tube 310, and the distal end of the balloon body 320 is sealed to the core tube 310. The extension tube 330 is located on the periphery of the core tube 310 and is connected to the proximal end of the balloon body 320. The proximal end of the extension tube 330 is connected to the control handle 370. The artificial heart valve 200 is sleeved on the periphery of the extension tube 330 and located on the proximal side of the balloon body 320. The extension tube 330 and the core tube 310 form a fluid channel for delivering fluid into the balloon body 320. The push tube 340 is slidably sleeved on the outer periphery of the extension tube 330 and located on the proximal side of the artificial heart valve 200. The proximal end of the push tube 340 is connected to and controlled by the control handle 370.

[0088] In this embodiment, during interventional delivery, the artificial heart valve 200 is located on the proximal side of the balloon body 320, which can further reduce the maximum outer diameter of the device and improve system compliance. When it is necessary to expand the artificial heart valve 200, the push tube 340 is operated by the control handle 370 to move distally, pushing the artificial heart valve 200 to the periphery of the balloon body 320.

[0089] See Figure 12 In some embodiments, the balloon body 320 is further provided with an axial limiting member 321 connected to the core tube 310. The axial limiting member 321 causes the balloon body 320 to expand radially outward at both ends of the artificial heart valve 200, and is slightly larger than the inner diameter of the artificial heart valve 200. This maintains the relative position of the artificial heart valve 200 and the balloon body 320, preventing unintended misalignment. The axial limiting member 321 is positioned by radially protruding relative to the core tube 310, and can be a shape memory alloy-made, radially expandable mesh or support arm.

[0090] To obtain the pre-installed systems of the embodiments described above, one embodiment of this application also provides a method for pre-installing an artificial heart valve, comprising: An artificial heart valve 200 and a first delivery device 300 with a catheter assembly are provided. The artificial heart valve 200 has a deformable structure and has a relative expansion state and a compression state. The artificial heart valve 200 is fitted into the catheter assembly in a compressed state; A second delivery device 400 with a sheath 410 is provided, which is fitted onto the catheter assembly and wraps around the artificial heart valve 200.

[0091] See Figures 13-16 This illustration demonstrates the process of performing interventional surgery using the pre-installed system of this application (similarly for in vitro simulated surgical training). It can also be understood that an embodiment of this application provides a method for deploying an artificial heart valve, or a method for deploying an artificial heart valve based on in vitro simulation. This embodiment uses an artificial aortic valve replacement surgery as an example. For aspects not detailed herein, refer to relevant operations of this type of surgery in the prior art. The deployment method of this embodiment includes: A pre-loading system for an artificial heart valve according to any of the embodiments described above is provided. For example, the pre-loading system includes a first delivery device 300 and a second delivery device 400 that can be used in conjunction with each other, and an artificial heart valve 200. The artificial heart valve 200 has a deformable structure and has a relatively expanded state and a compressed state. The first delivery device 300 includes a catheter assembly suitable for interventional delivery and a control handle 370 connected to the proximal end of the catheter assembly. The artificial heart valve 200 is loaded in a compressed state at the distal end of the catheter assembly. The second delivery device 400 includes a sheath 410 slidably sleeved on the periphery of the catheter assembly and a connecting seat 420 fixed to the proximal end of the sheath 410. The sheath 410 wraps around the artificial heart valve 200 and holds the artificial heart valve 200 in a compressed state.

[0092] The deployment method of this embodiment also includes delivering the artificial heart valve 200 along the guide wire 360 ​​via the first delivery device 300 and the second delivery device 400, for example, via the lower limb arteries, carotid arteries, etc. This embodiment takes delivery via the lower limb arteries as an example. Figure 13 As can be seen in heart 100, artificial heart valve 200 is delivered to native aortic valve 120 via aorta 110. During this process, depending on the length of sheath 410, the distal end of sheath 410 can extend to different positions. Figure 13 The length of the middle sheath 410 is sufficient to carry the artificial heart valve 200 across the valve for pre-positioning. In other embodiments, Figure 13 The length of the middle sheath 410 is at least sufficient to carry an artificial heart valve 200 across the aortic arch and adjacent to the native aortic valve 120.

[0093] Combination Figure 14 In this embodiment, the artificial heart valve 200 is released by balloon expansion. During operation, the first delivery device 300 and the second delivery device 400 are slid relative to each other, so that the artificial heart valve 200 is exposed to the second delivery device 400. For example, the connecting seat 420 can be retracted proximally relative to the control handle 370, and the artificial heart valve 200 is exposed to the sheath 410. After confirming that the spatial position of the artificial heart valve 200 meets the expectations, the balloon body 320 can be inflated, so that the artificial heart valve 200 is switched to the expanded state and positioned at the location of the native aortic valve 120.

[0094] Combination Figure 15 After the artificial heart valve 200 is in place, the first delivery device 300 and the second delivery device 400 can be withdrawn from the body together, or the second delivery device 400 can be kept in the intervention state, that is, the distal part of the sheath 410 is still kept in the body, and the first delivery device 300 is slid relative to it, that is, the control handle 370 is retracted proximally relative to the connecting seat 420 until the guide head 311 abuts against the sheath 410.

