Heart valve release mechanism, release catheter and prosthetic heart valve delivery system

Abstract

The application discloses a heart valve releasing mechanism, a releasing catheter and an artificial heart valve conveying system. The heart valve releasing mechanism is used for clamping and releasing an artificial heart valve and comprises a clamping jaw, a moving part and a clamping jaw. The clamping jaw comprises a first clamping arm and a second clamping arm which are arranged at intervals. The moving part has a moving space. At least a part of the first clamping arm and at least a part of the second clamping arm are movably arranged in the moving space. The clamping jaw has a clamping state and a releasing state. In the clamping state, at least a part of the artificial heart valve is clamped between the first clamping arm and the second clamping arm. In the releasing state, the distance between the first clamping arm and the second clamping arm is increased, and the artificial heart valve can be separated from the clamping jaw. The clamping jaw can be switched between the clamping state and the releasing state by moving the moving part relative to the clamping jaw. The releasing mechanism has simple structure and convenient operation, and can facilitate the assembly and disassembly of the artificial heart valve.

Description

Technical Field

[0001] This invention relates to the medical field, and more particularly to a heart valve release mechanism, a release catheter, and an artificial heart valve delivery system. Background Technology

[0002] The heart is divided into left and right ventricular septa, each containing a ventricle and an atrium. The ventricles and atria are separated by the interventricular septum and interatrial septum, respectively. Valves prevent backflow of blood between the atria, ventricles, and arteries. Specifically, the mitral valve is located between the left atrium and left ventricle; the tricuspid valve is located between the right atrium and right ventricle; the aortic valve is located between the left ventricle and the great artery; and the pulmonary valve is located between the right ventricle and the pulmonary artery.

[0003] The aforementioned valves open and close accordingly with the heart's contraction and relaxation. Therefore, the heart valves must be able to withstand the constant flow of blood and the compression of blood and surrounding valvular rings over a long period. When the valves cannot close completely or open insufficiently, it will lead to insufficient blood supply and regurgitation. To improve blood supply and regurgitation, doctors sometimes recommend placing a heart valve stent through minimally invasive interventional surgery.

[0004] In the treatment of other human diseases, minimally invasive interventional surgery is also required to place stents. During stent implantation, the stent needs to be delivered to a predetermined location and then released so that it remains in place. Currently, existing stent implantation devices are relatively complex in structure, difficult to operate, and the installation and release of stents are also challenging. Summary of the Invention

[0005] To address the aforementioned technical problems, the present invention aims to provide a heart valve release mechanism, a release catheter, and an artificial heart valve delivery system. The release mechanism has a simple structure, is easy to operate, and facilitates the assembly and disassembly of artificial heart valves.

[0006] To achieve the above objectives, the present invention provides a heart valve release mechanism for clamping and releasing an artificial heart valve, comprising:

[0007] The gripper includes a first gripping arm and a second gripping arm that are spaced apart;

[0008] The movable component has a movable space, and at least a portion of the first clamping arm and at least a portion of the second clamping arm are respectively movably mounted in the movable space;

[0009] The gripper has a gripping state and a released state. In the gripping state, at least a portion of the artificial heart valve is adapted to be gripped between the first gripping arm and the second gripping arm. In the released state, the distance between the first gripping arm and the second gripping arm increases, and the artificial heart valve can be separated from the gripper. The movable member relative to the gripper can control the gripper to switch between the gripping state and the released state.

[0010] In some preferred embodiments, the movable element is slidably mounted on the gripper, and sliding the movable element relative to the gripper can control the gripper to switch between the gripping state and the releasing state.

[0011] In some preferred embodiments, the first clamping arm has a first slot at a predetermined position on the side facing the second clamping arm, and / or the second clamping arm has a second slot at a predetermined position on the side facing the first clamping arm.

[0012] In some preferred embodiments, the first clamping arm and the second clamping arm of the gripper have a distal end and a proximal end, the radial dimension of the distal end being greater than the radial dimension of the proximal end, the gripper being in the clamping state when the movable member slides to the distal end, and the gripper being in the released state when the movable member slides to the proximal end.

[0013] In some preferred embodiments, the gripper further includes a mounting arm, wherein the first clamping arm and the second clamping arm are respectively connected to the mounting arm, and the mounting arm has a plurality of compression grooves.

[0014] In some preferred embodiments, the heart valve release mechanism further includes a first catheter and a second catheter, the second catheter having a telescopic space inside, and the first catheter being telescopically mounted in the telescopic space;

[0015] The gripper is mounted at the distal end of the first conduit, and the movable part is mounted at the distal end of the second conduit; or, the gripper is mounted at the distal end of the second conduit, and the movable part is mounted at the distal end of the first conduit.

[0016] When the second conduit slides in the telescopic space, it can drive the gripper and the movable part to slide relative to each other, so as to control the gripper to switch between the clamping state and the releasing state.

[0017] In some preferred embodiments, the distal end of the second catheter is provided with three grippers at preset intervals, and the distal end of the first catheter is provided with three movable parts accordingly.

[0018] According to another aspect of the invention, a release catheter is further provided for delivering a positioning frame and a valve stent for an artificial heart valve, comprising:

[0019] The first catheter, the second catheter, the third catheter, and the fourth catheter are sequentially inserted from the inside out;

[0020] The first release mechanism includes any of the preceding heart valve release mechanisms; the gripper of the first release mechanism is mounted on the first catheter and the movable part is mounted on the second catheter; or, the movable part of the first release mechanism is mounted on the first catheter and the gripper is mounted on the second catheter; the first release mechanism is used to deliver a valve stent.

