JP2019193874A - Device and method for mitral valve regurgitation treatment - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a mitral valve replacement device which can be effectively fixed at a position of a mitral valve annulus of a person without piercing natural tissue. A mitral valve replacement device (20a) is adapted to be deployed at the position of the mitral valve in the human heart. The device is disposed between an atrial ridge 22a defining the atrial end of the device, a ventricular portion having a height in the range of 2 mm to 15 mm defining the ventricular end of the device, and between the atrial ridge and the ventricular portion. It has an annulus support 24a. The annulus support includes an annulus of anchors 29a extending radially from the annulus support, with an annular clipping space defined between the atrial ridge and the annulus of the anchor. A plurality of leaflet retainers are located at the atrial end of the atrial ridge and a plurality of leaflets are secured to the leaflet retainer and are located inside the atrial ridge at a position above the native annulus. . [Selection diagram] Fig. 16

Description

RELATED APPLICATIONS This application is a provisional application of US Provisional Application No. 62 / 024,097 filed July 14, 2014
, US provisional application 61 / 927,490 filed January 15, 2014, and US provisional application 61 / 887,343 filed October 5, 2013 is there. This application is filed on US patent application Ser. No. 14/279, filed May 16, 2014,
No. 511, which is a continuation-in-part application, the entire disclosure of which is hereby incorporated by reference as if fully set forth herein.
TECHNICAL FIELD The present invention relates generally to medical devices and methods useful for the repair 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 regurgitation by replacing the function of the native heart valve.

The human heart has four chambers and four valves. The heart valve controls the direction of blood flow. A fully functioning heart valve ensures that proper blood circulation is maintained during the cardiac cycle. Heart valve regurgitation or leakage is caused by a disease in the valve leaflet, such as congenital rupture of the chordae, extension of the chordae, enlarged left ventricle, damaged papillary muscle, valve structure damaged by infection, degenerative process, valve leaflet Calcification,
Occurs when the annulus does not completely contact (join) due to the extension of the annulus and increased papillary muscle distance.

Whatever the cause, reflux disease prevents the heart from functioning because it allows blood to flow back through the valve in the wrong direction. Depending on the degree of reflux disease, this reflux can have a self-destructive effect not only on heart function but also on heart shape. Alternatively, an abnormal heart shape can also cause reflux disease, and these two processes can “cooperate” to speed up abnormal heart function. The direct result of cardiac reflux is a decrease in anterior cardiac output. Depending on the severity of the leak, the effectiveness of the heart to deliver proper blood flow to other parts of the body can be compromised.

The mitral valve is a bilobal (bicuspid) that lies between the left atrium (LA) and the left ventricle (LV) in the heart
It is a valve. During diastole, a normally functioning mitral valve opens as a result of increased pressure (preload) from the left atrium when the left atrium inflates with blood. When the left atrial pressure becomes higher than the left ventricular pressure, the mitral valve opens, facilitating passive flow of blood into the left ventricle. The diastole ends with an atrial contraction that drains the rest of the blood, which travels from the left atrium to the left ventricle. The mitral valve closes at the end of the atrial contraction to prevent retrograde blood flow from the left ventricle to the left atrium. A human mitral valve typically has an open area of 4-6 cm ² . There are two leaflets, an anterior leaflet and a posterior leaflet,
These cover the opening of the mitral valve. The opening of the mitral valve is surrounded by an annulus called a mitral valve annulus. Two leaflets are mounted on the circumference of the mitral valve annulus and can be opened and closed by hinges from this annulus during the cardiac cycle. In a normally functioning mitral valve, the leaflet is connected to the papillary muscle in the left ventricle by a chord. When the left ventricle contracts, intraventricular pressure causes the mitral valve to close, while the chords hold the junction of the two leaflets (the two leaflets escape into the left atrium and cause mitral regurgitation) And prevent the mitral valve from opening in the wrong direction (thus preventing blood from flowing back into the left atrium).

Currently, standard cardiac regurgitation treatment options include surgical repair / treatment and endovascular clipping. Standard surgical repair or replacement procedures require open heart surgery, use of cardiopulmonary bypass and cardiac arrest. Due to the invasive nature of surgical procedures, death risks, stroke, bleeding, dyspnea, kidney damage and other complications are so prominent that many patients are excluded from surgical procedures.

In recent years, endovascular clipping techniques have been developed by several device companies. In this method, an implantable clip made of a biocompatible material is used in the heart valve.
Inserted between two leaflets to clip the central part of the two leaflets (mainly A2 and P2 leaflets) together to prevent leaflet prolapse. However, some drawbacks such as positioning difficulties, removal when mis-implanted, recurrence of heart valve reflux disease, the need for multiple clips for one procedure, strict patient selection, etc. It became clear in the actual application of endovascular clipping.

In conclusion, there is a great need to develop new medical devices for treating mitral regurgitation. None of the medical devices that exist so far address this need adequately. The present invention is for the treatment of mitral regurgitation that provides a medical device that can avoid traumatic surgical procedures and can instead be implanted by catheter-based, less invasive procedures. It is an object of the present invention to provide doctors with devices and methods.

It is an object of the present invention to provide a mitral valve replacement device that can be effectively secured to the position of a human mitral valve annulus without puncturing the native tissue.

Another object of the present invention is a method of deploying a mitral valve replacement device at the position of a person's mitral valve annulus, wherein the position of the device is adjusted before the final opening of the device is completed. Is to provide a way to do this.

Yet another object of the present invention is to provide a novel leaflet structure that provides more efficient valve control and flow.

To achieve the objects of the present invention, the present invention provides a mitral valve replacement device adapted to be placed at the position of a mitral valve in a human heart. The device includes an atrial apex that defines the atrial end of the device and a ventricular portion that defines the ventricular end of the device and is 2 mm to 15 mm
A ventricular portion having a height in the range of, and an annulus support located between the atrial ridge and the ventricular portion;
Have The annulus support includes a ring of anchors extending radially from the annulus support, and an annular clip space is defined between the atrial ridge and the anchor ring. The device further includes a plurality of leaflet holders positioned at the atrial end of the atrial ridge, and a plurality of leaflet holders fixed to the valve leaflet holder and disposed inside the atrial ridge at a position above the native annulus. And a leaflet of the same.

