WO2024060826A1

WO2024060826A1 - Implant for heart valve ring repair and delivery apparatus of implant

Info

Publication number: WO2024060826A1
Application number: PCT/CN2023/109334
Authority: WO
Inventors: 刘祥; 孙睿奎; 李磊; 何东; 魏勇强
Original assignee: 江苏臻亿医疗科技有限公司
Priority date: 2022-09-19
Filing date: 2023-07-26
Publication date: 2024-03-28
Also published as: CN117752464A

Abstract

Provided are an implant for heart valve ring repair and a delivery apparatus of an implant. The implant comprises an implant body (10) having an expanded state and a contracted state. In the expanded state, the implant body (10) has two free ends in the axial direction, and the two free ends are separated, such that the implant body (10) forms a non-closed-ring structure. In the contracted state, the two free ends of the implant body (10) are connected, such that the implant body (10) forms a closed-ring structure. In the contracted state, the shape of the implant body (10) fits the anatomical structure of the native mitral valve ring, and the implant body (10) has different rigidities in the circumferential direction. The implant is high in anchoring reliability and is not prone to detachment or local stress concentration in the valve in a cardiac cycle, thus featuring a good valve-repairing effect.

Description

Implants and implant delivery devices for cardiac valve annulus repair

Technical field

The present invention relates to the technical field of medical devices, and in particular to an implant for repairing a heart valve ring and a delivery device for the implant.

Background technique

The heart contains four chambers, the right atrium (RA), right ventricle (RV), left atrium (LA), and left ventricle (LV). Throughout the cardiac cycle, the pumping action of the left and right sides of the heart generally occurs simultaneously. The valve that separates the atrium from the ventricle is called the atrioventricular valve. The atrioventricular valve acts as a one-way valve to ensure the normal flow of blood in the cardiac chambers. The atrioventricular valve between the left atrium and the left ventricle is the mitral valve, and the atrioventricular valve between the right atrium and the right ventricle is the tricuspid valve. The pulmonary valve directs blood flow to the pulmonary artery and from there to the lungs, where blood returns to the left atrium through the pulmonary veins. The aortic valve directs blood flow through the aorta and from there to the periphery. There are usually no direct connections between the ventricles or between the atria.

At the beginning of ventricular filling (diastole), the aortic and pulmonary valves close to prevent the backflow of blood from the arteries into the ventricles. The atrioventricular valves then open to allow unimpeded flow of blood from the atria into the corresponding ventricles. During ventricular systole (i.e., ventricular emptying), the tricuspid and mitral valves close normally, forming a seal that prevents backflow from the ventricles into the corresponding atria. When the atrioventricular valve structure is abnormal, the valve closes improperly, causing the atrioventricular valve to fail to function properly. The atrioventricular valve is a complex structure, usually including annulus, leaflets, chordae tendineae and supporting structures. Each atrium is connected to the corresponding valve through the atrial vestibule. The mitral valve has two leaflets, and the attachment or engagement of the corresponding surfaces of each leaflet to each other helps the valve close or seal, thereby preventing blood from flowing in the wrong direction. The inability of the valve leaflets to seal during ventricular contraction is called malcoaptation, causing blood to flow in the opposite direction through the valve (regurgitation). Heart valve insufficiency can have serious consequences for patients, often leading to heart failure, reduced blood flow, lowered blood pressure, and/or reduced oxygen flow to the body's tissues. Mitral regurgitation can also cause blood to flow from the left atrium back into the pulmonary veins, causing congestion. Severe valvular insufficiency, if left untreated, can lead to permanent disability or death. Ischemic heart disease causes mitral regurgitation through the combination of ischemic dysfunction of the papillary muscles and left ventricular dilation present in ischemic heart disease, with subsequent papillary muscle displacement and mitral annular dilation. Dilation of the mitral annulus prevents the leaflets from fully coapting during valve closure. Mitral regurgitation of blood from the left ventricle to the left atrium results in increased total stroke volume and decreased cardiac output, as well as eventual left ventricular weakening secondary to left atrial volume overload and pressure overload.

Transcatheter mitral valve repair surgery uses a catheter intervention method to deliver the artificial valve annulus through a delivery device along the vascular path or through the apex of the heart to the human mitral valve annulus, and release the anchor of the artificial valve annulus. It is fixed at the mitral valve annulus to reshape the valve annulus and achieve the purpose of eliminating regurgitation while retaining the native valve tissue. Compared with surgery, transcatheter mitral valve repair does not require an extracorporeal circulation auxiliary device, is less invasive, allows the patient to recover quickly, and the patient's hemodynamic parameters can be significantly improved after surgery. Mitral valve annulus repair technology is developing rapidly, and there are many types of repair devices. However, there are still some recognized problems in product design, mainly including the following aspects:

(1) Poor anchorage: If the artificial valve annulus is a flexible non-closed ring structure, its anchoring reliability is low and it is easy to loosen;

(2) Poor remodeling effect: The reshaping effect of the flexible non-closed ring structure on the valve annulus is weaker than that of the rigid closed ring structure, but the rigid closed ring structure has a two-dimensional shape and is a rigid body as a whole, making the rigid closed ring structure less effective during the cardiac cycle. It is easy to cause local stress concentration in the valve, causing valve tear, leading to failure of valve repair; at the same time, it is also easy to cause left ventricular outflow tract obstruction;

(3) Instrument operation is cumbersome: Current annulus repair products are too cumbersome in terms of anchoring operation, anchor positioning, implant control, etc., which place high demands on the operator and increase the difficulty of the operation;

(4) Limited scope of application: the artificial valve annulus can only be adjusted to a certain size, but cannot adjust the size of the annular contraction in real time based on the cardiogram during the operation, making it inflexible to use.

Contents of the invention

The object of the present invention is to provide an implant for heart valve annulus repair and a delivery device for the implant, in which the implant has high anchoring reliability, is not easy to loosen, and is not easy to cause local stress on the valve during the cardiac cycle. Concentrated, the valve repair effect is good, and when delivering the implant, it simplifies the surgical operation process and reduces the difficulty of the operation.

In order to achieve the above object, the present invention provides an implant for heart valve annulus repair, which includes an implant body having an expanded state and a contracted state; the implant in the expanded state The object body has two free ends along the axial direction, and the two free ends are separated so that the implant body forms a non-closed loop structure; the two free ends of the implant body in a contracted state connected so that the implant body forms a closed ring structure; the shape of the implant body in the contracted state matches the native mitral annulus anatomy, and the implant body in the contracted state It has different stiffness in the circumferential direction.

In one embodiment, the implant body in the contracted state has a first part and a second part in the circumferential direction. The first part has a spatial three-dimensional shape in the contracted state, and the second part has a three-dimensional shape in the contracted state. Plane two-dimensional shape, and the stiffness of the first part is greater than the stiffness of the second part; in the unfolded state, the first part is arranged between two sections of the second part, and all the parts of the second part The two free ends of the two sections are connected in a contracted state; the first part is expanded The length in the expanded state accounts for 1/3 to 1/2 of the total length of the implant body in the expanded state, and the length of the second part in the expanded state accounts for the total length of the implant body in the expanded state. 1/2~2/3.

In one embodiment, the implant further includes a retractable component connected to the implant body, and the retractable component is used to adjust the radial and circumferential directions of the implant body in a contracted state. size.

