Heart valve positioning device, artificial heart valve system, implantation system and method

Abstract

The present application provides a heart valve positioning system, which includes: a pre-guiding device, which can be delivered to the heart valve via the delivery system and capture the native leaflets; a positioning device, which includes: a tubular first positioning structure and a locking structure, the first positioning structure is provided with a first end, a second end and a penetration portion, the first end and the second end are separated from each other in the delivery state, and the penetration portion is used for the pre-guiding device to penetrate the inner cavity of the first positioning structure, so that the first end and the second end are connected to each other through the locking structure under the guidance of the pre-guiding device, and the first positioning structure forms a closed ring, so as to gather at least a part of the native leaflets inside the closed ring. The heart valve positioning device of the present application and the artificial valve are delivered through the atrial septum from the same pathway, which is simple to operate and can avoid causing damage to the aortic valve.

Description

Technical Field

[0001] The embodiments of the present application relate to the field of medical device technology, and in particular to a heart valve positioning device, an artificial heart valve system, an implantation system, and a method. Background Art

[0002] The mitral valve, also known as the left atrioventricular valve, is a barrier formed between the left ventricle and the left atrium. Under normal circumstances, the opening and closing of the mitral valve is regulated by the pressure difference between the left atrium and the left ventricle. During diastole, the pressure in the left atrium is greater than that in the left ventricle, and the mitral valve opens. Conversely, during systole, the pressure in the left ventricle is greater than that in the left atrium, and the mitral valve closes. The mitral valve has a complex structure and is composed of the valve annulus, valve leaflets, chordae tendineae, and papillary muscles. Organic or functional changes in any of these parts may cause mitral regurgitation, that is, the mitral valve cannot close completely during systole, allowing blood from the left ventricle to flow back into the left ventricle. Treatments for mitral regurgitation include valve repair and replacement. Valve repair is the common first choice of treatment, but valve replacement is the ultimate and fundamental solution.

[0003] Valve replacement can be performed through surgery or transcatheter intervention. For some patients with mitral regurgitation, who are not suitable for surgery due to high-risk factors such as poor heart function, multiple comorbidities, and advanced age, transcatheter intervention treatment can be used. Transcatheter aortic valve replacement is a well-established treatment for aortic valve disease, with several transcatheter aortic valve products currently on the market. While various transcatheter mitral valve designs and delivery methods have emerged in recent years, most remain in the research phase, primarily due to the following limitations: The mitral valve is structurally complex. Compared to the aortic valve, the mitral valve has a D-shaped overall structure, a larger annulus, and less calcification, which in turn prevents the prosthetic valve from providing sufficient support to secure it to the diseased mitral valve. Anatomically, the left ventricular outflow tract is adjacent to the anterior mitral leaflet, and implantation of the mitral prosthesis may also cause left ventricular outflow tract obstruction (LVOTO), which must be avoided during prosthetic valve design. The mitral valve annulus is larger, requiring a larger diameter stent for a single-layer prosthesis compared to the aortic valve. This increases the leaflet area corresponding to the prosthesis, reducing leaflet fatigue resistance and increasing the size of the delivery system, thereby increasing the risk of vascular complications.

[0004] Therefore, there is an urgent need for a product that does not require changing the heart structure and can treat valvular regurgitation through a minimally invasive approach. Summary of the Invention

[0005] In view of the above problems, the present application provides a method to overcome the above problems or at least partially solve the above problems.

[0006] An embodiment of the present application provides a heart valve positioning system, which can be delivered to a heart valve via a delivery system, wherein the heart valve includes native leaflets and a native valve ring, and the heart valve positioning system includes: a pre-guiding device, which can be delivered to the heart valve via the delivery system and capture the native leaflets; a positioning device, which includes: a tubular first positioning structure and a locking structure, the first positioning structure is provided with a first end, a second end and a penetration portion, the first end and the second end are separated from each other in a delivery state, and the penetration portion is provided for the pre-guiding device to penetrate into the inner cavity of the first positioning structure, so that the first end and the second end are connected to each other through the locking structure under the guidance of the pre-guiding device, and the first positioning structure forms a closed ring to gather at least a portion of the native leaflets inside the closed ring.

[0007] Optionally, the pre-guidance device has a main body and a third end and a fourth end arranged at both ends of the main body, the third end is used to be delivered to the heart valve via the delivery system and drive the main body to capture the native valve leaflet, and the fourth end is located outside the patient's body; the heart valve positioning system also includes a capture device, which is used to be delivered to the heart valve via the delivery system, capture the third end and drag the third end out of the patient's body.

