Patent Grant
11389292
Certain embodiments disclosed herein relate generally to prostheses for implantation within a lumen or body cavity and delivery systems for a prosthesis. In particular, the prostheses and delivery systems relate in some embodiments to replacement heart valves, such as replacement mitral heart valves.
Human heart valves, which include the aortic, pulmonary, mitral and tricuspid valves, function essentially as one-way valves operating in synchronization with the pumping heart. The valves allow blood to flow downstream, but block blood from flowing upstream. Diseased heart valves exhibit impairments such as narrowing of the valve or regurgitation, which inhibit the valves' ability to control blood flow. Such impairments reduce the heart's blood-pumping efficiency and can be a debilitating and life threatening condition. For example, valve insufficiency can lead to conditions such as heart hypertrophy and dilation of the ventricle. Thus, extensive efforts have been made to develop methods and apparatuses to repair or replace impaired heart valves.
Prostheses exist to correct problems associated with impaired heart valves. For example, mechanical and tissue-based heart valve prostheses can be used to replace impaired native heart valves. More recently, substantial effort has been dedicated to developing replacement heart valves, particularly tissue-based replacement heart valves that can be delivered with less trauma to the patient than through open heart surgery. Replacement valves are being designed to be delivered through minimally invasive procedures and even percutaneous procedures. Such replacement valves often include a tissue-based valve body that is connected to an expandable frame that is then delivered to the native valve's annulus.
Development of prostheses including but not limited to replacement heart valves that can be compacted for delivery and then controllably expanded for controlled placement has proven to be particularly challenging. An additional challenge relates to the ability of such prostheses to be secured relative to intralumenal tissue, e.g., tissue within any body lumen or cavity, in an atraumatic manner.
Delivering a prosthesis to a desired location in the human body, for example delivering a replacement heart valve to the mitral valve, can also be challenging. Obtaining access to perform procedures in the heart or in other anatomical locations may require delivery of devices percutaneously through tortuous vasculature or through open or semi-open surgical procedures. The ability to control the deployment of the prosthesis at the desired location can also be challenging.
Embodiments of the present disclosure are directed to a prosthesis, such as but not limited to a replacement heart valve. Further embodiments are directed to methods of delivering a prosthesis into a body cavity and/or securing a prosthesis to intralumenal tissue. In some embodiments, a replacement heart valve and methods for delivering a replacement heart valve to a native heart valve, such as a mitral valve, are provided. Embodiments of different delivery systems and methods are also disclosed herein.
The present disclosure includes, but is not limited to, the following numbered embodiments.
A flexible delivery system for replacement mitral valve implantation, the delivery system comprising an outer sheath comprising a proximal segment and a distal segment, wherein the distal segment is configured to cover a replacement mitral valve, wherein the distal segment is formed from two or more layers.
The flexible delivery system of Embodiment 1, wherein the distal segment is formed from an inner layer, an outer layer, and one or more intermediate layers positioned between the inner and outer layers.
The flexible delivery system of Embodiment 2, wherein the inner layer and outer layer comprises ePTFE.
The flexible delivery system of Embodiment 2 or 3, wherein the one or more intermediate layers comprises a nitinol hypotube.
The flexible delivery system of any of Embodiments 2-4, wherein the one or more intermediate layers comprises ePTFE.
The flexible delivery system of Embodiment 2 or 3, wherein the distal segment comprises a proximal portion and a distal portion, wherein the proximal portion comprises a first intermediate layer and the distal portion comprises a second intermediate layer located distal to the first intermediate layer.
The flexible delivery system of Embodiment 6, wherein the second intermediate layer comprises a nitinol hypotube and the first intermediate layer comprises ePTFE.
The flexible delivery system of Embodiment 6, wherein the second intermediate layer comprises ePTFE and the first intermediate layer comprises a nitinol hypotube.
The flexible delivery system of any of Embodiments 6-8, wherein a gap exists between the first intermediate layer and the second intermediate layer.
A transseptal delivery system for replacement mitral valve implantation, the delivery system comprising a nose cone shaft having a proximal end and a distal end and a lumen extending therethrough, a nose cone provided on the distal end of the nose cone shaft, an inner retention shaft slideably positioned over the nose cone shaft, the inner retention shaft having a proximal end and a distal end, an inner retention ring provided on the distal end of the inner retention shaft, the inner retention ring configured to receive struts at a proximal portion of a replacement mitral valve prosthesis, a mid shaft slideably positioned over the inner retention shaft, the mid shaft having a proximal end and a distal end, an outer retention ring provided on the distal end of the mid shaft, the outer retention ring configured to be positioned over the inner retention ring to hold the proximal portion of the replacement mitral valve prosthesis within the inner retention ring, and an outer sheath assembly slideably positioned over the mid shaft and over the outer retention ring, the outer sheath assembly configured to radially restrain a distal portion of the replacement mitral valve prosthesis when the proximal portion of the replacement mitral valve prosthesis is held by the outer retention ring within the inner retention ring.
The transseptal delivery system of Embodiment 10, wherein the outer sheath assembly is configured to slide over the nose cone.
The transseptal delivery system of Embodiment 10 or 11, further comprising a replacement heart valve prosthesis, wherein the replacement heart valve prosthesis comprises struts at a proximal portion thereof received within the inner retention ring and covered by the outer retention ring, and a distal portion covered by the outer sheath assembly.
The transseptal delivery system of Embodiment 12, wherein the replacement heart valve prosthesis further comprises a plurality of proximal anchors extending distally and a plurality of distal anchors extending proximally when the prosthesis is in an expanded configuration.
The transseptal delivery system of Embodiment 13, wherein the proximal anchors extend distally when in a delivery configuration within the outer sheath assembly.
The transseptal delivery system of Embodiment 13 or 14, wherein the distal anchors extend proximally when in a delivery configuration within the outer sheath assembly.
The transseptal delivery system of Embodiment 13 or 14, wherein the distal anchors extend distally when in a delivery configuration within the outer sheath assembly.
A flexible delivery system for replacement mitral valve implantation, the delivery system comprising: an outer sheath comprising a distal segment configured to cover a replacement mitral valve, wherein the distal segment is formed from an inner polymer layer and an outer polymer layer, and wherein the distal segment further comprises a proximal section comprising a hypotube sandwiched between the inner and outer polymer layers, and a distal section comprising an intermediate polymer layer sandwiched between the inner and outer polymer layers.
The flexible delivery system of Embodiment 17, wherein the distal section has a greater diameter than the proximal section.
The flexible delivery system of Embodiment 17 or 18, wherein the inner polymer layer, the outer polymer layer, and the intermediate polymer layer comprise ePTFE.
The flexible delivery system of any of Embodiments 17-19, further comprising a polymer reinforcement in the distal section that at least partially overlaps the intermediate polymer layer.
The flexible delivery system of Embodiment 20, wherein the polymer reinforcement comprises a fluorinated ethylene propylene insert.
The flexible delivery system of any of Embodiments 17-21, wherein the inner polymer layer and the outer polymer layer comprise ePTFE with generally longitudinally extending polymer chains, and the intermediate polymer layer comprises ePTFE having generally circumferentially extending polymer chains.
The flexible delivery system of any of Embodiments 17-22, wherein the hypotube comprises a plurality of circumferentially extending cuts along a longitudinal length thereof.
The flexible delivery system of any of Embodiments 17-23, further comprising a replacement mitral valve loaded within the distal section of the distal segment, wherein the replacement mitral valve comprises ventricular anchors that apply a radially outward force to the distal section of the distal segment.
A delivery system for replacement mitral valve implantation, the delivery system comprising an outer sheath assembly configured to radially constrain a first end of a replacement mitral valve, a mid shaft comprising a longitudinally pre-compressed polymer tube located within the outer sheath assembly, the mid shaft having a tubular outer retention ring located on a distal end of the mid shaft, the outer retention ring configured to radially constrain a second end of the replacement valve, and an inner retention shaft having an inner retention member located on a distal end of the inner retention member, the inner retention member configured to releasably couple with the second end of the replacement valve, wherein the pre-compressed polymer tube is configured so that deflection of the mid shaft does not substantially change the location of the outer retention ring relative to the inner retention member.
The delivery system of Embodiment 25, wherein the pre-compressed polymer tube comprises a pre-compressed HDPE tube.
The delivery system of Embodiment 25 or 26, wherein the mid shaft provides a distal force on the outer retention ring.
The delivery system of any of Embodiments 25-27, wherein the pre-compressed polymer tube is compressed at least ¼ inch.
The delivery system of any of Embodiments 25-28, wherein the outer retention ring is configured to cover at least ¼ of the replacement mitral valve.
The delivery system of any of Embodiments 25-29, wherein the outer retention ring is at least 15 mm in length.
A delivery system, the delivery system comprising a nose cone shaft comprising a proximal end and a distal end and a lumen extending therethrough, the nose cone shaft being configured to be delivered over a guidewire to a body location, and a nose cone connected to the distal end of the nose cone shaft, wherein the nose cone comprises an elongate hollow body that is distally tapered to facilitate bending of the nose cone when the nose cone is delivered over a guidewire and comes into contact with an internal body surface.
A flexible delivery system for replacement mitral valve implantation, the delivery system comprising an outer sheath comprising a proximal segment and a distal segment, wherein the distal segment is configured to cover a replacement mitral valve, wherein the distal segment is formed from two or more layers.
The flexible delivery system of Embodiment 32, wherein the distal segment is formed from an inner layer, an outer layer, and one or more intermediate layers positioned between the inner and outer layers.
The flexible delivery system of Embodiment 33, wherein the inner layer and outer layer comprises ePTFE.
The flexible delivery system of Embodiment 33 or 34, wherein the one or more intermediate layers comprises a nitinol hypotube.
The flexible delivery system of any of Embodiments 33-35, wherein the one or more intermediate layers comprises ePTFE.
The flexible delivery system of any of Embodiments 32-33, wherein the distal segment comprises a proximal portion and a distal portion, wherein the proximal portion comprises a first intermediate layer and the distal portion comprises a second intermediate layer located distal to the first intermediate layer.
The flexible delivery system of Embodiment 37, wherein the second intermediate layer comprises a nitinol hypotube and the first intermediate layer comprises ePTFE.
The flexible delivery system of Embodiment 37, wherein the second intermediate layer comprises ePTFE and the first intermediate layer comprises a nitinol hypotube.
The flexible delivery system of any of Embodiments 37-39, wherein a gap exists between the first intermediate layer and the second intermediate layer.
A delivery system for controlled deployment of a replacement mitral valve, the delivery system comprising a nose cone shaft comprising a proximal end and a distal end and a lumen extending therethrough, a nose cone connected to the distal end of the nose cone shaft, wherein the nose cone comprises an elongate hollow body that is distally tapered, an inner retention shaft slideably positioned over the nose cone shaft, the inner retention shaft comprising a proximal end and a distal end, an inner retention member provided on the distal end of the inner retention shaft, the inner retention member configured to engage struts at a proximal portion of a replacement mitral valve prosthesis, a mid shaft slideably positioned over the inner retention shaft, the mid shaft comprising a proximal end and a distal end, wherein the mid-shaft is at least partially composed of a pre-compressed HDPE material, an outer retention member provided on the distal end of the mid shaft, the outer retention member configured to be positioned over the inner retention member to hold the proximal portion of the replacement mitral valve prosthesis in engagement with the inner retention member, and an outer sheath assembly slideably positioned over the mid shaft and within a generally-rigid live-on sheath, the outer sheath assembly configured to extend over the outer retention member, the outer sheath assembly configured to radially restrain a distal portion of the replacement mitral valve prosthesis when the proximal portion of the replacement mitral valve prosthesis is held by the outer retention member in engagement with the inner retention member, wherein a distal portion of the outer sheath assembly is formed from an inner ePTFE layer and an outer ePTFE layer, the distal portion comprising a proximal section comprising a cut nitinol tube between the inner ePTFE layer and an outer ePTFE layer, and a distal section comprising an ePTFE insert located between the inner ePTFE layer and the outer ePTFE layer, the ePTFE insert having a polymer orientation approximately perpendicular to that of the inner ePTFE layer and an outer ePTFE layer, and a fluorinated ethylene propylene strip located on a distal end of the distal section, wherein the distal section has a larger diameter than the proximal section.