[0021] The second release mechanism includes the heart valve release mechanism described in any of the preceding embodiments, wherein the gripper of the second release mechanism is mounted on the third catheter and the movable part is mounted on the fourth catheter; or, the gripper of the second release mechanism is mounted on the fourth catheter and the movable part is mounted on the third catheter; the second release mechanism is used to deliver the positioning frame.

[0022] In some preferred embodiments, the heart valve release catheter further includes an intermediate movable rod and a distal sleeve movably mounted in the first catheter. The distal sleeve is fitted over the outside of the intermediate movable rod, and the distal end of the distal sleeve is connected to the distal end of the intermediate movable rod. In the initial state, the distal sleeve is fitted over the outside of the valve stent. When the intermediate movable rod is pushed distally relative to the first catheter, the distal sleeve is misaligned with the valve stent, and the valve stent can expand from a collapsed state to an deployed state.

[0023] In some preferred embodiments, the heart valve release catheter further includes an outer sheath movably fitted over the outside of the fourth catheter. In the initial state, the distal end of the outer sheath is fitted over the outside of the positioning frame. The outer sheath is moved proximally relative to the fourth catheter, and the distal end of the outer sheath is offset from the positioning frame. The positioning frame can expand from a contracted state to an open state.

[0024] According to another aspect of the invention, an artificial heart valve delivery system is further provided, comprising:

[0025] Artificial heart valves, including positioning frames and valve stents;

[0026] In any of the above-mentioned release catheters, the positioning frame and the valve stent are respectively installed at the distal end of the release catheter;

[0027] A delivery control component, connected to the proximal end of the release catheter, is used to control the extension and retraction of the catheter to control the delivery and release of the artificial heart valve.

[0028] Compared with the prior art, the heart valve release mechanism, release catheter, and artificial heart valve delivery system provided by the present invention have at least one of the following advantages:

[0029] 1. The heart valve release mechanism, release catheter, and artificial heart valve delivery system provided in the preferred embodiment of the present invention have a simple structure and are easy to operate, which facilitates the assembly and disassembly of the artificial heart valve.

[0030] 2. The heart valve release mechanism, release catheter, and artificial heart valve delivery system provided in the preferred embodiment of the present invention have slots provided in the first clamping arm and / or the second clamping arm of the gripper, which can improve the stability of artificial heart valve installation.

[0031] 3. The heart valve release mechanism, release catheter and artificial heart valve delivery system provided in the preferred embodiment of the present invention have compression grooves on the mounting arms of the grippers, which can reduce the rigidity of the mounting arms and facilitate bending. Attached Figure Description

[0032] The preferred embodiments will now be described in a clear and easy-to-understand manner, in conjunction with the accompanying drawings, to further explain the above-mentioned characteristics, technical features, advantages, and implementation methods of the present invention.

[0033] Figure 1 This is a schematic diagram of the overall structure of a delivery system for implanting an artificial prosthesis into a patient, according to a preferred embodiment of the present invention.

[0034] Figure 2 This is a three-dimensional structural schematic diagram of a control mechanism for a delivery system for implanting an artificial prosthesis into a patient, according to a preferred embodiment of the present invention.

[0035] Figure 3 This is a three-dimensional structural schematic diagram of a stent control assembly of a delivery system for implanting an artificial prosthesis into a patient, according to a preferred embodiment of the present invention.

[0036] Figure 4 yes Figure 3 Axial sectional view of the bracket control assembly in the middle;

[0037] Figure 5 This is a three-dimensional structural schematic diagram of a positioning control component of a delivery system for implanting an artificial prosthesis into a patient, according to a preferred embodiment of the present invention.

[0038] Figure 6 yes Figure 5 Axial sectional view of the positioning control component in the middle;

[0039] Figure 7This is a three-dimensional structural schematic diagram of a bending control component of a delivery system for implanting an artificial prosthesis into a patient, according to a preferred embodiment of the present invention.

[0040] Figure 8 yes Figure 7 Axial sectional view of the bending control component;

[0041] Figure 9 This is a three-dimensional structural schematic diagram of the threaded part of a bending control component of a delivery system for implanting an artificial prosthesis into a patient, according to a preferred embodiment of the present invention.

[0042] Figure 10 This is a three-dimensional structural schematic diagram of a guide wire fixation component of a delivery system for implanting an artificial prosthesis into a patient, according to a preferred embodiment of the present invention.

[0043] Figure 11a This is an exploded structural diagram of a sliding mechanism of a delivery system for implanting an artificial prosthesis into a patient, according to a preferred embodiment of the present invention.

[0044] Figure 11b yes Figure 11a Enlarged view of point a in the middle;

[0045] Figure 12 This is a schematic diagram of the structure of a delivery system frame for implanting an artificial prosthesis into a patient, according to a preferred embodiment of the present invention.

[0046] Figure 13 This is a schematic diagram of the end structure of a catheter mechanism in a delivery system for implanting an artificial prosthesis into a patient, according to a preferred embodiment of the present invention.

[0047] Figure 14 This is a schematic diagram of the loading state of a delivery system for implanting an artificial prosthesis into a patient, according to a preferred embodiment of the present invention.

[0048] Figure 15 This is a schematic diagram of the disengaged positioning frame of a delivery system for implanting an artificial prosthesis into a patient, according to a preferred embodiment of the present invention.

