KR102256192B1 - Device and method for mitral valve regurgitation method - Google Patents

Abstract

In order to achieve the object of the present invention, the present invention provides a mitral valve replacement device adapted to be deployed in a mitral valve position in the heart of the human body. The device has an atrial flange forming the atrial end of the device, a ventricular portion forming the ventricular end of the device, a ventricular portion having a height of 2 mm to 15 mm, and an annular support arranged between the atrial flange and the ventricular portion. The annular body support portion includes a ring of an anchor extending radially from the annular body support portion, and an annular clipping space is formed between the ring of the anchor and the atrial flange. A plurality of leaflet holders are arranged at the atrial end of the atrial flange, and a plurality of leaflet leaflets are fixed to the leaflet holder and positioned within the atrial flange above the innate annulus.

Description

Device and method for preventing mitral regurgitation {DEVICE AND METHOD FOR MITRAL VALVE REGURGITATION METHOD}

Related events

This application is related to provisional application No. 62/024,097 filed on July 14, 2014, provisional application No. 61/927,490 filed on January 15, 2014, and provisional application No. 61/887,343 filed on October 5, 2013 do. This application is a continuation of U.S. Application No. 14/279511, filed May 16, 2014, with reference to the full disclosures fully published in this application.

Field of invention

The present invention relates generally to medical devices and methods for use in the treatment and/or reconstruction of human mitral valve function. In particular, the present invention relates to a medical device that can be used to treat mitral valve regurgitation by replacing the native heart valve.

The human heart has four ventricles and four valves. The human heart controls the direction of blood flow. A fully functioning heart valve ensures adequate blood circulation is maintained during the cardiac cycle. Congenital or diseased or degenerative processes, calcification of leaflets, enlargement of the annulus, chordae tendineae or sagging dryness, enlarged left ventricle, damaged papillary muscle, injured Heart valve reflux or leakage occurs when the leaflets of the heart valve are not in full contact due to diseases such as valve structure. Regardless of the cause, reflux interferes with heart function because blood flows in the wrong direction through the valve due to the regurgitation pattern. Depending on the degree of reflux, the reflux can have a self-destructive effect not only on function but also on the geometry of the heart. Optionally, abnormal geometry may also be the cause of reflux, and the two processes accelerate abnormal cardiac function with each other. The direct result of the heart reflux is a decrease in forward cardiac output. Depending on the severity of the leak, the heart's efficiency in pumping adequate blood flow to other parts of the body can be reduced.

The mitral valve is a dual flap (bi-leaflet) inside the heart and is arranged between the left atrium (LA) and the left ventricle (LV). During the diastolic phase, the normally functioning mitral valve opens with increased pressure from the atrium as the atrium fills with blood (preloading). When the atrial pressure increases above the left ventricular pressure, the mitral valve opens, facilitating the passive flow of blood into the left ventricle. The diastolic is terminated by atrial contraction and releases the remaining blood from the left atrium to the left ventricle. The mitral valve is sealed at the end of atrial contraction, preventing blood flow from reversing from the left ventricle to the left atrium. The human mitral valve typically has an open area of ^{4 to 6 cm 2.} Two leaflets, an anterior leaflet and a posterior leaflet, cover the opening of the mitral valve. The opening of the mitral valve is surrounded by a fibrous ring called the mitral valve annulus. The two leaflets are attached to the mitral valve annulus in a circumferential direction and can be opened and closed by a hinge connection from the annulus during a cardiac cycle. In a normally functioning mitral valve, the leaflets are connected to the papillary muscles in the left ventricle by dry color. When the left ventricle contracts, the blood vessel pressure seals the mitral valve, and the dry color maintains the contact state of the two leaflets (prevents the two leaflets from escaping into the left atrium and prevents mitral regurgitation), and the mitral valve is in the wrong direction. (And thus prevents blood from flowing back into the left atrium).

Currently, standard methods of treating heart valve reflux include surgical reconstruction/treatment and endovascular clipping. The standard surgical reconstruction or replacement procedure requires open heart surgery, cardiac bypass and cardiac arrest. Due to the invasive nature of the surgical procedure, the risk of death, stroke, bleeding, respiratory problems, kidney problems and other complications is serious and many patients do not receive surgical treatment.

Recently, intravascular clipping technology has been developed by several equipment companies. According to this method, an implant-type clip made of a biocompatible material is inserted into the heart between two leaflets to clip and fix the middle portions of the two leaflets (mainly A2 and P2 leaflets). Prevent escape. However, some disadvantages such as difficulty in positioning, difficulty in removal once inaccurately implanted, recurrence of heart valve reflux, multiple clips required in one process, strict patient selection, etc. are actually applied to intravascular clipping. Was discovered while doing.
Prior art literature
US2012/0078353 (published on March 29, 2012)
WO2013/028387 (published on February 28, 2013)
US2012/0303116 (published on November 29, 2012)
No. US2013/0131793 (published on May 23, 2013)
No. US2009/0234446 (Publication date September 17, 2009)
No. US2005/0137686 (published on June 23, 2005)

Consequently, there is a great need for novel medical devices to treat mitral regurgitation. None of the medical devices that exist today have been able to fully meet this need to this day. It is an object of the present invention to provide a device and method for avoiding traumatic surgical procedures for surgeons and to provide a medical device that can be implanted through a less invasive and catheter-based procedure for mitral regurgitation treatment.

An object of the present invention is to provide a mitral valve replacement device that can be effectively fixed to the position of the mitral valve annular body of the human body without perforating the innate tissue.

Another object of the present invention is to provide a method of deploying a mitral valve replacement device at a position of a human mitral valve annulus, and the position of the device can be adjusted before the final release of the device is completed.

Another object of the present invention is to provide a novel valve structure that provides more effective valve control and flow.

In order to achieve the object of the present invention, the present invention provides a mitral valve replacement device adapted to be deployed in a mitral valve position in the heart of the human body. The device has an atrial flange forming the atrial end of the device, a ventricular portion forming the ventricular end of the device, a ventricular portion having a height of 2 mm to 15 mm, and an annular support arranged between the atrial flange and the ventricular portion. The annular body support portion includes a ring of an anchor extending radially from the annular body support portion, and an annular clipping space is formed between the ring of the anchor and the atrial flange. A plurality of leaflet holders are arranged at the atrial end of the atrial flange, and a plurality of leaflet leaflets are fixed to the leaflet holder and positioned within the atrial flange above the innate annulus.