1 is a perspective view of a mitral valve device according to a first embodiment of the present invention. FIG. FIG. 2 is a bottom view of the device of FIG. 1. FIG. 2 is a top view of the device of FIG. FIG. 2 is a side view of the device of FIG. FIG. 5 is another side view of the device of FIG. 1 rotated 90 degrees from the side view of FIG. FIG. 2 shows the device of FIG. 1 positioned on the mitral valve annulus of a human heart. FIG. 2 shows a two-dimensional flat configuration of the device of FIG. 1 after being laser cut from a metal or polymer tube. 6B is a three-dimensional perspective view of the laser cut pattern device shown in FIG. 6A before forming the final shape shown in FIG. The final shaped device can be integrated with a tissue leaflet and skirt, can be compressed to a smaller profile, and can be mounted within a delivery system. FIG. 2 is a top view of an assembled mitral valve replacement device including a leaflet incorporated into the device of FIG. 1 with the leaflet in an open position. FIG. 7B is a bottom view of the assembled mitral valve replacement device of FIG. 7A with the leaflets in an open position. FIG. 2 is a top view of an assembled mitral valve replacement device including a leaflet incorporated into the device of FIG. 1 with the leaflet in a closed position. FIG. 8B is a bottom view of the assembled mitral valve replacement device of FIG. 8A with the leaflets in a closed position. FIG. 7B is a perspective view of the leaflet assembly of FIG. 7A when the leaflets are open and the mitral valve is closed. FIG. 7B is a perspective view of the valve leaflet assembly of FIG. 7A when the valve leaflets are closed and the mitral valve is opened. FIG. 7B is a top view of the leaflet assembly of FIG. 7A when the leaflets are open and the mitral valve is closed. FIG. 7B is a bottom view of the leaflet assembly of FIG. 7A when the leaflets are open and the mitral valve is closed. FIG. 7B is a top view of the valve leaflet assembly of FIG. 7A when the valve leaflets are closed and the mitral valve is opened. FIG. 6 is a perspective view of a mitral valve device according to a second embodiment of the present invention. FIG. 13 is a side view of the device of FIG. 12. FIG. 14 is another side view of the device of FIG. 12 rotated 90 degrees from the side view of FIG. 13. FIG. 13 shows the device of FIG. 12 positioned on the mitral valve annulus of a human heart. FIG. 6 is a perspective view of a mitral valve device according to a third embodiment of the present invention. FIG. 17 is a bottom view of the device of FIG. 16. FIG. 17 is a top view of the device of FIG. FIG. 17 is a side view of the device of FIG. FIG. 17 shows the device of FIG. 16 positioned on the mitral valve annulus of a human heart. FIG. 17 shows a two-dimensional flat configuration of the device of FIG. 16 after being laser cut from a metal or polymer tube. FIG. 22 is a three-dimensional perspective view of the laser cut pattern device shown in FIG. 21 before forming the final shape shown in FIG. 16. The final shaped device can be integrated with a tissue leaflet and skirt, can be compressed to a smaller profile, and can be mounted within a delivery system. FIG. 17 shows the position of the leaflets of the device of FIG. 16 within the patient's left atrium.

The following detailed description relates to the best mode currently contemplated for carrying out the present invention. This description should not be construed in a limiting sense, but merely as an illustration of the general principles of embodiments of the invention. The scope of the invention is best defined by the appended claims.

The subject technology generally relates to a mitral regurgitation device and to the manner in which the device is positioned and secured within a human heart. The device includes an atrial portion and a ventricular portion. The atrial portion of the device is “placed” in the area of the mitral valve annulus and forms a “seal” to prevent leakage from the area surrounding the device (backflow of blood from the left ventricle to the left atrium) . The ventricular portion of the device includes a valve body and an immobilization element. The anchoring element can be partially or wholly covered by the fabric or tissue to form a “seal” that prevents leakage. The valve body includes a tissue leaflet and a leaflet support structure. During the normal cardiac cycle, the valves and leaflets open and close to control the direction and amount of blood flow between the left atrium and the left ventricle.
The function of the immobilization element is to maintain the proper position of the device to prevent potential movement during the cardiac cycle. The fixation element provides a fixation effect by interacting with the native leaflets and / or annulus and / or other subvalvular structures. One structure of the anchoring element is to use a biocompatible adhesive / glue to form a bond between the device and the native valve and / or heart structure to maintain the position of the prosthetic valve. is there.

In use, the device is delivered to the mitral valve space using transcatheterization,
Interact with the internal and subvalve structures to restore mitral valve function. In addition, the device can be implanted surgically or by other minimally invasive procedures. The device can be implanted inside the lumen of the heart or human vasculature, which improves, replaces and / or reconstructs the function of the native mitral valve leaflet and mitral valve To help.

The present invention also includes an anchoring element (clip structure) that utilizes the native leaflets and / or annulus and / or other sub-annular structures to secure the device in place during the cardiac cycle. Provide effect. When the device is placed in the position of the mitral valve, the anchoring element on the device engages / interacts with the native leaflets and / or annulus and / or other subvalvular structures. Prevent the device from moving during the cardiac cycle. The atrial portion of the device can provide some additional fixation effect by interacting with the annulus of the heart over the annulus and the annulus that is in contact with the atrial portion of the device.

The present invention further provides a novel leaflet structure. The leaflet three-dimensional structure can include 1 to 6 leaflets, which are bound inside the leaflet support structure to form an umbrella-shaped outer shape that can be opened and closed during the cardiac cycle. Can control blood flow. During cardiac contraction (heart contraction), the umbrella-shaped leaflets open to a larger profile and can close the mitral valve so that there is no blood flow back from the left ventricle to the left atrium. During diastole (heart relaxation), the umbrella-shaped leaflet closes to a smaller profile and can open the mitral valve so that blood can flow from the left atrium to the left ventricle. The advantages of this novel leaflet structure include: (i) There is no axial contraction / restriction of the leaflet support structure by the leaflet during the cardiac cycle, thereby reducing the fatigue resistance of the support structure. Improved, (ii) a better joint of the leaflets between the leaflets and the skirt on the support structure minimizes the possibility of central leakage, and (iii) the middle of the leaflets “There is no free end” in the part. There is no joint between the leaflets. This feature is important.
This is because any deformation or twisting of the valve support structure will result in minimal central leakage.