[0049] Figure 16 This is a schematic diagram of the valve stent disengagement state of a delivery system for implanting an artificial prosthesis into a patient, according to a preferred embodiment of the present invention.

[0050] Figure 17 This is a schematic diagram of the installation structure of a movable component of a delivery system for implanting an artificial prosthesis into a patient, according to a preferred embodiment of the present invention.

[0051] Figure 18This is a schematic diagram of the installation structure of the gripper of a delivery system for implanting an artificial prosthesis into a patient, according to a preferred embodiment of the present invention.

[0052] Figure 19 yes Figure 18 Enlarged structural diagram at point b in the middle;

[0053] Figure 20 This is a three-dimensional structural schematic diagram of a heart valve release mechanism in a delivery system for implanting an artificial prosthesis into a patient, according to a preferred embodiment of the present invention.

[0054] Figure 21 This is a schematic diagram of the connection structure between the intermediate movable rod and the distal sleeve of a delivery system for implanting an artificial prosthesis into a patient, according to a preferred embodiment of the present invention.

[0055] Figure 22 This is a three-dimensional structural diagram of the intermediate movable rod of a delivery system for implanting an artificial prosthesis into a patient, according to a preferred embodiment of the present invention.

[0056] Explanation of icon numbers:

[0057] Frame 10, base 11, rack and pinion track 111, base 112, horizontal plate 1121, vertical plate 1122, slider 113, distal fixed plate 1131, proximal fixed plate 1132, threaded adjusting rod 114, sliding mechanism 12, sliding frame 121, clamping groove 1211, rack and pinion channel 1212, rotating component 122, rack and pinion engagement pin 1221, pulley 1222, control knob 1223, damping component 1224, first sliding mechanism 1231, second... Sliding mechanism 1232, third sliding mechanism 1233, catheter mechanism 20, stent catheter assembly 21, first catheter 211, second catheter 212, intermediate movable rod 213, distal sleeve 214, distal loading head 2131, positioning catheter assembly 22, third catheter 221, fourth catheter 222, outer cannula 23, artificial heart valve 30, valve stent 31, positioning frame 32, control mechanism 40, stent control assembly 41, first housing 411, first catheter Fixing component 412, second conduit fixing component 413, first knob 414, first connector 415, movable rod fixing component 416, second knob 417, second connector 418, positioning control assembly 42, second housing 421, third conduit fixing component 422, fourth conduit fixing component 423, third knob 424, third connector 425, bending control assembly 43, third housing 431, fourth knob 432, movable block assembly 433, threaded component 4331, through-hole Threaded component 4332, sleeve groove 43320, threading hole 43321, guide wire fixing component 4333, inner tube 4334, heart valve release mechanism 50, gripper 51, first clamping arm 511, first slot 5110, second clamping arm 512, second slot 5120, mounting arm 513, compression groove 5130, movable component 52, movable space 520, guide plate 521, second elongated hole 1110, first elongated hole 11320, fixing rod 11321. Detailed Implementation

[0058] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the specific implementation methods of the present invention will be described below with reference to the accompanying drawings. Obviously, the drawings described below are merely some embodiments of the present invention. For those skilled in the art, other drawings and other implementation methods can be obtained based on these drawings without any creative effort.

[0059] To keep the drawings concise, each figure only schematically shows the parts relevant to the invention, and these do not represent the actual structure of the product. Furthermore, to facilitate understanding, in some figures, only one of components with the same structure or function is schematically depicted, or only one is labeled. In this document, "one" not only means "only one," but can also mean "more than one."

[0060] It should also be further understood that the term “and / or” as used in this application specification and the appended claims means any combination of one or more of the associated listed items and all possible combinations, and includes such combinations.

[0061] In this document, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections or electrical connections; they can refer to direct connections or indirect connections through an intermediate medium; and they can refer to the internal communication between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0062] Furthermore, in the description of this application, the terms "first," "second," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0063] In this application, "proximal" and "distal" refer to the relative orientation, position, and direction of the components or actions relative to each other from the perspective of a physician using the medical device. Although "proximal" and "distal" are not restrictive, "proximal" generally refers to the end of the medical device that is closer to the physician during normal operation, while "distal" generally refers to the end that first enters the patient's body.

[0064] refer to Figures 1 to 22 A preferred embodiment of the present invention describes a delivery system for implanting an artificial prosthesis into a patient. The delivery system includes a frame 10, a catheter mechanism 20, and a control mechanism 40. The catheter mechanism 20 includes a stent catheter assembly 21 and a positioning catheter assembly 22 nested together. The artificial prosthesis includes a stent and a positioning frame; the stent is mounted at the distal end of the stent catheter assembly 21, and the positioning frame is mounted at the distal end of the positioning catheter assembly 22. The control mechanism 40 is mounted on the frame 10 and includes a stent control assembly 41 and a positioning control assembly 42. The proximal end of the stent catheter assembly 21 is connected to the stent control assembly 41, and the proximal end of the positioning catheter assembly 22 is connected to the positioning control assembly 42. The positioning control component 42 is used to drive the positioning catheter assembly 22 to control the release and disengagement of the positioning frame, so as to implant the positioning frame into a preset position in the human body; the stent control component 41 is used to drive the stent catheter assembly 21 to control the release and disengagement of the stent, and can adjust the position between the stent and the positioning frame, and assemble the stent with the positioning frame in the human body.

[0065] Specifically, the stent is preferably a valve stent 31, the positioning frame is a positioning frame 32 for heart valves, and the artificial prosthesis is an artificial heart valve 30.

