A direct puncture adjustable mitral valve repair device

Abstract

The present invention relates to a direct puncture adjustable mitral valve repair device, belonging to the technical field of medical devices. It comprises an atrial septum anchoring device 1, a coronary sinus great cardiac vein or heart wall anchoring device 2 and a stretching line; a stretching line is arranged between the atrial septum anchoring device 1 and the coronary sinus great cardiac vein or heart wall anchoring device 2; the atrial septum anchoring device 1 is provided with a structure for adjusting the position of the stretching line. The present invention overcomes the defects of the prior art, and the position and angle of the stretching line are adjusted during the implantation of the device to obtain the best shortened anterior-posterior diameter of the heart, thereby improving mitral valve regurgitation. A one-way locking anchor is attached to the stretching line that tightens the atrium to prevent the stretching line from loosening and falling off, and plays the role of locking after stretching and shortening the anterior-posterior diameter of the atrium; the fixed end of the coronary sinus great cardiac vein or heart wall anchoring device adopts a barbed anchor or a spring anchor to prevent damage to the atrial wall or blood vessels, increase the contact area with the tissue, enhance stability, and promote tissue endothelialization.

Description

Technical Field

[0001] The invention relates to a direct puncture adjustable mitral valve repair device, belonging to the technical field of medical devices. Background Art

[0002] Mitral regurgitation (MR) is the most common valvular disease. Epidemiological research data from Europe and the United States show that the incidence of MR in people over 75 years old is as high as 10%, which is significantly higher than aortic valve disease. Similarly, as the aging of the population in my country worsens, mitral regurgitation will also lead to 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 MR patients with severe symptoms do not choose surgical treatment, and the reason is largely related to their surgical risks. This large group of patients with poor tolerance to surgery urgently need a less invasive treatment method as an alternative, so interventional mitral valve treatment technology has emerged. In the past decade, several transcatheter mitral valve repair technologies derived from different surgical procedures have emerged and are used to treat patients at high risk of surgery or who cannot undergo surgery. The transcatheter mitral valve repair “toolbox” is rapidly expanding, with as many as five devices approved for clinical use in Europe (CE mark), including MitraClip (Abbott Vascular–edge-to-edge leaflet repair), the DS1000 device (NeoChord, Inc, interventional prosthetic chord repair), the Carillon (Cardiac Dimensions, transcoronary sinus annuloplasty device), the CardioBand (Edward Valtech Cardio, interventional mitral annuloplasty ring), and the Mitralign device (Mitralign, mitral annulus folding technology). In current clinical practice, the device used for transcatheter mitral valve repair is mainly the MitraClip device that imitates the edge-to-edge leaflet repair proposed by Alfieri. Since the launch of MitraClip in 2003, more than 80,000 patients have been treated and it has been approved by the FDA. Two mitral valve repair devices, MitralStitch (Dejin Medical-interventional artificial chord repair) and ValveClamp (Hanyu Medical-interventional edge-to-edge leaflet repair), jointly developed by Chinese scholars and medical technology companies, have also made progress.

[0003] One of the internationally leading technologies, with its unique design, makes the most of the natural cavity of the human body and has a good effect on a large part of mitral regurgitation. This technology uses an interventional surgical device to implant an atrial septum anchoring device, an anchoring device in the coronary sinus and the great cardiac vein, and a stretching line connected to the two. Relying on physical tension, the left atrium and mitral valve are physically reshaped, thereby reducing or eliminating blood reflux caused by mitral valve insufficiency. In this technology, one anchoring device needs to be punctured from the jugular vein, enter the right atrium, and then enter the great cardiac vein through the coronary sinus. The other anchoring device enters the right atrium through the femoral vein, punctures the atrial septum and anchors on the atrial septum, so there are two approaches. If one approach (preferably the femoral vein is used to enter the right atrium for puncture) can be used to fix one side of the anchoring device (such as fixing one side of the anchoring device on the atrial septum), and the contralateral anchoring device can be anchored to the great cardiac vein or the heart wall (outside), the surgical path can be greatly simplified, reducing risks and surgical time. In addition, when entering the atrial septum from the femoral vein, the puncture point is generally at the oval fossa through the right atrium, but due to different individuals and different anatomical structures, the puncture point position is different; and the anchoring device on the other side in the outer wall (free wall) of the left atrium or the great cardiac vein may also be in different positions, which may cause the tightened stretching line (preferably surgical suture) to be not perpendicular to the anterior and posterior walls of the heart. In this way, the oblique pull on the left atrium of the heart may not achieve the best effect of shortening the anterior-posterior diameter of the heart and thus improving mitral regurgitation. If the position and angle of the stretching line can be adjusted by design during the implantation of the device, the best effect of shortening the anterior-posterior diameter of the heart and thus improving mitral regurgitation can be achieved. Summary of the invention

[0004] The purpose of the invention is to solve the technical problem of how to shorten the anterior-posterior diameter of the heart to improve mitral valve regurgitation.