1 is a perspective view showing a mitral valve device according to a first embodiment of the present invention.
Fig. 2 is a bottom view of the device shown in Fig. 1;
Fig. 3 is a plan view of the device shown in Fig. 1;
Figure 4 is a side view of the device shown in Figure 1;
FIG. 5A is another side view showing the device of FIG. 1 rotated 90 degrees from the view of FIG. 4;
5B shows the device of FIG. 1 located in the mitral valve annulus of the human heart.
Figure 6A shows a balanced two-dimensional structure of the device of Figure 1 after it has been laser cut from metal or polymer tubing.
Fig. 6B is a two-dimensional perspective view showing the laser cutting pattern of the apparatus shown in Fig. 6A prior to molding the final shape shown in Fig. 1; The device in its final shape can be integrally configured with the tissue leaflet(s) and skirt(s), pressed into a relatively small profile, and loaded into a delivery system.
FIG. 7A is a plan view showing an assembled mitral valve replacement device including leaflet(s) included in the apparatus of FIG. 1 when the leaflets are in an open position.
7B is a plan view showing the assembled mitral valve replacement device shown in FIG. 7A with the leaflet(s) in an open position.
8A is a plan view showing an assembled mitral valve replacement device including leaflets included in the apparatus of FIG. 1 when the leaflets are in a closed position.
Fig. 8B is a bottom view showing the assembled mitral valve replacement device shown in Fig. 8A with the leaflet(s) closed.
9A is a perspective view showing the leaflet assembly shown in FIG. 7A when the mitral valve is closed and the leaflets are open.
9B is a perspective view showing the leaflet assembly shown in FIG. 7A when the mitral valve is open and the leaflets are closed.
10A is a plan view showing the leaflet assembly shown in FIG. 7A when the mitral valve is closed and the leaflets are open.
10B is a bottom view showing the leaflet assembly shown in FIG. 7A when the mitral valve is closed and the leaflets are open.
11 is a plan view showing the leaflet assembly shown in FIG. 7A when the mitral valve is open and the leaflets are closed.
12 is a perspective view showing a mitral valve device of a second embodiment according to the present invention.
Fig. 13 is a side view showing the device shown in Fig. 12;
Fig. 14 is another side view showing the device of Fig. 12 rotated 90 degrees from the view of Fig. 13;
Figure 15 shows the device of Figure 12 located in the mitral valve annular body of the human heart.
16 is a perspective view showing a mitral valve device according to a third embodiment of the present invention.
Fig. 17 is a bottom view showing the device shown in Fig. 16;
Fig. 18 is a plan view showing the device shown in Fig. 16;
Fig. 19 is a side view showing the device shown in Fig. 16;
Figure 20 shows the device of Figure 16 located in the mitral valve annular body of the human heart.
FIG. 21 shows a planar two-dimensional structure of the device shown in FIG. 16 after laser cutting from metal or polymer tubing.
FIG. 22 is a two-dimensional perspective view showing a laser cutting pattern of the apparatus shown in FIG. 21 before forming the final shape shown in FIG. 16. The device in its final shape can be integrally configured with the tissue leaflet(s) and skirt(s), pressed into a relatively small profile and loaded into a delivery system.
23 is a view showing the location of the leaflets of the device of FIG. 16 in the left atrium of a patient.

The following detailed description is in the form considered to be the best for carrying out the present invention. This description is not intended to limit the present invention, but to explain the general principles of the embodiments of the present invention. The scope of the invention is best defined by the appended claims.

TECHNICAL FIELD The present technology relates generally to a mitral valve reflux treatment device and to a method of positioning and securing the device within the heart of the human body. The atrial portion of the device “seats” and “seals” to the mitral annulus region and prevents leakage (return of blood from the left ventricle to the left atrium) from the region surrounding the autogenous region. The ventricular portion of the device includes a valve body and a fixation feature. The fixation features are partially or completely covered by fibers or tissue to form a "sealing body" and prevent leakage. The valve body includes a tissue leaflet(s) and a leaflet support structure. During a normal cardiac cycle, the valve and leaflet(s) open and close to control the volume and direction of blood flow between the left atrium and left ventricle. The function of the fixation features is to maintain the proper position of the device to prevent potential migration during the cardiac cycle. The fixation features work together with the congenital leaflet(s) and/or annulus and/or other subvalvular structures to provide a fixation effect. The design of the fixation feature is to use a biocompatible adhesive/glue to form a bond between the congenital valve and/or cardiac structure and the device to maintain the position of the valve prosthesis.

When used, the device is delivered to the mitral valve space by using a catheter and works with the inner plate structure and the lower plate structure to rebuild the function of the mitral valve. In addition, the device can be implanted surgically or through minimally invasive procedures. The device may be implanted into the heart or intravascular lumen of the human body and used to improve, replace and/or reconstruct the function of the congenital mitral leaflet(s) and mitral valve.

The invention also includes a fixation feature (clip design) that provides a fixation effect using the congenital leaflet(s) and/or annulus and/or other sub-annular structures and holds the device in place during the cardiac cycle. do. When the device is arranged in the mitral valve position, the anchoring feature(s) of the device connects/interacts with the congenital leaflet(s), and/or annulus, and/or other subplatelet structures so that the device can be operated during a cardiac cycle. Prevent movement. The atrial portion of the device may also interact with the atrial portion and annulus of the device over the annulus in contact with the atrial portion of the device to provide some additional fixation effect.

The present invention also provides a novel leaflet design. The leaflet structure may include one to six leaflets that can be stitched together within the leaflet support structure to form an umbrella-shaped profile that can be opened and closed during a cardiac cycle to control flow. During systole (constriction of the heart), the umbrella-shaped leaflets open with a relatively large profile and close the mitral valve, so that blood cannot flow back from the left ventricle to the left atrium. During the diastolic phase (relaxation of the heart), the umbrella-shaped leaflets are sealed with a relatively small profile and open the mitral valve, so that blood can flow from the left atrium to the left ventricle. According to the advantage of the novel valve leaflet design, (i) there is no axial contraction/compression of the leaflet support structure by the leaflet(s) during the cardiac cycle in order to improve the fatigue resistance of the leaflet support structure, ( ii) when coaptation is formed between the leaflet(s) and the skirt(s) on the leaflet support structure, adhesion of the leaflet(s) is improved to minimize the possibility of central leakage, (iii) There is no "free edge" in the central part of the leaflet. There is no adhesion between the leaflets. This feature is important because deformation or twisting of the valve support structure also causes minimal central leakage.