The mitral valve replacement device of the present invention is compressed into a small profile and placed on a delivery system, and then brought to a target location by use of a delivery catheter with a non-invasive medical procedure, such as a transapical or transfemoral or transseptal procedure. Can be delivered. The mitral valve replacement device comprises a self-expandable support structure that arrives at the target implant location, either by inflation of the balloon (in the case of a balloon expandable support structure) or stored in the device When the elastic energy (in the case of a device) is ready to expand to its normal (expanded) profile, it can be released from the delivery system.

The leaflet of the mitral valve replacement device of the present invention is a thin biocompatible metal element (for example, stainless steel, Co—Cr alloy, nitinol, Ta, Ti, etc.) from processed animal tissue / pericardium.
Or from biocompatible polymeric materials such as polyisoprene, polybutadiene and copolymers thereof, neoprene and nitrile rubber, polyurethane elastomer, silicone rubber, fluoroelastomer and fluorosilicone rubber, polyester and PTFE, and the like. The leaflets are given drugs or biological agents,
Performance can be improved, thrombus formation can be prevented, and endothelialization can also be promoted. The leaflets of the mitral valve device can be treated with or applied with a surface layer / coating to prevent calcification. If desired, the cover of the valve body and leaflet support structure can be a combined layer of fabric and tissue. For example, the upper part of the cover can be made from fabric, while the lower part can be made from tissue, or vice versa. The atrial portion of the device and the body of the leaflet support structure can be completely or partially covered with fabric or tissue to provide improved sealing and healing effects. Immobilization elements provided on the device are completely or partially covered with fabric or tissue to promote tissue growth, prevent peri-valvular leakage (PVL), and potential to the surrounding heart internal structures Damage can be reduced.

The leaflets can be integrated into the leaflet support structure by mechanical interweaving, stitching, and chemical, physical or adhesive bonding methods. The leaflets can also be formed from elements of the support structure. For example, the leaflet support structure and the leaflet can be molded and formed directly from a polymeric material or a metallic material together. The leaflets can also be formed by vapor deposition, sputtering, reflow, chemical bath, molding, extrusion processes or other mechanisms for bonding two or more materials together.

Tissue leaflets can also be coated with drugs or other biological agents to prevent thrombus formation in the heart. An anti-calcification material is coated or applied on the surface,
It can also prevent calcification.

1-5 show a first embodiment of a mitral valve device 20 according to the present invention. Device 20
Are the atrial ridge 22, the annulus support 24, and the neck 2 connecting the atrial ridge 22 to the annulus support 24.
6 and a valve body 28 that functions as a leaflet support structure. Each of these elements is defined by a strut, which defines a cell, which then constitutes a cellular matrix.

The atrial ridge 22, the annulus support 24 and the valve body 28 are either Nitinol superelastic material or stainless steel, Co-Cr based alloy, titanium and its alloys and other balloon inflatable biocompatible materials. Can be made from. Other polymeric biocompatible materials can also be used to fabricate these elements of device 20. In use, device 20 can be folded or compressed into a delivery system and delivered to the position of the mitral valve by transcatheter delivery (eg, transfemoral or transseptal). Upon reaching the mitral valve location, the device 20 can be released from the delivery system and placed in the mitral valve annulus area. The atrial ridge 22 can be placed at or above the natural annulus of the mitral valve, with a portion of the atrial ridge 22 extending into the left atrium. See FIG. 5B.
The atrial protrusion 22 has a surface area equal to or greater than the mitral valve annulus area. In use, the atrial ridge 22 is covered with a biocompatible polymer fabric, tissue or other biocompatible material to provide a sealing effect around the device 20 and promote tissue growth and accelerate healing. be able to.

The annulus support 24 functions as an immobilization element and can interact with the annulus, native leaflets and other internal heart structures, subvalvular structures to provide the desired fixation results. See FIG. 5B. In addition to the locking effect provided by the annulus support 24, the atrial ridge 22 and the annulus support 24
The “clip effect” formed by the device 20 also self-adjusts the position,
It can also help resist potential movements during the cardiac cycle. As the device 20 is released from the delivery system, the elements of the device 20 will be released in turn from the delivery system. For example, during transapical delivery, the atrial ridge 22 is first deployed from the delivery system and then the annulus support 24 is deployed. In contrast, during transfemoral (transseptal) delivery, the annulus support 24 is first deployed and then the atrial ridge 22 is deployed. These procedures can be performed according to guidance by X-ray, TEE, ICE, etc.

4 and 5A show typical size or shape ranges for each element of the device 20. The atrial ridge 22 can have a circular profile or a profile that is different from a perfect circle. When the atrial protrusion 22 has a circular outer shape, the diameter of the atrial portion is 20 mm to 7 mm.
It can be in the range of 0 mm. If the atrial ridge 22 has an outer shape different from a perfect circle, its major axis can range from 20 to 70 mm and its minor axis can range from 15 to 65 mm. Further, the height H1 of the atrial ridge 22 can be in the range of 0.5 mm to 20 mm. At the upper atrial end of the atrial ridge 22, each cell defining the atrial ridge 22 has a top and a trough, with a rounded atraumatic end 34 at each top.

The angle Θ1 of the atrial ridge 22 with respect to the axis of the valve body 28 can range from 0 to 150 degrees. The atrial ridge 22 can be completely or partially covered by a woven or tissue material, or a combination of tissue and woven material. The atrial ridge 22 can have hooked hairs or spikes on the side facing the atrium floor to help engage the atrial tissue and / or annulus. The valve body 28 may have a height H3 that is in the range of 2 mm to 30 mm. The end of the valve body 28 closer to the atrium side can extend higher than the atrial ridge 22 and reduce the length of the valve body 28 inside the ventricle. Valve body 2
The cross-sectional shape of 8 can be a complete circle or an outer shape different from the circular shape. If the valve body 28 has a complete circular profile, its diameter can range from 15 mm to 50 mm. When the valve body 28 has an outer shape different from a circular shape, the major axis is 1
The short axis can be in the range of 10 mm to 45 mm. The valve body 28 can also have an outer shape that varies along its height. For example, the portion of the valve body 28 near the atrial ridge 22 can have an oval profile or some other profile that is different from a full circle. On the other hand, the portion of the valve body 28 that is remote from the atrial ridge 22 can have a full circular profile. The tissue leaflet can be fully integrated within the circular portion of the valve body 28, or it can be integrated including both its circular and non-circular portions.