[0005] In order to achieve the purpose of solving the above-mentioned problems, the technical solution adopted by the present invention is to provide a direct puncture adjustable mitral valve repair device, including an atrial septum anchoring device one, a coronary sinus great cardiac vein or heart wall anchoring device two and a stretching line; a stretching line is provided between the atrial septum anchoring device one and the coronary sinus great cardiac vein or heart wall anchoring device two; the atrial septum anchoring device one is provided with a structure for adjusting the position of the stretching line.

[0006] Preferably, the coronary sinus, great cardiac vein or heart wall anchoring device 2 is provided with a compressible structure, on which a water-swellable material and an absorbable material are provided.

[0007] Preferably, the stretching line is provided with a plurality of one-way locking anchors for being clamped on the atrial septum anchoring device.

[0008] Preferably, the coronary sinus, great cardiac vein or heart wall anchoring device 2 is provided with a barbed structure for anchoring.

[0009] Preferably, the coronary sinus, great cardiac vein or heart wall anchoring device 2 is provided with a spring coil structure for anchoring.

[0010] Preferably, the drawing wire is provided with a preformed conduit for guiding the drawing wire.

[0011] Preferably, the preformed catheter is a nickel-titanium preformed catheter.

[0012] Preferably, the atrial septum anchoring device is provided with two rotatable disc structures that are linked internally and externally, and the central axes of the two disc structures do not overlap; the inner disc is connected to one end of the stretching line.

[0013] Preferably, the two disc structures are respectively arranged at two ends of the atrial septum anchoring device, and the inner disc is arranged in the intra-atrial area of ​​the left atrium.

[0014] Preferably, a locking device for locking the relative position of the drawing line and the inner disc is provided between the inner disc and the drawing line.

[0015] Compared with the prior art, the present invention has the following beneficial effects:

[0016] 1. It overcomes the defects of the existing technology. One side of the anchoring device can be fixed on the atrial septum by puncturing the right atrium through the femoral vein, and the opposite side anchoring device can be anchored on the great cardiac vein or the heart wall, which greatly simplifies the surgical path and reduces risks and operation time.

[0017] 2. During the implantation of the device, the position and angle of the stretch line are adjusted to obtain the optimal shortened anterior-posterior diameter of the heart, thereby improving the effect of mitral regurgitation.

[0018] 3. The stretching line that tightens the atrium is attached with a one-way locking anchor (conical, spherical, etc.), which is equidistantly fixed on the stretching line. After tightening, it prevents the stretching line from loosening and falling off, and plays the role of stretching and shortening the diameter of the anterior and posterior walls of the atrium and then locking it.

[0019] 4. The fixed end of the coronary sinus, great cardiac vein or heart wall anchoring device adopts a barbed anchor. The tip of the anchor rolls inward after puncture to prevent damage to the atrial wall or blood vessels. At the same time, it increases the contact area with the tissue, enhances stability, and promotes tissue endothelialization coverage, so that it can be fixed in the tissue as soon as possible;

[0020] 5. The fixing end of the coronary sinus, great cardiac vein or heart wall anchoring device adopts a spring-type anchor. The spring side fixation prevents damage to the atrial wall or blood vessels, while increasing the contact area with the tissue to enhance stability, and can promote tissue endothelialization coverage and fix it in the tissue as soon as possible. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 It is a schematic diagram of the structure of the present invention.

[0022] Figure 2 It is a schematic diagram of the one-way locking anchor structure on the drafting line of the present invention.

[0023] Figure 3 It is a schematic diagram of the structure of the anchoring device on the coronary sinus and great cardiac vein of the present invention.

[0024] Figure 4 This is a diagram of the atrial septum anchoring device of the present invention.

[0025] Figure 5 The present invention is provided with a preformed catheter structure on the drawing line.