[0066] refer to Figure 3 , Figure 4 as well as Figure 13 Specifically, the stent conduit assembly 21 includes a second conduit 212 and a first conduit 211 nested together. The stent control assembly 41 includes a first housing 411, a second conduit fixing member 412, a first conduit fixing member 413, a first knob 414, and a first connector 415.

[0067] The second catheter fixation member 412 is mounted at the distal end of the first housing 411, and the first catheter fixation member 413 is mounted at the proximal end of the first housing 411 relative to the second catheter fixation member 412. The proximal end of the second catheter 212 is fixedly connected to the second catheter fixation member 412, and the proximal end of the first catheter 211 is fixedly connected to the first catheter fixation member 413. The first knob 414 is movably mounted on the outside of the first housing 411. One end of the first connector 415 is connected to the first knob 414, and the other end is connected to the first catheter fixation member 413. Axial movement of the first knob 414 relative to the first housing 411 can drive the first catheter fixation member 413 to move within the first housing 411, thereby moving the first catheter 211.

[0068] The first knob 414 is rotatably connected to the outside of the first housing 411. The first knob 414 is threadedly connected to the first housing 411. Rotating the first knob 414 relative to the first housing 411 can change the position of the first knob 414 relative to the first housing 411.

[0069] The first connector 415 is a rod-shaped body, preferably a metal rod. The first housing 411 has a movable elongated hole at a predetermined position. One end of the first connector 415 is fixedly connected to the first conduit fixing member 413, and the other end extends outward through the movable elongated hole. The inner wall of the first knob 414 has a receiving groove at a predetermined position. When the first knob 414 is installed in the first housing 411, the other end of the first connector 415 is located within the receiving groove. When the first knob 414 is rotated relative to the first housing 411, as the first knob 414 moves relative to the first housing 411, the other end of the first connector 415 slides within the receiving groove and moves with the first knob 414 relative to the first housing 411, thereby causing the first conduit fixing member 413 to move within the first housing 411.

[0070] refer to Figure 3 , Figure 14 , Figure 21 as well as Figure 22 The stent catheter assembly 21 further includes an intermediate movable rod 213 and a distal sleeve 214. The distal sleeve 214 is sleeved on the outside of the intermediate movable rod 213, and the distal end of the distal sleeve 214 is connected to the distal end of the intermediate movable rod 213. The intermediate movable rod 213 is movably installed inside the first catheter 211.

[0071] The distal end of the intermediate movable rod 213 has a distal loading head 2131, and the distal sleeve 214 is detachably mounted to the distal loading head 2131. Preferably, the distal sleeve 214 is threaded to the distal loading head 213. In some other preferred embodiments, the distal sleeve 214 can also be connected to the distal loading head 2131 by snap-fit ​​or interference fit.

[0072] The support control assembly 41 further includes a movable rod fixing member 416, a second knob 417, and a second connector 418. The movable rod fixing member 416 is installed at the proximal end of the first housing 411 relative to the first conduit fixing member 413. The second knob 417 is correspondingly installed on the outside of the first housing 411. One end of the second connector 418 is connected to the second knob 417, and the other end is connected to the movable rod fixing member 416. With axial movement relative to the first housing 411, the second knob 417 can drive the movable rod fixing member 416 to move within the first housing 411.

[0073] Similarly, the second knob 417 is rotatably mounted on the outside of the first housing 411, and when the second knob 417 rotates relative to the first housing 411, it can drive the movable rod fixing member 416 to move within the first housing 411 via the second connector 418, thereby driving the central movable rod 213 to move axially relative to the first housing 411, so as to change the position of the distal sleeve 214 at the distal end of the intermediate movable rod 213 relative to the second conduit 212.

[0074] The second connector 418 has the same structure as the first connector 415, and will not be described again here.

[0075] Specifically, sealing rings are provided inside the second catheter fixation member 412, the first catheter fixation member 413, and the movable rod fixation member 416 to prevent the injected saline or other liquids from flowing backward. Drainage pipes communicating with the outside are respectively provided between the second catheter fixation member 412 and the first catheter fixation member 413, and between the first catheter fixation member 413 and the movable rod fixation member 416. Saline or other liquids are injected through these drainage pipes into the gaps between the second catheter 212 and the first catheter 211, and between the intermediate movable rod 213 and the first catheter 211, to expel air from between the catheters.

[0076] refer to Figure 5 , Figure 6 as well as Figure 13 The positioning catheter assembly 22 includes a third catheter 221 and a fourth catheter 222 that are sequentially sleeved on the outside of the second catheter 212.

[0077] The positioning control assembly 42 includes a second housing 421, a fourth conduit fixation member 422, a third conduit fixation member 423, a third knob 424, and a third connector 425. The fourth conduit fixation member 422 is mounted at the distal end of the second housing 421. The third conduit fixation member 423 is mounted at the proximal end of the second housing 421 relative to the fourth conduit fixation member 422. The proximal end of the fourth conduit 222 is fixedly connected to the fourth conduit fixation member 422, and the proximal end of the third conduit 221 is fixedly connected to the third conduit fixation member 423. The third knob 424 is movably mounted on the outside of the second housing 421. One end of the third connector 425 is connected to the third knob 424, and the other end is connected to the third conduit fixation member 423. Axial movement relative to the second housing 421 allows the third knob 424 to move the third conduit fixation member 423 within the second housing 421.

