WO2023219596A2

WO2023219596A2 - Mitral valve replacement device

Info

Publication number: WO2023219596A2
Application number: PCT/TR2023/050432
Authority: WO
Inventors: Saim BALIN
Original assignee: Balin Saim
Priority date: 2022-05-11
Filing date: 2023-05-11
Publication date: 2023-11-16
Also published as: WO2023219596A3

Abstract

The invention relates to a transapical/transcatheter mitral valve replacement (TAT- MVR) device that can be used in a minimally invasive (not completely non-surgical) way to restore and/or repair the function of the mitral valve, which is one of the heart valves.

Description

MITRAL VALVE REPLACEMENT DEVICE

Technical Field

State of the Art

The wide variety of approaches adopted today in the design of transcatheter mitral valve replacement (TMVR) devices also points to the many challenges faced for a successful device. The very slow process in the evolution of these devices is associated with the anatomical and pathophysiological complex/complicated structure of the mitral valve. The mitral valve is dynamic, asymmetrical, and heterogeneous, with a saddle-shaped ring and a complex subvalvular apparatus. This complex structure assumes a perfect and flawless function as a whole. The structural imperfection or malfunction of one or more parts of this complex structure affects the valve to varying degrees and causes dysfunction.

The valve is affected by a wide variety of pathologies that result in incompetence and/or stenosis. Mitral regurgitation (backward flow) is typically classified as functional mitral regurgitation, degenerative mitral regurgitation, or mixed, and therapeutic options may be different for each. This combination of complex anatomy and disease processes presents a number of challenges for the delivery, parking and anchoring of the designed device. The most important disadvantages of existing and studied devices are the difficulties in parking and anchoring the device to the complex mitral valve.

When these devices are parked to the mitral annulus (entrance) via the delivery (sending, distribution, transport, transapical/transcatheter/transseptal etc.) system, the anchoring function of the device occurs spontaneously/automatically. The anchoring feature cannot be manipulated, and inappropriate parking and inadequate anchoring often occur due to the complex nature of the mitral valve. All these prevent the placed device from functioning optimally. Compared to transcatheter aortic valve replacement devices, the evolution process of transcatheter mitral valve replacement devices progresses very slowly.

Mitral valve docking devices and systems are mentioned in the application which was validated in Turkey with TR 2017/18178 number from the application with the publication number EP2809263 B1 in the state of the art. The invention relates to a system for placing a mitral valve prosthesis, comprising: a coil guide catheter (68): a stem portion and a distal portion connected to the stem portion in a first curved shape, the distal portion having a second curved shape configured to generally follow the curvature of the mitral valve annulus, said first and second curved portions having a preformed shape capable of being delivered in straightened configurations and activated to the first and second curved shapes within the heart proximate the mitral valve, and a helical anchor: this is convenient to be received in and delivered from the coil guide catheter, the helical anchor formed as multiple coils having a preformed, coiled configuration after being delivered from the coil guide catheter and adapted to support a prosthetic mitral valve upon being fully delivered from the coil guide catheter and implanted with coil portions above and below the mitral valve annulus.

Similarly, document no US2021161659A1 can be given as an example of the state of the art. It can even be selected as the closest prior art document to the invention from some points of view. In said application, valve replacement using movable restraints and angled struts and features of a heart valve device. The device may include a frame with anchors configured to anchor the device to tissue. The frame may include a flared end or skirt for additional anchoring of the implanted device. The device may include a seal such as a barrier and/or cuff for preventing leakage. The device may contract for endovascular delivery of the device to the heart and expand for anchoring within the heart, such as the within the native mitral valve annulus. The device may include a replacement valve. The valve may have leaflets configured to re-direct blood flow along a primary flow axis.

In the document no US2021038382A, which is another document in the state of the art, methods, devices and systems for transcatheter mitral valve replacement in a doubleorifice mitral valve are described. In various embodiments, provided herein are methods, devices and systems for transcatheter mitral valve replacement in a doubleorifice mitral valve. These methods, devices and systems are used to treat patients with mitral valve disease, particularly those who have had failed edge-to-edge leaflet repair, or patients presently considered anatomically unsuitable for edge-to-edge leaflet repair alone.

