CN113017923A

CN113017923A - Mitral valve prosthetic devices with adjustable direct puncture

Info

Publication number: CN113017923A
Application number: CN202110246721.0A
Authority: CN
Inventors: 王超
Original assignee: Shanghai Lixiao Medical Technology Co ltd
Current assignee: Shanghai Lixiao Medical Technology Co ltd
Priority date: 2021-03-05
Filing date: 2021-03-05
Publication date: 2021-06-25
Anticipated expiration: 2041-03-05
Also published as: CN113017923B

Abstract

The invention relates to a direct puncture and adjustable mitral valve repairing device, which belongs to the technical field of medical instruments. It includes atrial septum anchoring device 1, coronary sinus great cardiac vein or heart wall anchoring device 2 and a stretch line; a stretcher is provided between the atrial septum anchoring device 1 and coronary sinus great cardiac vein or heart wall anchoring device 2 Wire; atrial septal anchoring device - is provided with a structure for adjusting the position of the drawing wire. The invention overcomes the defects of the prior art, and can improve the mitral valve regurgitation by adjusting the position and angle of the drawing line during the implantation of the device to obtain the best shortened anterior and posterior diameter of the heart. A one-way locking anchor is attached to the stretch line that tightens the atrium to prevent the stretch line from loosening and falling off, and has the effect of stretching and shortening the diameter of the anterior and posterior walls of the atrium. Barb anchors or spring anchors prevent damage to the atrial wall or blood vessels, increase the contact area with tissue, enhance stability, and promote tissue endothelialization.

Description

Mitral valve prosthetic devices with adjustable direct puncture

Technical Field

The invention relates to a mitral valve repair device capable of being adjusted by direct puncture, and belongs to the technical field of medical instruments.

Background

Mitral Regurgitation (MR) is the most common valvular lesion, and european and american epidemiological research data show that MR prevalence rates in people over 75 years of age reach 10%, significantly exceeding aortic valvular lesions. Also, with the growing progress of the aging lesion of the population in China, mitral regurgitation lesion will also cause a heavy medical burden. Mitral valve repair or replacement is the gold standard for MR treatment, but some studies have shown that up to half of the severely symptomatic MR patients have not selected surgical treatment for reasons largely related to their surgical risk. This large proportion of patients with less tolerance to surgery urgently require a less invasive treatment as an alternative, and interventional mitral valve treatment techniques have emerged. Over the past decade, several transcatheter mitral valve repair techniques derived from different surgical approaches have emerged and are used to treat patients at high surgical risk or who are inoperable. Transcatheter mitral valve repair "kits" are expanding rapidly, with as many as 5 devices approved for clinical use (CE mark) in europe, including MitraClip (Abbott valve-edge-to-edge valve repair), the DS1000 device (NeoChord, Inc, interventional artificial chordae repair), the carllon (Cardiac Dimensions, trans-coronary sinus annuloplasty device), the CardioBand (Edward valve annuloplasty ring), the mitrilign device (mitrilign, mitral valve annulus folding technique). In current clinical practice, devices used for transcatheter mitral valve repair are mostly MitraClip devices proposed by alferi for marginal valve repair, over 80,000 patients have received treatment since the release of MitraClip in 2003 and have obtained FDA approval, and two mitral valve repair devices mitralsti (delta medical-interventional artificial chordal repair) and ValveClamp (maintenance medical-interventional marginal valve repair) developed together by chinese scholars and medical science and technology companies have also progressed.

One of the leading international technologies utilizes the natural orifice of human body to the maximum extent by its unique design, and has good effect on the most of mitral regurgitation. The technique is characterized in that an interatrial septum anchoring device, a coronary sinus great cardiac vein anchoring device and a drafting line connected with the interatrial septum anchoring device and the coronary sinus great cardiac vein anchoring device are implanted through an interventional operation device, and the left atrium and the mitral valve are subjected to physical space remodeling by means of physical tension, so that blood backflow caused by mitral valve insufficiency is reduced or eliminated. In this technique, one anchor needs to be punctured from the jugular vein into the right atrium and then into the great cardiac vein via the coronary sinus ostium, and the other anchor enters the right atrium through the femoral vein and punctures and anchors the interatrial septum, thus providing two approaches. If one access (preferably femoral vein access to right atrial puncture) can be used to anchor one side anchoring device (e.g., one side anchoring device at the interatrial septum) and the opposite side anchoring device can be anchored to the great cardiac vein or heart wall (outside), the surgical path can be greatly simplified, reducing risk and surgical time. In addition, when entering the puncture interatrial space from the femoral vein, the puncture point is generally positioned at the fossa ovalis through the right atrium, but the puncture point is positioned differently due to different individuals and different anatomical structures; while the other side may be in the outer wall of the left atrium (free wall) or the anchoring device of the great cardiac vein, which may cause the tensioned stretching lines (preferably surgical sutures) not to be perpendicular to the anterior and posterior walls of the heart, so that the diagonal drawing of the left atrium of the heart may not have the optimal effect of shortening the anterior and posterior diameters of the heart so as to improve the mitral regurgitation. If the position and the angle of the extension line can be adjusted through design in the process of implanting the instrument, the optimal effect of shortening the anteroposterior diameter of the heart and improving the mitral valve regurgitation can be achieved.

