US20100256750A1 - Prosthetic Heart Valves, Scaffolding Structures, and Systems and Methods for Implantation of Same - Google Patents
Prosthetic Heart Valves, Scaffolding Structures, and Systems and Methods for Implantation of Same Download PDFInfo
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- US20100256750A1 US20100256750A1 US12/755,655 US75565510A US2010256750A1 US 20100256750 A1 US20100256750 A1 US 20100256750A1 US 75565510 A US75565510 A US 75565510A US 2010256750 A1 US2010256750 A1 US 2010256750A1
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- support member
- prosthetic valve
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/243—Deployment by mechanical expansion
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- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2418—Scaffolds therefor, e.g. support stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
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Definitions
- the present invention relates generally to medical devices and methods. More particularly, the present invention relates to prosthetic heart valves, structures for providing scaffolding of body lumens, and devices and methods for delivering and deploying these valves and structures.
- stenosis refers to a failure of the valve to open fully, due to stiffened valve tissue.
- Incompetence refers to valves that cause inefficient blood circulation by permitting backflow of blood in the heart.
- Medication may be used to treat some heart valve disorders, but many cases require replacement of the native valve with a prosthetic heart valve.
- Prosthetic heart valves can be used to replace any of the native heart valves (aortic, mitral, tricuspid or pulmonary), although repair or replacement of the aortic or mitral valves is most common because they reside in the left side of the heart where pressures are the greatest.
- Two primary types of prosthetic heart valves are commonly used, mechanical heart valves and prosthetic tissue heart valves.
- the caged ball design is one of the early mechanical heart valves.
- the caged ball design uses a small ball that is held in place by a welded metal cage.
- another prosthetic valve was designed that used a tilting disc to better mimic the natural patterns of blood flow.
- the tilting-disc valves had a polymer disc held in place by two welded struts.
- the bileaflet valve was introduced in the late 1970s. It included two semicircular leaflets that pivot on hinges. The leaflets swing open completely, parallel to the direction of the blood flow. They do not close completely, which allows some backflow.
- Prosthetic tissue valves include human tissue valves and animal tissue valves. Both types are often referred to as bioprosthetic valves. The design of bioprosthetic valves are closer to the design of the natural valve. Bioprosthetic valves do not require long-term anticoagulants, have better hemodynamics, do not cause damage to blood cells, and do not suffer from many of the structural problems experienced by the mechanical heart valves.
- Human tissue valves include homografts, which are valves that are transplanted from another human being, and autografts, which are valves that are transplanted from one position to another within the same person.
- Animal tissue valves are most often heart tissues recovered from animals.
- the recovered tissues are typically stiffened by a tanning solution, most often glutaraldehyde.
- the most commonly used animal tissues are porcine, bovine, and equine pericardial tissue.
- the animal tissue valves are typically stented valves. Stentless valves are made by removing the entire aortic root and adjacent aorta as a block, usually from a pig. The coronary arteries are tied off, and the entire section is trimmed and then implanted into the patient.
- a conventional heart valve replacement surgery involves accessing the heart in the patent's thoracic cavity through a longitudinal incision in the chest. For example, a median sternotomy requires cutting through the sternum and forcing the two opposing halves of the rib cage to be spread apart, allowing access to the thoracic cavity and heart within. The patient is then placed on cardiopulmonary bypass which involves stopping the heart to permit access to the internal chambers.
- Such open heart surgery is particularly invasive and involves a lengthy and difficult recovery period.
- a less invasive approach to valve replacement is desired.
- the percutaneous implantation of a prosthetic valve is a preferred procedure because the operation is performed under local anesthesia, does not require cardiopulmonary bypass, and is less traumatic.
- Current attempts to provide such a device generally involve stent-like structures, which are very similar to those used in vascular stent procedures with the exception of being larger diameter as required for the aortic anatomy, as well as having leaflets attached to provide one way blood flow.
- These stent structures are radially contracted for delivery to the intended site, and then expanded/deployed to achieve a tubular structure in the annulus.
- the stent structure needs to provide two primary functions. First, the structure needs to provide adequate radial stiffness when in the expanded state.
- Radial stiffness is required to maintain the cylindrical shape of the structure, which assures the leaflets coapt properly. Proper leaflet coaption assures the edges of the leaflets mate properly, which is necessary for proper sealing without leaks. Radial stiffness also assures that there will be no paravalvular leakage, which is leaking between the valve and aorta interface, rather than through the leaflets. An additional need for radial stiffness is to provide sufficient interaction between the valve and native aortic wall that there will be no valve migration as the valve closes and holds full body blood pressure. This is a requirement that other vascular devices are not subjected to.
- the second primary function of the stent structure is the ability to be crimped to a reduced size for implantation.
- Prior devices have utilized traditional stenting designs which are produced from tubing or wire wound structures. Although this type of design can provide for crimpability, it provides little radial stiffness. These devices are subject to “radial recoil” in that when the device is deployed, typically with balloon expansion, the final deployed diameter is smaller than the diameter the balloon and stent structure were expanded to. The recoil is due in part because of the stiffness mismatches between the device and the anatomical environment in which it is placed. These devices also commonly cause crushing, tearing, or other deformation to the valve leaflets during the contraction and expansion procedures. Other stenting designs have included spirally wound metallic sheets.
- This type of design provides high radial stiffness, yet crimping results in large material strains that can cause stress fractures and extremely large amounts of stored energy in the constrained state.
- Replacement heart valves are expected to survive for many years when implanted. A heart valve sees approximately 500,000,000 cycles over the course of 15 years. High stress states during crimping can reduce the fatigue life of the device.
- Still other devices have included tubing, wire wound structures, or spirally wound sheets formed of nitinol or other superelastic or shape memory material. These devices suffer from some of the same deficiencies as those described above.
- the scaffolding structures and prosthetic valves described herein address both attributes of high radial stiffness along with crimpability, and maximizing fatigue life.
- the present invention provides apparatus and methods for deploying support structures in body lumens.
- the methods and apparatus are particularly adapted for use in percutaneous aortic valve replacement.
- the methods and apparatus may also find use in the peripheral vasculature, the abdominal vasculature, and in other ducts such as the biliary duct, the fallopian tubes, and similar lumen structures within the body of a patient.
- the apparatus and methods may also find application in the treatment of animals.
- a prosthetic valve in one aspect of the invention, includes a support member and a valvular body attached to the support member.
- the prosthetic valve has an expanded state in which the support member has a cross-sectional shape that is generally cylindrical or generally oval and which has a first cross-sectional dimension (e.g., diameter), and a contracted state in which the support member has a second cross-sectional dimension (e.g., diameter) smaller than the first.
- the prosthetic valve is in its contracted state during delivery of the prosthetic valve to a treatment location, and in its expanded state after deployment at the treatment location.
- the cross-sectional dimension of the support member in its expanded state is sufficiently large, and the support member possesses sufficient radial strength, to cause the support member to positively physically engage the internal surface of the body lumen, such as the aortic valve annulus or another biologically acceptable aortic position (e.g., a location in the ascending or descending aorta), thereby providing a strong friction fit.
- the aortic valve annulus or another biologically acceptable aortic position e.g., a location in the ascending or descending aorta
- the support member has a cross-sectional dimension that is slightly larger than the dimension of the treatment location, such as a body lumen.
- the support member may be provided with a cross-sectional dimension that is from about 0 to about 25% larger than the cross-sectional dimension of the valve annulus.
- Cross-sectional dimensions even larger than 25% greater than that of the body lumen may also be used, depending upon the nature of the treatment location.
- the support member once deployed, the support member extends to its full cross-sectional dimension—i.e., it does not compress radially due to the radial force imparted by the lumen or other tissue.
- the support member will expand the cross-sectional dimension of the lumen or other tissue at the treatment location. In this way, the support member reduces the possibility of fluid leakage around the periphery of the device. In addition, due to the strength of the interference fit that results from the construction of the device, the support member will have proper apposition to the lumen or tissue to reduce the likelihood of migration of the device once deployed.
- the support member is a structure having at least two peripheral segments, at least two of which segments are connected to each other by a foldable junction.
- segment refers to a constituent part into which the support member is divided by foldable junctions or other junctions connecting adjacent segments.
- each segment comprises a panel, with two or more connected panels making up the support member.
- segments may comprise beams, braces, struts, or other structural members extending between the foldable junctions provided on the support member. Any of these (or any other) alternative structures, or any combinations thereof, may be provided as one or more segments of the support member.
- the foldable junction may comprise any structural member that allows two adjacent segments to partially or completely fold one upon another.
- the foldable junction comprises a hinge. Suitable hinges include mechanical hinges, membrane hinges, living hinges, or combinations of such hinges.
- two adjacent panels may be connectable by a selectively locking junction, such as pairs of opposed tabs and slots.
- a selectively locking junction such as pairs of opposed tabs and slots.
- a combination of foldable junctions and locking junctions may be used.
- the support structure may be provided with one or more anchoring members that are adapted to engage the internal wall of the body lumen.
- Each anchoring member may comprise a barb, a tooth, a hook, or any other member that protrudes from the external surface of the support structure to physically engage the internal wall of the body lumen.
- the anchoring member may comprise an aperture formed in the support structure that allows tissue to invaginate therethrough, i.e., the outward radial force of the support member against the vessel wall causes the frame portion of the support member to slightly embed into the vessel wall, thereby causing some of the tissue to penetrate through the aperture into the interior of the support member.
- the tissue invagination acts to anchor the support structure in place.
- An anchoring member may be selectively engageable, such as by an actuator, or it may be oriented so as to be permanently engaged. Alternatively, the anchoring member may be self-actuating, or it may be deployed automatically during deployment of the support member.
- the anchoring member advantageously may perform functions in addition to engaging the internal wall of the body lumen.
- the anchoring member may ensure proper positioning of the support structure within the body lumen. It may also prevent migration or other movement of the support structure, and it may provide additional or enhanced sealing of the support structure to the body lumen, such as by creating better tissue adherence.
- the support structure may also be provided with an optional sealing member, such as a gasket.
- the sealing member preferably is fixed to the external surface of the support structure around all or a portion of the circumference of the support structure, and serves to decrease or eliminate the flow of fluids between the vessel wall and the support member.
- the sealing member may comprise a relatively soft biocompatible material, such as a polyurethane or other polymer.
- the sealing member is porous or is otherwise capable of expanding or swelling when exposed to fluids, thereby enhancing the sealing ability of the sealing member.
- the sealing member may include a functional composition such as an adhesive, a fixative, or therapeutic agents such as drugs or other materials.
- a coating may be applied to or created on any of the surfaces of the support member. Coatings may be applied or created to provide any desired function. For example, a coating may be applied to carry an adhesive, a fixative, or therapeutic agents such as drugs or other materials. Coatings may be created on the external surface of the support member to facilitate tissue penetration (e.g., ingrowth) into the support structure. Coatings may also be provided to promote sealing between the support member and the native tissue, or to reduce the possibility that the support member may migrate from its intended location. Other coating functions will be recognized by those skilled in the art.
- the valvular body may be of a single or multi-piece construction, and includes a plurality of leaflets.
- the valvular body may be attached either to the internal or external surface of the support structure.
- the valvular body includes a base portion that is attachable to the support structure, and a plurality of (and preferably three) leaflets extending from the base portion.
- the valvular body includes a plurality of (preferably three) members, each including a base portion that is attachable to the support structure and a leaflet portion. In either case, the base portion(s) of the valvular body are attached to a portion of the internal or external surface of the support structure, and the leaflets extend away from the base portion and generally inwardly toward each other to form the valve.
- the valvular body may comprise a homogeneous material, for example, a polymer such as polyurethane or other suitable elastomeric material.
- the valvular body may comprise a coated substrate, wherein the substrate comprises a polymer (e.g., polyester) or metallic (e.g., stainless steel) mesh, and the coating comprises a polymer such as polyurethane or other suitable elastomeric material.
- the substrate comprises a polymer (e.g., polyester) or metallic (e.g., stainless steel) mesh
- the coating comprises a polymer such as polyurethane or other suitable elastomeric material.
- Other suitable constructions are also possible.
- the valvular body may comprise human (including homograft or autograft) or animal (e.g., porcine, bovine, equine, or other) tissue.
- human including homograft or autograft
- animal e.g., porcine, bovine, equine, or other
- the valvular body may be attached to the support structure by any suitable mechanism.
- an attachment lip formed of a polymer, fabric, or other flexible material may be molded or adhered to the surface of the support member, and the valvular body sewn, adhered, or molded onto the attachment lip.
- an edge portion of the valvular body may be sandwiched between a pair of elastomeric strips that are attached to the surface of the support member.
- Other and further attachment mechanisms may also be used.
- each of the foregoing embodiments of the prosthetic valve preferably has a fully expanded state for deployment within a body lumen, and a contracted state for delivery to the lumen in a minimally invasive interventional procedure through the patient's vasculature.
- each of the segments of the support member is oriented peripherally and adjacent to one another, attached to each adjacent segment by a foldable junction or an locking junction.
- the segments are folded together at the foldable junctions and, preferably, then formed into a smaller diameter tubular structure.
- the contracted state may be achieved in different combinations and manners of folding and rolling the segments and junctions, depending on the particular structure of the prosthetic valve.
- the prosthetic valve comprises a generally cylindrical support member made up of three panels, with each panel connected to its adjacent panel by a hinge.
- the hinges may be mechanical hinges, membrane hinges, living hinges, or a combination of such hinges.
- each panel of the prosthetic valve In its fully expanded state, each panel of the prosthetic valve is an arcuate member that occupies approximately 120°, or one third, of the circular cross-section of the cylindrical support member.
- one or more of the panels may span a smaller portion of the cylindrical support member, while the other panel(s) are relatively larger.
- a relatively shorter panel may be provided on a side of the valve corresponding to the non-coronary native valve leaflet, which is generally smaller than the other native valve leaflets.
- a valvular body is attached to the internal surface of each of the three panels.
- the contracted state is obtained by first inverting each of the panels at its centerline, i.e., changing each panel from a convex shape to a concave shape by bringing the centerline of each panel toward the longitudinal axis running through the center of the generally cylindrical support member. This action causes the foldable junctions to fold, creating a vertex at each foldable junction.
- a three vertex star-shaped structure results.
- a four vertex star-shaped structure would result.
- the valvular body which is formed of generally flexible, resilient materials, generally follows the manipulations of the support member without any substantial crimping, tearing, or permanent deformation.
- Inversion of the panels results in a structure having a relatively smaller maximum transverse dimension than that of the fully expanded structure.
- each vertex is curled back toward the central axis to create a plurality of lobes equi-spaced about the central axis, i.e., in the three-panel structure, three lobes are formed.
- the resulting multi-lobe structure has an even further reduced maximum transverse dimension, and represents one embodiment of the contracted state of the prosthetic valve.
- the prosthetic valve comprises a generally cylindrical support member made up of three panels defining three junctions, two of which comprise hinges, and one of which comprises a set of locking tabs and slots.
- the hinges may be mechanical hinges, membrane hinges, living hinges, other hinge types, or a combination of such hinges.
- each panel of the prosthetic valve in its fully expanded state, is an arcuate member that occupies approximately 120°, or one third, of the circular cross-section of the cylindrical support member.
- a valvular body is attached to the internal surface of each of the three panels, with at least one separation in the valvular body corresponding with the location of the locking junction on the support member.
- the contracted state in this alternative embodiment is obtained by first disengaging the locking tabs and slots at the non-hinge junction between a first two of the panels.
- the locking tabs and slots may be simply unlocked to permit relative motion while remaining slidably engaged.
- the third panel, opposite the non-hinge junction is then inverted, i.e., changed from convex to concave by bringing the centerline of the panel toward the longitudinal axis running through the center of the generally cylindrical support member.
- the other two panels are then nested behind the third panel, each retaining its concave shape, by rotating the hinges connecting each panel to the third panel.
- the resulting structure is a curved-panel shaped member.
- the valvular body which is formed of generally flexible, resilient materials, generally follows the manipulations of the support member without any substantial crimping, tearing, or permanent deformation.
- the structure is then curled into a tubular structure having a relatively small diameter in relation to that of the fully expanded prosthetic valve, and which represents an alternative embodiment of the contracted state of the prosthetic valve.
- the prosthetic valve comprises a generally oval-shaped support member made up of two panels, with a hinge provided at the two attachment edges between the panels.
- the hinges may be mechanical hinges, membrane hinges, living hinges, or a combination of such hinges.
- a valvular body is attached to the internal surface of each of the two panels.
- the contracted state is obtained by first inverting one of the two panels at its centerline, i.e., changing the panel from a convex shape to a concave shape by bringing the centerline of the panel toward the longitudinal axis running through the center of the generally oval support member. This action causes the foldable junctions to fold, creating a vertex at each foldable junction, and causes the two panels to come to a nested position.
- the valvular body which is formed of generally flexible, resilient materials, generally follows the manipulations of the support member without any substantial crimping, tearing, or permanent deformation.
- the structure is then curled into a tubular structure having a relatively small diameter in relation to that of the fully expanded prosthetic valve, and which represents another alternative embodiment of the contracted state of the prosthetic valve.
- the support structure is a generally tubular member constructed such that it is capable of transforming from a contracted state having a relatively small diameter and large length, to an expanded state having a relatively large diameter and small length.
- the transformation from the contracted state to the expanded state entails causing the tubular member to foreshorten in length while expanding radially.
- the forced foreshortening transformation may be achieved using any of a wide range of structural components and/or methods.
- the support structure comprises an axially activated support member.
- the axially activated support member includes a generally tubular body member formed of a matrix of flexible struts.
- struts are arranged in crossing pairs forming an “X” pattern, with the ends of a first crossing pair of struts being connected to the ends of a second crossing pair of struts by a band connector, thereby forming a generally cylindrical member.
- Additional generally cylindrical members may be incorporated into the structure by interweaving the struts contained in the additional cylindrical member with one or more of the struts included in the first cylindrical member.
- An axial member is connected to at least two opposed band connectors located on opposite ends of the structure. When the axial member is decreased in length, the support member is expanded to a large diameter state, accompanied by a degree of foreshortening of the support member.
- the support member When the axial member is increased in length, the support member is contracted to a smaller diameter state, accompanied by a degree of lengthening of the support member.
- the expanded state may be used when the support member is deployed in a body lumen, and the contracted state may be used for delivery of the device.
- a valvular body, as described above, may be attached to the internal or external surface of the support member.
- the axial member may be replaced by a circumferential member, a spirally wound member, or any other structure adapted to cause the tubular member to foreshorten and thereby to transform to the expanded state.
- the axial or other member may be attached to opposed connectors, to connectors that are not opposed, or connectors may not be used at all.
- the support member may be formed of a plurality of braided wires or a single wire formed into a tubular shape by wrapping around a mandrel. In either case, the structure is caused to radially expand by inducing foreshortening.
- the support structure (or portions thereof) may be self-expanding, such as by being formed of a resilient or shape memory material that is adapted to transition from a relatively long tubular member having a relatively small cross-sectional dimension to a relatively shorter tubular member having a relatively larger cross-sectional dimension.
- the support structure may partially self-expand by foreshortening, after which an expansion device may be used to cause further radial expansion and longitudinal foreshortening.
- the support member comprises a multiple panel hinged ring structure.
- the multiple panel hinged ring structure includes a plurality of (preferably three) circumferential rings interconnected by one or more (preferably three) longitudinal posts.
- Each ring structure is composed of a plurality of segments, such as curved panels, each connected to its adjacent panels by a junction member, such as a polymeric membrane hinge.
- the hinges are rotated to transform the structure from an expanded state for deployment, to a contracted state for delivery.
- a valvular body as described elsewhere herein, is attached to the internal or external surface of the support member.
- the support member comprises a collapsing hinged structure.
- the collapsing hinged structure includes a plurality of (preferably about twenty-four) panels arranged peripherally around the generally tubular structure, each panel having a tab on its edge that overlaps and engages a mating tab on the opposed edge of the adjacent panel, interlocking the adjacent panels.
- An elastic membrane is attached to an external surface of adjacent panels and provides a force biasing the adjacent panels together to assist the tabs in interlocking each adjacent pair of panels.
- the elastic membrane is attached to the main body of each panel, but not at the opposed edges.
- the tabs may be disengaged and the panels rotated to form a vertex at each shared edge, thereby defining a multi-vertex “star” shape that corresponds with the contracted state of the support member.
- the support member is transformed to its expanded state by applying an outward radial force that stretches the elastic membrane and allows the tabs to re-engage.
- a valvular body as described elsewhere herein, is attached to the internal or external surface of the support member.
- the various support members may be incorporated in a prosthetic valve, as described above, by attaching a valvular body to the external or internal surface of the support member.
- any of the foregoing support members may be utilized without a valvular body to provide a support or scaffolding function within a body lumen, such as a blood vessel or other organ.
- the multi-segment, multi-hinged support member may be used as a scaffolding member for the treatment of abdominal aortic aneurisms, either alone, or in combination with another support member, graft, or other therapeutic device.
- Other similar uses are also contemplated, as will be understood by those skilled in the art.
- Each of the foregoing prosthetic valves and support members is adapted to be transformed from its expanded state to its contracted state to be carried by a delivery catheter to a treatment location by way of a minimally invasive interventional procedure, as described more fully elsewhere herein.
- delivery devices for delivering a prosthetic valve to a treatment location in a body lumen are provided, as are methods for their use.
- the delivery devices are particularly adapted for use in minimally invasive interventional procedures, such as percutaneous aortic valve replacements.
- the delivery devices include an elongated delivery catheter having proximal and distal ends.
- a handle is provided at the proximal end of the delivery catheter.
- the handle may be provided with a knob, an actuator, a slider, other control members, or combinations thereof for controlling and manipulating the catheter to perform the prosthetic valve delivery procedure.
- a retractable outer sheath may extend over at least a portion of the length of the catheter.
- a guidewire lumen extends proximally from the distal end of the catheter.
- the guidewire lumen may extend through the entire length of the catheter for over-the-wire applications, or the guidewire lumen may have a proximal exit port closer to the distal end of the catheter than the proximal end for use with rapid-
- the distal portion of the catheter includes a carrier adapted to receive and retain a prosthetic valve and to maintain the prosthetic valve in a contracted state, and to deploy the prosthetic valve at a treatment location within a body lumen.
- the distal portion of the catheter is provided with a delivery tube having a plurality of longitudinal slots at its distal end, and a gripper having a longitudinal shaft and a plurality of fingers that extend longitudinally from the distal end of the gripper.
- the delivery tube has the same number of longitudinal slots, and the gripper includes the same number of fingers, as there are segments on the prosthetic valve to be delivered.
- the longitudinal slots on the distal end of the delivery tube are equally spaced around the periphery of the tube.
- the fingers are arranged in a generally circular pattern. For example, in the case of three fingers, all three are spaced apart on an imaginary circle and are separated from each other by approximately 120°. In the case of four fingers, the fingers are separated from each other by approximately 90°, and so on.
- the spacing and orientation of the longitudinal slots and fingers may vary from these preferred values while still being sufficient to perform the delivery function in the manner described herein.
- the gripper is slidably and rotatably received within the delivery tube, and the delivery tube is internal of the outer sheath.
- the outer sheath is retractable to expose at least the longitudinal slots on the distal portion of the delivery tube.
- the gripper is able to be advanced at least far enough to extend the fingers distally outside the distal end of the delivery tube.
- the gripper fingers may comprise wires, fibers, hooks, sleeves, other structural members extending distally from the distal end of the gripper, or combinations of any of the foregoing.
- a primary function of the fingers is to retain a prosthetic valve on the distal end of the gripper, and to restrain segments of the support member of the valve in an inverted state. Accordingly, any of the above (or other) structural members able to perform the above function may be substituted for the fingers described above.
- An optional atraumatic tip or nosecone may be provided at the distal end of the device.
- the tip is preferably formed of a relatively soft, elastomeric material and has a rounded to conical shape.
- a central lumen is provided in the tip to allow passage of the guidewire. The shape and physical properties of the tip enhance the ability of the delivery device to safely pass through the vasculature of a patient without damaging vessel walls or other portions of the anatomy.
- the atraumatic tip may enhance the ability of the distal portion of the device to cross the native heart valve when the leaflets of the native valve are fully or partially closed due to calcification from disease or other disorder.
- the delivery device is particularly adapted for use in a minimally invasive surgical procedure to deliver a multi-segment prosthetic valve, such as those described above, to a body lumen.
- the prosthetic valve is first loaded into the delivery device.
- the delivery tube will have three longitudinal slots at its distal end, and the gripper will be provided with three fingers.
- the prosthetic valve is loaded into the delivery device by first inverting the three segments to produce a three vertex structure. Inverting of the prosthetic valve segments may be performed manually, or with the aid of a tool.
- the prosthetic valve is then placed onto the distal end of the gripper, which has been previously extended outside the distal end of the delivery tube, with each of the three fingers retaining one of the inverted segments in its inverted position.
- the gripper and fingers, with the prosthetic valve installed thereon, are then retracted back into the delivery tube.
- the gripper and fingers are rotationally aligned with the delivery tube such that the three vertices of the prosthetic valve align with the three longitudinal slots on the distal end of the delivery tube.
- each of the three vertices of the prosthetic valve extends radially outside the delivery tube through the longitudinal slots.
- the gripper is then rotated relative to the delivery tube (or the delivery tube rotated relative to the gripper), which action causes each of the folded segments of the prosthetic valve to engage an edge of its respective delivery tube slot. Further rotation of the gripper relative to the delivery tube causes the folded segments to curl back toward the longitudinal axis of the prosthetic valve internally of the delivery tube, creating three lobes located fully within the delivery tube.
- the prosthetic valve is thereby loaded into the delivery device.
- the outer sheath may then be advanced over the distal portion of the catheter, including the delivery tube, to prepare the delivery device for use.
- the prosthetic valve is delivered by first introducing a guidewire into the vascular system and to the treatment location of the patient by any conventional method, preferably by way of the femoral artery.
- a suitable introducer sheath may be advanced to facilitate introduction of the delivery device.
- the delivery catheter is then advanced over the guidewire to the treatment location.
- the outer sheath is then retracted to expose the delivery tube.
- the gripper is then rotated relative to the delivery tube (or the delivery tube rotated relative to the gripper), thereby causing the folded segments of the prosthetic valve to uncurl and to extend radially outward through the longitudinal slots of the delivery tube.
- the delivery tube is then retracted (or the gripper advanced) to cause the prosthetic valve (restrained by the fingers) to advance distally out of the delivery tube.
- the gripper is then retracted relative to the prosthetic valve, releasing the prosthetic valve into the treatment location.
- the inverted segments then revert to the expanded state, causing the valve to lodge against the internal surface of the body lumen (e.g., the aortic valve root or another biologically acceptable aortic position).
- Additional expansion of the prosthetic valve may be provided, if needed, by a suitable expansion member, such as an expansion balloon or an expanding mesh member (described elsewhere herein), carried on the delivery catheter or other carrier.
- the distal portion of the catheter includes a restraining sheath, an orientation sheath, a plurality of grippers, an expander, and a plurality of struts.
- An optional atraumatic tip or nosecone, as described above, may also be fixed to the distal end of the device.
- Each of the grippers includes a wire riding within a tube, and a tip at the distal end of the tube.
- the wire of each gripper is adapted to engage the vertex of a prosthetic valve support member having multiple segments, and to selectively restrain the prosthetic valve in a contracted state.
- the expander is adapted to selectively cause the grippers to expand radially outwardly when it is actuated by the user by way of an actuator located on the handle.
- the prosthetic valve may be loaded into the delivery device by contracting the prosthetic valve (either manually or with a tool) by inverting each panel and then attaching each vertex to a respective gripper on the delivery device.
- the grippers receive, retain, and restrain the prosthetic valve in its contracted state.
- the gripper assembly having the prosthetic valve installed is then retracted into each of the orientation sheath and the restraining sheath to prepare the device for insertion into the patient's vasculature.
- the device is then advanced over a guidewire to a treatment location, such as the base annulus of the native aortic valve or another biologically acceptable aortic position (e.g., a location in the ascending or descending aorta).
- the restraining sheath is then retracted to allow the prosthetic valve to partially expand (e.g., to about 85% of its full transverse dimension), where it is constrained by the orientation sheath.
- the prosthetic valve is then finally positioned by manipulation of the grippers, after which the orientation sheath is retracted and the grippers released.
- the prosthetic valve then is fixedly engaged in the treatment location.
- the distal portion of the catheter includes one or more restraining tubes having at least one (and preferably two) adjustable restraining loops.
- the restraining tube(s) extend distally from a catheter shaft out of the distal end of the delivery device, and each restraining loop is a wire or fiber loop that extends transversely from the restraining tube.
- Each restraining loop is a flexible loop capable of selectively restraining a contracted prosthetic valve.
- the restraining loop may be selectively constricted or released by a control member, such as a knob, located on the handle of the device, or by another external actuation member.
- An optional retractable outer sheath may be provided to cover the distal portion of the catheter.
- an optional atraumatic tip or nosecone as described above, may be provided at the distal end of the device.
- the prosthetic valve may be loaded onto the delivery device by contracting the prosthetic valve (either manually or with a tool) into its contracted state, for example, by inverting each panel and curling each inverted panel into a lobe.
- the contracted prosthetic valve is then placed onto the restraining tube(s) and through the one or more restraining loops.
- the loops are constricted around the contracted prosthetic valve, thereby restraining the prosthetic valve in its contracted state.
- the optional outer sheath may then be advanced over the prosthetic valve and the restraining tube(s) to prepare the delivery device for use.
- the device is then advanced over a guidewire to a treatment location, such as the base annulus of the native aortic valve or another biologically acceptable aortic position (e.g., a location in the ascending or descending aorta).
- a treatment location such as the base annulus of the native aortic valve or another biologically acceptable aortic position (e.g., a location in the ascending or descending aorta).
- the restraining sheath is then retracted to expose the contracted prosthetic valve.
- the restraining loops are released, such as by rotating the control knob, thereby releasing the prosthetic valve and allowing it to self-expand.
- the prosthetic valve is thereby fixedly engaged in the treatment location.
- An expansion member may be advanced to the interior of the prosthetic valve (or retracted from distally of the valve) and expanded to provide additional expansion force, if needed or desired.
- the user is able to deploy the device in a careful, controlled, and deliberate manner. This allows the user to, among other things, pause the delivery procedure and reposition the device if needed to optimize the delivery location. This added degree of control is a feature that is not available in many of the previous percutaneous device delivery methods.
- an expansion member for performing dilation functions in minimally invasive surgical procedures.
- the expansion member may be used in procedures such as angioplasty, valvuloplasty, stent or other device placement or expansion, and other similar procedures.
- the expansion member may be used to provide additional expansion force to the support members used on the prosthetic valves described herein.
- the expansion member comprises a plurality of inflation balloons oriented about a longitudinal axis.
- Each inflation balloon is connected at its proximal end by a feeder lumen to a central lumen that provides fluid communication between the inflation balloons and a source of inflation media associated with a handle portion of a catheter.
- the central lumen itself is provided with a guidewire lumen to allow passage of a guidewire through the expansion member.
- a flexible member is attached to the distal end of each of the inflation balloons, and also includes a guidewire lumen.
- the expansion member includes three inflation balloons, although fewer or more balloons are possible.
- the balloons may each be inflated individually, all together, or in any combination to obtain a desired force distribution.
- the multiple inflation balloon structure provides a number of advantages, including the ability to provide greater radial forces than a single balloon, and the ability to avoid occluding a vessel undergoing treatment and to allow blood or other fluid to flow through the device.
- the expansion member comprises a flexible, expandable mesh member.
- the expandable mesh member includes a shaft and a cylindrical woven mesh member disposed longitudinally over the shaft. A distal end of the cylindrical mesh member is attached to the distal end of the shaft. The proximal end of the cylindrical mesh member is slidably engaged to the shaft by a collar proximally of the distal end. As the collar is advanced distally along the shaft, the body of the cylindrical mesh member is caused to expand radially, thereby providing a radially expansion member.
- the proximal end of the mesh member may be fixed to the shaft and the distal end may have a collar engagement allowing it to advance proximally along the shaft to cause the mesh member to expand radially. Still further, each of the proximal and distal ends of the mesh member may be slidably engaged to the shaft, and each moved toward the other to cause radial expansion.
- FIG. 1A is a perspective view of a prosthetic valve in accordance with the present invention.
- FIG. 1B is a perspective view of a support member in accordance with the present invention.
- FIG. 2A is a perspective view of a support member having illustrating inverted panels.
- FIG. 2B is a top view of the support member of FIG. 2A .
- FIG. 2C is a top view of a support member in a contracted state.
- FIG. 3A is a perspective view of another support member in accordance with the present invention.
- FIG. 3B is a close-up view of a hinge on the support member of FIG. 3A .
- FIG. 3C is a close-up view of an locking tab and slot on the support member of FIG. 3A .
- FIG. 3D is a perspective view of the support member shown in FIG. 3A , illustrating inversion of a panel.
- FIG. 3E is a perspective view of the support member shown in FIG. 3A , illustrating a nested arrangement of the three panels.
- FIG. 3F is a perspective view of the support member shown in FIG. 3A , illustrating a contracted state of the support member.
- FIG. 3G is an end view of the support member shown in FIG. 3A , illustrating a contracted state of the support member.
- FIG. 3H is a top view of another support member, illustrating a nested arrangement of the three panels.
- FIG. 3I is a side view of the support member shown in FIG. 3H .
- FIG. 4A is a perspective view illustrating a hinge connecting two panels of a support member.
- FIG. 4B is a perspective view of the hinge shown in FIG. 4A , illustrating the hinge in is folded state.
- FIG. 4C is a perspective view of another hinge connecting two panels of a support member.
- FIG. 4D is a perspective view of another hinge connecting two panels of a support member.
- FIG. 5A is a perspective view of a support member having inverted panels, illustrating removable hinge pins.
- FIG. 5B is a perspective view of a support member after separation of its three panels.
- FIG. 6 is a perspective view of another support member.
- FIG. 7 is a close-up view of an attachment mechanism for attaching a valvular body to a support member.
- FIG. 8A is a perspective view of a valvular body.
- FIG. 8B is a perspective view showing separate leaflets of the valvular body of FIG. 8A .
- FIG. 9A is a perspective view of an axially activated support member in its contracted state.
- FIG. 9B is a perspective view of the axially activated support member of FIG. 9A , shown in its expanded state.
- FIG. 10A is a perspective view of a multiple panel hinged ring prosthetic valve.
- FIG. 10B is an end view of the prosthetic valve shown in FIG. 10A .
- FIG. 10C is a perspective view of a multiple panel hinged ring support member.
- FIG. 10D is an end view of the support member shown in FIG. 10C .
- FIG. 10E is a close-up view of a panel contained on the support member shown in FIG. 10C .
- FIG. 10F is a perspective view of a portion of a ring of panels contained on the support member shown in FIG. 10C .
- FIG. 10G is a top view of a ring of panels contained on a support member, shown in a contracted state.
- FIG. 10H is a perspective view of the support member shown in FIG. 10C , shown in the contracted state.
- FIG. 10I is a top view of a ring of panels contained on another support member, shown in a contracted state.
- FIG. 10J is a perspective view of the support member shown in FIG. 10I , shown in the contracted state.
- FIG. 11A is a perspective view of a collapsing hinged support member, shown in its expanded state.
- FIG. 11B is a perspective view of the collapsing hinged support member, shown in its contracted state.
- FIG. 11C is a close-up view of a portion of the collapsing hinged support member shown in FIG. 11A .
- FIG. 12A is a perspective view of a prosthetic valve retained on a delivery device.