A replacement mitral valve prosthesis, comprising an expandable frame having a proximal end and a distal end and a longitudinal axis extending therebetween, wherein the expandable frame comprises a plurality of foreshortening cells, a plurality of distal anchors each extending distally from a distal portion of the expandable frame and curving to extend proximally at ends of each of the plurality of distal anchors, the distal anchors being shaped and configured to extend between chordae tendineae and behind native mitral valve leaflets when the expandable frame is expanded within a native mitral valve annulus, a plurality of proximal anchors extending distally from a proximal portion of the expandable frame and curving radially outwardly away from the frame, the proximal anchors being shaped and configured to be positioned in the left atrium when the expandable frame is expanded within a native mitral valve annulus, and a plurality of locking tabs each extending proximally from a proximal portion of the expandable frame and radially inwardly toward the longitudinal axis.
The replacement mitral valve prosthesis of Embodiment 42, wherein when the frame is in an expanded configuration, the frame has a width as measured perpendicular to the longitudinal axis that is greater than a height measured parallel to the longitudinal axis.
The replacement mitral valve prosthesis of Embodiment 42 or 43, wherein the frame comprises at least two rows of foreshortening cells.
The replacement mitral valve prosthesis of any of Embodiments 42-44, wherein the frame further comprises at least one row of hexagonal-shaped cells proximal to the foreshortening cells.
The replacement mitral valve prosthesis of Embodiment 45, wherein when the frame is in an expanded configuration, the proximal anchors extend distally within hexagonal-shaped cells and then curve radially outwardly outside of the hexagonal cells.
The replacement mitral valve prosthesis of Embodiment 46, wherein when the frame is in an expanded configuration, each of the hexagonal-shaped cells has a proximal end inclined radially-inwardly toward the longitudinal axis relative to a distal end of each hexagonal-shaped cell.
The replacement mitral valve prosthesis of any of Embodiments 42-47, wherein when the frame is in an expanded configuration, the ends of the proximal anchors extend substantially perpendicular to the longitudinal axis.
The replacement mitral valve prosthesis of any of Embodiments 42-48, wherein when the frame is in an expanded configuration, the ends of the distal anchors extend substantially parallel to the longitudinal axis.
The replacement mitral valve prosthesis of Embodiment 49, wherein when the frame is in an expanded configuration, the ends of the distal anchors are positioned radially outward of the ends of the proximal anchors.
The replacement mitral valve prosthesis of any of Embodiments 42-50, wherein the plurality of proximal anchors are equally spaced circumferentially around the expandable frame, and the plurality of distal anchors are equally spaced circumferentially around the expandable frame.
The replacement mitral valve prosthesis of any of Embodiments 42-51, wherein at least one of the proximal anchors comprises an eyelet.
The replacement mitral valve prosthesis of any of Embodiments 42-52, wherein when the frame is in an expanded configuration, the hexagonal-shaped cells comprise at least a portion that is substantially longitudinally non-foreshortening.
The replacement mitral valve prosthesis of any of Embodiments 42-53, further comprising a valve body attached to the expandable frame.
The replacement mitral valve prosthesis of any of Embodiments 42-54, further comprising an annular flap surrounding an exterior of the expandable frame positioned distal to the proximal anchors, the annular flap configured to expand with blood on an atrial side of a native mitral valve annulus when the expandable frame is expanded within a native mitral valve annulus.
A replacement mitral valve prosthesis, comprising an expandable frame having a proximal end and a distal end and a longitudinal axis extending therebetween, wherein the expandable frame in an expanded configuration comprises a distal portion comprising at least one row of diamond-shaped cells, wherein the diamond-shaped cells are configured to cause the distal portion to radially expand and longitudinally foreshorten when the expandable frame is expanded, and a plurality of distal anchors each extending distally from a distalmost corner of a diamond-shaped cell, the distal anchors curving to extend proximally at ends of each of the plurality of distal anchors, and a proximal portion comprising at least one row of hexagonal-shaped cells, each of the hexagonal-shaped cells formed from a proximal row of undulating struts, a pair of vertical struts attached to two distalmost valleys of the proximal row of undulating struts, and two proximalmost struts forming the diamond-shaped cells, wherein the at least one row of hexagonal-shaped cells is configured to be circumferentially expandable when the expandable frame is expanded, a plurality of proximal anchors extending from a proximalmost corner of the hexagonal-shaped cells, each of the plurality of proximal anchors extending distally and curving radially outwardly away from the hexagonal-shaped cells, and a plurality of locking tabs each extending proximally from the proximalmost ends of the hexagonal-shaped cells, the locking tabs having enlarged proximal ends, wherein the expandable frame is configured to be collapsible to a radially compacted configuration for delivery and expandable to a radially expanded configuration for implantation.
The replacement mitral valve prosthesis of Embodiment 56, further comprising two rows of diamond-shaped cells.
The replacement mitral valve prosthesis of Embodiment 56 or 57, wherein the plurality of locking tabs are inclined when the frame is in the expanded configuration so that the enlarged proximal ends are closer to the longitudinal axis than distal ends of the plurality of locking tabs.
The replacement mitral valve prosthesis of any of Embodiments 56-58, wherein the ends of the distal anchors are parallel to the longitudinal axis.
The replacement mitral valve prosthesis of any of Embodiments 56-59, wherein the plurality of proximal anchors comprises enlarged ends.
The replacement mitral valve prosthesis of Embodiment 60, wherein the enlarged ends extend substantially perpendicular to the longitudinal axis.
The replacement mitral valve prosthesis of any of Embodiments 56-61, wherein the proximal portion comprises a single row of hexagonal-shaped cells.
The replacement mitral valve prosthesis of any of Embodiments 56-62, wherein the enlarged proximal ends of the plurality of locking tabs are generally mushroom-shaped.
The replacement mitral valve prosthesis of any of Embodiments 56-63, wherein the plurality of distal anchors first extends generally distally and radially inward, then extends distally and radially outward, and then extends proximally and parallel to the longitudinal axis.
An expandable prosthesis comprising a row of hexagonal-shaped cells, a plurality of locking tabs, each locking tab extending proximally from a proximalmost corner of the hexagonal-shaped cells, a plurality of proximal anchors, each proximal anchor extending distally from a proximalmost corner of the hexagonal-shaped cells, such that each proximalmost corner of the row of hexagonal-shaped cells comprises one proximal anchor and one locking tab, a proximal row and a distal row of diamond-shaped cells distal to the row of hexagonal-shaped cells, each diamond-shaped cell in the proximal row of diamond shaped cells sharing two struts with a hexagonal-shaped cell and two struts with a diamond shaped cell in the second row of diamond-shaped cells, and a plurality of distal anchors, each distal anchor extending distally from a distalmost corner of a diamond-shaped cell in the first row of diamond shaped cells, the plurality of distal anchors curving proximally after extending distally.
A delivery system for replacement mitral valve implantation, the delivery system comprising a mid shaft comprising a tubular outer retention ring located on a distal end of the mid shaft, the outer retention ring configured to radially constrain a portion of a replacement mitral valve, an inner retention shaft having an inner retention member located on a distal end of the inner retention member, the inner retention member configured to releasably couple with a portion of the replacement mitral valve, a spring located within the tubular outer retention ring, and a cover attached to a distal end of the spring, the cover configured to cover at least a portion of the inner retention member, wherein the spring is configured to retain the cover at least partially over the inner retention member until the outer retention ring is translated relative to the inner retention member proximally a particular distance.
A delivery system for replacement mitral valve implantation, the delivery system comprising one or more delivery components configured to deliver a replacement mitral valve to a native mitral valve, and a guide sheath having a lumen and a distal end with an open or openable wall, the distal end of the guide sheath being articulable to a plurality of shapes suitable for guiding the one or more delivery components to the native mitral valve, wherein the one or more delivery components are configured to pass through the lumen of the guide sheath and out the open or openable wall.
A guidewire assembly for replacement mitral valve implantation, the guide wire comprising a guidewire having a proximal end and a distal end, and an anchor mechanism attached or attachable to the distal end of the guide wire, the anchor mechanism comprising a tubular component having a lumen, the lumen configured to receive the distal end of the guide wire, and a plurality of hooks extending outwardly from the tubular component, wherein tips of the plurality of hooks are configured to extend distally in a compressed position and extend proximally in a released position, wherein the anchor mechanism is configured to anchor to tissue.
The guidewire assembly of Embodiment 68, further comprising a catheter configured to hold the plurality of hooks in the compressed position, wherein removing the catheter allows the plurality of hooks to translate into the released position
A method of using the guidewire assembly of Embodiment 68 or 69, comprising delivering the guidewire with the anchor mechanism attached thereto through a native mitral valve into a chamber of the heart, anchoring the anchor mechanism to a wall of the heart, and advancing one or more delivery components carrying a replacement mitral valve over the guidewire to the native mitral valve.
These and other features, aspects and advantages are described below with reference to the drawings, which are intended to illustrate but not to limit the invention.
The present specification and drawings provide aspects and features of the disclosure in the context of several embodiments of replacement heart valves, delivery systems and methods that are configured for use in the vasculature of a patient, such as for replacement of natural heart valves in a patient. These embodiments may be discussed in connection with replacing specific valves such as the patient's aortic or mitral valve. However, it is to be understood that the features and concepts discussed herein can be applied to products other than heart valve implants. For example, the controlled positioning, deployment, and securing features described herein can be applied to medical implants, for example other types of expandable prostheses, for use elsewhere in the body, such as within an artery, a vein, or other body cavities or locations. In addition, particular features of a valve, delivery system, etc. should not be taken as limiting, and features of any one embodiment discussed herein can be combined with features of other embodiments as desired and when appropriate. While certain of the embodiments described herein are described in connection with a transfemoral delivery approach, it should be understood that these embodiments can be used for other delivery approaches such as, for example, transapical approaches. Moreover, it should be understood that certain of the features described in connection with some embodiments can be incorporated with other embodiments, including those which are described in connection with different delivery approaches.
Delivery System
With reference to
The delivery system 10 can be used to deploy an expandable prosthesis 70 (shown in
As shown in
As shown in cross-sectional view of
As shown, the outer sheath assembly 22 can form a radially outer covering, or sheath, to surround an implant retention area 16. Moving radially inward, the mid shaft assembly 20 can be composed of a mid shaft 50 with its distal end attached to outer retention member 40, such as an outer retention ring. Moving further inwards, the inner assembly 18 can be composed of an inner retention shaft 24 and an inner retention member 32. Further, the most radially-inward assembly is the nose cone assembly 31 which includes the nose cone shaft 30 having the distal end connected to the nose cone 28.
The elongate shaft assembly 12, and more specifically the nose cone assembly 31, inner assembly 18, mid shaft assembly 20, and outer sheath assembly 22, can be configured to deliver a prosthesis positioned within the implant retention area 16 to a treatment location. One or more of the subassemblies can then be moved to allow the prosthesis to be released at the treatment location. For example, one or more of the subassemblies may be movable with respect to one or more of the other subassemblies. The handle 14 can include various control mechanisms that can be used to control the movement of the various subassemblies as will also be described in more detail below. In this way, the prosthesis can be controllably loaded onto the delivery system 10 and then later deployed within the body.