The mitral valve replacement device according to the present invention is compressed into a low profile and loaded into a delivery system, followed by using a delivery catheter through a transapical or transfemoral or transseptal process. It can be delivered to the target location by the same non-invasive medical procedure. When the mitral valve replacement device reaches the target implantation position, the mitral valve replacement device is released from the delivery system and inflates the balloon (for a support structure capable of inflating the balloon) or inside the device (for devices with a self-inflatable support structure). It can be expanded into a normal (expanded) profile by the elastic energy stored in it.

The leaflet(s) inside the mitral valve replacement device according to the present invention are treated animal tissue/pericardium, thin-walled living organisms (such as stainless steel, Co-Cr base alloy, Nitinol, Ta and Ti, etc.) Suitable metal urea, polyisoprene, polybutadiene and their co-polymers, neoprene and nitrile rubbers, polyurethane polymers (polyurethane elastomers), silicone rubber, fluorine And biocompatible polymeric materials such as fluoroelastomers and fluorosolicone rubbers, polyesters, and polytetrafluoroethylline (ptfe). Leaflets can have drugs or biologics to improve performance, prevent thrombus formation, and promote endotheliolization. On the mitral valve device the leaflet(s) can also be treated to prevent calcification or have a surface layer/coating. The valve body and the cover on the plate support structure may also, if desired, be a layer made from a combination of fibers and tissues. For example, the upper portion of the cover may be made of fibers and the lower portion may be made from tissue or vice versa. The atrial portion of the device and the body of the leaflet support structure may be partially or completely covered by fibers or tissues to provide improved sealing and therapeutic effects. The fixation feature(s) formed on the device are partially or completely covered by fibers or tissue to promote tissue growth, prevent Perivalunaer leakage (PVL), and damage to the surrounding internal heart structure. Decrease.

The leaflet(s) may be integrated with the leaflet support structure by mechanical interweaving, suture sewing, and chemical, physical or adhesive bonding methods. The leaflet(s) may be formed from elements of the support structure. For example, the leaflet support structure and leaflet(s) may be formed together or directly molded from a polymer or metallic material. The leaflet(s) may be formed by vapor deposition, sputtering, reflow, dipping, casting, extrusion processes or other mechanisms for attaching two or more materials to each other.

Tissue leaflets can also be coated with drugs or other bioagents to prevent clotting in the heart. Anti-calcification materials may be coated or provided on the surface to prevent calcification.

1 to 5 show a first embodiment of a mitral valve device 20 according to the present invention. The mitral valve device 20 is an atrial flange 22, an annular support 24, a neck portion 26 connecting the atrial flange 22 to the annular support 24, and a leaf leaf support structure. It has a actuated valve body 28. Each of these parts is made up of a scaffold that forms cells that form a cellular matrix.

The atrial flange 22, annular support 24 and valve body 28 are made from nitinol superelastic materials or stainless steel, Co-Cr base alloys, titanium and alloys thereof, and other biocompatible materials capable of inflating the balloon. Can be manufactured. Other polymeric biocompatible materials may be used to manufacture the components of the mitral valve device 20. When used, the mitral valve device 20 may be folded or compressed into a delivery system and delivered to the location of the mitral valve through catheter pass delivery (eg, pass through the thigh or pass through the apex). Once at the location of the mitral valve, the mitral valve device 20 is released from the delivery system and is located in the mitral valve annulus area. The atrial flange 22 is arranged on or on the congenital annular body of the mitral valve, and a portion of the atrial flange 22 extends within the left atrium. See Figure 5B. The atrial flange 22 may have a surface area greater than or equal to the mitral annular body area. In use, the atrial flange 22 is covered by a biocompatible polymer fiber, tissue or biocompatible material to provide a sealing effect around the mitral valve device 20 and promote tissue growth and accelerate the therapeutic effect.

The annular support 24 can act as a fixing feature and work with the annulus, congenital leaflet(s) and other internal cardiac or subplatelet structures to provide a desired fixation effect. See Figure 5B. In addition to the fixation effect provided by the annular support 24, the mitral valve device 20 by means of the "clipping effect" formed by the atrial flange 22 and the annular support 24 allows the mitral valve device 20 to be Automatic alignment and suppression of potential movement. During the process of discharging the device 20 from the delivery system, the components of the device 20 are, in turn, released from the delivery system. For example, during the pass-through delivery process, the atrial flange 22 is first deployed from the delivery system and then the annular support 24 is deployed. In contrast, during the transfemoral (transseptal) delivery process, the annular support 24 is deployed first and then the atrial flange 22 is deployed. The process may be performed according to guidance from X-rays and/or TEE, ICE, and the like.