[0008] Optionally, the heart valve positioning system also includes: a first auxiliary catheter for the pre-guide device to pass through; and a second auxiliary catheter for the capture device to pass through, so as to capture the third end portion passing through the first auxiliary catheter and drag the third end portion out of the patient's body; wherein the first auxiliary catheter and the second auxiliary catheter are configured to each bend into an arc in a released state, and be withdrawn from the patient's body after the third end portion is dragged out of the patient's body.

[0009] Optionally, the pre-guiding device is configured to be withdrawn from the penetration portion after the first positioning structure forms a closed loop.

[0010] Optionally, the penetration portion includes: a first penetration portion, which is used for the third end of the pre-guiding device to penetrate into the inner cavity of the first positioning structure; and a second penetration portion, which is used for the third end of the pre-guiding device to penetrate out of the inner cavity of the first positioning structure.

[0011] Optionally, the heart valve positioning system also includes: a second positioning structure and a connector, wherein the second positioning structure and the connector are both tubular structures, the first positioning structure and the second positioning structure are connected by the connector to form a bent structure, and in the released state the first positioning structure and the second positioning structure each form a bent structure, and the second positioning structure is anchored to the inner side of the native valve ring.

[0012] Optionally, the diameter of the second positioning structure is not smaller than the diameter of the first positioning structure.

[0013] Optionally, the width of the first positioning structure is greater than the width of the second positioning structure, and the width of the first positioning structure is greater than the width of the connector.

[0014] Optionally, the locking structure includes a receptor and a fitting body, and the receptor and the fitting body are respectively arranged at one of the first end and the second end. The receptor and the fitting body can be connected to each other in a cooperative manner, and the outer diameter of the fitting body is less than the inner diameter of the receptor, so that when the receptor and the fitting body are connected to each other in a cooperative manner, the fitting body enters the interior of the receptor.

[0015] Optionally, the receptor has an extension portion, the fitting body has an expansion portion and a contraction portion, and the outer diameter of the expansion portion is greater than the outer diameter of the contraction portion; when the receptor and the fitting body are in a docking state, the expansion portion applies an expansion force to the extension portion to expand the inner diameter of the extension portion and the fitting body enters the receptor; when the receptor and the fitting body are in an engaged state, the extension portion is engaged with the contraction portion, and the inner diameter of the extension portion returns to its initial state.

[0016] Optionally, the extension portion includes: a first extension portion, which extends radially outward from the first end portion; and a second extension portion, which is elastic and extends radially inward from the end portion of the first extension portion, so that the first extension portion and the second extension portion together form a trumpet-shaped structure.

[0017] Optionally, the extension portion extends radially inward from the first end portion, and a side wall of the first end portion is provided with at least one opening.

[0018] Optionally, the end of the expansion portion is a tapered structure.

[0019] Optionally, the mating body has a boss, and a spring sheet is provided on the outer periphery of the receiving body, which extends radially outward from the second end; when the receiving body and the mating body are in a docking state, the boss applies pressure to the spring sheet so that the spring sheet is squeezed and passes over the boss; when the receiving body and the mating body are in a locked state, the spring sheet returns to an expanded state and is locked to the inner side of the boss.

[0020] Optionally, the receiving body and the matching body are respectively provided with one of a first protrusion and a first groove, and when the receiving body and the matching body are docked, the first protrusion enters the first groove.

[0021] Optionally, the receiving body is provided with a second protrusion, and when the receiving body and the matching body are docked, the second protrusion is engaged with the outer surface of the matching body.

[0022] On the other hand, the present application also provides an artificial heart valve system, which includes: the above-mentioned heart valve positioning system; an artificial valve, which includes: artificial valve leaflets; and a tubular support member, which is circumferentially fixed to the inner side of the support member, and the support member is adapted to the heart valve positioning system so that when the heart valve positioning system is released, the artificial valve is implanted into the inner side of the first positioning structure.

[0023] In another aspect, the present application provides an artificial heart valve implantation system, which includes: the artificial heart valve system described above; and a delivery system having a delivery pipeline for delivering the heart valve positioning system to the heart and then releasing it.

[0024] On the other hand, the present application also provides an implantation method of an artificial heart valve system, which includes: delivering the pre-guide device to the heart valve via the delivery system and capturing the native leaflets; penetrating the pre-guide device into the inner cavity of the first positioning structure through the penetration portion, delivering the first positioning structure through the atrial septum to the native leaflet commissure and then slowly releasing it, so that the first end and the second end are connected to each other through the locking structure under the guidance of the pre-guide device, so that the first positioning structure moves around the native leaflets to form a closed ring, and at least a part of the native leaflets are gathered on the inner side of the closed ring; withdrawing the pre-guide device, releasing the connector and the second positioning structure; delivering the artificial valve through the atrial septum to the inner side of the first positioning structure and releasing it.