In one embodiment, the retractable component includes a retractable member and a retractable control member; one free end of the implant body is connected to the retractable member; the retractable control member is provided on the The outside of the implant body is connected to the implant body; after one end of the retractable piece is connected to one of the free ends of the implant body, the body of the retractable piece passes through the The implant body is connected to the retractable and retractable control member; the retractable and retractable control member is used to drive the retractable and retractable member to move, so that the radial and circumferential dimensions of the implant body in the contracted state are generated. Variety.

In one embodiment, the retractable and retractable control member is a spool.

In one embodiment, the implant body includes an elastic skeleton, an outer sleeve and an anchoring component; the elastic skeleton is arranged in the outer sleeve; the anchoring component, the elastic skeleton and the outer sleeve are connected to each other ; The anchoring component has a constrained state and a non-constrained state; the anchoring component in the constrained state is integrally disposed in the outer sleeve; the anchoring component in the non-constrained state partially passes through and penetrates the outer sleeve Target tissue for anchoring the implant.

In one embodiment, the elastic skeleton includes a plurality of elastic members, the plurality of elastic members are arranged sequentially in the axial direction of the outer sleeve, and at least one of the elastic members is disposed between two adjacent elastic members. Anchor components.

In one embodiment, the implant further includes a joint part, and the joint parts are provided on both free ends. In the contracted state, the two joint parts of the two free ends are connected in a cooperative manner. .

In one embodiment, the two joint portions of the two free ends are snap-connected.

In one embodiment, the anchoring component includes a shell and an anchoring piece connected to the shell. The outer wall of the shell is attached to and connected to the inner wall of the outer tube, and the elastic piece is connected to the shell. The anchor is configured to remain stationary relative to the housing when restrained and is integrally provided in the housing; the anchor is further configured to be able to remain stationary relative to the housing after being released from restraint. The housing moves and partially penetrates the housing and outer cannula to penetrate the target tissue.

In one embodiment, the anchoring member is an elastic structure that elastically deforms when restrained, and moves relative to the housing under the action of its own elastic force after being released from restraint.

In one embodiment, the anchoring member is a line-like structure or a sheet-like structure.

In one embodiment, the anchoring component further includes a driving member disposed in the housing. The driving member is in contact with the anchoring member and is used to drive the anchoring member after the anchoring member is released from restraint. Anchored The piece moves toward the outside of the outer sleeve.

In one embodiment, the driving member is an elastic element.

In one embodiment, the implant further includes at least two anchoring release control members, one end of the at least two anchoring release control members is detachably connected to the implant body, and the other end passes through All said anchoring components and simultaneously binding all said anchors, said other end of each said anchor release control member can be pulled to sequentially release all said anchors.

In one embodiment, the anchoring component further includes a blocking portion disposed in the housing, and at least two of the anchor release control members block two opposite sides of the anchoring member on the inside of the anchoring member. parts move toward each other, and the blocking portion blocks the two opposite portions of the anchoring member from moving backward on the outside of the anchoring member.

In order to achieve the above object, the present invention also provides an implant delivery device, which is used to deliver any of the implants for heart valve annulus repair; the delivery device includes a bending control catheter and an operating catheter. and an attitude control catheter; the operating catheter is used to be inserted into the inner cavity of the bending control catheter, and used to push the implant to move along the axial direction of the bending control catheter; at least two of the attitude control catheters pass through through the operating catheter and partially protruding from the side wall of the operating catheter to abut the implant body in the contracted state, and at least two of the attitude control catheters are connected to the implant body in the contracted state. The object body abuts at different positions in the circumferential direction.

In one embodiment, the delivery device further includes a multi-lumen tube and at least two attitude control guide wires, the multi-lumen tube is placed in the inner cavity of the operating catheter; each of the attitude control guide wires One end is detachably connected to the implant body outside the implant body, and the other end enters the corresponding lumen in the multi-lumen tube from the side wall of the operating catheter and extends axially to the The proximal end of the multi-lumen tube; each attitude control catheter moves along a corresponding attitude control guide wire, and at least two attitude control guide wires are circumferentially aligned with the implant body. Connect at different locations.

In one embodiment, the delivery device further includes a multi-lumen tube, a driving tool and a retractable guide wire; the multi-lumen tube is placed in the inner cavity of the operating catheter; one end of the retractable guide wire The outside of the implant body is detachably connected to the retraction control member in the implant, and the other end enters a corresponding lumen in the multi-lumen tube from the distal end of the multi-lumen tube and Extending axially to the proximal end of the multi-lumen tube; the driving tool is used to move along the retraction guide wire and is detachably connected to the retraction control member.

In one embodiment, the delivery device further includes a multi-lumen tube and a closing control wire. The multi-lumen tube is placed in the inner cavity of the operating catheter; one end of the closing control wire is on the implant body. The outside is detachably connected to the distal end of the implant body in the delivery state, and the other end enters a corresponding lumen of the multi-lumen tube pair from the distal end of the multi-lumen tube and extends axially to The multi-lumen tube Proximal end; the closing control wire is used to control the connection of the two free ends of the implant body in the expanded state.

In one embodiment, the delivery device further includes a multi-lumen tube and a turning control wire. The multi-lumen tube is placed in the inner cavity of the operating catheter; one end of the turning control wire is in contact with the turning control wire in the unfolded state. The implant body is detachably connected, and the other end enters a corresponding lumen of the multi-lumen tube from the distal end of the multi-lumen tube and extends axially to the proximal end of the multi-lumen tube. Before the object body forms a closed ring structure, the turning control wire controls the operating catheter to rotate to a position perpendicular to the main plane of the implant.

Compared with the existing technology, the technical solution provided by the present invention has at least the following beneficial effects:

(1) The shape of the implant body of the above implant in the contracted state matches the anatomical structure of the native mitral valve annulus, so that the implant can adapt to the shape of the native mitral valve during the systolic phase of the cardiac cycle, This allows the stress of the repaired mitral valve to be more evenly distributed throughout the cardiac cycle, thereby reducing the risk of valve and annulus tearing, maximizing the alignment of the leaflets, and optimizing the hemodynamics of the mitral valve. Improves the lifespan of the original valve after valve annulus repair. Therefore, the implant of the present invention can reshape its three-dimensional geometric configuration and improve the valve repair effect. In addition, it also helps reduce the risk of left ventricular outflow tract obstruction. At the same time, the three-dimensional geometric configuration of the implant can also prevent valve tearing and increase the success rate of valve repair.

(2) The implant bodies of the above implants have different stiffnesses in the circumferential direction in the contracted state to adapt to the physiological characteristics of the native mitral valve annulus, thereby providing the valve annulus with a better stability on the basis of reshaping the valve annulus. It has better stability and support, and at the same time, has little impact on the movement of the valve annulus during the cardiac cycle, ensuring the normal operation of left ventricular function. Moreover, the anchoring reliability of the implant is high and it is not easy to loosen.

(3) The above delivery device can achieve stable and precise positioning of the implant through the cooperation of the bending control catheter, the operating catheter and the posture control catheter, and the entire control process is simpler and more convenient.

(3) The above implant is preferably provided with a retractable component, which can adjust the radial and circumferential dimensions of the implant body in the contracted state, thereby making the implant wider applicable and more flexible in use.

