CN112190294A

CN112190294A - Myocardial anchoring device

Info

Publication number: CN112190294A
Application number: CN202010874077.7A
Authority: CN
Inventors: 周元军
Original assignee: Individual
Current assignee: Individual
Priority date: 2020-08-27
Filing date: 2020-08-27
Publication date: 2021-01-08

Abstract

The invention discloses a myocardial anchoring device, and belongs to the field of medical instruments. The technical scheme of the invention is as follows: comprises an inner anchoring piece, an outer anchoring piece and a tightening mechanism; the inner anchor is used for contacting with a first wall of an implanted object, and the outer anchor is used for contacting with a second wall of the implanted object; the tightening mechanism is connected with the inner anchoring piece and penetrates through the outer anchoring piece, the outer anchoring piece is connected with the tightening mechanism in a matched mode, and the outer anchoring piece can move towards the direction close to the inner anchoring piece along the tightening mechanism; the inner anchoring piece and the outer anchoring piece are both self-adaptive elastic structures, and the self-adaptive elastic structures can be compressed to a first size under a first environment and can be expanded to a second size under a second environment; the size of the delivery structure is reduced, so that the trauma of the delivery structure to the tissue is reduced, and the strength and the effectiveness of myocardial fixation can be improved.

Description

Myocardial anchoring device

Technical Field

The invention belongs to the field of medical instruments, and particularly relates to a myocardial anchoring device.

Background

Heart failure is the terminal stage of most cardiovascular diseases. Although the application of heart failure drugs has obviously benefited heart failure patients in recent 20 years, the death rate of the end-stage heart failure patients is still high. The pathophysiological basis of heart failure is cardiac remodeling. Cardiac remodeling is clinically manifested by progressive dilation of the ventricles, impaired systolic and diastolic function, which is associated with the progressive progression of heart failure and increased mortality.

The myocardial anchoring technique is a relatively simple surgical intervention that does not require extracorporeal circulation support. The anterior wall necrotic, non-contractile myocardium is treated by interventional anchoring, restoring the geometry and function of the left ventricle. Compared to conventional surgical ventricular volume reduction, the myocardial anchoring technique is a relatively less invasive procedure, does not require support from extracorporeal circulation, does not require ablation of the necrotic myocardium of the free wall of the left ventricle, does not require sutures and patches, and is relatively less damaging to the left ventricle.

However, the sheath used in the conventional myocardial anchoring device is large in size, causes a large trauma to the tissue, and requires improvement in the anchoring effectiveness and stability.

Disclosure of Invention

The technical problems to be solved by the invention are as follows: it is an object of the present invention to provide a myocardial anchoring device that facilitates a reduction in the size of the delivery structure, thereby reducing trauma to the tissue caused by the delivery mechanism, and also improves the strength and effectiveness of myocardial fixation.

In order to solve the technical problems, the invention adopts the following technical scheme:

a myocardial anchoring device; the implant comprises an inner anchor part, an outer anchor part and a tightening mechanism, wherein the inner anchor part is used for being in contact with a first wall of an implanted object, the outer anchor part is used for being in contact with a second wall of the implanted object, the tightening mechanism is connected with the inner anchor part and penetrates through the outer anchor part, the outer anchor part is connected with the tightening mechanism in a matched mode, and the outer anchor part can move towards the direction close to the inner anchor part along the tightening mechanism; the inner anchoring piece and the outer anchoring piece are both self-adaptive elastic structures, and the self-adaptive elastic structures can be compressed to a first size under a first environment and expanded to a second size under a second environment.

The self-adaptive elastic structure is a telescopic net structure, and the net structure is in a disc shape.

Wherein the adaptive elastic structure is composed of one of the mesh structures.

Wherein an axial diameter of the first dimension of the adaptive elastic structure is greater than a radial diameter, and a radial diameter of the second dimension of the adaptive elastic structure is greater than the axial diameter.

Wherein, the surface of the self-adaptive elastic structure is provided with a polymer braided fabric.