[0078] Similarly, the third knob 424 is rotatably mounted on the outside of the second housing 421 and is threadedly connected to the second housing 421. Rotating the third knob 424 relative to the second housing 421 controls the movement of the third knob 424 relative to the second housing 421. The third knob 424 moving relative to the second housing 421 can drive the third conduit fixing member 423 to move within the second housing 421 via the third connector 425.

[0079] It should be noted that the first knob 414, the second knob 417, and the third knob 424 have the same structure. Similarly, the first connector 415, the second connector 418, and the third connector 425 also have the same structure. In this preferred embodiment, rotating the first knob 414, the second knob 417, and the third knob 424 can correspondingly control the axial movement of the first conduit 211, the intermediate movable rod 213, and the third conduit 221, resulting in a simple structure and convenient operation. In some modified embodiments, the first knob 414, the second knob 417, and the third knob 424 can also be axially movably mounted on the first housing 411 and the second housing 421, and the axial movement of the first conduit 211, the intermediate movable rod 213, and the third conduit 221 can be controlled by axially sliding the first knob 414, the second knob 417, and the third knob 424.

[0080] Specifically, sealing rings are provided between the fourth catheter fixation member 422 and the third catheter fixation member 423, and at the proximal end of the third catheter fixation member 423. Drainage tubes communicating with the outside are provided between the fourth catheter fixation member 422 and the third catheter fixation member 423, and at the proximal end of the third catheter fixation member 423. Physiological saline or other liquids are injected into the gap between the fourth catheter 222 and the third catheter 221 through the drainage tubes to expel air from between the catheters.

[0081] refer to Figure 7 , Figure 8 as well as Figure 13 The catheter mechanism 20 further includes an outer sheath 23 sleeved over the fourth catheter 222. The control mechanism 40 further includes a bending control component 43, which is located distal to the support body 10 relative to the stent control component 41. The bending control component 43 is connected to the proximal end of the outer sheath 23 and is used to adjust the curvature of the outer sheath 23. In this preferred embodiment, adjusting the angle of the outer sheath 23 via the bending control component 43 allows for better adaptation to the curvature of the human body channel during implantation.

[0082] Specifically, the bending control assembly 43 includes a third housing 431, a fourth knob 432, a movable block assembly 433, and a guide wire. The movable block assembly 433 is installed inside the third housing 431, and the fourth knob 432 is correspondingly installed on the outside of the third housing 431. The movable block assembly 433 is connected to the fourth knob 432. The proximal end of the outer sleeve 23 is connected to the third housing 431, and the distal end of the guide wire is connected to the distal end of the outer sleeve 23. The proximal end of the guide wire is connected to the movable block assembly 433. Moving the fourth knob 432 relative to the third housing 431 can cause the movable block assembly 433 to move within the third housing 431, thereby controlling the bending of the outer sleeve 23.

[0083] The movable block assembly 433 includes a threaded component 4331, a threaded wire threading component 4332, a wire guide fixing component 4333, and an inner tube 4334. Rotating the fourth knob 432 drives the threaded component 4331 to rotate. The threaded component 4331 engages with the threaded wire threading component 4332. When the threaded component 4331 moves the threaded wire threading component 4332 proximally, it pushes the wire guide fixing component 4333 proximally and tightens the wire, controlling the bending of the distal end of the outer sleeve 23. The inner tube 4334 fits tightly with the outer sleeve 23, and a vent hole is provided at the proximal end of the inner tube 4334 to expel air between the outer sleeve 23 and the fourth conduit 222. The outer surface of the inner tube 4334 is slidably fitted with the threaded wire threading component 4332.

[0084] refer to Figure 9 The threaded part 4332 has a guide groove 43320 and a threading hole 43321. The guide wire passes through the threading hole 43321, and the inner tube 4334 passes through the guide groove 43320.

[0085] refer to Figure 1 , Figure 2 and Figure 11a Specifically, the frame 10 includes a base 11 and a sliding mechanism 12. The sliding mechanism 12 is movably mounted on the base 11. A sliding mechanism 12 is connected to the lower part of the first housing 411, the second housing 421, and the third housing 432, respectively, namely a first sliding mechanism 1231, a second sliding mechanism 1232, and a third sliding mechanism 1233, for adjusting the positions of the first housing 411, the second housing 421, and the third housing 431, respectively.

[0086] A rack and pinion track 111 is provided on the base 11. The sliding mechanism 12 includes a sliding frame 121 and a rotating member 122. The top connecting end of the sliding frame 121 is connected to the first housing 411, the second housing 421, or the third housing 431. The bottom connecting end of the sliding frame 121 is slidably mounted on the rack and pinion track 111. The rotating member 122 is rotatably mounted on the sliding frame 121 and engages with the rack and pinion track 111. Rotating the rotating member 122 can drive the sliding frame 121 to move along the rack and pinion track 111.

[0087] refer to Figure 11a The top connecting end of the sliding frame 121 has a clamping groove 1211 for placing the first housing 411, the second housing 421, or the third housing 431. The bottom connecting end of the sliding frame 121 has a rack channel 1212, and the rack rail 111 is movably mounted in the rack channel 1212.

[0088] refer to Figure 11b The rotating component 122 is a threaded rotating component, including a rack engagement pin 1221, a pulley 1222, a control knob 1223, and a damping component 1224. The rack engagement pin 1221, the pulley 1222, the control knob 1223, and the damping component 1224 are relatively fixedly connected or integrally formed. The rack engagement pin 122 engages with the rack track 111. Rotating the control knob 1223 can drive the rack engagement pin 1221 to engage and move along the rack track 111, thereby driving the bending control component 43, the positioning control component 42, or the bracket control component 41 to move.

