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Publication numberUS20050165477 A1
Publication typeApplication
Application numberUS 11/083,702
Publication dateJul 28, 2005
Filing dateMar 18, 2005
Priority dateSep 11, 2002
Also published asUS6875231, US20040049266, WO2004023980A2, WO2004023980A3
Publication number083702, 11083702, US 2005/0165477 A1, US 2005/165477 A1, US 20050165477 A1, US 20050165477A1, US 2005165477 A1, US 2005165477A1, US-A1-20050165477, US-A1-2005165477, US2005/0165477A1, US2005/165477A1, US20050165477 A1, US20050165477A1, US2005165477 A1, US2005165477A1
InventorsJames Anduiza, Rodolfo Quijano, Hosheng Tu
Original Assignee3F Therapeutics, Inc., A California Corporation
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Percutaneously deliverable heart valve
US 20050165477 A1
Abstract
This invention discloses a percutaneously deliverable heart valve and delivery means thereof, wherein the percutaneously deliverable heart valve is a foldable heart valve prosthesis to replace a diseased valve of a patient comprising: a support structure with a diameter, wherein the support structure is foldable to a smaller diameter, the support structure comprising a plurality of crossbar frames, wherein each crossbar frame has a plurality of crossbars connected at an end of each crossbar; a flexible tissue heart valve with a plurality of valvular leaflets attached to the support structure; and a plurality of slidable ring connectors, wherein at least a slidable ring connector encircles a first crossbar from a first crossbar frame and a second crossbar from a second crossbar frame configured to coupling the first and the second crossbars.
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Claims(24)
1. A foldable heart valve prosthesis comprising:
a foldable support structure having a plurality of crossbar frames, the support structure being sized to fit within a catheter in a folded state and being sized to fit within an aortic orifice when said support structure is in an expanded state;
an artificial heart valve attached to said support structure; and
a plurality of slidable connectors connected to said support structure.
2. The foldable heart valve prosthesis of claim 1, wherein the support structure further comprises a plurality of crossbar frames.
3. The foldable heart valve prosthesis of claim 2, wherein the crossbar frames further comprise a plurality of crossbars connected at an end of each crossbar.
4. The foldable heart valve prosthesis of claim 2, wherein at least one crossbar frame further comprises a recess on the first cross bar.
5. The foldable heart valve prosthesis of claim 1, wherein the slidable connectors are made of an elastic material.
6. The foldable heart valve prosthesis of claim 1, wherein the slidable connectors are made of a shape-memory material.
7. The foldable heart valve prosthesis of claim 6, wherein the shape-memory material is either a plastic shape-memory material or a Nitinol shape-memory material.
8. The foldable heart valve prosthesis of claim 1, wherein the slidable connectors are made of a coil spring material.
9. The foldable heart valve prosthesis of claim 1, wherein the artificial heart valve is an atrioventricular valve.
10. The foldable heart valve prosthesis of claim 1, wherein the artificial heart valve is an aortic valve.
11. The foldable heart valve prosthesis of claim 1, wherein the artificial heart valve is a pulmonary valve.
12. The foldable heart valve prosthesis of claim 1, wherein the artificial heart valve is chemically treated with a chemical selected from a group consisting of glutaraldehyde, formaldehyde, dialdehyde starch, and polyepoxy compounds.
13. The foldable heart valve prosthesis of claim 1, wherein the support structure is self-expandable.
14. A method for minimally invasively delivering a foldable heart valve prosthesis into a patient, a foldable support structure having a plurality of crossbar frames, the support structure being sized to fit within a catheter in a folded state and being sized to fit within an aortic orifice when said support structure is in an expanded state;
delivering said delivery apparatus to a valvular annulus of a patient;
unfolding the foldable heart valve prosthesis; and
placing the foldable heart valve within the valvular annulus of a patient.
15. The method of claim 14, wherein the delivery apparatus comprises a cannula.
16. The method of claim 15, wherein the delivery apparatus comprises a catheter.
17. The method of claim 16, wherein the delivery step further comprises the placement of the delivery apparatus
18. The method of claim 14 further comprising a step of removing at least a portion of a patient's heart valve by means of a cutting tool introduced through the percutaneous intercostal penetration and through an internal penetration on a cardiac wall before the unfolding step.
19. The method of claim 18, wherein the step of removing is carried out by providing radio frequency energy to the cutting tool.
20. The method of claim 14 further comprising a step of fastening the unfolded heart valve within the valvular annulus by means of an instrument introduced through the percutaneous intercostal penetration and through an internal penetration on a cardiac wall after the unfolding step.
21. The method of claim 14, wherein the artificial heart valve is an aortic valve.
22. The method of claim 14, wherein the artificial heart valve is a pulmonary valve.
23. The method of claim 14, wherein the artificial heart valve is an atrioventricular valve.
24. The method of claim 14, wherein the unfolding step is carried out by an inflatable balloon on a catheter.
Description
    RELATED APPLICATION
  • [0001]
    The present application is a continuation of U.S. patent application Ser. No. 10/241,718, the entirety of which is hereby incorporated by reference.
  • FIELD OF THE INVENTION
  • [0002]
    The present invention relates to a prosthetic valve for implantation in a body channel, more particularly, to a percutaneously implantable prosthetic heart valve suitable for replacement of a defect or diseased human heart valve.
  • BACKGROUND OF THE INVENTION
  • [0003]
    Replacement heart valves or heart valve prostheses have been fabricated or manufactured for the last forty years. Such devices have been assembled from a variety of materials. Specifically the materials have been of the biologic or artificial nature, generally leading to two distinct categories of the prostheses as biological or mechanical replacement heart valves.
  • [0004]
    The prosthetic heart valves are fabricated to replace the natural heart valves that, because of disease, congenital malformations, aging or trauma have become dysfunctional and require repair to their functional elements or partial or complete replacement. Characteristics for a desirable prosthetic heart valve may include hemodynamic performance, thrombogenicity, durability and ease of surgical implantation.
  • [0005]
    Human heart valves under the conditions of normal physiological functions are passive devices that open under the pressure of blood flow on their leaflets. There are four valves in the heart that serve to direct the flow of blood through all chambers in a forward direction. In general, blood leaves the heart's lower chambers in the direction to the rest of the body or to the lungs for required oxygenation, or blood enters the lower chambers from the upper chambers of the heart. Similarly, they close under the pressure exerted on the same leaflet elements when blood flow is retrograde, thus impeding return of blood flow to the chamber it has just left. This, under normal conditions (that is, when the body is not under physical stresses and the heart is beating at the normal resting rate of about 70 beats per minute) equates to the leaflets opening by separation from each other, thereby producing an opening or closing by apposing to each other approximately 38 million times per year. It can be surmised that under stress conditions this may be happening at higher rates, thus increasing the number of separations and appositions, as well as the forces of impact between the leaflets during the closing.
  • [0006]
    When disease conditions affect the structure of the materials of the components of the valve apparatus, the valve itself will decay, degenerate or disrupt and require repair or replacement to restore proper function necessary for the continuation of life.
  • [0007]
    The shape of the leaflet and surrounding elements of a valve or a valve apparatus is dependent on the function of the heart. In the case of the atrioventricular valves, otherwise known as mitral (in the left lower chamber of the heart) and tricuspid (in the right ventricle), the valve is part of a continuum that extends from the myocardium or muscular wall of the lower chambers, through the papillary muscles, to which is attached a confluence of tendinous rope-like elements known as chordae tendinae that themselves are attached to the edges of differently shaped leaflets which form the flow-allowing and flow-stopping or obstructing elements (leaflets). These leaflets continue and end at a ring-like structure usually known as annulus, that is part of the skeleton of the heart. It is this continuum which should be called an apparatus rather than just valve.
  • [0008]
    Thus, there is a tricuspid valve apparatus in the right ventricular chamber, and more importantly the mitral valve apparatus within the lower left heart chamber or left ventricle, the pumping function of which provides the systemic flow of blood through the aorta, to keep all tissues of the body supplied with oxygenated blood necessary for cellular function and life. Hence during the cardiac cycle, the valves function as part of a unit composed of multiple interrelated parts, including the ventricular and atria walls, the valve leaflets, the fibrous skeleton of the heart at the atrioventricular ring, and the subvalvular apparatus. The subvalvular apparatus includes the papillary muscle within the ventricle, and the chordae tendinae which connect the papillary muscle to the valve leaflets.
  • [0009]
    Aortic and pulmonary valves have been replaced with simple trileaflet chemically treated biological valves obtained from animals, or bileaflet mechanical valves without extreme deficiencies in valvular or cardiac function. This is not the case when mitral or tricuspid valves are replaced and the necessary involvement of chordae tendinae and muscular element of the chamber wall are not united to function in harmony with the valve leaflets. Those valves used in the aortic position cannot alone replace the mitral valve apparatus without anatomical and functional compromise.