As mentioned,
Additional details and example designs for a prosthesis are described in U.S. Pat. Nos. 8,403,983, 8,414,644, 8,652,203 and U.S. Patent Publication Nos. 2011/0313515, 2012/0215303, 2014/0277390, 2014/0277422, 2014/0277427, the entirety of these patents and publications are hereby incorporated by reference and made a part of this specification. Further details and embodiments of a replacement heart valve or prosthesis and its method of implantation are described in U.S. Patent Publication No. 2015/0328000, filed May 19, 2015, the entirety of which is hereby incorporated by reference and made a part of this specification. Further discussion on the annular flap 81 can be found in U.S. Patent Publication No. 2015/0328000, hereby incorporated by reference in its entirety.
As will be discussed below, the inner retention member 32, the outer retention member 40, the outer sheath assembly 22 as illustrated in
As shown in
The delivery system 10 may be provided to users with a prosthesis 70 preinstalled. In other embodiments, the prosthesis 70 can be loaded onto the delivery system shortly before use, such as by a physician or nurse.
The outer sheath assembly 22 will now be described, which is shown in
The first segment 56 may be a tube and is preferably formed plastic, but could also be a metal hypotube or other material. In some embodiments, the tube 56 is formed of a polyether block amide (PEBA) or other type of a thermoplastic elastomer (TPE). In particular, the tube 56 can be a wire braided reinforced PEBA which can enhance pushability and trackability.
The second segment 58 can be a metal hypotube which in some embodiments may be cut or have slots. The tube 58 can be covered or encapsulated with a layer of ePTFE, PTFE, or other material so that the outer surface of the outer sheath assembly is generally smooth. The third segment 60 can be a tube formed of a plastic or metal material. In a preferred embodiment, the third segment 60 is formed of ePTFE or PTFE. In some embodiments this sheathing material can be relatively thick to prevent tearing and to help maintain a self-expanding implant in a compacted configuration. In some embodiments the material of the third segment 60 is the same material as the coating on the cut hypotube 1058. The full construction of the second segment 58 and third segment 60 are discussed in detail below with respect to
In some embodiments the third segment 60 can include one or more wings or tabs 63, shown in
Through the use of the handle, the mid shaft assembly 20 can translate or slide over the inner assembly 18, which thereby causes the outer retention member 40 to slide over the inner assembly 18 and encircle the inner retention member 32 described below. As shown in
The mid shaft 50 itself can be made of, for example, high density polyethylene (HDPE), as well as other appropriate materials as described herein. The mid shaft 50 can be formed of a longitudinally pre-compressed HDPE tube, which can provide certain benefits. For example, the pre-compressed HDPE tube can apply a force distally onto the outer retention member 40, thus preventing accidental, inadvertent, and/or premature release of the prosthesis 70. Specifically, the distal force by the mid shaft 50 keeps the distal end of the outer retention member 40 distal to the inner retention member 32, thus preventing the outer retention member 40 from moving proximal to the inner retention member 32 before it is desired by a user to release the prosthesis 70. This can remain true even when the delivery system 10 is being bent at a sharp angle. Further, the pre-compressed HDPE tube allows the delivery system 10 to remain flexible in order to bend to a particular section, while still applying a distally directed force on the outer retention member 40. The pre-compressed HDPE tube can be reduced a length of about ⅛, ⅙, ¼, ½, or 1 inches from its natural state to form the pre-compressed HDPE tube. In other embodiments, the mid shaft 50 can comprise a spring to hold the outer retention member 40 in place.
In some embodiments, a spring can be used to cover the prosthesis 70 to prevent accidental, inadvertent, and/or premature release of the prosthesis 70. The spring can be used in conjunction to the pre-compressed HDPE tube described above, or as a replacement of such a tube. An embodiment of the spring retention section is shown with respect to
As shown in
In some embodiments, the spring 41 can be designed such that the spring length in the relaxed position is greater than or equal to the length of the outer retention member 40. In some embodiments, the spring length in the relaxed position can be greater than or equal to 1 mm, 2 mm, 3 mm, 4 mm, or 5 mm longer than the length of the outer retention member 40 for safety, though the particular excess length greater than the length of the outer retention member 40 is not limiting.
As mentioned, a cover 43 can be attached to a distal end of the spring 41. The cover 43 can be generally cylindrical, and shaped in a similar manner as the outer retention member 40. In some embodiments, the cover 43 can be ring shaped, donut shaped, etc. In particular, the cover 43 can be sized and configured to at least partially cover the inner retention member 32. Accordingly, the cover 43 can have an outer diameter greater than the outer diameter of the inner retention member 32. Further, the cover 43 can contain a lumen for the inner retention shaft 24 to pass through. In some embodiments, the cover 43 can abut a proximal surface of the inner retention member 32 on a distal surface of the cover 43.
The cover 43 can act as a secondary temporary outer retention member 40 in case the outer retention member 40 is prematurely withdrawn proximally, thereby exposing the inner retention member 32, in particular the slots in the inner retention member 32. Specifically, when the inner retention member 32 moves forward or juggles, such as because of slop or bending of the delivery system 10, the cover 43 attached to the spring 41 can remain forward to cover the inner retention member 32, preventing inadvertent release of the prosthesis 70. Thus, if the outer retention member 40 is accidentally pulled back over the inner retention member 32, the cover 43 still remains over the inner retention member 32 preventing accidental release. It is only on the application of further proximal force to the outer retention member 40 that would uncover the inner retention member 32, thus allowing release of the prosthesis 70.
Further, in some embodiments, as shown in
As mentioned the inner assembly 18 can be composed of the inner retention shaft 42 with the inner retention member 32 attached to the distal end of the inner retention shaft 42. Similar to the assemblies above, the inner retention shaft 42 can comprise a tube, such as a hypodermic tube or hypotube (not shown). The tube can be made from one of any number of different materials including nitinol, stainless steel, and medical grade plastics. The tube can be a single piece tube or multiple pieces connected together. Using a tube made of multiple pieces can allow the tube to provide different characteristics along different sections of the tube, such as rigidity and flexibility.
In some embodiments a first segment (not shown) of the inner assembly 18 can be made of a hypotube can extend along a majority of the length of the inner assembly 18. For example, metal hypotube extends from within the handle 14 at the proximal end towards the distal end up until a second segment of the inner assembly 18 before the implant retention area 16. The hypotube can provide column strength (pushability) to the inner assembly. A second segment 42 of the inner assembly 18 can be made of a more flexible material. For example, the second segment 42 can comprise a wire such as a multi-stranded wire, wire rope, or wire coil. The wire can surround a more flexible tube, such as a plastic tube, or it may be formed as a tube without any additional inner materials or core. Thus, in some embodiments, the wire can be a hollow core wire rope. The wire can provide the inner assembly 18 with strength, but it can also provide more flexibility to allow for navigating the curvosities of the vasculature, such as within the heart.
The inner assembly 18 can also include a prosthesis retention mechanism such as an inner retention member 32 at a distal end of the second segment 42 that can be used to engage with the prosthesis, as discussed with respect to
Further, as shown in
The nose cone shaft 30 may include a lumen sized and configured to slidably accommodate a guidewire so that the delivery system 10 can be advanced over the guidewire through the vasculature. The nose cone shaft 30 may be connected from the nose cone 28 to the handle, or may be formed of different segments such as the other assemblies. Further, the nose cone shaft 30 can be formed of different materials, such as plastic or metal, similar to those described in detail above.
This view also illustrates that the nose cone shaft 36 can be slidably disposed within the inner assembly 18, thus allowing the nose cone shaft 28 (and thus nose cone 28) and the inner retention member 32 to move separately from one another during deployment and use.
The inner and outer retention rings and the delivery system generally may be similar to those disclosed in U.S. Pat. Nos. 8,414,644 and 8,652,203, the entire contents of both of which are hereby incorporated by reference herein and made a part of this specification. This is inclusive of the entire disclosure, including other apparatuses and methods described therein, and is not in any way limited to the disclosure of the inner and outer retentions and/or the delivery system.
Outer Sheath Assembly Construction
As shown in the illustrated embodiments of
It should be noted that the second segment 58, relative to the overall length of the delivery system 10, is still generally positioned at a distal portion of the delivery system 10 while the delivery system 10 is being used to deliver the replacement valve towards the in situ implantation site. Moreover, the outer sheath assembly 22 may include other segments positioned proximal of the second segment 58. Such segments may, for example, couple the second segment 58 to a handle of the delivery system 10. The third segment 60 can be positioned radially outward from a prosthesis 70 when the delivery system 10 is in an initial, delivery configuration such that the prosthesis 70 is maintained in the delivery system 10 in an undeployed configuration.
The outer sheath assembly 22 can include a lumen running therethrough to allow the sheath assembly 22 to be moveable or slideable relative to components contained therein. The walls forming the third segment 60 and/or the walls forming the second segment 58 can be formed from one or more materials, such as PTFE, ePTFE, PEBAX, ULTEM, PEEK, urethane, nitinol, stainless steel, and/or any other biocompatible material. Preferably, the third segment 60 is formed from one or more materials which allow the third segment 60 to be compliant and flexible while still maintaining a sufficient degree of radial strength to maintain a replacement valve within the third segment 60 without substantial radial deformation which could increase friction between the third segment 60 and a replacement valve contained therein, sufficient column strength to resist buckling of the third segment 60, and sufficient tear resistance to reduce the likelihood that the prosthesis 70 causes the third segment 60 to tear. Flexibility of the third segment 60 can be advantageous, particularly for a transseptal approach. For example, while being retracted along a curved member, the third segment 60 can follow the curved member without applying significant forces upon the curved member which may cause the curved member to decrease in radius. Rather, the third segment 60 can bend and/or kink as it is being retracted along such a curved member such that the radius of the curved member is maintained. Lack of flexibility in the third segment 60 can cause the distal portion of the delivery system 10 to straighten as the third segment 60 is retracted along the curved member. This straightening could cause the third segment 60 of the delivery system 10 to move thereby placing the third segment 60 in misalignment relative to the in situ implantation site, thereby also moving and placing the prosthesis 70 contained in the third segment 60 of the delivery system 10 in misalignment relative to the in situ implantation site.
In some embodiments, the wall of the third segment 60 and/or the wall of the second segment 58 can be formed as a composite with one or more layers. In some embodiments, the construction of the walls in the different segments can be different. This can advantageously provide different structural characteristics for both the third and second segments 60, 58. In some embodiments, the construction of the walls in the different segments can be the same. As shown in the illustrated embodiment of
As shown in the embodiment in
The hypotube 150 can provide structural rigidity, while the cuts can provide for flexibility in the hypotube. For example, they hypotube 150 can be a laser cut nitinol tube designed to allow adequate flexibility but with sufficient column strength to provide finite control for stepwise retraction of the outer sheath during deployment. The remaining material can form a series of interconnected “H”s that are offset by 90 degrees. As another example, the hypotube 150 can be cut into a series of rings with small connecting members extending between the rings. For example, two equally spaced connecting members can be used to connect two rings and the subsequent connecting members can be offset 90 degrees. Other numbers of connecting members such as one, two, three, four, etc. can also be used.
Further, an ePTFE insert 160 can be incorporated as an intermediate layer as well. The ePTFE insert 160 can have a generally tube like shape or can be formed as a partial tube. The ePTFE insert 160 can be located in a section away from the nitinol hypotube 150. For example, as shown in
The ePTFE insert 160 can be formed of the same material as the inner layer 82 and outer layer 84 (e.g., ePTFE). However, the ePTFE insert 160 can be formed so that it has a polymer chain alignment approximately perpendicular to that of the inner and outer layers 82/84. For example, if the polymer chains of the inner and outer layers 82/84 are aligned distally-to-proximally, the polymer chains of the ePTFE insert 160 can be aligned radially. This will allow the outer sheath assembly 22 to have both tensile and compressive strength, while still allowing the outer sheath assembly 22 to remain flexible. In some embodiments, the ePTFE insert 160 can have polymer chains that have different orientation throughout. The ePTFE insert 160 can have a different thickness from the inner/outer layers 82/84 as well. For example, as shown in the illustrated embodiment, the ePTFE insert 160 can be thicker than the ePTFE of the inner layer 82 and outer layer 84 of the wall. However, other materials and configurations of the insert can be used.
