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EP-4467103-B1 - MITRAL VALVE DOCKING DEVICES AND SYSTEMS

EP4467103B1EP 4467103 B1EP4467103 B1EP 4467103B1EP-4467103-B1

Inventors

  • SPENCE, PAUL A.
  • TOMPKINS, LANDON H.

Dates

Publication Date
20260513
Application Date
20130131

Claims (15)

  1. A helical anchor (160) for docking a prosthetic mitral valve (120) in a native mitral valve (44) of a heart, the helical anchor (160) adapted to be received in and delivered from a coil guide catheter (68), and comprising: a plurality of coils (164a; 164b) having a preformed, coiled configuration after being delivered from the coil guide catheter (68) and adapted to support the prosthetic mitral valve (120) upon being fully delivered from the coil guide catheter (68) and implanted with respective coil portions above and below a mitral valve annulus (84) of the native mitral valve (44), wherein the plurality of coils (164a; 164b) include an upper, atrial coil (164b) adapted to be placed above the native mitral valve annulus (84) and a lower, ventricular coil (164a) adapted to be placed below the native mitral valve annulus (84), and further comprising an extension (162) extending out of a plane of the upper coil and spaced from the upper coil so as to engage the wall (46a) of the atrium and provide stabilization upon implantation in the heart.
  2. The helical anchor (160) of claim 1, further comprising a solid wire.
  3. The helical anchor (160) of claim 1, further comprising a hollow wire configured to be delivered over a guidewire.
  4. The helical anchor (160) of any one of claims 1 to 3, wherein the extension (162) is an end coil portion formed as an enlarged diameter coil relative to the next adjacent coil, the end coil portion (162) configured to engage the atrial wall (46a) of the heart (14) when the plurality of coils (164a, 164b) have been fully delivered at the valve annulus (84).
  5. The helical anchor (160) of any one of claims 1 to 4, wherein the extension (162) is thicker than the lower coil (164a).
  6. The helical anchor (160) of any one of claims 1 to 5, wherein the extension (162) has a helical shape.
  7. The helical anchor (160) of any one of claims 1 to 5, wherein the extension (162) comprises a straight segment passing outward from the helical anchor (160) at an angle of approximately 90 degrees.
  8. The helical anchor (160) of any one of claims 1 to 7, further comprising a gap between the upper coil (164b) and the lower coil (164a) creating a space prior to implantation of the coils such that the upper coil (164b) and the lower coil (162a) do not trap mitral leaflet tissue upon implantation.
  9. The helical anchor (160) of any one of claims 1 to 8, wherein the lower coils (164a) are configured to engage anterior and posterior leaflets (38; 42) below the mitral valve annulus (84).
  10. A system for docking a prosthetic mitral valve (630), comprising: a coil guide catheter (68) including a stem portion and a distal portion connected to the stem portion at a first curved shape, the distal portion having a second curved shape configured to generally follow the curvature of a mitral valve annulus (84) of a native mitral valve (44), said first and second curved portions capable of being delivered in straightened configurations and activated to the first and second curved shapes proximate the native mitral valve (44), and a helical anchor (160) according to any one of claims 1 to 9.
  11. The system of claim 10, further comprising a radially expandable prosthetic mitral valve (120; 630) capable of being expanded inside the helical anchor (160).
  12. The system of claim 11, wherein the prosthetic mitral valve (120; 630) is balloon expandable.
  13. The system of claim 12, wherein the prosthetic mitral valve (120; 630) comprises stainless steel.
  14. The system of claim 11, wherein the prosthetic mitral valve (120; 630) is self-expanding.
  15. The system of claim 14, wherein the prosthetic mitral valve (120; 630) comprises a shape memory material, in particular Nitinol.

Description

Cross-Reference to Related Applications This application claims the priority of U.S. Provisional Application Serial Nos. 61/796,964, filed November 26, 2012 (pending); 61/744,468, filed September 27, 2012 (pending); 61/687,898, filed May 3, 2012 (pending); 61/592,796, filed January 31, 2012 (pending). Technical Field The present invention generally relates to medical procedures and devices pertaining to heart valves such as replacement techniques and apparatus. More specifically, the invention relates to the replacement of heart valves having various malformations and dysfunctions. Background Complications of the mitral valve, which controls the flow of blood from the left atrium into the left ventricle of the human heart, have been known to cause fatal heart failure. In the developed world, one of the most common forms of valvular heart disease is mitral valve leak, also known as mitral regurgitation, which is characterized by the abnormal leaking of blood from the left ventricle through the mitral valve and back into the left atrium. This occurs most commonly due to ischemic heart disease when the leaflets of the mitral valve no longer meet or close properly after multiple infarctions, idiopathic and hypertensive cardiomyopathies where the left ventricle enlarges, and with leaflet and chordal abnormalities, such as those caused by a degenerative disease. In addition to mitral regurgitation, mitral narrowing or stenosis is most frequently the result of rheumatic disease. While this has been virtually eliminated in developed countries, it is still common where living standards are not as high. Similar to complications of the mitral valve are complications of the aortic valve, which controls the flow of blood from the left ventricle into the aorta. For example, many older patients develop aortic valve stenosis. Historically, the traditional treatment had been valve replacement by a large open heart procedure. The procedure takes a considerable amount of time for recovery since it is so highly invasive. Fortunately, in the last decade great advances have been made in replacing this open heart surgery procedure with a catheter procedure that can be performed quickly without surgical incisions or the need for a heart-lung machine to support the circulation while the heart is stopped. Using catheters, valves are mounted on stents or stent-like structures, which are compressed and delivered through blood vessels to the heart. The stents are then expanded and the valves begin to function. The diseased valve is not removed, but instead it is crushed or deformed by the stent which contains the new valve. The deformed tissue serves to help anchor the new prosthetic valve. Delivery of the valves can be accomplished from arteries which can be easily accessed in a patient. Most commonly this is done from the groin where the femoral and iliac arteries can be cannulated. The shoulder region is also used, where the subclavian and axillary arteries can also be accessed. Recovery from this procedure is remarkably quick. Not all patients can be served with a pure catheter procedure. In some cases the arteries are too small to allow passage of catheters to the heart, or the arteries are too diseased or tortuous. In these cases, surgeons can make a small chest incision (thoractomy) and then place these catheter-based devices directly into the heart. Typically, a purse string suture is made in the apex of the left ventricle and the delivery system is place through the apex of the heart. The valve is then delivered into its final position. These delivery systems can also be used to access the aortic valve from the aorta itself. Some surgeons introduce the aortic valve delivery system directly in the aorta at the time of open surgery. The valves vary considerably. There is a mounting structure that is often a form of stent. Prosthetic leaflets are carried inside the stent on mounting and retention structure. Typically, these leaflets are made from biologic material that is used in traditional surgical valves. The valve can be actual heart valve tissue from an animal or more often the leaflets are made from pericardial tissue from cows, pigs or horses. These leaflets are treated to reduce their immunogenicity and improve their durability. Many tissue processing techniques have been developed for this purpose. In the future biologically engineered tissue may be used or polymers or other non-biologic materials may be used for valve leaflets. There are in fact more patients with mitral valve disease than aortic valve disease. In the course of the last decade many companies have been successful in creating catheter or minimally invasive implantable aortic valves, but implantation of a mitral valve is more difficult and to date there has been no good solution. Patients would be benefited by implanting a device by a surgical procedure employing a small incision or by a catheter implantation such as from the groin. From the patient's poin