Description of the drawings

Figure 1 is a schematic diagram of the overall structure of an implant for heart valve annulus repair in an expanded state according to an embodiment of the present invention;

Figure 2 is a scene diagram of the implant used for heart valve annulus repair provided by the embodiment of the present invention being applied to the mitral valve;

Figure 3 is a partial enlarged view of the implant used for heart valve annulus repair in Figure 2 after forming a closed ring structure and being positioned at the mitral valve;

Figure 4 is a schematic structural diagram of an implant for heart valve annulus repair provided by an embodiment of the present invention that forms a closed ring structure and has a spatial three-dimensional shape corresponding to the anterior valve annulus and a planar two-dimensional shape corresponding to the posterior valve annulus;

FIG5 is a schematic structural diagram of an implant for repairing a heart valve ring provided by an embodiment of the present invention having two parts with different stiffnesses;

Figure 6 is a schematic diagram of the state when the anchor release control member is pulled to release the anchor member according to the embodiment of the present invention;

Figure 7 is a schematic cross-sectional structural diagram of an anchoring component provided by an embodiment of the present invention;

Figure 8 is a schematic structural diagram of the anchoring member in the anchoring component provided by the embodiment of the present invention when it is restrained;

Figure 9 is a schematic diagram of the state when the anchoring member in the anchoring component provided by the embodiment of the present invention is released from restraint and partially penetrates into the target tissue;

FIG10 is a schematic structural diagram of an implant for heart valve ring repair provided by an embodiment of the present invention and a delivery device for the implant when the implant cooperates;

Fig. 11 is a cross-sectional view along line B-B in Fig. 10;

Figure 12 is a cross-sectional view along line C-C in Figure 10;

FIG13 is a diagram showing a state in which an implant for heart valve ring repair provided by an embodiment of the present invention is pushed out of a bending-control catheter and gradually closed;

Figure 14 is a diagram of a state where the implant for heart valve annulus repair is about to be closed according to an embodiment of the present invention;

Figure 15 is a diagram of a closed state of the implant used for heart valve annulus repair provided by an embodiment of the present invention;

Figures 16 to 18 are diagrams showing the positioning and placement of the implant for heart valve annulus repair provided by the embodiment of the present invention after forming a closed ring structure;

Figure 19 is a state diagram of the implant for heart valve annulus repair releasing the anchor after positioning is completed according to an embodiment of the present invention;

Figure 20 is a state diagram of the implant used for heart valve annulus repair using a driving tool to adjust the radial and circumferential dimensions according to an embodiment of the present invention;

Figure 21 is a diagram of the state of the implant for heart valve annulus repair provided by the embodiment of the present invention after the driving tool is withdrawn after adjusting the radial and circumferential dimensions.

[Reference symbols are explained as follows:]
10. Implant body; 11. First part; 12. Second part; 1. Elastic skeleton; 111-elastic member; 2. Anchor component; 210. Anchor component; 220. Blocking part; 240. Driving component; 250 ,case; 3. Outer sleeve; 4. Joint part; 41. First joint; 42. Second joint; 6. Retractable and retractable parts; 61-retractable and retractable parts; 62-retractable and retractable control parts; 7. Anchor release control parts; 51 , posterior annulus; 52, anterior annulus; 53, left ventricular outflow tract; H1, bulge height; P, main plane of the implant; S - target tissue; 310, delivery sheath; 320, control bend catheter; 330. Operating catheter; 340. Attitude control catheter; 350. Driving tool; 301. Attitude control guide wire; 302. Retracting and releasing guide wire; 303. Closing control wire; 304. Turning control wire; 331. Multi-lumen tube.

Detailed ways

In order to make the content of the present invention clearer and easier to understand, the present invention will be further described below with reference to the accompanying drawings. Of course, the present invention is not limited to this specific embodiment, and general substitutions known to those skilled in the art are also covered by the protection scope of the present invention.

The terminology used in this application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. As used in this application, the singular forms "a," "the" and "the" are intended to include the plural forms as well, unless the context clearly dictates otherwise. It should be understood that similar words such as "one" or "one" do not indicate a quantitative limit, but indicate the presence of at least one; "plurality" indicates a quantity of two or more. "Including" or "includes" and other similar words mean that the elements or things appearing before "includes" or "includes" cover the elements or things listed after "includes" or "includes" and their equivalents, and do not exclude other elements. or objects. Secondly, the present invention is described in detail using schematic diagrams, but these schematic diagrams are only for convenience of describing examples of the present invention in detail and should not be used as limitations of the present invention. In this article, "circumferential direction" corresponds to the circumferential direction of the implant in the contracted state; "radial direction" corresponds to the diameter direction of the implant in the contracted state; "axial direction" corresponds to the axis direction of the outer sleeve; The term "proximal" generally refers to the end of the implant or delivery device that is closer to the operator during delivery, and "distal" refers to the end of the implant or delivery device that is farther from the operator during delivery. It is also understood that "radial dimension" refers to the radial diameter; "circumferential dimension" refers to the circumference.

The present invention will be further described below with reference to the accompanying drawings and preferred embodiments. If there is no conflict, the following embodiments and features in the embodiments may complement or be combined with each other.

FIG. 1 schematically shows the structure of an implant for heart valve annulus repair in an unfolded state according to an embodiment of the present invention. FIG. 2 schematically shows an implant for heart valve annulus repair provided by an embodiment of the present invention. Figure 3 is a partial enlarged view of the implant for cardiac annulus repair forming a closed ring structure and being positioned at the mitral valve in Figure 2. For the sake of clarity, in the following description, implants used for heart valve annulus repair are simply referred to as implants.

The implant of this embodiment is delivered to the mitral valve ring of the human body through a catheter intervention, and then the implant is released and anchored in the mitral valve ring to reshape the valve ring, thereby achieving the goal of retaining the native valve tissue. Compared with open-chest surgery, transcatheter mitral valve repair does not require an extracorporeal circulation device, so it is less traumatic and the patient recovers quickly. The hemodynamic indicators of patients can be significantly improved after surgery.

As shown in FIG. 1 , the implant includes an implant body 10 . The implant body 10 has a deployed state. In the deployed state, the implant body 10 has two free ends along the axial direction. At this time, the two free ends are separated and not connected, so that the implant body 10 as a whole forms a non-closed loop structure, that is, the implant The object body 10 does not form a ring. The implant body 10 in the expanded state is easy to transport in the transport device, and the implant body 10 is transported almost in a straight line. As shown in Figures 2 and 3, the implant body 10 also has a contracted state. In the contracted state, the two free ends of the implant body 1 are connected, so that the implant body 10 as a whole forms a closed ring structure, and the shape of the closed ring structure is similar to a D shape.

It should be understood that the mitral annulus is a fibrous connective tissue located between the left atrium and left ventricular myocardium, providing the origin of the atrial and ventricular myocardium, with the anterolateral and posteromedial junctions dividing the mitral annulus into the posterior annulus 51 and anterior annulus 52. It can be understood that the anterior valve annulus 52 is the attachment part of the anterior valve leaflets, that is, the common continuation part of the left and right fibrous triangles and the aortic valve annulus. The anterior valve annulus 52 is located between the left and right fibrous triangles. During the cardiac cycle, it There is no significant change in shape and length. The posterior annulus 51 is the attachment part of the posterior valve leaflets. Compared with the anterior annulus 52, the posterior annulus 51 is more stretchable, and its shape and length change significantly during the cardiac cycle. Mitral valve insufficiency is mainly due to The expansion of the posterior valve annulus 51, and therefore the contraction of the posterior valve annulus, can achieve better repair results, and the soft ring is more in line with physiological characteristics than the hard ring, which is conducive to the recovery of left heart function and has better results.