- FIG. 12B is a top view of the prosthetic valve and delivery device shown in FIG. 12A .
- FIG. 12C is a side view of the prosthetic valve and delivery device shown in FIG. 12A .
- FIG. 12D is another top view of the prosthetic valve and delivery device shown in FIG. 12A .
- FIG. 12E is another top view the prosthetic valve and delivery device shown in FIG. 12A .
- FIG. 12F is another top view of the prosthetic valve and delivery device shown in FIG. 12A .
- FIG. 13A is a perspective view, shown in partial cross-section, of a prosthetic valve delivery device.
- FIG. 13B is a close-up view of a portion of the prosthetic valve delivery device shown in FIG. 13A .
- FIG. 13C is another close-up view of a portion of the prosthetic valve delivery device shown in FIG. 13A
- FIG. 13D is another perspective view, shown in partial cross-section, of the prosthetic valve delivery device shown in FIG. 13A .
- FIG. 13E is an illustration showing the delivery device of FIG. 13A delivering a prosthetic valve to a treatment location.
- FIG. 14A is a perspective view of another prosthetic valve delivery device.
- FIG. 14B is a close-up view of a distal portion of the prosthetic valve delivery device shown in FIG. 14A .
- FIG. 14C is another close-up view of the distal portion of the prosthetic valve delivery device shown in FIG. 14A .
- FIG. 14D is an illustration showing the delivery device of FIG. 14A delivering a prosthetic valve to a treatment location.
- FIG. 14E is another illustration showing the delivery device of FIG. 14A delivering a prosthetic valve to a treatment location.
- FIG. 15A is a perspective view of another prosthetic valve delivery device.
- FIG. 15B is a close-up view of a distal portion of the prosthetic valve delivery device shown in FIG. 15A .
- FIG. 16A is a perspective view of another prosthetic valve delivery device.
- FIG. 16B is another perspective view of the prosthetic valve delivery device shown in FIG. 16A .
- FIG. 17A is a perspective view of a multi-balloon expansion device.
- FIG. 17B is another perspective view of the multi-balloon expansion device shown in FIG. 17A .
- FIG. 18A is a perspective view of an expandable mesh member, shown in its contracted state.
- FIG. 18B is another perspective view of the expandable mesh member of FIG. 18A , shown in its expanded state.
- FIG. 18C is an illustration showing the expandable mesh member being advanced into the interior space of a prosthetic valve.
- FIG. 18D is another illustration showing the expandable mesh member being advanced into the interior space of a prosthetic valve.
- the prosthetic valve 30 is particularly adapted for use as a replacement aortic valve, but may be used for other indications as well.
- the prosthetic valve 30 includes a generally cylindrical support member 32 and a valvular body 34 attached to the internal surface of the support member.
- a generally cylindrical support member is shown, support members having other than circular cross-sectional shapes, such as oval, elliptical, or irregular, may also be provided depending upon the nature of the treatment location and environment in which the prosthetic valve or the support structure are intended to be used.
- the support member in the embodiment shown in FIG. 1A is made up of three generally identical curved panels 36 , with each panel spanning approximately 120° of the circular cross-section of the support member. (As noted elsewhere herein, the panels need not be generally identical in terms of size, materials, thickness, or other properties.)
- Each panel 36 includes a frame 38 and a semi-circular aperture 40 extending over a large portion of the central portion of the panel.
- the aperture 40 includes a number of interconnecting braces 42 extending across the breadth of the aperture, thereby defining a number of sub-apertures 44 between the braces.
- the braces define several diamond-shaped sub-apertures 46 , partial diamond-shaped sub-apertures 48 , and an elongated sub-aperture 50 .
- Apertures and sub-apertures of different shapes and sizes than those shown in the FIG. 1A embodiment are also possible.
- a single semi-circular aperture 40 is provided, with no braces and no sub-apertures.
- a panel may comprise a solid member having no apertures or sub-apertures.
- the panels of the support member are typically the portion of the structure that engages the internal surface of the lumen at the treatment location. In the case of a prosthetic heart valve, among other functions, the panels physically engage and displace the leaflets of the native valve.
- the panels are also the primary portion of the structure that is in physical engagement with the body lumen and that is holding the structure in place and preventing migration. Therefore, the materials and structure of the panels are adapted, at least in part, to perform these functions. In some instances, a large aperture may be preferred, in other cases a particular bracing structure may be preferred, while in still other cases it is preferable not to have any apertures or bracing. These features may be varied to provide desired performance, depending upon the anatomical environment.
- each of the panels shown, and those described elsewhere herein, is preferably formed from a sheet of resilient, biocompatible material, such as stainless steel, other metals or metal alloys, resilient polymers such as plastics, or other suitable materials conventionally used for implantable medical devices.
- the panels are formed from a super-elastic shape-memory material, such as nitinol or other similar metal alloys.
- the panels may be molded, extruded, etched, cut, stamped or otherwise fabricated from sheets of material, or manufactured in other ways known to those skilled in the art.
- FIG. 1A includes three panels, those skilled in the art will recognize that fewer or more panels may be incorporated into the support member.
- a two panel structure may be employed, or structures having four, five, or many more panels.
- a structure may be provided having non-panel segments, such as beams, braces, struts, or other structural members extending between the foldable junctions provided on the support member. Any of these (or any other) alternative structures, or any combinations thereof, may be provided as one or more segments of the support member, provided that the structure is capable of providing the physical and structural characteristics needed to support the prosthetic valve in its intended function.
- each of the segments making up a support member may be identical to the other segments, it is also possible to provide segments having different physical properties.
- the panels may be made up of different materials, or one or more panels may have a different size or thickness than the other panel(s), or the physical properties between the different panels may be altered in some other manner. This may be done, for example, as an accommodation for the treatment location in which the prosthetic valve is to be placed.
- the wall thickness of the aortic root for example, varies around its circumference.
- a hinge 52 is provided at the junction formed between each pair of adjacent panels.
- the hinge is a membrane hinge comprising a thin sheet of elastomeric material 54 attached to the external edge 56 of each of a pair of adjacent panels 36 .
- the membrane hinge maintains the side-to-side orientation of each pair of adjacent panels, preventing any significant amount of slipping or sliding between the panels.
- the hinge 52 is also foldable so as to allow the panels 36 to invert and the edges 56 to fold together to form a vertex.
- the hinge (or other foldable junction member) to allow adjacent panels to invert and fold against each other at adjacent edges is a substantial feature in creating a contracted state for the support member, and the prosthetic valve.
- the hinge 52 (or other foldable junction) preferably is adapted to allow the support member 32 to physically conform to the internal surface of the body lumen at the treatment location.
- hinges and other foldable junctions may be used in alternative embodiments.
- other types of hinges include standard piano hinges, living hinges, and other types of mechanical hinges. See, for example, the support member 32 shown in FIG. 1B , in which each pair of adjacent panels 36 is connected by a standard piano hinge 58 , i.e., a long, narrow hinge with a pin 60 running the entire length of its joint that interconnects meshed sets of knuckles 62 formed on the edge of each of the pair of adjacent panels 36 .
- FIGS. 4A-D Several other alternative hinge structures are shown in FIGS. 4A-D , in which FIGS.
- FIG. 4A-B show another membrane hinge in which the elastomeric strip 54 is attached to each of a pair of adjacent panels 36 on the internal surface of the support member 32 .
- FIG. 4A shows a portion of the support structure 32 in its expanded state
- FIG. 4B shows the portion of the structure after the pair of adjacent panels 36 have been folded against each other at the membrane hinge 52 , thereby forming a vertex 64 .
- FIG. 4C shows a close-up view of another standard piano hinge 58 design, similar to that shown in FIG. 1B , showing the pin 60 and the meshing knuckles 62 formed on the edge of each of the pair of adjacent panels 36 .
- FIG. 4D shows a living hinge 66 that includes a flexible (e.g., elastomeric) hinge member 68 that is attached to each of the pair of adjacent panels 36 and that extends the length of the junction between the panels.
- FIG. 5A shows another support member (in a partially contracted condition) illustrating removable hinge pins.
- foldable junctions may also be used instead of hinges.
- a section of a sheet may be etched, scored, or otherwise thinned relative to the adjacent portions of the device to provide a weakened section that allows inversion and folding of a pair of adjacent segments of the sheet, thereby providing a foldable junction.
- Other alternative foldable junctions are also contemplated, and will be understood by persons of skill in the art, to be suitable for use in the support members described herein.
- the foldable junction may be provided with a lock-out feature that allows the foldable junction to fold in a direction that allows adjacent panels to invert, as described herein, but that prevents the foldable junction from folding in the opposite direction.
- a standard piano hinge may be constructed in a manner that provides only about 180° of rotation in a conventional manner, and attached to a pair of adjacent panels such that inward rotation is allowed, but outward rotation is prevented.
- Other suitable lock-out mechanisms may be possible, as will be recognized by those of skill in the art.
- hinges and other foldable junctions are preferably oriented uniformly vertically (i.e., parallel to the longitudinal axis of the support member) on the periphery of the support member, other orientations are possible.
- the hinges may be oriented horizontally (i.e., transverse) relative to the longitudinal axis, they may be oriented diagonally relative to the longitudinal axis, they may have a zig-zag or spiral orientation, or they may take on any geometric or irregular pattern.
- the valvular body 34 of the embodiment shown in the figure is a flexible artificial tissue multi-leaflet structure.
- the artificial tissue includes a unitary polymer material or a composite of polymer overlaid onto a flexible substrate, which may be in the form of a mesh.
- the polymer material is any suitable flexible, biocompatible material such as those conventionally used in implantable medical devices.
- the polymer material is polyurethane or another thermoplastic elastomer, although it is not limited to such materials.
- the material comprising the flexible mesh is preferably a flexible, shear-resistant polymeric or metallic material, such as a polyester or very fine metallic (e.g., stainless steel) mesh.
- the valvular body is described more fully below in relation to FIGS. 8A-B .
- the valvular body may be formed of human tissue, such as homografts or autografts, or animal tissue, such as porcine, bovine, or equine tissue (e.g., pericardial or other suitable tissue).
- human tissue such as homografts or autografts
- animal tissue such as porcine, bovine, or equine tissue (e.g., pericardial or other suitable tissue).
- porcine, bovine, or equine tissue e.g., pericardial or other suitable tissue.
- the prosthetic valves described herein have an expanded state that the prosthetic valve takes on when it is in use.
- the FIG. 1A illustration shows a prosthetic valve 30 in its expanded state.
- the support member In the expanded state of the prosthetic valve, the support member is fully 32 extended in its cylindrical (or alternative) shape, with each hinge 52 (or other foldable junction) in its extended, or non-folded state.
- the support member 32 preferably has a cross-sectional dimension (e.g., diameter) that is from about 0 to about 25% larger than that of the body lumen or other treatment location. Once deployed, the support member extends to its full cross-sectional dimension—i.e., it does not compress radially due to the radial force imparted by the lumen or other tissue.
- the present prosthetic valves also have a contracted state that is used in order to deliver the prosthetic valve to a treatment location with the body of a patient.
- the contracted state generally comprises a state having a smaller transverse dimension (e.g., diameter) relative to that of the expanded state.
- FIGS. 2A-C a method for transforming a prosthetic valve from its expanded state to its contracted state is illustrated.
- These Figures show a three-panel support member without a valvular body attached.
- the method for contracting a full prosthetic valve, including the attached valvular body, is similar to that described herein in relation to the support member alone.
- each of the panels 36 is first inverted, by which is meant that a longitudinal centerline 80 of each of the panels is forced radially inward toward the central longitudinal axis 82 of the support member.
- This action is facilitated by having panels formed of a thin, resilient sheet of material having generally elastic properties, and by the presence of the hinges 58 located at the junction between each pair of adjacent panels 36 .
- the edges 56 of each of the adjacent pairs of panels fold upon one another at the hinge 58 .
- the resulting structure shown in FIGS. 2A-B , is a three-vertex 64 star shaped structure.
- Those skilled in the art will recognize that a similar procedure may be used to invert a four (or more) panel support member, in which case the resulting structure would be a four-(or more) vertex star shaped structure.
- the prosthetic valve 30 may be further contracted by curling each of the vertices 64 of the star shaped structure to form a multi-lobe structure, as shown in FIG. 2C .
- each of the three vertices 64 is rotated toward the center longitudinal axis of the device, causing each of the three folded-upon edges of the adjacent pairs of panels to curl into a lobe 84 .
- the resulting structure, illustrated in FIG. 2C is a three-lobe structure that represents the fully contracted state of the prosthetic valve. Manipulation and use of the fully contracted device is described more fully below. Those skilled in the art will recognize that a similar procedure may be used to fully contract a four (or more) panel support member, in which case the resulting structure would be a four-(or more) lobed structure.
- the support member may be contracted by first inverting one of the two panels to cause it to come into close relationship with the other of the two panels to form a nested panel structure.
- the pair of nested panels is then rolled into a small diameter tubular member, which constitutes the contracted state of the two-panel support member.
- FIGS. 3A-I another embodiment of a support member suitable for use in a prosthetic valve is shown.
- This embodiment is structurally similar to the preceding embodiment, but is capable of being transformed to a contracted state in a different manner than that described above.
- the embodiment includes three panels 36 , each having a semi-circular aperture 40 .
- a standard piano hinge 58 is provided at two of the junctions between adjacent pairs of panels. (See FIG. 3B ).
- the third junction does not have a hinge, instead having a locking member 90 .
- the locking member includes a tab 92 attached to each of the top and bottom portions of the edge of the first 36 a of a pair of adjacent panels, and a slot 94 provided along both the top and bottom edges of the second 36 b of the pair adjacent panels. (See FIG. 3C ).
- the tabs 92 on the first panel 36 a are able to extend through and ride in the slots 94 on the second panel 36 b, thereby allowing the first panel 36 a to slide relative to the second panel 36 b while remaining physically engaged to the panel, and then to slide back to the original position.
- a locking tab 96 may be provided on the second panel 36 b to selectively lock the first panel tab 92 in place in the slot 94 .
- FIGS. 3D-G illustrate the manner in which the preceding support member is transformed to its contracted state.
- the panel 36 c situated opposite the locking junction 90 is inverted while leaving the other two panels 36 a - b in their uninverted state.
- the tabs 92 on the first panels 36 a are then slid along the slots 94 in the second panel 36 b , causing the first and second panels 36 a - b to come into a nested arrangement behind the inverted panel 36 c, with the first panel 36 a nested between the inverted panel 36 c and the second panel 36 b. (See FIG. 3E ).
- the nested panels are then able to be curled into a relatively small diameter tubular member 98 , as shown in FIGS. 3F and 3G , which constitutes the contracted state of the support member.
- FIGS. 3H-I illustrate a similar support member in its partially contracted state in which the three panels 36 a - c are in the nested arrangement.
- the support member shown in FIGS. 3H-I also include a plurality of brace members 42 extending through the aperture 40 , forming diamond-shaped sub-apertures 46 , partial diamond-shaped sub-apertures 48 , and an elongated sub-aperture 50 .
- a plurality of raised surfaces 100 , or bumps, are provided over the surfaces of each of the panels 36 a - c to provide positive spacing for the valvular body 34 when the prosthetic valve 30 is placed in the contracted state.
- the positive spacing provided by the raised surfaces 100 serve to decrease the possibility of squeezing, crimping, folding, or otherwise damaging the valvular body 34 or its constituent parts when the prosthetic valve is contracted.
- the raised surfaces 100 (or other spacing member) of the support member may be used on any of the embodiments of the prosthetic valves described herein.
- FIG. 5A illustrates a support member 32 having three panels 36 a - c and three standard piano hinges 58 at the junctions between the three panels.
- the support member is shown with each of its three panels 36 a - c in the inverted position.
- Each of the piano hinges 58 has a removable hinge pin 60 .
- the hinge pins 60 When the hinge pins 60 are removed, the panels 36 a - c may be separated from each other, as illustrated in FIG. 5B .
- the ability to separate the panels may be used to facilitate surgical (or other) removal of the support member, or the prosthetic valve, or the panels may need to be separated for another purpose.
- piano hinges with removable hinge pins are shown in FIGS.
- alternative removable hinge structures may also be used.
- a membrane hinge having a tearable membrane strip will facilitate removal of the support member.
- Further alternatives may include melting or unzipping a hinge.
- Other removable hinge structures are also contemplated. In each of these cases, provision of a hinge that may be easily defeated by some mechanism creates that ability for the user to more easily remove or otherwise manipulate a prosthetic valve or support member for any desired purpose.
- FIG. 6 shows another embodiment of a support member 32 suitable for use in a prosthetic valve 30 .
- the support member 32 includes three panels 36 a - c , each panel having an elongated aperture 50 and a semi-circular aperture 40 .
- the support member includes an elastomeric strip 54 at the foldable junction between each pair of adjacent panels, each of which forms a membrane hinge.
- a valvular body attachment lip 104 is attached to the interior surface of each of the panels 36 a - c to facilitate attachment of the valvular body 34 to the support member 32 .
- the attachment lip 104 may comprise a polymer material suitable for sewing, adhering, or otherwise attaching to the valvular body.
- the attachment lip 104 is preferably molded or adhered onto the interior surface of each of the panels of the support member. Although the attachment lip 104 facilitates one method for attaching the valvular body to the support member, it is not the only method for doing so, and use of the attachment lip 104 is optional.
- FIG. 7 illustrates another structure and method used to attach the valvular body to the support member panels.
- a first strip 110 of polymeric material is adhered to the interior surface of the edge 56 of each panel.
- the first strip 110 of polymeric material does not need to extend along the entire edge, but generally about half of the length.
- the first strip 110 is adhered with any suitable adhesive material, or it may be molded directly onto the panel 36 .
- An attachment lip 120 formed on the base portion of the valvular body is then attached to each of the first strips 110 of polymeric material.
- the attachment lips 120 may be formed on the base portion of the valvular body 34 in any of the embodiments described below, including those having a unitary structure or those having a composite structure. (A composite structure is shown in FIG. 7 ).
- the attachment lips 110 may be attached to the strips of polymeric material using any suitable adhesive or any other suitable method.
- a second strip 112 of polymer material may be attached to the exposed surface of the valvular body attachment lip 120 , sandwiching the attachment lip 120 between the first 110 and second strips 112 of material.
- FIGS. 8A-B show perspective views of valvular bodies suitable for use in the prosthetic valves described herein.
- the valvular body 34 shown in FIG. 8A is of a unitary construction, while that shown in FIG. 8B is of a composite construction, including three separate leaflets 35 a - c .
- the valvular body 34 includes a generally cylindrical base portion 122 that then contracts down into a generally concave portion 124 (as viewed from the interior of the valvular body).
- the valvular body 34 has three lines of coaptation 126 formed on the bottom of the concave portion 124 .
- a slit 128 is either cut or molded into each of the lines of coaptation 126 to create three valve leaflets 130 that perform the valvular fluid regulation function when the valve is implanted in a patient.
- An optional attachment lip 120 may be formed on the outward facing lines of coaptation 126 , to facilitate attachment of the valvular body 34 to the support member in the manner described above in relation to FIG. 7 .
- each separate leaflet 35 a - c includes a base portion 132 and a generally concave portion 134 extending from the base.
- Each leaflet 35 a - c also includes a pair of top edges 136 and a pair of side edges 138 . The top edges and side edges of each leaflet 35 a - c are positioned against the top edges and side edges of each adjacent leaflet when the composite structure embodiment is attached to an appropriate support member.
- the valvular body may be formed solely from a single polymer material or polymer blend, or it may be formed from a substrate having a polymer coating.
- the materials suitable for use as the polymer, substrate, or coating are described above.
- the valvular body may comprise human or animal tissue.
- the valvular body may be attached to the support member by any suitable method.
- the valvular body may be attached to the support member by sewing, adhering, or molding the valvular body to an attachment lip, as described above in relation to FIG. 6 .
- the valvular body may be attached to the support member using the attachment strips described above in relation to FIG. 7 .
- the valvular body may be adhered directly to the support member using an adhesive or similar material, or it may be formed integrally with the support member.
- Other and further suitable attachment methods will be recognized by those skilled in the art.
- the multi-segment support member embodiments described above are suitable for use in the prosthetic valves described herein. Additional structures are also possible, and several are described below.
- the alternative support member is a tubular member that is capable of radial expansion caused by forced foreshortening. As noted earlier herein, several structures and/or methods are available that are capable of this form of transformation, one of which is described in FIGS. 9A-B .
- An axially activated support member 150 includes a generally tubular body member 152 formed of a matrix of flexible struts 154 .
- the struts 154 are arranged in crossing pairs forming an “X” pattern, with the ends of a first crossing pair of struts being connected to the ends of a second crossing pair of struts by a band connector 156 , thereby forming a generally cylindrical member. Additional generally cylindrical members are incorporated into the structure by interweaving the struts contained in the additional cylindrical member with the struts included in the first cylindrical member.
- An axial member 158 is connected to two opposed band connectors 156 located on opposite ends of the structure. When the axial member 158 is decreased in length, as shown in FIG.
- the support member 150 is expanded to a large diameter state, accompanied by a degree of lengthwise foreshortening of the support member.
- the axial member 158 is increased in length, as shown in FIG. 9A , the support member 150 is contracted to a smaller diameter state, accompanied by a degree of lengthening of the support member.
- the expanded state may be used when the support member is deployed in a body lumen, and the contracted state may be used for delivery of the device.
- a valvular body, as described above, may be attached to the internal or external surface of the support member.
- the support member comprises a multiple panel hinged ring structure 170 .
- the multiple panel hinged ring structure includes three circumferential rings 172 interconnected by three longitudinal posts 174 . More or fewer rings and/or posts may be used.
- Each ring structure is composed of a plurality of curved panels 176 , each connected to its adjacent panel by a junction member 178 , such as a polymeric membrane hinge.
- the individual panels 176 have a curvature 180 about the axis of the device as well as a curvature 182 in the transverse direction. (See FIG. 10E ).
- a coating material 184 maintains the panels in relation to one another, as well as providing a foldable junction 186 .
- the curvature of the panels in conjunction with the coating 184 maintains the ring structure in the expanded condition, as shown in FIGS. 10A , 10 C, and 10 D.
- the foldable junctions 186 are rotated to transform the structure from an expanded state 188 for deployment, to a contracted state 190 for delivery. (See FIG. 10E-J ).
- a valvular body, as described elsewhere herein, may be attached to the internal or external surface of the support member.
- the support member comprises a collapsing hinged structure 200 .
- the collapsing hinged structure shown in the Figures includes twenty-four panels 202 arranged peripherally around the generally tubular structure, each panel having a tab 204 on its edge that overlaps and engages a mating tab 206 on the opposed edge of the adjacent panel, interlocking the adjacent panels. More or fewer panels are possible.
- An elastic membrane 208 is attached to an external surface of adjacent panels and provides a force biasing the adjacent panels together to assist the tabs in interlocking each adjacent pair of panels.
- the elastic membrane 208 is attached to the main body of each panel 202 , but not at the opposed edges.
- the tabs 204 , 206 may be disengaged and the panels 202 rotated to form a vertex 210 at each shared edge, thereby defining a multi-vertex “star” shape that corresponds with the contracted state of the support member.
- the support member 200 is transformed to its expanded state by applying an outward radial force that stretches the elastic membrane 208 and allows the tabs 204 , 206 to re-engage.
- a valvular body is attached to the internal or external surface of the support member.
- All of the foregoing support members may be incorporated in a prosthetic valve, as described above, by attaching a valvular body to the external or internal surface of the support member.
- all of the foregoing support members may be utilized without a valvular body to provide a support or scaffolding function within a body lumen, such as a blood vessel or other organ.
- the multi-segment, multi-hinged support member may be used as a scaffolding member for the treatment of abdominal aortic aneurisms, either alone, or in combination with another support member, graft, or other therapeutic device.
- Other similar uses are also contemplated, as will be understood by those skilled in the art.
- anchoring members may be formed on or attached to any of the above-described support member embodiments.
- Each anchoring member may comprise a barb, a tooth, a hook, or any other member that protrudes from the external surface of the support structure to physically engage the internal wall of the body lumen.
- An anchoring member may be selectively engageable, such as by an actuator, or it may be oriented so as to be permanently in its engaged state.
- the anchoring member may comprise an aperture formed in the support structure that allows tissue to invaginate therethrough.
- FIGS One example of an anchoring member is illustrated in FIGS.
- a barb 358 is shown extending from the surface of a contracted prosthetic valve 30 .
- the barb 358 may be deflected inward while the prosthetic valve is retained in the delivery device. See FIG. 13C . Then, upon deployment, the barb 358 is released and extends radially outward to engage the surface of the body lumen or other tissue.
- other anchoring members and mechanisms are also contemplated for use with the devices described herein.
- the prosthetic heart valves and support members described herein provide a number of advantages over prior devices in the art.
- the prosthetic heart valves are able to be transformed to a contracted state and back to an expanded state without causing folding, tearing, crimping, or otherwise deforming the valve leaflets.
- the expanded state of the current device has a fixed cross-sectional size (e.g., diameter) that is not subject to recoil after expansion. This allows the structure to fit better at its treatment location and to better prevent migration. It also allows the valvular body to perform optimally because the size, shape and orientation of the valve leaflets may be designed to a known deployment size, rather than a range.
- the expanded state of the support structure is of a known shape (again, unlike the prior devices), the valve leaflets may be designed in a manner to provide optimal performance.
- FIGS. 14A and 15A illustrate two embodiments of the devices.
- the delivery devices 300 include an elongated delivery catheter 302 having proximal 304 and distal ends 306 .
- a handle 308 is provided at the proximal end of the delivery catheter.
- the handle 308 may be provided with a knob 310 , an actuator, a slider, other control members, or combinations thereof for controlling and manipulating the catheter to perform the prosthetic valve delivery procedure.
- a retractable outer sheath 312 may extend over at least a portion of the length of the catheter.
- a guidewire lumen extends proximally from the distal end of the catheter.
- the guidewire lumen may extend through the entire length of the catheter for over-the-wire applications, or the guidewire lumen may have a proximal exit port closer to the distal end of the catheter than the proximal end for use with rapid-exchange applications.
- the distal portion 306 of the catheter includes a carrier adapted to receive and retain a prosthetic valve in a contracted state, and to deploy the prosthetic valve at a treatment location within a body lumen.
- the device 300 includes a delivery tube 320 having three longitudinal slots 322 at its distal end, and a gripper 324 having a longitudinal shaft 326 and three fingers 328 that extend longitudinally from the distal end of the gripper. More or fewer longitudinal slots may be included on the delivery tube, and more or fewer fingers may be provided on the gripper.
- the delivery tube 320 has the same number of longitudinal slots, and the gripper 324 includes the same number of fingers, as there are segments on the prosthetic valve to be delivered.
- the longitudinal slots 322 on the distal end of the delivery tube are equally spaced around the periphery of the tube.
- the fingers 328 are arranged in an equi-spaced circular pattern. For example, in the case of three fingers, all three are equally spaced apart on an imaginary circle and are separated from each other by 120°. In the case of four fingers, the fingers would be separated from each other by 90°, and so on.
- the gripper 324 is slidably and rotatably received within the delivery tube 320 , and the delivery tube is internal of the outer sheath (not shown in FIGS. 12A-F ).
- the outer sheath is retractable to expose at least the longitudinal slots 322 on the distal portion of the delivery tube.
- the gripper 324 is able to be advanced at least far enough to extend the fingers 328 distally outside the distal end of the delivery tube.
- the gripper fingers 328 may comprise wires, fibers, hooks, or other structural members extending distally from the distal end of the gripper. As described below, a primary function of the fingers is to retain a prosthetic valve on the distal end of the gripper, and to restrain segments of the support member of the valve in an inverted state. Accordingly, any of the above (or other) structural members able to perform the above function may be substituted for the fingers described above.
- the delivery device 300 is particularly adapted for use in a minimally invasive surgical procedure to deliver a multi-segment prosthetic valve 30 , such as those described above, to a body lumen.
- the prosthetic valve 30 is first loaded into the delivery device 300 .
- FIGS. 12A-F illustrate the case of a prosthetic valve having a three segment support member.
- the prosthetic valve 30 is loaded into the delivery device 300 by first inverting the three panels 36 to produce a three vertex structure. Inverting of the prosthetic valve panels may be performed manually, or by using an inverting tool.
- the prosthetic valve 30 is then placed onto the distal end of the gripper 324 , which has been previously extended outside the distal end of the delivery tube 320 , with each of the three fingers 328 retaining one of the inverted panels 36 in its inverted position. (See FIG. 12A ).
- the gripper 324 and fingers 328 with the prosthetic valve 30 installed thereon, are then retracted back into the delivery tube 320 .
- the gripper 324 and fingers 328 are rotationally aligned with the delivery tube 320 such that the three vertices of the prosthetic valve align with the three longitudinal slots on the distal end of the delivery tube. (See FIG. 12B ).
- each of the three vertices of the prosthetic valve extends radially outside the delivery tube through the longitudinal slots 322 .
- the gripper 324 is then rotated relative to the delivery tube 320 , which action causes each of the folded segments of the prosthetic valve 30 to engage an edge of its respective delivery tube slot. (See FIG. 12D ). Further rotation of the gripper 324 relative to the delivery tube 320 causes the folded segments to curl back toward the longitudinal axis of the prosthetic valve internally of the delivery tube, creating three lobes located fully within the delivery tube 320 . (See FIG. 12E ).
- the prosthetic valve 30 is thereby loaded into the delivery device 300 .
- the outer sheath is then advanced over the distal portion of the catheter, including the delivery tube, to prepare the delivery device for use.
- the prosthetic valve 30 is delivered by first introducing a guidewire into the vascular system and to the treatment location of the patient by any conventional method, preferably by way of the femoral artery.
- a suitable introducer sheath may be advanced to facilitate introduction of the delivery device.
- the delivery catheter 302 is then advanced over the guidewire to the treatment location.
- the outer sheath 312 is then retracted to expose the delivery tube 320 .
- the gripper 324 is then rotated relative to the delivery tube 320 (or the delivery tube rotated relative to the gripper), thereby causing the folded panels of the prosthetic valve 30 to uncurl and to extend radially outward through the longitudinal slots 322 of the delivery tube 320 .
- the delivery tube 320 is then retracted (or the gripper advanced) to cause the prosthetic valve 30 (restrained by the fingers 328 ) to advance distally out of the delivery tube.
- the gripper 324 is then retracted relative to the prosthetic valve 30 , releasing the prosthetic valve 30 into the treatment location. (See FIG. 12F ).
- the inverted panels 36 then revert to the expanded state, causing the valve to lodge against the internal surface of the body lumen (e.g., the aortic valve root or another biologically acceptable aortic position). Additional expansion of the prosthetic valve may be provided, if needed, by a suitable expansion member, such as the expansion balloon or the expanding mesh member described elsewhere herein, carried on the delivery catheter 302 or other carrier.
- FIGS. 13A-E another embodiment of a distal portion of a prosthetic valve delivery device is shown.
- the distal portion of the catheter 302 includes a restraining sheath 340 , an orientation sheath 342 , a plurality of grippers 344 , an expander 346 , and a plurality of struts 348 .
- Each of the grippers 344 includes a wire 350 riding within a tube 352 , and a tip 354 at the distal end of the tube.
- the wire 350 of each gripper 344 has an end portion 356 formed to engage the vertex of a prosthetic valve support member 32 having multiple segments, and to selectively restrain the prosthetic valve 30 in a contracted state. (See FIG. 13B ).
- the expander 346 is adapted to selectively cause the grippers 344 to expand radially outwardly when it is actuated by the user by way of an actuator 310 located on the handle 308 .
- the prosthetic valve 30 may be loaded into the delivery device 300 by contracting the prosthetic valve (either manually or with an inverting tool) by inverting each panel 36 and then attaching each vertex to a respective end portion 356 of the wire contained on each gripper 344 on the delivery device.
- the gripper wires 350 receive, retain, and restrain the prosthetic valve 30 in its contracted state.
- the gripper 344 assembly having the prosthetic valve 30 installed is then retracted into each of the orientation sheath 342 and the restraining sheath 340 to prepare the device for insertion into the patient's vasculature.
- the device is then advanced over a guidewire to a treatment location, such as the base annulus of the native aortic valve. (See FIG. 13E ).
- the restraining sheath 340 is then retracted to allow the prosthetic valve 30 to partially expand (e.g., to about 85% of its full transverse dimension), where it is constrained by the orientation sheath 342 .
- the prosthetic valve 30 is then finally positioned by manipulation of the grippers 344 , after which the orientation sheath 342 is retracted and the grippers 344 released.
- the prosthetic valve 30 then lodges itself in the treatment location.
- the distal portion 306 of the catheter includes one or more restraining tubes 370 having at least one (and preferably two) adjustable restraining loops 372 .
- the device is provided with one restraining tube 370 and two restraining loops 372 .
- the device is provided with three restraining tubes 370 and two restraining loops 372 .
- the restraining tube(s) 370 extend distally from a catheter shaft 374 out of the distal end of the delivery device, and each restraining loop 372 is a wire or fiber loop that extends transversely of the restraining tube 370 .
- Each restraining loop 372 is a flexible loop capable of selectively restraining a contracted prosthetic valve.
- the restraining loops 372 may be selectively constricted or released by a control member, such as a knob 310 , located on the handle 308 of the device.
- a retractable outer sheath 376 covers the distal portion of the catheter.
- the prosthetic valve 30 may be loaded onto the delivery device by contracting the prosthetic valve (either manually or with an inverting tool) into its contracted state, for example, by inverting each panel 36 and curling each inverted panel into a lobe.
- the contracted prosthetic valve is then placed onto the restraining tube(s) 370 and through the one or more restraining loops 372 .
- the loops 372 are constricted around the contracted prosthetic valve 30 , thereby restraining the prosthetic valve in its contracted state.
- the outer sheath 376 is then advanced over the prosthetic valve and the restraining tube(s) to prepare the delivery device for use. (See FIG. 14C ).
- the device is then advanced over a guidewire to a treatment location, such as the base annulus of the native aortic valve. (See FIG. 14D ).
- the restraining sheath 376 is then retracted to expose the contracted prosthetic valve 30 .
- the restraining loops 372 are released, such as by rotating the control knob 310 , thereby releasing the prosthetic valve 30 and allowing it to self-expand. (See FIG. 14E ).
- the prosthetic valve 30 then lodges itself in the treatment location.
- An expansion member may be advanced to the interior of the prosthetic valve and expanded to provide additional expansion force, if needed or desired.
- FIGS. 16A-B Another embodiment of the delivery device is shown in FIGS. 16A-B .
- the distal portion of the catheter includes a gripper 400 that includes a base portion 402 having three restraining members 404 extending distally from the gripper base.
- each of the restraining members 404 includes a wire loop 406 extending through a sleeve 408 , with both the sleeve and the wire loop extending distally from the gripper base 402 .
- the wire loops 406 also extend proximally of the gripper base 402 , which is provided with a lumen 410 corresponding with each of the wire loops 406 , thereby allowing the gripper base 402 and the sleeves 404 to slide relative to the wire loops 406 .
- a delivery tube 412 may also be provided. As shown in the Figures, the gripper 400 is slidably received within the delivery tube 412 , and the tube has three longitudinal slots 414 corresponding with the three restraining members 404 on the gripper assembly.
- An atraumatic tip 416 or nosecone is attached to a central shaft 418 that extends through the center of the catheter 302 internally of the gripper 400 and the delivery tube 412 .
- the central shaft 418 includes a guidewire lumen to accommodate a guidewire used to assist deployment of the delivery device.
- the device shown in the Figures includes three restraining members 404 , fewer or additional restraining members may be used.