In order to determine the state of the art, document numbers R 2019/05933, TR 2018/03586, TR 2018/20159, TR 2019/04942, TR 2017/12648, TR 2021/019396, EP1482869 B1 , US2019175341 A1 , EP2976043 B1 , US2021259670 A1 , US2020315788 A1 and US5967972 A can be examined as well, however, it is considered that neither in the documents mentioned above nor in other descriptions in the state of the art is a document that includes all the elements of our invention such as the centre strut, ribs, stretchers, etc., and the technical benefit brought by the related elements.

Conclusively, due to the above described problems and the insufficiency of the existing solutions made it necessary to make an improvement in the relevant technical field.

The Aim of the Invention

The invention was created to solve the abovementioned negativities by being inspired by the current situation.

The main aim of the invention is to provide a transapical/transcatheter mitral valve replacement (TAT-MVR) device that can be used in a minimally invasive (not completely non-surgical) way to restore and/or repair the function of the mitral valve Main, which is one of the heart valves.

Another aim of the invention is to provide a transapical/transcatheter mitral valve replacement (TAT-MVR) device that is easy to park and fix to the complex mitral valve.

Another aim of the invention is to provide a transapical/transcatheter mitral valve replacement (TAT-MVR) device in which the parking process is at the operator's discretion. Another aim of the invention is to provide a transapical/transcatheter mitral valve replacement (TAT-MVR) device in which the anchoring process is at the operator's discretion.

Another aim of the invention is to provide a transapical/transcatheter mitral valve replacement (TAT-MVR) device that can be observed with unique imaging methods (Trans-thoracic and Trans-Oesophageal Echocardiography) while advancing the parking and anchoring procedures intraoperatively.

Another aim of the invention is to provide a transapical/transcatheter mitral valve replacement (TAT-MVR) device, in which, when there is a complication affecting the left ventricular outflow tract during the valve replacement process, this adverse process can be managed by the operator.

Another aim of the invention is to provide a transapical/transcatheter mitral valve replacement (TAT-MVR) device that contains leaflets that have optimal coaptation (conjunction) with the natural leaflets of the mitral valve by means of its downwardwidening skirt configuration.

Another aim of the invention is to provide a transapical/transcatheter mitral valve replacement (TAT-MVR) device designed ovally similar to the geometry of the mitral annulus.

Another aim of the invention is to provide a transapical/transcatheter mitral valve replacement (TAT-MVR) device that works with the umbrella principle (reverse mechanism).

Another aim of the invention is to provide a transapical/transcatheter mitral valve replacement (TAT-MVR) device that does not require an extensive surgical procedure.

Another aim of the invention is to provide a transapical/transcatheter mitral valve replacement (TAT-MVR) device that overcomes the problems of inappropriate parking and inadequate anchoring.

The structural and characteristic properties and all advantages of the invention will be more clearly understood with the figures given below and the detailed description written with reference to these figures and therefore, the assessment should also be made by taking these figures and the detailed description into account. Figures to Help Understand the Invention

Figure 1. is the representative perspective view of the mitral valve replacement device that is the subject of the invention.

Figure 2. is another representative perspective view of the mitral valve replacement device that is the subject of the invention.

Figure 3. is another representative perspective view of the mitral valve replacement device that is the subject of the invention.

Figure 4. is the detail view of the connections of the mitral valve replacement device that is the subject of the invention.

Figure 5. is another detail view of the connections of the mitral valve replacement device that is the subject of the invention.

Figure 6. is a detail view of the hexagonal frame configuration of the mitral valve replacement device that is the subject of the invention.