Therefore, the implant body 10 is configured to have a shape in the collapsed state that matches the native mitral annulus anatomy, that is, in the collapsed state, the implant body 10 is spaced corresponding to the first portion 11 of the anterior annulus 52 The second part 12 of the implant body 10 corresponding to the posterior annulus 51 has a three-dimensional shape (ie, a curved surface) and a planar two-dimensional shape (ie, a flat surface). This arrangement enables the shape of the implant body 10 to adapt to the posterior annulus 51 and the anterior annulus 52 . In this way, the implant of the present invention can adapt to the shape of the native mitral valve during the systolic phase of the cardiac cycle, so that the stress of the repaired mitral valve is more evenly distributed throughout the cardiac cycle, thereby reducing the risk of valve failure. , the risk of annular tear, and maximizes the alignment of the valve leaflets, optimizes the hemodynamics of the mitral valve, and increases the lifespan of the native valve after annular repair. Therefore, in the case where the valve annulus loses its original three-dimensional shape due to expansion, the implant provided by the present invention can reshape its three-dimensional geometric configuration and improve the valve repair effect. In addition, the three-dimensional shape of the implant body 10 at the position of the anterior valve annulus 52 is also beneficial to reducing the risk of left ventricular outflow tract 53 obstruction. At the same time, the three-dimensional geometric configuration of the implant can also prevent valve tearing and increase the success rate of valve repair.

In more detail, as shown in FIGS. 3 and 4 , the implant body 10 in the contracted state has a first part 11 and a second part 12 in the circumferential direction, and the shape of the first part 11 in the contracted state is consistent with the anterior annulus 52 Therefore, the first part 11 has a three-dimensional shape in space, and the shape of the second part 12 in the contracted state matches the posterior annulus 51 , so the second part 12 has a two-dimensional shape in plan. Therefore, in the contracted state, the first part 11 has a three-dimensional "saddle" shape with two lower ends and a higher middle. As shown in Figure 4, in the contracted state, the highest point of the first part 11 should correspond to the central highest point of the anterior annulus 52, and the joint portion of the two free ends of the implant body 10 should correspond to the posterior annulus 51 central location. The protrusion height H1 of the first part 11 should be set as required. The height of the highest point of the first part 11 relative to the main plane P of the implant body 10 is defined as the protrusion height H1 of the first part 11. The protrusion height H1 changes with different specifications of the implant to adapt to different patient. In one embodiment, the protrusion height H1 is 1.5 mm to 6 mm, and this height range can be adapted to most patients. Here, the main plane P can be understood as the plane on which the second part 12 is located.

In addition, the implant body 10 in the contracted state is also configured to have different stiffnesses in the circumferential direction to adapt to the physiological characteristics of the native mitral valve annulus. At this time, it should be understood that the implant body 10 in the deployed state has correspondingly different stiffnesses in the axial direction. The axial direction of the implant body in the expanded state corresponds to the circumferential direction of the implant body in the contracted state. Specifically, as shown in FIG. 5 , the stiffness of the first part 11 is greater than the stiffness of the second part 12 . Stiffness refers to the ability of a material or structure to resist elastic deformation when stressed. When so arranged, the second part 12 (i.e., the flexible section) corresponding to the posterior annulus 51 is connected to the left and right three-dimensional triangular regions of the relatively rigid fiber frame structure of the heart through the first part 11 (i.e., the rigid section) corresponding to the anterior annulus 52. , that is, the boundary between the first part 11 and the second part 12 is respectively located in the left and right three-dimensional triangular areas, thereby pulling the expanded native valve annulus back to the appropriate position and anchoring it to a relatively rigid part of the heart, during remodeling On the basis of strengthening the valve annulus, it provides better stability and support for the valve annulus. At the same time, the flexibility of the second part 12 corresponding to the posterior annulus 51 has less influence on the movement of the annulus during the cardiac cycle, ensuring the normal operation of the left ventricular function. Therefore, compared with the fully flexible non-closed ring structure in the prior art (such as a C-shaped artificial valve annulus), the implant of the present invention has high anchoring reliability and is not easy to loosen, and is different from the fully rigid structure in the prior art. Compared with closed ring structures (such as D-shaped planar artificial valve annulus), the implant of the present invention has a better repair effect on the valve annulus. It should also be understood that in the expanded state, the first part 11 is arranged between two sections of the second part 12, and the two free ends of the two sections of the second part 12 are connected in the contracted state.

As a specific embodiment, the length of the first part 11 in the deployed state accounts for 1/3 to 1/2 of the total length of the implant body 10 in the deployed state, and the length of the second part 12 in the deployed state accounts for 1/3 to 1/2 of the total length of the implant body 10 in the deployed state. 1/2～2/3 of the total length of the implant body 10. Preferably, the length of the first part 11 in the deployed state accounts for 1/3 of the total length of the implant body 10 in the deployed state, and the length of the second part 12 in the deployed state accounts for 1/3 of the total length of the implant body 10 in the deployed state. 2/3 of the length. Here, in the deployed state, the lengths of the implant body 10, the first part 11 and the second part 12 should be understood as linear lengths, that is, along the The axial length of the implant body 10.

As shown in FIG. 1 , in one embodiment, the implant body 10 includes an elastic skeleton 1 , an anchoring component 2 and an outer sleeve 3 . The elastic skeleton 1 is elastically deformable as a whole and is arranged in the outer sleeve 3 . The outer tube 3 is made of medical polymer material. There are no special requirements for the specific material. Generally, materials with good biocompatibility are selected. The outer tube 3 can be covered on the elastic frame 1 in the form of a film. The outer sleeve 3 can also be placed on the elastic frame 1 in the form of a tube. The anchoring component 2 has a constrained state and an unconstrained state. The anchoring component 2 in the constrained state is integrally arranged in the outer sleeve 3 . The anchoring component 2 in the unconstrained state partially passes through the outer cannula 3 and penetrates into the target tissue (ie, myocardial tissue) for fixing the implant, thereby positioning and fixing the entire implant at the mitral valve annulus. The anchoring component 2, the elastic frame 1 and the outer sleeve 3 are connected to each other.

The elastic skeleton 1 can be composed of springs, braided fabrics, corrugated tubes, cut pipes and other structures, and is not specifically limited. And the elastic skeleton 1 can adopt one or more structures among spring, braid, bellows and cut pipe. In addition, in order to make the implant body 10 have different stiffnesses in the circumferential direction, the structure of the elastic skeleton 1 can be adjusted. For example, adjusting the weaving density to adjust the stiffness, areas with high weaving density have relatively large stiffness, and areas with low weaving density have relatively small stiffness. Another example is adjusting the pitch of the spring to adjust stiffness. Areas where the springs are tightly wound have relatively low stiffness. Large, sparsely wound areas have relatively little stiffness. Of course, the adjustment of stiffness is not limited to the situation illustrated here.