[0026] Figure markings: 1. Atrial septum anchoring device 1; 2. Coronary sinus and great cardiac vein or heart wall anchoring device 2; 3. Retraction line; 4. Atrial septum; 5. Left atrium; 6. Compressible structure; 7. One-way locking anchor; 8. Coronary sinus and great cardiac vein; 9. Locking device; 10. Preformed catheter; 11. Disc structure; 12. Inner disc; 13. Outer disc. DETAILED DESCRIPTION

[0027] In order to make the present invention more clearly understood, a preferred embodiment is described in detail with reference to the accompanying drawings as follows:

[0028] like Figure 1-5 As shown, the present invention provides a direct puncture adjustable mitral valve repair device, including an atrial septum anchoring device 1, a coronary sinus great cardiac vein or heart wall anchoring device 2 and a stretching wire 3; a stretching wire 3 is provided between the atrial septum anchoring device 1 and the coronary sinus great cardiac vein or heart wall anchoring device 2; the atrial septum anchoring device 1 is provided with a structure for adjusting the position of the stretching wire; the coronary sinus great cardiac vein or heart wall anchoring device 2 is provided with a compressible structure 6, and the compressible structure 6 is provided with water-swellable material and absorbable material; the stretching wire 3 is provided with a plurality of one-way locking anchors 7 for being clamped on the atrial septum anchoring device 1; the coronary sinus great cardiac vein or heart wall anchoring device 2 is provided with a barbed structure for anchoring; the coronary sinus great cardiac vein 8 or heart wall anchoring device 2 is provided with a spring coil structure for anchoring; the stretching wire 3 is provided with a preformed catheter 10 for guiding the stretching wire; the preformed catheter 10 is set as a nickel-titanium preformed catheter. The atrial septum anchoring device 1 is provided with two rotatable disc structures 11 that are linked inside and outside, and the central axes of the two disc structures do not overlap; the inner disc 12 is connected to one end of the stretching line 3. The two disc structures are respectively arranged at the two ends of the atrial septum anchoring device 1, and the inner disc 12 is arranged in the intra-atrial area of ​​the left atrium 5. A locking device 9 is provided between the inner disc 12 and the stretching line 3 for locking the relative position of the stretching line 3 and the inner disc 12.

[0029] like Figure 1As shown, the present invention adopts a method of punching and fixing from the inside of the atrium to the outside, and uses an approach (preferably the femoral vein to enter the right atrium for puncture) to fix one side of the anchoring device 1 (such as fixing one side of the anchoring device 1 on the atrial septum 4), and can anchor the opposite side anchoring device 2 2 to the coronary sinus great cardiac vein 8 or the heart wall (outside), which can greatly simplify the surgical path, reduce risks and surgical time. The stretching line 3 is connected to the adjustable curved needle, punctures the coronary sinus great cardiac vein 8 from the left atrium 5, and comes out from the compressible thin structure 6 of the anchoring device 2 2.

[0030] The compressible structure 6 may be coated with a water-swellable material / absorbable material.

[0031] like Figure 2 As shown, an atrial septum anchoring device 1 is provided at the oval fossa at the puncture point of the atrial septum 4 at one end of the stretching line 3 of the present invention, and a one-way locking anchor 7 with a clamping structure such as an inverted triangle, a barb or a sphere is arranged on the stretching line 3. The one-way locking anchor 7 is clamped after passing through a hole with a smaller diameter than the one-way locking anchor 7 in the anchoring device 1 of the atrial septum 4 to achieve a locking effect; the anchoring device 2 at the other end of the stretching line 3 in the outer wall (free wall) of the left atrium 5 or the great cardiac vein 8 can have a variety of bending or spring-like deformation structures to avoid puncturing the heart tissue, and at the same time has elasticity and compliance and is not easy to shift, increasing the contact surface and promoting fixation after endothelialization. The stretching line 3 for tightening the atrium is attached with a one-way locking anchor 7 (such as a cone type, a ball type, etc.), which is equidistantly fixed on the stretching line 3 to prevent loosening and falling off after tightening, and to play the role of locking after stretching and shortening the diameter of the anterior and posterior walls of the atrium; the fixed end of the coronary sinus great cardiac vein 8 or the heart wall anchoring device 22 adopts a barbed anchor, and the tip rolls inward after puncture to prevent damage to the atrial wall or blood vessels, while increasing the contact area with the tissue, enhancing stability, and promoting tissue endothelial coverage, and fixing it in the tissue as soon as possible; the fixed end of the coronary sinus great cardiac vein or the heart wall anchoring device 22 adopts a spring anchor (such as Figure 3 As shown), the spring side is fixed to prevent damage to the atrial wall or blood vessels, while increasing the contact area with the tissue, enhancing stability, and promoting tissue endothelialization coverage, and fixing in the tissue as early as possible. The two ends of the coronary sinus cardiac vein or heart wall anchoring device 2 are fixed with a spring coil structure, and the excess material can be removed from the body by fusing.