Description of Part References

1. Major Ribs

2. Minor Ribs

3. Threaded Shaft

4. Major Stretcher Struts

5. Minor Stretcher Struts

6. Pipe

7. Nut

8. Leaflet Clamp

9. Skirt 10. Leaflets

11. Nut Adapter

12. Nut Adapter Lock

13. Hexagonal Frame

Detailed Description of the Invention

In this detailed description, the mitral valve replacement device that is the subject of the invention, and its preferred embodiments are explained only for a better understanding of the subject, without any limiting effect.

Figure 3 is a representative perspective view of the transapical/transcatheter mitral valve replacement device to be used in the healthcare industry to restore function of, and/or repair the mitral valve of the heart structure and/or function of which is impaired or lost.

The device will be placed in the target area, the mitral valve annulus (mouth), through a steerable sheath (Introducer Sheath) placed in the left ventricle (cavity) through a small incision in the anterior chest wall (apical area). This procedure will be managed by a cardiac team (Cardiologist, Cardiovascular Surgeon, Anaesthesiologist, Radiologist etc.). After the device is placed in the mitral valve area, it will be left there. The device can be produced in accordance with any diameter according to the need.

The mitral valve replacement device comprises a pipe (6) in the middle of the device, a threaded shaft (3) passing through said pipe (6) and a nut (7) that moves up and down on said threaded shaft (3) and enables the pipe (6) on the outer surface of the threaded shaft (3) to move in the same directions, opening the device from inside to outside and/or closing it by gathering from outside to inside.

A pipe (6) will be placed on the threaded shaft (3). In order for the pipe (6) to move freely on the threaded shaft (3), its inner diameter must be larger than the outer diameter of the threaded shaft (3). The pipe (6) must be shorter than the threaded shaft (3) and of appropriate length. A nut (7) must be placed on the lower end of the pipe (6) and this nut (7) must be integrated into the pipe (6). The nut (7) is positioned in such a way not to rotate the pipe (6) when it is rotated 360 degrees and to allow its up and down movement over the threaded shaft (3). The purpose of the nut (7) is to provide the up and down movement of the pipe (6) over the threaded shaft (3).

In the mitral valve replacement device, there also are ribs that form the main skeleton of the lateral surface of the device, enable the anchoring the device to the heart valve by means of the geometry of its outer surface, has an oval-shaped space in the middle that allows to sit on the mitral valve annulus and contains the mentioned tube (6) in this space, and enable the hexagonal frame (13) to open and close as well opening from the inside out and closing from the outside in with the movement of the pipe (6) by coming out of the upper end of said threaded shaft (3) and connecting to the hexagonal frame (13).

An oval-shaped space in the middle of the hexagonal frame (13) is formed by bringing together twelve hexagonal shapes and the main skeleton of the device is built on this structure.

The hexagonal frame (13) builds the basic geometric structure of the device, forming the main frame of the device, and the major/minor anchoring is provided over the outer surface.

In a preferred embodiment of the invention, the lower end of the threaded shaft (3) ends before it reaches the lower end of the hexagonal frame (13), and there is a lock system located at the lower end of said threaded shaft (3) that prevents the nut (7) from coming out of the threaded shaft (3).

Parking and anchoring process will be manageable with the discretion of the operator. The hexagonal frame (13) - preferably 12 pieces - will form the main frame of the device. Twelve hexagonal frames (13) will be brought together to form an oval ring in the middle. This oval ring will be similar to the geometry of the mitral annulus. The two narrowest regions of this oval ring (commisural region) will coincide with the posteromedial (posterior middle) and anterolateral (anterior) commissure (junction) region of the mitral valve. The profile thickness of two hexagonal shapes corresponding to the commisural region of the mitral valve will be twice as thick as the other hexagonal shapes, and by means of this design, major anchoring will be stronger from this region. The remaining 8 hexagonal frames (13) will be responsible for minor anchoring, four of which will be designed to coincide with the annulus region of the anterior mitral valve and the other four of the anterior mitral valve.