Wherein, the material of the self-adaptive elastic structure is shape memory alloy.

The right center of the left side and the right side of the outer anchoring part is provided with a second far end and a second near end which are opposite, wherein the second near end or the second far end can be matched and connected with the tightening mechanism, the second near end and the second far end are both hollow and can be penetrated by the tightening mechanism, and one side of the second near end on the outer anchoring part is provided with a conveying rod which can be detachably connected.

The device also comprises a shearing mechanism, wherein the shearing mechanism is arranged in the inner cavity of the conveying rod and consists of blades arranged on the periphery of the tightening mechanism.

Compared with other methods, the method has the beneficial technical effects that:

the myocardial anchoring device comprises an inner anchoring part which is used for being in contact with a first wall of an implanted object, an outer anchoring part which is used for being in contact with a second wall of the implanted object, and a tightening mechanism which is connected with the inner anchoring part, wherein the tightening mechanism penetrates through the outer anchoring part and is in matched connection with the outer anchoring part, and the outer anchoring part can move towards the direction close to the inner anchoring part along the tightening mechanism, so that the myocardial tightening is realized, and the geometric form and the function of a ventricle are recovered. Particularly, the inner anchoring piece and the outer anchoring piece are both constructed into self-adaptive elastic structures, the self-adaptive elastic structures can be compressed to a first size under a first environment and can be expanded to a second size under a second environment, so that on one hand, in the conveying process, the self-adaptive elastic structures can be compressed in the conveying structure to reduce the external size of the conveying structure, the size of the conveying structure is reduced, the injury of the conveying structure to heart tissues is reduced, on the other hand, after the conveying structure is separated from the conveying structure, the self-adaptive elastic structures can be expanded to restore the original shape, the self-adaptive elastic structures and the heart tissues are well fixed, and the self-adaptive elastic structures can be well deformed, so that the self-adaptive elastic structures are well attached to the tissue walls, can also adapt to the heart tissues of different individuals, and have a better myocardial fixing effect; the self-adaptive elastic structure is preferably a telescopic net structure, particularly a disc structure, and the disc structure has a large contact area with the tissue wall compared with a strip structure, so that the strength and the stability of the anchoring piece can be effectively improved; the self-adaptive elastic structure can also be composed of a plurality of net structures which are arranged side by side and connected in sequence, and compared with a single net structure, the anchoring piece has better strength and stability.

Drawings

FIG. 1 is a schematic illustration of the placement of the device of the present invention within the heart;

fig. 2 is a schematic view of the construction of the inner anchor 1 compressed to a first size in the delivery sheath 4 according to the present invention;

fig. 3 shows a schematic view of the inner anchor 1 expanded to a second size after detachment from the delivery sheath 4;

fig. 4 is a schematic view of the outer anchor 2 expanded to a second size after detachment from the delivery sheath 4 in accordance with the present invention;

1. an inner anchor; 11. a first proximal end; 12. a first distal end; 2. an outer anchor; 21. a second proximal end; 22. a second distal end; 3. a tightening mechanism; 4. a delivery sheath; 5. a shearing mechanism; 6. a conveying rod; 7. a diaphragm wall; 71. a right ventricle; 72. the left ventricle.

Detailed Description

The technical solutions in the embodiments of the present invention will be described clearly and completely with reference to the accompanying drawings in the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention. The words "upper", "lower", "left" and "right" when used herein are merely intended to designate corresponding upper, lower, left and right directions in the drawings, and do not limit the structure thereof.