  • [0010]
    Aortic stenosis is a disease of the aortic valve in the left ventricle of the heart. This aortic valvular orifice can become tightly stenosed, and therefore the blood cannot be freely ejected from the left ventricle. In fact, only a reduced amount of blood can be ejected by the left ventricle which has to markedly increase the ventricular chamber pressure to pass the stenosed aortic orifice. In such aortic diseases, patients can have syncope, chest pain, and difficulty in breathing. The evolution of such a disease is disastrous when symptoms of cardiac failure appear and many patients die in the year following the first symptoms of the disease.
  • [0011]
    The only commonly available treatment is the replacement of the stenosed aortic valve with a prosthetic valve via open-heart surgery. If surgery is impossible to perform, i.e., if the patient is deemed inoperable or operable only at a too-high surgical risk, an alternative possibility is to dilate the valve with a balloon catheter to enlarge the aortic orifice. Unfortunately, the result is sub-optimal with a high restenosis rate.
  • [0012]
    Aortic stenosis is a very common disease in people above seventy years old and occurs more and more frequently as the subject gets older. Until recently, the implantation of a valve prosthesis for the treatment of aortic stenosis is considered unrealistic to perform since it is deemed difficult to superimpose another implantable valve on the distorted stenosed native valve without excising the latter.
  • [0000]
    Percutaneous Catheter-Based Delivery
  • [0013]
    Andersen et al. in U.S. Pat. No. 6,168,614, the entire contents of which are incorporated herein by reference, discloses a heart valve prosthesis for implantation in the body by use of a catheter. The valve prosthesis is consisted of a support structure with a tissue valve connected to it, wherein the support structure is delivered in a collapsed shape through a blood vessel and secured to a desired valve location with the support structure in the expanded shape. However, the support structure is a generally fixed expandable-collapsible structure with little flexibility of modifying configuration at the collapsed shape for easy delivery percutaneously.
  • [0014]
    Andersen et al. in U.S. Pat. No. 5,840,081 and No. 5,411,552, the entire contents of both of which are incorporated herein by reference, discloses a system for implanting a valve in a body channel comprising a radially collapsible and expandable stent with a valve mounted to it and a catheter for introducing and securing the valve in the body channel. The catheter generally comprises an expandable member about which the cylindrical stent may be positioned together with the valve, fastening means on the expandable member on which the stent may be mounted to the expandable member, and a channel extending through the catheter for injecting a fluid into the expandable member so as to expand the expandable member from a collapsed profile suitable for introduction into the body channel to an expanded profile in which the stent engages the inner wall of the body channel so as to secure the valve therein. Again, the cylindrical stent is a generally fixed expandable-collapsible structure with little flexibility of modifying configuration at the collapsed stage for easy delivery percutaneously. This type of design is inherently fragile, and such structures are not strong enough to be used in the case of aortic stenosis because of the strong recoil that will distort this weak structure and because they would not be able to resist the balloon inflation performed to position the implantable valve.
  • [0015]
    Letac et al. in U.S. Patent Application Ser. No. 2001/0007956 and No. 2001/0010017, the entire contents of both are incorporated herein by reference, discloses a valve prosthesis for implantation in a body channel comprising a collapsible valvular structure and an expandable frame on which the valvular structure is mounted. However, the expandable frame is a generally fixed expandable-collapsible structure with little flexibility of modifying configuration or minimizing the profile at the collapsed stage for easy delivery percutaneously.
  • [0016]
    It is one aspect of the present invention to provide a percutaneously deliverable heart valve prosthesis comprising a tissue valve mounted on a support structure that has a plurality of collapsible crossbars with securing rings movably coupled with any two adjacent crossbars at an appropriate location upon expanding the support structure of the implantable heart valve prosthesis.
  • [0000]
    Percutaneous Intercostal Delivery
  • [0017]
    Various surgical techniques may be used to repair a diseased or damaged valve, including annuloplasty (contracting the valve annulus), quadrangular resection (narrowing the valve leaflets), commissurotomy (cutting the valve commissures to separate the valve leaflets), or decalcification of valve and annulus tissue. Alternatively, the valve may be replaced by excising the valve leaflets of the natural valve and securing a replacement valve in the valve position, usually by suturing the replacement valve to the natural valve annulus.
  • [0018]
    A conventional procedure for approaching the left atrium is by intravascular catheterization from a femoral vein through the cardiac septal which separates the right atrium and the left atrium. In some aspects, this intravascular procedure is not only dangerous and tedious because of the long tortuous route, but also of limited use because of the catheter size suitable for insertion intravascularly.
  • [0019]
    Sterman et al. in U.S. Pat. No. 6,283,127, the entire contents of which are incorporated herein by reference, discloses a device system and methods facilitating intervention within the heart or great vessels without the need for a median sternotomy or other form of gross thoracotomy, substantially reducing trauma, risk of complication, recovery time, and pain for the patient. Using the device systems and methods of the invention, surgical procedures may be performed through percutaneous penetrations within intercostal spaces of the patient's ribcage, without cutting, removing, or significantly displacing any of the patient's ribs or sternum. The device systems and methods are particularly well-adapted for heart valve repair and replacement, facilitating visualization within the patient's thoracic cavity, repair or removal of the patient's natural valve, and, if necessary, attachment of a replacement valve in the natural valve position.
  • [0020]
    Of particular interest in the present application are techniques for the implantation of an atrioventricular valve that can be retracted or folded inside a delivery system or cannula for delivering through a less-invasive intercostal penetration to the desired place, particularly in a left atrium. Thereafter the retracted valve with a support structure is released, expanded, crossbars secured by securing rings, separated from the delivery system, and secured to the desired anatomical place with a minimally invasive technique.
  • [0021]
    Most tissue valves applicable in the present invention are constructed by sewing the leaflets of pig aortic valves to a stent to hold the leaflets in proper position as a stented porcine valve. They may also be constructed by removing valve leaflets from the pericardial sac of cows or horses and sewing them to a stent as a stented pericardium valve. The stents may be rigid or slightly flexible and covered with cloth (usually a synthetic material sold under the trademark Dacron™ or Teflon™) and attached to a sewing ring for fixation to the patient's native tissue. In one embodiment, the porcine, bovine or equine tissue is chemically treated to alleviate any antigenicity.
  • [0022]
    The main advantage of tissue valves is that they do not cause blood clots to form as readily as do the mechanical valves, and therefore, the tissue valves do not typically require lifelong systemic anticoagulation. Another advantage is that a tissue valve is so flexible that it can be shaped and configured for delivery percutaneously. However, the presence of the support structure consisting of a stent and sewing ring prevents the tissue valve from being anatomically accurate in comparison to a normal heart valve. It is one aspect of the present invention to provide a prosthetic heart valve with the expandable-collapsible support structure having flexibility of modifying configuration at the collapsed stage for easy delivery percutaneously.
  • [0023]
    Therefore, it would be desirable to provide a delivery system for delivering a prosthetic heart valve to a patient's heart configured to be releasably folded inside a lumen of the delivery system through a percutaneous intercostal penetration of a patient's chest or an opening at a carotid artery, jugular vein, subclavian vein, femoral vein and other blood vessel.
  • SUMMARY OF THE INVENTION
  • [0024]
    It is one object of the present invention to provide a foldable heart valve prosthesis to replace a diseased valve of a patient. The foldable heart valve prosthesis comprises a support structure with a diameter, wherein the support structure is foldable to a smaller diameter, the support structure comprising a plurality of close-loop crossbar frames, wherein each crossbar frame has a plurality of crossbars connected at an end of any two adjacent crossbars, and a flexible tissue heart valve with a plurality of valvular leaflets attached to the support structure. The prosthesis may further comprise a plurality of slidable ring connectors, wherein at least a slidable ring connector encircles a first crossbar from a first crossbar frame and a second crossbar from a second crossbar frame configured to couple the first and the second crossbars. In one aspect, the slidable ring connector is shrinkable to a smaller diameter after encircling the two crossbars.
  • [0025]
    It is another object of the present invention to fabricate a flexible tissue heart valve to be coupled with the support structure, wherein the tissue valve may be a porcine valve or a valve fabricated from pericardium tissue selected from a group consisting of equine, bovine, porcine, and ovine.
  • [0026]
    It is still another object of the present invention to provide a method for minimally invasively delivering a foldable heart valve prosthesis into a patient. The method comprises folding the support structure with the attached tissue heart valve inside a lumen of a delivery apparatus; delivering the delivery apparatus to a target valvular annulus of the patient; unfolding the support structure to deploy the foldable heart valve prosthesis in place; and coupling the crossbars by sliding the slidable ring connectors to an appropriate location of the crossbars. In one embodiment, the method may further comprise a shrinking step after the coupling step, wherein the shrinking step reduces a circumferential length of the slidable ring connector.
  • [0027]
    It is a preferred object of the present invention to provide a delivery system and methods for minimally invasively delivering a foldable heart valve prosthesis into the anterior of a patient heart. In one embodiment, the delivery system has a differentially expandable balloon on the balloon catheter that is configured to expand the circularly folded valve into a deployed oval-shaped configuration, wherein the differentially expandable balloon comprises a longitudinal axis, a major traverse axis and a minor traverse axis, the major traverse axis being at least 10% longer than the minor traverse axis. Preferably, the major traverse axis is at least 50% longer than the minor traverse axis.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • [0028]
    Additional objects and features of the present invention will become more apparent and the invention itself will be best understood from the following Detailed Description of Exemplary Embodiments, when read with reference to the accompanying drawings.