[0095] Combination Figure 16 Since the guide head 311 in this embodiment adopts a deformable structure, by applying further force, the guide head 311 can be deformed and enter the sheath 410. The control handle 370 can be retracted proximally relative to the connecting seat 420 until the first delivery device 300 and the second delivery device 400 are separated, while the distal end of the sheath 410 is still in the body. Based on this, other instruments can be delivered into the body along the guide wire 360 ​​and through the sheath 410 as needed. For example, after the artificial heart valve 200 is deployed, a coronary stent can be deployed, or other interventional instruments for auxiliary testing and measurement can be deployed.

[0096] The deployment method described in the above embodiments can also be implemented based on in vitro simulation. The main difference is that a heart model is provided, and the heart model is operated through the pre-installed system of this application.

[0097] In other embodiments of this application, the artificial heart valve 200 is deployed by self-expansion, and the stent of the artificial heart valve 200 is made of, for example, a nickel-titanium alloy. The catheter assembly accordingly includes: The core tube 310 has a guide wire channel inside. The distal end of the core tube 310 has a guide head 311, and the proximal end is connected to the control handle 370. The connector is fixed to the core tube 310. The artificial heart valve 200 is sleeved on the outer periphery of the core tube 310 and located on the distal side of the connector. The artificial heart valve 200 and the connector are releasable positioning connections, such as by means of snap-fit ​​or wire control.

[0098] During deployment in the body, the artificial heart valve 200 is carried to a preset position in the body via the first delivery device 300 and the second delivery device 400. The sheath 410 is then retracted proximally to expose the artificial heart valve 200. The artificial heart valve 200 is decoupled from the connector and tends to a predetermined posture according to its own material properties to complete the deployment.

[0099] See Figures 17-20 In other embodiments of this application, the catheter assembly includes: The core tube 310 has a guide wire channel inside and a guide head 311 at its distal end. The balloon body 320 is located on the outer periphery of the core tube 310, and the distal end of the balloon body 320 is sealed to the core tube 310. The extension tube 330 is located on the outer periphery of the core tube 310 and is connected to the proximal end of the balloon body 320. The artificial heart valve 200 is sleeved on the outer periphery of the extension tube 330 and located on the proximal side of the balloon body 320. The extension tube 330 and the core tube 310 form a fluid channel for delivering fluid into the balloon body 320. The loading tube 350 is slidably disposed on the periphery of the artificial heart valve 200, and during interventional delivery, the distal end of the loading tube 350 wraps around the artificial heart valve 200.

[0100] The proximal ends of the core tube 310, extension tube 330, and loading tube 350 are all connected to the control handle 370. After pre-installation, the sheath tube 410 wraps around the loading tube 350.

[0101] See Figure 18 When the artificial heart valve 200 is deployed in the body, the sheath 410 first moves proximally relative to the artificial heart valve 200 and exposes the artificial heart valve 200, but at this time the artificial heart valve 200 is still wrapped by the loading tube 350.

[0102] See Figure 19 The loading tube 350 then moves proximally relative to the artificial heart valve 200, exposing the artificial heart valve 200 to the in vivo environment. Finally, the artificial heart valve 200 is expanded by the balloon body 320 to complete the deployment. In this embodiment, if the artificial heart valve 200 is made of memory material, it can also self-expand and release when exposed to the in vivo environment without the need for a balloon body.

[0103] See Figure 21 In another embodiment of this application, a positioning component 220 may be provided on the outer periphery of the stent 210 in conjunction with the foregoing description. During interventional delivery, the positioning component 220 is held within the radial gap between the sheath 410 and the loading tube 350. When it is near or reaches the preset implantation position, the sheath 410 can expose the positioning component 220 first through relative axial movement. However, at this time, the artificial heart valve 200 is still wrapped by the loading tube 350. After the positioning component 220 expands outward by self-expansion and enters the bottom of the corresponding valve sinus, the loading tube 350 moves relative to the artificial heart valve 200 to expose the artificial heart valve 200 in the body. Taking the intervention direction via the aortic arch as an example, the positioning component 220 can be connected to the proximal side of the stent 210 and extend to the distal side of the stent 210. In order to avoid the loading tube 350 interfering with the outward expansion of the positioning component, the movement direction of the loading tube 350 when exposing the artificial heart valve 200 can be from the proximal end to the distal end. The loading tube 350 is connected to the control handle through the transmission component 351 slidably installed in the core tube 310, and the guide head 311 is also fixedly connected to the distal end of the loading tube 350. In this way, during interventional delivery, the loading tube 350 can only wrap the stent 210 (most of the distal side) and avoid the positioning component 220 connected to the proximal side of the stent 210.

[0104] The technical features of the above embodiments can be combined arbitrarily. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as the combination of these technical features does not contradict each other, it should be considered to be within the scope of this specification. When technical features of different embodiments are embodied in the same drawing, it can be regarded as the drawing also disclosing examples of combinations of the various embodiments involved.

[0105] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the scope of protection of this application. Therefore, the patent protection scope of this application should be determined by the appended claims.