Fig. 1 is a schematic view of the placement of a myocardial anchoring device in the heart according to an embodiment of the present invention, and as shown in fig. 1, the myocardial anchoring device includes an inner anchor 1, an outer anchor 2 and a tightening mechanism 3. In practical application, the inner anchor 1 is attached to the diaphragm wall of the right ventricle 71, and the outer anchor 2 is attached to the outer wall of the left ventricle 72 far away from the right ventricle 71; meanwhile, one end of the tightening mechanism 3 is connected with the inner anchoring piece 1, and the other end of the tightening mechanism penetrates through the outer anchoring piece 2 and is connected with the outer anchoring piece 2 in a matched mode; but also the outer anchor 2 can be moved in the direction of the tightening mechanism 3 towards the inner anchor 1. Here, the form fit connection preferably means that the outer anchor 2 and the tightening mechanism 3 are shaped or adapted to each other, wherein one part can be snapped into the other part and can be brought into relative rest without external forces or without exceeding a defined external force.

Specifically, the method comprises the following steps:

first, after completing the previous atrial septal puncture, a guide wire is fed into the right ventricle 71;

thereafter, the delivery sheath 4 carrying the inner anchor 1 is passed along the passage established in the body by the guide wire to the right ventricle 71;

then, the inner anchor 1 can be released by retracting the conveying sheath 4, so that the inner anchor 1 reaches the right ventricle 71, and after adjustment, the inner anchor 1 is attached to the diaphragm wall 7 of the right ventricle 71 at a specified position; obviously, the tightening mechanism 3 at this time also follows the inner anchor 1 into the left ventricle 72, and the tightening mechanism 3 extends further outside the left ventricle 72;

next, as shown in fig. 1, the delivery sheath 4 loaded with the outer anchor 2 is passed along the passage established in the body by the tightening mechanism 3 to the outside of the left ventricle 72, and the outer anchor 2 can be released in such a manner that the delivery sheath 4 is also withdrawn, so that the outer anchor 2 reaches the outside of the left ventricle 72;

then, compressing the outer anchor 2 and pulling the tightening mechanism 3 to move the outer anchor 2 along the tightening mechanism 3 in a direction close to the inner anchor 1, so as to gradually tighten the left ventricle 72 until the left ventricle 72 is tightened to a target form;

finally, the outer anchor 2 is locked with the tightening mechanism 3 and the associated delivery mechanism is removed, and the tightening mechanism 3 is also preferably sheared, thereby completing the fixation of the myocardium.

However, the conventional inner anchor 1 and outer anchor 2 are generally designed to be long and non-stretchable in shape and relatively large in size, and therefore, the conventional anchors increase the size of the delivery sheath 4, thereby increasing the trauma of the delivery sheath 4 to the human tissue. To solve this problem, the inner anchor 1 and the outer anchor 2 of the present embodiment are designed as a structure that is both collapsible and expandable, and the structure is specifically defined as an adaptive elastic structure, i.e. both the inner anchor 1 and the outer anchor 2 can be compressed to a first size in a first environment and can be expanded to a second size in a second environment.

It will be appreciated that the first and second dimensions both refer to the overall dimensions of the anchor, but the overall dimensions include, but are not limited to, length, width, and thickness. It should be noted that the first environment is referred to as the delivery sheath 4 in this embodiment, and thus the respective anchor is compressed to have a first size under the restriction of the delivery sheath 4, and then the respective anchor is expanded to have a second size after being detached from the delivery sheath 4.

Therefore, compared with the prior art, the inner anchor 1 and the outer anchor 2 provided by the embodiment of the present invention are both configured as adaptive elastic structures, so that, on one hand, during the transportation process, the adaptive elastic structures can be compressed in the transportation sheath 4 to reduce the external dimensions thereof, thereby reducing the dimensions of the transportation sheath 4, thereby reducing the trauma of the transportation sheath 4 to the cardiac tissue, and on the other hand, after the transportation sheath 4 is separated, the adaptive elastic structures can be expanded or even restored to the original shape, thereby achieving good fixation with the cardiac tissue, and since the adaptive elastic structures can be deformed well, the effect of fitting with the tissue wall is good, meanwhile, the present invention can also adapt to the cardiac tissue of different individuals, and the effect of fixing the cardiac muscle is better.