  • [0029]
    FIG. 1 is an expandable-collapsible heart valve prosthesis comprising a generally cylindrical support structure with slidable ring connectors at a fully expanded state in accordance with one embodiment of the present invention.
  • [0030]
    FIG. 2 is one embodiment of the crossbars with a slidable ring connector.
  • [0031]
    FIG. 3 is an expandable-collapsible heart valve prosthesis of FIG. 1 comprising a generally cylindrical support structure with slidable ring connectors at a collapsed state.
  • [0032]
    FIG. 4 is a cross-sectional view of a delivery apparatus enclosing an expandable-collapsible heart valve prosthesis comprising a generally cylindrical support structure at a collapsed state.
  • [0033]
    FIG. 5 is a first step for delivering an expandable-collapsible heart valve prosthesis at a folded state out of a delivery apparatus.
  • [0034]
    FIG. 6 is a perspective view of a tissue valve component of an expandable-collapsible aortic heart valve prosthesis comprising a plurality of tissue leaflets at a fully unfolded state.
  • [0035]
    FIG. 7 is a perspective view of an expandable-collapsible atrioventricular heart valve prosthesis at a fully unfolded state.
  • [0036]
    FIG. 8 is a partial perspective view of an expandable-collapsible atrioventricular heart valve prosthesis at a fully unfolded state.
  • DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS
  • [0037]
    Referring to FIGS. 1 to 8, what is shown is an embodiment of a percutaneously deliverable heart valve prosthesis and delivery means thereof, including an illustrative cardiac valve. The same principles of percutaneously implantable valves could also apply to implantation of a venous valve, an esophagus valve, ureter valve, a biliary valve, and a valve in the intestines or in the lymphatic systems. While the description sets forth various embodiment specific details, it will be appreciated that the description is illustrative only and should not to be construed in any way as limiting the invention. Furthermore, various applications of the invention, and modifications thereto, which may occur to those who are skilled in the art, are also encompassed by the general concepts described below.
  • [0038]
    Andersen et al. in U.S. Pat. No. 6,168,614, No. 5,840,081 and No. 5,411,552 discloses a valve prosthesis for implantation in the body by use of a catheter comprising a stent made from an expandable cylinder-shaped thread structure comprising several spaced apices. The elastically collapsible valve is mounted on the stent at the comrnmissural points of the valve and is secured to the projecting apices. The valve prosthesis can be compressed around the balloon of the balloon catheter and be inserted in the aorta. When the valve prosthesis is placed correctly, the balloon is inflated, thereby expanding the stent and wedging it against the wall of the aorta. The balloon is provided with beads to ensure a steady fastening of the valve prosthesis on the balloon during insertion and expansion. However, Andersen et al. does not teach a stent coupled with slidable ring connectors configured for maintaining the stent structure at its minimal profile when the stent structure is collapsibly loaded into the balloon catheter.
  • [0039]
    Letac et al. in U.S. Patent Application Ser. No. 2001/0007956 and No. 2001/0010017, the entire contents of both incorporated herein by reference, discloses a valve prosthesis for implantation in a body channel comprising a collapsible valvular structure and an expandable frame on which the valvular structure is mounted. The valvular structure is composed of a valvular tissue compatible with the human body and blood, the valvular tissue being sufficiently supple and resistant to allow the valvular structure to be deformed from a closed state to an opened state. The valvular tissue forms a continuous surface and is provided with guiding means formed or incorporated within, the guiding means creating stiffened zones which induce the valvular structure to follow a patterned movement in its expansion to its opened state and in its turning back to its closed state. However, Letac et al. does not teach an expandable frame secured with slidable ring connectors configured for maintaining the frame structure at its minimal profile when the frame structure is collapsibly loaded into the delivery catheter.
  • [0040]
    The crossbars of the support frame as taught by Letac et al. are soldered together. Therefore, substantial force is needed to compressively fold the frame structure. When the folded frame structure is accidentally released from a constraint, it is quite difficult to reload the folded frame structure back into the lumen of the delivery apparatus.
  • [0041]
    Garrison et al. in U.S. Pat. No. 6,425,916, the entire contents of which are incorporated herein by reference, discloses a valve implantation system comprising a valve displacer and a replacement valve. The valve displacer and the valve are in a collapsed condition during introduction and are expanded to deploy the valve displacer and the valve. However, Garrison et al. does not teach an expandable support structure secured with slidable ring connectors configured for maintaining the frame structure at its minimal profile when the support structure is collapsibly loaded into a delivery means.
  • [0042]
    FIG. 1 shows an expandable-collapsible heart valve prosthesis 10 comprising a generally cylindrical support structure 12 at a fully expanded or unfolded state in accordance with one embodiment of the present invention. In one aspect of the present invention, the support structure 12 may be made of a plurality of expandable metallic frames, each frame having crossbars 18, 19 configuration or other suitable configurations that are coupled by one or more of the slidable ring connectors 16. Each metallic frame forms a closed loop; that is, one end of the metallic frame is secured to the other end. The height of each of the crossbars 18, 19 is configured in a proper length sufficient to support a valvular structure or a tissue heart valve.
  • [0043]
    The cross-sectional diameter of the cylindrical support structure 12 is preferred to be about a few millimeters at a folded state to about 10 mm or larger at a fully unfolded state. The number and size of the crossbars 18, 19 are adapted to be sufficiently strong and rigid when the support structure is fully expanded in a target valvular orifice and coupled by the slidable ring connectors 16 to resist the strong recoil force exerted by the distorted stenosed valve orifice after unfolding the support structure 12. In one embodiment, upon being folded with little force, the diameter of the support structure is about 4 to 5 millimeters range, in view of its transcutaneous introduction. When positioned in the aortic orifice, the frame is able to expand under the force of an inflated balloon up to a size of 20 to 23 mm in diameter and locked in by the slidable ring connectors of the present invention. In another aspect of the present invention, the support structure along with its tissue heart valve is self-expandable or could be expanded by other means.
  • [0044]
    The expanded foldable heart valve prosthesis of the present invention is intended to replace a diseased valve of a patient. The valve prosthesis 10 may comprise a support structure 12 in a generally cylindrical or other appropriate configuration with a diameter, wherein the support structure 12 comprises a plurality of crossbar frames, the support structure being foldable to a smaller diameter. The valve prosthesis 10 may also comprise a flexible tissue valve with a plurality of valvular leaflets attached to the support structure 12. Finally, the valve prosthesis 10 comprises a plurality of slidable ring connectors to couple the crossbar frames. Each crossbar frame has an upper edge 13 and lower edge 14, wherein the edges 13, 14 may be configured to form a sharp edge or a round edge adapted for effectively supporting the tissue valve without undue stress or obstruction.
  • [0045]
    FIG. 2 shows one embodiment of the crossbars 18, 19 with a slidable ring connector 16. The crossbars 18, 19 have a trough or recess 33, 32, respectively at a medium region 31, wherein the medium region 31 may be located at a place away from the upper edge 13 or the lower edge 14. The slidable ring connector 16 is utilized to couple the two crossbars 18, 19 together to form the support structure 12 of the present invention. In one aspect, the ring connector 16 is made of an elastic material that can snugly compress against the crossbars 18, 19 at their recess zones 33, 32 or at other suitable zone. In another aspect, the slidable ring connector 16 is made of a coil-spring material or circumferentially compressible material. In still another aspect, the slidable ring connector is made of a shape-memory material configured to shrinkably coupling the two adjacent crossbars snugly, wherein the shape-memory material is either a plastic shape-memory material or a Nitinol shape-memory material. The shape-transition temperature of the shape-memory material is preferably between about 39 C. to about 90 C. The shape-transition temperature is more preferably between about 40 C. to about 50 C., a temperature range compatible to human tissue. One method to effect the shape-memory material to reach its shape-transition temperature is to apply radio frequency energy through an inserted conductive wire. Other means of raising the temperature to above the shape-transition temperature, such as warm saline flushing, is also applicable. The high frequency energy ablation or means for raising the temperature is well-known to an ordinary artisan who is skilled in the art.
  • [0046]
    The medium region 31 where the recess portions of two crossbars meet with a slidable ring connector 16 may be configured to be near the upper edge 13. In this case, the circumference of the upper extremity of the support structure is smaller than the circumference of the lower extremity of the support structure because the ring connector holds any two crossbars together at near the upper edge 13. Similarly, the recess portions of the two crossbars along with a slidable ring connector 16 may be configured to be near the lower edge 14 so that the circumference of the lower extremity of the support structure is smaller than the circumference of the upper extremity of the support structure. The angle θ formed between the two crossbars 18, 19 dictates the overall circumference of the support structure. The wider the angle θ, the larger the overall circumference. It is also within the scope of the present invention that the first angle θ formed between the first two crossbars may be different from the second angle θ formed between the second two crossbars. The slidable ring connector 16 is generally configured and sized to show minimal ring circumference after being coupled to the crossbars and shrunk, wherein the angle θ formed between the crossbars 18, 19 after being coupled is generally at least 15 degrees.