The valve body 28 can be completely or partially covered by a woven or tissue material or a combination of tissue and woven material. For example, the upper portion of the valve body 28 can be covered with a fabric, and the lower portion of the valve body 28 can be covered with tissue, or vice versa. In use, the woven material and tissue can be first sutured / bonded together to the valve body 28 or can be individually sutured / bonded. The valve body 28 can be covered on one surface (ie, the inner or outer surface) or both surfaces (ie, the inner and outer surfaces). At the bottom end of the valve body 28, each cell defining the valve body 28 has a top and a trough, and each bottom has a rounded atraumatic end 38.

An optional, smaller diameter neck 26 provides a transition from the atrial cusp 22 to the annulus support 24. When device 20 is in the deployed three-dimensional configuration, neck 26 is at the atrial ridge 2.
Extending radially inwardly from 2 forms a U-shaped neck 26. The cross-sectional shape of the neck 26 can be a complete circle or a shape different from the circle. Neck 2
If 6 has a perfect circular profile, its diameter can range from 15 mm to 50 mm. When the neck 26 has an outer shape different from a circle, the long axis is 15 mm to
The short axis can be in the range of 10 mm to 45 mm.

The neck 26 then transitions radially outward to the annulus support 24 and the annulus support 2
4 is a U-shaped section 2 that alternates with a ring of inverted V-shaped tabs 30 spaced apart.
Includes 9 rings. The neck 26 actually transitions radially outwards into a ring of U-shaped sections 29 that extend radially outward and then extend radially inward. Then, the process proceeds to the valve body 28. The tab 30 extends radially outward from the valve body 28 and thus defines a ring having a vertically upward bend and surrounding the neck 26. The number of tabs 30 is in the range of 1-20. The profile of the cross section of the ring of the tab 30 can be a perfect circle or a different profile than the circle. If the ring of tabs 30 has a perfect circular profile, its diameter can range from 15 mm to 70 mm. If the ring of tabs 30 has an outer shape different from a circle, its major axis can range from 15 mm to 70 mm and its minor axis can range from 10 mm to 65 mm.

The inverted V-shaped connection point of tab 30 is an enlarged point 32 whose function is to contact or press against the annulus or native leaflet of the mitral valve site of the heart in the annulus area. 20 is fixed, that is, functions as an immobilizing element. Each tab 30 is 0
. It has a height H4 in the range of 5 mm to 10 mm. The tab 30 can be completely or partially covered by tissue or fabric. For example, the enlarged point 32 can be exposed from the fabric / tissue, while the rest of the annulus support 24 can be covered by the fabric / tissue. The use of a fabric can promote tissue growth and provide better anchoring of the device 20 in the annulus, and additionally provide an additional sealing effect that prevents peri-valve leakage (PVL).

Thus, the ring of U-shaped section 29 has a diameter that is larger than the diameter of valve body 28 and neck 26 but smaller than the diameter of atrial ridge 22. Similarly, the ring of tabs 30 has a diameter that is larger than the diameter of the valve body 28 and neck 26 but smaller than the diameter of the atrial ridge 22. The tabs 30 and the U-shaped sections 29 can be arranged alternately in the same rough ring and can have substantially the same diameter as each other.

Two U-shaped tails 36 can extend from the valve body 28 at the end of the valve body 28. Although only two tails 36 are shown, only one tail 36 or more than three tails 3
It is also possible to provide a device 20 with 6. As best shown in FIG. 5A, each tail 36 is formed by extending from two bottom tips 38 of the valve body 28 and is connected to form a U-shaped bottom with a suture or Other threads can be used so that they can be tethered therewith, so that the suture or thread can be used to adjust the position of the device 20 while the device 20 is deployed. Can be done.
The tail 36 is also connected to several elements in the delivery system, (1) mounting the valve (ie, mounting the valve in the sheath of the delivery system) and (2) at the annulus region of the heart. It can also assist in aligning the valves. With regard to valve alignment, the tail 36 assists in adjusting the position and / or angle of the device 20 before the device 20 is finally released from the delivery system during deployment.

Another advantage of having a tail 36 is that the device 20 usually already begins to function (partially or fully) before the device 20 is fully deployed and released from the delivery system. This provides more time for the physician to adjust the position of the device 20 and hang it there before it is finally detached from the delivery system. The length of each tail 36 can range from 5 mm to 25 mm. The tail 36 can be shaped into a shape of bend so that the tail 36 can extend outside the circular profile defined by the valve body 28 if desired. For example, the tail 36 can be suspended from the distal end of the valve body 28 and bent inward toward the lumen of the valve body 28.

Referring to FIG. 5B, when the device 20 is deployed for use at the location of the native mitral valve site, the tab 30 is deployed and “stood” at / on the annulus. Ridge 22
Part of it extends inside the left atrium. This interaction of the atrial ridge 22 (from above) and the tab 30 (from below) provides a “clip effect”, which is effective to secure the device 20 in the desired position. When the device 20 is deployed, the U-shaped section 29 can be placed immediately below the annulus to provide an additional sealing effect. The strut / cell space within the atrium can be completely or partially covered or uncovered by the fabric and / or tissue. By deploying a partially or completely uncovered handed atrial ridge 22 inside the atrium, obstruction to forward blood flow can be minimized. The tissue leaflet 48 of the device 20 is integrated into the valve body 28 to replace the function of the native mitral valve leaflet. As shown in FIGS. 7A and 7B, the native leaflet is located on the outer surface adjacent to the valve body 28.