[0025] Optionally, the said delivering the pre-guide device to the heart valve via the delivery system and capturing the native leaflets further includes: after the pre-guide device is delivered to the heart valve via the delivery system, the capture device is delivered to the heart valve via the delivery system, captures the third end portion and drives the body to capture the native leaflet and then drags the third end portion out of the patient's body; the said passing the pre-guide device through the penetration portion into the inner cavity of the first positioning structure further includes: outside the patient's body, the third end portion of the pre-guide device is passed through the first penetration portion into the inner cavity of the first positioning structure, and then passed out of the inner cavity of the first positioning structure through the second penetration portion.

[0026] It can be seen from the above technical solutions that the artificial valve of the embodiment of the present application is relatively small in size, which can avoid problems such as vascular complications during transportation and premature failure of artificial valve leaflets after implantation caused by implanting larger artificial valves. In addition, the artificial valve of the present application has a lower subvalvular height, which can avoid blocking the left ventricular outflow tract and causing left ventricular outflow tract obstruction. Secondly, the subvalvular structure of the positioning device of the present application can form a closed ring through a locking structure, clamping the native leaflets between the subvalvular structure and the artificial valve, and utilizing the fit between the native leaflet tissue, the subvalvular structure and the artificial valve to achieve a good sealing effect, thereby avoiding the occurrence of paravalvular leakage after the artificial valve is implanted.

[0027] The present application can lock the subvalvular structure with the locking structure at one time when releasing the subvalvular structure, forming a closed ring and improving the efficiency of the operation.

[0028] The heart valve positioning device and the artificial valve of the embodiment of the present application are delivered through the atrial septum from the same pathway, which is simple to operate and can avoid tissue damage caused by multi-pathway delivery, such as damage to the aortic valve. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments recorded in the embodiments of the present application. For ordinary technicians in this field, other drawings can also be obtained based on these drawings.

[0030] Figure 1 is a schematic diagram of an embodiment of a pre-guiding device for a heart valve positioning device of the present application;

[0031] Figure 2 is a schematic diagram of a capture device of the present application capturing a pre-guided device for a heart valve;

[0032] Figure 3-4 They are respectively a three-dimensional view and a top view of an embodiment of a heart valve positioning system of the present application;

[0033] Figure 5 This is a schematic diagram of the pre-guiding device of the present application being inserted into the first positioning structure;

[0034] Figure 6 is a schematic diagram of an embodiment of the present application in which the locking structure of the first positioning structure is in a locked state to form a closed ring;

[0035] Figure 7 is a schematic diagram of an embodiment of the artificial heart valve system of the present application after release;

[0036] Figures 8A-8BSchematic diagrams of the first embodiment of the locking structure of the present application in the unlocked and locked states respectively;

[0037] Figure 9A 1 is a schematic diagram of the second embodiment of the locking structure of the present application in unlocked and locked states;

[0038] Figure 9B yes Figure 9A A cross-sectional view of an embodiment of the locking structure of the present application in a locked state is shown;

[0039] Figure 10 is a cross-sectional view of the third embodiment of the locking structure of the present application in a locked state;

[0040] Figure 11-13 They are cross-sectional views of the fourth to sixth embodiments of the locking structure of the present application in the locked state.

[0041] Component number

[0042] 10: Pre-guiding device; 20: Positioning device; 201: First positioning structure; 202: Locking structure; 203: First end; 204: Second end; 205: Penetrating portion; 101: Main body; 102: Third end; 30: Capturing device; 40: First auxiliary catheter; 50: Second auxiliary catheter; 206: First penetrating portion; 207: Second penetrating portion; 208: Second positioning structure; 209: Connecting body; 210: Connecting member; Receiving body 114; Matching body 115; 116: Expansion portion; 117: Contraction portion; 118: First extension portion; 119: Second extension portion; 120: Boss; 121: Shrapnel; 122: First protrusion; 123: First groove; 124: Second protrusion; 125: Artificial valve; 126: Support member; 127: Delivery system; 128: Delivery pipeline; 129: Extension portion; 130: Opening. DETAILED DESCRIPTION

[0043] In order to enable those skilled in the art to better understand the technical solutions in the embodiments of the present application, the technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the embodiments of the present application, all other embodiments obtained by ordinary technicians in this field should fall within the scope of protection of the embodiments of the present application.

[0044] The “distal end” refers to the end that is implanted in or close to the heart when the positioning device is implanted in the heart. The “proximal end” refers to the end that is away from the heart when the positioning device is implanted in the heart.

[0045] The specific implementation of the embodiment of the present application is further explained below in conjunction with the accompanying drawings of the embodiment of the present application.