As shown in Figure 1, in one embodiment, the elastic skeleton 1 includes a plurality of elastic members 111. The plurality of elastic members 111 are sequentially arranged in the axial direction of the outer sleeve 3. There are at least one elastic member 111 between adjacent two elastic members 111. An anchoring component 2. After this arrangement, a sufficient number of anchoring components 2 can be arranged in the axial direction of the outer cannula 3 to form segmented anchoring, and finally the implant can be stably and firmly positioned and fixed at the mitral valve annulus with good anchoring effect. Here, it should be understood that in the expanded state, the plurality of elastic members 111 are sequentially arranged in the axial direction of the outer sleeve 3 , and in the contracted state, the plurality of elastic members 111 are sequentially arranged in the circumferential direction of the outer sleeve 3 . The number of elastic members 111 is not limited and can be set as needed. The structures of all the elastic pieces 111 may be the same or different. Preferably, the structures of all the elastic pieces 111 are the same. Each elastic member 111 can be implemented using the above-mentioned spring, braid, bellows or cut pipe.

As shown in Figures 1 and 3, in one embodiment, the implant further includes a joint part 4, and joint parts 4 are provided on both free ends. In the contracted state, the two free ends The two joint parts 4 at the end are mated and connected. The joint part 4 is used to lock the two free ends of the implant body 10 to bind the implant body 10 in the expanded state into a closed ring structure.

As a specific embodiment, the two joint parts 4 are respectively a first joint 41 and a second joint 42. The first joint 41 is provided on a free end of the implant body 10, and the second joint 42 is provided on the implant body 10. Another free end of 10. The first connector 41 is used for mating connection with the second connector 42 . No. The matching connection method between the first joint 41 and the second joint 42 is not particularly limited. Snap-on connection is preferred, which is simple and convenient to operate. Optionally, both the first joint 41 and the second joint 42 are connected to the anchoring component 2 , or one of the first joint 41 and the second joint 42 is connected to the anchoring component 2 , and the other is connected to the elastic skeleton 1 . The snap connection between the first joint 41 and the second joint 42 may be elastic snap.

As shown in Figure 1, in one embodiment, the implant further includes a retractable component 6 connected to the implant body 10. The retractable component 6 is used to adjust the diameter of the implant body 10 in a contracted state. The circumferential and circumferential dimensions can be adjusted in real time according to the cardiogram during surgery, thus increasing the flexibility and application scope of the implant. The radial dimension is the diameter of the closed ring structure and the circumferential dimension is the circumference of the closed ring structure.

As a preferred embodiment, the stowing and unfolding component 6 includes a stowing and unfolding part 61 and a stowing and unfolding control part 62 . Referring to FIGS. 20 and 21 , one end of the retractable member 61 is connected to a free end of the implant body 10 . The retraction control member 62 is arranged outside the implant body 10 and connected with the implant body 10 . The position of the retractable control member 62 on the implant body 10 should be selected to be able to tighten the retractable member 61. For example, the retractable control member 62 is provided at the other free end of the implant body 10 or close to another free end. terminal settings. After one end of the retractable component 61 is connected to a free end of the implant body 10 , the body of the retractable component 61 passes through the implant body 10 and is connected to the retractable control component 62 . The retractable and retractable control member 62 is used to drive the retractable and retractable member 61 to move to tighten or loosen the retractable and retractable member 61 so that the radial and circumferential dimensions of the implant body 10 in the contracted state can change, but the radial and circumferential dimensions can be changed. The directional size can be made larger or smaller by adjusting the ring diameter and length based on the cardiogram.

As a specific embodiment, the retracting and releasing control member 62 is a spool, and the spool can be driven to rotate by the driving tool 350 (see Figure 20) in the conveying device. The spool can only rotate forward to tighten the retracting and retracting member 61. The spool can also be reversed to loosen the retractor 61. Under normal circumstances, the spool only needs to rotate forward to tighten the retractable member 61 and reduce the ring diameter and ring length. In this case, a device to prevent the reversal of the spool can be provided on the retractable member 6, or in the The handle of the conveying device is provided with a device to prevent the driving tool 350 from reversing. This application does not limit the direction of forward rotation, as long as the retractable member 61 can be tightened. Optionally, the spool has an interface matching the driving tool 350, and the spool is detachably connected to the driving tool 350 through the interface. The bobbin can be sewn on the outer peripheral surface of the outer sleeve 3 . In order to facilitate transcatheter operation, the rotation axis of the spool and the main plane P of the implant can be arranged perpendicularly. The retracting and releasing member 61 is, for example, a traction body such as a wire, a thread, or a rope.

In the embodiment of the present application, the number of anchoring components 2 is multiple, and the plurality of anchoring components 2 are sequentially spaced in the axial direction of the implant body 10, and may be uniformly or non-uniformly arranged.

As shown in Figures 6 and 7, in one embodiment, the anchoring component 2 includes a housing 250 and a The housing 250 is connected to the anchor 210 . The outer wall of the housing 250 is attached to and connected to the inner wall of the outer sleeve 3 , and the housing 250 is connected to the elastic member 111 . The anchor 210 is configured to remain stationary relative to the housing 250 when restrained, and is integrally provided in the housing 250. At this time, the anchor 210 is not exposed outside the outer sleeve 3, which can avoid damage control during transportation. The bending catheter 320 (see FIG. 10 ) can also prevent damage to human tissue after the implant breaks away from the bending control catheter 320 . The anchor 210 is further configured to move relative to the housing 250 after being released from restraint, and to partially pass through the housing 250 and the outer cannula 3 to penetrate the target tissue. Therefore, using the anchor 210, the entire implant can be positioned and fixed at the mitral valve. The anchor 210 is preferably a linear structure or a sheet-like structure with a smaller outer surface area to reduce damage to the human body during positioning and fixation. The line-like structure may be a spiral structure or a crossed line-like structure. Figure 1 shows the situation where the anchor 210 partially extends out of the outer cannula 3. The anchor 210 can have two opposite ends to penetrate into the target tissue. The ends of the anchor 210 can be configured to easily penetrate. The structure of the organization. The anchor 210 is preferably an elastic structure, which produces elastic deformation when restrained, and moves relative to the housing 250 under the action of its own elastic force after being released from restraint. The elastic setting of the anchor 210 makes the release process of the anchor 210 simpler and more convenient.

Preferably, the anchoring component 2 further includes a driving member 240 disposed in the housing 250 . The driving member 240 abuts the anchor 210 (the abutment may be connected or only abuts), and is used to release the restraint of the anchor 210 The anchoring member 210 is then driven to move toward the outside of the outer sleeve 3 to assist in the release of the anchoring member 210, allowing the anchoring member 210 to penetrate into the target tissue more quickly and accurately, which not only increases the firmness of the fixation, but also makes the anchoring member The positioning and release of 210 are more precise, and the release efficiency is also higher. The driving member 240 is preferably an elastic element, and the elastic element is a structure such as a spring or an elastic piece, preferably an elastic piece. The spring piece can be designed smaller to fit in a smaller housing 250 . The driving member 240 is also compressed when the anchoring member 210 is restrained, and the compression direction is the diameter direction of the outer sleeve 3; the driving member 240 needs to restore its original shape to generate elastic force after the anchoring member 210 is released from restraint, so that the driving member 240 The elastic force pushes the anchor 210 to move outward along the diameter direction of the outer sleeve 3 . One end of the driving member 240 is fixedly connected to the housing 250 , and the other end is in contact with the anchoring member 210 . The housing 250 may be provided with a gap that allows the anchor 210 to pass through. The manner of binding the anchor 210 may be various suitable methods, such as directly or indirectly blocking it by the housing 250 and/or adding the anchor release control member 7 to block it.