6A and 6B show a typical laser cut form of the device 20. Device 20 can be laser cut from a metal or polymer tube to the form shown in FIG. 6A. The cut structure is then subjected to the steps of shape setting, microblasting and electropolishing, as shown in FIGS. 1-5B, to obtain the desired outer shape / shape. The width of each strut 50 can range from 0.2 mm to 1.5 mm, and the thickness of each strut 50 can range from 0.2 mm to 0.75 mm. The length of each cell can range from 2 mm to 20 mm. The number of rings along the length of the device 20 can range from 2-20. The number of cells along the outer periphery of device 20 is 2 to
It can be in the range of 20. As an option, the device 20 can be made from a flat sheet and then rolled into the desired shape.

Device 20 can be delivered by more than one delivery method. For example, transapical delivery can be used, in which case the atrial apex 22 can be deployed first and transapical delivery can provide tactile feedback during the delivery procedure. The annulus support 24 (ie, tab 30) is finally opened and deployed to complete the implant of device 20. During transfemoral / transseptal delivery, tab 30 may be first deployed to provide haptic feedback during the delivery procedure. The atrial ridge 22 is finally opened and deployed to complete the implant of the device 20. During delivery, the tab 30 can be bent inward (upwardly inward or downwardly inward) toward the valve body 28. When tab 30 is opened / deployed, it can expand and press itself against the annulus or native leaflet.

In use, the device 20 can be compressed to a smaller profile for easy delivery and delivered and deployed once it reaches the target implant site. The outer shape of the compressed device can be less than 48 Fr (15.8 mm), and 15 F
r-40Fr (5.0 mm to 13.2 mm) is a typical range for such applications.

FIG. 7A shows a top view of the assembled mitral valve replacement device, which includes the leaflets 48 incorporated into the mitral valve device 20 as described above. FIG. 7B shows a bottom view of the assembly of FIG. 7A. FIGS. 7A and 7B show the leaflet 48 in an open position such that blood flow from the left ventricle to the left atrium is prevented. The junction area is between the leaflet 48 and the skirt, which is defined by the device 20 along the lumen of the device 20 within the valve body 28. Similarly, FIGS. 8A and 8B are top and bottom views, respectively, of the assembled mitral valve device of FIGS. 7A and 7B, which are closed to allow blood to flow from the left atrium to the left ventricle. The leaflet 48 is shown in the raised position. 7A-8B and similarly FIGS. 9A-1
As best shown in FIG. 1, the present invention further provides a novel leaflet conformation. Valve leaflet 4
8 is a three-dimensional structure that is essentially the opposite of the three-dimensional structure of the native valve leaflet so that the valve leaflet 48 opens inward and expands outward to contact the inner surface of the valve body 28. Have.
The leaflets 48 are attached to the device 20 in a manner that allows the leaflets to close freely inward to allow forward blood flow through the valve device. The height (depth) of the tissue leaflet can vary from 2 to 30 mm depending on the anatomical size of the heart.

The structure of the leaflets is best shown in FIGS. 7A-11, and this embodiment includes three longitudinal sutures, ie three sutures stitched together along suture lines 72, 74 and 76. Valve leaflet 4
The use of 8A, 48B and 48C is shown. The suture lines 72, 74, 76 are connected to the leaflets 48A, 48.
Extending along the outer ends of B and 48C, the leaflet structure forms a bond line that is attached to the valve body 28. The leaflets 48A, 48B, and 48C are stitched to the struts 50 that make up the valve body 28 along their ends. At the upper (atrial) end of the leaflets 48A, 48B and 48C, radial sutures, ie, suture lines 82, 84 and 86, are directed from the longitudinal suture lines 72, 74 and 76 to the center point 88, respectively. A flat tip 60 is disposed at the center point 88. Three internal sutures, namely suture lines 52, 54 and 56
Is formed from the apex 58 and the atrial ends of the leaflets 48A, 48B, 48C are crimped together so that the starting points of the sutures 52, 54, 56 are offset from the sutures 82, 84, 86. A flat tip 60 is formed. Each suture line 52, 54, 56 extends a short distance toward the suture lines 72, 74, and 76, respectively, and fuses with the suture lines 72, 74, and 76, respectively. This arrangement of stitches, ie suture lines, allows the three leaflets 48A, 48A and 48C to form an umbrella-shaped three-dimensional structure because of their valve structure, in which the leaflets 4
8A, 48B, 48C do not open all the way to the upper (atrial) end sutures 82, 84, 86 even under ventricular pressure, preventing the leaflets from turning over and minimizing leakage. Valve leaflets 48A, 4
Domed ceiling defined by 8B, 48C and suture line 82, 84, 8 at the upper (atrial) end
The distance between 6 is 0.25 mm to 10 mm. The leaflet structure inside the device 20 is
It can be created using multiple leaflets 48 (as shown and described above) or a single leaflet 48. In the case of a single leaflet, the single leaflet 48 can be folded and stitched into the shape shown in FIGS.

Thus, the novel leaflet structure of the present invention controls blood flow between the left atrium and the left ventricle using the reverse leaflet motion. This reverse or “umbrella-like” or “balloon-like” leaflet structure provides a better sealing / joining action and typically acts on a valve body 28 using a conventional leaflet structure. The fatigue performance of the valve body 28 is improved by eliminating shrinkage / throttling force / deformation.

FIGS. 12-14 illustrate a second embodiment of a mitral valve device 20 according to the present invention, which includes the addition of a clip 80. The device 20 of FIGS. 12-14 also has an atrial ridge 22, an annulus support 24, a neck 26 and a valve body 28 that connects the annulus support 24 to the atrial ridge 22, and the valve body. 28 functions as a leaflet support structure. All of these can be the same as the corresponding elements in FIGS. Each of these elements is also defined by a strut, which defines a cell, which in turn constitutes a cellular matrix.

The difference between the above two embodiments is the addition of a ring of clip 80, which is the position of the valve body 28 in a vertically spaced position below the annulus support 24. Provided in a style that is spaced around. These clips 80 are each clip 80
Extends vertically from any of the struts of the valve body 28, then extends radially horizontally,
Finally, it is somewhat L-shaped in that the tip can end with a short bend. Clip 80 functions to clip or retain a portion of the native leaflet after device 20 is deployed, as best shown in FIG. This clip feature helps secure device 20 to the annulus area of the mitral valve area. Although the clipping effect provided by the atrial ridge 22 and tab 30 works here as well, the clip 80 provides improved fixation. The height H2 defines the total height of the neck 26 and the annulus support 24 and can also be varied to include the clip 80, from 0 mm to
It can be in the range of 10 mm.