  • [0047]
    The recesses 33, 32 of the crossbars 18, 19 may face to each other and configure to have a minimal profile while yield an adequate strength for the support structure in its intended purposes for supporting the prosthesis. In one embodiment, the surface of the recess is flat so as to match both recess surfaces. In another embodiment, the surface of the recess is rough to enhance coupling force when compressed by the shrunk slidable ring connector 16. In still another embodiment, the surface of one recess is lined or curved to match the surface of the other matching recess.
  • [0048]
    The crossbars 18, 19 and the ring connector 16 are made of biocompatible material, wherein the slidable ring connector is sized and configured to secure the crossbars together as a part of the support structure 12 enabling effective mounting and/or functioning of the valvular structure. The support structure may have protrusions, barbs, needles, or other anchoring mechanism for engaging the valve prosthesis to the valvular annulus of a patient.
  • [0049]
    FIG. 3 shows an expandable-collapsible heart valve prosthesis of FIG. 1 comprising a generally cylindrical support structure 12 at a collapsed state. In one embodiment, at least one of the slidable ring connectors 16 is slid to near the upper edge 13. In another embodiment, at least one of the slidable ring connectors 16 is slid to near the lower edge 14 of the support structure 12. While sliding most of the ring connectors 16 to an upper edge 13 or lower edge 14, the overall profile at about that edge is relatively small. In some aspect of the present invention, the ring connector is loosely overlaid with the crossbars 18, 19 during the unfolded state. In this case, it requires little force to compress the foldable heart valve prosthesis to be inserted inside a delivery apparatus during the device delivery phase.
  • [0050]
    FIG. 4 shows a foldable heart valve prosthesis 10 of FIG. 1 comprising a generally cylindrical support structure at a folded state suitable for percutaneous delivery by a delivery apparatus 21, such as a catheter, a cannula or an endoscopic instrument. The crossbars 18, 19 according to the principles of the present invention are configured and sized to be flexible longitudinally for easy delivery passing the tortuous natural conduits or openings. It is particularly practical to loosen the crossbar coupling by sliding the ring connector 16 close to one edge 13, 14 of the crossbar frames. However, the crossbars 18, 19 of the crossbar frames have adequate hoop strength (that is, the strength in an outwardly radial direction of the circular support structure) to expand the valvular annulus and resist the strong recoil force exerted by the distorted stenosed valve orifice after snugly coupling any two adjacent crossbars.
  • [0051]
    FIG. 4 shows a cross-sectional view of a delivery apparatus enclosing a foldable heart valve prosthesis comprising a generally cylindrical support structure at a folded or collapsed state. In one embodiment, as shown in FIG. 4, the delivery apparatus may comprise a catheter 21, wherein the catheter passes through an opening of the body, such as an incision at a carotid artery, a jugular vein, a subclavian vein, or any body vessel. In another embodiment, the delivery apparatus may comprise a cannula, the cannula passing through a percutaneous intercostal penetration.
  • [0052]
    The foldable heart valve prosthesis of the present invention comprises a support structure and a flexible tissue heart valve with a plurality of valvular leaflets attached to the support structure. The flexible tissue heart valve may be a porcine valve or a valve fabricated from pericardium tissue selected from a group consisting of equine, bovine, porcine, and ovine. In one aspect of the present invention, the porcine valve is procured from a genetically modified porcine, wherein the procured porcine valve is with little rejection when transplanted. The flexible tissue heart valve may further be chemically treated to reduce antigenicity of the tissue material, wherein the chemical is selected from a group consisting of glutaraldehyde, formaldehyde, dialdehyde starch, and polyepoxy compounds. The flexible tissue heart valve is generally mounted on the support structure at the commissural points of the valve and is secured to the crossbar frames. In a further embodiment, the flexible tissue heart valve is fastened along a substantial portion of an expandable crossbar frame, by sewing, stitching, molding or gluing so as to fabricate the expandable-collapsible prosthesis to sufficiently prevent any regurgitation of the body fluid between the support structure and the valvular structure of the tissue heart valve.
  • [0053]
    It is some aspect of the present invention to provide a method for minimally invasively delivering a foldable heart valve prosthesis 10 into a patient. The method may comprise the steps of: (a) folding the support structure with the attached flexible tissue heart valve inside a lumen of a delivery apparatus; (b) delivering the delivery apparatus to a target valvular annulus of the patient; (c) unfolding the support structure to deploy the folded heart valve prosthesis in place; and (d) coupling the crossbars by sliding the slidable ring connector to an appropriate location of the crossbars. The method may further comprise a step of shrinking the ring to tightly coupling the crossbars with the ring connector.
  • [0054]
    In one embodiment, the method may further comprise a step of removing at least a portion of a patient's heart valve by means of a cutting tool introduced through the percutaneous intercostal penetration and through an internal penetration on a cardiac wall before the folding step. In some aspect of the present invention, the cutting tool may be made of an electrically conductive metal and radio frequency energy is provided to the cutting tool for enhanced valve removal. The high frequency energy ablation is well known to an ordinary artisan who is skilled in the art.
  • [0055]
    The method may further comprise a step of fastening the unfolded heart valve within the valvular annulus by means of an instrument introduced through the percutaneous intercostal penetration and through an internal penetration on a cardiac wall after the unfolding step. The process of removing at least a portion of a patient's heart valve by means of a cutting tool and the process of fastening the unfolded heart valve within the valvular annulus by means of an instrument introduced through the percutaneous intercostal penetration and through an internal penetration on a cardiac wall is well-known to an ordinary artisan who is skilled in the art.
  • [0056]
    The delivery apparatus 21 comprises a distal section 28, a distal end 23 and a lumen 22, wherein a device deployment mechanism (not shown) is located within the lumen 22 of the delivery apparatus 21. At least one slidable ring connector is slid to an end or close to an end of a crossbar when the heart valve prosthesis is being folded. The foldable heart valve prosthesis 10 in its folded state stays inside the lumen 22 of the delivery apparatus 21 as shown in FIG. 4 during the delivery phase through an intercostal penetration or through an opening of the blood vessel. In one embodiment, the folded heart valve prosthesis 10 is wrapped outside of a balloon 25 of an inner member 24, wherein the balloon 25 has a distal end 27 and a proximal end 26 securely attached onto the inner member 24. The inner member 24 has a distal end 29 and a fluid communication system for inflating the balloon 25. The balloon may be selected from a group consisting of compliant material, non-compliant material, and/or semi-compliant material.
  • [0057]
    Once the distal section of the delivery apparatus arrives at an appropriate location adjacent the valvular annulus of the diseased heart valve, the folded heart valve prosthesis 10 is pushed out of the distal end 23 of the delivery apparatus 21 (shown in FIG. 5). The delivery apparatus may further comprise an expanding element, for example a balloon 25 or an expandable basket, to unfold and expand the cylindrical support structure 12. In another aspect, the support structure is self-expandable.
  • [0058]
    FIG. 6 shows a perspective view of a tissue valve component 11 of an expandable-collapsible aortic heart valve prosthesis comprising a plurality of tissue leaflets 52 at a fully unfolded state. At a leaflet-open state, the opening 62 of the heart valve prosthesis allows blood to pass through. The flexible annular ring 63 as a part of the flexible tissue heart valve 11 has a central axial line 58 and commissural points 53. The flexible tissue heart valve is generally mounted onto the support structure at the commissural points of the valve and is secured to the crossbar frames of the support structure.
  • [0059]
    FIG. 7 shows a perspective view of an expandable-collapsible atrioventricular heart valve prosthesis 10 comprising a support structure 12 and a flexible tissue heart valve 11 with a plurality of tissue leaflets 64 at a fully unfolded state. At a leaflet-open state, the opening 62 allows blood to pass through. The flexible annular ring 63 as a part of the flexible tissue heart valve 11 has a central axial line 58 and the flexible tissue heart valve 11 is generally mounted and secured onto the support structure 12. The slidable ring connector 16 is deployed and utilized to enable unfolding the cylindrical crossbar frames against the strong recoil force exerted by the distorted stenosed valve orifice. In one aspect, at least a slidable ring connector encircles a first crossbar from a first crossbar frame and a second crossbar from a second crossbar frame configured to couple the first and the second crossbars. In another aspect, some pairs of the crossbars do not have a slidable ring connector to maintain the proper rigidity of the support structure 12. In still another aspect, some pairs of the crossbars have a plurality of slidable ring connectors spaced apart to maintain the proper rigidity of the support structure 12.
  • [0060]
    FIG. 8 shows a partial perspective view of an expandable-collapsible atrioventricular heart valve prosthesis at a fully expanded state. Myers et al. in U.S. Patent Application publication 2002/0052651, the entire contents of which are incorporated herein by reference, discloses a tubular prosthetic semilunar or atrioventricular heart valve by adding substantially rectangular commissural mounting pads at the distal end. The commissural mounting pad is generally used for stitching or suturing purposes. It is one aspect of the present invention to incorporate a mounting pad 69 at between the slidable ring connector 16 and the tissue of the flexible tissue valve for anchoring the slidable ring connector once the heart valve prosthesis is deployed at a target location of the patient.