- One function of the restraining members is to retain a prosthetic valve on the distal end of the delivery device, and to selectively maintain the valve in a contracted state.
- the number of restraining members will coincide with the number of segments (e.g., panels) included on the prosthetic valve.
- the delivery device 300 is shown with the delivery tube 412 and gripper 400 retracted relative to the wire loops 406 , thereby allowing the distal ends 420 of the wire loops to extend freely away from the central shaft 418 .
- the delivery device in this condition is adapted to have a prosthetic valve installed onto the device.
- the prosthetic valve 30 is first placed over the distal end of the device and the panels 36 of the valve are inverted.
- the valve panels 36 may be inverted prior to or simultaneous with placing the valve over the distal end of the delivery device.
- the wire loops 406 are then placed over the inverted panels 36 , and the gripper 400 is advanced to cause the sleeves 408 to physically engage the inverted panels 36 . See FIG.
- the sleeves 408 have sufficient strength to maintain the prosthetic valve panels in their inverted state.
- the delivery tube 412 may then be advanced over the distal end of the device, with the valve panel vertices extending out of the longitudinal slots 414 formed on the delivery tube 412 .
- the gripper 400 may then be rotated relative to the delivery tube (or vice versa) to contract the panel vertices within the interior of the delivery tube and to thereby prepare the device for delivery of the prosthetic valve.
- the valve is delivered in the same manner described above in relation to the device shown in FIGS. 12A-E .
- each of the foregoing delivery devices is suitable for use in delivering a prosthetic heart valve or a support member, such as those described herein.
- the delivery methods may be combined with other treatment devices, methods, and procedures, particularly procedures intended to open or treat a stenotic heart valve.
- a valvuloplasty procedure may be performed prior to the prosthetic heart valve deployment.
- the valvuloplasty procedure may be performed using a conventional balloon or a cutting balloon adapted to cut scarred leaflets so that they open more easily.
- Other treatments such as chemical treatments to soften calcifications or other disorders may also be performed.
- Each of the foregoing delivery devices may be provided with a tether connecting the delivery device to the prosthetic valve or support member.
- the tether is preferably formed of a material and has a size sufficient to control the prosthetic valve or support member in the event that it is needed to withdraw the device during or after deployment.
- the tether may be selectably disengaged by the user after deployment of the device.
- expansion members are provided for performing dilation functions in minimally invasive surgical procedures.
- the expansion members may be used, for example, in procedures such as angioplasty, valvuloplasty, stent or other device placement or expansion, and other similar procedures.
- the expansion members may be used to provide additional expansion force to the support members used on the prosthetic valves described herein.
- the expansion member 430 includes three elongated inflation balloons 432 a - c oriented about a longitudinal axis 434 .
- Each inflation balloon 432 is connected at its proximal end by a feeder lumen 436 to a central lumen 438 that provides fluid communication between the inflation balloons 432 a - c and a source of inflation media associated with a handle portion 308 of a catheter.
- the central lumen itself is provided with a guidewire lumen 440 to allow passage of a guidewire through the expansion member 430 .
- a flexible member 442 is attached to the distal end of each of the inflation balloons 432 a - c , and also includes a guidewire lumen.
- the expansion member shown in the Figures includes three inflation balloons, fewer or more balloons are possible. Moreover, each of the individual balloons may be inflated separately, all inflated together, or any combination thereof to obtain a desired force profile.
- the multiple inflation balloon structure provides a number of advantages, including the ability to provide greater radial forces than a single balloon, and the ability to avoid occluding a vessel undergoing treatment and to allow blood or other fluid to flow through the device.
- the expansion member 450 comprises a flexible, expandable mesh member 452 .
- the expandable mesh member 452 includes a shaft 454 and a cylindrical woven mesh member 452 disposed longitudinally over the shaft.
- a distal end 456 of the cylindrical mesh member is attached to the distal end 458 of the shaft.
- the proximal end 460 of the cylindrical mesh member is slidably engaged to the shaft by a collar 462 proximally of the distal end 456 .
- the body of the cylindrical mesh member 452 is caused to expand radially, thereby providing a radially expandable member.
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- Oral & Maxillofacial Surgery (AREA)
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Abstract
Prosthetic valves and their component parts are described, as are prosthetic valve delivery devices and methods for their use. The prosthetic valves are particularly adapted for use in percutaneous aortic valve replacement procedures. The delivery devices are particularly adapted for use in minimally invasive surgical procedures.
Description
- This application is a continuation of U.S. application Ser. No. 11/067,330, filed Feb. 25, 2005, which claims the benefit of U.S. Provisional Application Ser. No. 60/548,731, entitled “Foldable Stent for Minimally Invasive Surgery,” filed Feb. 27, 2004, and U.S. Provisional Application Ser. No. 60/559,199, entitled “Method and Multiple Balloon for Percutaneous Aortic Valve Implantation,” filed Apr. 1, 2004, each of which are fully incorporated herein by reference.
- The present invention relates generally to medical devices and methods. More particularly, the present invention relates to prosthetic heart valves, structures for providing scaffolding of body lumens, and devices and methods for delivering and deploying these valves and structures.
- Diseases and other disorders of the heart valve affect the proper flow of blood from the heart. Two categories of heart valve disease are stenosis and incompetence. Stenosis refers to a failure of the valve to open fully, due to stiffened valve tissue. Incompetence refers to valves that cause inefficient blood circulation by permitting backflow of blood in the heart.
- Medication may be used to treat some heart valve disorders, but many cases require replacement of the native valve with a prosthetic heart valve. Prosthetic heart valves can be used to replace any of the native heart valves (aortic, mitral, tricuspid or pulmonary), although repair or replacement of the aortic or mitral valves is most common because they reside in the left side of the heart where pressures are the greatest. Two primary types of prosthetic heart valves are commonly used, mechanical heart valves and prosthetic tissue heart valves.
- The caged ball design is one of the early mechanical heart valves. The caged ball design uses a small ball that is held in place by a welded metal cage. In the mid-1960s, another prosthetic valve was designed that used a tilting disc to better mimic the natural patterns of blood flow. The tilting-disc valves had a polymer disc held in place by two welded struts. The bileaflet valve was introduced in the late 1970s. It included two semicircular leaflets that pivot on hinges. The leaflets swing open completely, parallel to the direction of the blood flow. They do not close completely, which allows some backflow.
- The main advantages of mechanical valves are their high durability. Mechanical heart valves are placed in young patients because they typically last for the lifetime of the patient. The main problem with all mechanical valves is the increased risk of blood clotting.
- Prosthetic tissue valves include human tissue valves and animal tissue valves. Both types are often referred to as bioprosthetic valves. The design of bioprosthetic valves are closer to the design of the natural valve. Bioprosthetic valves do not require long-term anticoagulants, have better hemodynamics, do not cause damage to blood cells, and do not suffer from many of the structural problems experienced by the mechanical heart valves.
- Human tissue valves include homografts, which are valves that are transplanted from another human being, and autografts, which are valves that are transplanted from one position to another within the same person.
- Animal tissue valves are most often heart tissues recovered from animals. The recovered tissues are typically stiffened by a tanning solution, most often glutaraldehyde. The most commonly used animal tissues are porcine, bovine, and equine pericardial tissue.
- The animal tissue valves are typically stented valves. Stentless valves are made by removing the entire aortic root and adjacent aorta as a block, usually from a pig. The coronary arteries are tied off, and the entire section is trimmed and then implanted into the patient.
- A conventional heart valve replacement surgery involves accessing the heart in the patent's thoracic cavity through a longitudinal incision in the chest. For example, a median sternotomy requires cutting through the sternum and forcing the two opposing halves of the rib cage to be spread apart, allowing access to the thoracic cavity and heart within. The patient is then placed on cardiopulmonary bypass which involves stopping the heart to permit access to the internal chambers. Such open heart surgery is particularly invasive and involves a lengthy and difficult recovery period.
- A less invasive approach to valve replacement is desired. The percutaneous implantation of a prosthetic valve is a preferred procedure because the operation is performed under local anesthesia, does not require cardiopulmonary bypass, and is less traumatic. Current attempts to provide such a device generally involve stent-like structures, which are very similar to those used in vascular stent procedures with the exception of being larger diameter as required for the aortic anatomy, as well as having leaflets attached to provide one way blood flow. These stent structures are radially contracted for delivery to the intended site, and then expanded/deployed to achieve a tubular structure in the annulus. The stent structure needs to provide two primary functions. First, the structure needs to provide adequate radial stiffness when in the expanded state. Radial stiffness is required to maintain the cylindrical shape of the structure, which assures the leaflets coapt properly. Proper leaflet coaption assures the edges of the leaflets mate properly, which is necessary for proper sealing without leaks. Radial stiffness also assures that there will be no paravalvular leakage, which is leaking between the valve and aorta interface, rather than through the leaflets. An additional need for radial stiffness is to provide sufficient interaction between the valve and native aortic wall that there will be no valve migration as the valve closes and holds full body blood pressure. This is a requirement that other vascular devices are not subjected to. The second primary function of the stent structure is the ability to be crimped to a reduced size for implantation.
- Prior devices have utilized traditional stenting designs which are produced from tubing or wire wound structures. Although this type of design can provide for crimpability, it provides little radial stiffness. These devices are subject to “radial recoil” in that when the device is deployed, typically with balloon expansion, the final deployed diameter is smaller than the diameter the balloon and stent structure were expanded to. The recoil is due in part because of the stiffness mismatches between the device and the anatomical environment in which it is placed. These devices also commonly cause crushing, tearing, or other deformation to the valve leaflets during the contraction and expansion procedures. Other stenting designs have included spirally wound metallic sheets. This type of design provides high radial stiffness, yet crimping results in large material strains that can cause stress fractures and extremely large amounts of stored energy in the constrained state. Replacement heart valves are expected to survive for many years when implanted. A heart valve sees approximately 500,000,000 cycles over the course of 15 years. High stress states during crimping can reduce the fatigue life of the device. Still other devices have included tubing, wire wound structures, or spirally wound sheets formed of nitinol or other superelastic or shape memory material. These devices suffer from some of the same deficiencies as those described above. The scaffolding structures and prosthetic valves described herein address both attributes of high radial stiffness along with crimpability, and maximizing fatigue life.
- The present invention provides apparatus and methods for deploying support structures in body lumens. The methods and apparatus are particularly adapted for use in percutaneous aortic valve replacement. The methods and apparatus may also find use in the peripheral vasculature, the abdominal vasculature, and in other ducts such as the biliary duct, the fallopian tubes, and similar lumen structures within the body of a patient. Although particularly adapted for use in lumens found in the human body, the apparatus and methods may also find application in the treatment of animals.
- In one aspect of the invention, a prosthetic valve is provided. The prosthetic valve includes a support member and a valvular body attached to the support member. The prosthetic valve has an expanded state in which the support member has a cross-sectional shape that is generally cylindrical or generally oval and which has a first cross-sectional dimension (e.g., diameter), and a contracted state in which the support member has a second cross-sectional dimension (e.g., diameter) smaller than the first. The prosthetic valve is in its contracted state during delivery of the prosthetic valve to a treatment location, and in its expanded state after deployment at the treatment location. Preferably, the cross-sectional dimension of the support member in its expanded state is sufficiently large, and the support member possesses sufficient radial strength, to cause the support member to positively physically engage the internal surface of the body lumen, such as the aortic valve annulus or another biologically acceptable aortic position (e.g., a location in the ascending or descending aorta), thereby providing a strong friction fit.
- Specifically, in several preferred embodiments, the support member has a cross-sectional dimension that is slightly larger than the dimension of the treatment location, such as a body lumen. For example, if the treatment location is the root annulus of the aortic valve, the support member may be provided with a cross-sectional dimension that is from about 0 to about 25% larger than the cross-sectional dimension of the valve annulus. Cross-sectional dimensions even larger than 25% greater than that of the body lumen may also be used, depending upon the nature of the treatment location. As described in more detail below, once deployed, the support member extends to its full cross-sectional dimension—i.e., it does not compress radially due to the radial force imparted by the lumen or other tissue. Rather, the support member will expand the cross-sectional dimension of the lumen or other tissue at the treatment location. In this way, the support member reduces the possibility of fluid leakage around the periphery of the device. In addition, due to the strength of the interference fit that results from the construction of the device, the support member will have proper apposition to the lumen or tissue to reduce the likelihood of migration of the device once deployed.
- In several embodiments, the support member is a structure having at least two peripheral segments, at least two of which segments are connected to each other by a foldable junction. As used herein, the term “segment” refers to a constituent part into which the support member is divided by foldable junctions or other junctions connecting adjacent segments. In several embodiments, each segment comprises a panel, with two or more connected panels making up the support member. Alternatively, and without intending to otherwise limit the descriptions provided, segments may comprise beams, braces, struts, or other structural members extending between the foldable junctions provided on the support member. Any of these (or any other) alternative structures, or any combinations thereof, may be provided as one or more segments of the support member.
- In the above embodiments of the support member, the foldable junction may comprise any structural member that allows two adjacent segments to partially or completely fold one upon another. In several preferred embodiments, the foldable junction comprises a hinge. Suitable hinges include mechanical hinges, membrane hinges, living hinges, or combinations of such hinges.
- In addition to the foldable junctions, two adjacent panels may be connectable by a selectively locking junction, such as pairs of opposed tabs and slots. In embodiments that include three or more segments, a combination of foldable junctions and locking junctions may be used.
- The support structure may be provided with one or more anchoring members that are adapted to engage the internal wall of the body lumen. Each anchoring member may comprise a barb, a tooth, a hook, or any other member that protrudes from the external surface of the support structure to physically engage the internal wall of the body lumen. Alternatively, the anchoring member may comprise an aperture formed in the support structure that allows tissue to invaginate therethrough, i.e., the outward radial force of the support member against the vessel wall causes the frame portion of the support member to slightly embed into the vessel wall, thereby causing some of the tissue to penetrate through the aperture into the interior of the support member. The tissue invagination acts to anchor the support structure in place. An anchoring member may be selectively engageable, such as by an actuator, or it may be oriented so as to be permanently engaged. Alternatively, the anchoring member may be self-actuating, or it may be deployed automatically during deployment of the support member.
- The anchoring member advantageously may perform functions in addition to engaging the internal wall of the body lumen. For example, the anchoring member may ensure proper positioning of the support structure within the body lumen. It may also prevent migration or other movement of the support structure, and it may provide additional or enhanced sealing of the support structure to the body lumen, such as by creating better tissue adherence.
- The support structure may also be provided with an optional sealing member, such as a gasket. The sealing member preferably is fixed to the external surface of the support structure around all or a portion of the circumference of the support structure, and serves to decrease or eliminate the flow of fluids between the vessel wall and the support member. The sealing member may comprise a relatively soft biocompatible material, such as a polyurethane or other polymer. Preferably, the sealing member is porous or is otherwise capable of expanding or swelling when exposed to fluids, thereby enhancing the sealing ability of the sealing member. The sealing member may include a functional composition such as an adhesive, a fixative, or therapeutic agents such as drugs or other materials.
- As an additional option, a coating may be applied to or created on any of the surfaces of the support member. Coatings may be applied or created to provide any desired function. For example, a coating may be applied to carry an adhesive, a fixative, or therapeutic agents such as drugs or other materials. Coatings may be created on the external surface of the support member to facilitate tissue penetration (e.g., ingrowth) into the support structure. Coatings may also be provided to promote sealing between the support member and the native tissue, or to reduce the possibility that the support member may migrate from its intended location. Other coating functions will be recognized by those skilled in the art.
- The valvular body may be of a single or multi-piece construction, and includes a plurality of leaflets. The valvular body may be attached either to the internal or external surface of the support structure. In the case of a single-piece construction, the valvular body includes a base portion that is attachable to the support structure, and a plurality of (and preferably three) leaflets extending from the base portion. In the case of a multi-piece construction, the valvular body includes a plurality of (preferably three) members, each including a base portion that is attachable to the support structure and a leaflet portion. In either case, the base portion(s) of the valvular body are attached to a portion of the internal or external surface of the support structure, and the leaflets extend away from the base portion and generally inwardly toward each other to form the valve.
- The valvular body, either single-piece or multi-piece, may comprise a homogeneous material, for example, a polymer such as polyurethane or other suitable elastomeric material. Alternatively, the valvular body may comprise a coated substrate, wherein the substrate comprises a polymer (e.g., polyester) or metallic (e.g., stainless steel) mesh, and the coating comprises a polymer such as polyurethane or other suitable elastomeric material. Other suitable constructions are also possible.
- Alternatively, the valvular body may comprise human (including homograft or autograft) or animal (e.g., porcine, bovine, equine, or other) tissue.
- The valvular body may be attached to the support structure by any suitable mechanism. For example, an attachment lip formed of a polymer, fabric, or other flexible material may be molded or adhered to the surface of the support member, and the valvular body sewn, adhered, or molded onto the attachment lip. Alternatively, an edge portion of the valvular body may be sandwiched between a pair of elastomeric strips that are attached to the surface of the support member. Other and further attachment mechanisms may also be used.
- As described above, each of the foregoing embodiments of the prosthetic valve preferably has a fully expanded state for deployment within a body lumen, and a contracted state for delivery to the lumen in a minimally invasive interventional procedure through the patient's vasculature. In the fully expanded state, each of the segments of the support member is oriented peripherally and adjacent to one another, attached to each adjacent segment by a foldable junction or an locking junction. In the contracted state, the segments are folded together at the foldable junctions and, preferably, then formed into a smaller diameter tubular structure. The contracted state may be achieved in different combinations and manners of folding and rolling the segments and junctions, depending on the particular structure of the prosthetic valve.
- For example, in one embodiment, the prosthetic valve comprises a generally cylindrical support member made up of three panels, with each panel connected to its adjacent panel by a hinge. The hinges may be mechanical hinges, membrane hinges, living hinges, or a combination of such hinges. In its fully expanded state, each panel of the prosthetic valve is an arcuate member that occupies approximately 120°, or one third, of the circular cross-section of the cylindrical support member. Alternatively, one or more of the panels may span a smaller portion of the cylindrical support member, while the other panel(s) are relatively larger. For example, a relatively shorter panel may be provided on a side of the valve corresponding to the non-coronary native valve leaflet, which is generally smaller than the other native valve leaflets. A valvular body is attached to the internal surface of each of the three panels. The contracted state is obtained by first inverting each of the panels at its centerline, i.e., changing each panel from a convex shape to a concave shape by bringing the centerline of each panel toward the longitudinal axis running through the center of the generally cylindrical support member. This action causes the foldable junctions to fold, creating a vertex at each foldable junction. For the foregoing three panel support member, a three vertex star-shaped structure results. In the case of a four panel support member, a four vertex star-shaped structure would result. The valvular body, which is formed of generally flexible, resilient materials, generally follows the manipulations of the support member without any substantial crimping, tearing, or permanent deformation.
- Inversion of the panels results in a structure having a relatively smaller maximum transverse dimension than that of the fully expanded structure. To further reduce the transverse dimension, each vertex is curled back toward the central axis to create a plurality of lobes equi-spaced about the central axis, i.e., in the three-panel structure, three lobes are formed. The resulting multi-lobe structure has an even further reduced maximum transverse dimension, and represents one embodiment of the contracted state of the prosthetic valve.
- In another embodiment, the prosthetic valve comprises a generally cylindrical support member made up of three panels defining three junctions, two of which comprise hinges, and one of which comprises a set of locking tabs and slots. The hinges may be mechanical hinges, membrane hinges, living hinges, other hinge types, or a combination of such hinges. As with the prior embodiment, in its fully expanded state, each panel of the prosthetic valve is an arcuate member that occupies approximately 120°, or one third, of the circular cross-section of the cylindrical support member. A valvular body is attached to the internal surface of each of the three panels, with at least one separation in the valvular body corresponding with the location of the locking junction on the support member. The contracted state in this alternative embodiment is obtained by first disengaging the locking tabs and slots at the non-hinge junction between a first two of the panels. Alternatively, the locking tabs and slots may be simply unlocked to permit relative motion while remaining slidably engaged. The third panel, opposite the non-hinge junction, is then inverted, i.e., changed from convex to concave by bringing the centerline of the panel toward the longitudinal axis running through the center of the generally cylindrical support member. The other two panels are then nested behind the third panel, each retaining its concave shape, by rotating the hinges connecting each panel to the third panel. The resulting structure is a curved-panel shaped member. The valvular body, which is formed of generally flexible, resilient materials, generally follows the manipulations of the support member without any substantial crimping, tearing, or permanent deformation. The structure is then curled into a tubular structure having a relatively small diameter in relation to that of the fully expanded prosthetic valve, and which represents an alternative embodiment of the contracted state of the prosthetic valve.
- In still another embodiment, the prosthetic valve comprises a generally oval-shaped support member made up of two panels, with a hinge provided at the two attachment edges between the panels. The hinges may be mechanical hinges, membrane hinges, living hinges, or a combination of such hinges. A valvular body is attached to the internal surface of each of the two panels. The contracted state is obtained by first inverting one of the two panels at its centerline, i.e., changing the panel from a convex shape to a concave shape by bringing the centerline of the panel toward the longitudinal axis running through the center of the generally oval support member. This action causes the foldable junctions to fold, creating a vertex at each foldable junction, and causes the two panels to come to a nested position. The valvular body, which is formed of generally flexible, resilient materials, generally follows the manipulations of the support member without any substantial crimping, tearing, or permanent deformation. The structure is then curled into a tubular structure having a relatively small diameter in relation to that of the fully expanded prosthetic valve, and which represents another alternative embodiment of the contracted state of the prosthetic valve.
- Several alternative support members are also provided. In one such alternative embodiment, the support structure is a generally tubular member constructed such that it is capable of transforming from a contracted state having a relatively small diameter and large length, to an expanded state having a relatively large diameter and small length. The transformation from the contracted state to the expanded state entails causing the tubular member to foreshorten in length while expanding radially. The forced foreshortening transformation may be achieved using any of a wide range of structural components and/or methods. In a particularly preferred form, the support structure comprises an axially activated support member. The axially activated support member includes a generally tubular body member formed of a matrix of flexible struts. In one embodiment, struts are arranged in crossing pairs forming an “X” pattern, with the ends of a first crossing pair of struts being connected to the ends of a second crossing pair of struts by a band connector, thereby forming a generally cylindrical member. Additional generally cylindrical members may be incorporated into the structure by interweaving the struts contained in the additional cylindrical member with one or more of the struts included in the first cylindrical member. An axial member is connected to at least two opposed band connectors located on opposite ends of the structure. When the axial member is decreased in length, the support member is expanded to a large diameter state, accompanied by a degree of foreshortening of the support member. When the axial member is increased in length, the support member is contracted to a smaller diameter state, accompanied by a degree of lengthening of the support member. The expanded state may be used when the support member is deployed in a body lumen, and the contracted state may be used for delivery of the device. A valvular body, as described above, may be attached to the internal or external surface of the support member.
- In the foregoing embodiment, the axial member may be replaced by a circumferential member, a spirally wound member, or any other structure adapted to cause the tubular member to foreshorten and thereby to transform to the expanded state. The axial or other member may be attached to opposed connectors, to connectors that are not opposed, or connectors may not be used at all. Alternatively, the support member may be formed of a plurality of braided wires or a single wire formed into a tubular shape by wrapping around a mandrel. In either case, the structure is caused to radially expand by inducing foreshortening.
- As a further alternative, the support structure (or portions thereof) may be self-expanding, such as by being formed of a resilient or shape memory material that is adapted to transition from a relatively long tubular member having a relatively small cross-sectional dimension to a relatively shorter tubular member having a relatively larger cross-sectional dimension. In yet further alternatives, the support structure may partially self-expand by foreshortening, after which an expansion device may be used to cause further radial expansion and longitudinal foreshortening.
- In another alternative embodiment, the support member comprises a multiple panel hinged ring structure. The multiple panel hinged ring structure includes a plurality of (preferably three) circumferential rings interconnected by one or more (preferably three) longitudinal posts. Each ring structure, in turn, is composed of a plurality of segments, such as curved panels, each connected to its adjacent panels by a junction member, such as a polymeric membrane hinge. The hinges are rotated to transform the structure from an expanded state for deployment, to a contracted state for delivery. A valvular body, as described elsewhere herein, is attached to the internal or external surface of the support member.
- In still another alternative embodiment, the support member comprises a collapsing hinged structure. The collapsing hinged structure includes a plurality of (preferably about twenty-four) panels arranged peripherally around the generally tubular structure, each panel having a tab on its edge that overlaps and engages a mating tab on the opposed edge of the adjacent panel, interlocking the adjacent panels. An elastic membrane is attached to an external surface of adjacent panels and provides a force biasing the adjacent panels together to assist the tabs in interlocking each adjacent pair of panels. Preferably, the elastic membrane is attached to the main body of each panel, but not at the opposed edges. Thus, the tabs may be disengaged and the panels rotated to form a vertex at each shared edge, thereby defining a multi-vertex “star” shape that corresponds with the contracted state of the support member. The support member is transformed to its expanded state by applying an outward radial force that stretches the elastic membrane and allows the tabs to re-engage. A valvular body, as described elsewhere herein, is attached to the internal or external surface of the support member.
- The various support members may be incorporated in a prosthetic valve, as described above, by attaching a valvular body to the external or internal surface of the support member. In the alternative, any of the foregoing support members may be utilized without a valvular body to provide a support or scaffolding function within a body lumen, such as a blood vessel or other organ. For example, the multi-segment, multi-hinged support member may be used as a scaffolding member for the treatment of abdominal aortic aneurisms, either alone, or in combination with another support member, graft, or other therapeutic device. Other similar uses are also contemplated, as will be understood by those skilled in the art.
- Each of the foregoing prosthetic valves and support members is adapted to be transformed from its expanded state to its contracted state to be carried by a delivery catheter to a treatment location by way of a minimally invasive interventional procedure, as described more fully elsewhere herein.
- In other aspects of the invention, delivery devices for delivering a prosthetic valve to a treatment location in a body lumen are provided, as are methods for their use. The delivery devices are particularly adapted for use in minimally invasive interventional procedures, such as percutaneous aortic valve replacements. The delivery devices include an elongated delivery catheter having proximal and distal ends. A handle is provided at the proximal end of the delivery catheter. The handle may be provided with a knob, an actuator, a slider, other control members, or combinations thereof for controlling and manipulating the catheter to perform the prosthetic valve delivery procedure. A retractable outer sheath may extend over at least a portion of the length of the catheter. Preferably, a guidewire lumen extends proximally from the distal end of the catheter. The guidewire lumen may extend through the entire length of the catheter for over-the-wire applications, or the guidewire lumen may have a proximal exit port closer to the distal end of the catheter than the proximal end for use with rapid-exchange applications.
- The distal portion of the catheter includes a carrier adapted to receive and retain a prosthetic valve and to maintain the prosthetic valve in a contracted state, and to deploy the prosthetic valve at a treatment location within a body lumen. In one embodiment, the distal portion of the catheter is provided with a delivery tube having a plurality of longitudinal slots at its distal end, and a gripper having a longitudinal shaft and a plurality of fingers that extend longitudinally from the distal end of the gripper. Preferably, the delivery tube has the same number of longitudinal slots, and the gripper includes the same number of fingers, as there are segments on the prosthetic valve to be delivered. The longitudinal slots on the distal end of the delivery tube are equally spaced around the periphery of the tube. Similarly, as viewed from the distal end of the gripper, the fingers are arranged in a generally circular pattern. For example, in the case of three fingers, all three are spaced apart on an imaginary circle and are separated from each other by approximately 120°. In the case of four fingers, the fingers are separated from each other by approximately 90°, and so on. The spacing and orientation of the longitudinal slots and fingers may vary from these preferred values while still being sufficient to perform the delivery function in the manner described herein. The gripper is slidably and rotatably received within the delivery tube, and the delivery tube is internal of the outer sheath. The outer sheath is retractable to expose at least the longitudinal slots on the distal portion of the delivery tube. The gripper is able to be advanced at least far enough to extend the fingers distally outside the distal end of the delivery tube.
- In alternative embodiments of the above delivery device, the gripper fingers may comprise wires, fibers, hooks, sleeves, other structural members extending distally from the distal end of the gripper, or combinations of any of the foregoing. As described below, a primary function of the fingers is to retain a prosthetic valve on the distal end of the gripper, and to restrain segments of the support member of the valve in an inverted state. Accordingly, any of the above (or other) structural members able to perform the above function may be substituted for the fingers described above.
- An optional atraumatic tip or nosecone may be provided at the distal end of the device. The tip is preferably formed of a relatively soft, elastomeric material and has a rounded to conical shape. A central lumen is provided in the tip to allow passage of the guidewire. The shape and physical properties of the tip enhance the ability of the delivery device to safely pass through the vasculature of a patient without damaging vessel walls or other portions of the anatomy. In addition, the atraumatic tip may enhance the ability of the distal portion of the device to cross the native heart valve when the leaflets of the native valve are fully or partially closed due to calcification from disease or other disorder.
- The delivery device is particularly adapted for use in a minimally invasive surgical procedure to deliver a multi-segment prosthetic valve, such as those described above, to a body lumen. To do so, the prosthetic valve is first loaded into the delivery device. In the case of a prosthetic valve having a three segment support member, the delivery tube will have three longitudinal slots at its distal end, and the gripper will be provided with three fingers. The prosthetic valve is loaded into the delivery device by first inverting the three segments to produce a three vertex structure. Inverting of the prosthetic valve segments may be performed manually, or with the aid of a tool. The prosthetic valve is then placed onto the distal end of the gripper, which has been previously extended outside the distal end of the delivery tube, with each of the three fingers retaining one of the inverted segments in its inverted position. The gripper and fingers, with the prosthetic valve installed thereon, are then retracted back into the delivery tube. During the retraction, the gripper and fingers are rotationally aligned with the delivery tube such that the three vertices of the prosthetic valve align with the three longitudinal slots on the distal end of the delivery tube. When the gripper and fingers are fully retracted, each of the three vertices of the prosthetic valve extends radially outside the delivery tube through the longitudinal slots. The gripper is then rotated relative to the delivery tube (or the delivery tube rotated relative to the gripper), which action causes each of the folded segments of the prosthetic valve to engage an edge of its respective delivery tube slot. Further rotation of the gripper relative to the delivery tube causes the folded segments to curl back toward the longitudinal axis of the prosthetic valve internally of the delivery tube, creating three lobes located fully within the delivery tube. The prosthetic valve is thereby loaded into the delivery device. The outer sheath may then be advanced over the distal portion of the catheter, including the delivery tube, to prepare the delivery device for use.
- The prosthetic valve is delivered by first introducing a guidewire into the vascular system and to the treatment location of the patient by any conventional method, preferably by way of the femoral artery. Optionally, a suitable introducer sheath may be advanced to facilitate introduction of the delivery device. The delivery catheter is then advanced over the guidewire to the treatment location. The outer sheath is then retracted to expose the delivery tube. The gripper is then rotated relative to the delivery tube (or the delivery tube rotated relative to the gripper), thereby causing the folded segments of the prosthetic valve to uncurl and to extend radially outward through the longitudinal slots of the delivery tube. The delivery tube is then retracted (or the gripper advanced) to cause the prosthetic valve (restrained by the fingers) to advance distally out of the delivery tube. The gripper is then retracted relative to the prosthetic valve, releasing the prosthetic valve into the treatment location. Preferably, the inverted segments then revert to the expanded state, causing the valve to lodge against the internal surface of the body lumen (e.g., the aortic valve root or another biologically acceptable aortic position). Additional expansion of the prosthetic valve may be provided, if needed, by a suitable expansion member, such as an expansion balloon or an expanding mesh member (described elsewhere herein), carried on the delivery catheter or other carrier.
- In another embodiment of the delivery device, the distal portion of the catheter includes a restraining sheath, an orientation sheath, a plurality of grippers, an expander, and a plurality of struts. An optional atraumatic tip or nosecone, as described above, may also be fixed to the distal end of the device. Each of the grippers includes a wire riding within a tube, and a tip at the distal end of the tube. The wire of each gripper is adapted to engage the vertex of a prosthetic valve support member having multiple segments, and to selectively restrain the prosthetic valve in a contracted state. The expander is adapted to selectively cause the grippers to expand radially outwardly when it is actuated by the user by way of an actuator located on the handle.
- The prosthetic valve may be loaded into the delivery device by contracting the prosthetic valve (either manually or with a tool) by inverting each panel and then attaching each vertex to a respective gripper on the delivery device. The grippers receive, retain, and restrain the prosthetic valve in its contracted state. The gripper assembly having the prosthetic valve installed is then retracted into each of the orientation sheath and the restraining sheath to prepare the device for insertion into the patient's vasculature. The device is then advanced over a guidewire to a treatment location, such as the base annulus of the native aortic valve or another biologically acceptable aortic position (e.g., a location in the ascending or descending aorta). The restraining sheath is then retracted to allow the prosthetic valve to partially expand (e.g., to about 85% of its full transverse dimension), where it is constrained by the orientation sheath. The prosthetic valve is then finally positioned by manipulation of the grippers, after which the orientation sheath is retracted and the grippers released. The prosthetic valve then is fixedly engaged in the treatment location.
- In yet another embodiment of the delivery device, the distal portion of the catheter includes one or more restraining tubes having at least one (and preferably two) adjustable restraining loops. The restraining tube(s) extend distally from a catheter shaft out of the distal end of the delivery device, and each restraining loop is a wire or fiber loop that extends transversely from the restraining tube. Each restraining loop is a flexible loop capable of selectively restraining a contracted prosthetic valve. The restraining loop may be selectively constricted or released by a control member, such as a knob, located on the handle of the device, or by another external actuation member. An optional retractable outer sheath may be provided to cover the distal portion of the catheter. Additionally, an optional atraumatic tip or nosecone, as described above, may be provided at the distal end of the device.
- The prosthetic valve may be loaded onto the delivery device by contracting the prosthetic valve (either manually or with a tool) into its contracted state, for example, by inverting each panel and curling each inverted panel into a lobe. The contracted prosthetic valve is then placed onto the restraining tube(s) and through the one or more restraining loops. The loops are constricted around the contracted prosthetic valve, thereby restraining the prosthetic valve in its contracted state. The optional outer sheath may then be advanced over the prosthetic valve and the restraining tube(s) to prepare the delivery device for use. The device is then advanced over a guidewire to a treatment location, such as the base annulus of the native aortic valve or another biologically acceptable aortic position (e.g., a location in the ascending or descending aorta). The restraining sheath is then retracted to expose the contracted prosthetic valve. The restraining loops are released, such as by rotating the control knob, thereby releasing the prosthetic valve and allowing it to self-expand. The prosthetic valve is thereby fixedly engaged in the treatment location. An expansion member may be advanced to the interior of the prosthetic valve (or retracted from distally of the valve) and expanded to provide additional expansion force, if needed or desired.
- In each of the foregoing device delivery methods, the user is able to deploy the device in a careful, controlled, and deliberate manner. This allows the user to, among other things, pause the delivery procedure and reposition the device if needed to optimize the delivery location. This added degree of control is a feature that is not available in many of the previous percutaneous device delivery methods.
- In another aspect of the invention, an expansion member is provided for performing dilation functions in minimally invasive surgical procedures. For example, the expansion member may be used in procedures such as angioplasty, valvuloplasty, stent or other device placement or expansion, and other similar procedures. In relation to the devices and methods described above and elsewhere herein, the expansion member may be used to provide additional expansion force to the support members used on the prosthetic valves described herein.