4 and 5A show a typical three-dimensional or geometrical range for each component of the mitral valve device 20. The atrial flange 22 may have a circular profile or a profile other than a complete circle. As long as the atrial flange 22 has a circular profile, the diameter of the atrial portion may have a range of 20 mm to 70 mm. If the atrial flange 22 has a profile different from the complete circle, the long axis may have a range of 20 to 70 mm and the relatively short axis may have a range of 15 to 65 mm. In addition, the height H1 of the atrial flange 22 may have a range of 0.5mm to 20mm. Each cell forming the atrial flange 22 at the upper atrial end of the atrial flange 22 has peaks and valleys, and a round non traumatic tip at each peak ( 34). The angle θ1 of the atrial flange 22 with respect to the valve body 28 may range from 1 to 150 degrees. The atrial flange 22 may be completely or partially covered by a fiber or tissue material or a combination of tissue and fiber materials. The atrial flange 22 has thorns or spikes on the side facing the bottom of the atrium to facilitate connection with the atrial tissue and/or the annular body. The valve body 28 may have a height H3 ranging from 2mm to 30mm. The end of the valve body 28 closer to the atrial side is relatively higher and is extruded over the atrial flange 22 to reduce the length of the valve body 28 within the ventricle. The transverse profile of the valve body 28 may be a complete circular shape or a profile different from the circular shape. As long as the valve body 28 has a complete circular profile, the diameter of the valve body may range from 15 mm to 50 mm. As long as the valve body 28 has a profile different from the circular shape, the long axis may have a range of 15 mm to 50 mm and the relatively short axis may have a range of 10 to 45 mm. The valve body 28 may have a variable profile along its height. For example, a portion of the valve body 28 at a position close to the atrial flange 22 may have an oval-shaped profile or some other profile different from a complete circle, and a position further away from the atrial flange 22 In the part of the valve body 28 may have a complete circular profile. The tissue leaflet(s) may be completely integrated into the valve body 28 in a circular portion or may surround circular and non-circular portions. The valve body 28 may be completely or partially covered by a fibrous or tissue material or a combination of tissue and fibrous materials. For example, the upper portion of the valve body 28 may be covered by fibers and the lower portion of the valve body 28 may be covered by tissue or vice versa. In use, the fibrous material and tissue may be first stitched or connected to each other or individually stitched or connected to the valve body 28. The valve body 28 may be covered along one surface (ie, inner or outer surface) or may be covered along both surfaces (ie, inner and outer surfaces). Each cell forming the valve body 28 at the bottom end of the valve body 28 has a circular tip 38 with peaks and valleys and no trauma at the bottom.

An optional neck 26 with a relatively small diameter provides a transition from the atrial flange 22 to the annular support 24. When the mitral valve device 20 has an unfolded structure, the neck 26 extends inward from the atrial flange 22 along the radial direction to form a U-shaped neck 26. The transverse profile of the neck 26 may be completely circular or may be of a different profile than the original. As long as the neck 26 has a perfectly circular profile, the diameter of the neck may range from 15 mm to 50 mm. As long as the neck 26 has a profile different from the circular shape, the long axis may have a range of 15 mm to 50 mm, and the relatively short axis may have a range of 10 mm to 45 mm.

Next, the neck 26 is transferred radially outward with respect to the annular body support 24 to include a ring of U-shaped section 29, and the U-shaped section 29 is spaced apart. And are arranged alternately with the inverted V-shaped tabs 30. The neck 26 actually transitions radially outward with respect to the ring of the U-shaped section 29 and extends radially outwardly before extending inward along the radial direction to transition to the valve body 28. Is extended to. The tabs 30 extend radially outward from the valve body 28 and have a generally vertical upward bend to form a ring surrounding the neck 26. The number of tabs 30 is 1 to 20. The cross-sectional profile of the ring of the tab 30 may be a completely circular shape or a profile different from the circular shape. The ring of the tab 30 has a complete circular profile and the diameter of the ring may range from 15mm to 70mm. When the ring of the tab 30 has a profile different from that of the circular shape, the tightening axis may have a range of 15 mm to 70 mm, and the relatively short axis may have a range of 10 mm to 65 mm. The inverted V-shaped connection portion for the tab 30 is an enlarged point 32, which has a function of contacting or pressing the congenital leaflet(s) or annular body of the mitral valve region of the heart. It fixes the mitral valve device 20 in the area and acts as a fixation feature along it. The height H4 of each tab 30 has a range of 0.5mm to 10mm. The tab 30 is completely covered or partially covered by tissues or fibers. For example, the enlarged point 32 can be exposed by the fibers/tissue, and the rest of the annular support 24 is covered. When the fiber is used, the fixation of the mitral valve device 20 is improved in the annular body and not only promotes the in-growth of the tissue, but also provides an additional sealing effect to prevent perivalvular leakage. Can be prevented.

Accordingly, the ring of the U-shaped section 29 is larger than the diameter of the valve body 28 and the neck 26 but smaller than the diameter of the atrial flange 22. Similarly, the ring of the tab 30 is larger than the diameter of the valve body 28 and the neck 26 but smaller than the diameter of the atrial flange 22. The tab 30 and the U-shaped section 29 may be formed to be alternately arranged with each other in the same overall ring and may have approximately the same diameter with each other.

Two tails 36 having a U-shaped shape may extend from the valve body 28 at the end of the valve body 28. Although two tails 36 are shown, a mitral valve device 20 having only one tail 36 or more than three tails 36 may be provided. As best shown in Fig. 5A, each tail 36 is formed extending from the two lower tips 38 of the valve body 28 to connect with the U-shaped bottom, and a suture or other thread is attached thereto. The suture or thread can be used to adjust the position of the mitral valve device while the mitral valve device is deployed, such that it is used to be tied to the tail. The tail 36 also combines with some features within the delivery system to: 1) the valve loading (i.e. the valve is loaded into the delivery system sheath and 2) the ring of the heart. It facilitates positioning of the valve in the clamping area. With regard to valve positioning, the tail 36 adjusts the position and/or angle of the mitral valve device 20 before the mitral valve device 20 is finally released from the delivery system during the deployment process. According to another advantage of having the tails 36, the mitral valve device 20 is generally already (partially or fully) operational before the mitral valve device 20 is fully deployed and released from the delivery system. This gives the surgeon more time to adjust the position and hang of the mitral valve device 20 before the mitral valve device 20 is finally separated from the delivery system. The length of each tail 36 may have a range of 5mm to 25mm. The tail 36 can be shaped set or bent into a specific shape so that the tails 36 can extend away from the circular profile formed by the valve body 28 if desired. For example, the tail 36 may hang from the distal end of the valve body 28 and bend inward toward the lumen of the valve body 28.

5B, when the mitral valve device 20 is deployed in the congenital mitral valve position when in use, the tab 30 is deployed and “seat” in/on an annular body, and a portion of the atrial flange 22 Extends in the left atrium. The interaction of the atrial flange 22 (from above) and the tabs 30 (from below) provides a "clipping effect" that effectively secures the mitral valve device 20 in a desired position. When the mitral valve device 20 is deployed, the U-shaped section 29 is arranged in a position just below the annular body to provide an additional sealing effect. The support/cell space within the atrium may not be partially or completely covered by fibers and/or tissue. If the atrial flange 22 has a partially uncovered arrangement in the atrium, interference to the anterior blood flow can be minimized. The tissue leaflet(s) 48 of the mitral valve device 20 is integrally configured into the valve body 28 to replace the functions of the congenital mitral valve leaflets. As shown in FIGS. 7A and 7B, the congenital leaflets are arranged adjacent to the valve body 28 and adjacent to the outer surface of the valve body 28.