Further, the third segment 60 can additionally include a reinforcement material, such as fluorinated ethylene propylene (FEP) tube 164 between inner and outer layers 82/84 as an intermediate layer, as shown in
It is contemplated that the intermediate layers can be spaced apart longitudinally such that a gap exists between the intermediate layers or the intermediate layers can be positioned adjacent one another. A spaced apart configuration is shown in
Other types of materials and structures are also contemplated for the intermediate layers, including the FEP tube 164 and ePTFE insert 160, including, but not limited to, FEP, ePTFE, PTFE, PEBAX, ULTEM, PEEK, urethane, stainless steel, and other biocompatible materials. In some embodiments, the material may serve as a marker to assist the user in properly positioning the delivery system 10 at an in situ implantation location. For example, the material can be radiopaque. Moreover, these materials can be formed as fibers, wires, rings, wraps, braided structures, coils, springs, ribs, laser cut structures, and the like. In some embodiments, such as those utilizing fibers, wires and/or wraps, the direction of the fibers, wires and/or wraps can be advantageously chosen to obtain desirable structural characteristics along certain directions without compromising desirable structural characteristics along other directions. It is also contemplated that fewer or greater numbers of intermediate layers, can be used. For example, in some embodiments, there can be no intermediate layers, one intermediate layer, two intermediate layers, three, intermediate layers, or more. In some embodiments, there can be one or more additional layers between the intermediate layer and the inner and/or outer layers 82/84.
The above intermediate layers can advantageously allow the outer sheath assembly 22 to have structural characteristics which differ throughout the length of the assembly 22. Moreover, the layered structure described herein can allow the outer sheath assembly 22 be compliant and flexible while still maintaining a sufficient degree of radial strength, column strength, and tear resistance.
In some embodiments, the outer sheath assembly 22 can include one or more additional layers applied to an inner surface of the inner layer 82 and/or an outer surface of the outer layer 84. For example, additional layers can be positioned on an inner surface of the inner layer 82. These additional layers can provide additional reinforcement to specific portions of the outer sheath assembly 22, such as those which may be subject to a greater amount of stress due structural features of the replacement valve contained therein.
As noted above, fewer or greater numbers of intermediate layers can be used. One or more of these intermediate layers can be positioned in a spaced relationship similar to intermediate layers. It is contemplated that the wall can include one or more ring structures as intermediate layers with these one or more ring structures spaced apart from each other, thereby providing sufficient structural characteristics throughout the outer sheath assembly 22 while also maintaining a significant amount of flexibility.
The different layers described herein can be attached via mechanical fasteners, such as screws, rivets, sutures and any other type of mechanical fastener as desired, chemical fasteners such as adhesives and any other type of chemical fastener as desired, fastening techniques such as sintering, welding, and any other type of fastening technique as desired, and/or a combination of such fasteners and techniques. For example, in some embodiments, the layers can be sintered together.
The structural characteristics of the wall of the outer assembly can be further modified after the wall is formed with the layers described herein. For example, the wall can incorporate one or more cutouts, such as holes or slots, disposed along the wall. Such cutouts can be advantageously positioned in areas where further flexibility is desired and/or where the wall is subject to lesser degrees of stresses. In this manner, specific portions of the wall can be designed to bend and/or kink due to increased flexibility along these regions. Other types of structural features can be formed along the wall, including, but not limited to, ribs. These structural features, such as holes, slots, and ribs, can be formed by a variety of methods including laser cutting, etching, machining, and the like.
Nose Cone Construction
With reference back to the embodiment of
With reference particularly to the embodiment of
Moreover, as shown in
The hollow and flexible nose cone 28 can provide significant advantages while passing through the vasculature of a patient, especially in the transfemoral approach. Specifically, the blood vessels that the system 10 passes through will not necessarily be straight, and thus it can be advantageous for the system 10 to follow the blood vessels without any undue damage or catching. As shown in
Accordingly, as the nose cone 28 follows guidewire 105 through blood vessels in the body, the hollow nose cone 28 will bend 103 in order to continue following the blood vessel. This can advantageously reduce damage to the blood vessel 100 while still maintaining control of the device 10 so that it does not get caught.
Delivery Method
Methods of use of the delivery system in connection with a replacement mitral valve will now be described. In particular, the delivery system 10 can be used in a method for percutaneous delivery of the replacement mitral valve to treat patients with moderate to severe mitral regurgitation. The below methods are just a few examples of the how the delivery system may be used. It will be understood that the delivery systems described herein can be used as part of other methods as well.
As shown in
With the guidewire 105 in place, the delivery system 10 can be advanced over the guidewire. The delivery system 10 can then be advanced to the right atrium, through the septal puncture and the left atrium 1078 and into the left ventricle. A steering snare may be used to help advance and position the delivery system correctly. In addition, tension can be applied to one end of the externalized guidewire to help advance and position the delivery system. Further, the nose cone 28 can be hollow, as described above, allowing the nose cone 28 to follow along the curving path of the body. This can be particularly useful to get the delivery system 10 to make the bend from extending up into the right atrium and then extending down into the left ventricle.
The construction and flexibility of the delivery system 10 can allow it to make the relatively sharp turns described above, in particular the turns from entering the right atrium to the septum and then from the septum to the mitral valve. It should be understood that the bending experienced by the delivery system 10 especially between the right atrium and the mitral valve are relatively complex and are generally not in a single plane. This part of the delivery system 10 may experience bending between 110-180 degrees and typically between 130-160 degrees, of course this is dependent on the actual anatomy of the patient.
Specifically, a method of operating the delivery system 10 and releasing an intralumenal frame assembly, such as prosthetic 70, to intralumenal tissue at an in situ target location is disclosed. The steps of this method can be carried out while the intralumenal frame assembly is in a radially compacted state within an outer member, such as outer sheath assembly 22. In some embodiments, the longitudinal axis of the frame assembly, which runs between the first and second ends of the intralumenal frame assembly, can be parallel to and/or concentric with the longitudinal axis of one or more shafts of the delivery system 10. The steps of this method can be used to transeptally deliver a replacement heart valve to a mitral valve location.
A proximal segment of the delivery system 10 can be flexible such that it can be manipulated into a curved configuration via forces exerted upon the proximal segment. For example, the proximal segment can be manipulated into a curved configuration as the proximal segment travels over a curved guidewire. In this manner, the third segment 60 can be oriented in a direction different from that of second 58 or third 60 segments. This can advantageously allow delivery of a replacement valve to an in situ implantation site, such as a native mitral valve, via a wider variety of approaches, such as a transseptal approach.
The delivery system 10 can be in a preliminary configuration with the outer sheath assembly 22 covering the prosthesis 70. In this configuration, the delivery system 10 has a relatively compact form factor which facilitates delivery of the implant to the in situ target location. As mentioned, the outer sheath assembly 22 extends through a transseptal puncture towards the native mitral valve. In order to properly orient the distal segment relative to the native mitral valve, the proximal segment is manipulated into a curved or rounded configuration. Accordingly, the outer sheath assembly 22 can form a curved or rounded configuration thereby allowing the distal portion of the delivery system 10 to remain in proper position relative to the native mitral valve. The delivery system 10 can retract the outer sheath assembly 22 such that the entirety of the prosthesis 70 is exposed. Portions of the prosthesis remain attached to the delivery system 70 via mechanisms similar to inner retention member 32 and outer retention member 40 described in connection with delivery system 10.
Though the entire elongate shaft assembly 12 may be experiencing some bending or flex, typically it is predominantly the second segments 42, 50, and 58 of the subassemblies that will be experiencing most of the bending. This can be both when making the turns as the delivery system is being advanced, and also when the prosthesis is being positioned at the mitral valve. The nose cone 28 can also be flexible and may be bent during turning and at various other times during the procedure, such as described above with respect to
The second segments of the assemblies can have a bendable length that is substantially aligned with one another. The second segments may each have a bendable length of at least between about 3.5 to 4 inches (8.9 to 10.2 cm). In some embodiments, the second segment 58 of the outer sheath assembly 22 can have a bendable length of about 3⅝ inches (9.2 cm), the second segment 50 of the mid shaft assembly 20 can have a bendable length of about 4¾ inches (12.1 cm), and the second segment 42 of the inner assembly 18 can have a bendable length of about 5.5 to 6 inches (14 to 15.2 cm). In some embodiments, the relative bendable lengths of the second segments can increase going from the outermost subassembly to the innermost subassembly of the elongate shaft assembly 12.
The delivery system 10 can include a radially-compacted replacement mitral valve (e.g., prosthesis 70) that has been preloaded within the implant retention area 16. With the distal end of the delivery system 10 within the left ventricle, the operator can begin to deploy the prosthesis 70. Throughout the procedure, the prosthesis 70 can be allowed to expand partially or in full. Using one or more of the delivery system 10, the guidewire 105, and a snare, the distal end of the delivery system 10 can be positioned to be substantially perpendicular to the plane of the mitral annulus. It can also be positioned so that the tips of the distal anchors 80 on the prosthesis 70 are midway between a plane formed by the top of the mitral annulus 106 and a plane formed by the tops of the papillaries 110. The chordae tendineae 110 extend between the native leaflets 108 attached to the mitral annulus 106 and the papillaries 110. The implanted prosthesis, and structures of the heart 83, are shown with respect to
In some embodiments, a handle 14 can control all or part of the expansion of the prosthesis 70. The user can then begin rotating a retraction knob to retract the outer sheath assembly 22 until the distal anchors 80 begin to extend out from the outer sheath assembly 22. Retracting the outer sheath assembly 22 can allow the valve to self-expand. In other embodiments, such as described below, retraction of the outer sheath assembly 22 can cause the distal anchors 80 to flip from a delivery orientation where they extend distally to a deployed orientation where they extend proximally. In some embodiments, the outer sheath assembly 22 can be at least partially retracted. The distal anchors 80 can then be positioned between the chordae tendineae 110. The angle and depth of the distal anchors 80 then be adjusted to engage one or more leaflet 108 of the mitral valve. Thus, the distal anchors 80 can be move back towards the annulus 106 and in some embodiments may engage the leaflet 108 and/or the ventricular side of the annulus 106. At the same time, the first end 301 of the prosthesis 70 can remain retained by the delivery system 10 in an at least partially radially compacted state. This can allow the position of the prosthesis 70 to still be readily adjusted.
In some embodiments, the distal anchors 80 can be positioned first at one side of the left ventricle to engage the chordae tendineae 110 and one valve leaflet 108 before engaging the other side and the other leaflet 108. As the mitral valve is a bicuspid valve, the delivery system 10 can be used to attach the distal anchors 80 first to the posterior leaflet and then to anterior leaflet. This second part can be done after the prosthesis 70 is expanded or further expanded by further retracting the outer sheath assembly 22.
In some embodiments, the entrance route of the delivery system 10 into the left atrium can bias the delivery system 10 towards one side of the mitral valve. For example, the delivery system 10 may be biased towards the posterior leaflet of the mitral valve. This can facilitate securing the distal anchors 80 to the posterior side or the posterior leaflet first, prior to expanding or further expanding the replacement heart valve 70. The distal anchors 80 can then be secured to the anterior side of the mitral valve or to the anterior leaflet.