- In one embodiment, the expansion member comprises a plurality of inflation balloons oriented about a longitudinal axis. Each inflation balloon is connected at its proximal end by a feeder lumen to a central lumen that provides fluid communication between the inflation balloons and a source of inflation media associated with a handle portion of a catheter. The central lumen itself is provided with a guidewire lumen to allow passage of a guidewire through the expansion member. A flexible member is attached to the distal end of each of the inflation balloons, and also includes a guidewire lumen. In a preferred embodiment, the expansion member includes three inflation balloons, although fewer or more balloons are possible. The balloons may each be inflated individually, all together, or in any combination to obtain a desired force distribution. The multiple inflation balloon structure provides a number of advantages, including the ability to provide greater radial forces than a single balloon, and the ability to avoid occluding a vessel undergoing treatment and to allow blood or other fluid to flow through the device.
- In an alternative embodiment, the expansion member comprises a flexible, expandable mesh member. The expandable mesh member includes a shaft and a cylindrical woven mesh member disposed longitudinally over the shaft. A distal end of the cylindrical mesh member is attached to the distal end of the shaft. The proximal end of the cylindrical mesh member is slidably engaged to the shaft by a collar proximally of the distal end. As the collar is advanced distally along the shaft, the body of the cylindrical mesh member is caused to expand radially, thereby providing a radially expansion member. Alternatively, the proximal end of the mesh member may be fixed to the shaft and the distal end may have a collar engagement allowing it to advance proximally along the shaft to cause the mesh member to expand radially. Still further, each of the proximal and distal ends of the mesh member may be slidably engaged to the shaft, and each moved toward the other to cause radial expansion.
- Other aspects, features, and functions of the inventions described herein will become apparent by reference to the drawings and the detailed description of the preferred embodiments set forth below.
-
FIG. 1A is a perspective view of a prosthetic valve in accordance with the present invention. -
FIG. 1B is a perspective view of a support member in accordance with the present invention. -
FIG. 2A is a perspective view of a support member having illustrating inverted panels. -
FIG. 2B is a top view of the support member ofFIG. 2A . -
FIG. 2C is a top view of a support member in a contracted state. -
FIG. 3A is a perspective view of another support member in accordance with the present invention. -
FIG. 3B is a close-up view of a hinge on the support member ofFIG. 3A . -
FIG. 3C is a close-up view of an locking tab and slot on the support member ofFIG. 3A . -
FIG. 3D is a perspective view of the support member shown inFIG. 3A , illustrating inversion of a panel. -
FIG. 3E is a perspective view of the support member shown inFIG. 3A , illustrating a nested arrangement of the three panels. -
FIG. 3F is a perspective view of the support member shown inFIG. 3A , illustrating a contracted state of the support member. -
FIG. 3G is an end view of the support member shown inFIG. 3A , illustrating a contracted state of the support member. -
FIG. 3H is a top view of another support member, illustrating a nested arrangement of the three panels. -
FIG. 3I is a side view of the support member shown inFIG. 3H . -
FIG. 4A is a perspective view illustrating a hinge connecting two panels of a support member. -
FIG. 4B is a perspective view of the hinge shown inFIG. 4A , illustrating the hinge in is folded state. -
FIG. 4C is a perspective view of another hinge connecting two panels of a support member. -
FIG. 4D is a perspective view of another hinge connecting two panels of a support member. -
FIG. 5A is a perspective view of a support member having inverted panels, illustrating removable hinge pins. -
FIG. 5B is a perspective view of a support member after separation of its three panels. -
FIG. 6 is a perspective view of another support member. -
FIG. 7 is a close-up view of an attachment mechanism for attaching a valvular body to a support member. -
FIG. 8A is a perspective view of a valvular body. -
FIG. 8B is a perspective view showing separate leaflets of the valvular body ofFIG. 8A . -
FIG. 9A is a perspective view of an axially activated support member in its contracted state. -
FIG. 9B is a perspective view of the axially activated support member ofFIG. 9A , shown in its expanded state. -
FIG. 10A is a perspective view of a multiple panel hinged ring prosthetic valve. -
FIG. 10B is an end view of the prosthetic valve shown inFIG. 10A . -
FIG. 10C is a perspective view of a multiple panel hinged ring support member. -
FIG. 10D is an end view of the support member shown inFIG. 10C . -
FIG. 10E is a close-up view of a panel contained on the support member shown inFIG. 10C . -
FIG. 10F is a perspective view of a portion of a ring of panels contained on the support member shown inFIG. 10C . -
FIG. 10G is a top view of a ring of panels contained on a support member, shown in a contracted state. -
FIG. 10H is a perspective view of the support member shown inFIG. 10C , shown in the contracted state. -
FIG. 10I is a top view of a ring of panels contained on another support member, shown in a contracted state. -
FIG. 10J is a perspective view of the support member shown inFIG. 10I , shown in the contracted state. -
FIG. 11A is a perspective view of a collapsing hinged support member, shown in its expanded state. -
FIG. 11B is a perspective view of the collapsing hinged support member, shown in its contracted state. -
FIG. 11C is a close-up view of a portion of the collapsing hinged support member shown inFIG. 11A . -
FIG. 12A is a perspective view of a prosthetic valve retained on a delivery device. -
FIG. 12B is a top view of the prosthetic valve and delivery device shown inFIG. 12A . -
FIG. 12C is a side view of the prosthetic valve and delivery device shown inFIG. 12A . -
FIG. 12D is another top view of the prosthetic valve and delivery device shown inFIG. 12A . -
FIG. 12E is another top view the prosthetic valve and delivery device shown inFIG. 12A . -
FIG. 12F is another top view of the prosthetic valve and delivery device shown inFIG. 12A . -
FIG. 13A is a perspective view, shown in partial cross-section, of a prosthetic valve delivery device. -
FIG. 13B is a close-up view of a portion of the prosthetic valve delivery device shown inFIG. 13A . -
FIG. 13C is another close-up view of a portion of the prosthetic valve delivery device shown inFIG. 13A -
FIG. 13D is another perspective view, shown in partial cross-section, of the prosthetic valve delivery device shown inFIG. 13A . -
FIG. 13E is an illustration showing the delivery device ofFIG. 13A delivering a prosthetic valve to a treatment location. -
FIG. 14A is a perspective view of another prosthetic valve delivery device. -
FIG. 14B is a close-up view of a distal portion of the prosthetic valve delivery device shown inFIG. 14A . -
FIG. 14C is another close-up view of the distal portion of the prosthetic valve delivery device shown inFIG. 14A . -
FIG. 14D is an illustration showing the delivery device ofFIG. 14A delivering a prosthetic valve to a treatment location. -
FIG. 14E is another illustration showing the delivery device ofFIG. 14A delivering a prosthetic valve to a treatment location. -
FIG. 15A is a perspective view of another prosthetic valve delivery device. -
FIG. 15B is a close-up view of a distal portion of the prosthetic valve delivery device shown inFIG. 15A . -
FIG. 16A is a perspective view of another prosthetic valve delivery device. -
FIG. 16B is another perspective view of the prosthetic valve delivery device shown inFIG. 16A . -
FIG. 17A is a perspective view of a multi-balloon expansion device. -
FIG. 17B is another perspective view of the multi-balloon expansion device shown inFIG. 17A . -
FIG. 18A is a perspective view of an expandable mesh member, shown in its contracted state. -
FIG. 18B is another perspective view of the expandable mesh member ofFIG. 18A , shown in its expanded state. -
FIG. 18C is an illustration showing the expandable mesh member being advanced into the interior space of a prosthetic valve. -
FIG. 18D is another illustration showing the expandable mesh member being advanced into the interior space of a prosthetic valve. - Before the present invention is described, it is to be understood that this invention is not limited to particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.
- Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which these inventions belong. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present invention, the preferred methods and materials are now described. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and/or materials in connection with which the publications are cited.
- It must be noted that as used herein and in the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise.
- The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed.
- As will be apparent to those of skill in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present inventions.
- Turning first to
FIG. 1A , an embodiment of a prosthetic valve is shown. Theprosthetic valve 30 is particularly adapted for use as a replacement aortic valve, but may be used for other indications as well. As shown, theprosthetic valve 30 includes a generallycylindrical support member 32 and avalvular body 34 attached to the internal surface of the support member. Although a generally cylindrical support member is shown, support members having other than circular cross-sectional shapes, such as oval, elliptical, or irregular, may also be provided depending upon the nature of the treatment location and environment in which the prosthetic valve or the support structure are intended to be used. - The support member in the embodiment shown in
FIG. 1A is made up of three generally identicalcurved panels 36, with each panel spanning approximately 120° of the circular cross-section of the support member. (As noted elsewhere herein, the panels need not be generally identical in terms of size, materials, thickness, or other properties.) Eachpanel 36 includes aframe 38 and asemi-circular aperture 40 extending over a large portion of the central portion of the panel. Theaperture 40 includes a number of interconnecting braces 42 extending across the breadth of the aperture, thereby defining a number of sub-apertures 44 between the braces. The braces define several diamond-shaped sub-apertures 46, partial diamond-shaped sub-apertures 48, and anelongated sub-aperture 50. Apertures and sub-apertures of different shapes and sizes than those shown in theFIG. 1A embodiment are also possible. For example, in the alternative support member embodiment shown inFIG. 1B , a singlesemi-circular aperture 40 is provided, with no braces and no sub-apertures. Alternatively, a panel may comprise a solid member having no apertures or sub-apertures. - The panels of the support member are typically the portion of the structure that engages the internal surface of the lumen at the treatment location. In the case of a prosthetic heart valve, among other functions, the panels physically engage and displace the leaflets of the native valve. The panels are also the primary portion of the structure that is in physical engagement with the body lumen and that is holding the structure in place and preventing migration. Therefore, the materials and structure of the panels are adapted, at least in part, to perform these functions. In some instances, a large aperture may be preferred, in other cases a particular bracing structure may be preferred, while in still other cases it is preferable not to have any apertures or bracing. These features may be varied to provide desired performance, depending upon the anatomical environment.
- Each of the panels shown, and those described elsewhere herein, is preferably formed from a sheet of resilient, biocompatible material, such as stainless steel, other metals or metal alloys, resilient polymers such as plastics, or other suitable materials conventionally used for implantable medical devices. In a preferred embodiment, the panels are formed from a super-elastic shape-memory material, such as nitinol or other similar metal alloys. The panels may be molded, extruded, etched, cut, stamped or otherwise fabricated from sheets of material, or manufactured in other ways known to those skilled in the art.
- Although the support member embodiment shown in
FIG. 1A includes three panels, those skilled in the art will recognize that fewer or more panels may be incorporated into the support member. For example, a two panel structure may be employed, or structures having four, five, or many more panels. Alternatively, a structure may be provided having non-panel segments, such as beams, braces, struts, or other structural members extending between the foldable junctions provided on the support member. Any of these (or any other) alternative structures, or any combinations thereof, may be provided as one or more segments of the support member, provided that the structure is capable of providing the physical and structural characteristics needed to support the prosthetic valve in its intended function. - In addition, although each of the segments making up a support member may be identical to the other segments, it is also possible to provide segments having different physical properties. For example, in a multi-panel support member, the panels may be made up of different materials, or one or more panels may have a different size or thickness than the other panel(s), or the physical properties between the different panels may be altered in some other manner. This may be done, for example, as an accommodation for the treatment location in which the prosthetic valve is to be placed. The wall thickness of the aortic root, for example, varies around its circumference. Thus, desirable results may be obtained by providing a support member having a first panel that provides greater structural strength (or resistance to collapse) than the other panels. Other variations are also possible.
- Turning again to
FIG. 1A , ahinge 52 is provided at the junction formed between each pair of adjacent panels. In the embodiment shown inFIG. 1A , the hinge is a membrane hinge comprising a thin sheet ofelastomeric material 54 attached to theexternal edge 56 of each of a pair ofadjacent panels 36. In the expanded state of the support member, as shown inFIG. 1A , the membrane hinge maintains the side-to-side orientation of each pair of adjacent panels, preventing any significant amount of slipping or sliding between the panels. As described more fully below, thehinge 52 is also foldable so as to allow thepanels 36 to invert and theedges 56 to fold together to form a vertex. The ability of the hinge (or other foldable junction member) to allow adjacent panels to invert and fold against each other at adjacent edges is a substantial feature in creating a contracted state for the support member, and the prosthetic valve. In addition, the hinge 52 (or other foldable junction) preferably is adapted to allow thesupport member 32 to physically conform to the internal surface of the body lumen at the treatment location. - As noted below and elsewhere, various types of hinges and other foldable junctions may be used in alternative embodiments. For example, and without intending to otherwise limit the descriptions contained herein, other types of hinges that may be used include standard piano hinges, living hinges, and other types of mechanical hinges. See, for example, the
support member 32 shown inFIG. 1B , in which each pair ofadjacent panels 36 is connected by astandard piano hinge 58, i.e., a long, narrow hinge with apin 60 running the entire length of its joint that interconnects meshed sets ofknuckles 62 formed on the edge of each of the pair ofadjacent panels 36. Several other alternative hinge structures are shown inFIGS. 4A-D , in whichFIGS. 4A-B show another membrane hinge in which theelastomeric strip 54 is attached to each of a pair ofadjacent panels 36 on the internal surface of thesupport member 32.FIG. 4A shows a portion of thesupport structure 32 in its expanded state, andFIG. 4B shows the portion of the structure after the pair ofadjacent panels 36 have been folded against each other at themembrane hinge 52, thereby forming avertex 64.FIG. 4C shows a close-up view of anotherstandard piano hinge 58 design, similar to that shown inFIG. 1B , showing thepin 60 and the meshingknuckles 62 formed on the edge of each of the pair ofadjacent panels 36.FIG. 4D shows a livinghinge 66 that includes a flexible (e.g., elastomeric)hinge member 68 that is attached to each of the pair ofadjacent panels 36 and that extends the length of the junction between the panels. In addition,FIG. 5A shows another support member (in a partially contracted condition) illustrating removable hinge pins. - Several alternative foldable junctions may also be used instead of hinges. For example, a section of a sheet may be etched, scored, or otherwise thinned relative to the adjacent portions of the device to provide a weakened section that allows inversion and folding of a pair of adjacent segments of the sheet, thereby providing a foldable junction. Other alternative foldable junctions are also contemplated, and will be understood by persons of skill in the art, to be suitable for use in the support members described herein.
- Optionally, the foldable junction may be provided with a lock-out feature that allows the foldable junction to fold in a direction that allows adjacent panels to invert, as described herein, but that prevents the foldable junction from folding in the opposite direction. For example, a standard piano hinge may be constructed in a manner that provides only about 180° of rotation in a conventional manner, and attached to a pair of adjacent panels such that inward rotation is allowed, but outward rotation is prevented. Other suitable lock-out mechanisms may be possible, as will be recognized by those of skill in the art.
- In addition, although the hinges and other foldable junctions are preferably oriented uniformly vertically (i.e., parallel to the longitudinal axis of the support member) on the periphery of the support member, other orientations are possible. For example, the hinges may be oriented horizontally (i.e., transverse) relative to the longitudinal axis, they may be oriented diagonally relative to the longitudinal axis, they may have a zig-zag or spiral orientation, or they may take on any geometric or irregular pattern.
- Returning again to
FIG. 1A , thevalvular body 34 of the embodiment shown in the figure is a flexible artificial tissue multi-leaflet structure. The artificial tissue includes a unitary polymer material or a composite of polymer overlaid onto a flexible substrate, which may be in the form of a mesh. The polymer material is any suitable flexible, biocompatible material such as those conventionally used in implantable medical devices. Preferably, the polymer material is polyurethane or another thermoplastic elastomer, although it is not limited to such materials. The material comprising the flexible mesh is preferably a flexible, shear-resistant polymeric or metallic material, such as a polyester or very fine metallic (e.g., stainless steel) mesh. The valvular body is described more fully below in relation toFIGS. 8A-B . - In other embodiments, the valvular body may be formed of human tissue, such as homografts or autografts, or animal tissue, such as porcine, bovine, or equine tissue (e.g., pericardial or other suitable tissue). The construction and preparation of prosthetic tissue valvular bodies is beyond the scope of the present application, but is generally known to those of skill in the art and is readily available in the relevant technical literature.
- The prosthetic valves described herein have an expanded state that the prosthetic valve takes on when it is in use. The
FIG. 1A illustration shows aprosthetic valve 30 in its expanded state. In the expanded state of the prosthetic valve, the support member is fully 32 extended in its cylindrical (or alternative) shape, with each hinge 52 (or other foldable junction) in its extended, or non-folded state. As described previously, in the expanded state, thesupport member 32 preferably has a cross-sectional dimension (e.g., diameter) that is from about 0 to about 25% larger than that of the body lumen or other treatment location. Once deployed, the support member extends to its full cross-sectional dimension—i.e., it does not compress radially due to the radial force imparted by the lumen or other tissue. Rather, the support member will expand the cross-sectional dimension of the lumen or other tissue at the treatment location. In this way, the support member reduces the possibility of fluid leakage around the periphery of the device. In addition, due to the strength of the interference fit that results from the construction of the device, the support member will have proper apposition to the lumen or tissue to reduce the likelihood of migration of the device once deployed. The present prosthetic valves also have a contracted state that is used in order to deliver the prosthetic valve to a treatment location with the body of a patient. The contracted state generally comprises a state having a smaller transverse dimension (e.g., diameter) relative to that of the expanded state. The contracted states of several of the prosthetic valve embodiments described herein are discussed below. - Turning to
FIGS. 2A-C , a method for transforming a prosthetic valve from its expanded state to its contracted state is illustrated. These Figures show a three-panel support member without a valvular body attached. The method for contracting a full prosthetic valve, including the attached valvular body, is similar to that described herein in relation to the support member alone. - As shown in
FIGS. 2A-B , each of thepanels 36 is first inverted, by which is meant that alongitudinal centerline 80 of each of the panels is forced radially inward toward the centrallongitudinal axis 82 of the support member. This action is facilitated by having panels formed of a thin, resilient sheet of material having generally elastic properties, and by the presence of thehinges 58 located at the junction between each pair ofadjacent panels 36. During the inversion step, theedges 56 of each of the adjacent pairs of panels fold upon one another at thehinge 58. The resulting structure, shown inFIGS. 2A-B , is a three-vertex 64 star shaped structure. Those skilled in the art will recognize that a similar procedure may be used to invert a four (or more) panel support member, in which case the resulting structure would be a four-(or more) vertex star shaped structure. - The
prosthetic valve 30 may be further contracted by curling each of thevertices 64 of the star shaped structure to form a multi-lobe structure, as shown inFIG. 2C . As shown in that Figure, each of the threevertices 64 is rotated toward the center longitudinal axis of the device, causing each of the three folded-upon edges of the adjacent pairs of panels to curl into alobe 84. The resulting structure, illustrated inFIG. 2C , is a three-lobe structure that represents the fully contracted state of the prosthetic valve. Manipulation and use of the fully contracted device is described more fully below. Those skilled in the art will recognize that a similar procedure may be used to fully contract a four (or more) panel support member, in which case the resulting structure would be a four-(or more) lobed structure. - In the case of a two panel support member, the support member may be contracted by first inverting one of the two panels to cause it to come into close relationship with the other of the two panels to form a nested panel structure. The pair of nested panels is then rolled into a small diameter tubular member, which constitutes the contracted state of the two-panel support member.
- Turning to
FIGS. 3A-I , another embodiment of a support member suitable for use in a prosthetic valve is shown. This embodiment is structurally similar to the preceding embodiment, but is capable of being transformed to a contracted state in a different manner than that described above. The embodiment includes threepanels 36, each having asemi-circular aperture 40. Astandard piano hinge 58 is provided at two of the junctions between adjacent pairs of panels. (SeeFIG. 3B ). The third junction does not have a hinge, instead having a lockingmember 90. In the embodiment shown, the locking member includes atab 92 attached to each of the top and bottom portions of the edge of the first 36 a of a pair of adjacent panels, and aslot 94 provided along both the top and bottom edges of the second 36 b of the pair adjacent panels. (SeeFIG. 3C ). Thetabs 92 on thefirst panel 36 a are able to extend through and ride in theslots 94 on thesecond panel 36 b, thereby allowing thefirst panel 36 a to slide relative to thesecond panel 36 b while remaining physically engaged to the panel, and then to slide back to the original position. A lockingtab 96 may be provided on thesecond panel 36 b to selectively lock thefirst panel tab 92 in place in theslot 94. -
FIGS. 3D-G illustrate the manner in which the preceding support member is transformed to its contracted state. As shown inFIG. 3D , thepanel 36 c situated opposite the lockingjunction 90 is inverted while leaving the other twopanels 36 a-b in their uninverted state. Thetabs 92 on thefirst panels 36 a are then slid along theslots 94 in thesecond panel 36 b, causing the first andsecond panels 36 a-b to come into a nested arrangement behind theinverted panel 36 c, with thefirst panel 36 a nested between theinverted panel 36 c and thesecond panel 36 b. (SeeFIG. 3E ). The nested panels are then able to be curled into a relatively smalldiameter tubular member 98, as shown inFIGS. 3F and 3G , which constitutes the contracted state of the support member. -
FIGS. 3H-I illustrate a similar support member in its partially contracted state in which the threepanels 36 a-c are in the nested arrangement. The support member shown inFIGS. 3H-I also include a plurality ofbrace members 42 extending through theaperture 40, forming diamond-shaped sub-apertures 46, partial diamond-shaped sub-apertures 48, and anelongated sub-aperture 50. A plurality of raisedsurfaces 100, or bumps, are provided over the surfaces of each of thepanels 36 a-c to provide positive spacing for thevalvular body 34 when theprosthetic valve 30 is placed in the contracted state. The positive spacing provided by the raisedsurfaces 100 serve to decrease the possibility of squeezing, crimping, folding, or otherwise damaging thevalvular body 34 or its constituent parts when the prosthetic valve is contracted. The raised surfaces 100 (or other spacing member) of the support member may be used on any of the embodiments of the prosthetic valves described herein. - Turning to
FIGS. 5A-B , as described above,FIG. 5A illustrates asupport member 32 having threepanels 36 a-c and three standard piano hinges 58 at the junctions between the three panels. The support member is shown with each of its threepanels 36 a-c in the inverted position. Each of the piano hinges 58 has aremovable hinge pin 60. When the hinge pins 60 are removed, thepanels 36 a-c may be separated from each other, as illustrated inFIG. 5B . The ability to separate the panels may be used to facilitate surgical (or other) removal of the support member, or the prosthetic valve, or the panels may need to be separated for another purpose. Although piano hinges with removable hinge pins are shown inFIGS. 5A-B , alternative removable hinge structures may also be used. For example, a membrane hinge having a tearable membrane strip will facilitate removal of the support member. Further alternatives may include melting or unzipping a hinge. Other removable hinge structures are also contemplated. In each of these cases, provision of a hinge that may be easily defeated by some mechanism creates that ability for the user to more easily remove or otherwise manipulate a prosthetic valve or support member for any desired purpose. -
FIG. 6 shows another embodiment of asupport member 32 suitable for use in aprosthetic valve 30. Thesupport member 32 includes threepanels 36 a-c, each panel having anelongated aperture 50 and asemi-circular aperture 40. The support member includes anelastomeric strip 54 at the foldable junction between each pair of adjacent panels, each of which forms a membrane hinge. A valvularbody attachment lip 104 is attached to the interior surface of each of thepanels 36 a-c to facilitate attachment of thevalvular body 34 to thesupport member 32. Theattachment lip 104 may comprise a polymer material suitable for sewing, adhering, or otherwise attaching to the valvular body. Theattachment lip 104 is preferably molded or adhered onto the interior surface of each of the panels of the support member. Although theattachment lip 104 facilitates one method for attaching the valvular body to the support member, it is not the only method for doing so, and use of theattachment lip 104 is optional. -
FIG. 7 illustrates another structure and method used to attach the valvular body to the support member panels. Afirst strip 110 of polymeric material is adhered to the interior surface of theedge 56 of each panel. Thefirst strip 110 of polymeric material does not need to extend along the entire edge, but generally about half of the length. Thefirst strip 110 is adhered with any suitable adhesive material, or it may be molded directly onto thepanel 36. Anattachment lip 120 formed on the base portion of the valvular body is then attached to each of thefirst strips 110 of polymeric material. Theattachment lips 120 may be formed on the base portion of thevalvular body 34 in any of the embodiments described below, including those having a unitary structure or those having a composite structure. (A composite structure is shown inFIG. 7 ). Theattachment lips 110 may be attached to the strips of polymeric material using any suitable adhesive or any other suitable method. Next, and optionally, asecond strip 112 of polymer material may be attached to the exposed surface of the valvularbody attachment lip 120, sandwiching theattachment lip 120 between the first 110 andsecond strips 112 of material. -
FIGS. 8A-B show perspective views of valvular bodies suitable for use in the prosthetic valves described herein. Thevalvular body 34 shown inFIG. 8A is of a unitary construction, while that shown inFIG. 8B is of a composite construction, including three separate leaflets 35 a-c. Turning first to the unitary structure embodiment shown inFIG. 8A , thevalvular body 34 includes a generallycylindrical base portion 122 that then contracts down into a generally concave portion 124 (as viewed from the interior of the valvular body). Thevalvular body 34 has three lines ofcoaptation 126 formed on the bottom of theconcave portion 124. Aslit 128 is either cut or molded into each of the lines ofcoaptation 126 to create threevalve leaflets 130 that perform the valvular fluid regulation function when the valve is implanted in a patient. Anoptional attachment lip 120 may be formed on the outward facing lines ofcoaptation 126, to facilitate attachment of thevalvular body 34 to the support member in the manner described above in relation toFIG. 7 . - Turning to the composite structure embodiment shown in
FIG. 8B , each separate leaflet 35 a-c includes abase portion 132 and a generallyconcave portion 134 extending from the base. Each leaflet 35 a-c also includes a pair oftop edges 136 and a pair of side edges 138. The top edges and side edges of each leaflet 35 a-c are positioned against the top edges and side edges of each adjacent leaflet when the composite structure embodiment is attached to an appropriate support member. - As described above, in either the unitary or composite construction embodiments, the valvular body may be formed solely from a single polymer material or polymer blend, or it may be formed from a substrate having a polymer coating. The materials suitable for use as the polymer, substrate, or coating are described above. Alternatively, the valvular body may comprise human or animal tissue.
- The valvular body may be attached to the support member by any suitable method. For example, the valvular body may be attached to the support member by sewing, adhering, or molding the valvular body to an attachment lip, as described above in relation to
FIG. 6 . Or, the valvular body may be attached to the support member using the attachment strips described above in relation toFIG. 7 . Alternatively, the valvular body may be adhered directly to the support member using an adhesive or similar material, or it may be formed integrally with the support member. Other and further suitable attachment methods will be recognized by those skilled in the art. - The multi-segment support member embodiments described above are suitable for use in the prosthetic valves described herein. Additional structures are also possible, and several are described below. For example, in reference to
FIGS. 9A-B , an alternative support member is illustrated. The alternative support member is a tubular member that is capable of radial expansion caused by forced foreshortening. As noted earlier herein, several structures and/or methods are available that are capable of this form of transformation, one of which is described inFIGS. 9A-B . An axially activatedsupport member 150 includes a generallytubular body member 152 formed of a matrix offlexible struts 154. In the embodiment shown in the Figures, thestruts 154 are arranged in crossing pairs forming an “X” pattern, with the ends of a first crossing pair of struts being connected to the ends of a second crossing pair of struts by aband connector 156, thereby forming a generally cylindrical member. Additional generally cylindrical members are incorporated into the structure by interweaving the struts contained in the additional cylindrical member with the struts included in the first cylindrical member. Anaxial member 158 is connected to twoopposed band connectors 156 located on opposite ends of the structure. When theaxial member 158 is decreased in length, as shown inFIG. 9B , thesupport member 150 is expanded to a large diameter state, accompanied by a degree of lengthwise foreshortening of the support member. When theaxial member 158 is increased in length, as shown inFIG. 9A , thesupport member 150 is contracted to a smaller diameter state, accompanied by a degree of lengthening of the support member. The expanded state may be used when the support member is deployed in a body lumen, and the contracted state may be used for delivery of the device. A valvular body, as described above, may be attached to the internal or external surface of the support member. - Another support member is shown in
FIGS. 10A-J . In this alternative embodiment, the support member comprises a multiple panel hingedring structure 170. The multiple panel hinged ring structure includes threecircumferential rings 172 interconnected by threelongitudinal posts 174. More or fewer rings and/or posts may be used. Each ring structure, in turn, is composed of a plurality ofcurved panels 176, each connected to its adjacent panel by a junction member 178, such as a polymeric membrane hinge. Theindividual panels 176 have acurvature 180 about the axis of the device as well as acurvature 182 in the transverse direction. (SeeFIG. 10E ). Acoating material 184 maintains the panels in relation to one another, as well as providing afoldable junction 186. The curvature of the panels in conjunction with thecoating 184 maintains the ring structure in the expanded condition, as shown inFIGS. 10A , 10C, and 10D. Thefoldable junctions 186 are rotated to transform the structure from an expandedstate 188 for deployment, to a contractedstate 190 for delivery. (SeeFIG. 10E-J ). A valvular body, as described elsewhere herein, may be attached to the internal or external surface of the support member. - In still another alternative embodiment, as shown in
FIGS. 11A-C , the support member comprises a collapsing hingedstructure 200. The collapsing hinged structure shown in the Figures includes twenty-fourpanels 202 arranged peripherally around the generally tubular structure, each panel having atab 204 on its edge that overlaps and engages amating tab 206 on the opposed edge of the adjacent panel, interlocking the adjacent panels. More or fewer panels are possible. Anelastic membrane 208 is attached to an external surface of adjacent panels and provides a force biasing the adjacent panels together to assist the tabs in interlocking each adjacent pair of panels. Preferably, theelastic membrane 208 is attached to the main body of eachpanel 202, but not at the opposed edges. Thus, thetabs panels 202 rotated to form a vertex 210 at each shared edge, thereby defining a multi-vertex “star” shape that corresponds with the contracted state of the support member. Thesupport member 200 is transformed to its expanded state by applying an outward radial force that stretches theelastic membrane 208 and allows thetabs - All of the foregoing support members may be incorporated in a prosthetic valve, as described above, by attaching a valvular body to the external or internal surface of the support member. In the alternative, all of the foregoing support members may be utilized without a valvular body to provide a support or scaffolding function within a body lumen, such as a blood vessel or other organ. For example, the multi-segment, multi-hinged support member may be used as a scaffolding member for the treatment of abdominal aortic aneurisms, either alone, or in combination with another support member, graft, or other therapeutic device. Other similar uses are also contemplated, as will be understood by those skilled in the art.
- Moreover, several additional features and functions may be incorporated on or in the prosthetic valve or its components, including the support member and the valvular body. For example, one or more anchoring members may be formed on or attached to any of the above-described support member embodiments. Each anchoring member may comprise a barb, a tooth, a hook, or any other member that protrudes from the external surface of the support structure to physically engage the internal wall of the body lumen. An anchoring member may be selectively engageable, such as by an actuator, or it may be oriented so as to be permanently in its engaged state. Alternatively, the anchoring member may comprise an aperture formed in the support structure that allows tissue to invaginate therethrough. One example of an anchoring member is illustrated in
FIGS. 13B and 13C , where abarb 358 is shown extending from the surface of a contractedprosthetic valve 30. Thebarb 358 may be deflected inward while the prosthetic valve is retained in the delivery device. SeeFIG. 13C . Then, upon deployment, thebarb 358 is released and extends radially outward to engage the surface of the body lumen or other tissue. As noted above, other anchoring members and mechanisms are also contemplated for use with the devices described herein. - The prosthetic heart valves and support members described herein provide a number of advantages over prior devices in the art. For example, the prosthetic heart valves are able to be transformed to a contracted state and back to an expanded state without causing folding, tearing, crimping, or otherwise deforming the valve leaflets. In addition, unlike prior devices, the expanded state of the current device has a fixed cross-sectional size (e.g., diameter) that is not subject to recoil after expansion. This allows the structure to fit better at its treatment location and to better prevent migration. It also allows the valvular body to perform optimally because the size, shape and orientation of the valve leaflets may be designed to a known deployment size, rather than a range. Still further, because the expanded state of the support structure is of a known shape (again, unlike the prior devices), the valve leaflets may be designed in a manner to provide optimal performance.
- Devices for delivering a prosthetic valve to a treatment location in a body lumen are described below, as are methods for their use. The delivery devices are particularly adapted for use in minimally invasive interventional procedures, such as percutaneous aortic valve replacements.