[0089] The rack engagement pin 1221 fixes the pulley 1222 and the damping element 1224 to the control knob 1223, and the pulley 1222 engages with the rack track 111. Rotating the control knob 1223 drives the pulley 1222 to rotate, and the pulley 1222 drives the rack track 1111 to move, thereby driving the bending control assembly 43 to move. By setting the damping element 1224, the pulley 1222 is less likely to loosen.

[0090] refer to Figure 1Specifically, the base 11 includes a base 112, a slider 113, and a threaded adjusting rod 114. The base 112 includes a horizontal plate 1121 and a vertical plate 1122 connected to each other. The slider 113 is slidably mounted on the horizontal plate 1121, the rack and pinion track 111 is mounted on the slider 113, the distal end of the threaded adjusting rod 114 is connected to the slider 113, and the threaded adjusting rod 114 is rotatably connected to the vertical plate 1122. Rotating the threaded adjusting rod 114 relative to the vertical plate 1122 controls the slider 113 to slide along the horizontal plate 1121. Rotating the threaded adjusting rod 114 relative to the base 112 causes the sliding mechanism 12 to move as a whole.

[0091] The distal end and proximal end of the slider 113 are respectively equipped with a distal end fixing plate 1131 and a proximal end fixing plate 1132. The distal end of the rack track 111 is rotatably connected to the distal end fixing plate 1131, and the proximal end of the rack track 111 is slidably connected to the proximal end fixing plate 1132. Changing the position of the proximal end of the rack track 111 relative to the proximal end fixing plate 1132 can adjust the angle between the rack track 111 and the slider 113, thereby changing the angle of the control mechanism 40.

[0092] refer to Figure 12 Specifically, the proximal fixing plate 1132 has a first elongated hole 11320, and the proximal end of the rack track 111 has a second elongated hole 1110. The first elongated hole 11320 and the second elongated hole 1110 are staggered. The fixing rod 11321 passes through the first elongated hole 11320 and the second elongated hole 1110 to connect the rack track 111 to the proximal fixing plate 1132. Changing the relative position between the first elongated hole 11320 and the second elongated hole 1110 changes the position where the proximal end of the rack track 111 is fixed to the proximal fixing plate 1132, thereby changing the angle between the rack track 111 and the slider 113.

[0093] refer to Figures 17 to 20 Furthermore, the delivery system for implanting an artificial prosthesis into a patient further includes a heart valve release mechanism 50 mounted at the distal end of the stent catheter assembly 31 and the distal end of the positioning catheter assembly 21. The heart valve release mechanism 50 includes grippers 51 and a movable member 52. The grippers 51 include a first gripping arm 511 and a second gripping arm 512 spaced apart. The movable member 52 has a movement space 520 in which at least a portion of the first gripping arm 511 and at least a portion of the second gripping arm 512 are movably mounted.

[0094] The gripper 51 has a gripping state and a releasing state. In the gripping state, at least a portion of the artificial heart valve 30 is adapted to be gripped between the first gripping arm 511 and the second gripping arm 512. In the releasing state, the distance between the first gripping arm 511 and the second gripping arm 512 increases, and the artificial heart valve 30 can be separated from the gripper 51. The movable member 52 relative to the gripper 51 can control the gripper 51 to switch between the gripping state and the releasing state.

[0095] Specifically, the movable member 52 is slidably mounted on the gripper 51. Sliding the movable member 52 relative to the gripper 51 controls the gripper 51 to switch between the clamping state and the releasing state. In some preferred embodiments, rotating the movable member 52 relative to the gripper 51 controls the gripper 51 to switch between the clamping state and the releasing state.

[0096] Specifically, the first clamping arm 511 and the second clamping arm 512 of the gripper 51 have a distal end and a proximal end, the radial dimension of the distal end is greater than the radial dimension of the proximal end, the gripper 51 is in the clamping state when the movable member 52 slides to the distal end, and the gripper is in the releasing state when the movable member 52 slides to the proximal end.

[0097] The first gripping arm 511 and the second gripping arm 512 of the gripper 51 are both made of shape memory alloy through a heat treatment process. After entering the body, they can automatically open and release the support in an unrestrained state. In some modified embodiments, the first gripping arm 511 and the second gripping arm 512 are metal springs, or they can be made of polymer materials. When not installed within the movable space 520 of the movable member 52, there is a certain gap between the first clamping arm 511 and the second clamping arm 512; when the first clamping arm 511 and the second clamping arm 512 are installed in the movable space 520 of the movable member 52, the distance between the first clamping arm 511 and the second clamping arm 512 decreases; when the first clamping arm 511 and the second clamping arm 512 are removed from the movable space 520 of the movable member 52, the distance between the first clamping arm 511 and the second clamping arm 512 increases under the action of their own elastic restoring force.

[0098] Specifically, the movable component 52 is mounted at the distal end of the first conduit 211, and the gripper 51 is mounted at the distal end of the second conduit 212. Rotating the first knob 414 controls its movement proximally relative to the first housing 411, causing the first conduit 211 to move proximally. The first conduit 211 then moves the movable component 52 proximally, causing the distal ends of the first clamping arm 511 and the second clamping arm 512 to extend from the movable component 52's active space 520, and the gripper 51 switches to the released state. Rotating the first knob 414 controls its movement distally relative to the first housing 411, causing the first conduit 211 to move distally. The first conduit 211 then moves the movable component 52 distally, causing the distal ends of the first clamping arm 511 and the second clamping arm 512 to enter the active space 520, and the gripper 51 switches to the clamping state.