[0032] like Figure 4As shown: the atrial septum anchoring device 1 is provided with two rotatable disc structures 11 that are linked internally and externally, and the central axes of the two disc structures 11 do not overlap; the inner disc 12 is connected to one end of the stretching line 3. The two disc structures 11 are respectively arranged at the two ends of the atrial septum anchoring device 1, and the inner disc 12 is arranged in the intra-atrial area of ​​the left atrium 5. A locking device 9 is provided between the inner disc 12 and the stretching line 3 for locking the relative position of the stretching line 3 and the inner disc 12. The locking device 9 and the disc are combined into one part, and this new synthetic part can act as a gasket and can also clamp the stretching line; a nickel-titanium preformed catheter 10 is put on the stretching line 3 to guide the stretching line 3 to change the stretching direction (such as Figure 5 shown).

[0033] The two eccentric disc structures 11 can solve the problem of unstable angle caused by unstable puncture points. Generally, the puncture point through the right atrium is at the oval fossa, but the puncture point position varies due to individual differences and anatomical structures; and the other end of the stretching line 3 may also be located in different positions in the outer wall (free wall) of the left atrium or the fixed anchoring device of the great cardiac vein, which may cause the stretched stretching line (such as surgical suture) to be not perpendicular to the anterior and posterior walls of the heart, so that the oblique pull on the left atrium of the heart may not achieve the best effect of shortening the anterior-posterior diameter of the heart and thus improving mitral regurgitation.

[0034] The two disc structures 11 of the atrial septum anchoring device 1 of the present invention are not concentric, and the outer disc 13 can adjust the position of the inner disc 12 in the left atrium 5 after rotation, thereby changing the position of the lead-out point of the stretching line 3 (surgical suture line), so that the stretched stretching line 3 (surgical suture line) is perpendicular to the anterior and posterior walls of the heart, so that the pulling of the left atrium of the heart can achieve the best effect of shortening the anterior-posterior diameter of the heart and thus improving mitral regurgitation.

[0035] The above is only a preferred embodiment of the present invention, and is not any formal or substantial limitation of the present invention. It should be pointed out that ordinary technicians in this technical field can make several improvements and supplements without departing from the present invention, and these improvements and supplements should also be regarded as the protection scope of the present invention. Any technician familiar with this profession, without departing from the spirit and scope of the present invention, can make some changes, modifications and equivalent changes made by using the technical content disclosed above, which are equivalent embodiments of the present invention; at the same time, any changes, modifications and evolutions of any equivalent changes made to the above embodiments based on the essential technology of the present invention are still within the scope of the technical solution of the present invention.

Claims

1. A direct puncture adjustable mitral valve repair device, characterized in that: It comprises an atrial septum anchoring device 1, a coronary sinus great cardiac vein or heart wall anchoring device 2 and a stretching line; a stretching line is arranged between the atrial septum anchoring device 1 and the coronary sinus great cardiac vein or heart wall anchoring device 2; the atrial septum anchoring device 1 is provided with a structure for adjusting the position of the stretching line; The atrial septum anchoring device is provided with two inner and outer linked rotatable disc structures, the central axes of the two disc structures do not overlap; the inner disc is connected to one end of the stretching line; The two disc structures are respectively arranged at the two ends of the atrial septum anchoring device, and the inner disc is arranged in the intra-atrial area of ​​the left atrium; A locking device for locking the relative position of the drawing line and the inner disc is provided between the inner disc and the drawing line; The stretching line is provided with a plurality of one-way locking anchors for being clamped on the atrial septum anchoring device.

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

3. A direct puncture adjustable mitral valve repair device as claimed in claim 2, characterized in that: The coronary sinus, great cardiac vein or heart wall anchoring device 2 is provided with a barbed structure for anchoring.

4. A direct puncture adjustable mitral valve repair device as claimed in claim 3, characterized in that: The coronary sinus, great cardiac vein or heart wall anchoring device 2 is provided with a spring coil structure for anchoring.

5. A direct puncture adjustable mitral valve repair device as claimed in claim 4, characterized in that: The drawing line is provided with a preformed guide tube for guiding the drawing line.

6. A direct puncture adjustable mitral valve repair device as claimed in claim 5, characterized in that: The preformed catheter is a nickel-titanium preformed catheter.

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