[0046] See also Figures 1 to 13 In a specific implementation of the present application, a heart valve positioning system is provided, which can be delivered to a heart valve via a delivery system, wherein the heart valve includes native leaflets and a native valve ring, and the heart valve positioning system includes: a pre-guiding device 10, which can be delivered to the heart valve via the delivery system and capture the native leaflets; a positioning device 20, which includes: a tubular first positioning structure 201 and a locking structure 202, the first positioning structure 201 having a first end 203, a second end 204 and a penetration portion 205, the first end 203 and the second end 204 being separated from each other in a delivery state, the penetration portion 205 allowing the pre-guiding device 10 to penetrate the inner cavity of the first positioning structure 201, so that the first end 203 and the second end 204 are connected to each other through the locking structure 202 under the guidance of the pre-guiding device 10, so that the first positioning structure 201 forms a closed ring, so as to gather at least a portion of the native leaflets inside the closed ring. The penetration portion 205 can divide the first positioning structure 201 into two parts, such as two half rings, and the inner cavities of the two parts can be connected or not.

[0047] The pre-guiding device 10 is a linear body in the delivery state, and forms a ring shape after capturing the native valve leaflets after release. Figure 1 As shown, in one embodiment, the pre-guiding device 10 comprises a body 101 and third and fourth ends 102 and 103 disposed at opposite ends of the body 101. In the delivery state, the third and fourth ends 102 are separated. The third end 102 is used to be delivered to the heart valve via the delivery system and to drive the body 101 to capture the native valve leaflets. The fourth end is located outside the patient's body. The heart valve positioning system also includes a capture device 30, which is used to be delivered to the heart valve via the delivery system, capture the third end 102, and then pull it out of the patient's body. The capture device 30 is also completely pulled out of the patient's body. At this point, the pre-guiding device 10 captures the native valve leaflets, forming a nearly annular shape. The body 101 can be a linear structure, such as a guidewire, or other shaped structure. The third end 102 can be provided with an auxiliary capture structure to facilitate capture by the capture device 30. The auxiliary capture structure can be integral with the pre-guiding device 10 and can be formed by bending and shaping the third end 102 of the pre-guiding device 10 into a J-shape, S-shape, spiral, or other shape. The auxiliary capture structure can also be separated from the pre-guiding device 10, and the two are connected together by bonding, welding, riveting, etc. to form a spherical, cylindrical, J-shaped, S-shaped, spiral, etc. shape.

[0048] In one embodiment, the pre-guide device 10 and the capture device 30 can be made of memory material and pre-made into an arc shape, such as a semicircular shape. When the heart valve is released, the pre-guide device 10 and the capture device 30 form a semicircle, and the capture device 30 can easily capture the pre-guide device 10.

[0049] In another embodiment, if Figure 1 As shown, the heart valve positioning system further includes: a first auxiliary catheter 40 for passing the pre-guiding device 10; and a second auxiliary catheter 50 for passing the capturing device 30 to capture the third end portion 102 that has passed through the first auxiliary catheter 40 and pull the third end portion 102 out of the patient's body; wherein the first auxiliary catheter 40 and the second auxiliary catheter 50 are configured to each bend into an arc shape in a released state and be withdrawn from the patient's body after the third end portion 102 is pulled out of the patient's body. The first auxiliary catheter 40 and the second auxiliary catheter 50 can have a certain hardness and be pre-formed into an arc shape.

[0050] The distal ends of the first auxiliary catheter 40 and the second auxiliary catheter 50 can be free ends to facilitate adjustment of the bending angle to fit the structure of the native valve. After being released, the first auxiliary catheter 40 and the second auxiliary catheter 50 extend along the anterior and posterior leaflets of the native valve leaflets, respectively, until their distal ends approach each other. Then, the capture device 30 located in the second auxiliary catheter 50 extends to capture the third end 102 of the pre-guiding device 10 located in the first auxiliary catheter 40, captures the third end 102 into the second auxiliary catheter 50 and pulls it out of the body. Finally, the first auxiliary catheter 40 and the second auxiliary catheter 50 are withdrawn from the body, so that the pre-guiding device 10 forms an annular guide structure in the ventricle.

[0051] After the first positioning structure 201 forms a closed loop, the pre-guiding device 10 can be withdrawn from the penetration portion 205 .