[0099] refer to Figure 19 The first clamping arm 511 has a first slot 5110 at a predetermined position on the side facing the second clamping arm 512, and the second clamping arm 512 has a second slot 5120 at a predetermined position on the side facing the first clamping arm 511. When the connecting part of the artificial heart valve 30 is installed between the first clamping arm 511 and the second clamping arm 512, and the gripper 51 is in the clamping state, the connecting part of the artificial heart valve 30 is located in the receiving space formed by the first slot 5110 and the second slot 5120 and is engaged with each other to achieve a better clamping effect on the artificial heart valve 30.

[0100] The gripper 51 further includes a mounting arm 513. The first gripping arm 511 and the second gripping arm 512 are respectively connected to the mounting arm 513, and the mounting arm 513 has a plurality of compression grooves 5130. The first gripping arm 511 and the second gripping arm 512 are respectively mounted at the distal end of the mounting arm 513, and the proximal end of the mounting arm 513 is mounted at the distal end of the second conduit 212. The compression grooves 5130 on the mounting arm 513 facilitate bending of the mounting arm 513 and reduce its rigidity. The second conduit 212, the mounting arm 513, the first gripping arm 511, and the second gripping arm 512 are preferably integrally formed and connected.

[0101] The second conduit 212 has a telescopic space inside, and the first conduit 211 is telescopically installed in the telescopic space. The gripper 51 is installed at the distal end of the second conduit 212, and the movable member 52 is installed at the distal end of the first conduit 211. In some modified embodiments, the gripper 51 is installed at the distal end of the first conduit 211, and the movable member 52 is installed at the distal end of the second conduit 212.

[0102] The heart valve release mechanism 50 further includes a guide plate 521 connected to the movable member 52. The movable member 52 is mounted on one end of the guide plate 521, and the other end of the guide plate 521 is connected to the first catheter 211. The guide plate 521 is stacked with the mounting arm 513.

[0103] The distal end of the second conduit 212 is provided with three clamps 51 at preset intervals, and the distal end of the first conduit 211 is correspondingly provided with three movable members 52 and three guide plates 521. (Reference) Figure 16 When the distal sleeve 214 is fitted onto the outside of the valve stent 31, the valve stent 31 is in a compressed state; after the distal sleeve 214 is misaligned from the valve stent 31, the valve stent 31 switches to an open state.

[0104] Similarly, the distal end of the third conduit 221 is provided with three movable elements 52 and three guide plates 521, and the distal end of the fourth conduit 222 is provided with three grippers 51. (Reference) Figure 15 When the outer sleeve 23 is fitted onto the outside of the positioning frame, the positioning frame is in a collapsed state and the three guide pieces 521 are brought together; after the distal sleeve 214 is separated from the positioning frame, the positioning frame switches to an unfolded state and the three guide pieces 521 separate from each other.

[0105] In some preferred embodiments of the present invention, the present invention further provides a release catheter, including a first catheter 211, a second catheter 212, a third catheter 221, a fourth catheter 222, a first release mechanism, and a second release mechanism. The first release mechanism and the second release mechanism have the same structure as the heart valve release mechanism 50. A movable element 52 of the first release mechanism is mounted on the first catheter 211, and a gripper 51 is mounted on the second catheter 212; or, the gripper 51 of the first release mechanism is mounted on the first catheter 211, and the movable element 52 is mounted on the second catheter 212; the first release mechanism is used to deliver a valve stent 31. A gripper 51 of the second release mechanism is mounted on the fourth catheter 222, and the movable element 52 is mounted on the third catheter 221; or, the gripper 51 of the second release mechanism is mounted on the third catheter 221, and the movable element 52 is mounted on the fourth catheter 222; the second release mechanism is used to deliver a positioning frame.

[0106] The release catheter further includes the intermediate movable rod 213 and the distal sleeve 214 movably mounted in the first catheter 211. The distal sleeve 214 is sleeved on the outside of the intermediate movable rod 213, and the distal end of the distal sleeve 214 is connected to the distal end of the intermediate movable rod 213. In the initial state, the distal sleeve 214 is sleeved on the outside of the valve stent 31. When the intermediate movable rod 213 is pushed distally relative to the first catheter 211, the distal sleeve 214 is misaligned with the valve stent 31, and the valve stent 31 can expand from a collapsed state to an deployed state.

[0107] The release catheter also includes an outer sheath 23 movably sleeved outside the fourth catheter 222. In the initial state, the distal end of the outer sheath 23 is sleeved outside the positioning frame 32. The outer sheath 23 moves proximally relative to the fourth catheter 222, and the distal end of the outer sheath 23 is offset from the positioning frame. The positioning frame can expand from a contracted state to an open state.