After the distal anchors 80 are released, the delivery system 10 and prosthesis 70 can be moved proximally, which in some embodiments, causes the distal anchors 80 to engage the native leaflets 108 and/or native valve annulus 106. In addition to physically moving the delivery system, this may also be done by pushing the guidewire 105 from the venous side towards the mitral annulus 106. Once the distal anchors 80 are properly placed, the delivery system 10 can then release the proximal anchors 82 and the proximal end of the prosthesis 70. This can allow further self-expansion of the prosthesis 70 so that the proximal anchors 82 engage the upstream or atrial side of the native annulus, and the prosthesis 70 is deployed in operational condition. This can be by fully retracting the outer sheath assembly 22, such as by rotating the control knob, until the prosthesis 70 has reached its fully expanded state. However, the proximal anchors 82 do not necessarily engage the native annulus 106, and may be positioned above the annulus 106 or engage the wall of the atrium 102.
While the delivery system 10 as described above involves retraction of an outer sheath assembly 22 to uncover and deploy a prosthesis 70 contained therein, in some embodiments the delivery system 10 can deploy a prosthesis 70 with little to no proximal retraction of the outer sheath assembly 22. For example, components of the outer sheath assembly 22 can be designed to separate, as discussed below, to allow for deployment of the prosthesis 70.
For example, in some embodiments, the third segment 60 of the outer sheath assembly 22 can incorporate one or more breakaway stitches to allow the third segment 60 to separate. Breakage of the breakaway stitch can be controlled by the user of the delivery system 10. For example, the handle 14 of the delivery system 10 can include an actuator which is coupled to a component which causes the stitch to break. In some embodiments, breakage can be keyed to specific activity related to use of the delivery system 10. For example, the breakaway stitch can be designed to break after the outer sheath assembly 22 has been partially retracted relative to a replacement valve contained therein. This could, for example, be caused by changes in stresses along the distal segment as the distal segment is moved relative to the replacement valve. Other portions of the delivery system 10 can include similar structures and/or mechanisms.
In some embodiments, the third segment 60 of the outer sheath assembly 22 can be peeled away to uncover the replacement valve (e.g., prosthesis 70) contained therein. For example, the one or more tabs of the distal segment can be pulled proximally while the remaining portions of the distal segment is maintained in position. This can cause the third segment 60 to separate and expose the replacement valve contained therein. The one or more tabs can be attached to an actuator of the handle via one or more tethers, wires or sutures to allow the user to pull the tabs and control separation of the distal segment. Other portions of the delivery system 10 can include similar structures and/or mechanisms.
It will be understood that in some embodiments the prosthesis 70 may not be self expanding, and the partial and full deployment may be accomplished by one or more inflatable balloons or the like. In addition, one of more inflatable balloons may be a part of the delivery system, such as part of the inner assembly 18 and can positioned at the implant retention area 16 as part of the third segment 36.
Control mechanisms and components at the handle can be used to move different portions of the device 10. To move the outer sheath assembly 22 between the advanced position and the retracted position, a control mechanism is actuated, such as a retraction knob that is rotated. This causes a lead screw connected to the outer sheath assembly 22 to move proximally. Then, to move the mid shaft assembly 20, the control mechanism is pulled backwards. Springs can be used to give feedback to the user and to better control the movement of the mid shaft assembly 20 to thereby provide a controlled release of the prosthesis. In addition, the pre-compressed mid shaft 50 can maintain a continuous extension force between the inner assembly 18 and the mid shaft assembly 20 to keep the inner retention member 32 bottomed out inside the outer retention member 40 so that the distal tip of the delivery system 10 maintains maximum flexibility and freedom of motion and the prosthesis does not unlock and prematurely deploy.
The handle 14 can also include any number of luers that can allow all subassemblies to be perfused with saline. The perfusion of saline can eliminate or reduce air embolism risk due to catheter use and can also provide flushing capability for the delivery procedure.
Reference is now made to
As shown in the situation illustrated in
As illustrated in
During delivery, the distal anchors 80 (along with the frame) can be moved toward the ventricular side of the annulus 106 with the distal anchors 80 extending between at least some of the chordae tendineae 110 to provide tension on the chordae tendineae 110. The degree of tension provided on the chordae tendineae 110 can differ. For example, little to no tension may be present in the chordae tendineae 110 where the leaflet 108 is shorter than or similar in size to the distal anchors 80. A greater degree of tension may be present in the chordae tendineae 110 where the leaflet 108 is longer than the distal anchors 80 and, as such, takes on a compacted form and is pulled proximally. An even greater degree of tension may be present in the chordae tendineae 110 where the leaflets 108 are even longer relative to the distal anchors 80. The leaflet 108 can be sufficiently long such that the distal anchors 80 do not contact the annulus 106.
The proximal anchors 82 can be positioned such that the ends or tips of the proximal anchors 82 are adjacent the atrial side of the annulus 106 and/or tissue of the left atrium 102 beyond the annulus 106. In some situations, some or all of the proximal anchors 82 may only occasionally contact or engage atrial side of the annulus 106 and/or tissue of the left atrium 102 beyond the annulus 106. For example, as illustrated in
The annular flap 81 can be positioned such that a proximal portion of the annular flap 81 is positioned along or adjacent an atrial side of the annulus 106. The proximal portion can be positioned between the atrial side of the annulus 106 and the proximal anchors 82. The proximal portion can extend radially outward such that the annular flap 81 is positioned along or adjacent tissue of the left atrium 102 beyond the annulus 106. The annular flap 81 can create a seal over the atrial side of the annulus 106 when the flap 81 is in the expanded state.
Guide Sheath
In some embodiments, a guide sheath can be used in conjunction with the delivery system 10 disclosed herein, such as shown in
In particular, the guide sheath 90 can be configured to at least partially cover the distal end of the delivery system 10 during insertion of the delivery system 10 into the patient and prevent the delivery system 10 from injuring tissue during its insertion. Thus, in some embodiments the guide sheath 90 can be inserted into the proper location, such as by following a guide wire discussed above, and then the delivery system 10 can pass through the lumen of the guide sheath 90 and out or along a distal end of the guide sheath 90.
As shown in
The guide sheath 90 can be formed of a plastic or metal material, and the particular material is not limiting. The distal tip 92 can be formed of the same or different material than the tube portion 89. In some embodiments, the distal tip 92 can be semi-rigid. The distal tip 92 may be pre-shaped to match the desired anatomy, and/or it may be articulable into a plurality of different shapes and adapt to anatomical structures. Further, in some embodiments an inner wall of the distal tip 92 can also be covered or encapsulated with a layer 99 of ePTFE, PTFE, or other material so that an inner surface of the distal tip 92 is generally smooth. The smooth PTFE inner lining 99 of the distal tip 92 can reduce friction when the delivery system 10 is advanced along the distal tip 92. In some embodiments, the layer 99 can be incorporated into the lumen of the tube portion 89.
As shown in
In some embodiments, the partial circle segment 94 can flatten (or unfold) to form an arc with a larger diameter than a diameter of the full circle cross-section of the guide sheath 90. Thus, the partial circle segment 94 may be able to change in dimension (e.g., widen out) under certain circumstances.
In some embodiments, a distalmost segment 95 of the distal tip 92 can form a full circle again, and thus the open segment 96 may not extend along the entire distal tip 92. In some embodiments, the open segment 96 may extend along the entire distal tip 92. In some embodiments, the distalmost segment 95 of the distal tip 92 can be tapered. In some embodiments, the distal tip 92 can terminate at a rounded atraumatic end to minimize tissue damage during implantation. In some embodiments, the distal tip 92 can have a lumen which can allow it to pass over a guidewire.
In some embodiments, the distal tip 92 can be pre-shaped to match a desired anatomical location. For example, the distal tip 92 can comprise a preset nitinol spine, such as discussed below, having a curvature that matches the desired anatomical location. Thus, the distal tip 92 can bend in the same direction as the curvature required for the delivery system 10 to travel from the septum hole to the mitral valve.
In some embodiments, as shown in
In some embodiments, the distal tip 92 can comprise an articulated spine 98, such as a laser-cut nitinol spine, that is semi-rigid. In some embodiments, the spine 98 can have a preset curvature for passing along the patient's vasculature.
The perforations 982 can be located on the flanges 987. In some embodiments, the flanges 987 can each contain two perforations 982, with one perforation 982 located radially outward from the other preformation 982.
In some embodiments, the spine 98 can contain two end portions 989 on opposite longitudinal ends of the spine 98. The end portions 989 can be generally rectangular in shape, though one or both may be modified to accept one of the slits 982. Further, the end portions 989 may include a number of perforations 982.
In other embodiments, the wall of the distal tip 92 can also have cutouts of various shapes not discussed above, and the particular shapes are not limiting.
The laser-cut spine 98 can be rolled up to form a wall of the distal tip 92, which can be open (with an open segment) or openable (with overlapping walls that can be opened by expanding the spine 98 to remove the overlap). Specifically, the laser-cut spine 98 can be rolled up such that a first longitudinal edge 986 of the spine 98 does not touch a second longitudinal edge 988 of the spine 98, forming a partial circle segment similar to the partial circle segment 94 shown in
In some embodiments, an expandable piece of cloth (not shown in
Embodiments of the disclosed guide sheath 90 can be advantageous for insertion of the delivery system 10 to transeptally deliver a replacement heart valve to a mitral valve location, specifically by reducing or preventing any damage to the vasculature through the insertion of the delivery system 10 and by making it easier to track the delivery system 10 and implant 70 to the native mitral valve. Similar to the steps shown in
With the guidewire in place, the guide sheath 90 can be introduced into the body over the guidewire to the mitral valve from the left atrial septum. The guide sheath 90 can be positioned such that the tube portion 89 is positioned and crosses the transseptal puncture. Alternatively, the distal tip 92 may be placed in the transseptal puncture, where the openable wall would be compressed by the septum. The distal tip 92 can reach before, at or past the mitral valve. In one embodiment, an introducer sheath and/or catheter (not shown in
The guide sheath 90 described herein advantageously serves several functions. In percutaneous procedures, it can be difficult to introduce a device through the anatomy to the desired location due to the length or size of the implant and the delivery device. Specifically, during transseptal mitral procedures, a sharp turn may need to be made across the septum in order for the implant and the delivery device to reach and cross the mitral valve. This can be especially difficult when attempting to introduce a long and stiff device, such as a transcatheter mitral valve.
Accordingly, the guide sheath 90 can eliminate the need for the distal portion 29 of the delivery system 10 to make a sharp turn to reach the desired location. The distal tip 92 of the guide sheath allows the delivery system 10 to utilize a diagonal length across the atrium as its limiting dimension for crossing instead of a horizontal distance across the atrium. For example, a long and rigid delivery component passing through the septal puncture into the left atrium will be limited by the horizontal distance across the atrium before it can be articulated vertically in order to pass through the mitral valve annulus. By comparison, when using a guide sheath 90 as described herein, the delivery system 10 can be advanced along a diagonal pathway in the left atrium. A diagonal pathway potentially allows even longer implant devices to be introduced into the desired location. Further, the guide sheath 90 also prevents the prosthesis 70 or the delivery system 10 from getting caught on the non-uniform heart tissue and potentially causing damage to the heart tissue.
As shown in
Once the prosthesis 70 has been delivered to its desired location using the delivery system 10, it can be deployed using the methods described herein. In some embodiments, the distal tip 92 can be an attachment to a conventional catheter used to cross a transseptal puncture and remains during deployment of the prosthesis 70. Having the distal tip 92 as an attachment provides the advantage of not adding additional accessories to the procedure because the crossing catheter is a standard part of the procedure. In other embodiments, the guide sheath 90 is an independent unit. The guide sheath 90 can have a working length of about 80 cm and can act as both a femoral sheath and a septal working hole. The guide sheath 90 can advantageously be retracted once the delivery system 10 crosses the mitral valve so as to not avoid interfering with deployment of the prosthesis 70.