Claims

1. A pre-installed artificial heart valve system, characterized in that, include: An artificial heart valve, wherein the artificial heart valve has a deformable structure and has a relative expansion state and a compression state; A first delivery device includes a catheter assembly suitable for interventional delivery and a control handle connected to the proximal end of the catheter assembly, the catheter assembly having opposing distal and proximal ends, and the artificial heart valve being loaded in a compressed state at the distal end of the catheter assembly. The second delivery device includes a sheath that is slidably sleeved on the periphery of the catheter assembly and a connecting seat fixed to the proximal end of the sheath. The sheath wraps around the artificial heart valve and keeps the artificial heart valve in a compressed state. A hemostatic valve is provided inside the connecting seat to close the radial gap with the catheter assembly. The second conveying device is opposite to the first conveying device: In the coupled state, the catheter assembly extends through the second delivery device, and the distal end of the catheter assembly has a guide head, which is located on the distal side of the sheath in the coupled state. In the dissociated state, in contrast to the coupled state, the catheter assembly moves proximally and detaches from the second delivery device, such that at least a portion of the sheath still maintains the constructed interventional channel; The guide head is a deformable structure with the following characteristics: A preset shape is provided so that the distal end of the sheath abuts against and blocks the sheath along the axial direction; The shape is converging radially relative to a preset shape and is able to enter the sheath, allowing the second delivery device to tend towards a separation state.

2. The pre-installation system for an artificial heart valve as described in claim 1, characterized in that, The sheath is 60cm to 120cm in length, and in the coupled state, the sheath has the following characteristics relative to the artificial heart valve: The sheath encloses the artificial heart valve at the loading position; The release position, relative to the loading position, further shifts the sheath proximally and exposes the artificial heart valve.

3. The pre-installed artificial heart valve system as described in claim 2, characterized in that, The distal portion of the sheath has a structural reinforcement section, through which the artificial heart valve is wrapped when the sheath is in the loaded position; The distal end of the sheath has a deformable expansion structure, which includes a plurality of elastic plates arranged circumferentially, and the distal ends of the plurality of elastic plates can be turned outward or brought together relative to each other.

4. The pre-installation system for an artificial heart valve as described in claim 1, characterized in that, The guide head is made of an elastically deformable material, which can switch between a preset shape and a folded shape through elastic deformation.

5. The pre-installation system for an artificial heart valve as described in claim 1, characterized in that, The guide head has a core hole inside for the guide wire to extend. In the closed shape, the cross-section of the core hole is reduced relative to the preset state. At least a portion of the core hole is an enlarged diameter region to absorb the deformation of the guide head.

6. The pre-installation system for an artificial heart valve as described in claim 1, characterized in that, The guide head has a limiting step on its outer periphery, and the guide head, in a preset shape, prevents the sheath from moving relative to the distal end through the limiting step; the step surface of the limiting step is a conical surface, and gradually converges towards the proximal end.

7. The pre-installation system for an artificial heart valve as described in claim 1, characterized in that, The guide head is provided with a deformation release groove on its outer periphery; the deformation release groove extends along the axial and / or circumferential directions.

8. The pre-installation system for an artificial heart valve as described in claim 1, characterized in that, The guide head adopts a radially deformable metal mesh cage structure, which is made of woven metal wire or cut metal tubing.

9. The pre-installation system for an artificial heart valve as described in claim 1, characterized in that, The catheter assembly includes: The core tube has a guide wire channel inside, and the guide head is fixed to the distal end of the core tube; The balloon body is located on the outer periphery of the core tube, and the distal end of the balloon body is sealed to the core tube. The artificial heart valve is sleeved on the outer periphery of the balloon body, and the interior of the balloon body is also provided with an axial limiting member connected to the core tube. An extension tube is located on the outer periphery of the core tube and is connected to the proximal end of the balloon body. The extension tube and the core tube form a fluid channel for delivering fluid into the balloon body.

10. The pre-installation system for an artificial heart valve as described in claim 1, characterized in that, The catheter assembly includes: The core tube has a guide wire channel inside, and the guide head is fixed to the distal end of the core tube; A balloon body is located on the outer periphery of the core tube, and the distal end of the balloon body is sealed to the core tube. An extension tube is located on the outer periphery of the core tube and is connected to the proximal end of the balloon body. The artificial heart valve is sleeved on the outer periphery of the extension tube and located on the proximal side of the balloon body. The extension tube and the core tube form a fluid channel for delivering fluid into the balloon body. The push tube is slidably sleeved on the outer periphery of the extension tube and located on the proximal side of the artificial heart valve, and is used to push the artificial heart valve to the outer periphery of the balloon body.

11. A method for pre-loading an artificial heart valve, characterized in that, Based on the pre-installation system according to any one of claims 1 to 10, the pre-installation method includes: An artificial heart valve and a first delivery device with a catheter assembly are provided, the artificial heart valve having a deformable structure and having a relative expanded state and a compressed state. The artificial heart valve is fitted into the catheter assembly in a compressed state; A second delivery device with a sheath is provided to fit the sheath onto the catheter assembly and enclose the artificial heart valve.

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