FIGS. 14A and 15A illustrate two embodiments of the devices. Thedelivery devices 300 include anelongated delivery catheter 302 having proximal 304 and distal ends 306. Ahandle 308 is provided at the proximal end of the delivery catheter. Thehandle 308 may be provided with aknob 310, an actuator, a slider, other control members, or combinations thereof for controlling and manipulating the catheter to perform the prosthetic valve delivery procedure. A retractableouter sheath 312 may extend over at least a portion of the length of the catheter. Preferably, a guidewire lumen extends proximally from the distal end of the catheter. The guidewire lumen may extend through the entire length of the catheter for over-the-wire applications, or the guidewire lumen may have a proximal exit port closer to the distal end of the catheter than the proximal end for use with rapid-exchange applications. Thedistal portion 306 of the catheter includes a carrier adapted to receive and retain a prosthetic valve in a contracted state, and to deploy the prosthetic valve at a treatment location within a body lumen. - Turning first to
FIGS. 12A-F , a first embodiment of adistal portion 306 of a prosthetic valve delivery device is shown. Thedevice 300 includes adelivery tube 320 having threelongitudinal slots 322 at its distal end, and agripper 324 having a longitudinal shaft 326 and threefingers 328 that extend longitudinally from the distal end of the gripper. More or fewer longitudinal slots may be included on the delivery tube, and more or fewer fingers may be provided on the gripper. Preferably, thedelivery tube 320 has the same number of longitudinal slots, and thegripper 324 includes the same number of fingers, as there are segments on the prosthetic valve to be delivered. Thelongitudinal slots 322 on the distal end of the delivery tube are equally spaced around the periphery of the tube. Similarly, as viewed from the distal end of thegripper 324, thefingers 328 are arranged in an equi-spaced circular pattern. For example, in the case of three fingers, all three are equally spaced apart on an imaginary circle and are separated from each other by 120°. In the case of four fingers, the fingers would be separated from each other by 90°, and so on. - The
gripper 324 is slidably and rotatably received within thedelivery tube 320, and the delivery tube is internal of the outer sheath (not shown inFIGS. 12A-F ). The outer sheath is retractable to expose at least thelongitudinal slots 322 on the distal portion of the delivery tube. Thegripper 324 is able to be advanced at least far enough to extend thefingers 328 distally outside the distal end of the delivery tube. - In alternative embodiments of the above delivery device, the
gripper fingers 328 may comprise wires, fibers, hooks, or other structural members extending distally from the distal end of the gripper. As described below, a primary function of the fingers is to retain a prosthetic valve on the distal end of the gripper, and to restrain segments of the support member of the valve in an inverted state. Accordingly, any of the above (or other) structural members able to perform the above function may be substituted for the fingers described above. - The
delivery device 300 is particularly adapted for use in a minimally invasive surgical procedure to deliver a multi-segmentprosthetic valve 30, such as those described above, to a body lumen. To do so, theprosthetic valve 30 is first loaded into thedelivery device 300.FIGS. 12A-F illustrate the case of a prosthetic valve having a three segment support member. Theprosthetic valve 30 is loaded into thedelivery device 300 by first inverting the threepanels 36 to produce a three vertex structure. Inverting of the prosthetic valve panels may be performed manually, or by using an inverting tool. Theprosthetic valve 30 is then placed onto the distal end of thegripper 324, which has been previously extended outside the distal end of thedelivery tube 320, with each of the threefingers 328 retaining one of theinverted panels 36 in its inverted position. (SeeFIG. 12A ). Thegripper 324 andfingers 328, with theprosthetic valve 30 installed thereon, are then retracted back into thedelivery tube 320. During the retraction thegripper 324 andfingers 328 are rotationally aligned with thedelivery tube 320 such that the three vertices of the prosthetic valve align with the three longitudinal slots on the distal end of the delivery tube. (SeeFIG. 12B ). When thegripper 324 andfingers 328 are fully retracted, each of the three vertices of the prosthetic valve extends radially outside the delivery tube through thelongitudinal slots 322. (SeeFIG. 12C ). Thegripper 324 is then rotated relative to thedelivery tube 320, which action causes each of the folded segments of theprosthetic valve 30 to engage an edge of its respective delivery tube slot. (SeeFIG. 12D ). Further rotation of thegripper 324 relative to thedelivery tube 320 causes the folded segments to curl back toward the longitudinal axis of the prosthetic valve internally of the delivery tube, creating three lobes located fully within thedelivery tube 320. (SeeFIG. 12E ). Theprosthetic valve 30 is thereby loaded into thedelivery device 300. The outer sheath is then advanced over the distal portion of the catheter, including the delivery tube, to prepare the delivery device for use. - The
prosthetic valve 30 is delivered by first introducing a guidewire into the vascular system and to the treatment location of the patient by any conventional method, preferably by way of the femoral artery. Optionally, a suitable introducer sheath may be advanced to facilitate introduction of the delivery device. Thedelivery catheter 302 is then advanced over the guidewire to the treatment location. Theouter sheath 312 is then retracted to expose thedelivery tube 320. Thegripper 324 is then rotated relative to the delivery tube 320 (or the delivery tube rotated relative to the gripper), thereby causing the folded panels of theprosthetic valve 30 to uncurl and to extend radially outward through thelongitudinal slots 322 of thedelivery tube 320. Thedelivery tube 320 is then retracted (or the gripper advanced) to cause the prosthetic valve 30 (restrained by the fingers 328) to advance distally out of the delivery tube. Thegripper 324 is then retracted relative to theprosthetic valve 30, releasing theprosthetic valve 30 into the treatment location. (SeeFIG. 12F ). Preferably, theinverted panels 36 then revert to the expanded state, causing the valve to lodge against the internal surface of the body lumen (e.g., the aortic valve root or another biologically acceptable aortic position). Additional expansion of the prosthetic valve may be provided, if needed, by a suitable expansion member, such as the expansion balloon or the expanding mesh member described elsewhere herein, carried on thedelivery catheter 302 or other carrier. - Turning to
FIGS. 13A-E , another embodiment of a distal portion of a prosthetic valve delivery device is shown. The distal portion of thecatheter 302 includes a restrainingsheath 340, anorientation sheath 342, a plurality ofgrippers 344, anexpander 346, and a plurality ofstruts 348. Each of thegrippers 344 includes awire 350 riding within atube 352, and atip 354 at the distal end of the tube. Thewire 350 of eachgripper 344 has anend portion 356 formed to engage the vertex of a prostheticvalve support member 32 having multiple segments, and to selectively restrain theprosthetic valve 30 in a contracted state. (SeeFIG. 13B ). Theexpander 346 is adapted to selectively cause thegrippers 344 to expand radially outwardly when it is actuated by the user by way of anactuator 310 located on thehandle 308. - The
prosthetic valve 30 may be loaded into thedelivery device 300 by contracting the prosthetic valve (either manually or with an inverting tool) by inverting eachpanel 36 and then attaching each vertex to arespective end portion 356 of the wire contained on eachgripper 344 on the delivery device. Thegripper wires 350 receive, retain, and restrain theprosthetic valve 30 in its contracted state. Thegripper 344 assembly having theprosthetic valve 30 installed is then retracted into each of theorientation sheath 342 and the restrainingsheath 340 to prepare the device for insertion into the patient's vasculature. The device is then advanced over a guidewire to a treatment location, such as the base annulus of the native aortic valve. (SeeFIG. 13E ). The restrainingsheath 340 is then retracted to allow theprosthetic valve 30 to partially expand (e.g., to about 85% of its full transverse dimension), where it is constrained by theorientation sheath 342. Theprosthetic valve 30 is then finally positioned by manipulation of thegrippers 344, after which theorientation sheath 342 is retracted and thegrippers 344 released. Theprosthetic valve 30 then lodges itself in the treatment location. - Other embodiments of the delivery device are illustrated in
FIGS. 14A-E and 15A-B. As shown in those Figures, thedistal portion 306 of the catheter includes one ormore restraining tubes 370 having at least one (and preferably two)adjustable restraining loops 372. In the embodiment shown inFIGS. 14A-E , the device is provided with onerestraining tube 370 and two restrainingloops 372. In the embodiment shown inFIGS. 15A-B , the device is provided with three restrainingtubes 370 and two restrainingloops 372. The restraining tube(s) 370 extend distally from acatheter shaft 374 out of the distal end of the delivery device, and each restrainingloop 372 is a wire or fiber loop that extends transversely of the restrainingtube 370. Each restrainingloop 372 is a flexible loop capable of selectively restraining a contracted prosthetic valve. The restrainingloops 372 may be selectively constricted or released by a control member, such as aknob 310, located on thehandle 308 of the device. A retractableouter sheath 376 covers the distal portion of the catheter. - The
prosthetic valve 30 may be loaded onto the delivery device by contracting the prosthetic valve (either manually or with an inverting tool) into its contracted state, for example, by inverting eachpanel 36 and curling each inverted panel into a lobe. The contracted prosthetic valve is then placed onto the restraining tube(s) 370 and through the one ormore restraining loops 372. (See, e.g.,FIG. 14B ). Theloops 372 are constricted around the contractedprosthetic valve 30, thereby restraining the prosthetic valve in its contracted state. Theouter sheath 376 is then advanced over the prosthetic valve and the restraining tube(s) to prepare the delivery device for use. (SeeFIG. 14C ). The device is then advanced over a guidewire to a treatment location, such as the base annulus of the native aortic valve. (SeeFIG. 14D ). The restrainingsheath 376 is then retracted to expose the contractedprosthetic valve 30. The restrainingloops 372 are released, such as by rotating thecontrol knob 310, thereby releasing theprosthetic valve 30 and allowing it to self-expand. (SeeFIG. 14E ). Theprosthetic valve 30 then lodges itself in the treatment location. An expansion member may be advanced to the interior of the prosthetic valve and expanded to provide additional expansion force, if needed or desired. - Another embodiment of the delivery device is shown in
FIGS. 16A-B . As shown there, the distal portion of the catheter includes agripper 400 that includes abase portion 402 having three restrainingmembers 404 extending distally from the gripper base. In the embodiment shown, each of the restrainingmembers 404 includes awire loop 406 extending through asleeve 408, with both the sleeve and the wire loop extending distally from thegripper base 402. Thewire loops 406 also extend proximally of thegripper base 402, which is provided with alumen 410 corresponding with each of thewire loops 406, thereby allowing thegripper base 402 and thesleeves 404 to slide relative to thewire loops 406. Adelivery tube 412 may also be provided. As shown in the Figures, thegripper 400 is slidably received within thedelivery tube 412, and the tube has threelongitudinal slots 414 corresponding with the three restrainingmembers 404 on the gripper assembly. Anatraumatic tip 416 or nosecone is attached to acentral shaft 418 that extends through the center of thecatheter 302 internally of thegripper 400 and thedelivery tube 412. Thecentral shaft 418 includes a guidewire lumen to accommodate a guidewire used to assist deployment of the delivery device. - Although the device shown in the Figures includes three restraining
members 404, fewer or additional restraining members may be used. One function of the restraining members is to retain a prosthetic valve on the distal end of the delivery device, and to selectively maintain the valve in a contracted state. In the preferred embodiment, the number of restraining members will coincide with the number of segments (e.g., panels) included on the prosthetic valve. - Turning to
FIG. 16A , thedelivery device 300 is shown with thedelivery tube 412 andgripper 400 retracted relative to thewire loops 406, thereby allowing the distal ends 420 of the wire loops to extend freely away from thecentral shaft 418. The delivery device in this condition is adapted to have a prosthetic valve installed onto the device. To do so, theprosthetic valve 30 is first placed over the distal end of the device and thepanels 36 of the valve are inverted. Alternatively, thevalve panels 36 may be inverted prior to or simultaneous with placing the valve over the distal end of the delivery device. Thewire loops 406 are then placed over theinverted panels 36, and thegripper 400 is advanced to cause thesleeves 408 to physically engage theinverted panels 36. SeeFIG. 16B . Thesleeves 408 have sufficient strength to maintain the prosthetic valve panels in their inverted state. Thedelivery tube 412 may then be advanced over the distal end of the device, with the valve panel vertices extending out of thelongitudinal slots 414 formed on thedelivery tube 412. Thegripper 400 may then be rotated relative to the delivery tube (or vice versa) to contract the panel vertices within the interior of the delivery tube and to thereby prepare the device for delivery of the prosthetic valve. The valve is delivered in the same manner described above in relation to the device shown inFIGS. 12A-E . - As noted, each of the foregoing delivery devices is suitable for use in delivering a prosthetic heart valve or a support member, such as those described herein. In the case of a prosthetic heart valve, the delivery methods may be combined with other treatment devices, methods, and procedures, particularly procedures intended to open or treat a stenotic heart valve. For example, a valvuloplasty procedure may be performed prior to the prosthetic heart valve deployment. The valvuloplasty procedure may be performed using a conventional balloon or a cutting balloon adapted to cut scarred leaflets so that they open more easily. Other treatments, such as chemical treatments to soften calcifications or other disorders may also be performed.
- Each of the foregoing delivery devices may be provided with a tether connecting the delivery device to the prosthetic valve or support member. The tether is preferably formed of a material and has a size sufficient to control the prosthetic valve or support member in the event that it is needed to withdraw the device during or after deployment. Preferably, the tether may be selectably disengaged by the user after deployment of the device.
- Turning to
FIGS. 17A-B and 18A-D, two types of expansion members are provided for performing dilation functions in minimally invasive surgical procedures. The expansion members may be used, for example, in procedures such as angioplasty, valvuloplasty, stent or other device placement or expansion, and other similar procedures. In relation to the devices and methods described above and elsewhere herein, the expansion members may be used to provide additional expansion force to the support members used on the prosthetic valves described herein. - In one embodiment, illustrated in
FIGS. 17A-B , theexpansion member 430 includes three elongated inflation balloons 432 a-c oriented about alongitudinal axis 434. Each inflation balloon 432 is connected at its proximal end by afeeder lumen 436 to acentral lumen 438 that provides fluid communication between the inflation balloons 432 a-c and a source of inflation media associated with ahandle portion 308 of a catheter. The central lumen itself is provided with aguidewire lumen 440 to allow passage of a guidewire through theexpansion member 430. Aflexible member 442 is attached to the distal end of each of the inflation balloons 432 a-c, and also includes a guidewire lumen. Although the expansion member shown in the Figures includes three inflation balloons, fewer or more balloons are possible. Moreover, each of the individual balloons may be inflated separately, all inflated together, or any combination thereof to obtain a desired force profile. The multiple inflation balloon structure provides a number of advantages, including the ability to provide greater radial forces than a single balloon, and the ability to avoid occluding a vessel undergoing treatment and to allow blood or other fluid to flow through the device. - In an alternative embodiment, shown in
FIGS. 18A-D , theexpansion member 450 comprises a flexible,expandable mesh member 452. Theexpandable mesh member 452 includes ashaft 454 and a cylindrical wovenmesh member 452 disposed longitudinally over the shaft. Adistal end 456 of the cylindrical mesh member is attached to thedistal end 458 of the shaft. Theproximal end 460 of the cylindrical mesh member is slidably engaged to the shaft by acollar 462 proximally of thedistal end 456. As thecollar 462 is advanced distally along theshaft 454, the body of thecylindrical mesh member 452 is caused to expand radially, thereby providing a radially expandable member. - The preferred embodiments of the inventions that are the subject of this application are described above in detail for the purpose of setting forth a complete disclosure and for the sake of explanation and clarity. Those skilled in the art will envision other modifications within the scope and spirit of the present disclosure. Such alternatives, additions, modifications, and improvements may be made without departing from the scope of the present inventions, which is defined by the claims.
Claims (20)
1. A method for delivering a prosthetic heart valve, comprising:
advancing a prosthetic heart valve through the vasculature of a patient to a treatment site along a wall of a blood vessel, the prosthetic heart valve comprising (i) a tubular support structure comprising a plurality of independently expandable segments oriented along the periphery of the support structure, and (ii) a plurality of valve leaflets coupled with the plurality of segments;
expanding an expansion member within the tubular support structure such that the tubular support structure expands and contacts the vessel wall, wherein the blood vessel is not occluded after the expansion member is expanded.
2. The method of claim 1 , wherein the expansion member comprises a plurality of expandable elements.
3. The method of claim 2 , wherein expanding the expansion member comprises expanding a first one of the plurality of expandable elements.
4. The method of claim 3 , further comprising expanding a second one of the expandable elements after expanding the first one of the expandable elements.
5. The method of claim 4 , wherein the tubular support structure comprises exactly three expandable segments, each being coupled together by a hinge, and wherein the expansion member comprises exactly three expandable elements.
6. The method of claim 5 , wherein the expandable elements are balloons.
7. The method of claim 2 , wherein expanding the expansion member comprises expanding each of the plurality of expandable elements together.
8. The method of claim 4 , wherein the tubular support structure comprises exactly three expandable segments, each being coupled together by a hinge, and wherein the expansion member comprises exactly three expandable elements.
9. The method of claim 2 , wherein, when each of the plurality of expandable elements is expanded, blood is free to flow through the prosthetic heart valve between the expandable elements.
10. The method of claim 2 , wherein the expandable member is configured to allow each of the expandable elements to be separately expandable and to be expanded together to obtain different force distributions.
11. The method of claim 1 , wherein the prosthetic heart valve is advanced through the vasculature by a delivery catheter that further comprises the expansion member.
12. The method of claim 11 , wherein the delivery catheter is coupled to a proximal handle configured to control the delivery of the prosthetic valve and to cause expansion of the expandable member.
13. The method of claim 1 , wherein the prosthetic heart valve is advanced through the vasculature by a delivery catheter separate from a carrier that carries the expansion member.
14. The method of claim 1 , further comprising advancing the expansion member into the tubular support structure prior to expanding the expansion member.
15. The method of claim 1 , further comprising retracting the expansion member into the tubular support structure prior to expanding the expansion member.
16. The method of claim 1 , wherein the tubular support structure is configured to self-expand and the expansion of the expansion member provides additional expansion force to the self-expandable tubular support structure.
17. The method of claim 1 , further comprising self-expanding the tubular support structure prior to expanding the expansion member.
18. The method of claim 1 , wherein the expansion member comprises (i) a plurality of expandable elements, each being oriented about a centrally located longitudinal axis, and (ii) a central lumen configured to allow passage of a guidewire through the expansion member.
19. The method of claim 17 , wherein each of the expandable elements is a balloon coupled with a separate feeder lumen for passage of an inflation medium.
20. The method of claim 18 , wherein each of the expandable elements has a distal end attached to a flexible member having a guidewire lumen.
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US13/333,901 US9168134B2 (en) | 2004-02-27 | 2011-12-21 | Method for delivering a prosthetic heart valve with an expansion member |
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20120239143A1 (en) * | 2010-09-30 | 2012-09-20 | BioStable Science & Engineering, Inc. | Non-Axisymmetric Aortic Valve Devices |
US10130462B2 (en) | 2006-10-06 | 2018-11-20 | BioStable Science & Engineering, Inc. | Intra-annular mounting frame for aortic valve repair |
Families Citing this family (497)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0850607A1 (en) | 1996-12-31 | 1998-07-01 | Cordis Corporation | Valve prosthesis for implantation in body channels |
US6626899B2 (en) | 1999-06-25 | 2003-09-30 | Nidus Medical, Llc | Apparatus and methods for treating tissue |
US6454799B1 (en) | 2000-04-06 | 2002-09-24 | Edwards Lifesciences Corporation | Minimally-invasive heart valves and methods of use |
US8366769B2 (en) | 2000-06-01 | 2013-02-05 | Edwards Lifesciences Corporation | Low-profile, pivotable heart valve sewing ring |
US6409758B2 (en) | 2000-07-27 | 2002-06-25 | Edwards Lifesciences Corporation | Heart valve holder for constricting the valve commissures and methods of use |
WO2002015793A2 (en) | 2000-08-18 | 2002-02-28 | Atritech, Inc. | Expandable implant devices for filtering blood flow from atrial appendages |
US6893459B1 (en) * | 2000-09-20 | 2005-05-17 | Ample Medical, Inc. | Heart valve annulus device and method of using same |
US6602286B1 (en) | 2000-10-26 | 2003-08-05 | Ernst Peter Strecker | Implantable valve system |
US7556646B2 (en) | 2001-09-13 | 2009-07-07 | Edwards Lifesciences Corporation | Methods and apparatuses for deploying minimally-invasive heart valves |
US6733525B2 (en) | 2001-03-23 | 2004-05-11 | Edwards Lifesciences Corporation | Rolled minimally-invasive heart valves and methods of use |
FR2826863B1 (en) | 2001-07-04 | 2003-09-26 | Jacques Seguin | ASSEMBLY FOR PLACING A PROSTHETIC VALVE IN A BODY CONDUIT |
US6893460B2 (en) | 2001-10-11 | 2005-05-17 | Percutaneous Valve Technologies Inc. | Implantable prosthetic valve |
US7201771B2 (en) | 2001-12-27 | 2007-04-10 | Arbor Surgical Technologies, Inc. | Bioprosthetic heart valve |
US6752828B2 (en) | 2002-04-03 | 2004-06-22 | Scimed Life Systems, Inc. | Artificial valve |
US7959674B2 (en) | 2002-07-16 | 2011-06-14 | Medtronic, Inc. | Suture locking assembly and method of use |
US8551162B2 (en) | 2002-12-20 | 2013-10-08 | Medtronic, Inc. | Biologically implantable prosthesis |
US6945957B2 (en) | 2002-12-30 | 2005-09-20 | Scimed Life Systems, Inc. | Valve treatment catheter and methods |
US8021421B2 (en) | 2003-08-22 | 2011-09-20 | Medtronic, Inc. | Prosthesis heart valve fixturing device |
US20050075725A1 (en) | 2003-10-02 | 2005-04-07 | Rowe Stanton J. | Implantable prosthetic valve with non-laminar flow |
US9579194B2 (en) | 2003-10-06 | 2017-02-28 | Medtronic ATS Medical, Inc. | Anchoring structure with concave landing zone |
US20060259137A1 (en) * | 2003-10-06 | 2006-11-16 | Jason Artof | Minimally invasive valve replacement system |
US7842084B2 (en) * | 2005-06-21 | 2010-11-30 | 3F Therapeutics, Inc. | Method and systems for sizing, folding, holding, and delivering a heart valve prosthesis |
US7556647B2 (en) | 2003-10-08 | 2009-07-07 | Arbor Surgical Technologies, Inc. | Attachment device and methods of using the same |
US8128681B2 (en) | 2003-12-19 | 2012-03-06 | Boston Scientific Scimed, Inc. | Venous valve apparatus, system, and method |
US7854761B2 (en) | 2003-12-19 | 2010-12-21 | Boston Scientific Scimed, Inc. | Methods for venous valve replacement with a catheter |
US7824442B2 (en) | 2003-12-23 | 2010-11-02 | Sadra Medical, Inc. | Methods and apparatus for endovascularly replacing a heart valve |
US7329279B2 (en) | 2003-12-23 | 2008-02-12 | Sadra Medical, Inc. | Methods and apparatus for endovascularly replacing a patient's heart valve |
US8182528B2 (en) | 2003-12-23 | 2012-05-22 | Sadra Medical, Inc. | Locking heart valve anchor |
US7748389B2 (en) | 2003-12-23 | 2010-07-06 | Sadra Medical, Inc. | Leaflet engagement elements and methods for use thereof |
US20050137687A1 (en) | 2003-12-23 | 2005-06-23 | Sadra Medical | Heart valve anchor and method |
US20120041550A1 (en) | 2003-12-23 | 2012-02-16 | Sadra Medical, Inc. | Methods and Apparatus for Endovascular Heart Valve Replacement Comprising Tissue Grasping Elements |
US7445631B2 (en) | 2003-12-23 | 2008-11-04 | Sadra Medical, Inc. | Methods and apparatus for endovascularly replacing a patient's heart valve |
US7824443B2 (en) | 2003-12-23 | 2010-11-02 | Sadra Medical, Inc. | Medical implant delivery and deployment tool |
US7959666B2 (en) | 2003-12-23 | 2011-06-14 | Sadra Medical, Inc. | Methods and apparatus for endovascularly replacing a heart valve |
US8343213B2 (en) | 2003-12-23 | 2013-01-01 | Sadra Medical, Inc. | Leaflet engagement elements and methods for use thereof |
US8828078B2 (en) | 2003-12-23 | 2014-09-09 | Sadra Medical, Inc. | Methods and apparatus for endovascular heart valve replacement comprising tissue grasping elements |
US7780725B2 (en) | 2004-06-16 | 2010-08-24 | Sadra Medical, Inc. | Everting heart valve |
US7988724B2 (en) | 2003-12-23 | 2011-08-02 | Sadra Medical, Inc. | Systems and methods for delivering a medical implant |
EP2529698B1 (en) | 2003-12-23 | 2014-01-29 | Sadra Medical, Inc. | Repositionable heart valve |
US20050137694A1 (en) | 2003-12-23 | 2005-06-23 | Haug Ulrich R. | Methods and apparatus for endovascularly replacing a patient's heart valve |
US9526609B2 (en) | 2003-12-23 | 2016-12-27 | Boston Scientific Scimed, Inc. | Methods and apparatus for endovascularly replacing a patient's heart valve |
US7381219B2 (en) | 2003-12-23 | 2008-06-03 | Sadra Medical, Inc. | Low profile heart valve and delivery system |
US8603160B2 (en) | 2003-12-23 | 2013-12-10 | Sadra Medical, Inc. | Method of using a retrievable heart valve anchor with a sheath |
US11278398B2 (en) | 2003-12-23 | 2022-03-22 | Boston Scientific Scimed, Inc. | Methods and apparatus for endovascular heart valve replacement comprising tissue grasping elements |
US8287584B2 (en) | 2005-11-14 | 2012-10-16 | Sadra Medical, Inc. | Medical implant deployment tool |
US8579962B2 (en) | 2003-12-23 | 2013-11-12 | Sadra Medical, Inc. | Methods and apparatus for performing valvuloplasty |
US9005273B2 (en) | 2003-12-23 | 2015-04-14 | Sadra Medical, Inc. | Assessing the location and performance of replacement heart valves |
US8840663B2 (en) | 2003-12-23 | 2014-09-23 | Sadra Medical, Inc. | Repositionable heart valve method |
US7871435B2 (en) | 2004-01-23 | 2011-01-18 | Edwards Lifesciences Corporation | Anatomically approximate prosthetic mitral heart valve |
US8430925B2 (en) | 2004-02-27 | 2013-04-30 | Cardiacmd, Inc. | Prosthetic heart valves, scaffolding structures, and systems and methods for implantation of same |
ITTO20040135A1 (en) | 2004-03-03 | 2004-06-03 | Sorin Biomedica Cardio Spa | CARDIAC VALVE PROSTHESIS |
US7976539B2 (en) | 2004-03-05 | 2011-07-12 | Hansen Medical, Inc. | System and method for denaturing and fixing collagenous tissue |
US8349001B2 (en) * | 2004-04-07 | 2013-01-08 | Medtronic, Inc. | Pharmacological delivery implement for use with cardiac repair devices |
US8377118B2 (en) | 2004-05-05 | 2013-02-19 | Direct Flow Medical, Inc. | Unstented heart valve with formed in place support structure |
US7763065B2 (en) | 2004-07-21 | 2010-07-27 | Reva Medical, Inc. | Balloon expandable crush-recoverable stent device |
US7971333B2 (en) | 2006-05-30 | 2011-07-05 | Advanced Cardiovascular Systems, Inc. | Manufacturing process for polymetric stents |
US7731890B2 (en) | 2006-06-15 | 2010-06-08 | Advanced Cardiovascular Systems, Inc. | Methods of fabricating stents with enhanced fracture toughness |
US8747879B2 (en) | 2006-04-28 | 2014-06-10 | Advanced Cardiovascular Systems, Inc. | Method of fabricating an implantable medical device to reduce chance of late inflammatory response |
US20140107761A1 (en) | 2004-07-26 | 2014-04-17 | Abbott Cardiovascular Systems Inc. | Biodegradable stent with enhanced fracture toughness |
US7566343B2 (en) | 2004-09-02 | 2009-07-28 | Boston Scientific Scimed, Inc. | Cardiac valve, system, and method |
US8182530B2 (en) | 2004-10-02 | 2012-05-22 | Christoph Hans Huber | Methods and devices for repair or replacement of heart valves or adjacent tissue without the need for full cardiopulmonary support |
US8292944B2 (en) | 2004-12-17 | 2012-10-23 | Reva Medical, Inc. | Slide-and-lock stent |
DE102005003632A1 (en) | 2005-01-20 | 2006-08-17 | Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. | Catheter for the transvascular implantation of heart valve prostheses |
US7854755B2 (en) | 2005-02-01 | 2010-12-21 | Boston Scientific Scimed, Inc. | Vascular catheter, system, and method |
US20060173490A1 (en) | 2005-02-01 | 2006-08-03 | Boston Scientific Scimed, Inc. | Filter system and method |
CA2496095A1 (en) * | 2005-02-04 | 2006-08-04 | Sango S.A.S. Di Cattani Rita & C. | External support for restoring competence to venous valves by traction of their intercommissural walls |
US7878966B2 (en) | 2005-02-04 | 2011-02-01 | Boston Scientific Scimed, Inc. | Ventricular assist and support device |
US7780722B2 (en) | 2005-02-07 | 2010-08-24 | Boston Scientific Scimed, Inc. | Venous valve apparatus, system, and method |
US7670368B2 (en) | 2005-02-07 | 2010-03-02 | Boston Scientific Scimed, Inc. | Venous valve apparatus, system, and method |