  • [0061]
    It is one object of the present invention to provide an expandable-collapsible heart valve prosthesis to replace a diseased valve of a patient. The diseased heart valve to be replaced may be selected from a group consisting of an aortic valve, a pulmonary valve, and an atrioventricular valve of mitral or tricuspid valves. The foldable heart valve prosthesis is usually folded to be within a delivery catheter of about less than 24 French, corresponding to about 8 mm in diameter. The heart valve prosthesis may comprise: (a) a support structure with a diameter, wherein the support structure is foldable to a smaller diameter, the support structure comprising a plurality of crossbar frames, wherein each crossbar frame has a plurality of crossbars; (b) a flexible tissue heart valve with a plurality of valvular leaflets attached to the support structure; and (c) a plurality of slidable ring connectors, wherein at least a slidable ring connector encircles a first crossbar from a first crossbar frame and a second crossbar from a second crossbar frame configured to couple the first and the second crossbars.
  • [0062]
    The delivery apparatus 21 may be made from plastic material, metal or composite material. In one embodiment, the delivery apparatus may be made of the material selected from the group consisting of polyethylene, polypropylene, polycarbonate, nylon, polytetrafluoroethylene, polyurethane, stainless steel, Nitinol, titanium, polyimide, polyester, and the like.
  • [0063]
    In operation, a delivery apparatus 21 of the present invention may be deployed through an intercostal penetration. The delivery apparatus may be introduced through a cannula or trocar positioned in one of percutaneous intercostal penetrations, the cannula or trocar having a proximal end disposed outside of the patient and a distal end disposed within the chest. The delivery means through a percutaneous intercostal penetration is well known to one who is skilled in the art, such as that proposed and taught by Sterman et al. in U.S. Pat. No. 6,283,127, entire contents of which are incorporated herein by reference, disclosing a device system and methods facilitating intervention within the heart without the need for a median stemotomy or other form of gross thoracotomy, substantially reducing trauma, risk of complication, recovery time, and pain for the patient.
  • [0064]
    It is one object of the present invention to provide a method for minimally invasively delivering a foldable heart valve into a patient. The method comprises: folding the valve within a lumen of delivery means for delivering the valve to a target valvular annulus of the patient; unfolding the valve in place by a balloon catheter, wherein a differentially expandable balloon of the balloon catheter is configured to expand the circularly folded valve into an oval unfolded valve, and coupling the crossbars by sliding the slidable ring connector to an appropriate location of the crossbars and locking in, wherein the foldable heart valve comprises a support structure having a plurality of crossbars and a plurality of shrinkable slidable ring connectors.
  • [0065]
    In one aspect of the present invention, the differentially expandable balloon comprises a longitudinal axis, a major traverse axis and a minor traverse axis, the major traverse axis being at least 10% longer than the minor traverse axis. Preferably, the major traverse axis is at least 50% longer than the minor traverse axis. In another aspect of the present invention, the differentially expandable balloon is delivered through a percutaneous intercostal penetration of the patient.
  • [0066]
    The method may further comprise a shrinking step after the coupling step, wherein the shrinking step reduces a circumferential length of the slidable ring connector. In one aspect, the shrinking step is carried out by raising a temperature of the ring connector above a shape-transition temperature of a shape-memory material, the slidable ring connector being made of the shape-memory material, wherein the shape-memory material is either a plastic shape-memory material or a Nitinol shape-memory material. The shape-transition temperature of the shape-memory material is preferably between about 39 C. to about 90 C., more preferably between about 40 C. to about 50 C.
  • [0067]
    From the foregoing description, it should now be appreciated that a percutaneously deliverable heart valve prosthesis suitable for replacement of a diseased human heart valve and delivery means thereof have been disclosed. While the invention has been described with reference to a specific embodiment, the description is illustrative of the invention and is not to be construed as limiting the invention. Various modifications and applications may occur to those who are skilled in the art, without departing from the true spirit and scope of the invention, as described by the appended claims.
Patent Citations
Cited PatentFiling datePublication dateApplicantTitle
US5411552 *Jun 14, 1994May 2, 1995Andersen; Henning R.Valve prothesis for implantation in the body and a catheter for implanting such valve prothesis
US5840081 *Feb 19, 1997Nov 24, 1998Andersen; Henning RudSystem and method for implanting cardiac valves
US5957949 *May 1, 1997Sep 28, 1999World Medical Manufacturing Corp.Percutaneous placement valve stent
US6168614 *Feb 20, 1998Jan 2, 2001Heartport, Inc.Valve prosthesis for implantation in the body
US6283127 *Sep 25, 1998Sep 4, 2001Wesley D. StermanDevices and methods for intracardiac procedures
US6302907 *Oct 5, 1999Oct 16, 2001Scimed Life Systems, Inc.Flexible endoluminal stent and process of manufacture
US6347119 *Dec 15, 2000Feb 12, 2002Sony CorporationCommunication apparatus, communication method and storage medium
US6425916 *Feb 10, 1999Jul 30, 2002Michi E. GarrisonMethods and devices for implanting cardiac valves
US6440164 *Oct 21, 1999Aug 27, 2002Scimed Life Systems, Inc.Implantable prosthetic valve
US6558418 *Jun 14, 1999May 6, 2003Edwards Lifesciences CorporationFlexible heart valve
US6733525 *Mar 23, 2001May 11, 2004Edwards Lifesciences CorporationRolled minimally-invasive heart valves and methods of use
US6875231 *Sep 11, 2002Apr 5, 20053F Therapeutics, Inc.Percutaneously deliverable heart valve
US20010007956 *Feb 28, 2001Jul 12, 2001Brice LetacValve prosthesis for implantation in body channels
US20010010017 *Feb 28, 2001Jul 26, 2001Brice LetacAlve prosthesis for implantation in body channels
US20020022875 *Apr 13, 2001Feb 21, 2002Strecker Ernst PeterEndoprosthesis percutaneously implantable in the body of a patient
US20020032481 *Oct 9, 2001Mar 14, 2002Shlomo GabbayHeart valve prosthesis and sutureless implantation of a heart valve prosthesis
US20020052651 *Jan 29, 2001May 2, 2002Keith MyersProsthetic heart valve
US20020188344 *Jul 13, 2001Dec 12, 2002American Medical SystemsRetrievable stent and method of use thereof
US20040049262 *Jun 9, 2003Mar 11, 2004Obermiller Joseph F.Stent valves and uses of same
US20040098100 *Jan 15, 2003May 20, 2004Williams Michael S.Endoprostheses and methods of manufacture
Referenced by
Citing PatentFiling datePublication dateApplicantTitle
US7670368Feb 7, 2005Mar 2, 2010Boston Scientific Scimed, Inc.Venous valve apparatus, system, and method
US7682385Jul 3, 2006Mar 23, 2010Boston Scientific CorporationArtificial valve
US7682390Jul 30, 2002Mar 23, 2010Medtronic, Inc.Assembly for setting a valve prosthesis in a corporeal duct
US7708775May 24, 2006May 4, 2010Edwards Lifesciences CorporationMethods for rapid deployment of prosthetic heart valves
US7712606Feb 2, 2006May 11, 2010Sadra Medical, Inc.Two-part package for medical implant
US7722666Apr 15, 2005May 25, 2010Boston Scientific Scimed, Inc.Valve apparatus, system and method