In some embodiments, a portion of the openable segment of the distal tip 92 instead of the full-circle section of the guide sheath 90 can span across the septum hole. Having an openable segment across the septum allows the space of the right atrium to be utilized for delivering even longer lengths can access the left atrium. The overlapping walls discussed above can be compressed by the septum and provide a smooth working surface across the septum hole while still guiding the long device.
In some embodiments, short devices can also require a specified septal puncture distance above the annulus in order to make the sharp turn toward the mitral valve. The guide sheath 90 can allow for septum punctures having lower than ideal heights and still guide the implant device to be coaxial with the mitral valve.
In some embodiments, the guide sheath may be used to provide a bearing surface to redirect any long implantable devices that are required to be advanced around corners in the patient's anatomy. For example, the guide sheath may be used to redirect a delivery device and implants to cross the tricuspid valves.
Anchored Guide Wire
Embodiments of the delivery system 10 can eliminate the need for snaring as discussed above through the use of an anchored guidewire shown in
For example, an anchored guidewire 500, 500′, 500″ can comprise one or more anchors 514, 514′, 514″ attached to a guidewire to form an anchored guidewire 500, 500′, 500″ as shown in
To assemble the anchor 514, the anchor connector 516 can slide into the lumen of the anchor portion 513 from the distal end of the anchor portion 513. The anchor connector 516 can include a plurality of raised portions 517 on an outer surface proximate a distal end of the anchor connector 516. The raised portions 517 can abut the ring portion 522 of the anchor portion 513 on a distal end of the ring portion 522 to stop the anchor connector 516 from sliding past the anchor connector 516. The retainer ring 512 can then slide past the tapered proximal end 526 of the anchor connector 516 and abut the ring portion 522 of the anchor portion 513 on a proximal end of the ring portion 522. The retainer ring 512 can then be secured to the anchor connector 516 in a manner described above, for example, by welding. The torque shaft 510 can also slide into the lumen of the anchor connector 516 from the proximal end of the anchor connector 516 and be secured to the anchor connector 516 in a manner described above, for example, by welding. The guidewire can then be attached to the anchor 514, forming the anchored guidewire 500. The anchored guidewire 500 is configured to be used with the delivery system 10. The anchored guidewire 500 is also configured to be used with other delivery devices with a single lumen or multiple lumens.
During a surgical procedure, a catheter 540, such as an articulating catheter (the distal end of which is shown in
The anchored guidewire 500, 500′, 500″ can then be inserted through the catheter 540 to reach the left ventricle. The hooks 520, 520′, 520″ of the anchor portions 513, 513′, 513″ can be deflected distally when the anchor portions 513, 513′, 513″ travel inside the catheter 540. Thus, as the anchored guidewire 500, 500′, 500″ is translated distally, the hooks 520, 520′, 520″ can pierce the heart tissue. The hooks 520, 520′, 520″ of the anchor portions 513, 513′, 513″ can then deflect radially outward and back proximally once outside of the catheter 540 to catch the wall of the left ventricle, thus keeping the anchored guidewire 500, 500′, 500″ stable.
In some embodiments, the anchored guidewire 500, 500′, 500″ can be pre-loaded into a lumen of the catheter 540, such as an articulating catheter (the distal end of which is shown in
For the anchored guidewire 500, 500′, 500″ that has a lumen 515, 515″, a separate guidewire can be inserted through the lumen 515, 515″ prior to deploying the prosthesis 70. A balloon loaded on the separate guidewire can be inflated to detect any chordae tendineae when crossing the mitral valve. In some embodiments, the catheter 540 can have a balloon (not shown in
Following deployment of the prosthesis 70, the catheter 540 can be reintroduced to abut against the heart tissue around the anchored guidewire 500, 500′, 500″. The anchored guidewire 500, 500′, 500″ can then be pulled into the catheter 540, compressing the hooks 520, 520′, 520″ within the catheter 540 to disengage the hooks 520, 520′, 520″ from the heart tissue and retract the anchored guidewire 500, 500′, 500″.
The anchored guidewire 500, 500′, 500″ allow for a recapturable method of gaining secure guidewire placement. The catheter 540 ensures that the user is able to place the anchor portions 513, 513′, 513″ in a desired location. The torque shaft 510, 510″ of the anchored guidewire 500, 500″ or the standard guidewire of the anchored guidewire 500′ can act as a rail as opposed to other methods such as snaring, where the user must manipulate multiple devices in order for the delivery system 10 to cross the mitral valve.
Additional Embodiments of Prostheses and Replacement Valves
With reference to
The frame 1020 can be made of many different materials, but is preferably made from metal. In some embodiments, the frame 1020 can be made from a shape memory material, such as nitinol. A wire frame or a metal tube can be used to make the frame 1020. The wire frame of a metal tube can be cut or etched to remove all but the desired metal skeleton. In some embodiments a metal tube is laser cut in a repeating pattern to form the frame 1020.
As shown, the frame when in an expanded configuration, such as in a fully expanded configuration, has a bulbous or slightly bulbous shape, with a middle portion 1033 being larger than the proximal 1032 and distal 1034 ends. In some embodiments, the inside diameter of the both ends can be the same, or it can be bigger on one end than the other, while still having a middle portion 1033 larger than both the proximal and distal ends 1032/1034. In some embodiments, the effective diameter of the distal frame end 1034 is smaller than the effective diameter of the middle portion 1033. The bulbous shape of the frame 1020 can advantageously allow the frame 1020 to engage a native valve annulus or other body cavity, while spacing the inlet and outlet from the heart or vessel wall. This can help reduce undesired contact between the prosthesis and the heart or vessel, such as the ventricular wall of the heart. In some embodiments, the frame 1020 may not have a bulbous portion, and can have substantially the same outer dimension along its entire length (e.g., cylindrical), or it may have one end larger than the other end. The prosthesis 1010 and frame 1020 may be similar to the replacement heart valves and associated frames disclosed in U.S. Pat. No. 8,403,983 and U.S. Publication Nos. 2010/0298931, 2011/0313515, 2012/0078353, 2014/0277390, 2014/0277422, and 2014/0277427 the entireties of each of which are hereby incorporated by reference and made a part of this specification. This is inclusive of the entire disclosure and is not in any way limited to the disclosure of the replacement heart valves and associated frames.
A number of struts collectively make up the frame 1020.
The proximal struts 1012 and the vertical struts 1015 may be arranged so that they are parallel or generally or substantially parallel to a longitudinal axis of the frame. The proximal struts 1012 and the vertical struts 1015 can further be inclined relative to the longitudinal axis so that the proximal ends of the proximal struts 1012 are closer to the longitudinal axis than distal ends of the proximal struts 1012. The longitudinal axis of the frame 1020 may be defined as the central axis that extends through the center of the frame 1020 between the proximal 1032 and distal 1034 ends.
The illustrated embodiment includes one ring, or row of hexagonal or generally hexagonal cells 1021 shown in proximal portion 1016 of the frame 1020, and two rows of diamond-shaped cells 1023 shown in distal portion 1018. As discussed in more detail below, the proximal portion 1016 includes the portion of the hexagonal cells 1021 extending proximally from the distal end of vertical struts 1015 and may be considered to be or to include a substantially non-foreshortening portion. Foreshortening refers to the ability of the frame to longitudinally shorten as the frame radially expands. The distal portion 1018 includes the diamond-shaped cells 1023 extending distally from the distal ends of the vertical struts 1015 and may be considered a foreshortening portion. In some embodiments, the hexagonal cells 1021 can be irregular hexagons. For example, the hexagonal cells 1021 can be symmetrical about a vertical axis extending from proximal to distal ends of the hexagonal cell 1021. Vertical struts 1015 can form opposite sides, while circumferentially-expansible struts 1014 of two adjacent diamond-shaped cells 1023 in the proximalmost row can form a base of the hexagonal cell 1021 ending at a distalmost corner that is distal to the distal ends of the vertical struts 1015. These circumferentially-expansible struts 1014 can connect to the vertical struts 1015. Further, the proximal row of circumferentially-expansible struts 1017 can form the upper sides of the hexagonal cell 1021 that extend to a proximalmost corner of the hexagonal cell 1021 that is proximal to the proximal ends of vertical struts 1015. These circumferentially-expansible struts 1017 can connect to the proximal ends of the vertical struts 1015. In some embodiments, two of the sides of the hexagonal cells 1021 can be one length, while the other four sides of the hexagonal cells 1021 can be a greater length. In some embodiments, the two sides with the same length can be generally parallel to one another.
As described above, the frame 1020 has a proximal portion 1016 and a distal portion 1018. In
The frame 1020 shown in
Foreshortening of the frame 1020 can be used to engage and secure the prosthesis to intralumenal tissue in a body cavity, for example tissue at or adjacent a native valve, such as a native valve annulus and/or leaflets. Opposing anchors 1022, 1024 can be constructed on the frame 1020 so that portions of the anchors, such as tips or ends 1026, 1028, move closer together as the frame foreshortens. As one example, this can allow the anchors 1022, 1024 to grasp tissue on opposite sides of the native mitral annulus to thereby secure the prosthesis at the mitral valve. In some embodiments, one set of anchors (such as anchors 1024) are secured to or grasp tissue, while the other set of anchors (such as anchors 1022) are used to provide stabilization and help align the prosthesis, and may or may not directly engage tissue, as described further below.
The anchors 1022, 1024 and anchor tips 1026, 1028 are preferably located along the frame 1020 with at least part of the foreshortening portion positioned between the anchors so that a portion of the anchors will move closer together with expansion of the frame. As shown, distal anchors 1024 are connected to the distal portion 1018, and may extend from distalmost corners of the diamond-shaped cells 1023. As illustrated, the distal anchors 1024 extend distally from distalmost corners of the proximal row of diamond-shaped cells 1023, such that the second, distal row of diamond-shaped cells 1023 extend longitudinally alongside a portion of the distal anchors.
Preferably, each of the anchors 1022, 1024 is positioned or extends generally radially outwardly from the frame 1020 so that the anchor tips 1026, 1028 are generally spaced away or radially outward from the rest of the frame 1020 and from where the base of the anchors connect to the frame. For example, the anchor tips may be located radially outward from the middle portion 1033 of the frame, with the tips 1026 and 1028 being axially spaced from one another. The middle portion 1033, which has the largest cross-sectional dimension when the frame is radially expanded, can be defined by the proximalmost row of diamond-shaped cells 1023. The anchors 1022, 1024 can include a base located on the anchor on a side opposite the tip. The base can be for example where the anchor begins to extend from or away from the frame 1020.
Proximal anchors 1022 are shown having a single strut extending into the hexagonal cells 1021 of portion 1016. Thus, the anchor 1022 extends from a proximal intersection of two segments of the hexagonal cell 1021, for example, from the proximalmost corner of the hexagonal cells 1021. As shown, the proximal anchors 1022 extend generally distally into the hexagonal cells 1021 while curving outwards away from the frame 1020. Thus, the anchor 1022 extends radially outwardly from the frame 1020 as it extends generally distally towards the tip 1026. The tips 1026 of the proximal anchors 1022 can end after extending approximately half the length or more of the hexagonal cells 1021. Further, the tips 1026 can extend farther outwards than the main body of the frame 1020.
In some embodiments, the tip 1026 of the anchor 1022 also includes an enlarged or bulbed portion 1026, which can be generally circular in shape, though the particular shape is not limiting. As illustrated, the bulbed portion 1026 is located at the distal end, though the bulbed portion 1026 can be positioned in other locations along the anchor 1022. The bulbed portion 1026 can have a radius greater than the width of the rest of the anchor 1022, making the bulbed portion 1026 larger than the rest of the anchor 1022. As illustrated, the enlarged or bulbed portions can extend in a direction generally or substantially perpendicular to the longitudinal axis, caused for example by gradual bending of the anchor 1022 distally and radially outwardly.