As shown in FIG. 7 , in one embodiment, the anchoring component 2 further includes a blocking portion 220 disposed in the housing 250 , and the blocking portion 220 blocks the movement of the anchor 210 on one side of the anchor 210 . In one embodiment, a blocking portion 220 is provided on the outside of the anchor 210, and the blocking portion 220 prevents the two opposite parts of the anchor 210 from moving backward. Dorsal motion is the direction away from the target tissue. The blocking part 220 may be a blocking block, which is formed separately from the housing 250 . The blocking block extends and protrudes from the inner wall of the housing 250 , and is limited at the periphery of the anchor 210 . Further, the blocking portion 220 is provided to allow the driving member to 240 passes through, this channel can preferably limit the movement direction of the driving member 240 to avoid deviation in the movement direction of the driving member 240.

As shown in FIGS. 7 and 19 , in one embodiment, the implant further includes at least two anchor release control members 7 , one end of the at least two anchor release control members 7 can be connected to the implant body 210 To be detachably connected, the other end passes through all anchor components 2 and simultaneously binds all anchors 210 , and the other end of each anchor release control member 7 can be pulled to sequentially release all anchors 210 . In one embodiment, at least two anchor release controls 7 on the inside of the anchor 21 prevent the two opposite parts of the anchor 210 from moving toward each other. Opposite motion is the direction closer to the target tissue. The anchor release control member 7 can be a traction body such as a wire, a line, or a rope. The other end of the anchor release control member 7 can extend outside the body to facilitate the operator to withdraw the anchor release control member 7 . Further, a positioning hole may be provided on the blocking part 220, and the anchor release control member 7 passes through the positioning hole.

In the embodiment of the present application, the anchor 210 is a linear elastic structure. As shown in FIG8 , before the two anchor release control members 7 are withdrawn, the two opposite parts of the anchor 210 will be stretched apart to prevent the two ends of the anchor 210 from piercing the target tissue S. As shown in FIG9 , after the implant forms a closed loop structure and completes positioning, the anchor 210 is released. At this time, the anchor release control member 7 is pulled in the direction indicated by the arrow in FIG6 . The anchor 210 loses the restraining effect of the anchor release control member 7, and under the action of its own elastic restoring force (i.e., the elastic force in the direction of the arrows on both sides) and the elastic pressure of the driving member 240 (i.e., the downward arrow direction), the two ends of the anchor 210 are pierced into the target tissue S until the anchoring and locking action is completed.

Next, the delivery and release process of the implant provided by the present invention will be further described.

Figure 10 schematically shows the state of the implant provided by one embodiment of the present invention when it is in cooperation with its delivery device, Figure 11 is a cross-sectional view along the B-B line in Figure 10, and Figure 12 is a cross-sectional view along the C-C line in Figure 10.

As shown in FIGS. 10 to 18 , the delivery device includes a delivery sheath 310 , a bend control catheter 320 , an operating catheter 330 and an attitude control catheter 340 , and preferably also includes a multi-lumen tube 331 . A multi-lumen tube 331, an operating catheter 330, a bending control catheter 320 and a delivery sheath 310 are arranged in sequence from the inside to the outside, wherein the attitude control catheter 340 is arranged in one of the lumens of the multi-lumen tube 331. The delivery sheath 310 is used to first establish a delivery channel in the body, and then the bending catheter 320 travels along the delivery channel established by the delivery sheath 310 . The operating catheter 330 is inserted into the inner cavity of the bending control catheter 320 and is used to push the implant to move along the axial direction of the bending control catheter 320 to control the delivery and release of the implant and also control the posture of the implant. The operating catheter 330 is a fulcrum for adjusting the position of the implant. After the implantation is completed, the distal end of the operating catheter 330 can be detached from the implant. The decoupling method is generally mechanical detachment. At least two posture control conduits 340 are used to pass through the operating conduit 330 and partially extend from the side walls of the operating conduit 330 to abut the retracted state. The implant body 10 when. Preferably, during the delivery process, the multi-lumen tube 331 is inserted into the inner lumen of the operating catheter 330, and at least two attitude control catheters 340 pass through two independent lumens of the multi-lumen tube 331. At least two posture control tubes 340 abut against the implant body 10 in the contracted state at different positions in the circumferential direction. Thereby, at least two posture control catheters 340 control the implant body 10 in the contracted state, so that the implant body 10 is stably and accurately positioned and released at the mitral valve annulus, and shaped into the same shape as the original mitral valve annulus. The shape matches the anatomy, and the entire manipulation process is simpler and more convenient.

In one embodiment, the delivery device further includes at least two attitude control guide wires 301 , one end of each attitude control guide wire 301 is detachably connected to the implant body 10 outside the implant body 10 , the other end enters the corresponding lumen in the multi-lumen tube 331 from the side wall of the operating catheter 330 and extends axially to the proximal end of the multi-lumen tube 331 . Each posture control catheter 340 is used to move along a corresponding posture control guide wire 301 . Specifically, the posture control catheter 340 enters the multi-lumen tube 331 from the proximal end of the multi-lumen tube 331 and travels along the posture control guidewire 301 until the distal end of the posture control catheter 340 extends from the side wall of the operating catheter 330, causing the posture to The distal end of the control catheter 340 abuts against the implant body 10 in the collapsed state.

At least two attitude control guide wires 301 are arranged independently of each other and are connected to the implant body 10 at different positions in the circumferential direction. The number of attitude control guide wires 301 is preferably two. If the number of attitude control guide wires 301 is too many, although it is more beneficial to the attitude control of the implant after looping, it will also increase the complexity of the delivery device. , therefore it is preferred to have two posture control guide wires 301 and two posture control catheters 340 . Taking two attitude control guide wires 301 as an example, one attitude control guide wire 301 is connected at a position 1/3 of the length from the joint point on the implant body 10, and the other attitude control guide wire 301 is connected at A position 2/3 of the length from the joint point on the implant body 10. Here, the joint point refers to the location where the two free ends of the implant body 10 are connected.

As shown in FIG. 20 , in one embodiment, the conveying device further includes a driving tool 350 . As shown in Figure 10, preferably, the delivery device further includes a retractable guide wire 302. One end of the retractable guide wire 302 is detachably connected to the retractable control member 62 outside the implant body 10, and the other end is detachably connected to the retractable control member 62 outside the implant body 10. One end enters a corresponding lumen in the multi-lumen tube 331 from the distal end of the multi-lumen tube 331 and extends axially to the proximal end of the multi-lumen tube 331 . The driving tool 350 is used to travel along the retracting and retracting guide wire 302 to accurately connect with the retracting and retracting control member 62 . More specifically, the driving tool 350 enters the multi-lumen tube 331 from the proximal end of the multi-lumen tube 331 and travels along the retraction guidewire 302 until the distal end of the driving tool 350 extends from the distal end of the multi-lumen tube 331, so that the driving tool 350 The distal end of the tool 350 is connected to the retraction control member 62 . The driving tool 350 and the retraction control member 62 are mechanically detachable. Retracting and retracting the guide wire 302 allows the driving tool 350 to accurately connect with the retracting and retracting control member 62, thereby improving surgical efficiency and reducing surgical difficulty.