US8574257B2 (en) | 2005-02-10 | 2013-11-05 | Edwards Lifesciences Corporation | System, device, and method for providing access in a cardiovascular environment |
ITTO20050074A1 (en) | 2005-02-10 | 2006-08-11 | Sorin Biomedica Cardio Srl | CARDIAC VALVE PROSTHESIS |
US7867274B2 (en) | 2005-02-23 | 2011-01-11 | Boston Scientific Scimed, Inc. | Valve apparatus, system and method |
FR2883721B1 (en) * | 2005-04-05 | 2007-06-22 | Perouse Soc Par Actions Simpli | NECESSARY TO BE IMPLANTED IN A BLOOD CIRCULATION CONDUIT, AND ASSOCIATED TUBULAR ENDOPROTHESIS |
US7513909B2 (en) | 2005-04-08 | 2009-04-07 | Arbor Surgical Technologies, Inc. | Two-piece prosthetic valves with snap-in connection and methods for use |
US7722666B2 (en) | 2005-04-15 | 2010-05-25 | Boston Scientific Scimed, Inc. | Valve apparatus, system and method |
US7962208B2 (en) | 2005-04-25 | 2011-06-14 | Cardiac Pacemakers, Inc. | Method and apparatus for pacing during revascularization |
WO2006127756A2 (en) | 2005-05-24 | 2006-11-30 | Edwards Lifesciences Corporation | Rapid deployment prosthetic heart valve |
EP1895942B1 (en) | 2005-05-27 | 2020-05-13 | Medtronic, Inc. | Gasket with collar for prosthetic heart valves |
US8568477B2 (en) | 2005-06-07 | 2013-10-29 | Direct Flow Medical, Inc. | Stentless aortic valve replacement with high radial strength |
US8012198B2 (en) | 2005-06-10 | 2011-09-06 | Boston Scientific Scimed, Inc. | Venous valve, system, and method |
US7780723B2 (en) | 2005-06-13 | 2010-08-24 | Edwards Lifesciences Corporation | Heart valve delivery system |
US20060287668A1 (en) * | 2005-06-16 | 2006-12-21 | Fawzi Natalie V | Apparatus and methods for intravascular embolic protection |
US7682391B2 (en) | 2005-07-13 | 2010-03-23 | Edwards Lifesciences Corporation | Methods of implanting a prosthetic mitral heart valve having a contoured sewing ring |
US7914574B2 (en) | 2005-08-02 | 2011-03-29 | Reva Medical, Inc. | Axially nested slide and lock expandable device |
US9149378B2 (en) * | 2005-08-02 | 2015-10-06 | Reva Medical, Inc. | Axially nested slide and lock expandable device |
US20070049804A1 (en) * | 2005-08-25 | 2007-03-01 | Albert Wong | One-piece retractable stent |
US7712606B2 (en) | 2005-09-13 | 2010-05-11 | Sadra Medical, Inc. | Two-part package for medical implant |
US7569071B2 (en) | 2005-09-21 | 2009-08-04 | Boston Scientific Scimed, Inc. | Venous valve, system, and method with sinus pocket |
US8167932B2 (en) | 2005-10-18 | 2012-05-01 | Edwards Lifesciences Corporation | Heart valve delivery system with valve catheter |
US20070112361A1 (en) * | 2005-11-07 | 2007-05-17 | Schonholz Steven M | Surgical repair systems and methods of using the same |
US9254163B2 (en) | 2005-12-06 | 2016-02-09 | St. Jude Medical, Atrial Fibrillation Division, Inc. | Assessment of electrode coupling for tissue ablation |
US20070213813A1 (en) | 2005-12-22 | 2007-09-13 | Symetis Sa | Stent-valves for valve replacement and associated methods and systems for surgery |
US20070168022A1 (en) * | 2006-01-17 | 2007-07-19 | Eldridge Charles J | Heart valve |
US7799038B2 (en) | 2006-01-20 | 2010-09-21 | Boston Scientific Scimed, Inc. | Translumenal apparatus, system, and method |
US7967857B2 (en) | 2006-01-27 | 2011-06-28 | Medtronic, Inc. | Gasket with spring collar for prosthetic heart valves and methods for making and using them |
WO2008029296A2 (en) | 2006-02-16 | 2008-03-13 | Endocor Pte Ltd. | Minimally invasive heart valve replacement |
US8147541B2 (en) | 2006-02-27 | 2012-04-03 | Aortx, Inc. | Methods and devices for delivery of prosthetic heart valves and other prosthetics |
US7749266B2 (en) * | 2006-02-27 | 2010-07-06 | Aortx, Inc. | Methods and devices for delivery of prosthetic heart valves and other prosthetics |
US8075615B2 (en) | 2006-03-28 | 2011-12-13 | Medtronic, Inc. | Prosthetic cardiac valve formed from pericardium material and methods of making same |
WO2007130881A2 (en) | 2006-04-29 | 2007-11-15 | Arbor Surgical Technologies, Inc. | Multiple component prosthetic heart valve assemblies and apparatus and methods for delivering them |
US8021161B2 (en) | 2006-05-01 | 2011-09-20 | Edwards Lifesciences Corporation | Simulated heart valve root for training and testing |
US8585594B2 (en) | 2006-05-24 | 2013-11-19 | Phoenix Biomedical, Inc. | Methods of assessing inner surfaces of body lumens or organs |
US7811316B2 (en) | 2006-05-25 | 2010-10-12 | Deep Vein Medical, Inc. | Device for regulating blood flow |
US8092517B2 (en) * | 2006-05-25 | 2012-01-10 | Deep Vein Medical, Inc. | Device for regulating blood flow |
US8500799B2 (en) | 2006-06-20 | 2013-08-06 | Cardiacmd, Inc. | Prosthetic heart valves, support structures and systems and methods for implanting same |
CA2657433A1 (en) | 2006-06-20 | 2007-12-27 | Aortx, Inc. | Torque shaft and torque drive |
AU2007260951A1 (en) | 2006-06-21 | 2007-12-27 | Aortx, Inc. | Prosthetic valve implantation systems |
US20080004696A1 (en) * | 2006-06-29 | 2008-01-03 | Valvexchange Inc. | Cardiovascular valve assembly with resizable docking station |
US8252036B2 (en) | 2006-07-31 | 2012-08-28 | Syntheon Cardiology, Llc | Sealable endovascular implants and methods for their use |
US9408607B2 (en) | 2009-07-02 | 2016-08-09 | Edwards Lifesciences Cardiaq Llc | Surgical implant devices and methods for their manufacture and use |
US9585743B2 (en) | 2006-07-31 | 2017-03-07 | Edwards Lifesciences Cardiaq Llc | Surgical implant devices and methods for their manufacture and use |
CA2661959A1 (en) | 2006-09-06 | 2008-03-13 | Aortx, Inc. | Prosthetic heart valves, systems and methods of implanting |
CA2976839C (en) | 2006-09-08 | 2020-04-28 | Edwards Lifesciences Corporation | Integrated heart valve delivery system |
US8133213B2 (en) | 2006-10-19 | 2012-03-13 | Direct Flow Medical, Inc. | Catheter guidance through a calcified aortic valve |
US7935144B2 (en) | 2006-10-19 | 2011-05-03 | Direct Flow Medical, Inc. | Profile reduction of valve implant |
US20100087918A1 (en) * | 2006-10-23 | 2010-04-08 | Ivan Vesely | Cardiovascular valve and assembly |
US8236045B2 (en) | 2006-12-22 | 2012-08-07 | Edwards Lifesciences Corporation | Implantable prosthetic valve assembly and method of making the same |
US8133270B2 (en) | 2007-01-08 | 2012-03-13 | California Institute Of Technology | In-situ formation of a valve |
US8460369B2 (en) * | 2007-01-18 | 2013-06-11 | Valvexchange Inc. | Tools for removal and installation of exchangeable cardiovascular valves |
US7704275B2 (en) | 2007-01-26 | 2010-04-27 | Reva Medical, Inc. | Circumferentially nested expandable device |
WO2008097589A1 (en) | 2007-02-05 | 2008-08-14 | Boston Scientific Limited | Percutaneous valve, system, and method |
US7896915B2 (en) | 2007-04-13 | 2011-03-01 | Jenavalve Technology, Inc. | Medical device for treating a heart valve insufficiency |
JP5264264B2 (en) * | 2007-04-23 | 2013-08-14 | セント ジョセフズ トランスレーショナル リサーチ インスティテュート インコーポレイテッド | Replacement heart valve and method of manufacturing the same |
US8828079B2 (en) | 2007-07-26 | 2014-09-09 | Boston Scientific Scimed, Inc. | Circulatory valve, system and method |
US9814611B2 (en) | 2007-07-31 | 2017-11-14 | Edwards Lifesciences Cardiaq Llc | Actively controllable stent, stent graft, heart valve and method of controlling same |
US9566178B2 (en) | 2010-06-24 | 2017-02-14 | Edwards Lifesciences Cardiaq Llc | Actively controllable stent, stent graft, heart valve and method of controlling same |
US8486138B2 (en) | 2007-08-21 | 2013-07-16 | Valvexchange Inc. | Method and apparatus for prosthetic valve removal |
CA2697364C (en) | 2007-08-23 | 2017-10-17 | Direct Flow Medical, Inc. | Translumenally implantable heart valve with formed in place support |
US20090093876A1 (en) * | 2007-08-31 | 2009-04-09 | Edwards Lifesciences Corporation | Recoil inhibitor for prosthetic valve |
DE102007043830A1 (en) | 2007-09-13 | 2009-04-02 | Lozonschi, Lucian, Madison | Heart valve stent |
US9848981B2 (en) | 2007-10-12 | 2017-12-26 | Mayo Foundation For Medical Education And Research | Expandable valve prosthesis with sealing mechanism |
US8142490B2 (en) * | 2007-10-24 | 2012-03-27 | Cordis Corporation | Stent segments axially connected by thin film |
EP2211773A4 (en) | 2007-11-30 | 2015-07-29 | Reva Medical Inc | Axially-radially nested expandable device |
DK3494930T3 (en) | 2007-12-14 | 2020-03-02 | Edwards Lifesciences Corp | Blade attachment frame for a prosthetic flap |
US7892276B2 (en) | 2007-12-21 | 2011-02-22 | Boston Scientific Scimed, Inc. | Valve with delayed leaflet deployment |
JP5591120B2 (en) | 2008-01-16 | 2014-09-17 | セント ジュード メディカル インコーポレイテッド | Collapsible / expandable prosthetic heart valve delivery and retrieval system |
US9044318B2 (en) | 2008-02-26 | 2015-06-02 | Jenavalve Technology Gmbh | Stent for the positioning and anchoring of a valvular prosthesis |
WO2011104269A1 (en) | 2008-02-26 | 2011-09-01 | Jenavalve Technology Inc. | Stent for the positioning and anchoring of a valvular prosthesis in an implantation site in the heart of a patient |
EP3915525A1 (en) | 2008-02-28 | 2021-12-01 | Medtronic, Inc. | Prosthetic heart valve systems |
AU2009219005B2 (en) | 2008-02-29 | 2013-07-11 | Edwards Lifesciences Corporation | Expandable member for deploying a prosthetic device |
US20090276040A1 (en) | 2008-05-01 | 2009-11-05 | Edwards Lifesciences Corporation | Device and method for replacing mitral valve |
US9061119B2 (en) | 2008-05-09 | 2015-06-23 | Edwards Lifesciences Corporation | Low profile delivery system for transcatheter heart valve |
CA2728231C (en) | 2008-06-06 | 2016-08-23 | Edwards Lifesciences Corporation | Low profile transcatheter heart valve |
US8323335B2 (en) | 2008-06-20 | 2012-12-04 | Edwards Lifesciences Corporation | Retaining mechanisms for prosthetic valves and methods for using |
EP3878408A1 (en) | 2008-07-21 | 2021-09-15 | Jenesis Surgical, LLC | Endoluminal support apparatus |
US8652202B2 (en) | 2008-08-22 | 2014-02-18 | Edwards Lifesciences Corporation | Prosthetic heart valve and delivery apparatus |
CA2736817A1 (en) | 2008-09-12 | 2010-03-18 | Valvexchange Inc. | Valve assembly with exchangeable valve member and a tool set for exchanging the valve member |
US8092722B2 (en) * | 2008-09-30 | 2012-01-10 | Sabic Innovative Plastics Ip B.V. | Varnish compositions for electrical insulation and method of using the same |
US8790387B2 (en) | 2008-10-10 | 2014-07-29 | Edwards Lifesciences Corporation | Expandable sheath for introducing an endovascular delivery device into a body |
ES2409693T3 (en) | 2008-10-10 | 2013-06-27 | Sadra Medical, Inc. | Medical devices and supply systems to supply medical devices |
US8690936B2 (en) | 2008-10-10 | 2014-04-08 | Edwards Lifesciences Corporation | Expandable sheath for introducing an endovascular delivery device into a body |
EP2331014B1 (en) | 2008-10-10 | 2017-08-09 | Reva Medical, Inc. | Expandable slide and lock stent |
US8449625B2 (en) | 2009-10-27 | 2013-05-28 | Edwards Lifesciences Corporation | Methods of measuring heart valve annuluses for valve replacement |
EP2367504B1 (en) * | 2008-10-30 | 2014-08-06 | St. Jude Medical, Inc. | Collapsible/expandable prosthetic heart valve delivery system and methods |
CN102223910B (en) * | 2008-11-25 | 2014-05-07 | 爱德华兹生命科学公司 | Apparatus for in situ expansion of prosthetic device |
US8308798B2 (en) | 2008-12-19 | 2012-11-13 | Edwards Lifesciences Corporation | Quick-connect prosthetic heart valve and methods |
EP2201911B1 (en) | 2008-12-23 | 2015-09-30 | Sorin Group Italia S.r.l. | Expandable prosthetic valve having anchoring appendages |
US20100174363A1 (en) * | 2009-01-07 | 2010-07-08 | Endovalve, Inc. | One Piece Prosthetic Valve Support Structure and Related Assemblies |
US20100179561A1 (en) * | 2009-01-09 | 2010-07-15 | Medtronic, Inc. | Tool for retracting a tine element of a medical lead |
US9402720B2 (en) | 2009-01-12 | 2016-08-02 | Valve Medical Ltd. | Modular percutaneous valve structure and delivery method |
US9980818B2 (en) | 2009-03-31 | 2018-05-29 | Edwards Lifesciences Corporation | Prosthetic heart valve system with positioning markers |
US8512397B2 (en) * | 2009-04-27 | 2013-08-20 | Sorin Group Italia S.R.L. | Prosthetic vascular conduit |
US8348998B2 (en) | 2009-06-26 | 2013-01-08 | Edwards Lifesciences Corporation | Unitary quick connect prosthetic heart valve and deployment system and methods |
US8439970B2 (en) | 2009-07-14 | 2013-05-14 | Edwards Lifesciences Corporation | Transapical delivery system for heart valves |
US8449599B2 (en) | 2009-12-04 | 2013-05-28 | Edwards Lifesciences Corporation | Prosthetic valve for replacing mitral valve |
US8870950B2 (en) | 2009-12-08 | 2014-10-28 | Mitral Tech Ltd. | Rotation-based anchoring of an implant |
AU2010328106A1 (en) | 2009-12-08 | 2012-07-05 | Avalon Medical Ltd. | Device and system for transcatheter mitral valve replacement |
US9504562B2 (en) * | 2010-01-12 | 2016-11-29 | Valve Medical Ltd. | Self-assembling modular percutaneous valve and methods of folding, assembly and delivery |
EA201892282A1 (en) * | 2010-01-12 | 2019-07-31 | Вэлв Медикал Лтд | INSERTED THROUGH THE SKIN MODULAR VALVE STRUCTURE AND METHOD OF DELIVERY |
DE102010008338A1 (en) * | 2010-02-17 | 2011-08-18 | Transcatheter Technologies GmbH, 93053 | Device intended to be attached to or attached to a catheter, catheter and method |
US20110208293A1 (en) * | 2010-02-23 | 2011-08-25 | Medtronic, Inc. | Catheter-Based Heart Valve Therapy System with Sizing Balloon |
US8795354B2 (en) | 2010-03-05 | 2014-08-05 | Edwards Lifesciences Corporation | Low-profile heart valve and delivery system |
PT3335670T (en) | 2010-03-05 | 2022-07-27 | Edwards Lifesciences Corp | Retaining mechanisms for prosthetic valves |
US8998980B2 (en) * | 2010-04-09 | 2015-04-07 | Medtronic, Inc. | Transcatheter prosthetic heart valve delivery system with recapturing feature and method |
US8926692B2 (en) * | 2010-04-09 | 2015-01-06 | Medtronic, Inc. | Transcatheter prosthetic heart valve delivery device with partial deployment and release features and methods |
US8523936B2 (en) | 2010-04-10 | 2013-09-03 | Reva Medical, Inc. | Expandable slide and lock stent |
EP3795119A1 (en) | 2010-05-10 | 2021-03-24 | Edwards Lifesciences Corporation | Prosthetic heart valve with collapsible frame and cantilevered commissure portions |
US9554901B2 (en) | 2010-05-12 | 2017-01-31 | Edwards Lifesciences Corporation | Low gradient prosthetic heart valve |
US9603708B2 (en) | 2010-05-19 | 2017-03-28 | Dfm, Llc | Low crossing profile delivery catheter for cardiovascular prosthetic implant |
BR112012029896A2 (en) | 2010-05-25 | 2017-06-20 | Jenavalve Tech Inc | prosthetic heart valve for stent graft and stent graft |
US8657872B2 (en) | 2010-07-19 | 2014-02-25 | Jacques Seguin | Cardiac valve repair system and methods of use |
US11653910B2 (en) | 2010-07-21 | 2023-05-23 | Cardiovalve Ltd. | Helical anchor implantation |
WO2012012761A2 (en) | 2010-07-23 | 2012-01-26 | Edwards Lifesciences Corporation | Retaining mechanisms for prosthetic valves |
EP2611388B1 (en) * | 2010-09-01 | 2022-04-27 | Medtronic Vascular Galway | Prosthetic valve support structure |
US9370418B2 (en) | 2010-09-10 | 2016-06-21 | Edwards Lifesciences Corporation | Rapidly deployable surgical heart valves |
US9125741B2 (en) | 2010-09-10 | 2015-09-08 | Edwards Lifesciences Corporation | Systems and methods for ensuring safe and rapid deployment of prosthetic heart valves |
US8641757B2 (en) | 2010-09-10 | 2014-02-04 | Edwards Lifesciences Corporation | Systems for rapidly deploying surgical heart valves |
CN106073946B (en) | 2010-09-10 | 2022-01-04 | 西美蒂斯股份公司 | Valve replacement device, delivery device for a valve replacement device and method of producing a valve replacement device |
US8845720B2 (en) | 2010-09-27 | 2014-09-30 | Edwards Lifesciences Corporation | Prosthetic heart valve frame with flexible commissures |
ES2875847T3 (en) | 2010-10-05 | 2021-11-11 | Edwards Lifesciences Corp | Prosthetic heart valve with delivery catheter |
IT1402784B1 (en) * | 2010-10-26 | 2013-09-18 | Minozzi | TENDINI FIXING DEVICE, IN PARTICULAR FOR THE FRONT CRYSTAL LATCH AND REAR CRUSADER. |
US20130274872A1 (en) * | 2011-01-06 | 2013-10-17 | Valvexchange Inc. | Resizable valve base for cardiovascular valve assembly |
US9155619B2 (en) | 2011-02-25 | 2015-10-13 | Edwards Lifesciences Corporation | Prosthetic heart valve delivery apparatus |
EP4119095A1 (en) | 2011-03-21 | 2023-01-18 | Cephea Valve Technologies, Inc. | Disk-based valve apparatus |
EP2520251A1 (en) | 2011-05-05 | 2012-11-07 | Symetis SA | Method and Apparatus for Compressing Stent-Valves |
US8968394B2 (en) * | 2011-05-12 | 2015-03-03 | Edwards Lifesciences Corporation | Mitral heart valve holder and storage system |
CN105943214B (en) * | 2011-05-16 | 2018-06-12 | Hlt 公司 | For the overturning conveying device and method of prosthese |
US8945209B2 (en) | 2011-05-20 | 2015-02-03 | Edwards Lifesciences Corporation | Encapsulated heart valve |
US9289282B2 (en) | 2011-05-31 | 2016-03-22 | Edwards Lifesciences Corporation | System and method for treating valve insufficiency or vessel dilatation |
EP2731550B1 (en) | 2011-07-12 | 2016-02-24 | Boston Scientific Scimed, Inc. | Coupling system for a replacement valve |
US8795357B2 (en) | 2011-07-15 | 2014-08-05 | Edwards Lifesciences Corporation | Perivalvular sealing for transcatheter heart valve |
US9339384B2 (en) | 2011-07-27 | 2016-05-17 | Edwards Lifesciences Corporation | Delivery systems for prosthetic heart valve |
US9668859B2 (en) | 2011-08-05 | 2017-06-06 | California Institute Of Technology | Percutaneous heart valve delivery systems |
EP3705090B1 (en) | 2011-08-11 | 2023-12-06 | Tendyne Holdings, Inc. | Improvements for prosthetic valves and related inventions |
EP2763708B1 (en) | 2011-10-05 | 2022-01-05 | Boston Scientific Scimed, Inc. | Profile reduction seal for prosthetic heart valve |
US9039757B2 (en) | 2011-10-19 | 2015-05-26 | Twelve, Inc. | Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods |
US11202704B2 (en) | 2011-10-19 | 2021-12-21 | Twelve, Inc. | Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods |
US9827093B2 (en) | 2011-10-21 | 2017-11-28 | Edwards Lifesciences Cardiaq Llc | Actively controllable stent, stent graft, heart valve and method of controlling same |
US9131926B2 (en) | 2011-11-10 | 2015-09-15 | Boston Scientific Scimed, Inc. | Direct connect flush system |
US8940014B2 (en) | 2011-11-15 | 2015-01-27 | Boston Scientific Scimed, Inc. | Bond between components of a medical device |
US8951243B2 (en) | 2011-12-03 | 2015-02-10 | Boston Scientific Scimed, Inc. | Medical device handle |
PL2787926T3 (en) | 2011-12-09 | 2022-11-14 | Edwards Lifesciences Corporation | Prosthetic heart valve improved commissure supports |
US8652145B2 (en) | 2011-12-14 | 2014-02-18 | Edwards Lifesciences Corporation | System and method for crimping a prosthetic valve |
US9827092B2 (en) | 2011-12-16 | 2017-11-28 | Tendyne Holdings, Inc. | Tethers for prosthetic mitral valve |
US9510945B2 (en) | 2011-12-20 | 2016-12-06 | Boston Scientific Scimed Inc. | Medical device handle |
US9277993B2 (en) | 2011-12-20 | 2016-03-08 | Boston Scientific Scimed, Inc. | Medical device delivery systems |
US9078747B2 (en) * | 2011-12-21 | 2015-07-14 | Edwards Lifesciences Corporation | Anchoring device for replacing or repairing a heart valve |
EP2842517A1 (en) * | 2011-12-29 | 2015-03-04 | Sorin Group Italia S.r.l. | A kit for implanting prosthetic vascular conduits |
US10172708B2 (en) | 2012-01-25 | 2019-01-08 | Boston Scientific Scimed, Inc. | Valve assembly with a bioabsorbable gasket and a replaceable valve implant |
CN108283534B (en) | 2012-01-31 | 2019-09-24 | 米特拉尔维尔福科技有限责任公司 | Bicuspid valve parking device and system |
CA3097321A1 (en) | 2012-02-22 | 2013-08-29 | Edwards Lifesciences Cardiaq Llc | Actively controllable stent, stent graft, heart valve and method of controlling same |
US9579198B2 (en) | 2012-03-01 | 2017-02-28 | Twelve, Inc. | Hydraulic delivery systems for prosthetic heart valve devices and associated methods |
US9445897B2 (en) | 2012-05-01 | 2016-09-20 | Direct Flow Medical, Inc. | Prosthetic implant delivery device with introducer catheter |
CA2873838C (en) | 2012-05-15 | 2018-11-27 | Valve Medical Ltd. | System and method for assembling a folded percutaneous valve |
CA2875525C (en) * | 2012-06-07 | 2017-04-11 | Boston Scientific Scimed, Inc. | Apparatus for replacing a native heart valve and method of making the same |
US9883941B2 (en) | 2012-06-19 | 2018-02-06 | Boston Scientific Scimed, Inc. | Replacement heart valve |
US9283072B2 (en) | 2012-07-25 | 2016-03-15 | W. L. Gore & Associates, Inc. | Everting transcatheter valve and methods |
WO2014022124A1 (en) | 2012-07-28 | 2014-02-06 | Tendyne Holdings, Inc. | Improved multi-component designs for heart valve retrieval device, sealing structures and stent assembly |
WO2014021905A1 (en) | 2012-07-30 | 2014-02-06 | Tendyne Holdings, Inc. | Improved delivery systems and methods for transcatheter prosthetic valves |
US20140067048A1 (en) | 2012-09-06 | 2014-03-06 | Edwards Lifesciences Corporation | Heart Valve Sealing Devices |
US8628571B1 (en) | 2012-11-13 | 2014-01-14 | Mitraltech Ltd. | Percutaneously-deliverable mechanical valve |
EP2922592B1 (en) | 2012-11-21 | 2022-09-21 | Edwards Lifesciences Corporation | Retaining mechanisms for prosthetic heart valves |
US9737398B2 (en) * | 2012-12-19 | 2017-08-22 | W. L. Gore & Associates, Inc. | Prosthetic valves, frames and leaflets and methods thereof |
US9144492B2 (en) | 2012-12-19 | 2015-09-29 | W. L. Gore & Associates, Inc. | Truncated leaflet for prosthetic heart valves, preformed valve |
US9101469B2 (en) | 2012-12-19 | 2015-08-11 | W. L. Gore & Associates, Inc. | Prosthetic heart valve with leaflet shelving |
US9968443B2 (en) | 2012-12-19 | 2018-05-15 | W. L. Gore & Associates, Inc. | Vertical coaptation zone in a planar portion of prosthetic heart valve leaflet |
CA2896333C (en) | 2012-12-27 | 2021-01-12 | Transcatheter Technologies Gmbh | Apparatus and set for folding or unfolding a medical implant comprising a clamping mechanism |
US11439525B2 (en) | 2012-12-27 | 2022-09-13 | Venus Medtech (Hangzhou) Inc. | Implant delivery device adapted to be attached to or interconnected with a catheter, catheter and method |
US20150351906A1 (en) | 2013-01-24 | 2015-12-10 | Mitraltech Ltd. | Ventricularly-anchored prosthetic valves |
US9439763B2 (en) | 2013-02-04 | 2016-09-13 | Edwards Lifesciences Corporation | Prosthetic valve for replacing mitral valve |
US9168129B2 (en) | 2013-02-12 | 2015-10-27 | Edwards Lifesciences Corporation | Artificial heart valve with scalloped frame design |
EP2958521A1 (en) * | 2013-02-20 | 2015-12-30 | Mvalve Technologies Ltd. | Delivery systems for cardiac valve support devices |
US9408732B2 (en) | 2013-03-14 | 2016-08-09 | Reva Medical, Inc. | Reduced-profile slide and lock stent |
EP2967863B1 (en) | 2013-03-15 | 2018-01-31 | Edwards Lifesciences Corporation | Valved aortic conduits |
US11007058B2 (en) | 2013-03-15 | 2021-05-18 | Edwards Lifesciences Corporation | Valved aortic conduits |
EP2967945B1 (en) | 2013-03-15 | 2020-10-28 | California Institute of Technology | Handle mechanism and functionality for repositioning and retrieval of transcatheter heart valves |
US11224510B2 (en) | 2013-04-02 | 2022-01-18 | Tendyne Holdings, Inc. | Prosthetic heart valve and systems and methods for delivering the same |
US9486306B2 (en) | 2013-04-02 | 2016-11-08 | Tendyne Holdings, Inc. | Inflatable annular sealing device for prosthetic mitral valve |
US10463489B2 (en) | 2013-04-02 | 2019-11-05 | Tendyne Holdings, Inc. | Prosthetic heart valve and systems and methods for delivering the same |
US10478293B2 (en) | 2013-04-04 | 2019-11-19 | Tendyne Holdings, Inc. | Retrieval and repositioning system for prosthetic heart valve |
WO2014179763A1 (en) | 2013-05-03 | 2014-11-06 | Medtronic Inc. | Valve delivery tool |
CN107334563B (en) | 2013-05-20 | 2019-05-14 | 爱德华兹生命科学公司 | Heart valve prosthesis delivery apparatus |
US9610159B2 (en) | 2013-05-30 | 2017-04-04 | Tendyne Holdings, Inc. | Structural members for prosthetic mitral valves |
US9468527B2 (en) | 2013-06-12 | 2016-10-18 | Edwards Lifesciences Corporation | Cardiac implant with integrated suture fasteners |
JP6461122B2 (en) | 2013-06-25 | 2019-01-30 | テンダイン ホールディングス,インコーポレイテッド | Thrombus management and structural compliance features of prosthetic heart valves |
US9237948B2 (en) * | 2013-07-11 | 2016-01-19 | Medtronic, Inc. | Delivery system with projections |
US8870948B1 (en) | 2013-07-17 | 2014-10-28 | Cephea Valve Technologies, Inc. | System and method for cardiac valve repair and replacement |
EP3027144B1 (en) | 2013-08-01 | 2017-11-08 | Tendyne Holdings, Inc. | Epicardial anchor devices |
US10034749B2 (en) | 2013-08-12 | 2018-07-31 | Mitral Valve Technologies Sarl | Apparatus and methods for implanting a replacement heart valve |
US10226330B2 (en) | 2013-08-14 | 2019-03-12 | Mitral Valve Technologies Sarl | Replacement heart valve apparatus and methods |
US9919137B2 (en) | 2013-08-28 | 2018-03-20 | Edwards Lifesciences Corporation | Integrated balloon catheter inflation system |
WO2015028209A1 (en) | 2013-08-30 | 2015-03-05 | Jenavalve Technology Gmbh | Radially collapsible frame for a prosthetic valve and method for manufacturing such a frame |
US10195028B2 (en) | 2013-09-10 | 2019-02-05 | Edwards Lifesciences Corporation | Magnetic retaining mechanisms for prosthetic valves |
EP3046512B1 (en) | 2013-09-20 | 2024-03-06 | Edwards Lifesciences Corporation | Heart valves with increased effective orifice area |
WO2015052663A1 (en) | 2013-10-08 | 2015-04-16 | Medical Research, Infrastructure And Health Services Fund Of The Tel Aviv Medical Center | Cardiac prostheses and their deployment |
WO2015058039A1 (en) | 2013-10-17 | 2015-04-23 | Robert Vidlund | Apparatus and methods for alignment and deployment of intracardiac devices |
CA2924389C (en) | 2013-10-28 | 2021-11-09 | Tendyne Holdings, Inc. | Prosthetic heart valve and systems and methods for delivering the same |
US9526611B2 (en) | 2013-10-29 | 2016-12-27 | Tendyne Holdings, Inc. | Apparatus and methods for delivery of transcatheter prosthetic valves |
US20150122687A1 (en) | 2013-11-06 | 2015-05-07 | Edwards Lifesciences Corporation | Bioprosthetic heart valves having adaptive seals to minimize paravalvular leakage |
SG10201804045TA (en) | 2013-11-11 | 2018-06-28 | Edwards Lifesciences Cardiaq Llc | Systems and methods for manufacturing a stent frame |
US9622863B2 (en) | 2013-11-22 | 2017-04-18 | Edwards Lifesciences Corporation | Aortic insufficiency repair device and method |
US10098734B2 (en) | 2013-12-05 | 2018-10-16 | Edwards Lifesciences Corporation | Prosthetic heart valve and delivery apparatus |
US9901444B2 (en) | 2013-12-17 | 2018-02-27 | Edwards Lifesciences Corporation | Inverted valve structure |
JP6492087B2 (en) | 2013-12-20 | 2019-03-27 | マイクロベンション インコーポレイテッドMicrovention, Inc. | Device delivery system |
WO2015120122A2 (en) | 2014-02-05 | 2015-08-13 | Robert Vidlund | Apparatus and methods for transfemoral delivery of prosthetic mitral valve |
US9986993B2 (en) | 2014-02-11 | 2018-06-05 | Tendyne Holdings, Inc. | Adjustable tether and epicardial pad system for prosthetic heart valve |
EP3107500B1 (en) | 2014-02-18 | 2021-11-24 | Edwards Lifesciences Corporation | Flexible commissure frame |
SG11201606836TA (en) | 2014-02-20 | 2016-09-29 | Mitral Valve Technologies Sarl | Coiled anchor for supporting prosthetic heart valve, prosthetic heart valve, and deployment device |
EP3782585B1 (en) | 2014-02-21 | 2023-06-28 | Mitral Valve Technologies Sàrl | Prosthetic mitral valve and anchoring device |
CA2937566C (en) | 2014-03-10 | 2023-09-05 | Tendyne Holdings, Inc. | Devices and methods for positioning and monitoring tether load for prosthetic mitral valve |
US9549816B2 (en) | 2014-04-03 | 2017-01-24 | Edwards Lifesciences Corporation | Method for manufacturing high durability heart valve |
ES2807174T3 (en) * | 2014-04-23 | 2021-02-22 | Applied Med Resources | Systems for tissue extraction |
US10154904B2 (en) | 2014-04-28 | 2018-12-18 | Edwards Lifesciences Corporation | Intravascular introducer devices |
US9585752B2 (en) | 2014-04-30 | 2017-03-07 | Edwards Lifesciences Corporation | Holder and deployment system for surgical heart valves |
US10195025B2 (en) | 2014-05-12 | 2019-02-05 | Edwards Lifesciences Corporation | Prosthetic heart valve |
US9532870B2 (en) | 2014-06-06 | 2017-01-03 | Edwards Lifesciences Corporation | Prosthetic valve for replacing a mitral valve |
CA2914094C (en) | 2014-06-20 | 2021-01-05 | Edwards Lifesciences Corporation | Surgical heart valves identifiable post-implant |
USD867594S1 (en) | 2015-06-19 | 2019-11-19 | Edwards Lifesciences Corporation | Prosthetic heart valve |
US10195026B2 (en) | 2014-07-22 | 2019-02-05 | Edwards Lifesciences Corporation | Mitral valve anchoring |
EP3174502B1 (en) | 2014-07-30 | 2022-04-06 | Cardiovalve Ltd | Apparatus for implantation of an articulatable prosthetic valve |
US10058424B2 (en) | 2014-08-21 | 2018-08-28 | Edwards Lifesciences Corporation | Dual-flange prosthetic valve frame |
US10016272B2 (en) | 2014-09-12 | 2018-07-10 | Mitral Valve Technologies Sarl | Mitral repair and replacement devices and methods |
CA3211010A1 (en) * | 2014-11-13 | 2016-05-19 | Applied Medical Resources Corporation | Systems and methods for tissue removal |
US20160144156A1 (en) | 2014-11-20 | 2016-05-26 | Edwards Lifesciences Corporation | Inflatable device with etched modifications |
US9901445B2 (en) | 2014-11-21 | 2018-02-27 | Boston Scientific Scimed, Inc. | Valve locking mechanism |
CR20170245A (en) | 2014-12-05 | 2017-09-14 | Edwards Lifesciences Corp | DIRIGIBLE CATETER WITH TRACTION CABLE |
US10869755B2 (en) | 2014-12-09 | 2020-12-22 | Cephea Valve Technologies, Inc. | Replacement cardiac valves and methods of use and manufacture |
CN109893298A (en) * | 2014-12-19 | 2019-06-18 | 国立研究开发法人国立循环器病研究中心 | Artificial valve |
EP3037064B1 (en) | 2014-12-23 | 2018-03-14 | Venus MedTech (HangZhou), Inc. | Minimally invasive mitral valve replacement with brim |
JP6826035B2 (en) | 2015-01-07 | 2021-02-03 | テンダイン ホールディングス,インコーポレイテッド | Artificial mitral valve, and devices and methods for its delivery |
WO2016115375A1 (en) | 2015-01-16 | 2016-07-21 | Boston Scientific Scimed, Inc. | Displacement based lock and release mechanism |
US9861477B2 (en) | 2015-01-26 | 2018-01-09 | Boston Scientific Scimed Inc. | Prosthetic heart valve square leaflet-leaflet stitch |
US10201417B2 (en) | 2015-02-03 | 2019-02-12 | Boston Scientific Scimed Inc. | Prosthetic heart valve having tubular seal |
US9788942B2 (en) | 2015-02-03 | 2017-10-17 | Boston Scientific Scimed Inc. | Prosthetic heart valve having tubular seal |
CN110141399B (en) | 2015-02-05 | 2021-07-27 | 卡迪尔维尔福股份有限公司 | Prosthetic valve with axially sliding frame |
EP3253331B1 (en) | 2015-02-05 | 2021-04-07 | Tendyne Holdings, Inc. | Prosthetic heart valve with tether and expandable epicardial pad |
US9974651B2 (en) | 2015-02-05 | 2018-05-22 | Mitral Tech Ltd. | Prosthetic valve with axially-sliding frames |
US10231834B2 (en) | 2015-02-09 | 2019-03-19 | Edwards Lifesciences Corporation | Low profile transseptal catheter and implant system for minimally invasive valve procedure |
US10039637B2 (en) | 2015-02-11 | 2018-08-07 | Edwards Lifesciences Corporation | Heart valve docking devices and implanting methods |
US10285809B2 (en) | 2015-03-06 | 2019-05-14 | Boston Scientific Scimed Inc. | TAVI anchoring assist device |
US10426617B2 (en) | 2015-03-06 | 2019-10-01 | Boston Scientific Scimed, Inc. | Low profile valve locking mechanism and commissure assembly |
US10080652B2 (en) | 2015-03-13 | 2018-09-25 | Boston Scientific Scimed, Inc. | Prosthetic heart valve having an improved tubular seal |
US10792471B2 (en) | 2015-04-10 | 2020-10-06 | Edwards Lifesciences Corporation | Expandable sheath |