When device 20 is implanted, atrial ridge 22, valve body 28, and device 2
A locking mechanism (e.g., by the atrial prosthesis and the tab 30) that is built into the zero or created by the interaction of the device 20 with the native leaflets and other internal heart structures (or other subvalvular structures) The clipping effect, the addition of the clip 80) will keep the device 20 in the desired position. During ventricular systole, when the valve formed by valve leaflet 48 and valve body 28 closes, the pressure from the left ventricle creates lift and tends to push device 20 toward the atrium. This is the device 2 after device 20 is implanted.
This is one of the reasons why a reliable and proper locking mechanism is required to keep 0 in place. For example, the tissue leaflet 48 will close the valve lumen so that blood is pumped toward the aortic valve leading to the aorta during cardiac contraction. Meanwhile, the native leaflets are lifted (inward) toward the outer surface of the valve body 28 (enveloping the valve body 28) and try to seal / close the mitral valve to prevent PVL. Immobilization elements incorporated into device 20 can engage the native leaflets and other internal heart structures to prevent device 20 from being pushed up.
During cardiac relaxation, the tissue leaflet 48 of the device 20 will deform to a smaller profile, allowing blood to flow through it and fill the left ventricle. During the cardiac cycle, the tissue leaflet 48
Actuated by the combined effects of blood flow, cardiac pressure and periodic pulsatile movement of the support structure (
Open and close).

In addition to the locking effect of the locking mechanism (annular support 24 and tab 30), the pressure applied to the valve body 28 by the native leaflet during ventricular systole also applies a clamping force to the device 20, It can help to prevent 20 from being lifted towards the atria. This is a dynamic fixation mechanism, which only appears to be effective during the ventricular systole, at which stage the device 20 is under maximum lift that attempts to push the device 20 in the atrial direction. This additional dynamic locking effect helps maintain the proper position of device 20,
Reduce the fixation forces and their duration that affect the anatomy of the native heart. Over time, tissue growth / healing will couple / fuse the native leaflets to the valve body 28.

16-22 illustrate a third embodiment of a mitral valve device 20a according to the present invention. The device 20a of FIGS. 16-22 also includes an atrial ridge 22a, an annulus support 24a, and a neck segment 26a that connects the atrial ridge 22a to the annulus support 24a.
The valve body VB is here defined by an atrial ridge 22a, annulus support 24a and a ventricular portion, which is defined by a V-shaped tab 28a.

The atrial protrusion 22a is similar to the atrial protrusion 22 except that the atrial protrusion 22a may have a lower profile. The spaced ring of inverted V-shaped tabs 34a defines the apex and troughs for the atrial ridge 22a, with rounded atraumatic ends 35a at each end of the tabs 34a. Have. A plurality of leaflet holders or posts 37a are selected at the selected end 35a.
Each of which functions to support and hold a portion of the leaflet. Each post 37
a can be straight or curved.

The atrial ridge 22a is placed at or on the natural annulus of the mitral valve, and the atrial ridge 2
A part of 2a can extend into the left atrium. See FIG. Atrial ridge 2
2a has a surface area equal to or greater than the mitral valve annulus area. In use, the atrial ridge 22a is covered with a biocompatible polymer fabric, tissue or other biocompatible material to provide a sealing effect around the outside of the device 20a, promote tissue growth,
The healing result can be accelerated.

The atrial ridge 22a may have a circular outline or an outline different from a perfect circle (ie, D
Shape or oval). When the atrial protrusion 22a has a circular outer shape, the diameter of the atrial part can be in the range of 12 mm to 75 mm. Atrial protrusion 22a
Can have an outer shape different from a perfect circle, its major axis can range from 12 to 75 mm and its minor axis can range from 6 to 70 mm. Further, the height H11 of the atrial protrusion 22a can be in the range of 0.5 mm to 30 mm. The atrial ridge 22a can be completely or partially covered by a woven material or tissue material or a combination of tissue material and woven material.

The annulus support 24a functions as an immobilization element and can interact with the native leaflets and other internal cardiac structures or subvalvular structures to provide the desired fixation effect. Annulus support 24
In addition to the fixation effect imparted by a, the “clip effect” produced by the atrial ridge 22a and anchor 29a (described below) also allows the device 20a to adjust its position and Helping to resist potential movement between. Upon release of device 20a from the delivery system, the elements of device 20a will be released sequentially from the delivery system. For example, during transapical delivery, the atrial ridge 22a is first deployed from the delivery system, and then the annulus support 24a is deployed, or vice versa. In contrast, during transfemoral (transseptal) delivery, the annulus support 24a is first deployed and then the atrial ridge 22a is deployed. These procedures can be performed according to guidance from X-ray, TEE, ICE, etc.

The neck 26a transitions to the annulus support 24a radially outward from the projecting edge 22a,
The annulus support 24a includes a ring of anchors 29a. The neck 26a actually transitions radially outwardly into a ring of anchor 29a, which anchor 29a extends radially outward and then extends radially inward to form a V-shaped tab. Transitioning to 28a, the tab 28a extends into the ventricular portion. The number of anchors 29a is in the range of 1-20. The cross-sectional outer shape of the ring of the anchor 29a can be a perfect circle or a different shape (for example, oval or D-shape) from the circle. If the anchor 29a has a perfect circular profile, its diameter can range from 10 mm to 75 mm. If the anchor 29a has an outer shape different from a perfect circle, its major axis can range from 10 to 75 mm and its minor axis can range from 5 to 70 mm.

An annular clipping space is defined between the ring of anchor 29a and the atrial ridge 22a, which has a height H14 (see FIG. 19), and this height H1.
4 can range from 0.5 mm to 30 mm. Each anchor 29a ends with a rounded end 32a, and the function of the end 32a contacts or presses against the annulus or native leaflet of the heart's mitral valve site to place the device 20a in the annulus. It is to be fixed to the area and therefore functions as an immobilization element. Each anchor 29a can be completely or partially covered by tissue or fabric. Thus, the ring of anchor 29a may have a diameter that is greater than the diameter of valve body VB and neck 26a, but may be less than, equal to, or even greater than the diameter of atrial ridge 22a.