Disclosure of Invention

The invention aims to solve the technical problem of how to shorten the anteroposterior diameter of the heart so as to improve mitral regurgitation.

In order to solve the above problems, the present invention provides a directly puncturing adjustable mitral valve repair device, which comprises a first atrial septum anchor device, a second coronary sinus great cardiac vein or cardiac wall anchor device, and a stretching line; a drawing line is arranged between the atrial septal anchoring device I and the coronary sinus great cardiac vein or heart wall anchoring device II; the first chamber-space anchoring device is provided with a structure for adjusting the position of the drafting line.

Preferably, the coronary sinus great cardiac vein or heart wall anchoring device II is provided with a compressible structure, and the compressible structure is provided with a water-absorbing expansion material and an absorbable material.

Preferably, a plurality of one-way locking anchors clamped on the first atrial septum anchoring device are arranged on the drafting line.

Preferably, the coronary sinus great cardiac vein or heart wall anchoring device II is provided with a barb type structure for anchoring.

Preferably, the coronary sinus great cardiac vein or heart wall anchoring device two is provided with a spring ring structure for anchoring.

Preferably, the drawing line is provided with a preformed duct for guiding the drawing line.

Preferably, the preformed catheter is provided as a nitinol preformed catheter.

Preferably, the first atrial septal anchoring device is provided with two rotatable disc structures which are linked inside and outside, and the central axes of the two disc structures are not coincident; the inner disc is connected with one end of the drafting line.

Preferably, the two disk structures are respectively arranged at two ends of the interatrial septum anchoring device, and the inner disk is arranged in the left atrial region.

Preferably, a locking device for locking the relative position of the drafting line and the inner disc is arranged between the inner disc and the drafting line.

Compared with the prior art, the invention has the following beneficial effects:

1. the defect of the prior art is overcome, one approach can be adopted to enter the right atrium from the femoral vein for puncture to fix the anchoring device at one side at the interatrial interval, and the anchoring device at the opposite side is anchored on the great cardiac vein or the heart wall, so that the operation path is greatly simplified, and the risk and the operation time are reduced.

2. The position and the angle of the extension lines are adjusted during the implantation of the appliance, so that the optimal shortened anteroposterior diameter of the heart is obtained, and the effect of mitral valve regurgitation is improved.

3. The drafting line for tensioning the atrium is attached with one-way locking anchors (cone type, ball type and the like) fixed on the drafting line at equal intervals, and after tensioning, the drafting line is prevented from loosening and falling off, thereby playing a role in locking after stretching and shortening the diameter of the front wall and the rear wall of the atrium.

4. The fixed end of the coronary sinus great cardiac vein or cardiac wall anchoring device adopts a barb type anchor, the tip of the anchor is curled inwards after puncture, the damage to the cardiac wall or blood vessel is prevented, meanwhile, the contact area with the tissue is increased, the stability is enhanced, the endothelialization coverage of the tissue can be promoted, and the anchor can be fixed in the tissue as early as possible;

5. the fixed end of the coronary sinus great cardiac vein or cardiac wall anchoring device adopts a spring type anchor, the side surface of the spring is fixed to prevent the damage of the cardiac wall or blood vessel, meanwhile, the contact area with the tissue is increased to enhance the stability, and the tissue endothelialization coverage can be promoted to be fixed in the tissue as early as possible.

Drawings

FIG. 1 is a schematic view of the structure of the present invention.

Fig. 2 is a schematic view of the structure of the one-way locking anchor on the drafting line of the present invention.

Fig. 3 is a schematic structural view of the anchoring device on the great cardiac vein of coronary sinus of the present invention.

Figure 4 is a view of the atrial septum anchoring device of the present invention.

FIG. 5 is a schematic diagram of a drawing line with preformed conduits disposed thereon according to the present invention.

Reference numerals: 1. a first atrial septal anchoring device; 2. a coronary sinus great cardiac vein or heart wall anchoring device II; 3. drafting the yarn; 4. the atrial septum; 5. the left atrium; 6. a crushable structure; 7. a one-way locking anchor; 8. the coronary sinus great cardiac vein; 9. a locking device; 10. pre-forming a catheter; 11. a disk structure; 12. an inner disc; 13. and an outer disk.