6A and 6B show an exemplary laser cutting structure of the mitral valve device 20. The mitral valve device 20 may be laser cut from metal or polymer tubing to reach the structure of FIG. 6A. The cut structure is then subjected to shape setting, microblasting, and electro polishing processes to have the desired profile/shape shown in FIGS. 1 to 5B. The width of each support 50 may have a range of 0.2mm to 1.5mm, and the thickness of each support 50 may have a range of 0.2mm to 0.75mm. The length of each cell may have a range of 2mm to 20mm. The number of rings along the length of the mitral valve device 20 may range from 2 to 20. The number of cells along the periphery of the mitral valve device 20 may range from 2 to 20. Optionally, the mitral valve device 20 may be manufactured from a flat sheet and then rolled into a desired shape. The mitral valve device 20 may be delivered according to one or more delivery methods. For example, through apical transmission may be used so that the atrial flange 22 is first deployed and provides tatile feedback during the delivery process. The annular body support 24 (ie, tab 30) is released and finally deployed to complete the implantation of the mitral valve device 20. During the femoral passage/transseptal delivery process, the tab 30 is first deployed and can provide tactile feedback during the delivery process. The atrial flange 22 is released and finally deployed to complete the implantation of the mitral valve device 20. During the delivery process, the tabs 30 may be bent toward the valve body 28 toward the inside (towards the upper and the inner side or toward the lower and the inner side). When the tabs 30 are released/unconstrained, the tabs expand and press the valve annulus or congenital leaflet(s).

In use, the mitral valve device 20 is compressed and delivered in a relatively small profile for easy delivery and deployed once it reaches the target implantation position. The profile of the compressed device is less than 48Fr, and the typical range for these applications is 15Fr to 40 Fr.

The plan view of FIG. 7A shows the mitral valve replacement device in an assembled state including the leaflets 48 integrally configured with the mitral valve device 20. Fig. 7B is a bottom view showing the assembly of Fig. 7A. 7A and 7B show the leaflet 48 in an open position, in which blood flow from the left ventricle to the left atrium is prevented. A contact area is located between the leaflet 48 and the skirt formed by the mitral valve device 20 in the valve body 28 along the inner lumen of the mitral valve device 20. Similarly, FIGS. 8A and 8B showing a top view and a bottom view of the mitral valve device in the illustrated assembled state are shown in FIGS. 7A and 7B. The leaflets 48 are arranged in a closed position so that blood can flow from the left atrium to the left ventricle. . As best shown in Figs. 7A-8B, the present invention also provides a novel leaflet structure. The leaflets 48 have a structure opposite to the congenital leaflet structure so that the leaflets 48 are opened inward and open to the outside to be sealed, and contact the inner surface of the valve body 28. The leaflets 48 are attached to the mitral valve device 20 so that the leaflets are freely sealed toward the inside and an anterior blood flow flows through the valve device. The height (depth) of the tissue leaflet(s) varies from 2 to 30 mm depending on the anatomy of the heart.

The structure of the leaflet(s) is best shown in Figs. 7A-11 and the embodiment shows the use of three leaflets 48A, 48B, 48C and the leaflets are longitudinal stitches or sutures 72 ,74,76) are sewn together. The suture lines 72, 74, 76 extend along the outer edges of the leaflets 48A, 48B, and 48C, and form a connection line through which the leaflet structure is connected to the valve body 28. The leaflets 48A, 48B, 48C are sewn on a support 50 forming a valve body 28 along the edges. At the upper (atrial) edge of the leaflets 48A, 48B, 48C, the radial stitches or sutures 82,84,86 are centered on the flat tip 60 from the longitudinal sutures 72,74,76. It extends towards point 88. The three inner sutures 52, 54, 56 start from the apex 58 where the leaflets 48A, 48B, 48C form a corrugated structure with each other to form a central flat tip 60, and the suture lines 52, 54 The starting point of ,56 is offset with the seams 82,84,86. Each suture line 52,54,56 extends toward each suture line 72,74,76 over a short distance and merges with each of the suture lines 72,74,76. By the arrangement of the sutures, the three leaflets 48A, 48B, 48C form an umbrella-shaped structure for the valve structure, and the leaflets 48A, 48B, 48C are upper (atrial) sutures when ventricular pressure acts. It does not open continuously until (82,84,86), preventing the leaflet(s) from flipping over and minimizing leakage. The distance between the domed ceiling and the upper (atrial) sutures 82, 84 and 86 formed by the leaflets 48A, 48B and 48C is 0.25 mm to 10 mm. The structure of the leaflet in the mitral valve device 20 may be formed by a plurality of leaflets 48 or a single leaflet 48 (in the above description and drawings). In the case of a single leaflet, a single piece of leaflet 48 may be folded and sewn into the shape shown in FIGS. 7A-11.

Thus, the novel leaflet design according to the present invention uses a reverse leaflet action to control blood flow between the left atrium and the left ventricle. The shrinkage/compression load/deformation typically acting on the valve body 28 by means of the inverted or “umbrella” or “balloon-shaped” leaflet(s) design improving sealing/contact and also by prior art leaflet design. This is eliminated to improve the fatigue performance of the valve body 28.

12 to 14 show a second embodiment of the mitral valve device 20 according to the invention and further comprise a clip 80. The mitral valve device 20 shown in FIGS. 12-14 also includes an atrial flange 22, an annular support 24, and a neck portion 26 connecting the atrial flange 22 to the annular support 24. And a valve body 28 which acts as a leaflet support structure, all of which are identical to the corresponding elements shown in FIGS. 1 to 5. Each of these parts is also constructed by a scaffold that forms cells that form a cellular matrix.