[0108] During use, the distal end of the release catheter is inserted through the femoral artery. When passing the arch, the fourth knob 432 is rotated to adjust the outer cannula 23 to a suitable angle, ensuring the coaxiality of the distal valve loading portion of the release catheter with the original valve. The control knob 1223 of the sliding mechanism 12 corresponding to the bending control component 43 is rotated to move the outer cannula 22 proximally, exposing the positioning frame. The control knob 1223 of the sliding mechanism 12 corresponding to the positioning control component 42 is rotated to move the positioning control component 42 distally, releasing the positioning frame to the sinus base of the three aortic sinuses. The control knob 1223 of the sliding mechanism 12 corresponding to the stent control component 41 is rotated to adjust the distance between the valve stent 31 and the positioning frame. Relative position; rotate the second knob 417 of the stent control assembly 41 to control the intermediate movable rod 213 to drive the distal sleeve 214 to move distally, so that the valve stent switches from a collapsed state to an deployed state; rotate the third knob 424 of the positioning control assembly 42 to control the movement of the third catheter 221 relative to the fourth catheter 222, disengaging the positioning frame from the corresponding heart valve release mechanism; rotate the first knob 414 of the stent control assembly 41 to control the relative movement of the first catheter 211 and the second catheter 212, disengaging the valve stent from the heart valve release mechanism; rotate the fourth knob 432 of the bending control assembly 43 to control the movement of the outer sheath 23 distally to the closed position, and then retract the entire device.

[0109] It should be noted that the above embodiments can be freely combined as needed. The above are merely preferred embodiments of the present invention. It should be pointed out that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A heart valve release mechanism for clamping and releasing an artificial heart valve, characterized in that, include: The gripper includes a first gripping arm and a second gripping arm spaced apart; it also includes a mounting arm, wherein the first gripping arm and the second gripping arm are respectively connected to the mounting arm, and the mounting arm has a plurality of extrusion grooves; A movable component is slidably mounted on the gripper, the movable component having an active space, and at least a portion of the first gripping arm and at least a portion of the second gripping arm are respectively movably mounted in the active space; The guide plate is connected to the movable component and is stacked with the mounting arm; The gripper has a gripping state and a released state. In the gripping state, at least a portion of the artificial heart valve is adapted to be gripped between the first gripping arm and the second gripping arm. In the released state, the distance between the first clamping arm and the second clamping arm increases, allowing the artificial heart valve to separate from the grippers; Sliding the movable member relative to the gripper allows the gripper to switch between the gripping state and the releasing state. The artificial heart valve has a compressed state and an open state. In the compressed state, the guide plate and the mounting arm stacked with the guide plate are both radially retracted inward. In the open state, the guide plate and the mounting arm stacked with the guide plate are both radially moved outward as the artificial heart valve opens, until the artificial heart valve is in a fully open state.

2. The release mechanism according to claim 1, characterized in that, The first and second gripping arms of the gripper have a distal end and a proximal end, the radial dimension of the distal end being greater than the radial dimension of the proximal end. When the movable member slides to the distal end, the gripper is in the gripping state, and when the movable member slides to the proximal end, the gripper is in the released state.

3. The release mechanism according to claim 1, characterized in that, The first clamping arm has a first slot at a preset position on the side facing the second clamping arm, and / or the second clamping arm has a second slot at a preset position on the side facing the first clamping arm.

4. The heart valve release mechanism according to any one of claims 1-3, characterized in that, It also includes a first conduit and a second conduit, the second conduit having an internal telescopic space, and the first conduit being telescopically installed in the telescopic space; The gripper is mounted at the distal end of the first conduit, and the movable part is mounted at the distal end of the second conduit; or, the gripper is mounted at the distal end of the second conduit, and the movable part is mounted at the distal end of the first conduit. When the second conduit slides in the telescopic space, it can drive the gripper and the movable part to slide relative to each other, so as to control the gripper to switch between the clamping state and the releasing state.

5. The heart valve release mechanism according to claim 4, characterized in that, The distal end of the second conduit is provided with three clamps at a preset distance, and the distal end of the first conduit is provided with three movable parts.

6. A release catheter for delivering a positioning frame and valve stent for an artificial heart valve, characterized in that, include: The first catheter, the second catheter, the third catheter, and the fourth catheter are sequentially inserted from the inside out; The first release mechanism includes the heart valve release mechanism according to any one of claims 1-5; the gripper of the first release mechanism is mounted on the first catheter and the movable part is mounted on the second catheter; or, the movable part of the first release mechanism is mounted on the first catheter and the gripper is mounted on the second catheter; the first release mechanism is used to deliver a valve stent. The second release mechanism includes the heart valve release mechanism according to any one of claims 1-5, wherein the gripper of the second release mechanism is mounted on the third catheter and the movable part is mounted on the fourth catheter; or, the gripper of the second release mechanism is mounted on the fourth catheter and the movable part is mounted on the third catheter; the second release mechanism is used to deliver the positioning frame.

7. The release catheter according to claim 6, characterized in that, It also includes an intermediate movable rod and a distal sleeve movably installed in the first catheter. The distal sleeve is sleeved on the outside of the intermediate movable rod, and the distal end of the distal sleeve is connected to the distal end of the intermediate movable rod. In the initial state, the distal sleeve is sleeved on the outside of the valve stent. When the intermediate movable rod is pushed distally relative to the first catheter, the distal sleeve is misaligned with the valve stent, and the valve stent can expand from a contracted state to an expanded state.

8. The release catheter according to claim 7, characterized in that, It also includes an outer sheath that is movably fitted outside the fourth catheter. In the initial state, the distal end of the outer sheath is fitted outside the positioning frame. When the outer sheath is moved proximally relative to the fourth catheter, the distal end of the outer sheath is offset from the positioning frame. The positioning frame can expand from a contracted state to an open state.

9. An artificial heart valve delivery system, characterized in that, include: Artificial heart valves, including positioning frames and valve stents; The release catheter according to any one of claims 6-8, wherein the positioning frame and the valve stent are respectively mounted at the distal end of the release catheter; A delivery control component, connected to the proximal end of the release catheter, is used to control the extension and retraction of the catheter to control the delivery and release of the artificial heart valve.

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