As another example, the distal anchors 1024 are shown having looped ends 1048. The looped ends can be larger near the tip to form a type of elongated teardrop. In some embodiments, the tips 1028 may be substantially flat. The looped end may assist the frame in not getting caught up on structures at or near the treatment location. For example, each loop can be configured so that when the frame is deployed in-situ and expands, the movement of each loop from a delivered position to a deployed position avoids getting caught on the papillary muscles.
Each distal anchor 1024 is connected to the frame at a base 1042. As illustrated in
It will be understood that the anchors can have various other configurations, including the various embodiments that follow. In some embodiments, each of the anchors can extend radially outwardly from the frame at an anchor base and terminate at an anchor tip. The anchors can be connected to the frame at one of many different locations including apices, junctions, other parts of struts, etc. The anchors can comprise first, second, third, or more spaced apart bending stages along the length of each anchor. The anchors can also extend either distally or proximally before and/or after one or more of the bending stages. A portion of the anchor may extend with the frame before or after any bending stages.
The tips or ends 1013 of proximal struts 1012 can be enlarged relative to other portions of the tips 1013. For example, the ends of tips 1013 can have a generally “mushroom” shape. The proximal struts 1012 and enlarged tips 1013 can form locking tabs used to engage a locking mechanism of a delivery system for the prosthesis. In some embodiments, the longitudinal extensions 1012 and the mushroom tips 1013 can be inclined generally radially inward.
In the illustrated embodiment of
In addition, the distal and proximal anchors may be arranged so the bases of the distal anchors and the bases of the proximal anchors are not circumferentially aligned, but rather are circumferentially offset from each other with the bases of the proximal anchors circumferentially located mid-way between adjacent bases of the distal anchors. As shown in
The anchor tips 1026 and 1028 as described above advantageously provide atraumatic surfaces that may be used to grasp intralumenal tissue without causing unnecessary or undesired trauma to tissue. For example, the proximal anchors tips 1026 and distal anchor tips 1028 may form flat, substantially flat, curved or other non-sharp surfaces to allow the tips to engage and/or grasp tissue, without necessarily piercing or puncturing through tissue.
With reference to the embodiments of
In some embodiments, covers/cushions can be used to surround or partially surround the distal anchors 1024, specifically the tips 1028 of the distal anchors 1024, such as those described in U.S. Patent Publication No. 2015/032800, hereby incorporated by reference in its entirety. In some embodiments, the covers can either fit snuggly around the tips 1028 or can have extra padding so that the covers extend radially away from the frame 1020. In some embodiments, all of the distal anchors 1024 have the snug fitting covers. In some embodiments, all of the distal anchors 1024 have the padded covers. In some embodiments, some of the distal anchors 1024 have the padded covers and some have the snug covers. In some embodiments, not all of the distal anchors 1024 can have covers. In some embodiments, all of the distal anchors 1024 can have some sort of cover.
Reference is now made to
As shown in the situations illustrated in
With reference first to the situations illustrated in
During delivery, the distal anchors 1024 (along with the frame 1010) can be moved toward the ventricular side of the annulus 106 with the distal anchors 1024 extending between at least some of the chordae tendineae 110 to provide tension on the chordae tendineae 110 after the prosthesis 1010 is finally delivered. The degree of tension provided on the chordae tendineae 110 can differ. For example, little to no tension may be present in the chordae tendineae 110 as shown in
The proximal anchors 1022 can be positioned such that the ends or tips 1026 of the proximal anchors 1022 are on or adjacent the atrial side of the annulus 106 and/or tissue of the left atrium 102 beyond the annulus 106. In some situations, some or all of the proximal anchors 1022 may only occasionally contact or engage atrial side of the annulus 106 and/or tissue of the left atrium 102 beyond the annulus 106. For example, as shown in
The flap 1050 can transition from the collapsed state to the expanded state during systole when pressure in the left ventricle 104 increases. This increased pressure within the left ventricle 104 can cause blood within the left ventricle 104 to be directed to areas of lower pressure, such as the aorta (not shown) and the left atrium 102. During systole the valve body may be closed to prevent blood from flowing back into the left atrium 102. A substantial portion of blood can be forced around the frame 1020 and valve body and into the annular flap 1050 such that the flap 1050 can expand. Sealing along an atrial side of the annulus 106 can be particularly effective. The left atrium 102 can be at a lower pressure in comparison to the pressure of the space between the annular flap 1050 and the valve body 1020, which is closer to the pressure of the left ventricle 104. The existence of such a pressure differential between the left atrium 102 and the space during systole can allow the flap 1050 to apply a greater force to surrounding tissue within the left atrium 102. During diastole, where blood flows from the left atrium 102 towards the left ventricle 104, the flap 1050 can transition from the expanded state back to the collapsed state.
In some situations such as those shown in
As noted above, although the in vivo situations of
From the foregoing description, it will be appreciated that an inventive product and approaches for implant delivery systems are disclosed. While several components, techniques and aspects have been described with a certain degree of particularity, it is manifest that many changes can be made in the specific designs, constructions and methodology herein above described without departing from the spirit and scope of this disclosure.
Certain features that are described in this disclosure in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable subcombination. Moreover, although features may be described above as acting in certain combinations, one or more features from a claimed combination can, in some cases, be excised from the combination, and the combination may be claimed as any subcombination or variation of any subcombination.
Moreover, while methods may be depicted in the drawings or described in the specification in a particular order, such methods need not be performed in the particular order shown or in sequential order, and that all methods need not be performed, to achieve desirable results. Other methods that are not depicted or described can be incorporated in the example methods and processes. For example, one or more additional methods can be performed before, after, simultaneously, or between any of the described methods. Further, the methods may be rearranged or reordered in other implementations. Also, the separation of various system components in the implementations described above should not be understood as requiring such separation in all implementations, and it should be understood that the described components and systems can generally be integrated together in a single product or packaged into multiple products. Additionally, other implementations are within the scope of this disclosure.
Conditional language, such as “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include or do not include, certain features, elements, and/or steps. Thus, such conditional language is not generally intended to imply that features, elements, and/or steps are in any way required for one or more embodiments.
Conjunctive language such as the phrase “at least one of X, Y, and Z,” unless specifically stated otherwise, is otherwise understood with the context as used in general to convey that an item, term, etc. may be either X, Y, or Z. Thus, such conjunctive language is not generally intended to imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z.
Language of degree used herein, such as the terms “approximately,” “about,” “generally,” and “substantially” as used herein represent a value, amount, or characteristic close to the stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms “approximately”, “about”, “generally,” and “substantially” may refer to an amount that is within less than or equal to 10% of, within less than or equal to 5% of, within less than or equal to 1% of, within less than or equal to 0.1% of, and within less than or equal to 0.01% of the stated amount. If the stated amount is 0 (e.g., none, having no), the above recited ranges can be specific ranges, and not within a particular % of the value. For example, within less than or equal to 10 wt./vol. % of, within less than or equal to 5 wt./vol. % of, within less than or equal to 1 wt./vol. % of, within less than or equal to 0.1 wt./vol. % of, and within less than or equal to 0.01 wt./vol. % of the stated amount.
Some embodiments have been described in connection with the accompanying drawings. The figures are drawn to scale, but such scale should not be limiting, since dimensions and proportions other than what are shown are contemplated and are within the scope of the disclosed inventions. Distances, angles, etc. are merely illustrative and do not necessarily bear an exact relationship to actual dimensions and layout of the devices illustrated. Components can be added, removed, and/or rearranged. Further, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like in connection with various embodiments can be used in all other embodiments set forth herein. Additionally, it will be recognized that any methods described herein may be practiced using any device suitable for performing the recited steps.
While a number of embodiments and variations thereof have been described in detail, other modifications and methods of using the same will be apparent to those of skill in the art. Accordingly, it should be understood that various applications, modifications, materials, and substitutions can be made of equivalents without departing from the unique and inventive disclosure herein or the scope of the claims.
This application claims the benefit of U.S. application Ser. No. 15/141,684, filed Apr. 28, 2016, which claims the benefit of U.S. Provisional Application No. 62/155,405, filed Apr. 30, 2015, titled “FLEXIBLE DELIVERY DEVICE AND METHODS OF USE,” U.S. Provisional Application No. 62/163,932, filed May 19, 2015, titled “DELIVERY DEVICE FOR REPLACEMENT MITRAL VALVE AND METHODS OF USE,” U.S. Provisional Application No. 62/210,165, filed Aug. 26, 2015, titled “DELIVERY SYSTEM FOR REPLACEMENT MITRAL VALVE AND METHODS OF USE,”, and U.S. Provisional Application No. 62/300,478, filed Feb. 26, 2016, titled “REPLACEMENT MITRAL VALVE, DELIVERY SYSTEM FOR REPLACEMENT MITRAL VALVE AND METHODS OF USE,” the entirety of each of which is incorporated herein by reference.