US10327896B2 (en) | 2015-04-10 | 2019-06-25 | Edwards Lifesciences Corporation | Expandable sheath with elastomeric cross sectional portions |
US10010417B2 (en) | 2015-04-16 | 2018-07-03 | Edwards Lifesciences Corporation | Low-profile prosthetic heart valve for replacing a mitral valve |
JP6694948B2 (en) | 2015-04-16 | 2020-05-20 | テンダイン ホールディングス,インコーポレイテッド | Device and method for delivery, repositioning and retrieval of a transcatheter prosthetic valve |
US10064718B2 (en) | 2015-04-16 | 2018-09-04 | Edwards Lifesciences Corporation | Low-profile prosthetic heart valve for replacing a mitral valve |
US10441416B2 (en) | 2015-04-21 | 2019-10-15 | Edwards Lifesciences Corporation | Percutaneous mitral valve replacement device |
US10232564B2 (en) | 2015-04-29 | 2019-03-19 | Edwards Lifesciences Corporation | Laminated sealing member for prosthetic heart valve |
CN107530168B (en) | 2015-05-01 | 2020-06-09 | 耶拿阀门科技股份有限公司 | Device and method with reduced pacemaker ratio in heart valve replacement |
WO2016183523A1 (en) | 2015-05-14 | 2016-11-17 | Cephea Valve Technologies, Inc. | Cardiac valve delivery devices and systems |
EP3294221B1 (en) | 2015-05-14 | 2024-03-06 | Cephea Valve Technologies, Inc. | Replacement mitral valves |
US10195392B2 (en) | 2015-07-02 | 2019-02-05 | Boston Scientific Scimed, Inc. | Clip-on catheter |
CA2989437C (en) | 2015-07-02 | 2023-08-08 | Edwards Lifesciences Corporation | Hybrid heart valves adapted for post-implant expansion |
US10335277B2 (en) | 2015-07-02 | 2019-07-02 | Boston Scientific Scimed Inc. | Adjustable nosecone |
CA2990733C (en) | 2015-07-02 | 2023-07-18 | Edwards Lifesciences Corporation | Integrated hybrid heart valves |
US9974650B2 (en) | 2015-07-14 | 2018-05-22 | Edwards Lifesciences Corporation | Prosthetic heart valve |
US10327892B2 (en) | 2015-08-11 | 2019-06-25 | Boston Scientific Scimed Inc. | Integrated adaptive seal for prosthetic heart valves |
US10179041B2 (en) | 2015-08-12 | 2019-01-15 | Boston Scientific Scimed Icn. | Pinless release mechanism |
US10136991B2 (en) | 2015-08-12 | 2018-11-27 | Boston Scientific Scimed Inc. | Replacement heart valve implant |
US10179046B2 (en) | 2015-08-14 | 2019-01-15 | Edwards Lifesciences Corporation | Gripping and pushing device for medical instrument |
US11026788B2 (en) | 2015-08-20 | 2021-06-08 | Edwards Lifesciences Corporation | Loader and retriever for transcatheter heart valve, and methods of crimping transcatheter heart valve |
WO2017041029A1 (en) | 2015-09-02 | 2017-03-09 | Edwards Lifesciences Corporation | Spacer for securing a transcatheter valve to bioprosthetic cardiac structure |
US10779940B2 (en) | 2015-09-03 | 2020-09-22 | Boston Scientific Scimed, Inc. | Medical device handle |
US10588744B2 (en) | 2015-09-04 | 2020-03-17 | Edwards Lifesciences Corporation | Delivery system for prosthetic heart valve |
US10080653B2 (en) | 2015-09-10 | 2018-09-25 | Edwards Lifesciences Corporation | Limited expansion heart valve |
US10327894B2 (en) | 2015-09-18 | 2019-06-25 | Tendyne Holdings, Inc. | Methods for delivery of prosthetic mitral valves |
US10314703B2 (en) | 2015-09-21 | 2019-06-11 | Edwards Lifesciences Corporation | Cylindrical implant and balloon |
US10350067B2 (en) | 2015-10-26 | 2019-07-16 | Edwards Lifesciences Corporation | Implant delivery capsule |
US20190000624A1 (en) * | 2015-11-02 | 2019-01-03 | Peter Wilson | Distal anchor apparatus and methods for mitral valve repair |
US11259920B2 (en) | 2015-11-03 | 2022-03-01 | Edwards Lifesciences Corporation | Adapter for prosthesis delivery device and methods of use |
US10470876B2 (en) | 2015-11-10 | 2019-11-12 | Edwards Lifesciences Corporation | Transcatheter heart valve for replacing natural mitral valve |
US10376364B2 (en) | 2015-11-10 | 2019-08-13 | Edwards Lifesciences Corporation | Implant delivery capsule |
US10321996B2 (en) | 2015-11-11 | 2019-06-18 | Edwards Lifesciences Corporation | Prosthetic valve delivery apparatus having clutch mechanism |
US10265169B2 (en) | 2015-11-23 | 2019-04-23 | Edwards Lifesciences Corporation | Apparatus for controlled heart valve delivery |
US11033387B2 (en) | 2015-11-23 | 2021-06-15 | Edwards Lifesciences Corporation | Methods for controlled heart valve delivery |
US10583007B2 (en) | 2015-12-02 | 2020-03-10 | Edwards Lifesciences Corporation | Suture deployment of prosthetic heart valve |
WO2017096157A1 (en) | 2015-12-03 | 2017-06-08 | Tendyne Holdings, Inc. | Frame features for prosthetic mitral valves |
US10357351B2 (en) | 2015-12-04 | 2019-07-23 | Edwards Lifesciences Corporation | Storage assembly for prosthetic valve |
US11008676B2 (en) | 2015-12-16 | 2021-05-18 | Edwards Lifesciences Corporation | Textured woven fabric for use in implantable bioprostheses |
CA3006010C (en) | 2015-12-28 | 2023-09-26 | Tendyne Holdings, Inc. | Atrial pocket closures for prosthetic heart valves |
US10342660B2 (en) | 2016-02-02 | 2019-07-09 | Boston Scientific Inc. | Tensioned sheathing aids |
US10363130B2 (en) | 2016-02-05 | 2019-07-30 | Edwards Lifesciences Corporation | Devices and systems for docking a heart valve |
US10179043B2 (en) | 2016-02-12 | 2019-01-15 | Edwards Lifesciences Corporation | Prosthetic heart valve having multi-level sealing member |
US10531866B2 (en) | 2016-02-16 | 2020-01-14 | Cardiovalve Ltd. | Techniques for providing a replacement valve and transseptal communication |
US20210212824A1 (en) * | 2016-03-08 | 2021-07-15 | Dura Llc | Heart valve leaflet replacement devices and multi-stage, multi-lumen heart valve delivery systems and method for use |
US10667904B2 (en) | 2016-03-08 | 2020-06-02 | Edwards Lifesciences Corporation | Valve implant with integrated sensor and transmitter |
US10779941B2 (en) | 2016-03-08 | 2020-09-22 | Edwards Lifesciences Corporation | Delivery cylinder for prosthetic implant |
US10799677B2 (en) | 2016-03-21 | 2020-10-13 | Edwards Lifesciences Corporation | Multi-direction steerable handles for steering catheters |
US10799676B2 (en) | 2016-03-21 | 2020-10-13 | Edwards Lifesciences Corporation | Multi-direction steerable handles for steering catheters |
US11219746B2 (en) | 2016-03-21 | 2022-01-11 | Edwards Lifesciences Corporation | Multi-direction steerable handles for steering catheters |
CN112190366A (en) | 2016-03-24 | 2021-01-08 | 爱德华兹生命科学公司 | Delivery system for prosthetic heart valves |
US10470877B2 (en) | 2016-05-03 | 2019-11-12 | Tendyne Holdings, Inc. | Apparatus and methods for anterior valve leaflet management |
US10245136B2 (en) | 2016-05-13 | 2019-04-02 | Boston Scientific Scimed Inc. | Containment vessel with implant sheathing guide |
US10583005B2 (en) | 2016-05-13 | 2020-03-10 | Boston Scientific Scimed, Inc. | Medical device handle |
EP4183371A1 (en) | 2016-05-13 | 2023-05-24 | JenaValve Technology, Inc. | Heart valve prosthesis delivery system and method for delivery of heart valve prosthesis with introducer sheath and loading system |
US10456245B2 (en) | 2016-05-16 | 2019-10-29 | Edwards Lifesciences Corporation | System and method for applying material to a stent |
US10201416B2 (en) | 2016-05-16 | 2019-02-12 | Boston Scientific Scimed, Inc. | Replacement heart valve implant with invertible leaflets |
WO2017218375A1 (en) | 2016-06-13 | 2017-12-21 | Tendyne Holdings, Inc. | Sequential delivery of two-part prosthetic mitral valve |
EP3471665B1 (en) | 2016-06-17 | 2023-10-11 | Cephea Valve Technologies, Inc. | Cardiac valve delivery devices |
CN109640887B (en) | 2016-06-30 | 2021-03-16 | 坦迪尼控股股份有限公司 | Prosthetic heart valve and apparatus and method for delivering same |
US10828150B2 (en) | 2016-07-08 | 2020-11-10 | Edwards Lifesciences Corporation | Docking station for heart valve prosthesis |
US10856981B2 (en) | 2016-07-08 | 2020-12-08 | Edwards Lifesciences Corporation | Expandable sheath and methods of using the same |
WO2018013515A1 (en) | 2016-07-12 | 2018-01-18 | Tendyne Holdings, Inc. | Apparatus and methods for trans-septal retrieval of prosthetic heart valves |
CN207708054U (en) * | 2016-07-29 | 2018-08-10 | 上海沃比医疗科技有限公司 | Implantation material transport system |
GB201613219D0 (en) | 2016-08-01 | 2016-09-14 | Mitraltech Ltd | Minimally-invasive delivery systems |
US11096781B2 (en) | 2016-08-01 | 2021-08-24 | Edwards Lifesciences Corporation | Prosthetic heart valve |
CA3031187A1 (en) | 2016-08-10 | 2018-02-15 | Cardiovalve Ltd. | Prosthetic valve with concentric frames |
CR20190069A (en) | 2016-08-26 | 2019-05-14 | Edwards Lifesciences Corp | Heart valve docking coils and systems |
US10722359B2 (en) | 2016-08-26 | 2020-07-28 | Edwards Lifesciences Corporation | Heart valve docking devices and systems |
US10357361B2 (en) | 2016-09-15 | 2019-07-23 | Edwards Lifesciences Corporation | Heart valve pinch devices and delivery systems |
US10575944B2 (en) | 2016-09-22 | 2020-03-03 | Edwards Lifesciences Corporation | Prosthetic heart valve with reduced stitching |
US10463484B2 (en) | 2016-11-17 | 2019-11-05 | Edwards Lifesciences Corporation | Prosthetic heart valve having leaflet inflow below frame |
US10973631B2 (en) | 2016-11-17 | 2021-04-13 | Edwards Lifesciences Corporation | Crimping accessory device for a prosthetic valve |
US10702381B2 (en) | 2016-12-01 | 2020-07-07 | Boston Scientific Scimed, Inc. | Heart valve remodeling device |
US10603165B2 (en) | 2016-12-06 | 2020-03-31 | Edwards Lifesciences Corporation | Mechanically expanding heart valve and delivery apparatus therefor |
CR20190219A (en) | 2016-12-16 | 2019-09-30 | Edwards Lifesciences Corp | Deployment systems, tools, and methods for delivering an anchoring device for a prosthetic valve |
USD846122S1 (en) | 2016-12-16 | 2019-04-16 | Edwards Lifesciences Corporation | Heart valve sizer |
EP3906893A1 (en) | 2016-12-20 | 2021-11-10 | Edwards Lifesciences Corporation | Systems and mechanisms for deploying a docking device for a replacement heart valve |
US10813749B2 (en) | 2016-12-20 | 2020-10-27 | Edwards Lifesciences Corporation | Docking device made with 3D woven fabric |
CN108245281A (en) * | 2016-12-28 | 2018-07-06 | 上海微创心通医疗科技有限公司 | Valve prosthesis |
US10653523B2 (en) | 2017-01-19 | 2020-05-19 | 4C Medical Technologies, Inc. | Systems, methods and devices for delivery systems, methods and devices for implanting prosthetic heart valves |
US11654023B2 (en) | 2017-01-23 | 2023-05-23 | Edwards Lifesciences Corporation | Covered prosthetic heart valve |
US11185406B2 (en) | 2017-01-23 | 2021-11-30 | Edwards Lifesciences Corporation | Covered prosthetic heart valve |
CN110621260B (en) | 2017-01-23 | 2022-11-25 | 科菲瓣膜技术有限公司 | Replacement mitral valve |
AU2018203053B2 (en) | 2017-01-23 | 2020-03-05 | Cephea Valve Technologies, Inc. | Replacement mitral valves |
US11013600B2 (en) | 2017-01-23 | 2021-05-25 | Edwards Lifesciences Corporation | Covered prosthetic heart valve |
US10561495B2 (en) | 2017-01-24 | 2020-02-18 | 4C Medical Technologies, Inc. | Systems, methods and devices for two-step delivery and implantation of prosthetic heart valve |
CN110392557A (en) | 2017-01-27 | 2019-10-29 | 耶拿阀门科技股份有限公司 | Heart valve simulation |
USD867595S1 (en) | 2017-02-01 | 2019-11-19 | Edwards Lifesciences Corporation | Stent |
US12029647B2 (en) | 2017-03-07 | 2024-07-09 | 4C Medical Technologies, Inc. | Systems, methods and devices for prosthetic heart valve with single valve leaflet |
US10667934B2 (en) * | 2017-04-04 | 2020-06-02 | Medtronic Vascular, Inc. | System for loading a transcatheter valve prosthesis into a delivery catheter |
US10463485B2 (en) | 2017-04-06 | 2019-11-05 | Edwards Lifesciences Corporation | Prosthetic valve holders with automatic deploying mechanisms |
US11224511B2 (en) | 2017-04-18 | 2022-01-18 | Edwards Lifesciences Corporation | Heart valve sealing devices and delivery devices therefor |
US10575950B2 (en) | 2017-04-18 | 2020-03-03 | Twelve, Inc. | Hydraulic systems for delivering prosthetic heart valve devices and associated methods |
WO2018195215A2 (en) | 2017-04-18 | 2018-10-25 | Edwards Lifesciences Corporation | Heart valve sealing devices and delivery devices therefor |
US10973634B2 (en) | 2017-04-26 | 2021-04-13 | Edwards Lifesciences Corporation | Delivery apparatus for a prosthetic heart valve |
EP3614969B1 (en) | 2017-04-28 | 2023-05-03 | Edwards Lifesciences Corporation | Prosthetic heart valve with collapsible holder |
US10959846B2 (en) | 2017-05-10 | 2021-03-30 | Edwards Lifesciences Corporation | Mitral valve spacer device |
US10842619B2 (en) | 2017-05-12 | 2020-11-24 | Edwards Lifesciences Corporation | Prosthetic heart valve docking assembly |
US11135056B2 (en) | 2017-05-15 | 2021-10-05 | Edwards Lifesciences Corporation | Devices and methods of commissure formation for prosthetic heart valve |
US11839539B2 (en) | 2017-05-15 | 2023-12-12 | Edwards Lifesciences Corporation | Valve sealing tissue and mesh structure |
EP3630013B1 (en) | 2017-05-22 | 2024-04-24 | Edwards Lifesciences Corporation | Valve anchor |
US12064341B2 (en) | 2017-05-31 | 2024-08-20 | Edwards Lifesciences Corporation | Sealing member for prosthetic heart valve |
US10646338B2 (en) | 2017-06-02 | 2020-05-12 | Twelve, Inc. | Delivery systems with telescoping capsules for deploying prosthetic heart valve devices and associated methods |
US11026785B2 (en) | 2017-06-05 | 2021-06-08 | Edwards Lifesciences Corporation | Mechanically expandable heart valve |
US10869759B2 (en) | 2017-06-05 | 2020-12-22 | Edwards Lifesciences Corporation | Mechanically expandable heart valve |
WO2018226915A1 (en) | 2017-06-08 | 2018-12-13 | Boston Scientific Scimed, Inc. | Heart valve implant commissure support structure |
US12036113B2 (en) | 2017-06-14 | 2024-07-16 | 4C Medical Technologies, Inc. | Delivery of heart chamber prosthetic valve implant |
WO2018237020A1 (en) | 2017-06-21 | 2018-12-27 | Edwards Lifesciences Corporation | Dual-wireform limited expansion heart valves |
US10639152B2 (en) | 2017-06-21 | 2020-05-05 | Edwards Lifesciences Corporation | Expandable sheath and methods of using the same |
EP3644902B1 (en) | 2017-06-30 | 2024-05-22 | Edwards Lifesciences Corporation | Lock and release mechanisms for trans-catheter implantable devices |
EP4292572A3 (en) | 2017-06-30 | 2024-04-17 | Edwards Lifesciences Corporation | Docking stations for transcatheter valves |
US10857334B2 (en) | 2017-07-12 | 2020-12-08 | Edwards Lifesciences Corporation | Reduced operation force inflator |
AU2018301815A1 (en) | 2017-07-13 | 2020-01-23 | Tendyne Holdings, Inc. | Prosthetic heart valves and apparatus and methods for delivery of same |
US10918473B2 (en) | 2017-07-18 | 2021-02-16 | Edwards Lifesciences Corporation | Transcatheter heart valve storage container and crimping mechanism |
EP3661458A1 (en) | 2017-08-01 | 2020-06-10 | Boston Scientific Scimed, Inc. | Medical implant locking mechanism |
US10888421B2 (en) | 2017-09-19 | 2021-01-12 | Cardiovalve Ltd. | Prosthetic heart valve with pouch |
US10575948B2 (en) | 2017-08-03 | 2020-03-03 | Cardiovalve Ltd. | Prosthetic heart valve |
US11246704B2 (en) | 2017-08-03 | 2022-02-15 | Cardiovalve Ltd. | Prosthetic heart valve |
US11793633B2 (en) | 2017-08-03 | 2023-10-24 | Cardiovalve Ltd. | Prosthetic heart valve |
US12064347B2 (en) | 2017-08-03 | 2024-08-20 | Cardiovalve Ltd. | Prosthetic heart valve |
US10537426B2 (en) | 2017-08-03 | 2020-01-21 | Cardiovalve Ltd. | Prosthetic heart valve |
CR20200068A (en) | 2017-08-11 | 2020-05-31 | Edwards Lifesciences Corp | Sealing element for prosthetic heart valve |
US11083575B2 (en) | 2017-08-14 | 2021-08-10 | Edwards Lifesciences Corporation | Heart valve frame design with non-uniform struts |
US10932903B2 (en) | 2017-08-15 | 2021-03-02 | Edwards Lifesciences Corporation | Skirt assembly for implantable prosthetic valve |
CN111225633B (en) | 2017-08-16 | 2022-05-31 | 波士顿科学国际有限公司 | Replacement heart valve coaptation assembly |
US10898319B2 (en) | 2017-08-17 | 2021-01-26 | Edwards Lifesciences Corporation | Sealing member for prosthetic heart valve |
US10973628B2 (en) | 2017-08-18 | 2021-04-13 | Edwards Lifesciences Corporation | Pericardial sealing member for prosthetic heart valve |
USD890333S1 (en) | 2017-08-21 | 2020-07-14 | Edwards Lifesciences Corporation | Heart valve docking coil |
US10722353B2 (en) | 2017-08-21 | 2020-07-28 | Edwards Lifesciences Corporation | Sealing member for prosthetic heart valve |
US10806573B2 (en) | 2017-08-22 | 2020-10-20 | Edwards Lifesciences Corporation | Gear drive mechanism for heart valve delivery apparatus |
CN111031967B (en) | 2017-08-28 | 2022-08-09 | 坦迪尼控股股份有限公司 | Prosthetic heart valve with tether connection features |
US11051939B2 (en) | 2017-08-31 | 2021-07-06 | Edwards Lifesciences Corporation | Active introducer sheath system |
US10973629B2 (en) | 2017-09-06 | 2021-04-13 | Edwards Lifesciences Corporation | Sealing member for prosthetic heart valve |
US11147667B2 (en) | 2017-09-08 | 2021-10-19 | Edwards Lifesciences Corporation | Sealing member for prosthetic heart valve |
EP3681440A1 (en) | 2017-09-12 | 2020-07-22 | W. L. Gore & Associates, Inc. | Leaflet frame attachment for prosthetic valves |
EP3687452A1 (en) | 2017-09-27 | 2020-08-05 | W. L. Gore & Associates, Inc. | Prosthetic valves with mechanically coupled leaflets |
JP7068444B2 (en) | 2017-09-27 | 2022-05-16 | ダブリュ.エル.ゴア アンド アソシエイツ,インコーポレイティド | Artificial valves with expandable frames, as well as related systems and methods |
EP3694445B1 (en) | 2017-10-13 | 2024-07-10 | Edwards Lifesciences Corporation | Telescoping prosthetic valve and delivery system |
AU2018351966B2 (en) | 2017-10-18 | 2021-04-01 | Edwards Lifesciences Corporation | Catheter assembly |
IL274054B1 (en) | 2017-10-19 | 2024-08-01 | Anteris Tech Corporation | Replacement heart valve with reduced suturing |
US11207499B2 (en) | 2017-10-20 | 2021-12-28 | Edwards Lifesciences Corporation | Steerable catheter |
US11439502B2 (en) | 2017-10-31 | 2022-09-13 | W. L. Gore & Associates, Inc. | Medical valve and leaflet promoting tissue ingrowth |
CN107928841B (en) * | 2017-11-27 | 2020-07-28 | 上海形状记忆合金材料有限公司 | Split aortic valve bracket assembly |
GB201720803D0 (en) | 2017-12-13 | 2018-01-24 | Mitraltech Ltd | Prosthetic Valve and delivery tool therefor |
GB201800399D0 (en) | 2018-01-10 | 2018-02-21 | Mitraltech Ltd | Temperature-control during crimping of an implant |
US11191641B2 (en) | 2018-01-19 | 2021-12-07 | Boston Scientific Scimed, Inc. | Inductance mode deployment sensors for transcatheter valve system |
WO2019144071A1 (en) | 2018-01-19 | 2019-07-25 | Boston Scientific Scimed, Inc. | Medical device delivery system with feedback loop |
CN111565678B (en) | 2018-01-23 | 2023-07-07 | 爱德华兹生命科学公司 | Prosthetic valve holders, systems, and methods |
WO2019157156A1 (en) | 2018-02-07 | 2019-08-15 | Boston Scientific Scimed, Inc. | Medical device delivery system with alignment feature |
WO2019165394A1 (en) | 2018-02-26 | 2019-08-29 | Boston Scientific Scimed, Inc. | Embedded radiopaque marker in adaptive seal |
CN108814771B (en) * | 2018-03-05 | 2020-02-21 | 何铭权 | Two-leaf biological valve |
US11318011B2 (en) | 2018-04-27 | 2022-05-03 | Edwards Lifesciences Corporation | Mechanically expandable heart valve with leaflet clamps |
EP3793478A1 (en) | 2018-05-15 | 2021-03-24 | Boston Scientific Scimed, Inc. | Replacement heart valve commissure assembly |
US11666439B2 (en) * | 2018-05-18 | 2023-06-06 | Anteris Technologies Corporation | Inverted heart valve for transcatheter valve replacement |
EP3793481A4 (en) | 2018-05-18 | 2022-03-09 | Anteris Technologies Corporation | Heart valve with gathered sealing region |
CA3101165A1 (en) | 2018-05-23 | 2019-11-28 | Sorin Group Italia S.R.L. | A cardiac valve prosthesis |
US11844914B2 (en) | 2018-06-05 | 2023-12-19 | Edwards Lifesciences Corporation | Removable volume indicator for syringe |
WO2019241477A1 (en) | 2018-06-13 | 2019-12-19 | Boston Scientific Scimed, Inc. | Replacement heart valve delivery device |
USD908874S1 (en) | 2018-07-11 | 2021-01-26 | Edwards Lifesciences Corporation | Collapsible heart valve sizer |
US11857441B2 (en) | 2018-09-04 | 2024-01-02 | 4C Medical Technologies, Inc. | Stent loading device |
EP3622922A1 (en) * | 2018-09-13 | 2020-03-18 | ETH Zürich | Self-expandable stent, method and device to produce the self-expandable stent |
WO2020081893A1 (en) | 2018-10-19 | 2020-04-23 | Edwards Lifesciences Corporation | Prosthetic heart valve having non-cylindrical frame |
US11779728B2 (en) | 2018-11-01 | 2023-10-10 | Edwards Lifesciences Corporation | Introducer sheath with expandable introducer |
US11241312B2 (en) | 2018-12-10 | 2022-02-08 | Boston Scientific Scimed, Inc. | Medical device delivery system including a resistance member |
WO2020150378A1 (en) | 2019-01-17 | 2020-07-23 | Edwards Lifesciences Corporation | Frame for prosthetic heart valve |
US11273032B2 (en) * | 2019-01-26 | 2022-03-15 | Vdyne, Inc. | Collapsible inner flow control component for side-deliverable transcatheter heart valve prosthesis |
US11278402B2 (en) * | 2019-02-21 | 2022-03-22 | Medtronic, Inc. | Prosthesis for transcatheter delivery having an infolding longitudinal segment for a smaller radially compressed profile |
US11497601B2 (en) | 2019-03-01 | 2022-11-15 | W. L. Gore & Associates, Inc. | Telescoping prosthetic valve with retention element |
CN113873973B (en) | 2019-03-26 | 2023-12-22 | 爱德华兹生命科学公司 | prosthetic heart valve |
US11439504B2 (en) | 2019-05-10 | 2022-09-13 | Boston Scientific Scimed, Inc. | Replacement heart valve with improved cusp washout and reduced loading |
US11648110B2 (en) | 2019-12-05 | 2023-05-16 | Tendyne Holdings, Inc. | Braided anchor for mitral valve |
CA3143302A1 (en) | 2019-12-16 | 2021-06-24 | Edwards Lifesciences Corporation | Valve holder assembly with suture looping protection |
US11648114B2 (en) | 2019-12-20 | 2023-05-16 | Tendyne Holdings, Inc. | Distally loaded sheath and loading funnel |
US11931253B2 (en) | 2020-01-31 | 2024-03-19 | 4C Medical Technologies, Inc. | Prosthetic heart valve delivery system: ball-slide attachment |
US12053375B2 (en) | 2020-03-05 | 2024-08-06 | 4C Medical Technologies, Inc. | Prosthetic mitral valve with improved atrial and/or annular apposition and paravalvular leakage mitigation |
US11992403B2 (en) | 2020-03-06 | 2024-05-28 | 4C Medical Technologies, Inc. | Devices, systems and methods for improving recapture of prosthetic heart valve device with stent frame having valve support with inwardly stent cells |
US11951002B2 (en) | 2020-03-30 | 2024-04-09 | Tendyne Holdings, Inc. | Apparatus and methods for valve and tether fixation |
WO2021202636A1 (en) | 2020-04-03 | 2021-10-07 | Edwards Lifesciences Corporation | A multi-layer covering for a prosthetic heart valve |
EP4167911A1 (en) | 2020-06-18 | 2023-04-26 | Edwards Lifesciences Corporation | Crimping methods |
US20230248513A1 (en) | 2020-07-07 | 2023-08-10 | Anteris Technologies Corporation | Expandable frame for improved hemodynamic performance of transcatheter replacement heart valve |
US11678980B2 (en) | 2020-08-19 | 2023-06-20 | Tendyne Holdings, Inc. | Fully-transseptal apical pad with pulley for tensioning |
MX2023001747A (en) | 2020-08-24 | 2023-04-25 | Edwards Lifesciences Corp | Balloon cover for a delivery apparatus for an expandable prosthetic heart valve. |
JP2023540067A (en) | 2020-08-31 | 2023-09-21 | エドワーズ ライフサイエンシーズ コーポレイション | Systems and methods for crimping and device preparation |
WO2022159427A1 (en) | 2021-01-20 | 2022-07-28 | Edwards Lifesciences Corporation | Connecting skirt for attaching a leaflet to a frame of a prosthetic heart valve |
US11622853B1 (en) | 2022-09-30 | 2023-04-11 | Anteris Technologies Corporation | Prosthetic heart valves |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4878495A (en) * | 1987-05-15 | 1989-11-07 | Joseph Grayzel | Valvuloplasty device with satellite expansion means |
US5957949A (en) * | 1997-05-01 | 1999-09-28 | World Medical Manufacturing Corp. | Percutaneous placement valve stent |
US20060069424A1 (en) * | 2004-09-27 | 2006-03-30 | Xtent, Inc. | Self-constrained segmented stents and methods for their deployment |
Family Cites Families (290)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US376531A (en) | 1888-01-17 | Tinee chamotte fabeie actien-gesellschaft | ||
US1314601A (en) | 1919-09-02 | Flexible shaft | ||
US749270A (en) * | 1904-01-12 | Saw-set | ||
US3587115A (en) | 1966-05-04 | 1971-06-28 | Donald P Shiley | Prosthetic sutureless heart valves and implant tools therefor |
US3579642A (en) | 1968-04-15 | 1971-05-25 | Bart T Heffernan | Heart valve assembly and method of implanting in the body |
US3566965A (en) * | 1968-07-22 | 1971-03-02 | B & W Inc | Variable size,multi-hinge centralizer |
US3671979A (en) | 1969-09-23 | 1972-06-27 | Univ Utah | Catheter mounted artificial heart valve for implanting in close proximity to a defective natural heart valve |
US3628535A (en) * | 1969-11-12 | 1971-12-21 | Nibot Corp | Surgical instrument for implanting a prosthetic heart valve or the like |
US3657744A (en) * | 1970-05-08 | 1972-04-25 | Univ Minnesota | Method for fixing prosthetic implants in a living body |
US3766581A (en) | 1970-08-05 | 1973-10-23 | Kanegafuchi Spinning Co Ltd | Process for continuously treating thread |
CA992255A (en) * | 1971-01-25 | 1976-07-06 | Cutter Laboratories | Prosthesis for spinal repair |
US3755823A (en) | 1971-04-23 | 1973-09-04 | Hancock Laboratories Inc | Flexible stent for heart valve |
US4192020A (en) * | 1975-05-07 | 1980-03-11 | Washington University | Heart valve prosthesis |
US4340091A (en) | 1975-05-07 | 1982-07-20 | Albany International Corp. | Elastomeric sheet materials for heart valve and other prosthetic implants |
CA1069652A (en) | 1976-01-09 | 1980-01-15 | Alain F. Carpentier | Supported bioprosthetic heart valve with compliant orifice ring |
US4056854A (en) | 1976-09-28 | 1977-11-08 | The United States Of America As Represented By The Department Of Health, Education And Welfare | Aortic heart valve catheter |
US4225160A (en) * | 1978-02-27 | 1980-09-30 | Exxon Production Research Company | Low friction remotely operable clamp type pipe connector |
US4340246A (en) * | 1980-04-14 | 1982-07-20 | Lawrence Brothers, Inc. | Latch assembly |
US4328839A (en) * | 1980-09-19 | 1982-05-11 | Drilling Development, Inc. | Flexible drill pipe |
US4351090A (en) * | 1980-10-31 | 1982-09-28 | Hinderliter Energy Equipment Corp. | Spring clip for wellhead slips |
US4339831A (en) | 1981-03-27 | 1982-07-20 | Medtronic, Inc. | Dynamic annulus heart valve and reconstruction ring |
IT1159433B (en) | 1983-07-25 | 1987-02-25 | Sorin Biomedica Spa | PROCEDURE AND EQUIPMENT FOR THE MANUFACTURE OF VALVE FLAPS FOR CARDIAC VALVE PROSTHESIS AND CARDIAC VALVE PROSTHESIS PROVIDED WITH SUCH FLAPS |
US4545436A (en) * | 1984-01-20 | 1985-10-08 | Antelope Oil Tool & Manufacturing Company | Centralizer band-collar connection |
US4692165A (en) | 1984-09-24 | 1987-09-08 | Carbomedics, Inc. | Heart valve |
US4822353A (en) | 1984-09-24 | 1989-04-18 | Carbomedics, Inc. | Heart valve |
US4683883A (en) * | 1985-04-30 | 1987-08-04 | Hemex Scientific, Inc. | Two-piece heart valve holder/rotator |
US4878906A (en) | 1986-03-25 | 1989-11-07 | Servetus Partnership | Endoprosthesis for repairing a damaged vessel |
US4822345A (en) * | 1986-08-14 | 1989-04-18 | Danforth John W | Controllable flexibility catheter |
IT1210722B (en) | 1987-05-11 | 1989-09-20 | Sorin Biomedica Spa | DEVICES FOR THE CONDITIONING OF BLOOD FLOWS |
US6350732B1 (en) | 1987-08-02 | 2002-02-26 | Carbomedics, Inc. | Method for extracting lipids from tissue samples using high osmolality storage medium and product |
DK163713C (en) * | 1987-09-02 | 1992-09-07 | Ole Gyring Nieben | DEVICE FOR THE POSITION OF A PARTICULAR CATHETTE IN A BODY |
IT1218947B (en) * | 1988-01-12 | 1990-04-24 | Sorin Biomedica Spa | CARDIAC VALVE PROSTHESIS |
US4960424A (en) | 1988-06-30 | 1990-10-02 | Grooters Ronald K | Method of replacing a defective atrio-ventricular valve with a total atrio-ventricular valve bioprosthesis |
US5328471A (en) | 1990-02-26 | 1994-07-12 | Endoluminal Therapeutics, Inc. | Method and apparatus for treatment of focal disease in hollow tubular organs and other tissue lumens |
US5213580A (en) | 1988-08-24 | 1993-05-25 | Endoluminal Therapeutics, Inc. | Biodegradable polymeric endoluminal sealing process |
IT1224479B (en) | 1988-10-11 | 1990-10-04 | Sorin Biomedica Spa | CARDIAC VALVE PROSTHESIS SHUTTER CARDIAC VALVE PROSTHESIS PROVIDED WITH SUCH A SHUTTER AND RELATED MANUFACTURING PROCEDURE |
US4856516A (en) | 1989-01-09 | 1989-08-15 | Cordis Corporation | Endovascular stent apparatus and method |
JPH039746A (en) * | 1989-03-27 | 1991-01-17 | Olympus Optical Co Ltd | In vivo stay type stent |
US4994077A (en) * | 1989-04-21 | 1991-02-19 | Dobben Richard L | Artificial heart valve for implantation in a blood vessel |
CN2055372U (en) * | 1989-06-22 | 1990-04-04 | 上海长海医院 | Short-pillar type artificial cardiac valves |
IT1240111B (en) | 1990-02-21 | 1993-11-27 | Sorin Biomedica Spa | SUTURE RING FOR CARDIAC VALVE PROSTHESES |
US5020843A (en) * | 1990-03-02 | 1991-06-04 | Lucas Charles E | Crane hook latch with sliding lock bar |
JPH03277377A (en) * | 1990-03-27 | 1991-12-09 | Olympus Optical Co Ltd | Biological pipeline expansion tool |
US5037434A (en) | 1990-04-11 | 1991-08-06 | Carbomedics, Inc. | Bioprosthetic heart valve with elastic commissures |
US5411552A (en) * | 1990-05-18 | 1995-05-02 | Andersen; Henning R. | Valve prothesis for implantation in the body and a catheter for implanting such valve prothesis |
DK124690D0 (en) | 1990-05-18 | 1990-05-18 | Henning Rud Andersen | FAT PROTECTION FOR IMPLEMENTATION IN THE BODY FOR REPLACEMENT OF NATURAL FLEET AND CATS FOR USE IN IMPLEMENTING A SUCH FAT PROTECTION |
US5163955A (en) | 1991-01-24 | 1992-11-17 | Autogenics | Rapid assembly, concentric mating stent, tissue heart valve with enhanced clamping and tissue alignment |
US5397351A (en) * | 1991-05-13 | 1995-03-14 | Pavcnik; Dusan | Prosthetic valve for percutaneous insertion |
IT1245750B (en) | 1991-05-24 | 1994-10-14 | Sorin Biomedica Emodialisi S R | CARDIAC VALVE PROSTHESIS, PARTICULARLY FOR REPLACING THE AORTIC VALVE |
US5238454A (en) | 1991-06-10 | 1993-08-24 | Build-A-Mold Limited | One-piece flexible coupling having a plurality of axially spaced disks |
US5370685A (en) | 1991-07-16 | 1994-12-06 | Stanford Surgical Technologies, Inc. | Endovascular aortic valve replacement |
US5123919A (en) | 1991-11-21 | 1992-06-23 | Carbomedics, Inc. | Combined prosthetic aortic heart valve and vascular graft |
US5163953A (en) | 1992-02-10 | 1992-11-17 | Vince Dennis J | Toroidal artificial heart valve stent |
IT1256900B (en) | 1992-07-27 | 1995-12-27 | Franco Vallana | PROCEDURE AND DEVICE TO DETECT CARDIAC FUNCTIONALITY. |
US5336178A (en) * | 1992-11-02 | 1994-08-09 | Localmed, Inc. | Intravascular catheter with infusion array |
US5718725A (en) * | 1992-12-03 | 1998-02-17 | Heartport, Inc. | Devices and methods for intracardiac procedures |
US5814097A (en) | 1992-12-03 | 1998-09-29 | Heartport, Inc. | Devices and methods for intracardiac procedures |
US6010531A (en) | 1993-02-22 | 2000-01-04 | Heartport, Inc. | Less-invasive devices and methods for cardiac valve surgery |
US5403305A (en) * | 1993-04-08 | 1995-04-04 | Carbomedics, Inc. | Mitral valve prosthesis rotator |
GB9314981D0 (en) * | 1993-07-20 | 1993-09-01 | Glaxo Spa | Chemical compounds |
US6027779A (en) | 1993-08-18 | 2000-02-22 | W. L. Gore & Associates, Inc. | Thin-wall polytetrafluoroethylene tube |
US5618290A (en) | 1993-10-19 | 1997-04-08 | W.L. Gore & Associates, Inc. | Endoscopic suture passer and method |
US5713950A (en) | 1993-11-01 | 1998-02-03 | Cox; James L. | Method of replacing heart valves using flexible tubes |
US5397348A (en) * | 1993-12-13 | 1995-03-14 | Carbomedics, Inc. | Mechanical heart valve with compressible stiffening ring |
US5443474A (en) * | 1994-03-07 | 1995-08-22 | Implemed, Inc. | Meniscectomy knife |
US5522885A (en) * | 1994-05-05 | 1996-06-04 | Autogenics | Assembly tooling for an autologous tissue heart valve |