According to a preferred embodiment of the invention, said ribs consist of major ribs (1) forming a dome on the upper outer surface of the device by coming out of the upper end of said threaded shaft (3) and connecting to the hexagonal frame (13), and minor ribs (2) that increase the strength of the structure by connecting said major ribs (1 ) to each other and/or to the hexagonal frame (13). The said major ribs (1) ensure that the threaded shaft (3) is kept fixed on the horizontal axis, while the minor ribs (2) wrap the major ribs (1) on both sides, supporting them and mediating the construction of a stronger dome.

A threaded shaft (3) will pass through the centre of the oval ring (space) formed by the hexagonal frame (13). The upper end of the threaded shaft (3) is long enough to allow a dome to form on the oval ring. Preferably 12 major ribs (1), starting from the upper hollow part of the 12 hexagonal frames (13), extend to the upper end of the threaded shaft (3) and these major ribs (1 ) should adhere to the upper end of the threaded shaft (3) at the top of the oval ring, forming a dome. The threaded shaft (3) will form the centre of this dome. The minor ribs (2), which will emerge from the left and right upper part of the hexagonal frame (13), adhere to them in such a way as to support the major ribs (1) from both sides. This design will create a more robust dome skeleton.

The mitral valve replacement device also includes stretcher struts that are connected to the inner surface of the hexagonal frame (13) coming out of the lower and/or upper end of the said pipe (6), enable the hexagonal frame (13) to be opened and closed by opening and closing with the up and down movement of the pipe (6), and providing an internal strength to the device in the open state.

The stretcher struts mentioned in a preferred embodiment of the invention consist of major stretcher struts (4) that come out of the lower end of said pipe (6) and connect to the inner surface of the hexagonal frame (13) around it, enabling the device to be opened and closed, and minor stretcher struts (5), that emerge from the upper end of said pipe (6) and connect to said major stretcher struts (4) and/or the inner surface of the hexagonal frame (13), providing an internal strength to the device.

Said nut (7) functions as the main element in the opening and closing of the device. By allowing the movement of the pipe (6), it functions in the opening and closing of the ribs, major and minor stretcher struts (4, 5). The nut (7) moves up and down over the threaded shaft (3).

While the major stretcher struts (4) perform the effective anchoring function, the minor stretcher struts (5) help the major stretcher struts (4) to provide optimal anchoring.

Parking and anchoring of the device is not done spontaneously, but external controls are done consciously. The device will work with umbrella working principles (reverse mechanism). In this way, the desired anchoring function of the device in the appropriate position will be entirely at the discretion of the operator. Inappropriate parking and anchoring of the device can be eliminated by operator manipulation. Our device will be opened and closed in line with the umbrella working principles (reverse mechanism) and loaded into the delivery system, first parked in the target area, the mitral annulus (mouth), and then opened, and anchoring process will be managed optimally. In a conventional (traditional) umbrella operating principle, when the pipe (6) moves towards the top of the threaded shaft (3), the ribs and stretcher struts move away from the threaded shaft (3) and the umbrella opens. When the pipe (6) is moved towards the lower end of the threaded shaft (3), the ribs and stretcher struts move towards the threaded shaft (3) and the umbrella is closed.

When the pipe (6) is moved towards the top of the threaded shaft (3) via the nut (7) in the device, the ribs and stretcher struts will move towards the threaded shaft (3) and close the device. When the pipe (6) is moved downwards, the ribs and stretcher struts will move away from the threaded shaft (3) and open the device. No existing device has this feature.

Stretcher struts - preferably eight each - are placed at the lower and upper ends of the pipe (6). The other end of the six major stretcher struts (4) placed at the lower end should adhere to the middle of the vertical columns of the hexagonal frame (13), which makes minor anchoring. Two major stretcher struts (4) coming to the hexagonal frame (13) making major anchoring split into three branches before reaching the vertical columns and then connected to the vertical columns. Vertical columns mediate the formation of hexagonal shapes and are the attachment points of major stretcher struts (4) on hexagonal shapes.