As shown in Figures 11 to 15, the conveying device preferably further includes a closing control wire 303. One end of the closing control wire 303 is detachably connected to the distal end of the implant body 10 in the delivery state outside the implant body 10, and the other end enters the corresponding position in the multi-lumen tube 331 from the distal end of the multi-lumen tube 331. One lumen extends axially to the proximal end of the multi-lumen tube 331. After the implant is at least partially separated from the bending control catheter 320, the operator only needs to pull the other end of the closing control wire 303 to pull the distal end of the implant body 10 closer to the proximal direction until the implant is in the expanded state. The two free ends of the entry body 10 along the axial direction are successfully docked.

As shown in Figures 10 and 11, in one embodiment, the delivery device further includes a turning control wire 304. One end of the turning control wire 304 is detachably connected to the implant body 10 in the expanded state, and the other end enters a corresponding cavity in the multi-lumen tube 331 from the distal end of the multi-lumen tube 331 and extends axially to the proximal end of the multi-lumen tube 331. Before the implant body 10 is closed to form a closed ring structure, the operating catheter 330 will rotate to a position perpendicular to the main plane P of the implant under the action of the turning control wire 304, and then withdraw from the turning control wire 304, so as to facilitate the operation of the subsequent posture control catheter 340.

As shown in Figure 13, after the implant is pushed out of the bending control catheter 320, the proximal end of the implant has not yet been exposed from the bending control catheter 320. At this time, the attitude control guide wire 301 and the closing control wire 303 are both at Tension state. As the implant is continuously transported forward and released, the distal end of the implant is pulled by the closing control wire 303, so that the implant gradually forms a ring.

Referring to Figures 14 and 15, after the implant is completely pushed out of the bending control catheter 320, during the process of forming a loop, the turning control wire 304 is first pulled to control the implant to turn to the extreme position, and then the closing control wire is pulled 303. The two free ends of the implant are buckled together to form a complete closed ring structure. At this time, the attitude control guide wire 301 remains in a tensioned state, and the distal part of the operating catheter 330 is perpendicular to the main plane P.

As shown in Figures 16 to 18, after the implant forms a closed ring structure, it needs to be released stably and accurately at the mitral valve annulus. Therefore, during the placement of the implant, the bending control of the delivery device and the handle Manipulate so that the annulus of the implant is roughly parallel to the valve annulus, and the plane center of the implant is approximately at the center of the valve annulus. At this time, the attitude control guide wire 301 remains in a moderately tense state, as shown in Figure 16 . As shown in Figure 17, after the implant is roughly positioned, the attitude control catheter 340 is used to advance the attitude control catheter 340 along the attitude control guide wire 301 until, as shown in Figure 18, the distal end of the attitude control catheter 340 The operating catheter 330 is extended to abut against the implant body 10 . At this time, the two posture control catheters 340 abut against different circumferential positions of the implant body 10 respectively, and the operating catheter 330 abuts against the implant body 10 . The joint forms a three-point support. Therefore, through the attitude control catheter 340 and the operation catheter 330, combined with the bending control and handle operation, fine adjustment of the implant can be achieved until the center of the implant is located at the center of the annulus and the joint of the implant is tight. The implant is pressed against the center of the posterior annulus 51 of the mitral annulus, while the part opposite the commissure is pressed against the center of the anterior annulus 52, so that the implant The shape matches the native mitral annulus and has the benefit of being stably and accurately positioned in the mitral annulus.

As shown in Figure 19, after the positioning of the implant at the mitral annulus is completed through the posture control catheter 340 and the operating catheter 330, the anchor 210 is released. During the anchoring process, all the anchoring members 210 can be released sequentially by pulling the anchoring release control member 7 in a certain direction. Each anchoring member 210 relies on its own elastic restoring force and the elastic force of the driving member 240 to penetrate. The myocardial tissue is locked, and the implant in the corresponding position segment is anchored to the myocardial tissue in the corresponding position. Therefore, by pulling the anchoring release control part 7, the self-shrinking anchoring part 210 located inside the implant is released, and the implant is anchored in sections, which is easy to operate, reliable anchoring, greatly shortens the anchoring time, and can achieve implantation. Stable and precise positioning of incoming objects.

As shown in FIG. 20 and FIG. 21 , in the embodiment of the present application, the retractable component 61 passes through all the anchoring components 210 in sequence, runs through the entire implant body 10 , and can finally pass out from the side of the implant body 10 Connected to the retractable control member 62. When it is necessary to adjust the ring diameter of the implant, the driving tool 350 can be used to rotate the retractable control member 62 in the direction of the arrow in Figure 20, and the retractable member 61 can be partially wound around the retractable control member 62. The reduction in the radial and circumferential dimensions of the implant effectively repairs the expanded annulus, achieves remodeling of the mitral annulus, and achieves better repair results. The adjustment of the radial and circumferential dimensions is a dynamic adjustment, and the adjusted results can be confirmed in real time through ultrasound until the reflux is eliminated or within a reasonable range. After the repair is completed, the delivery device will be evacuated from the human body.

Further, as shown in Figure 11, a multi-lumen tube 331 is provided in the inner cavity of the operating catheter 330, and the attitude control guide wire 301, the closing control wire 303, the turning control wire 304 and the anchoring release control member 7 are implanted The proximal end of the object is arranged through the multi-lumen tube 331 to prevent the control wires from intertwining and interfering with each other. In other embodiments of the present application, the multi-lumen tube 331 can be eliminated, and the attitude control guide wire 301, the closing control wire 303, the turning control wire 304 and the anchoring release control member 7 are directly arranged in the operating catheter 330. The setting of the multi-lumen tube 331, in addition to separating the attitude control guide wire 301, the closing control wire 303, the turning control wire 304 and the anchoring release control member 7, can also improve the compliance of the delivery device and ensure the bending of the delivery device performance. The multi-lumen tube 331 is made of relatively soft material.

To sum up, in the technical solution provided by the present invention, the implant forms a three-dimensional whole ring after being closed, in which the first part 11 corresponding to the anterior valve annulus 52 takes a three-dimensional "saddle" shape, which is different from the conventional planar shape and It has an open-ring structure and different stiffnesses, which can reshape the mitral valve annulus. While reshaping the mitral valve annulus, it can optimize valve dynamics and achieve better repair results. In addition, the implant of the present invention has a wide range of uses and is flexible to use. For example, through the retractable and retractable parts that run vertically inside the implant and the spool is configured, the implant can be used on the basis of reshaping the mitral valve annulus. During the operation, real-time adjustments are made based on the differentiated anatomical characteristics of the valve, making the repair of the valve annulus more flexible and controllable. It can also reduce the specifications of the implant and reduce the cost.

It should be noted that those of ordinary skill in the art can make several improvements and supplements without departing from the disclosure of the present invention, and these improvements and supplements should also be regarded as the protection scope of the present invention. Those skilled in the art who are familiar with this field may make slight changes, modifications and equivalent changes using the technical content disclosed above without departing from the spirit and scope of the present invention. At the same time, any equivalent changes, modifications and evolutions made to the above embodiments based on the essential technology of the present invention still fall within the scope of the technical solution of the present invention.