Detailed Description

In order to make the invention more comprehensible, preferred embodiments are described in detail below with reference to the accompanying drawings:

as shown in fig. 1-5, the present invention provides a directly puncturing adjustable mitral valve repair device, comprising an atrial septum anchor 1, a coronary sinus great cardiac vein or heart wall anchor 2 and a stretching line 3; a drawing line 3 is arranged between the atrial septal anchoring device 1 and the coronary sinus great cardiac vein or heart wall anchoring device 2; the first atrial septal anchoring device 1 is provided with a structure for adjusting the position of a drafting line; the coronary sinus great cardiac vein or heart wall anchoring device II 2 is provided with a compressible structure 6, and the compressible structure 6 is provided with a water-absorbing expansion material and an absorbable material; a plurality of unidirectional locking anchors 7 clamped on the first room interval anchoring device 1 are arranged on the drafting line 3; the coronary sinus great cardiac vein or heart wall anchoring device II 2 is provided with a barb type anchoring structure; the coronary sinus great cardiac vein 8 or the second cardiac wall anchoring device 2 is provided with a spring ring structure for anchoring; a preformed conduit 10 for guiding the drawing line is arranged on the drawing line 3; the preformed catheter 10 is provided as a nitinol preformed catheter. The first room interval anchoring device 1 is provided with two rotatable disc structures 11 which are linked inside and outside, and the central axes of the two disc structures are not coincident; the inner disc 12 is connected to one end of the draft line 3. The two disc structures are respectively arranged at two ends of the atrial septum anchoring device I1, and the inner disc 12 is arranged in the atrial region of the left atrium 5. A locking device 9 for locking the relative position of the drafting line 3 and the inner disc 12 is arranged between the inner disc 12 and the drafting line 3.

As shown in fig. 1, the present invention employs a method of perforation and fixation from inside to outside of the atrium, using an approach (preferably femoral vein into right atrial puncture) to anchor one anchoring device 1 (e.g., one anchoring device 1 at interatrial septum 4) and the opposite anchoring device 2 to the great coronary sinus vein 8 or the heart wall (outside), greatly simplifying the procedure and reducing the risk and time of the procedure. The extension thread 3 is connected to an adjustable curved needle, which penetrates into the great coronary sinus vein 8 from the left atrium 5 and out of the compressible structure 6 of the anchoring device two 2.

The crushable structure 6 may be coated with a water swellable/absorbable material.

As shown in fig. 2, a puncture point of an interatrial septum 4 at one end of a drafting line 3 is provided with an interatrial septum anchoring device I1 at an oval nest, a unidirectional locking anchor 7 with a clamping structure such as an inverted triangle, an agnail or a sphere is arranged on the drafting line 3, and the unidirectional locking anchor 7 is clamped after passing through a hole with a smaller diameter than the unidirectional locking anchor 7 in the interatrial septum 4 anchoring device I1, so that a locking effect is achieved; the anchoring device II 2 at the other end of the drafting line 3 in the outer wall (free wall) of the left atrium 5 or the great cardiac vein 8 can have various bent or spring-shaped deformation structures, so that the heart tissue is prevented from being punctured, meanwhile, the elastic and compliant anchoring device has elasticity, compliance and difficult displacement, and the contact surface is increased to promote endothelialization and post-fixation. The drafting line 3 for tensioning the atrium is attached with one-way locking anchors 7 (such as a cone type, a ball type and the like), and the one-way locking anchors are fixed on the drafting line 3 at equal intervals, so that the stretching device can prevent loosening and falling after tensioning, and plays a role in locking after stretching and shortening the diameter of the front wall and the rear wall of the atrium; the fixed end of the coronary sinus great cardiac vein 8 or the second cardiac wall anchoring device 2 adopts a barb type anchor, the tip is curled inwards after puncture, the damage to the atrial wall or blood vessel is prevented, meanwhile, the contact area with the tissue is increased, the stability is enhanced, the endothelialization coverage of the tissue can be promoted, and the coronary sinus great cardiac vein or the second cardiac wall anchoring device can be fixed in the tissue as early as possible; the fixed end of the coronary sinus great cardiac vein or cardiac wall anchoring device II 2 adopts a spring type anchor (as shown in figure 3) and is fixed by the side face of the spring, thereby preventing the damage to the atrial wall or blood vessel, increasing the contact area with the tissue, enhancing the stability, promoting the endothelialization coverage of the tissue and being fixed in the tissue as early as possible. Two ends of the fixed end of the coronary sinus great cardiac vein or the second cardiac wall anchoring device 2 are fixed by a spring ring structure, and redundant materials can be taken out of the body by adopting a fusing mode.