8 minor stretcher struts (5) coming out of the upper end of the pipe (6) extend to the middle of the major stretcher struts (4). Mitral valve replacement device also comprises leaflets (10) that extend down from the lower ends of said hexagonal frame (13) and close with the effect of increasing pressure in systole and open with the effect of increasing pressure in diastole throughout the cardiac cycle and the leaflet clamp (8) that brings together the lower ends of said leaflets (10) and creates a coaptation area between the leaves of the mitral valve and the leaflets (10) of the device.

In a preferred embodiment of the invention, the leaflets (10) mentioned are made of bovine or pig pericardium or a combination of these.

Two leaflets (10) of appropriate length will be sewn to the lower edge of the oval ring formed by the hexagonal frame (13). These leaflets (10) will hang down. These leaflets (10) will be designed with a wider opening at the top and a narrower opening below.

Preferably, two leaflets (10) are brought closer together by two leaflet clamps (8), in the narrowest region of the oval shape. The convergence of the leaflets (10) at the lowest level will form a coaptation area. These leaflet clamps (8) will start from the inner part of the hexagonal frame (13), which is responsible for the major anchoring, and first extend inward and towards each other in the horizontal plane, and after a certain distance they will point downwards with angulation (angle formation).

Contrary to the inventions in the state of the art, the related invention will preferably have bileaflets (10) due to the nature of the mitral valve.

In the mitral valve replacement device, there also is a skirt (9) that allows coaptation, extending from the lower ends of said hexagonal frame (13) and extending down around the leaflets (10), which cuts the contact between the leaves of the mitral valve and the leaflets (10) of the device during left ventricular systole and between the leaves of the mitral valve and the leaflets (10) of the device with the pressure.

Said leaflet clamp (8) design creates a smaller opening than the opening formed by the lower edge of the oval ring. A skirt (9) of suitable length will be placed on the lower edge of the oval ring and this skirt (9) will extend downwards. This skirt (9) will break the contact between the natural leaves of the mitral valve and the leaflets (10) of the device during left ventricular (cavity) systole (contraction phase) and will allow a more effective coaptation with pressure. Finally, the main embodiment of the mitral valve replacement device may also comprise a detachable nut adapter (11 ) that is located under said nut (7), enabling remote control of the nut (7), and a nut adapter lock (12) that is located between said nut adapter (11 ) and said nut (7), enabling the nut (7) to be connected and/or released when the nut adapter (11) is driven.

The nut adapter (11) allows the remote movement of the nut (7) as it can be locked and unlocked with the nut (7) and is removed from the device after optimal parking and anchoring of the device.

The device can be opened and closed using the umbrella operating principles (reverse mechanism) by means of a specially designed delivery system, which is placed on the threaded shaft (3) passing through the centre of the device and locked to the pipe (6) with the nut (7) integrated at the lower end. When the nut adapter (11) in the delivery system is turned clockwise, it can move the pipe (6) towards the top of the dome and close the device. When the nut adapter (11 ) is turned counterclockwise, it moves the pipe (6) downwards and opens the device. The nut (7) moves up and down through the threads on the threaded shaft (3). The nut adapter (11 ) can be locked onto the nut and unlocked prior to operation. This function of the nut adapter (11 ) can also be performed in the intraoperative process.

According to a preferred embodiment of the invention, said nut (7) is in hexagonal geometry, providing ease of grip for the nut adapter lock (12).

In a preferred embodiment of the invention, at least one of said pipe (6) and/or threaded shaft (3) and/or nut (7) and/or hexagonal frame (13) and/or ribs and/or stretcher struts and/or leaflets (10) and/or leaflet clamp (8) and/or skirt (9) and/or nut adapter (11) and/or nut adapter lock (12) configurations is made of self-expanding nitinol, cobalt-chromium, stainless steel and/or a mixture of at least two of these.

Thus, the transapical/transcatheter mitral valve replacement device has been introduced to restore the heart mitral valve function and/or repair the mitral valve.