The inner anchoring member 1 may adopt a telescopic net structure to realize the self-adaptive elastic function, and the forming mode may be weaving or laser cutting, but is not limited thereto. Preferably, the net-shaped structure is in a disc shape so as to increase the contact area with the tissue wall, thereby increasing the stressed area and enhancing the strength and stability of the net-shaped structure. More preferably, the net-like structure has a disk shape. Under the same size, the disc-shaped stress area is larger than the strip-shaped stress area, so that the disc-shaped inner anchoring piece 1 is more stable in use.

For the disc-shaped inner anchor 1, when it is received in the transportation sheath 4, its axial diameter is stretched and the radial diameter is compressed, so that the outer diameter of the transportation sheath 4 can be designed smaller, and the compressed radial diameter is preferably smaller than the compressed axial diameter. On the contrary, after the inner anchoring part 1 is separated from the conveying sheath pipe 4, the axial diameter of the inner anchoring part 1 is shortened, the radial diameter is prolonged, and the expanded radial diameter is larger than the expanded axial diameter, so that the structure not only can realize the quick release of the inner anchoring part 1, but also can improve the stress area of the inner anchoring part 1 through the larger radial diameter.

Further, inner anchor 1 has opposite first proximal end 11 and first distal end 12, first proximal end 11 being connected to tightening mechanism 3. The tightening mechanism 3 may be an elongated bar, and one end of the bar in the length direction is connected to the first proximal end 11, but the connection may be a fixed connection or a detachable connection, and is preferably a fixed connection to ensure the reliability of the connection. Further, the first distal end 12 is preferably closed to prevent blood leakage, to avoid thrombus formation,

in this embodiment, the tightening mechanism 3 is a hollow tubular member to allow a guide wire to pass through, and is selectively connected with the outer anchor 2 in a manner of movable snap, groove, or the like. For example, a plurality of buckles are arranged on the tightening mechanism 3 at intervals along the length direction thereof, and any one buckle can be matched and locked with a clamping groove on the outer anchor 2. Of course, a plurality of buckles on the tightening mechanism 3 can be replaced by a plurality of clamping grooves, correspondingly, the clamping grooves on the outer anchoring part 2 are replaced by the buckles, and the matching locking between the two parts can be realized. The buckle can be an elastic component or a structure with certain rigidity, and can deform under the condition of applying larger external force.

As shown in fig. 4, the outer anchoring member 2 also adopts a telescopic net structure to realize the self-adaptive elastic function. Similarly, for the disc-shaped outer anchor 2, when it is received in the transporting sheath 4, its axial diameter is stretched and its radial diameter is compressed, so that the outer diameter of the transporting sheath 4 can also be designed smaller, and the radial diameter after compression is preferably smaller than the axial diameter after compression; in contrast, after the outer anchoring member 2 is separated from the conveying sheath 4, the axial diameter of the outer anchoring member 2 is relatively shortened, the radial diameter is lengthened, and the expanded radial diameter is larger than the expanded axial diameter, so that the outer anchoring member 2 can be quickly released, and the stress area of the outer anchoring member 2 can be increased through the larger radial diameter.

Further, the outer anchor 2 has a second proximal end 21 and a second distal end 22 opposite to each other, wherein either the second proximal end 21 or the second distal end 22 is cooperatively connected to the tightening mechanism 3. Furthermore, said second proximal end 21 and said second distal end 22 are both of hollow design to allow the tightening mechanism 3 to pass through. The second proximal end 21 is preferably detachably connected to a delivery rod 6, and the release of the outer anchor 2 is accomplished by pushing the outer anchor 2 through the delivery rod 6. The delivery rod 6 and the second proximal end 21 are not limited to a threaded, snap-fit, or other detachable connection. Further, in actual operation, the feed rod 6 is inserted into the feed sheath 4, and the tightening mechanism 3 passes through the feed rod 6, whereby the feeding and tightening operations are performed.