The difference between the two embodiments is that a ring of clips 80 provided spaced apart around the valve body 28 at a position vertically away from the annular support 24 is added. Each clip 80 extends vertically from all supports within the valve body 28 and then extends horizontally along the radial direction before ending with a short bend at the tip of the clip, so that the clips 80 are somewhat L-shaped. Have. As best shown in Fig. 15, the clip 80 picks up or fixes a portion of the congenital leaflet after the mitral valve device 20 is deployed. The clipping function improves the fixing function of the mitral valve device 20 in the annular region of the mitral valve region. The clipping effect provided by the atrial flange 22 and tab 30 also works here, but the clip 80 provides an improved fixation function. The height H2 forms a combined height H2 of the neck 26 and the annular support 24 and is varied to accommodate the clip 80 and has a range of 0mm to 10mm.

When the mitral valve device 20 is implanted, the atrial flange 22, the valve body 28, and formed in the device or formed by the congenital leaflet(s) and other internal heart structures (or other subplatelets). A fixation mechanism (e.g., the clipping effect of the atrial flange and tab 30, the addition of the clip 80) holds the mitral valve device 20 in a desired position. During the systolic phase of the ventricle, when the valve formed by the leaflets 48 and the valve body 28 is closed, the pressure generated from the left ventricle creates an upward load and attempts to push the mitral valve device 20 upward toward the atrium. This is one of the reasons why a reliable and appropriate fixing mechanism is needed to fix the mitral valve device 20 in place after the mitral valve device 20 is implanted. For example, during the constriction of the heart, the leaflet(s) 48 of the tissue close the valve lumen, so that blood is pumped into the aorta towards the aortic valve. On the other hand, the congenital leaflet(s) moves upward (inwardly) toward the outer surface of the valve body 28 and seals/closes the mitral valve to prevent PVL. The fixing feature(s) configured inside the mitral valve device 20 is connected to the congenital leaflet(s) and other internal cardiac structures to prevent the mitral valve device 20 from being pressed upward. During the diastolic phase, the tissue leaflet(s) 48 of the mitral valve device 20 is tilted with a relatively small profile so that blood flows and fills through the left ventricle. The tissue leaflet(s) 48 may be activated (open or closed) by the combined effect of blood flow, cardiac pressure, and periodic pulsation during a cardiac cycle.

In addition to the fixation effect of the fixation mechanism (annular support 24 and tab 30), the mitral valve device 20 by the pressure applied to the valve body 28 by the congenital leaflet(s) during ventricular systolic It may be prevented from moving upward toward the atrium by applying a fixed load to the mitral valve device 20. This is a dynamic fixation mechanism and acts only during ventricular systole and the mitral valve device 20, which is subjected to the highest lifting load at this stage, presses the mitral valve device 20 upwards towards the atrium. Due to the additional dynamic fixation effect, the proper position of the mitral valve device 20 is easily maintained, and the fixation load and duration acting on the congenital heart structure are reduced. Tissue growth/treatment over time causes congenital leaflet(s) to connect/fuse with the valve body 28.

16 to 22 show a third embodiment of the mitral valve device 20a according to the present invention. The mitral valve device 20a of FIGS. 16 to 22 also includes an atrial flange 22a, an annular support 24a and a neck section 26a connecting the atrial flange 22a with the annular support 24a. Includes. The valve body VB is formed by a ventricular portion formed by an atrial flange 22a, an annular support portion 24a, and a V-shaped tab 28a.

The atrial flange 22a is similar to the atrial flange 22 except that the atrial flange 22a has a relatively low profile. The rings of spaced and flipped tabs 34a form peaks and valleys for the atrial flange 22a, with no trauma and a round tip 35a located at each peak. A plurality of leaflet holders or posts 37a extend from the selected tip 35a and respectively support and fix a portion of the leaflet. Each post 37a may have a straight or curved shape.

The atrial flange 22a is located on or arranged on the innate annulus of the mitral valve, and a portion of the atrial flange 22a extends within the left atrium. See FIG. 20. The atrial flange 22a may have a surface area equal to or greater than that of the mitral annular body area. In use, the atrial flange 22a is covered with a biocompatible polymer fiber, tissue or other biocompatible material to provide a sealing effect around the mitral valve device 20a, promote tissue growth and accelerate the therapeutic effect.

The atrial flange 22a may have a circular profile or a profile other than a complete circle (eg, D-shaped or elliptical). When the atrial flange 22a has a circular profile, the diameter of the atrial portion may have a range of 12mm to 75mm. If the atrial flange 22a has a profile different from that of a complete circle, the long axis may have a range of 12 mm to 75 mm, and the short axis may have a range of 6 mm to 70 mm. In addition, the height H11 of the atrial flange 22a may have a range of 0.5mm to 30mm. The atrial flange 22a may be completely or partially covered by a fiber or tissue material or a combination of fiber and tissue materials.

The annulus support 24a acts as a fixation feature and interacts with the annulus, the congenital leaflet(s) and other internal cardiac structures or subplatelets to provide the desired fixation effect. In addition to the fixing effect provided by the annular support 24a, the mitral valve device 20a is automatically aligned during the cardiac cycle by the "clipping effect" formed by the atrial flange 22a and the anchor 29a below. Inhibits potential movement. While the mitral valve device 20a is released from the delivery system, the components of the mitral valve device 20a will be continuously released from the delivery system. For example, during the pass-through delivery process, the atrial flange 22a may first be deployed from the delivery system and then the annular support 24a may be deployed or vice versa. In contrast, during the femoral passage (transseptal) delivery process, the annular support 24a is deployed first, followed by the atrial flange 22a. The process may be performed by being guided from X-rays and/or TEE, ICE, and the like.

The neck 26a transitions outward from the atrial flange 22a along the radial direction with respect to the annular body support 24a including the ring of the anchor 29a. The neck 26a actually transitions radially outward with respect to the ring of the anchor 29a, and the anchor transitions inwardly along the radial direction into a V-shaped tab 28a extending into the ventricular part. It extends outwardly along the radial direction before transitioning. The number of anchors 29a is 1 to 20. The cross-sectional profile of the ring of the anchor 29a may be a completely circular or different (eg, elliptical or D-shaped) profile. When the ring of the anchor 29a has a complete circular profile, the diameter of the ring may range from 10mm to 75mm. When the ring of the anchor 29a has a profile different from that of the circular shape, the long axis may have a range of 10 mm to 75 mm, and the short axis may have a range of 5 mm to 70 mm. A circular clipping space is formed between the ring of the anchor 29a and the atrial flange 22a, and the clipping space has a height H14 (see Fig. 19) that can range from 0.5mm to 30mm. Each anchor 29a ends with a round tip 32a, and the tip presses or contacts the congenital leaflet(s) or annular body of the mitral valve region of the heart to fix the mitral valve device 20a to the annular body region, and the The tip acts as a fixed feature. Each anchor 29a may be completely or partially covered by tissue or fibers. Thus, the ring of the anchor 29a is larger than the diameter of the valve body VB and the neck 26a but may be smaller, equal to or even larger than the diameter of the atrial flange 22a.