Claims

CLAIMS: The transapical/transcatheter mitral valve replacement device to restore the heart mitral valve function and/or repair the mitral valve, comprising;

• at least one pipe (6) located in the middle of the device,

• at least one threaded shaft (3) passing through said pipe (6),

• at least one nut (7), which, by moving up and down on said threaded shaft (3), enables the pipe (6) on the outer surface of the threaded shaft (3) to move in the same directions, to open the device from inside to outside and/or to close it by gathering from outside to inside,

• a hexagonal frame (13), which is the main skeleton of the lateral surface of the device, functions to anchor the device to the heart valve by means of the geometry of its outer surface, has an oval-shaped cavity in the middle that allows it to sit on the mitral valve annulus, and contains said pipe (6) in this space,

• ribs that come out from the upper end of said gear shaft (3) and connect to the hexagonal frame (13), and enable the hexagonal frame (13) to be opened and closed by opening and closing from the inside out with the movement of the pipe (6),

• stretcher struts that are connected to the inner surface of the hexagonal frame (13) coming out of the lower and/or upper end of the said pipe (6), enable the hexagonal frame (13) to be opened and closed by opening and closing with the up and down movement of the pipe, and providing an internal strength to the device in the open state,

• leaflets (10) that extend down from the lower ends of said hexagonal frame (13), close with the effect of increasing pressure in systole and open with the effect of increasing pressure in diastole throughout the cardiac cycle, allowing the device to be switched on and off, • at least one leaflet clamp (8) that brings together the lower ends of said leaflets (10) and forms a coaptation area between the leaves of the mitral valve and the leaflets (10) of the device,

• at least one skirt (9) that allows coaptation, extending from the lower ends of said hexagonal frame (13) and extending down around the leaflets (10), and cuts the contact between the leaves of the mitral valve and the leaflets (10) of the device during left ventricular systole and between the leaves of the mitral valve and the leaflets (10) of the device with the pressure,

• at least one detachable nut adapter (11 ) that is located under said nut

(7) and enables remote control of the nut (7), and

• at least one nut adapter lock (12) which is located between said nut adapter (11 ) and the nut (7), enabling the nut (7) to be connected and/or released when the nut adapter (11) is driven.

2. Mitral valve replacement device according to Claim 1 , wherein; said ribs comprise

• major ribs (1 ) that form a dome on the upper outer surface of the device by coming out of the upper end of said threaded shaft (3) and connecting to the hexagonal frame (13), and

• minor ribs (2) that increase the strength of the structure by connecting said major ribs (1) to each other and/or to the hexagonal frame (13).

3. Mitral valve replacement device according to any of the previous claims, wherein; said stretcher struts comprise

• major stretcher struts (4) that come out from the lower end of said pipe (6) and connect to the inner surface of the hexagonal frame (13) around it, enabling the device to be opened and closed, and minor stretcher struts (5) that come out of the upper end of said pipe (6) and connect to said major stretcher struts (4) and/or the inner surface of the hexagonal frame (13) providing an internal strength to the device.

4. Mitral valve replacement device according to any of the previous claims, wherein; said nut adapter lock (12) comprises at least one hexagonal nut (7) that provides ease of grip.

5. Mitral valve replacement device according to any of the previous claims, wherein; at least one of said pipe (6) and/or threaded shaft (3) and/or nut (7) and/or hexagonal frame (13) and/or ribs and/or stretcher struts and/or leaflets (10) and/or leaflet clamp (8) and/or skirt (9) and/or nut adapter (11) and/or nut adapter lock (12) configurations is made of self-expanding nitinol, cobaltchromium, stainless steel and/or a mixture of at least two of these.

6. Mitral valve replacement device according to any of the previous claims, comprising; at least one lock system which is located at the lower end of said threaded shaft (3) and prevents the nut (7) from coming out of the threaded shaft (3).

7. Mitral valve replacement device according to any of the previous claims, wherein; said leaflets (10) are made of bovine or porcine pericardium or a combination thereof.