A plurality of closed valve holders 36a can extend from a V-shaped tab 28a at the end of the ventricular portion. Although a specific number of retainers 36a are shown, any number of
It is possible to provide a device 20a with one or more ranges of number of holders 36a. As best shown in FIGS. 16, 19 and 21, each retainer 36a is coupled to an end 38a of a corresponding V-shaped tab 28a. A retainer 36a is provided to perform the same function as the tail 36. The length of each retainer 36a can range from 5 mm to 25 mm.

The ventricular portion can have a height H12 in the range of 2 mm to 15 mm. Therefore, the integrated valve body VB can have a height H13 in the range of 4 mm to 30 mm, preferably 8 mm to 20 mm. The cross-sectional profile of the ventricular portion can be a completely circular profile or a profile that is different from a circle (ie, D-shaped or oval).
If the ventricular portion has a perfect circular profile, its diameter can range from 10 mm to 75 mm. When the ventricle part has an outer shape different from a circular shape, the major axis is 10 to 10.
It can be in the range of 75 mm and the minor axis can be in the range of 5 to 70 mm. The ventricular portion can also have a contour that varies along its height. For example, annulus support 2
A portion of the ventricle portion near 4a can have an oval profile or some other profile that is different from a full circle, while a portion of the ventricle portion further away from the annulus support 24a ,
It can also have a perfect circular profile. Also, when implanted, the ventricular portion can be placed in the left ventricle only, in the left atrium only, or in both the left atrium and the left ventricle.

An important aspect of this embodiment is that the length (i.e., height H12) of the ventricular portion is shortened to provide a device 20a having a shorter profile than conventional valve replacement devices. A shorter profile is beneficial in that it minimizes potential LVOT closure and promotes better cardiac output. In addition, the shorter profile minimizes interference with heart structures in the left ventricle, such as chordae and papillary muscles, among others.

As a result of the shortened profile, the tissue leaflets are primarily within the atrial ridge 22 and the atrial ridge so that the post 37a can be used to hold or attach to the upper portion of the leaflet. 22 (see FIG. 23). The leaflets can also be integrated into the valve body VB, either completely in the circular part or including both circular and non-circular parts. The valve body VB can be completely or partially covered by a textile material or tissue material or a combination of tissue material and textile material. For example, the inner surface of the valve body VB can be covered with fabric and the outer surface can be covered with tissue, or vice versa. In use, the woven material and tissue can be first sutured / bonded together to the valve body VB, or can be individually sutured / bonded. The valve body VB can be covered along one surface (ie, the inner or outer surface) or along both surfaces (ie, the inner and outer surfaces).

During transapical delivery, the ventricular portion and retainer 36a can be retracted straight and inserted into the delivery system. When deployed, the annulus support 24a is deployed at the level of the native annulus or at a level below the native annulus, and the atrial ridge 22a.
The native valve structure is engaged by the clipping effect produced by clipping the native annulus and / or the native leaflet between the anchor 29a and the anchor 29a. See FIG. In order to deploy the device 20a, the atrial ridge 22a is such that the assembly of the device 20a and its leaflets can perform a partial or complete leaflet function.
Are first deployed in the left atrium and then the ventricular portion is deployed in the left ventricle (or vice versa). The tab 38a without the retainer 36a is then opened / deployed so that the annulus 24a can be securely held in place in the native annulus. Finally, device 2
0a is manipulated to adjust its position, and then the tab 38a with the retainer 36a is opened / deployed. This staged deployment action results in more accurate valve positioning and improved locking effects.

Device 20a can be used for mitral valve replacement or aortic valve replacement.
In the case of mitral valve replacement, the leaflets can be placed above, at or below the native annulus. In the case of aortic valve replacement, the leaflets can be placed at or on the location of the native annulus.

When the device 20a is fully deployed inside the heart at the position of the mitral valve, the leaflets will be placed primarily above the position of the native annulus. See FIG. The slightly higher leaflet position makes it possible to reduce the length of the valve body VB extending into the left ventricle.

Important advantages / novelty of the device 20 of the present invention include:
(1) The native leaflets and other internal and subvalve structures are preserved.
(2) The device 20 is a function of the natural structure of the heart, such as chordae, papillary muscle, left ventricle, LVO
Treat cardiac regurgitation with minimal interference / occlusion to T, aortic valve impact, etc.
(3) The structure of the device 20 takes into account the natural surface shape and anatomy of the heart valve,
There are minimal modifications to the native heart valve, the annulus shape, the surrounding structure and the valve structure.
(4) The device 20 has a structure that is self-adapting to the natural contour of the heart anatomy, and the sealed portion in the annulus can contract and expand like a normal native annulus.
(5) The external shape of the device 20 is, for example, “D” -shaped, “inverted C” in addition to a perfect circle.
It can be set to a shape like a letter shape or an oval shape, and can correspond to the outer shape of the natural annulus,
Also, the portion of the device 20 that contacts the annulus in the vicinity can have a “V” shaped profile to mimic the anatomical contour of a native mitral valve.
(6) The fixation element of the device 20 utilizes native leaflets and other internal or sub-valve structures.

(7) The device 20 can automatically adjust the size / contour to accommodate changes in the size / volume of the left ventricle after implantation.
(8) The device 20 has a variable profile, can assist in creating a sealing effect during ventricular systole, and provides a tightening effect through interaction with the native leaflet, It can help maintain the position of the systolic device. For example, device 20
Can have a “transition zone” between the atrial ridge 22 and the valve body 28. The “transition zone” can have a different profile than other parts of the device 20. One example is that the “transition zone” can have an oval profile instead of a full circular profile. The “transition zone” has a major axis and a minor axis, which can be determined in a direction along “from junction to junction”, while the other axis is shorter than the major axis. The oval profile in the “transition zone” can help to create an improved sealing effect in the transition area. The transition zone can also include a neck 26 to increase the “sealing” surface area. This is also
A dynamic immobilization effect is imparted to the device 20, which is effective during the ventricular systole when the lift acting on the device 20 is highest.
(9) The device 20 provides both a sealing effect and an immobilization effect by having a structure that utilizes native leaflets and chordae.