A plurality of enclosed valve holders 36a may extend from the V-shaped tab 28a at the end of the ventricular portion. Although a certain number of holders 36a are shown, the mitral valve device 20a may have any number of holders including one or more holders 36a. As best shown in Figs. 16, 19 and 21, each holder 36a is connected to the tip 38a of the corresponding V-shaped tab 28a. The holders 36a are provided to perform the same function as the tail 36. The length of each holder 36a may have a range of 5mm to 25mm.

The height H12 of the ventricular portion may have a range of 2mm to 15mm. Accordingly, the height H13 of the combined valve body VB may have a range of 4 mm to 30 mm and preferably 8 mm to 20 mm. The cross-sectional profile of the ventricular portion may be a completely circular or different (eg, elliptical or D-shaped) profile. If the ventricular portion has a completely circular profile, the diameter of the profile may range from 10 mm to 75 mm. If the ventricular portion has a profile different from the circular shape, the constriction may have a range of 10 mm to 75 mm and the short axis may have a range of 5 mm to 70 mm. The ventricular portion can also have a variable profile along the height. For example, a portion of the ventricle portion at a position close to the annular body support 24a has an elliptical profile or a profile different from a complete circle, and a portion of the ventricular portion further away from the annular body support 24a Can have a completely circular profile. In addition, once implanted, the ventricular portion may be arranged only in the left ventricle, only in the left atrium, or may be arranged in both the left atrium and the left ventricle.

According to an important feature of the above embodiment, the length (ie, height H12) of the ventricular portion is reduced so that the mitral valve device 20a has a shorter profile than that of the conventional valve replacement device. The relatively short profile is advantageous because potential LVOT disturbances are minimized and cardiac output is more easily improved. In addition, the relatively short profile, first of all, minimizes interference with the heart structures and the papillary muscles inside the left ventricle, such as chordaes.

Due to the shortened profile, the tissue leaflet(s) are mainly arranged in the atrial flange 22a and above the atrial flange 22a (see Fig. 23), so that the posts 37a hold the upper portions of the leaflet(s). It is used to fix or connect. The leaflet(s) may also be integrally configured into the valve body VB within a completely circular portion or surrounding circular and non-circular portions. The valve body VB may be completely covered or partially covered by a fiber or tissue material, or a combination of a fiber and tissue material. For example, the inner surface of the valve body VB may be covered by fibers and the outer surface may be covered by tissue or vice versa. In use, the fibrous material and tissue may first be sewn or connected together or individually sewn or connected on the valve body VB. The valve body VB may be covered along one surface (ie, an inner surface or an outer surface) or may be covered along both surfaces (ie, an inner surface and an outer surface).

During the pass-through delivery process, the ventricular portion and the holder 36a can be pulled straight and inserted into the delivery system. When deployed, the annulus support 24a is either unfolded at the height of the congenital annulus or is deployed at a height below the congenital annulus, and between the atrial flange 22a and the anchor 29a, the congenital annulus and/or congenital It is connected with the innate plate structure through a clipping effect formed by clipping the phosphorus leaflet(s). See FIG. 20. In order to deploy the mitral valve device 20a, the atrial flange 22a is first deployed in the left atrium and then the ventricular part is deployed in the left ventricle (or vice versa) so that the mitral valve device 20a and its leaflet assembly are partially Or experience complete leaflet action. Next, the tabs 38a that do not have the holder 36a are released/unfolded so that the annular ring 24a can be held firmly in the position of the innate annular body. Finally, the mitral valve device 20a is adjusted to adjust the position of the device and then the tabs 38a with the holder 36a are released/unfolded. The staged deployment action provides more precise valve positioning and improves the fixation effect.

The mitral valve device 20a may be used for mitral valve replacement or aortic valve replacement. For mitral valve replacement, the leaflet(s) may be arranged below or above the congenital annulus or flush with the annulus. For aortic valve replacement, the leaflet(s) may be arranged above the congenital annulus or flush with the annulus.

When the mitral valve device 20a is fully deployed inside the heart at the location of the mitral valve, the leaflet(s) are mainly arranged above the congenital annular body location. See FIG. 23. The length of the valve body VB extending in the left ventricle can be reduced by a slightly higher leaflet position.

The main advantages/newness of the mitral valve device 20 according to the present invention are as follows.

(1) Congenital leaflets and other internal valves and subplatelets are preserved.

(2) The mitral valve device 20 treats heart reflux with functions and minimal interference/disability of the innate structures of the heart such as dry color, papillary muscle, left ventricle, LVOT, impact on the aortic valve, and the like.

(3) The design of the mitral valve device 20 takes into account the innate geometry and anatomical structure of the heart valve through minimal modifications to the congenital heart valve, the toroidal profile, the surrounding structure, and the subvalve structure. .

(4) The mitral valve device 20 has a design that automatically adapts to the congenital contours of the heart anatomy, and the sealing portion of the annular body can contact and expand like a normal congenital annular body.

(5) The profile of the mitral valve device 20 may be set to a shape other than a complete circle such as a "D" shape, a ")" shape, or an elliptical shape that matches the profile of the congenital annular body, and the annular body A portion of the mitral valve device 20 in contact with the mitral valve may have a “V”-shaped profile to mimic the anatomical structure of the congenital mitral valve.

(6) The fixation features for the mitral valve device 20 utilize congenital leaflets and other internal valve or subvalve structures.

(7) The mitral valve device 20 can automatically adjust the size/profile of the device to adapt to the size/volume of the left ventricle after implantation.