[0052] The positioning device can independently complete the capture and anchoring of the native valve leaflet only by the first positioning structure 201. In another embodiment, the positioning device includes a first positioning structure 201, a second positioning structure 208 and a connector 209, wherein the second positioning structure 208 and the connector 209 are both hollow tubular structures or solid cylinders, and the first positioning structure 201 and the second positioning structure 208 are connected by the connector 209 to form a bending structure. In the released state, the first positioning structure 201 and the second positioning structure 208 each form a curved structure, and the second positioning structure 208 is anchored to the inner side of the native valve ring. A connector 210 can be provided on the second positioning structure 208 to be detachably connected to the delivery system. The connector 210 can be a perforation, a slot or other similar structure. The perforation portion 205 can be provided at a position of the first positioning structure 201 close to the connector 209 to facilitate withdrawal from the patient's body. The surfaces of the first positioning structure 201 , the second positioning structure 208 and the connector 209 may be coated with a high polymer film having good biocompatibility.

[0053] like Figure 4 As shown, the diameter of the second positioning structure 208 is not less than the diameter of the first positioning structure 201, so that the second positioning structure 208 can be more firmly anchored to the inner side of the native valve ring. The width of the first positioning structure 201 is greater than the width of the second positioning structure 208, and the width of the first positioning structure 201 is greater than the width of the connector 209, so as to enhance the stability of the first positioning structure 201 after capturing the native leaflet, and enhance the support force of the first positioning structure 201 on the artificial valve. However, the width of the first positioning structure 201 is not limited to this, and can also be less than or equal to the width of the second positioning structure 208. The "width" mentioned here refers to the diameter or maximum size of the cross section of the first positioning structure 201 or the second positioning structure 208.

[0054] The perforation portion 205 may be provided with one perforation or two perforations. Figure 3 As shown, in one embodiment, the penetration portion 205 is provided with two through-holes, including a first penetration portion 206 and a second penetration portion 207. The first penetration portion 206 is used to allow the third end portion 102 of the pre-guiding device 10 to penetrate into the inner cavity of the first positioning structure 201; the second penetration portion 207 is used to allow the third end portion 102 of the pre-guiding device 10 to pass through the inner cavity of the first positioning structure 201. In another embodiment, the penetration portion can be provided with a single through-hole, and the third end portion 102 of the pre-guiding device 10 can both enter and exit through this single through-hole.

[0055] In one embodiment, if Figure 5-6 , Figure 8A-14, the locking structure 202 includes a receiving body 114 and a matching body 115. The receiving body 114 and the matching body 115 are respectively disposed at one of the first end 203 and the second end 204. For example, the receiving body 114 is disposed at the first end 203 and the matching body 115 is disposed at the second end 204, or the two are interchangeable. The receiving body 114 and the matching body 115 can be mutually connected, and the outer diameter of the matching body 115 is smaller than the inner diameter of the receiving body 114, so that when the receiving body 114 and the matching body 115 are mutually connected, the matching body 115 enters the interior of the receiving body 114.

[0056] In one embodiment, if Figure 8A-10 As shown, the receiving body 114 has an extension portion, and the fitting body 115 has an expansion portion 116 and a contraction portion 117, and the outer diameter of the expansion portion 116 is greater than the outer diameter of the contraction portion 117; when the receiving body 114 and the fitting body 115 are in a docking state, the expansion portion 116 applies an expansion force to the extension portion to expand the inner diameter of the extension portion and the fitting body 115 enters the receiving body 114; when the receiving body 114 and the fitting body 115 are in an engaged state, the extension portion is engaged with the contraction portion 117, and the inner diameter of the extension portion returns to its initial state.

[0057] like Figures 8A-9B As shown, in one embodiment, the extension portion includes: a first extension portion 118 extending radially outward from the first end portion 203; and a second extension portion 119, which is elastic and extends radially inward from the end of the first extension portion 118, so that the first extension portion 118 and the second extension portion 119 together form a trumpet-shaped structure. One or both of the first extension portion 118 and the second extension portion 119 can be elastic. The constriction portion 117 can be a groove, which can be curved or not. The end of the expansion portion 116 can be a tapered structure to further facilitate the expansion portion 116 to be pushed into the receiving body 114. When the fitting body 115 enters the interior of the receiving body 114, the expansion portion 116 squeezes the second extension portion 119 radially outward, and the second extension portion 119 drives the first extension portion 118 to expand together, so that the expansion portion 116 enters the inner cavity of the receiving body 114 until the second extension portion 119 is engaged in the contraction portion 117, thereby realizing the mutual locking of the first end portion 203 and the second end portion 204, so that the first positioning structure 201 forms a closed ring.

[0058] like Figures 9A-10As shown, in one embodiment, the extension portion 129 extends radially inward from the first end portion 203, and the sidewall of the first end portion 203 is provided with at least one opening 130. The end of the expansion portion 116 is tapered. When the fitting body 115 enters the interior of the receiving body 114, the expansion portion 116 radially presses the extension portion outward, enlarging the opening 130 and allowing the expansion portion 116 to enter the inner cavity of the receiving body 114 until the extension portion 129 engages with the contraction portion 117, thereby locking the first end portion 203 and the second end portion 204 together, forming a closed loop of the first positioning structure 201.