(10) Device 20 can be surgically or minimally invasive procedures such as transapical,
Can be implanted by transseptal and transfemoral procedures.
(11) The tail 36 of the valve body 28 provides the physician with sufficient time to adjust the valve position / angle for ideal valve performance during deployment, and (12) within the delivery system. The inner shaft can be designed and made in such a way that it is movable during deployment of the valve. For example, during delivery, when most of the device 20 is released / deployed from the delivery system, the leaflet 48 of the device 20 will begin to function as a heartbeat. At this time, the inner axis of the delivery system can still be inside the lumen of the device 20 and can affect the movement of one of the leaflets of the device 20. In this situation, the inner shaft of the delivery system may be released from the proximal handle end of the delivery system and pulled back in the proximal direction so that the inner shaft is no longer inside the lumen of the device. Thus, all leaflets 48 of device 20 are free to move. this is,
It means that the device 20 can perform better valve function when the tail 36 is still connected to the delivery system. In other words, the fact that the leaflets 48 of the device 20 are functioning during deployment will give the physician more time to adjust the valve position / angle for optimal performance.

In addition to the fixation mechanism described above, an adhesive bond / interface can also be used to secure the device 20 in the position of the native mitral valve. One example is using a biocompatible glue / adhesive to couple / fix / secure the device 20 to the mitral valve location. In use, the biocompatible adhesive / glue is applied along the outer surface of the device 20, such as the valve body 28, the outer surface of the atrial ridge 22 or any native mitral valve structure, such as an annulus. Application to any surface of the device 20 that may come into contact with the atrial surface above the level of the annulus or at the level of the annulus, the native leaflets, heart muscle and other valve structures and / or subvalvular structures In this way, the position of the device 20 after implantation can be maintained. Bioagents can also be added into the biocompatible adhesive / glue to promote healing and tissue growth.

The adhesive / glue is fast in nature and can instantly form a bond with the native mitral valve structure upon contact with blood. They can also be initiated by heat or temperature, which heat or temperature passes through part or the whole structure of the device 20, electrolytic heating or FR heating or ultrasonic energy or magnetic energy or microwave energy or It can be produced / regulated by the blood temperature itself or by a chemical reaction.

The adhesive / glue is also slow in nature and can form a bond with the native mitral valve structure some time after contact with blood. The time required to form a bond can vary from 1 second to 2 hours, 1 second to 28 hours, and so forth.

The adhesive / glue can also react in a controlled manner in nature and form a bond with the native mitral valve structure in a controlled manner after contact with blood. One example of this concept is device 2
Applying the top layer (or top layers) of other biocompatible materials on top of the 0 adhesive / glue layer / material. This top layer (or layers) of biocompatible material can be removed / dissolved by the use of energy, heat, chemical reactions, or in a mechanically or magnetically controlled manner, It can be ensured that the adhesive / glue under the top layer effectively forms a bond with the native mitral valve structure. As used herein, “controlled mode” means that the time required to form a bond varies from 1 second to 48 hours.

Although the foregoing description refers to specific embodiments of the invention, it will be understood that many modifications may be made without departing from the spirit of the invention. The appended claims are intended to cover such modifications as would fall within the true scope and spirit of the present invention.

Claims (10)

A mitral valve replacement device adapted to be deployed at the position of a mitral valve in a person's heart,
An atrial ridge that defines the atrial end of the device;
A ventricular portion defining a ventricular end of the device, the ventricular portion having a height in the range of 2 mm to 15 mm;
An annulus clip disposed between the atrial ridge and the ventricular portion, the annulus support including a ring of anchors extending radially from the annulus support, and an annular clip An annulus support in which a space to be clamped is defined between the atrial ridge and the ring of the anchor;
A plurality of leaflet holders disposed at the atrial end of the atrial ridge,
A plurality of leaflets fixed to the leaflet retainer and positioned inside the atrial ridge at a position above the native annulus, and at least one tail extending from the ventricular end of the ventricular portion A mitral valve replacement device.   The device of claim 1, further comprising a neck disposed between the atrial ridge and the annulus support.   The device of claim 1, wherein at least a portion of one or more of the atrial ridge, the annulus support and the valve body is covered with tissue.   The device of claim 1, wherein at least a portion of one or more of the atrial ridge, the annulus support and the valve body is covered with a fabric.   The device of claim 1, wherein at least a portion of one or more of the atrial ridge, the annulus support, and the valve body is covered with tissue and fabric.   The device of claim 5, wherein the tissue and fabric are comprised of a combined tissue and fabric layer.   The device of claim 1, wherein at least a portion of one or more of the atrial ridge, the annulus support, and the valve body is coated with a biocompatible adhesive. A system for deploying a mitral valve replacement device at the location of a native mitral valve in a person's heart,
Means for preparing a mitral valve replacement device comprising:
A mitral valve replacement device adapted to be deployed at the position of a mitral valve in a person's heart,
An atrial ridge that defines the atrial end of the device;
A ventricular portion defining a ventricular end of the device, the ventricular portion having a height in the range of 2 mm to 15 mm;
An annulus clip disposed between the atrial ridge and the ventricular portion, the annulus support including a ring of anchors extending radially from the annulus support, and an annular clip An annulus support in which a space to be clamped is defined between the atrial ridge and the ring of the anchor;
A plurality of leaflet holders disposed at the atrial end of the atrial ridge,
A plurality of leaflets fixed to the leaflet holder and disposed inside the atrial ridge, and means being at least one tail extending from the ventricular end of the ventricular portion;
Means for positioning the atrial prosthesis in the atrium above the native mitral valve annulus in a person's heart such that the plurality of leaflets are positioned on the native mitral valve annulus; And means for positioning the native mitral valve annulus and / or the native mitral valve leaflet in the clipping space. Means for attaching a wire or line to the at least one tail, and means for manipulating the wire or line to adjust the position of the mitral valve replacement device to the position of the native mitral valve. Item 9. The system according to Item 8. The means of claim 8, further comprising: means for providing at least one clip extending from the annulus support; and means for clipping the native mitral valve leaflet with the at least one clip. system.

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