(8) The mitral valve device 20 has a variable profile to form a sealing effect during the ventricular contraction process, and also provides a fixation effect between the congenital leaflet(s) and maintains the position of the device during the ventricular contraction process. For example, the mitral valve device 20 may have a “transition region” between the atrial flange 22 and the valve body 28. The transition region may have a different profile from other parts of the mitral valve device 20. For example, the "transition region" may have an elliptical profile instead of a complete circular profile. There are major and short axes in the transition region, the long axis can be arranged in a direction along a "commisure to commisure" and the other axis is shorter than the long axis. The elliptical profile in the transition region can improve the sealing effect in the junction line regions. The transition area may include the neck 26 to increase the “sealed” surface area. Accordingly, a dynamic fixation effect is provided for the mitral valve device 20 and has an effect during the ventricular contraction process, and the uplifting load acting on the mitral valve device 20 at this stage is greatest.

(9) The mitral valve device 20 has a design that uses congenital leaflet(s) and dry color to provide a sealing effect and a fixation effect.

(10) The mitral valve device 20 may be surgically implanted or a minimally invasive process such as apex, transseptal, and femoral passage.

(11) By the tail 36a in the valve body 28, the surgeon can have enough time to adjust the valve position/angle for ideal valve performance during the deployment process.

(12) The inner shaft inside the delivery system can be designed and manufactured in such a way that the shaft can move during the valve development process. For example, during the delivery process, once most of the mitral valve device 20 is deconstrained/deployed from the delivery system, the leaflet(s) 48 on the mitral valve device 20 begin to actuate as the heart beats. At this time, the inner shaft of the delivery system is still located within the lumen of the mitral valve device 20 and may affect the movement of one of the leaflets on the mitral valve device 20. At this time, the inner shaft inside the delivery system is loosened and pulled distally rearward from the proximal handle end of the delivery system so that the inner shaft is not located within the lumen of the device. Therefore, all leaflet(s) 48 on the mitral valve device 20 can move freely. That is, when the tails 36a are still connected to the delivery system, the mitral valve device 20 can improve the valve function. In other words, the fact that the leaflet(s) 48 on the mitral valve device 20 operates during the deployment process allows the surgeon to have more time to adjust the position/angle of the valve for optimal performance.

In addition to the fixation mechanism, an adhesive bond/interface may be used to secure the mitral valve device 20 within the innate mitral valve position. For example, a biocompatible glue/adhesive is used to connect/fix the mitral valve device 20 to the mitral valve position. In use, all surfaces of the mitral valve device 20 in contact with all congenital mitral valve structures, such as the valve body 28, the outer surface of the atrial flange 22 or annulus, the congenital leaflet(s), cardiac muscles and others. A biocompatible glue/adhesive agent is applied along the outer surfaces of the mitral valve device 20 such as the atrium surface at the height of the valve and/or the subvalve, annular body, or the upper side, so that the position of the mitral valve device 20 can be maintained after implantation. have. Biologics are also added to biocompatible adhesives/glues to promote healing and tissue growth.

The adhesive/glue reacts quickly due to its nature and can instantly form a bond with the congenital mitral valve structure at the moment of contact with blood. It can also act by heat or temperature. Heat or temperature may be generated/controlled by electrode heating, FR heating or ultrasonic energy or magnetic energy or microwave energy or blood temperature itself or a chemical reaction through a part or the entire structure of the mitral valve device 20.

The adhesive/glue may react slowly due to its nature, and may form a bond with the congenital mitral valve structure after a certain period of time when in contact with blood. The time for forming the bond may vary from 1 second to 2 hours or from 1 second to 28 hours, and the like.

The adhesive/glue may also have a controlled reaction in nature and may be controlled when in contact with blood to form a bond with the innate mitral valve structure. Examples of the above concepts are:

It is to apply an upper layer (layers) of another biocompatible material to the adhesive/glue layer/material on the mitral valve device 20. The upper layer of the other biocompatible material can be separated or dissolved under energy, heating, chemical reaction, or mechanically or magnetically controlled, so that the adhesive/glue under the upper layer can effectively form a bond with the innate mitral valve structure. I can. As used herein, "controlled method" means that the time required to form a bond is between 1 second and 48 hours.

It should be understood that the above description describes specific embodiments in accordance with the present invention, and that a number of modifications may be constructed in accordance with the spirit of the present invention. The appended claims are intended to cover the above modifications that follow the scope and spirit of the present invention.

20......Mitral valve device,
22......atrial flange,
24......annular body support,
26......neck part,
28......Valve body.

Claims (11)

A mitral valve replacement device configured to be deployed at a position of a mitral valve in a human heart, wherein the mitral valve replacement device is
An atrial flange forming an atrial end of the device,
A ventricular portion forming a ventricular end of the device,
An annular body support portion arranged between the atrial flange and the ventricle portion, the annular body support portion includes a ring of anchors extending radially from the annular body support portion, and an annular clipping between the atrial flange and the ring of the anchor Space is formed,
Including a plurality of leaflet holders located at the atrial end of the atrial flange,
A plurality of valve leaflets fixed to the leaflet holders and arranged in the atrial flange on the congenital annulus,
The atrial flange includes a ring of spaced and inverted V-shaped tabs forming a peak and a valley for the atrial flange, and a round tip is positioned at each peak, and each tab is radially outward to the bend. And wherein the tab is bent in a longitudinal direction of the device toward an atrial end and then extends radially inward. The mitral valve replacement device of claim 1, further comprising at least one tail extending from a ventricular end of the ventricular portion. The mitral valve replacement device of claim 1, further comprising a neck positioned between the atrial flange and the annular body support. The mitral valve replacement apparatus according to claim 1, wherein at least a portion of at least one of the atrial flange, annular body support and ventricular portion is covered by tissue. The mitral valve replacement device according to claim 1, wherein at least a portion of at least one of the atrial flange, the annular body support and the ventricular portion is covered with fibers. The mitral valve replacement device according to claim 1, wherein at least a portion of at least one of the atrial flange, the annular body support, and the ventricular portion is covered by tissues and fibers. 7. The mitral valve replacement device of claim 6, wherein at least a portion of at least one of the atrial flange, annular support and ventricular portion is covered by a layer made from a combination of fibers and tissues. The mitral valve replacement apparatus according to claim 1, wherein at least a portion of at least one of the atrial flange, annular support and ventricular portion is coated with a biocompatible adhesive. The mitral valve replacement device of claim 1, wherein the ventricular portion has a height ranging from 2 mm to 15 mm. delete delete

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