EP0769926B2 (en) | 1994-07-08 | 2006-11-22 | ev3 Inc. | Intravascular filtering device |
US5554185A (en) | 1994-07-18 | 1996-09-10 | Block; Peter C. | Inflatable prosthetic cardiovascular valve for percutaneous transluminal implantation of same |
US6217610B1 (en) | 1994-07-29 | 2001-04-17 | Edwards Lifesciences Corporation | Expandable annuloplasty ring |
US5560487A (en) | 1994-07-29 | 1996-10-01 | Carbomedics, Inc. | Holder and packaging for bioprosthetic heart valve |
US6015429A (en) | 1994-09-08 | 2000-01-18 | Gore Enterprise Holdings, Inc. | Procedures for introducing stents and stent-grafts |
US5582607A (en) | 1994-09-09 | 1996-12-10 | Carbomedics, Inc. | Heart valve prosthesis rotator with bendable shaft and drive mechanism |
US5531094A (en) | 1994-11-14 | 1996-07-02 | Carbomedics, Inc. | Apparatus for testing prosthetic heart valve hinge mechanism |
IT1281839B1 (en) | 1995-01-19 | 1998-03-03 | Askoll Srl | PERFECTED DEVICE FOR STARTING THE ROTOR OF A SYNCHRONOUS PERMANENT MAGNET MOTOR |
EP0840579B1 (en) * | 1995-07-17 | 2003-11-26 | Alfred Edward Wood | A buttress for cardiac valve reconstruction |
JPH11509752A (en) * | 1995-07-18 | 1999-08-31 | エドワーズ,ガーランド,ユー. | Flexible shaft |
US5620456A (en) * | 1995-10-20 | 1997-04-15 | Lasersurge, Inc. | Trocar assembly |
US5607442A (en) * | 1995-11-13 | 1997-03-04 | Isostent, Inc. | Stent with improved radiopacity and appearance characteristics |
US6042605A (en) * | 1995-12-14 | 2000-03-28 | Gore Enterprose Holdings, Inc. | Kink resistant stent-graft |
US6613085B1 (en) | 1996-01-31 | 2003-09-02 | St. Jude Medical, Inc. | Prosthetic heart valve rotator tool |
US6182664B1 (en) * | 1996-02-19 | 2001-02-06 | Edwards Lifesciences Corporation | Minimally invasive cardiac valve surgery procedure |
US6402780B2 (en) | 1996-02-23 | 2002-06-11 | Cardiovascular Technologies, L.L.C. | Means and method of replacing a heart valve in a minimally invasive manner |
US5716370A (en) * | 1996-02-23 | 1998-02-10 | Williamson, Iv; Warren | Means for replacing a heart valve in a minimally invasive manner |
US5724705A (en) * | 1996-05-09 | 1998-03-10 | Hauser; David H. | Door security apparatus |
WO1997042879A1 (en) | 1996-05-14 | 1997-11-20 | Embol-X, Inc. | Aortic occluder with associated filter and methods of use during cardiac surgery |
US5891195A (en) * | 1996-05-24 | 1999-04-06 | Sulzer Carbomedics Inc. | Combined prosthetic aortic heart valve and vascular graft with sealed sewing ring |
AU3182897A (en) | 1996-06-20 | 1998-01-07 | Sulzer Vascutek Limited | Prosthetic repair of body passages |
US5855601A (en) * | 1996-06-21 | 1999-01-05 | The Trustees Of Columbia University In The City Of New York | Artificial heart valve and method and device for implanting the same |
US5662671A (en) | 1996-07-17 | 1997-09-02 | Embol-X, Inc. | Atherectomy device having trapping and excising means for removal of plaque from the aorta and other arteries |
US5755783A (en) | 1996-07-29 | 1998-05-26 | Stobie; Robert | Suture rings for rotatable artificial heart valves |
US5800531A (en) * | 1996-09-30 | 1998-09-01 | Baxter International Inc. | Bioprosthetic heart valve implantation device |
NL1004827C2 (en) * | 1996-12-18 | 1998-06-19 | Surgical Innovations Vof | Device for regulating blood circulation. |
US5695515A (en) * | 1996-12-26 | 1997-12-09 | Orejola; Wilmo C. | Mitral valve dilator |
IT1289815B1 (en) | 1996-12-30 | 1998-10-16 | Sorin Biomedica Cardio Spa | ANGIOPLASTIC STENT AND RELATED PRODUCTION PROCESS |
EP0850607A1 (en) | 1996-12-31 | 1998-07-01 | Cordis Corporation | Valve prosthesis for implantation in body channels |
US5928281A (en) | 1997-03-27 | 1999-07-27 | Baxter International Inc. | Tissue heart valves |
US6451049B2 (en) | 1998-04-29 | 2002-09-17 | Sorin Biomedica Cardio, S.P.A. | Stents for angioplasty |
US5921993A (en) | 1997-05-01 | 1999-07-13 | Yoon; Inbae | Methods of endoscopic tubal ligation |
US5868708A (en) * | 1997-05-07 | 1999-02-09 | Applied Medical Resources Corporation | Balloon catheter apparatus and method |
US6245102B1 (en) * | 1997-05-07 | 2001-06-12 | Iowa-India Investments Company Ltd. | Stent, stent graft and stent valve |
US5911734A (en) * | 1997-05-08 | 1999-06-15 | Embol-X, Inc. | Percutaneous catheter and guidewire having filter and medical device deployment capabilities |
US5928192A (en) * | 1997-07-24 | 1999-07-27 | Embol-X, Inc. | Arterial aspiration |
US7462324B2 (en) * | 1997-08-07 | 2008-12-09 | Panasonic Corporation | Measurement device and method for measuring electric signal from biological sample |
FR2768324B1 (en) | 1997-09-12 | 1999-12-10 | Jacques Seguin | SURGICAL INSTRUMENT FOR PERCUTANEOUSLY FIXING TWO AREAS OF SOFT TISSUE, NORMALLY MUTUALLY REMOTE, TO ONE ANOTHER |
US5984959A (en) | 1997-09-19 | 1999-11-16 | United States Surgical | Heart valve replacement tools and procedures |
US5925063A (en) | 1997-09-26 | 1999-07-20 | Khosravi; Farhad | Coiled sheet valve, filter or occlusive device and methods of use |
US6309414B1 (en) | 1997-11-04 | 2001-10-30 | Sorin Biomedica Cardio S.P.A. | Angioplasty stents |
US5823342A (en) | 1997-11-14 | 1998-10-20 | Sulzer Carbomedics Inc. | Packaging for mitral or aortic heart valve device |
IT1296619B1 (en) | 1997-12-10 | 1999-07-14 | Sorin Biomedica Cardio Spa | PROCEDURE FOR THE TREATMENT OF OPEN STRUCTURE PROSTHESES AND RELATED DEVICES. |
US6001126A (en) * | 1997-12-24 | 1999-12-14 | Baxter International Inc. | Stentless bioprosthetic heart valve with coronary protuberances and related methods for surgical repair of defective heart valves |
ATE449581T1 (en) * | 1997-12-29 | 2009-12-15 | The Cleveland Clinic Foundation | SYSTEM FOR THE MINIMALLY INVASIVE INTRODUCTION OF A HEART VALVE BIOPROSTHESIS |
US6530952B2 (en) * | 1997-12-29 | 2003-03-11 | The Cleveland Clinic Foundation | Bioprosthetic cardiovascular valve system |
US6090138A (en) | 1998-01-23 | 2000-07-18 | Sulzer Carbomedics Inc. | Universal heart valve holder |
US6162172A (en) | 1998-01-30 | 2000-12-19 | Edwards Lifesciences Corporation | Methods and apparatus for retracting tissue |
US6093530A (en) | 1998-02-06 | 2000-07-25 | Sulzer Carbomedics Inc. | Non-calcific biomaterial by glutaraldehyde followed by oxidative fixation |
US6638303B1 (en) | 1998-03-13 | 2003-10-28 | Carbomedics, Inc. | Heart valve prosthesis |
US5980570A (en) | 1998-03-27 | 1999-11-09 | Sulzer Carbomedics Inc. | System and method for implanting an expandable medical device into a body |
US6007557A (en) | 1998-04-29 | 1999-12-28 | Embol-X, Inc. | Adjustable blood filtration system |
US7452371B2 (en) * | 1999-06-02 | 2008-11-18 | Cook Incorporated | Implantable vascular device |
US6143024A (en) | 1998-06-04 | 2000-11-07 | Sulzer Carbomedics Inc. | Annuloplasty ring having flexible anterior portion |
US6117169A (en) | 1998-06-24 | 2000-09-12 | Sulzer Carbomedics Inc. | Living hinge attachment of leaflet to a valve body |
US6231578B1 (en) * | 1998-08-05 | 2001-05-15 | United States Surgical Corporation | Ultrasonic snare for excising tissue |
US6168586B1 (en) * | 1998-08-07 | 2001-01-02 | Embol-X, Inc. | Inflatable cannula and method of using same |
US6849088B2 (en) | 1998-09-30 | 2005-02-01 | Edwards Lifesciences Corporation | Aorto uni-iliac graft |
US6475239B1 (en) | 1998-10-13 | 2002-11-05 | Sulzer Carbomedics Inc. | Method for making polymer heart valves with leaflets having uncut free edges |
US6051014A (en) * | 1998-10-13 | 2000-04-18 | Embol-X, Inc. | Percutaneous filtration catheter for valve repair surgery and methods of use |
US6102945A (en) | 1998-10-16 | 2000-08-15 | Sulzer Carbomedics, Inc. | Separable annuloplasty ring |
US6736845B2 (en) | 1999-01-26 | 2004-05-18 | Edwards Lifesciences Corporation | Holder for flexible heart valve |
US6558418B2 (en) | 1999-01-26 | 2003-05-06 | Edwards Lifesciences Corporation | Flexible heart valve |
CA2358523C (en) * | 1999-01-26 | 2009-08-18 | Edwards Lifesciences Corporation | Anatomical orifice sizers and methods of orifice sizing |
US6338740B1 (en) * | 1999-01-26 | 2002-01-15 | Edwards Lifesciences Corporation | Flexible heart valve leaflets |
US6364905B1 (en) | 1999-01-27 | 2002-04-02 | Sulzer Carbomedics Inc. | Tri-composite, full root, stentless valve |
EP1023921A1 (en) | 1999-01-28 | 2000-08-02 | SORIN BIOMEDICA CARDIO S.p.A. | Implantable defibrillation apparatus |
EP1023916A1 (en) | 1999-01-28 | 2000-08-02 | SORIN BIOMEDICA CARDIO S.p.A. | Implantable cardiostimulation apparatus |
DE69918657T2 (en) | 1999-01-28 | 2005-09-08 | Sorin Biomedica Crm S.R.L., Saluggia | Cardiac stimulation device with electro-tonic blockade |
US6425916B1 (en) * | 1999-02-10 | 2002-07-30 | Michi E. Garrison | Methods and devices for implanting cardiac valves |
ATE484241T1 (en) * | 1999-04-09 | 2010-10-15 | Evalve Inc | METHOD AND DEVICE FOR HEART VALVE REPAIR |
US6283995B1 (en) | 1999-04-15 | 2001-09-04 | Sulzer Carbomedics Inc. | Heart valve leaflet with scalloped free margin |
US6231602B1 (en) | 1999-04-16 | 2001-05-15 | Edwards Lifesciences Corporation | Aortic annuloplasty ring |
US6132986A (en) | 1999-04-23 | 2000-10-17 | Sulzer Carbomedics Inc. | Tissue crosslinking for bioprostheses using activated difunctional or polyfunctional acids |
US6453062B1 (en) | 1999-04-28 | 2002-09-17 | Sulzer Carbomedics Inc. | Final assembly visual inspection system for packaged heart valves |
WO2000064381A2 (en) | 1999-04-28 | 2000-11-02 | St. Jude Medical, Inc. | Heart valve prostheses |
US6206918B1 (en) * | 1999-05-12 | 2001-03-27 | Sulzer Carbomedics Inc. | Heart valve prosthesis having a pivot design for improving flow characteristics |
US6199696B1 (en) * | 1999-05-26 | 2001-03-13 | Sulzer Carbomedics Inc. | Shock resistant packaging for a prosthetic heart valve |
US6287339B1 (en) | 1999-05-27 | 2001-09-11 | Sulzer Carbomedics Inc. | Sutureless heart valve prosthesis |
EP1057460A1 (en) | 1999-06-01 | 2000-12-06 | Numed, Inc. | Replacement valve assembly and method of implanting same |
US6299638B1 (en) | 1999-06-10 | 2001-10-09 | Sulzer Carbomedics Inc. | Method of attachment of large-bore aortic graft to an aortic valve |
US6626899B2 (en) * | 1999-06-25 | 2003-09-30 | Nidus Medical, Llc | Apparatus and methods for treating tissue |
SE514718C2 (en) * | 1999-06-29 | 2001-04-09 | Jan Otto Solem | Apparatus for treating defective closure of the mitral valve apparatus |
US6241765B1 (en) | 1999-07-15 | 2001-06-05 | Sulzer Carbomedics Inc. | Stapled heart prosthesis and method of installing same |
US6174331B1 (en) * | 1999-07-19 | 2001-01-16 | Sulzer Carbomedics Inc. | Heart valve leaflet with reinforced free margin |
US6348068B1 (en) * | 1999-07-23 | 2002-02-19 | Sulzer Carbomedics Inc. | Multi-filament valve stent for a cardisc valvular prosthesis |
US6544279B1 (en) * | 2000-08-09 | 2003-04-08 | Incept, Llc | Vascular device for emboli, thrombus and foreign body removal and methods of use |
US6706033B1 (en) * | 1999-08-02 | 2004-03-16 | Edwards Lifesciences Corporation | Modular access port for device delivery |
US6299637B1 (en) | 1999-08-20 | 2001-10-09 | Samuel M. Shaolian | Transluminally implantable venous valve |
US6494889B1 (en) | 1999-09-01 | 2002-12-17 | Converge Medical, Inc. | Additional sutureless anastomosis embodiments |
US6702828B2 (en) | 1999-09-01 | 2004-03-09 | Converge Medical, Inc. | Anastomosis system |
US6350281B1 (en) * | 1999-09-14 | 2002-02-26 | Edwards Lifesciences Corp. | Methods and apparatus for measuring valve annuluses during heart valve-replacement surgery |
US6371983B1 (en) | 1999-10-04 | 2002-04-16 | Ernest Lane | Bioprosthetic heart valve |
JP3529678B2 (en) * | 1999-10-06 | 2004-05-24 | アルプス電気株式会社 | Thin film magnetic head and method of manufacturing the same |
US6440164B1 (en) * | 1999-10-21 | 2002-08-27 | Scimed Life Systems, Inc. | Implantable prosthetic valve |
US6733513B2 (en) | 1999-11-04 | 2004-05-11 | Advanced Bioprosthetic Surfaces, Ltd. | Balloon catheter having metal balloon and method of making same |
US6666846B1 (en) * | 1999-11-12 | 2003-12-23 | Edwards Lifesciences Corporation | Medical device introducer and obturator and methods of use |
FR2801118B1 (en) * | 1999-11-17 | 2001-12-21 | Bull Cp8 | METHOD FOR LOADING APPLICATIONS IN A MULTI-APPLICATION ON-BOARD SYSTEM, CORRESPONDING ON-BOARD SYSTEM, AND METHOD FOR EXECUTING AN APPLICATION OF THE ON-BOARD SYSTEM |
US8579966B2 (en) | 1999-11-17 | 2013-11-12 | Medtronic Corevalve Llc | Prosthetic valve for transluminal delivery |
US7018406B2 (en) * | 1999-11-17 | 2006-03-28 | Corevalve Sa | Prosthetic valve for transluminal delivery |
US6458153B1 (en) | 1999-12-31 | 2002-10-01 | Abps Venture One, Ltd. | Endoluminal cardiac and venous valve prostheses and methods of manufacture and delivery thereof |
US7195641B2 (en) * | 1999-11-19 | 2007-03-27 | Advanced Bio Prosthetic Surfaces, Ltd. | Valvular prostheses having metal or pseudometallic construction and methods of manufacture |
EP1103234B1 (en) | 1999-11-23 | 2007-01-24 | Sorin Biomedica Cardio S.R.L. | Method for conveying radioactive agents on angioplasty stents and kit |
US6479079B1 (en) | 1999-12-13 | 2002-11-12 | Sulzer Carbomedics Inc. | Anticalcification treatments for fixed biomaterials |
US6663667B2 (en) | 1999-12-29 | 2003-12-16 | Edwards Lifesciences Corporation | Towel graft means for enhancing tissue ingrowth in vascular grafts |
US6293906B1 (en) * | 2000-01-14 | 2001-09-25 | Acorn Cardiovascular, Inc. | Delivery of cardiac constraint jacket |
DE60138683D1 (en) | 2000-01-25 | 2009-06-25 | Edwards Lifesciences Corp | BIOACTIVE COATINGS TO AVOID TISSUE GROWTH ON ARTIFICIAL HEART FLAPS |
US6682559B2 (en) | 2000-01-27 | 2004-01-27 | 3F Therapeutics, Inc. | Prosthetic heart valve |
US7011682B2 (en) * | 2000-01-31 | 2006-03-14 | Edwards Lifesciences Ag | Methods and apparatus for remodeling an extravascular tissue structure |
US6989028B2 (en) * | 2000-01-31 | 2006-01-24 | Edwards Lifesciences Ag | Medical system and method for remodeling an extravascular tissue structure |
US6821297B2 (en) | 2000-02-02 | 2004-11-23 | Robert V. Snyders | Artificial heart valve, implantation instrument and method therefor |
US6733500B2 (en) | 2000-03-31 | 2004-05-11 | Medtronic, Inc. | Method and system for delivering a medical electrical lead within a venous system |
US6836687B2 (en) * | 2000-03-31 | 2004-12-28 | Medtronic, Inc. | Method and system for delivery of a medical electrical lead within a venous system |
US6454799B1 (en) | 2000-04-06 | 2002-09-24 | Edwards Lifesciences Corporation | Minimally-invasive heart valves and methods of use |
US6942691B1 (en) * | 2000-04-27 | 2005-09-13 | Timothy A. M. Chuter | Modular bifurcated graft for endovascular aneurysm repair |
US6540735B1 (en) * | 2000-05-12 | 2003-04-01 | Sub-Q, Inc. | System and method for facilitating hemostasis of blood vessel punctures with absorbable sponge |
AU2001271667A1 (en) * | 2000-06-30 | 2002-01-14 | Viacor Incorporated | Method and apparatus for performing a procedure on a cardiac valve |
US6796972B1 (en) | 2000-07-14 | 2004-09-28 | Edwards Lifesciences Llc | Catheter anchoring balloon structure with irrigation |
US6409758B2 (en) | 2000-07-27 | 2002-06-25 | Edwards Lifesciences Corporation | Heart valve holder for constricting the valve commissures and methods of use |
SE0002878D0 (en) * | 2000-08-11 | 2000-08-11 | Kimblad Ola | Device and method of treatment of atrioventricular regurgitation |
US6635085B1 (en) | 2000-08-17 | 2003-10-21 | Carbomedics Inc. | Heart valve stent with alignment posts |
US6458155B1 (en) | 2000-09-01 | 2002-10-01 | Edwards Lifesciences Corporation | Fresh donor heart valve sizer and method of use |
US6461382B1 (en) | 2000-09-22 | 2002-10-08 | Edwards Lifesciences Corporation | Flexible heart valve having moveable commissures |
US6485512B1 (en) | 2000-09-27 | 2002-11-26 | Advanced Cardiovascular Systems, Inc. | Two-stage light curable stent and delivery system |
US6602288B1 (en) | 2000-10-05 | 2003-08-05 | Edwards Lifesciences Corporation | Minimally-invasive annuloplasty repair segment delivery template, system and method of use |
US6783988B1 (en) | 2000-10-19 | 2004-08-31 | Edwards Lifesciences Corporation | Methods for quantitative and qualitative analyses of phospholipids using one-dimensional thin layer chromatography |
US6482228B1 (en) * | 2000-11-14 | 2002-11-19 | Troy R. Norred | Percutaneous aortic valve replacement |
EP1337188B1 (en) | 2000-11-16 | 2012-03-07 | Donald J. Hill | Automatic suture fixation apparatus and method |
US6966925B2 (en) | 2000-12-21 | 2005-11-22 | Edwards Lifesciences Corporation | Heart valve holder and method for resisting suture looping |
US6596471B2 (en) | 2000-12-21 | 2003-07-22 | Carbomedics Inc. | Method of cross-linking tissue with a bis-maleimide compound |
US7510576B2 (en) | 2001-01-30 | 2009-03-31 | Edwards Lifesciences Ag | Transluminal mitral annuloplasty |
US20020107531A1 (en) | 2001-02-06 | 2002-08-08 | Schreck Stefan G. | Method and system for tissue repair using dual catheters |
US7214237B2 (en) | 2001-03-12 | 2007-05-08 | Don Michael T Anthony | Vascular filter with improved strength and flexibility |
US6733525B2 (en) * | 2001-03-23 | 2004-05-11 | Edwards Lifesciences Corporation | Rolled minimally-invasive heart valves and methods of use |
US7374571B2 (en) * | 2001-03-23 | 2008-05-20 | Edwards Lifesciences Corporation | Rolled minimally-invasive heart valves and methods of manufacture |
US7556646B2 (en) * | 2001-09-13 | 2009-07-07 | Edwards Lifesciences Corporation | Methods and apparatuses for deploying minimally-invasive heart valves |
JP2004525704A (en) * | 2001-03-26 | 2004-08-26 | マシーン ソリューションズ インコーポレイテッド | Balloon folding technology |
GB0107910D0 (en) * | 2001-03-29 | 2001-05-23 | Isis Innovation | Deployable stent |
WO2002087467A2 (en) * | 2001-04-30 | 2002-11-07 | Thorpe Patricia E | Replacement venous valve |
US6425902B1 (en) * | 2001-05-04 | 2002-07-30 | Cardiomend Llc | Surgical instrument for heart valve reconstruction |
US6682558B2 (en) * | 2001-05-10 | 2004-01-27 | 3F Therapeutics, Inc. | Delivery system for a stentless valve bioprosthesis |
US6858039B2 (en) * | 2002-07-08 | 2005-02-22 | Edwards Lifesciences Corporation | Mitral valve annuloplasty ring having a posterior bow |
ITMC20010029U1 (en) * | 2001-06-15 | 2002-12-16 | Piergiacomi Sud Srl | ANTI-TRAUMA SURGICAL PLATE FOR FASTENING MANDIBIOLAR ABUTMENTS |
US7201761B2 (en) * | 2001-06-29 | 2007-04-10 | Medtronic, Inc. | Method and apparatus for resecting and replacing an aortic valve |
FR2826863B1 (en) | 2001-07-04 | 2003-09-26 | Jacques Seguin | ASSEMBLY FOR PLACING A PROSTHETIC VALVE IN A BODY CONDUIT |
US6574843B1 (en) * | 2001-07-12 | 2003-06-10 | Thomas J. Meadows | Method and apparatus for installing and replacing valve stems |
EP1406561A4 (en) * | 2001-07-16 | 2008-03-12 | Edwards Lifesciences Corp | Tissue engineered heart valve |
US7011671B2 (en) * | 2001-07-18 | 2006-03-14 | Atritech, Inc. | Cardiac implant device tether system and method |
ES2266148T5 (en) | 2001-07-20 | 2012-11-06 | Sorin Biomedica Cardio S.R.L. | Stent |
FR2828091B1 (en) * | 2001-07-31 | 2003-11-21 | Seguin Jacques | ASSEMBLY ALLOWING THE PLACEMENT OF A PROTHETIC VALVE IN A BODY DUCT |
US6723122B2 (en) * | 2001-08-30 | 2004-04-20 | Edwards Lifesciences Corporation | Container and method for storing and delivering minimally-invasive heart valves |
US20060052821A1 (en) | 2001-09-06 | 2006-03-09 | Ovalis, Inc. | Systems and methods for treating septal defects |
DE10148185B4 (en) | 2001-09-28 | 2005-08-11 | Alveolus, Inc. | Instrument for implanting vascular prostheses |
US6893460B2 (en) * | 2001-10-11 | 2005-05-17 | Percutaneous Valve Technologies Inc. | Implantable prosthetic valve |
US6790219B1 (en) | 2001-11-06 | 2004-09-14 | Edwards Lifesciences Corporation | Filter with integrated obturator tip and methods of use |
US6805710B2 (en) | 2001-11-13 | 2004-10-19 | Edwards Lifesciences Corporation | Mitral valve annuloplasty ring for molding left ventricle geometry |
DE10158289A1 (en) * | 2001-11-20 | 2003-05-28 | Biotronik Mess & Therapieg | Device for implanting catheters |
US6752826B2 (en) | 2001-12-14 | 2004-06-22 | Thoratec Corporation | Layered stent-graft and methods of making the same |
US7033390B2 (en) | 2002-01-02 | 2006-04-25 | Medtronic, Inc. | Prosthetic heart valve system |
US6878168B2 (en) | 2002-01-03 | 2005-04-12 | Edwards Lifesciences Corporation | Treatment of bioprosthetic tissues to mitigate post implantation calcification |
US20030130720A1 (en) | 2002-01-08 | 2003-07-10 | Depalma Donald F. | Modular aneurysm repair system |
US6974464B2 (en) | 2002-02-28 | 2005-12-13 | 3F Therapeutics, Inc. | Supportless atrioventricular heart valve and minimally invasive delivery systems thereof |
US7351256B2 (en) | 2002-05-10 | 2008-04-01 | Cordis Corporation | Frame based unidirectional flow prosthetic implant |
AU2002367970A1 (en) | 2002-05-17 | 2003-12-02 | Bionethos Holding Gmbh | Medical device for the treatment of a body vessel or another tubular structure in the body |
EP1521550A4 (en) * | 2002-06-12 | 2011-02-23 | Mitral Interventions Inc | Method and apparatus for tissue connection |
US20060122633A1 (en) | 2002-06-13 | 2006-06-08 | John To | Methods and devices for termination |
EP1530441B1 (en) * | 2002-06-13 | 2017-08-02 | Ancora Heart, Inc. | Devices and methods for heart valve repair |
US20040015224A1 (en) * | 2002-07-22 | 2004-01-22 | Armstrong Joseph R. | Endoluminal expansion system |
US7041132B2 (en) | 2002-08-16 | 2006-05-09 | 3F Therapeutics, Inc, | Percutaneously delivered heart valve and delivery means thereof |
AU2003268220B8 (en) | 2002-08-28 | 2010-01-21 | Hlt, Inc. | Method and device for treating diseased valve |
US6875231B2 (en) * | 2002-09-11 | 2005-04-05 | 3F Therapeutics, Inc. | Percutaneously deliverable heart valve |
US6817717B2 (en) * | 2002-09-19 | 2004-11-16 | Hewlett-Packard Development Company, L.P. | Display system with low and high resolution modulators |
US8551162B2 (en) | 2002-12-20 | 2013-10-08 | Medtronic, Inc. | Biologically implantable prosthesis |
US7402171B2 (en) | 2003-03-12 | 2008-07-22 | Cook Incorporated | Prosthetic valve that permits retrograde flow |
US7399315B2 (en) * | 2003-03-18 | 2008-07-15 | Edwards Lifescience Corporation | Minimally-invasive heart valve with cusp positioners |
US20050075659A1 (en) | 2003-03-30 | 2005-04-07 | Fidel Realyvasquez | Apparatus and methods for minimally invasive valve surgery |
DE20321645U1 (en) | 2003-04-14 | 2008-08-21 | Synthes Gmbh | Intervertebral implant |
EP1626681B1 (en) * | 2003-05-19 | 2009-07-01 | Cook Incorporated | Implantable medical device with constrained expansion |
US6789265B1 (en) * | 2003-06-10 | 2004-09-14 | Bonnie Vonrinteln | Bib with side pockets |
JP4447011B2 (en) * | 2003-07-21 | 2010-04-07 | ザ・トラスティーズ・オブ・ザ・ユニバーシティ・オブ・ペンシルバニア | Percutaneous heart valve |
US7204255B2 (en) | 2003-07-28 | 2007-04-17 | Plc Medical Systems, Inc. | Endovascular tissue removal device |
US20050038497A1 (en) * | 2003-08-11 | 2005-02-17 | Scimed Life Systems, Inc. | Deformation medical device without material deformation |
US8021421B2 (en) * | 2003-08-22 | 2011-09-20 | Medtronic, Inc. | Prosthesis heart valve fixturing device |
US20050075725A1 (en) | 2003-10-02 | 2005-04-07 | Rowe Stanton J. | Implantable prosthetic valve with non-laminar flow |
US7101396B2 (en) * | 2003-10-06 | 2006-09-05 | 3F Therapeutics, Inc. | Minimally invasive valve replacement system |
US7004176B2 (en) * | 2003-10-17 | 2006-02-28 | Edwards Lifesciences Ag | Heart valve leaflet locator |
US20050090888A1 (en) * | 2003-10-28 | 2005-04-28 | Hines Richard A. | Pleated stent assembly |
US7070616B2 (en) | 2003-10-31 | 2006-07-04 | Cordis Corporation | Implantable valvular prosthesis |
WO2005048883A1 (en) | 2003-11-13 | 2005-06-02 | Fidel Realyvasquez | Methods and apparatus for valve repair |
US7186265B2 (en) * | 2003-12-10 | 2007-03-06 | Medtronic, Inc. | Prosthetic cardiac valves and systems and methods for implanting thereof |
US20050137696A1 (en) | 2003-12-23 | 2005-06-23 | Sadra Medical | Apparatus and methods for protecting against embolization during endovascular heart valve replacement |
US8182528B2 (en) | 2003-12-23 | 2012-05-22 | Sadra Medical, Inc. | Locking heart valve anchor |
US20050137687A1 (en) | 2003-12-23 | 2005-06-23 | Sadra Medical | Heart valve anchor and method |
US8603160B2 (en) | 2003-12-23 | 2013-12-10 | Sadra Medical, Inc. | Method of using a retrievable heart valve anchor with a sheath |
US20050137691A1 (en) | 2003-12-23 | 2005-06-23 | Sadra Medical | Two piece heart valve and anchor |
US7959666B2 (en) | 2003-12-23 | 2011-06-14 | Sadra Medical, Inc. | Methods and apparatus for endovascularly replacing a heart valve |
US7381219B2 (en) | 2003-12-23 | 2008-06-03 | Sadra Medical, Inc. | Low profile heart valve and delivery system |
US20050137686A1 (en) | 2003-12-23 | 2005-06-23 | Sadra Medical, A Delaware Corporation | Externally expandable heart valve anchor and method |
US7780725B2 (en) | 2004-06-16 | 2010-08-24 | Sadra Medical, Inc. | Everting heart valve |
US8840663B2 (en) | 2003-12-23 | 2014-09-23 | Sadra Medical, Inc. | Repositionable heart valve method |
US7824442B2 (en) | 2003-12-23 | 2010-11-02 | Sadra Medical, Inc. | Methods and apparatus for endovascularly replacing a heart valve |
WO2005069850A2 (en) * | 2004-01-15 | 2005-08-04 | Macoviak John A | Trestle heart valve replacement |
US7470285B2 (en) | 2004-02-05 | 2008-12-30 | Children's Medical Center Corp. | Transcatheter delivery of a replacement heart valve |
US8430925B2 (en) | 2004-02-27 | 2013-04-30 | Cardiacmd, Inc. | Prosthetic heart valves, scaffolding structures, and systems and methods for implantation of same |
ITTO20040135A1 (en) | 2004-03-03 | 2004-06-03 | Sorin Biomedica Cardio Spa | CARDIAC VALVE PROSTHESIS |
EP3603576B1 (en) | 2004-03-11 | 2021-01-20 | Percutaneous Cardiovascular Solutions Pty Limited | Percutaneous heart valve prosthesis |
US20050204617A1 (en) * | 2004-03-16 | 2005-09-22 | Sowers Ronald A | Christmas tree watering system |
US8377118B2 (en) * | 2004-05-05 | 2013-02-19 | Direct Flow Medical, Inc. | Unstented heart valve with formed in place support structure |
US7645285B2 (en) | 2004-05-26 | 2010-01-12 | Idx Medical, Ltd | Apparatus and methods for occluding a hollow anatomical structure |
US20050288766A1 (en) | 2004-06-28 | 2005-12-29 | Xtent, Inc. | Devices and methods for controlling expandable prostheses during deployment |
US7276078B2 (en) * | 2004-06-30 | 2007-10-02 | Edwards Lifesciences Pvt | Paravalvular leak detection, sealing, and prevention |
US8034102B2 (en) | 2004-07-19 | 2011-10-11 | Coroneo, Inc. | Aortic annuloplasty ring |
US20060052867A1 (en) * | 2004-09-07 | 2006-03-09 | Medtronic, Inc | Replacement prosthetic heart valve, system and method of implant |
FR2874813B1 (en) * | 2004-09-07 | 2007-06-22 | Perouse Soc Par Actions Simpli | VALVULAR PROSTHESIS |
AU2005284739B2 (en) * | 2004-09-14 | 2011-02-24 | Edwards Lifesciences Ag | Device and method for treatment of heart valve regurgitation |
US6951571B1 (en) * | 2004-09-30 | 2005-10-04 | Rohit Srivastava | Valve implanting device |
US8182530B2 (en) | 2004-10-02 | 2012-05-22 | Christoph Hans Huber | Methods and devices for repair or replacement of heart valves or adjacent tissue without the need for full cardiopulmonary support |
US7722629B2 (en) | 2004-10-29 | 2010-05-25 | Jeffrey W. Chambers, M.D. | System and method for catheter-based septal defect repair |
WO2006065665A1 (en) * | 2004-12-13 | 2006-06-22 | Robert Hunt Carpenter, Dvm, Pc | Multi-wall expandable device capable of drug delivery |
EP1846078A4 (en) | 2004-12-16 | 2009-12-23 | Carlos Ruiz | Separable sheath and method of using |
US7722666B2 (en) | 2005-04-15 | 2010-05-25 | Boston Scientific Scimed, Inc. | Valve apparatus, system and method |
US8167932B2 (en) | 2005-10-18 | 2012-05-01 | Edwards Lifesciences Corporation | Heart valve delivery system with valve catheter |
US20070185571A1 (en) | 2006-02-06 | 2007-08-09 | The Cleveland Clinic Foundation | Apparatus and method for treating a regurgitant valve |
CA2661959A1 (en) | 2006-09-06 | 2008-03-13 | Aortx, Inc. | Prosthetic heart valves, systems and methods of implanting |
-
2005
- 2005-02-25 US US11/066,126 patent/US8430925B2/en not_active Expired - Fee Related
- 2005-02-25 CA CA2557657A patent/CA2557657C/en not_active Expired - Fee Related
- 2005-02-25 AU AU2005218326A patent/AU2005218326A1/en not_active Abandoned
- 2005-02-25 CN CN2011102907202A patent/CN102488572A/en active Pending
- 2005-02-25 US US11/067,330 patent/US8128692B2/en not_active Expired - Fee Related
- 2005-02-25 CA CA2813136A patent/CA2813136A1/en not_active Abandoned
- 2005-02-25 WO PCT/US2005/006189 patent/WO2005084595A1/en active Application Filing
- 2005-02-25 CN CN200910165866A patent/CN101683291A/en active Pending
- 2005-02-25 JP JP2007501025A patent/JP4975609B2/en not_active Expired - Fee Related
- 2005-02-25 EP EP05723873A patent/EP1722711A4/en not_active Withdrawn
- 2005-02-25 US US11/066,124 patent/US7785341B2/en not_active Expired - Fee Related
- 2005-02-25 CN CN2005800127355A patent/CN101010047B/en not_active Expired - Fee Related
-
2010
- 2010-04-07 US US12/755,655 patent/US20100256750A1/en not_active Abandoned
- 2010-04-07 US US12/755,643 patent/US20100256724A1/en not_active Abandoned
- 2010-07-28 US US12/845,088 patent/US8608770B2/en not_active Expired - Fee Related
- 2010-08-24 JP JP2010187698A patent/JP2010284548A/en active Pending
- 2010-11-15 US US12/946,552 patent/US20110082540A1/en not_active Abandoned
-
2011
- 2011-12-21 US US13/333,901 patent/US9168134B2/en not_active Expired - Fee Related
-
2012
- 2012-01-30 US US13/361,553 patent/US8728156B2/en not_active Expired - Fee Related
-
2013
- 2013-03-14 US US13/829,542 patent/US20130268067A1/en not_active Abandoned
- 2013-11-15 US US14/081,789 patent/US20140222135A1/en not_active Abandoned
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4878495A (en) * | 1987-05-15 | 1989-11-07 | Joseph Grayzel | Valvuloplasty device with satellite expansion means |
US5957949A (en) * | 1997-05-01 | 1999-09-28 | World Medical Manufacturing Corp. | Percutaneous placement valve stent |
US20060069424A1 (en) * | 2004-09-27 | 2006-03-30 | Xtent, Inc. | Self-constrained segmented stents and methods for their deployment |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US10130462B2 (en) | 2006-10-06 | 2018-11-20 | BioStable Science & Engineering, Inc. | Intra-annular mounting frame for aortic valve repair |
US20120239143A1 (en) * | 2010-09-30 | 2012-09-20 | BioStable Science & Engineering, Inc. | Non-Axisymmetric Aortic Valve Devices |
US9161835B2 (en) * | 2010-09-30 | 2015-10-20 | BioStable Science & Engineering, Inc. | Non-axisymmetric aortic valve devices |
US9814574B2 (en) | 2010-09-30 | 2017-11-14 | BioStable Science & Engineering, Inc. | Non-axisymmetric aortic valve devices |
Also Published As
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JP4975609B2 (en) | 2012-07-11 |
US20120136432A1 (en) | 2012-05-31 |
CA2557657A1 (en) | 2005-09-15 |
EP1722711A4 (en) | 2009-12-02 |
US20050203614A1 (en) | 2005-09-15 |
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US20110082540A1 (en) | 2011-04-07 |
US8128692B2 (en) | 2012-03-06 |
US8430925B2 (en) | 2013-04-30 |
CN101683291A (en) | 2010-03-31 |
US20100256724A1 (en) | 2010-10-07 |
CA2813136A1 (en) | 2005-09-15 |
US20100305691A1 (en) | 2010-12-02 |
WO2005084595A1 (en) | 2005-09-15 |
US8728156B2 (en) | 2014-05-20 |
CN102488572A (en) | 2012-06-13 |
AU2005218326A1 (en) | 2005-09-15 |
JP2010284548A (en) | 2010-12-24 |
US7785341B2 (en) | 2010-08-31 |
JP2007525291A (en) | 2007-09-06 |
US20120095549A1 (en) | 2012-04-19 |
EP1722711A1 (en) | 2006-11-22 |
US9168134B2 (en) | 2015-10-27 |
US8608770B2 (en) | 2013-12-17 |
CA2557657C (en) | 2013-06-18 |
US20050203617A1 (en) | 2005-09-15 |
CN101010047B (en) | 2010-12-15 |
US20050203615A1 (en) | 2005-09-15 |
CN101010047A (en) | 2007-08-01 |
US20140222135A1 (en) | 2014-08-07 |
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