[0059] like Figure 10 As shown, in one embodiment, the mating body 115 has a boss 120, and the inner side wall of the receiving body 114 is provided with one or more spring pieces 121, which extend radially inward from the inner side wall; when the receiving body 114 and the mating body 115 are in a docking state, the boss 120 applies pressure to the spring piece 121 so that the spring piece 121 is squeezed and passes over the boss 120; when the receiving body 114 and the mating body 115 are in a locked state, the spring piece 121 returns to the expanded state and is locked to the inner side of the boss 120.

[0060] In one embodiment, the receiving body 114 and the matching body 115 are respectively provided with one of the first protrusion 122 and the first groove 123. Figure 11 As shown, the receiving body 114 is provided with a first protrusion 122, and the matching body 115 is provided with a first groove 123; Figure 12 As shown, the receiving body 114 is provided with a first groove 123, and the mating body 115 is provided with a first protrusion 122. When the receiving body 114 and the mating body 115 are docked, the first protrusion 122 enters the first groove 123, so that the first end 203 and the second end 204 are locked with each other, thereby forming the first positioning structure 201 into a closed ring.

[0061] In one embodiment, if Figure 13 As shown, the receiving body 114 is provided with a second protrusion 124. When the receiving body 114 and the matching body 115 are docked, the second protrusion 124 is engaged with the outer surface of the matching body 115, so that the first end 203 and the second end 204 are locked with each other, thereby forming the first positioning structure 201 into a closed ring.

[0062] like Figure 7As shown, in one embodiment, the present application further provides an artificial heart valve system, which includes: the above-mentioned heart valve positioning system and an artificial valve 125, wherein the artificial valve 125 includes: artificial valve leaflets; and a tubular support member 126, wherein the artificial valve leaflets are circumferentially fixed to the inner side of the support member 126, and the support member 126 is adapted to the positioning device 20, so that when the positioning device 20 is released, the artificial valve 125 is implanted inside the first positioning structure 201. In another embodiment, the present application further provides an artificial heart valve implantation system, which includes an artificial heart valve system and a delivery system 127, wherein the delivery system 127 has a delivery tube 128 for delivering the heart valve positioning device 20 to the heart valve and then releasing it, and the delivery system 127 may include one or more sets of structures including the delivery tube 128.

[0063] During delivery, delivery conduit 128 can be positioned at either leaflet commissure C1 or C2. If positioning device 20 is released from C1, second positioning structure 208 is designed to rotate counterclockwise. If positioning device 20 is released from C2, second positioning structure 208 is designed to rotate clockwise. After positioning device 20 is released, second positioning structure 208 is positioned at the posterior annulus, effectively securing positioning device 20 at the native annulus.

[0064] In another embodiment, the present application also provides an implantation method of an artificial heart valve system, which includes: after the pre-guiding device 10 is delivered to the heart valve via the delivery system 127, the capturing device 30 is delivered to the heart valve via the delivery system 127, capturing the third end 102 and driving the body 101 to capture the native leaflet and then dragging the third end 102 out of the patient's body; outside the patient's body, the third end 102 of the pre-guiding device 10 is passed through the first penetrating portion 206 into the inner cavity of the first positioning structure 201, and then passed through the second penetrating portion 207 from the third positioning structure 201. The first positioning structure 201 passes through the inner cavity of the positioning structure 201; the first positioning structure 201 is delivered to the native leaflet commissure through the atrial septum and then slowly released, so that the first end and the second end 204 are connected to each other through the locking structure 202 under the guidance of the pre-guidance device 10, so that the first positioning structure 201 moves around the native leaflet to form a closed ring, and at least a part of the native leaflet is gathered on the inner side of the closed ring; the pre-guidance device 10 is withdrawn, and the connector 209 and the second positioning structure 208 are released; the artificial valve is delivered to the inner side of the first positioning structure 201 through the atrial septum and released.