Still further, the myocardial anchoring device may further include a cutting mechanism 5 for cutting off the tightening mechanism 3 after completion of intracardiac tightening. Preferably, the cutting mechanism 5 is provided on the delivery sheath 4 or the delivery rod 6, specifically, in the lumen of these components, for example, the cutting mechanism 5 is provided in the lumen of the delivery rod 6 as shown in fig. 4. The cutting mechanism 5 may be composed of blades disposed around the tightening mechanism 3.

The inner anchoring member 1 may be implemented by a net structure, which is preferably disc-shaped, and more preferably, the surface of the net structure is wrapped with a polymer woven fabric. However, the polymer woven fabric may be wrapped on the inner surface of the mesh structure or the outer surface of the mesh structure, so as to help the inner anchoring member 1 to be endothelialized rapidly, and the friction force when the inner anchoring member 1 contacts the tissue wall may be increased to prevent the inner anchoring member 1 from falling off. The material of the polymer braided fabric can be polymer material such as Nylon, PTFE, PET and the like.

Similarly, the outer anchor 2 may be implemented by a mesh structure, and the surface of the mesh structure is preferably wrapped with a polymer fabric, however, the polymer fabric may be on the inner surface of the mesh structure or the outer surface of the mesh structure, so as to help the outer anchor 2 endothelialize rapidly, and increase the friction force when the outer anchor 2 contacts the tissue wall, so as to prevent the outer anchor 2 from falling off.

Further, the myocardial anchoring device may comprise a plurality of sets of anchors, each set comprising cooperating inner 1 and outer 2 anchors. Multiple sets of anchors can be implanted at different locations in the heart in the foregoing manner to better adjust the geometry of the left ventricle and achieve better surgical results.

The present invention has been further described with reference to specific embodiments, but it should be understood that the detailed description should not be construed as limiting the spirit and scope of the present invention, and various modifications made to the above-described embodiments by those of ordinary skill in the art after reading this specification are within the scope of the present invention.

Claims

1. A myocardial anchoring device, characterized by comprising an inner anchor (1) for contacting a first wall of an implanted subject, an outer anchor (2) for contacting a second wall of the implanted subject, and a tightening mechanism (3) connected to the inner anchor (1) and passing through the outer anchor (2), wherein the outer anchor (2) is connected to the tightening mechanism (3) in a fitting manner, and the outer anchor (2) is movable in a direction approaching the inner anchor (1) along the tightening mechanism (3); the inner anchor (1) and the outer anchor (2) are both self-adaptive elastic structures which can be compressed to a first size under a first environment and expanded to a second size under a second environment.

2. The myocardial anchoring device of claim 1, wherein the adaptive elastic structure is a stretchable mesh structure, the mesh structure being in the shape of a disk.

3. The myocardial anchoring device of claim 2, wherein the adaptive elastic structure is comprised of one of the mesh structures.

4. The myocardial anchoring device of claim 2 or 3, wherein the first dimension of the adaptive elastic structure has an axial diameter greater than a radial diameter, and the second dimension of the adaptive elastic structure has a radial diameter greater than the axial diameter.

5. The myocardial anchoring device of claim 1, wherein the surface of the adaptive elastic structure is provided with a polymer braid.

6. The myocardial anchoring device of claim 1, wherein the adaptive elastic structure is formed of a shape memory alloy.

7. Myocardial anchoring device according to claim 1, characterized in that the outer anchor (2) has opposite second distal (22) and proximal (21) ends centered on the right and left sides, wherein the second proximal (21) or distal (22) end is fittingly connectable to the tightening mechanism (3), and wherein the second proximal (21) and distal (22) ends are hollow and are penetrable by the tightening mechanism (3), and wherein a detachably connectable transport rod (6) is provided on the outer anchor (2) on the side where the second proximal (21) end is located.

8. A myocardial anchoring device according to claim 1 or 7, characterized in that the device further comprises a cutting mechanism (5), said cutting mechanism (5) being arranged in the lumen of the delivery rod (6), the cutting mechanism (5) consisting of blades arranged on the periphery of the tightening mechanism (3).