US7748389Oct 21, 2004Jul 6, 2010Sadra Medical, Inc.Leaflet engagement elements and methods for use thereof
US7758606Feb 5, 2004Jul 20, 2010Medtronic, Inc.Intravascular filter with debris entrapment mechanism
US7776053Dec 12, 2006Aug 17, 2010Boston Scientific Scimed, Inc.Implantable valve system
US7780627Jul 16, 2007Aug 24, 2010Boston Scientific Scimed, Inc.Valve treatment catheter and methods
US7780722Feb 7, 2005Aug 24, 2010Boston Scientific Scimed, Inc.Venous valve apparatus, system, and method
US7780725Jun 16, 2004Aug 24, 2010Sadra Medical, Inc.Everting heart valve
US7780726Jul 27, 2007Aug 24, 2010Medtronic, Inc.Assembly for placing a prosthetic valve in a duct in the body
US7799038Jan 20, 2006Sep 21, 2010Boston Scientific Scimed, Inc.Translumenal apparatus, system, and method
US7824442Nov 5, 2004Nov 2, 2010Sadra Medical, Inc.Methods and apparatus for endovascularly replacing a heart valve
US7824443Feb 2, 2006Nov 2, 2010Sadra Medical, Inc.Medical implant delivery and deployment tool
US7854755Feb 1, 2005Dec 21, 2010Boston Scientific Scimed, Inc.Vascular catheter, system, and method
US7854761Dec 19, 2003Dec 21, 2010Boston Scientific Scimed, Inc.Methods for venous valve replacement with a catheter
US7871436Feb 15, 2008Jan 18, 2011Medtronic, Inc.Replacement prosthetic heart valves and methods of implantation
US7878966Feb 4, 2005Feb 1, 2011Boston Scientific Scimed, Inc.Ventricular assist and support device
US7892276Dec 21, 2007Feb 22, 2011Boston Scientific Scimed, Inc.Valve with delayed leaflet deployment
US7892281Jan 5, 2009Feb 22, 2011Medtronic Corevalve LlcProsthetic valve for transluminal delivery
US7914569May 13, 2005Mar 29, 2011Medtronics Corevalve LlcHeart valve prosthesis and methods of manufacture and use
US7951189Jul 27, 2009May 31, 2011Boston Scientific Scimed, Inc.Venous valve, system, and method with sinus pocket
US7951197Apr 6, 2009May 31, 2011Medtronic, Inc.Two-piece prosthetic valves with snap-in connection and methods for use
US7959666Nov 5, 2004Jun 14, 2011Sadra Medical, Inc.Methods and apparatus for endovascularly replacing a heart valve
US7959672Aug 3, 2004Jun 14, 2011Sadra MedicalReplacement valve and anchor
US7959674Mar 3, 2004Jun 14, 2011Medtronic, Inc.Suture locking assembly and method of use
US7967853Feb 5, 2008Jun 28, 2011Boston Scientific Scimed, Inc.Percutaneous valve, system and method
US7967857Jan 29, 2007Jun 28, 2011Medtronic, Inc.Gasket with spring collar for prosthetic heart valves and methods for making and using them
US7972377Aug 29, 2008Jul 5, 2011Medtronic, Inc.Bioprosthetic heart valve
US7972378Jan 23, 2009Jul 5, 2011Medtronic, Inc.Stents for prosthetic heart valves
US7981153Mar 14, 2005Jul 19, 2011Medtronic, Inc.Biologically implantable prosthesis methods of using
US7988724Feb 14, 2007Aug 2, 2011Sadra Medical, Inc.Systems and methods for delivering a medical implant
US8002824Jul 23, 2009Aug 23, 2011Boston Scientific Scimed, Inc.Cardiac valve, system, and method
US8002826Oct 14, 2009Aug 23, 2011Medtronic Corevalve LlcAssembly for placing a prosthetic valve in a duct in the body
US8012198Jun 10, 2005Sep 6, 2011Boston Scientific Scimed, Inc.Venous valve, system, and method
US8016877Jun 29, 2009Sep 13, 2011Medtronic Corevalve LlcProsthetic valve for transluminal delivery
US8021421Aug 22, 2003Sep 20, 2011Medtronic, Inc.Prosthesis heart valve fixturing device
US8025695Jan 31, 2003Sep 27, 2011Medtronic, Inc.Biologically implantable heart valve system
US8048153Jun 3, 2008Nov 1, 2011Sadra Medical, Inc.Low profile heart valve and delivery system
US8052749Sep 20, 2005Nov 8, 2011Sadra Medical, Inc.Methods and apparatus for endovascular heart valve replacement comprising tissue grasping elements
US8052750Mar 23, 2007Nov 8, 2011Medtronic Ventor Technologies LtdValve prosthesis fixation techniques using sandwiching
US8070801Feb 23, 2009Dec 6, 2011Medtronic, Inc.Method and apparatus for resecting and replacing an aortic valve
US8075615Mar 28, 2007Dec 13, 2011Medtronic, Inc.Prosthetic cardiac valve formed from pericardium material and methods of making same
US8092487Jun 14, 2010Jan 10, 2012Medtronic, Inc.Intravascular filter with debris entrapment mechanism
US8109996Feb 25, 2005Feb 7, 2012Sorin Biomedica Cardio, S.R.L.Minimally-invasive cardiac-valve prosthesis
US8124127Oct 16, 2006Feb 28, 2012Atrium Medical CorporationHydrophobic cross-linked gels for bioabsorbable drug carrier coatings
US8128681Dec 19, 2003Mar 6, 2012Boston Scientific Scimed, Inc.Venous valve apparatus, system, and method
US8133270Jan 8, 2008Mar 13, 2012California Institute Of TechnologyIn-situ formation of a valve
US8136659May 10, 2010Mar 20, 2012Sadra Medical, Inc.Two-part package for medical implant
US8137394Jan 14, 2011Mar 20, 2012Boston Scientific Scimed, Inc.Valve with delayed leaflet deployment
US8137398Oct 13, 2008Mar 20, 2012Medtronic Ventor Technologies LtdProsthetic valve having tapered tip when compressed for delivery
US8157852Jan 22, 2009Apr 17, 2012Medtronic, Inc.Delivery systems and methods of implantation for prosthetic heart valves
US8157853Jan 22, 2009Apr 17, 2012Medtronic, Inc.Delivery systems and methods of implantation for prosthetic heart valves
US8182528Dec 23, 2003May 22, 2012Sadra Medical, Inc.Locking heart valve anchor
US8211169May 26, 2006Jul 3, 2012Medtronic, Inc.Gasket with collar for prosthetic heart valves and methods for using them
US8226710Mar 25, 2011Jul 24, 2012Medtronic Corevalve, Inc.Heart valve prosthesis and methods of manufacture and use
US8231670Nov 3, 2008Jul 31, 2012Sadra Medical, Inc.Repositionable heart valve and method
US8241274Sep 30, 2009Aug 14, 2012Medtronic, Inc.Method for guiding a medical device
US8246678Mar 9, 2007Aug 21, 2012Sadra Medicl, Inc.Methods and apparatus for endovascularly replacing a patient's heart valve
US8252052Feb 8, 2008Aug 28, 2012Sadra Medical, Inc.Methods and apparatus for endovascularly replacing a patient's heart valve
US8263102Sep 28, 2005Sep 11, 2012Atrium Medical CorporationDrug delivery coating for use with a stent
US8287584Nov 14, 2005Oct 16, 2012Sadra Medical, Inc.Medical implant deployment tool
US8312825Apr 16, 2009Nov 20, 2012Medtronic, Inc.Methods and apparatuses for assembly of a pericardial prosthetic heart valve
US8312836Jul 30, 2008Nov 20, 2012Atrium Medical CorporationMethod and apparatus for application of a fresh coating on a medical device
US8313525Mar 18, 2008Nov 20, 2012Medtronic Ventor Technologies, Ltd.Valve suturing and implantation procedures
US8328868Oct 13, 2009Dec 11, 2012Sadra Medical, Inc.Medical devices and delivery systems for delivering medical devices
US8343213Oct 21, 2004Jan 1, 2013Sadra Medical, Inc.Leaflet engagement elements and methods for use thereof
US8348995Mar 23, 2007Jan 8, 2013Medtronic Ventor Technologies, Ltd.Axial-force fixation member for valve
US8348996Mar 23, 2007Jan 8, 2013Medtronic Ventor Technologies Ltd.Valve prosthesis implantation techniques
US8348998Jun 23, 2010Jan 8, 2013Edwards Lifesciences CorporationUnitary quick connect prosthetic heart valve and deployment system and methods
US8348999Feb 13, 2012Jan 8, 2013California Institute Of TechnologyIn-situ formation of a valve
US8349003Apr 12, 2011Jan 8, 2013Medtronic, Inc.Suture locking assembly and method of use
US8367099Sep 22, 2006Feb 5, 2013Atrium Medical CorporationPerforated fatty acid films
US8414641Mar 2, 2012Apr 9, 2013Boston Scientific Scimed, Inc.Valve with delayed leaflet deployment
US8414643Mar 23, 2007Apr 9, 2013Medtronic Ventor Technologies Ltd.Sinus-engaging valve fixation member
US8430927Feb 2, 2009Apr 30, 2013Medtronic, Inc.Multiple orifice implantable heart valve and methods of implantation
US8460365May 27, 2011Jun 11, 2013Boston Scientific Scimed, Inc.Venous valve, system, and method with sinus pocket
US8460373Jul 1, 2011Jun 11, 2013Medtronic, Inc.Method for implanting a heart valve within an annulus of a patient