Claims

An implant for heart valve annulus repair, characterized in that it includes an implant body, and the implant body has an expanded state and a contracted state; the implant body in the expanded state has an axial direction Two free ends, the two free ends are separated so that the implant body forms a non-closed loop structure; the two free ends of the implant body in a contracted state are connected so that the implant body forms a non-closed loop structure. The implant body forms a closed ring structure; the shape of the implant body in the contracted state matches the anatomy of the native mitral valve annulus, and the implant body in the contracted state has different shapes in the circumferential direction. Stiffness.
The implant for heart valve annulus repair according to claim 1, wherein the implant body in the contracted state has a first part and a second part in the circumferential direction, and the first part in the contracted state The bottom is a three-dimensional shape in space, the second part is in a planar two-dimensional shape in the contracted state, and the stiffness of the first part is greater than the stiffness of the second part; in the expanded state, the first part is arranged on the Between the two sections of the second part, the two free ends of the two sections of the second part are connected in the contracted state; the length of the first part in the expanded state accounts for the length of the implant in the expanded state. The length of the second part in the expanded state accounts for 1/2 to 2/3 of the total length of the implant body in the expanded state.
The implant for heart valve annulus repair according to claim 1, further comprising a retractable component connected to the implant body, the retractable component being used to adjust all the valves in a contracted state. The radial and circumferential dimensions of the implant body.
The implant for heart valve annulus repair according to claim 3, wherein the retractable and retractable component includes a retractable and retractable component and a retractable and retractable control component; one of the free ends of the implant body is connected to The retractable and retractable component; the retractable and retractable control component is arranged outside the implant body and connected to the implant body; one end of the retractable and retractable component is connected to one of the two ends of the implant body; After the free end is connected, the body of the retractable component passes through the implant body and is connected to the retractable control component; the retractable control component is used to drive the retractable component to move to the contracted state. The radial and circumferential dimensions of the implant body vary.
The implant for heart valve annulus repair according to claim 4, wherein the retraction control member is a spool.
The implant for heart valve annulus repair according to any one of claims 1 to 5, characterized in that the implant body includes an elastic skeleton, an outer tube and an anchoring component; the elastic skeleton is disposed on the In the outer sleeve; the anchoring component, the elastic skeleton and the outer sleeve are connected to each other; the anchoring component has a constrained state and a non-constrained state; the anchoring component in the constrained state is arranged as a whole In the outer sleeve; the anchoring component in an unconstrained state partially passes through the outer sleeve and penetrates into the target tissue for fixing the implant.
The implant for heart valve annulus repair according to claim 6, wherein the elastic skeleton includes a plurality of elastic members, and the plurality of elastic members are arranged sequentially in the axial direction of the outer cannula, At least one anchoring component is disposed between two adjacent elastic components.
The implant for heart valve annulus repair according to claim 6, wherein the implant body further includes a joint portion, and the joint portions are provided on both free ends. In this state, the two joint parts of the two free ends are mated and connected.
The implant for heart valve annulus repair according to claim 8, wherein the two joint portions of the two free ends are snap-connected.
The implant for heart valve annulus repair according to claim 7, wherein the anchoring component includes a shell and an anchor connected to the shell, and the outer wall of the shell is connected to the anchor. The inner wall of the outer sleeve is attached and connected, and the elastic member is connected to the housing; the anchoring member is configured to remain stationary relative to the housing when restrained, and is integrally provided in the housing; The anchor is further configured to be movable relative to the housing after being released, and to partially pass through the housing and the outer cannula to penetrate the target tissue.
The implant for heart valve annulus repair according to claim 10, characterized in that the anchoring member is an elastic structure, which produces elastic deformation when being restrained, and after being released from restraint, it is relatively opposite under the action of its own elastic force. moves on the housing.
The implant for heart valve annulus repair according to claim 11, wherein the anchoring member is a line-like structure or a sheet-like structure.
The implant for heart valve annulus repair according to claim 10, wherein the anchoring component further includes a driving member disposed in the housing, and the driving member abuts against the anchoring member. is connected and used to drive the anchoring member to move toward the outside of the outer sleeve after the anchoring member is released from restraint.
The implant for heart valve annulus repair according to claim 13, wherein the driving member is an elastic element.
The implant for heart valve annulus repair according to claim 10, further comprising at least two anchoring release control parts, one end of the at least two anchoring release control parts is connected to the implant The object body is detachably connected, the other end passes through all the anchoring parts and binds all the anchoring parts at the same time, and the other end of each anchor release control part can be pulled to sequentially release all the anchoring parts. Binding of anchors.
The implant for heart valve annulus repair according to claim 15, wherein the anchoring component further includes a blocking portion disposed in the housing, and at least two of the anchoring release control members The two opposite parts of the anchor are prevented from moving toward each other on the inside of the anchor, and the blocking portion blocks the back movement of the two opposite parts of the anchor on the outside of the anchor.
An implant delivery device, characterized in that it is used to deliver the implant for heart valve annulus repair as claimed in any one of claims 1 to 16; the delivery device includes a bending control catheter and an operating catheter. and an attitude control catheter; the operating catheter is used to be inserted into the inner cavity of the bending control catheter, and is used to push the implant to move along the axial direction of the bending control catheter; at least two of the attitude control catheters are used for The implant body passes through the operating catheter and partially extends from the side wall of the operating catheter to abut the implant body in the contracted state, and at least two of the attitude control catheters are connected to all the posture control catheters in the contracted state. The implant body abuts at different positions in the circumferential direction.
The delivery device according to claim 17, further comprising a multi-lumen tube and at least two attitude control guide wires, the multi-lumen tube being placed in the inner cavity of the operating catheter; each of the attitude control guide wires One end of the control guide wire is detachably connected to the implant body outside the implant body, and the other end enters the corresponding lumen in the multi-lumen tube from the side wall of the operating catheter and moves along the axis extending to the proximal end of the multi-lumen tube; each attitude control catheter moves along a corresponding attitude control guide wire, and at least two attitude control guide wires are connected to the implant body Connect at different locations in the circumferential direction.
The delivery device as described in claim 17 is characterized in that it also includes a multi-lumen tube, a driving tool and a retractable guide wire; the multi-lumen tube is placed in the inner cavity of the operating catheter; one end of the retractable guide wire is releasably connected to the retractable control member in the implant outside the implant body, and the other end enters a corresponding cavity in the multi-lumen tube from the distal end of the multi-lumen tube and extends axially to the proximal end of the multi-lumen tube; the driving tool is used to move along the retractable guide wire and is releasably connected to the retractable control member.
The delivery device according to claim 17, further comprising a multi-lumen tube and a closing control wire, the multi-lumen tube being placed in the inner cavity of the operating catheter; one end of the closing control wire is on the The outside of the implant body is detachably connected to the distal end of the implant body in the delivery state, and the other end enters a corresponding lumen of the multi-lumen tube pair from the distal end of the multi-lumen tube and along the Extending axially to the proximal end of the multi-lumen tube, the closing control wire is used to control the connection of the two free ends of the implant body in the expanded state.
The delivery device as described in claim 17 is characterized in that it also includes a multi-lumen tube and a turning control wire, wherein the multi-lumen tube is placed in the inner cavity of the operating catheter; one end of the turning control wire is detachably connected to the implant body in the expanded state, and the other end enters a cavity corresponding to the multi-lumen tube from the distal end of the multi-lumen tube and extends axially to the proximal end of the multi-lumen tube, and before the implant body forms the closed loop structure, the turning control wire controls the operating catheter to rotate to A position perpendicular to the main plane of the implant.