[0065] In another embodiment, the delivery system 127 is first delivered to the left atrium through the atrial septum, and the distal end of the delivery system 127 is adjusted so that it passes through the valve leaflet commissure C2 and enters the left ventricle. Subsequently, the first auxiliary catheter 40 and the second auxiliary catheter 50 are simultaneously delivered to the position of the left ventricle close to the valve orifice through the delivery system 127, and the distal ends of the first auxiliary catheter 40 and the second auxiliary catheter 50 are pushed out of the delivery system 127. After ensuring that the distal ends of the first auxiliary catheter 40 and the second auxiliary catheter 50 are located outside the native valve leaflet, the first auxiliary catheter 40 and the second auxiliary catheter 50 are pushed out along the outside of the native valve leaflet until the first auxiliary catheter 40 and the second auxiliary catheter 50 are pushed out. After the distal ends of the auxiliary catheters 50 are close to each other, the third end 102 of the pre-guide device 10 in the first auxiliary catheter 40 and the distal end of the capture device 30 in the second auxiliary catheter 50 are pushed out, and the fourth end of the pre-guide device 10 and the proximal end of the capture device 30 outside the body are operated, and the capture device 30 is used to capture the third end 102 of the pre-guide device 10. After successful capture, the third end 102 of the pre-guide device 10 is brought into the second auxiliary catheter 50 until it is brought out of the body, so that the pre-guide device 10 forms an annular guide structure in the ventricle, and then the first auxiliary catheter 40 and the second auxiliary catheter 50 are withdrawn from the body.

[0066] Afterwards, the third end 102 of the pre-guiding device 10 outside the body is passed through the first penetrating portion 206 into the inner cavity of the first positioning structure 201, and then passed through the second penetrating portion 207 to exit the inner cavity of the first positioning structure 201, and then the conveying system 127 is connected to the connecting piece of the second positioning structure 208, and then the first positioning structure 201 is released from the conveying system 127, so that it slides along the annular guide structure formed by the pre-guiding device 10 in the ventricle until the receiving body and the matching body of the locking structure 202 are close to each other, and the distal end of the conveying system 127 is fixed, and the pre-guiding device 10 is pulled outward to reduce the diameter of the annular guide structure, thereby causing the receiving body and the matching body to move relative to each other until they are engaged, so that the first positioning structure 201 forms a closed ring, and the native leaflet is gathered inside the closed ring.

[0067] The second positioning structure 208 is then released from the delivery system, and the pre-guiding device 10 is subsequently withdrawn. Before the artificial valve is released, the native valve leaflets can still function normally, maintaining normal hemodynamics. The artificial valve can be released within the closed ring of the first positioning structure 201 and secured to the native valve by the radial force between the two, replacing the function of the native valve.

[0068] Compared with the prior art, the artificial valve 125 of the present application is smaller in size, which can avoid problems such as vascular complications during transportation and premature failure of the artificial valve leaflets after implantation caused by implanting a larger artificial valve 125. In addition, the artificial valve 125 of the present application has a lower subvalvular height, which can avoid blocking the left ventricular outflow tract and causing left ventricular outflow tract obstruction. Secondly, the first positioning structure 201 of the present application can form a closed ring through the locking structure 202, clamping the native leaflets between the first positioning structure 201 and the artificial valve 125, and utilizing the fit between the native leaflet tissue and the first positioning structure 201 and the artificial valve 125 to achieve a good sealing effect, thereby avoiding the occurrence of paravalvular leakage after the artificial valve 125 is implanted.

[0069] If the positioning device 20 and the artificial valve 125 are delivered through the aorta and the atrial septum respectively, the operation is complicated and there is a risk of damaging the aortic valve. The positioning device 20 and the artificial valve 125 in this application are delivered through the same pathway through the atrial septum to avoid causing damage to the aortic valve.

[0070] In addition, the cooperation between the pre-guiding device of the present application and the first and second auxiliary catheters makes the capture of the pre-guiding device relatively simple, and the difficulty of the surgical operation is also reduced.

[0071] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the embodiments of the present application, and not to limit them. Although the present application has been described in detail with reference to the aforementioned embodiments, ordinary technicians in this field should understand that they can still modify the technical solutions recorded in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. These modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present application.

Claims

1. A heart valve positioning system, which can be delivered to a heart valve via a delivery system, wherein: The heart valve includes native leaflets and a native valve ring, and is characterized in that the heart valve positioning system includes: a pre-guided device that can be delivered to the heart valve via the delivery system and capture the native valve leaflets; A positioning device comprising: a tubular first positioning structure and a locking structure, the first positioning structure having a first end, a second end, and a penetration portion, the first end and the second end being separated from each other in a delivery state, the penetration portion allowing the pre-guiding device to penetrate into an inner cavity of the first positioning structure, so that the first end and the second end are connected to each other through the locking structure under the guidance of the pre-guiding device, thereby forming a closed ring with the first positioning structure to gather at least a portion of the native valve leaflet inside the closed ring; The heart valve positioning system also includes: a second positioning structure and a connector, wherein the second positioning structure and the connector are both tubular structures, the first positioning structure and the second positioning structure are connected through the connector to form a bent structure, and in the released state, the first positioning structure and the second positioning structure each form a bent structure, and the second positioning structure is anchored to the inner side of the native valve ring, and the penetrating portion is arranged at a position of the first positioning structure close to the connector.