US8470023Jun 22, 2011Jun 25, 2013Boston Scientific Scimed, Inc.Percutaneous valve, system, and method
US8500798May 24, 2006Aug 6, 2013Edwards Lifesciences CorporationRapid deployment prosthetic heart valve
US8500802Mar 8, 2011Aug 6, 2013Medtronic, Inc.Two-piece prosthetic valves with snap-in connection and methods for use
US8501229Feb 24, 2012Aug 6, 2013Atrium Medical CorporationHydrophobic cross-linked gels for bioabsorbable drug carrier coatings
US8506620Nov 13, 2009Aug 13, 2013Medtronic, Inc.Prosthetic cardiac and venous valves
US8511244Oct 19, 2012Aug 20, 2013Medtronic, Inc.Methods and apparatuses for assembly of a pericardial prosthetic heart valve
US8512397Apr 27, 2009Aug 20, 2013Sorin Group Italia S.R.L.Prosthetic vascular conduit
US8512399Dec 28, 2009Aug 20, 2013Boston Scientific Scimed, Inc.Valve apparatus, system and method
US8535373Jun 16, 2008Sep 17, 2013Sorin Group Italia S.R.L.Minimally-invasive cardiac-valve prosthesis
US8539662Jun 16, 2008Sep 24, 2013Sorin Group Italia S.R.L.Cardiac-valve prosthesis
US8540768Dec 30, 2011Sep 24, 2013Sorin Group Italia S.R.L.Cardiac valve prosthesis
US8551162Dec 20, 2002Oct 8, 2013Medtronic, Inc.Biologically implantable prosthesis
US8562672Nov 18, 2005Oct 22, 2013Medtronic, Inc.Apparatus for treatment of cardiac valves and method of its manufacture
US8574627Oct 30, 2007Nov 5, 2013Atrium Medical CorporationCoated surgical mesh
US8579962Dec 20, 2005Nov 12, 2013Sadra Medical, Inc.Methods and apparatus for performing valvuloplasty
US8579966Feb 4, 2004Nov 12, 2013Medtronic Corevalve LlcProsthetic valve for transluminal delivery
US8591570Mar 14, 2008Nov 26, 2013Medtronic, Inc.Prosthetic heart valve for replacing previously implanted heart valve
US8603159Dec 11, 2009Dec 10, 2013Medtronic Corevalve, LlcProsthetic valve for transluminal delivery
US8603160Dec 23, 2003Dec 10, 2013Sadra Medical, Inc.Method of using a retrievable heart valve anchor with a sheath
US8603161Jul 6, 2009Dec 10, 2013Medtronic, Inc.Attachment device and methods of using the same
US8613765Jul 7, 2011Dec 24, 2013Medtronic, Inc.Prosthetic heart valve systems
US8617236Nov 2, 2011Dec 31, 2013Sadra Medical, Inc.Medical devices and delivery systems for delivering medical devices
US8623076Sep 22, 2011Jan 7, 2014Sadra Medical, Inc.Low profile heart valve and delivery system
US8623077Dec 5, 2011Jan 7, 2014Medtronic, Inc.Apparatus for replacing a cardiac valve
US8623078Jun 8, 2011Jan 7, 2014Sadra Medical, Inc.Replacement valve and anchor
US8623080Sep 22, 2011Jan 7, 2014Medtronic, Inc.Biologically implantable prosthesis and methods of using the same
US8628566Jan 23, 2009Jan 14, 2014Medtronic, Inc.Stents for prosthetic heart valves
US8628570Aug 18, 2011Jan 14, 2014Medtronic Corevalve LlcAssembly for placing a prosthetic valve in a duct in the body
US8641757Jun 23, 2011Feb 4, 2014Edwards Lifesciences CorporationSystems for rapidly deploying surgical heart valves
US8652204Jul 30, 2010Feb 18, 2014Medtronic, Inc.Transcatheter valve with torsion spring fixation and related systems and methods
US8668733Nov 12, 2008Mar 11, 2014Sadra Medical, Inc.Everting heart valve
US8672997Apr 24, 2012Mar 18, 2014Boston Scientific Scimed, Inc.Valve with sinus
US8673000May 20, 2011Mar 18, 2014Medtronic, Inc.Stents for prosthetic heart valves
US8685077Mar 14, 2012Apr 1, 2014Medtronics, Inc.Delivery systems and methods of implantation for prosthetic heart valves
US8685084Dec 28, 2012Apr 1, 2014Sorin Group Italia S.R.L.Prosthetic vascular conduit and assembly method
US8696742Oct 10, 2012Apr 15, 2014Edwards Lifesciences CorporationUnitary quick-connect prosthetic heart valve deployment methods
US8696743Apr 16, 2009Apr 15, 2014Medtronic, Inc.Tissue attachment devices and methods for prosthetic heart valves
US8721708Sep 23, 2011May 13, 2014Medtronic Corevalve LlcProsthetic valve for transluminal delivery
US8721714Sep 17, 2008May 13, 2014Medtronic Corevalve LlcDelivery system for deployment of medical devices
US8721717Jan 27, 2012May 13, 2014Boston Scientific Scimed, Inc.Venous valve apparatus, system, and method
US8747458Aug 20, 2007Jun 10, 2014Medtronic Ventor Technologies Ltd.Stent loading tool and method for use thereof
US8747459Dec 6, 2007Jun 10, 2014Medtronic Corevalve LlcSystem and method for transapical delivery of an annulus anchored self-expanding valve
US8747460Dec 23, 2011Jun 10, 2014Medtronic Ventor Technologies Ltd.Methods for implanting a valve prothesis
US8747463Aug 3, 2011Jun 10, 2014Medtronic, Inc.Methods of using a prosthesis fixturing device
US8771302Apr 6, 2007Jul 8, 2014Medtronic, Inc.Method and apparatus for resecting and replacing an aortic valve
US8771345Oct 31, 2011Jul 8, 2014Medtronic Ventor Technologies Ltd.Valve prosthesis fixation techniques using sandwiching
US8771346Jul 25, 2011Jul 8, 2014Medtronic Ventor Technologies Ltd.Valve prosthetic fixation techniques using sandwiching
US8777980Dec 23, 2011Jul 15, 2014Medtronic, Inc.Intravascular filter with debris entrapment mechanism
US8784478Oct 16, 2007Jul 22, 2014Medtronic Corevalve, Inc.Transapical delivery system with ventruculo-arterial overlfow bypass
US8795703Sep 28, 2005Aug 5, 2014Atrium Medical CorporationStand-alone film and methods for making the same
US8801779May 10, 2011Aug 12, 2014Medtronic Corevalve, LlcProsthetic valve for transluminal delivery
US8808369Oct 5, 2010Aug 19, 2014Mayo Foundation For Medical Education And ResearchMinimally invasive aortic valve replacement
US8821569Apr 30, 2007Sep 2, 2014Medtronic, Inc.Multiple component prosthetic heart valve assemblies and methods for delivering them
US8828078Sep 20, 2005Sep 9, 2014Sadra Medical, Inc.Methods and apparatus for endovascular heart valve replacement comprising tissue grasping elements
US8828079Jul 26, 2007Sep 9, 2014Boston Scientific Scimed, Inc.Circulatory valve, system and method
US8834563Dec 16, 2009Sep 16, 2014Sorin Group Italia S.R.L.Expandable prosthetic valve having anchoring appendages
US8834564Mar 11, 2010Sep 16, 2014Medtronic, Inc.Sinus-engaging valve fixation member
US8840661May 13, 2009Sep 23, 2014Sorin Group Italia S.R.L.Atraumatic prosthetic heart valve prosthesis
US8840662Oct 27, 2011Sep 23, 2014Sadra Medical, Inc.Repositionable heart valve and method
US8840663Dec 23, 2003Sep 23, 2014Sadra Medical, Inc.Repositionable heart valve method
US8845720Sep 20, 2011Sep 30, 2014Edwards Lifesciences CorporationProsthetic heart valve frame with flexible commissures
US8858620Jun 10, 2011Oct 14, 2014Sadra Medical Inc.Methods and apparatus for endovascularly replacing a heart valve
US8858978Sep 28, 2005Oct 14, 2014Atrium Medical CorporationHeat cured gel and method of making
US8876894Mar 23, 2007Nov 4, 2014Medtronic Ventor Technologies Ltd.Leaflet-sensitive valve fixation member
US8876895Mar 23, 2007Nov 4, 2014Medtronic Ventor Technologies Ltd.Valve fixation member having engagement arms
US8876896Dec 7, 2011Nov 4, 2014Medtronic Corevalve LlcProsthetic valve for transluminal delivery
US8894703Jun 22, 2011Nov 25, 2014Sadra Medical, Inc.Systems and methods for delivering a medical implant
US8911493Jul 30, 2013Dec 16, 2014Edwards Lifesciences CorporationRapid deployment prosthetic heart valves
US8920492Aug 21, 2013Dec 30, 2014Sorin Group Italia S.R.L.Cardiac valve prosthesis
US8932349Aug 22, 2011Jan 13, 2015Boston Scientific Scimed, Inc.Cardiac valve, system, and method
US8940014Nov 14, 2012Jan 27, 2015Boston Scientific Scimed, Inc.Bond between components of a medical device
US8951243Nov 29, 2012Feb 10, 2015Boston Scientific Scimed, Inc.Medical device handle
US8951280Jun 9, 2010Feb 10, 2015Medtronic, Inc.Cardiac valve procedure methods and devices
US8951299Oct 13, 2009Feb 10, 2015Sadra Medical, Inc.Medical devices and delivery systems for delivering medical devices
US8956402Sep 14, 2012Feb 17, 2015Medtronic, Inc.Apparatus for replacing a cardiac valve