As shown in fig. 4: the first room interval anchoring device 1 is provided with two rotatable disc structures 11 which are linked inside and outside, and the central axes of the two disc structures 11 are not overlapped; the inner disc 12 is connected to one end of the draft line 3. Two disc structures 11 are respectively arranged at two ends of the interatrial septum anchoring device I1, and an inner disc 12 is arranged in the atrial region of the left atrium 5. A locking device 9 for locking the relative position of the drafting line 3 and the inner disc 12 is arranged between the inner disc 12 and the drafting line 3. The locking device 9 and the disc are combined into a part, and the new combined part can be used as a gasket and can clamp the drafting line; the drafting line 3 is sleeved with a nickel titanium preformed catheter 10, and the drafting line 3 is guided to change the stretching direction (as shown in figure 5).

The eccentric two disk structures 11 can solve the problem that the puncture point is not fixed and the angle is not fixed. Generally, the puncture point is positioned at the fossa ovalis through the right atrium, but the positions of the puncture points are different due to different individuals and different anatomical structures; the other end of the extension line 3 may be in different positions in the outer wall (free wall) of the left atrium or in the fixed anchoring device of the great cardiac vein, which may cause the tensioned extension line (such as a surgical suture line) not to be perpendicular to the anterior and posterior wall surfaces of the heart, thus the diagonal drawing of the left atrium of the heart may not play an optimal role in shortening the anterior and posterior diameters of the heart so as to improve the mitral regurgitation.

The interatrial septum anchoring device 1 is provided with two internally and externally linked disk structures 11 which are not concentric, the position of an inner disk 12 in the left atrium 5 can be adjusted by rotating an outer disk 13, so that the position of a leading-out point of a drawing line 3 (surgical suture) is changed, the tensioned drawing line 3 (surgical suture) is perpendicular to the front wall surface and the rear wall surface of the heart, and the best effect of shortening the front diameter and the rear diameter of the heart and improving the backflow of the mitral valve can be achieved by drawing the left atrium.

While the invention has been described with respect to a preferred embodiment, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention. Those skilled in the art can make various changes, modifications and equivalent arrangements, which are equivalent to the embodiments of the present invention, without departing from the spirit and scope of the present invention, and which may be made by utilizing the techniques disclosed above; meanwhile, any changes, modifications and variations of the above-described embodiments, which are equivalent to those of the technical spirit of the present invention, are within the scope of the technical solution of the present invention.

Claims

1. a direct puncture adjustable mitral valve repairing device is characterized in that: comprise atrial septum anchoring device one, coronary sinus great cardiac vein or heart wall anchoring device two and drawing line; atrial septal anchoring device one A drawing line is arranged between the coronary sinus and the great cardiac vein or the second heart wall anchoring device; the first atrial septum anchoring device is provided with a structure for adjusting the position of the drawing line.

2. A direct puncture and adjustable mitral valve repair device as claimed in claim 1, characterized in that: the coronary sinus great cardiac vein or the second heart wall anchoring device is provided with a compressible structure, which can be compressible. The structure is provided with water swellable material and absorbable material.

3 . The direct puncture and adjustable mitral valve repair device according to claim 2 , wherein: the drafting line is provided with a plurality of one-way unidirectional anchoring devices for clamping the atrial septum anchoring device 1 . 4 . Lock the anchor.

4. A direct puncture-adjustable mitral valve repair device as claimed in claim 3, characterized in that: the coronary sinus great cardiac vein or the second heart wall anchoring device is provided with a barb type for anchoring. structure.

5 . The direct puncture and adjustable mitral valve repair device according to claim 4 , wherein the second coronary sinus or cardiac wall anchoring device is provided with a coil structure for anchoring. 6 .

6 . The direct puncture and adjustable mitral valve repair device according to claim 5 , wherein the drafting wire is provided with a preformed catheter for guiding the drafting wire. 7 .

7 . The direct puncture and adjustable mitral valve repair device according to claim 6 , wherein the preformed catheter is a nickel-titanium preformed catheter. 8 .

8. A direct puncture adjustable mitral valve repair device according to claim 1, wherein the atrial septum anchoring device is provided with two rotatable disc structures that are linked inside and outside, and the two The central axis of the disc structure is not coincident; the inner disc is connected with one end of the drafting line.

9 . The direct puncture and adjustable mitral valve repair device according to claim 8 , wherein the two disc structures are respectively arranged at both ends of the atrial septal anchoring device, and the inner disc is arranged at the left side. 10 . Intra-atrial area of the atrium.

10 . The direct puncture and adjustable mitral valve repair device according to claim 9 , wherein: between the inner disc and the draft wire, a device for locking the relative position of the draft wire and the inner disc is provided. 11 . Locking device.