2. The heart valve positioning system according to claim 1, characterized in that: The pre-guidance device has a main body and a third end and a fourth end arranged at both ends of the main body. The third end is used to be delivered to the heart valve via the delivery system and drive the main body to capture the native valve leaflet. The fourth end is located outside the patient's body; the heart valve positioning system also includes a capture device, which is used to be delivered to the heart valve via the delivery system, capture the third end and drag the third end out of the patient's body.

3. The heart valve positioning system according to claim 2, characterized in that: The heart valve positioning system also includes: a first auxiliary catheter for passing the pre-guiding device; and a second auxiliary catheter, for allowing the capture device to pass through, so as to capture the third end portion passing through the first auxiliary catheter and pull the third end portion out of the patient's body; The first auxiliary catheter and the second auxiliary catheter are configured to bend into an arc shape in a released state, and are withdrawn from the patient's body after the third end portion is pulled out of the patient's body.

4. The heart valve positioning system according to claim 1, wherein: The pre-guiding device is configured to be withdrawn from the penetrating portion after the first positioning structure forms a closed loop.

5. The heart valve positioning system according to claim 2, characterized in that: The threading part includes: a first penetrating portion, which is used for the third end portion of the pre-guiding device to penetrate into the inner cavity of the first positioning structure; The second penetration portion is used for allowing the third end portion of the pre-guiding device to penetrate through the inner cavity of the first positioning structure.

6. The heart valve positioning system according to claim 1, characterized in that: The diameter of the second positioning structure is not less than the diameter of the first positioning structure.

7. The heart valve positioning system according to claim 1, wherein: The width of the first positioning structure is greater than the width of the second positioning structure, and the width of the first positioning structure is greater than the width of the connector.

8. The heart valve positioning system according to claim 1, wherein: The locking structure includes a receptor and a mating body, wherein the receptor and the mating body are respectively arranged at one of the first end and the second end. The receptor and the mating body can be connected to each other in a mating manner, and the outer diameter of the mating body is less than the inner diameter of the receptor, so that when the receptor and the mating body are connected to each other in a mating manner, the mating body enters the interior of the receptor.

9. The heart valve positioning system according to claim 8, characterized in that: The receptor has an extension portion, and the fitting has an expansion portion and a contraction portion, wherein the outer diameter of the expansion portion is greater than the outer diameter of the contraction portion; when the receptor and the fitting are in a docking state, the expansion portion applies an expansion force to the extension portion to expand the inner diameter of the extension portion and the fitting enters the receptor; when the receptor and the fitting are in an engaged state, the extension portion is engaged with the contraction portion, and the inner diameter of the extension portion returns to its initial state.

10. The heart valve positioning system according to claim 9, characterized in that: The extension includes: a first extension portion extending radially outward from the first end portion; and The second extension portion is elastic and extends radially inward from the end portion of the first extension portion, so that the first extension portion and the second extension portion together form a trumpet-shaped structure.

11. The heart valve positioning system according to claim 9, wherein: The extension portion extends radially inward from the first end portion, and a side wall of the first end portion is provided with at least one opening.

12. The heart valve positioning system according to claim 9, wherein: The end of the expansion portion is a tapered structure.

13. The heart valve positioning system according to claim 8, wherein: The matching body has a boss, and the outer periphery of the receiving body is provided with a spring sheet, which extends radially outward from the second end; when the receiving body and the matching body are in a docking state, the boss applies pressure to the spring sheet so that the spring sheet is squeezed and passes over the boss; when the receiving body and the matching body are in a clamping state, the spring sheet returns to an expanded state and is clamped on the inner side of the boss.

14. The heart valve positioning system according to claim 8, characterized in that: The receiving body and the matching body are respectively provided with one of a first protrusion and a first groove. When the receiving body and the matching body are docked, the first protrusion enters the first groove.

15. The heart valve positioning system according to claim 8, wherein: The receiving body is provided with a second protrusion, and when the receiving body and the matching body are docked, the second protrusion is engaged with the outer surface of the matching body.

16. An artificial heart valve system, characterized in that: The artificial heart valve system includes: The heart valve positioning system according to any one of claims 1 to 15; An artificial valve, comprising: Prosthetic valve leaflets; and A cylindrical support member, the artificial valve leaflet is circumferentially fixed to the inner side of the support member, and the support member is adapted to the heart valve positioning system so that when the heart valve positioning system is released, the artificial valve is implanted into the inner side of the first positioning structure.

17. An artificial heart valve implantation system, characterized in that: The implant system includes: The artificial heart valve system of claim 16; The delivery system has a delivery channel and is used for delivering the heart valve positioning system to the heart and then releasing it.

Images