US8961593Dec 5, 2013Feb 24, 2015Medtronic, Inc.Prosthetic heart valve systems
US8986329Oct 28, 2013Mar 24, 2015Medtronic Corevalve LlcMethods for transluminal delivery of prosthetic valves
US8986361Oct 17, 2008Mar 24, 2015Medtronic Corevalve, Inc.Delivery system for deployment of medical devices
US8986374May 10, 2011Mar 24, 2015Edwards Lifesciences CorporationProsthetic heart valve
US8992608Jun 26, 2009Mar 31, 2015Sadra Medical, Inc.Everting heart valve
US8998976Jul 12, 2012Apr 7, 2015Boston Scientific Scimed, Inc.Coupling system for medical devices
US8998979Feb 11, 2014Apr 7, 2015Medtronic Corevalve LlcTranscatheter heart valves
US8998981Sep 15, 2009Apr 7, 2015Medtronic, Inc.Prosthetic heart valve having identifiers for aiding in radiographic positioning
US9000040Feb 3, 2009Apr 7, 2015Atrium Medical CorporationCross-linked fatty acid-based biomaterials
US9005273Apr 4, 2007Apr 14, 2015Sadra Medical, Inc.Assessing the location and performance of replacement heart valves
US9005277Dec 21, 2012Apr 14, 2015Edwards Lifesciences CorporationUnitary quick-connect prosthetic heart valve deployment system
US9011521Dec 13, 2011Apr 21, 2015Sadra Medical, Inc.Methods and apparatus for endovascularly replacing a patient's heart valve
US9012506Dec 1, 2008Apr 21, 2015Atrium Medical CorporationCross-linked fatty acid-based biomaterials
US9028542Sep 6, 2011May 12, 2015Boston Scientific Scimed, Inc.Venous valve, system, and method
US9060856Feb 11, 2014Jun 23, 2015Medtronic Corevalve LlcTranscatheter heart valves
US9060857Jun 19, 2012Jun 23, 2015Medtronic Corevalve LlcHeart valve prosthesis and methods of manufacture and use
US9066799Jan 20, 2011Jun 30, 2015Medtronic Corevalve LlcProsthetic valve for transluminal delivery
US9078747Nov 13, 2012Jul 14, 2015Edwards Lifesciences CorporationAnchoring device for replacing or repairing a heart valve
US9089422Jan 23, 2009Jul 28, 2015Medtronic, Inc.Markers for prosthetic heart valves
US9131926Nov 5, 2012Sep 15, 2015Boston Scientific Scimed, Inc.Direct connect flush system
US9138312Jun 6, 2014Sep 22, 2015Medtronic Ventor Technologies Ltd.Valve prostheses
US9138314Feb 10, 2014Sep 22, 2015Sorin Group Italia S.R.L.Prosthetic vascular conduit and assembly method
US9149357Dec 23, 2013Oct 6, 2015Medtronic CV Luxembourg S.a.r.l.Heart valve assemblies
US9149358Jan 23, 2009Oct 6, 2015Medtronic, Inc.Delivery systems for prosthetic heart valves
US9161836Feb 10, 2012Oct 20, 2015Sorin Group Italia S.R.L.Sutureless anchoring device for cardiac valve prostheses
US9226826Feb 24, 2010Jan 5, 2016Medtronic, Inc.Transcatheter valve structure and methods for valve delivery
US9237886Apr 14, 2008Jan 19, 2016Medtronic, Inc.Implant for treatment of a heart valve, in particular a mitral valve, material including such an implant, and material for insertion thereof
US9248017May 20, 2011Feb 2, 2016Sorin Group Italia S.R.L.Support device for valve prostheses and corresponding kit
US9277991Dec 31, 2013Mar 8, 2016Boston Scientific Scimed, Inc.Low profile heart valve and delivery system
US9277993Dec 14, 2012Mar 8, 2016Boston Scientific Scimed, Inc.Medical device delivery systems
US9278161Oct 19, 2009Mar 8, 2016Atrium Medical CorporationTissue-separating fatty acid adhesion barrier
US9289289Feb 10, 2012Mar 22, 2016Sorin Group Italia S.R.L.Sutureless anchoring device for cardiac valve prostheses
US9295550Mar 28, 2014Mar 29, 2016Medtronic CV Luxembourg S.a.r.l.Methods for delivering a self-expanding valve
US9301834Oct 16, 2009Apr 5, 2016Medtronic Ventor Technologies Ltd.Sinus-engaging valve fixation member
US9301843Nov 10, 2010Apr 5, 2016Boston Scientific Scimed, Inc.Venous valve apparatus, system, and method
US9308085Sep 23, 2014Apr 12, 2016Boston Scientific Scimed, Inc.Repositionable heart valve and method
US9314334Nov 25, 2013Apr 19, 2016Edwards Lifesciences CorporationConformal expansion of prosthetic devices to anatomical shapes
US9320599Sep 24, 2014Apr 26, 2016Boston Scientific Scimed, Inc.Methods and apparatus for endovascularly replacing a heart valve
US9331328Dec 12, 2011May 3, 2016Medtronic, Inc.Prosthetic cardiac valve from pericardium material and methods of making same
US9333078Nov 22, 2013May 10, 2016Medtronic, Inc.Heart valve assemblies
US9333100Nov 22, 2013May 10, 2016Medtronic, Inc.Stents for prosthetic heart valves
US9339382Jan 24, 2014May 17, 2016Medtronic, Inc.Stents for prosthetic heart valves
US9358106Nov 11, 2013Jun 7, 2016Boston Scientific Scimed Inc.Methods and apparatus for performing valvuloplasty
US9358110Dec 31, 2013Jun 7, 2016Boston Scientific Scimed, Inc.Medical devices and delivery systems for delivering medical devices
US9370418Mar 12, 2013Jun 21, 2016Edwards Lifesciences CorporationRapidly deployable surgical heart valves
US9370419Nov 30, 2010Jun 21, 2016Boston Scientific Scimed, Inc.Valve apparatus, system and method
US9370421Dec 30, 2014Jun 21, 2016Boston Scientific Scimed, Inc.Medical device handle
US9387071Sep 12, 2014Jul 12, 2016Medtronic, Inc.Sinus-engaging valve fixation member
US9387076Dec 30, 2014Jul 12, 2016Boston Scientific Scimed Inc.Medical devices and delivery systems for delivering medical devices
US9393094Feb 7, 2012Jul 19, 2016Boston Scientific Scimed, Inc.Two-part package for medical implant
US9393112Feb 27, 2014Jul 19, 2016Medtronic Ventor Technologies Ltd.Stent loading tool and method for use thereof
US9393113Dec 9, 2013Jul 19, 2016Boston Scientific Scimed Inc.Retrievable heart valve anchor and method
US9393115Jan 23, 2009Jul 19, 2016Medtronic, Inc.Delivery systems and methods of implantation for prosthetic heart valves
US9415225Mar 15, 2013Aug 16, 2016Cardiac Pacemakers, Inc.Method and apparatus for pacing during revascularization
US9421083Jun 24, 2013Aug 23, 2016Boston Scientific Scimed Inc.Percutaneous valve, system and method
US9427423Mar 10, 2009Aug 30, 2016Atrium Medical CorporationFatty-acid based particles
US9468527Jun 12, 2014Oct 18, 2016Edwards Lifesciences CorporationCardiac implant with integrated suture fasteners
US9474609Oct 7, 2015Oct 25, 2016Boston Scientific Scimed, Inc.Venous valve, system, and method with sinus pocket
US9480556Oct 23, 2013Nov 1, 2016Medtronic, Inc.Replacement prosthetic heart valve, system and method of implant
US9486313Nov 19, 2014Nov 8, 2016Sorin Group Italia S.R.L.Cardiac valve prosthesis
US9492596Feb 2, 2007Nov 15, 2016Atrium Medical CorporationBarrier layer with underlying medical device and one or more reinforcing support structures
US9498329Oct 21, 2013Nov 22, 2016Medtronic, Inc.Apparatus for treatment of cardiac valves and method of its manufacture
US20050137686 *Dec 23, 2003Jun 23, 2005Sadra Medical, A Delaware CorporationExternally expandable heart valve anchor and method
US20050137687 *Dec 23, 2003Jun 23, 2005Sadra MedicalHeart valve anchor and method
US20050261669 *Apr 26, 2005Nov 24, 2005Medtronic, Inc.Intracardiovascular access (ICVA™) system
US20060004442 *Jun 30, 2004Jan 5, 2006Benjamin SpenserParavalvular leak detection, sealing, and prevention
US20060067983 *Sep 28, 2005Mar 30, 2006Atrium Medical CorporationStand-alone film and methods for making the same
US20060206202 *Nov 18, 2005Sep 14, 2006Philippe BonhoefferApparatus for treatment of cardiac valves and method of its manufacture
US20060287668 *Jun 16, 2005Dec 21, 2006Fawzi Natalie VApparatus and methods for intravascular embolic protection
US20090240264 *Mar 18, 2008Sep 24, 2009Yosi TuvalMedical suturing device and method for use thereof
US20100174363 *Dec 30, 2009Jul 8, 2010Endovalve, Inc.One Piece Prosthetic Valve Support Structure and Related Assemblies
USD732666Aug 9, 2011Jun 23, 2015Medtronic Corevalve, Inc.Heart valve prosthesis
Classifications
U.S. Classification623/2.11, 623/900, 623/2.14
International ClassificationA61F2/24
Cooperative ClassificationA61F2220/0016, A61F2/2475, A61F2220/005, A61F2220/0075, A61F2230/0054, A61F2/2418
European ClassificationA61F2/24D6