| Number | Name | Date | Kind |
|---|---|---|---|
| 3657744 | Ersek | Apr 1972 | A |
| 3671979 | Moulopoulos | Jun 1972 | A |
| 3739402 | Cooley et al. | Jun 1973 | A |
| 4056854 | Boretos et al. | Nov 1977 | A |
| 4079468 | Liotta et al. | Mar 1978 | A |
| 4204283 | Bellhouse et al. | May 1980 | A |
| 4222126 | Boretos et al. | Sep 1980 | A |
| 4265694 | Boretos et al. | May 1981 | A |
| 4339831 | Johnson | Jul 1982 | A |
| 4340977 | Brownlee et al. | Jul 1982 | A |
| 4470157 | Love | Sep 1984 | A |
| 4477930 | Totten et al. | Oct 1984 | A |
| 4490859 | Black et al. | Jan 1985 | A |
| 4553545 | Maass et al. | Nov 1985 | A |
| 4777951 | Cribier et al. | Oct 1988 | A |
| 4865600 | Carpentier et al. | Sep 1989 | A |
| 4994077 | Dobben | Feb 1991 | A |
| 5007898 | Rosenbluth | Apr 1991 | A |
| 5250059 | Andreas | Oct 1993 | A |
| 5326371 | Love et al. | Jul 1994 | A |
| 5332402 | Teitelbaum | Jul 1994 | A |
| 5370685 | Stevens | Dec 1994 | A |
| 5415667 | Frater | May 1995 | A |
| 5545214 | Stevens | Aug 1996 | A |
| 5554185 | Block et al. | Sep 1996 | A |
| 5571135 | Fraser | Nov 1996 | A |
| 5697382 | Love et al. | Dec 1997 | A |
| 5840081 | Andersen et al. | Nov 1998 | A |
| 5855601 | Bessler et al. | Jan 1999 | A |
| 5957949 | Leonhardt et al. | Sep 1999 | A |
| 6086612 | Jansen | Jul 2000 | A |
| 6113631 | Jansen | Sep 2000 | A |
| 6168614 | Andersen et al. | Jan 2001 | B1 |
| 6251093 | Valley et al. | Jun 2001 | B1 |
| 6312465 | Griffin et al. | Nov 2001 | B1 |
| 6319280 | Schoon | Nov 2001 | B1 |
| 6358277 | Duran | Mar 2002 | B1 |
| 6425898 | Wilson | Jul 2002 | B1 |
| 6440164 | DiMatteo et al. | Aug 2002 | B1 |
| 6458153 | Bailey et al. | Oct 2002 | B1 |
| 6482228 | Norred | Nov 2002 | B1 |
| 6527800 | McGuckin, Jr. et al. | Mar 2003 | B1 |
| 6582462 | Andersen et al. | Jun 2003 | B1 |
| 6591472 | Noone | Jul 2003 | B1 |
| 6610088 | Gabbay | Aug 2003 | B1 |
| 6629534 | St. Goar et al. | Oct 2003 | B1 |
| 6652578 | Bailey et al. | Nov 2003 | B2 |
| 6676698 | McGuckin, Jr. et al. | Jan 2004 | B2 |
| 6695878 | McGuckin, Jr. et al. | Feb 2004 | B2 |
| 6712836 | Berg et al. | Mar 2004 | B1 |
| 6716207 | Farnholtz | Apr 2004 | B2 |
| 6729356 | Baker et al. | May 2004 | B1 |
| 6730118 | Spenser et al. | May 2004 | B2 |
| 6746422 | Noriega et al. | Jun 2004 | B1 |
| 6749560 | Konstorum et al. | Jun 2004 | B1 |
| 6767362 | Schreck | Jul 2004 | B2 |
| 6780200 | Jansen | Aug 2004 | B2 |
| 6790229 | Berreklouw | Sep 2004 | B1 |
| 6790230 | Beyersdorf et al. | Sep 2004 | B2 |
| 6875231 | Anduiza et al. | Apr 2005 | B2 |
| 6893460 | Spenser et al. | May 2005 | B2 |
| 6908481 | Cribier | Jun 2005 | B2 |
| 7018406 | Seguin et al. | Mar 2006 | B2 |
| 7186265 | Sharkawy et al. | Mar 2007 | B2 |
| 7192440 | Andreas et al. | Mar 2007 | B2 |
| 7198646 | Figulla et al. | Apr 2007 | B2 |
| 7201772 | Schwammenthal et al. | Apr 2007 | B2 |
| 7276078 | Spenser et al. | Oct 2007 | B2 |
| 7329278 | Seguin et al. | Feb 2008 | B2 |
| 7381219 | Salahieh et al. | Jun 2008 | B2 |
| 7393360 | Spenser et al. | Jul 2008 | B2 |
| 7429269 | Schwammenthal et al. | Sep 2008 | B2 |
| 7442204 | Schwammenthal et al. | Oct 2008 | B2 |
| 7445631 | Salahieh et al. | Nov 2008 | B2 |
| 7462191 | Spenser et al. | Dec 2008 | B2 |
| 7510575 | Spenser et al. | Mar 2009 | B2 |
| 7524330 | Berreklouw | Apr 2009 | B2 |
| 7553324 | Andreas et al. | Jun 2009 | B2 |
| 7585321 | Cribier | Sep 2009 | B2 |
| 7618446 | Andersen et al. | Nov 2009 | B2 |
| 7621948 | Herrmann et al. | Nov 2009 | B2 |
| 7628805 | Spenser et al. | Dec 2009 | B2 |
| 7748389 | Salahieh et al. | Jul 2010 | B2 |
| 7753949 | Lamphere et al. | Jul 2010 | B2 |
| 7803185 | Gabbay | Sep 2010 | B2 |
| 7806919 | Bloom et al. | Oct 2010 | B2 |
| 7815673 | Bloom et al. | Oct 2010 | B2 |
| 7824443 | Salahieh et al. | Nov 2010 | B2 |
| 7892281 | Seguin et al. | Feb 2011 | B2 |
| 7914569 | Nguyen et al. | Mar 2011 | B2 |
| 7947075 | Goetz et al. | May 2011 | B2 |
| 7959672 | Salahieh et al. | Jun 2011 | B2 |
| 7972378 | Tabor et al. | Jul 2011 | B2 |
| 7981151 | Rowe | Jul 2011 | B2 |
| 7993392 | Righini et al. | Aug 2011 | B2 |
| 8016877 | Seguin et al. | Sep 2011 | B2 |
| 8048153 | Salahieh et al. | Nov 2011 | B2 |
| 8052750 | Tuval et al. | Nov 2011 | B2 |
| 8070800 | Lock et al. | Dec 2011 | B2 |
| 8070802 | Lamphere et al. | Dec 2011 | B2 |
| 8075615 | Eberhardt et al. | Dec 2011 | B2 |
| 8080054 | Rowe | Dec 2011 | B2 |
| 8092520 | Quadri | Jan 2012 | B2 |
| 8109996 | Stacchino et al. | Feb 2012 | B2 |
| 8118866 | Herrmann et al. | Feb 2012 | B2 |
| 8136218 | Millwee et al. | Mar 2012 | B2 |
| 8137398 | Tuval et al. | Mar 2012 | B2 |
| 8157852 | Bloom et al. | Apr 2012 | B2 |
| 8167934 | Styrc et al. | May 2012 | B2 |
| 8182528 | Salahieh et al. | May 2012 | B2 |
| 8182530 | Huber | May 2012 | B2 |
| 8206427 | Ryan | Jun 2012 | B1 |
| 8216301 | Bonhoeffer et al. | Jul 2012 | B2 |
| 8219229 | Cao et al. | Jul 2012 | B2 |
| 8220121 | Hendriksen et al. | Jul 2012 | B2 |
| 8221493 | Boyle et al. | Jul 2012 | B2 |
| 8226710 | Nguyen et al. | Jul 2012 | B2 |
| 8236045 | Benichou et al. | Aug 2012 | B2 |
| 8246675 | Zegdi | Aug 2012 | B2 |
| 8246678 | Salahieh et al. | Aug 2012 | B2 |
| 8252051 | Chau et al. | Aug 2012 | B2 |
| 8252052 | Salahieh et al. | Aug 2012 | B2 |
| 8287584 | Salahieh et al. | Oct 2012 | B2 |
| 8303653 | Bonhoeffer et al. | Nov 2012 | B2 |
| 8313525 | Tuval et al. | Nov 2012 | B2 |
| 8323335 | Rowe et al. | Dec 2012 | B2 |
| 8353953 | Giannetti et al. | Jan 2013 | B2 |
| 8403983 | Quadri et al. | Mar 2013 | B2 |
| 8414644 | Quadri et al. | Apr 2013 | B2 |
| 8414645 | Dwork et al. | Apr 2013 | B2 |
| 8444689 | Zhang | May 2013 | B2 |
| 8449599 | Chau et al. | May 2013 | B2 |
| 8454685 | Hariton et al. | Jun 2013 | B2 |
| 8460368 | Taylor et al. | Jun 2013 | B2 |
| 8470023 | Eidenschink et al. | Jun 2013 | B2 |
| 8475521 | Suri et al. | Jul 2013 | B2 |
| 8475523 | Duffy | Jul 2013 | B2 |
| 8479380 | Malewicz et al. | Jul 2013 | B2 |
| 8486137 | Suri et al. | Jul 2013 | B2 |
| 8491650 | Wiemeyer et al. | Jul 2013 | B2 |
| 8500733 | Watson | Aug 2013 | B2 |
| 8500798 | Rowe et al. | Aug 2013 | B2 |
| 8511244 | Holecek et al. | Aug 2013 | B2 |
| 8512401 | Murray, III et al. | Aug 2013 | B2 |
| 8518096 | Nelson | Aug 2013 | B2 |
| 8518106 | Duffy et al. | Aug 2013 | B2 |
| 8562663 | Mearns et al. | Oct 2013 | B2 |
| 8579963 | Tabor | Nov 2013 | B2 |
| 8579964 | Lane et al. | Nov 2013 | B2 |
| 8579965 | Bonhoeffer et al. | Nov 2013 | B2 |
| 8585755 | Chau et al. | Nov 2013 | B2 |
| 8585756 | Bonhoeffer et al. | Nov 2013 | B2 |
| 8591566 | Newell | Nov 2013 | B2 |
| 8591570 | Revuelta et al. | Nov 2013 | B2 |
| 8597348 | Rowe et al. | Dec 2013 | B2 |
| 8608792 | Silveira | Dec 2013 | B2 |
| 8617236 | Paul et al. | Dec 2013 | B2 |
| 8640521 | Righini et al. | Feb 2014 | B2 |
| 8647381 | Essinger et al. | Feb 2014 | B2 |
| 8652145 | Maimon et al. | Feb 2014 | B2 |
| 8652201 | Oberti et al. | Feb 2014 | B2 |
| 8652202 | Alon | Feb 2014 | B2 |
| 8652203 | Quadri et al. | Feb 2014 | B2 |
| 8668733 | Haug et al. | Mar 2014 | B2 |
| 8673000 | Tabor et al. | Mar 2014 | B2 |
| 8679174 | Ottma et al. | Mar 2014 | B2 |
| 8679404 | Liburd et al. | Mar 2014 | B2 |
| 8685086 | Navia et al. | Apr 2014 | B2 |
| 8721708 | Seguin et al. | May 2014 | B2 |
| 8721714 | Kelley | May 2014 | B2 |
| 8728154 | Alkhatib | May 2014 | B2 |
| 8728155 | Montorfano et al. | May 2014 | B2 |
| 8740974 | Lambrecht et al. | Jun 2014 | B2 |
| 8740976 | Tran et al. | Jun 2014 | B2 |
| 8747458 | Tuval et al. | Jun 2014 | B2 |
| 8747459 | Nguyen et al. | Jun 2014 | B2 |
| 8747460 | Tuval et al. | Jun 2014 | B2 |
| 8758432 | Solem | Jun 2014 | B2 |
| 8764818 | Gregg | Jul 2014 | B2 |
| 8771344 | Fran et al. | Jul 2014 | B2 |
| 8771345 | Tuval et al. | Jul 2014 | B2 |
| 8771346 | Tuval et al. | Jul 2014 | B2 |
| 8778020 | Gregg et al. | Jul 2014 | B2 |
| 8784337 | Voeller et al. | Jul 2014 | B2 |
| 8784478 | Tuval et al. | Jul 2014 | B2 |
| 8784481 | Alkhatib et al. | Jul 2014 | B2 |
| 8790387 | Nguyen et al. | Jul 2014 | B2 |
| 8795356 | Quadri et al. | Aug 2014 | B2 |
| 8795357 | Yohanan et al. | Aug 2014 | B2 |
| 8808356 | Braido et al. | Aug 2014 | B2 |
| 8828078 | Salahieh et al. | Sep 2014 | B2 |
| 8828079 | Thielen et al. | Sep 2014 | B2 |
| 8834564 | Tuval et al. | Sep 2014 | B2 |
| 8845718 | Tuval et al. | Sep 2014 | B2 |
| 8858620 | Salahieh et al. | Oct 2014 | B2 |
| 8870948 | Erzberger et al. | Oct 2014 | B1 |
| 8870950 | Hacohen | Oct 2014 | B2 |
| 8876893 | Dwork et al. | Nov 2014 | B2 |
| 8876894 | Tuval et al. | Nov 2014 | B2 |
| 8876895 | Tuval et al. | Nov 2014 | B2 |
| 8911455 | Quadri et al. | Dec 2014 | B2 |
| 8926693 | Duffy et al. | Jan 2015 | B2 |
| 8926694 | Costello | Jan 2015 | B2 |
| 8939960 | Rosenman et al. | Jan 2015 | B2 |
| 8945209 | Bonyuet et al. | Feb 2015 | B2 |
| 8951299 | Paul et al. | Feb 2015 | B2 |
| 8961593 | Bonhoeffer et al. | Feb 2015 | B2 |
| 8961595 | Alkhatib | Feb 2015 | B2 |
| 8974524 | Yeung et al. | Mar 2015 | B2 |
| 8979922 | Jayasinghe et al. | Mar 2015 | B2 |
| 8986372 | Murry, III et al. | Mar 2015 | B2 |
| 8986375 | Garde et al. | Mar 2015 | B2 |
| 8992608 | Haug et al. | Mar 2015 | B2 |
| 8998979 | Seguin et al. | Apr 2015 | B2 |
| 8998980 | Shipley et al. | Apr 2015 | B2 |
| 9005273 | Salahieh et al. | Apr 2015 | B2 |
| 9011521 | Haug et al. | Apr 2015 | B2 |
| 9011523 | Seguin | Apr 2015 | B2 |
| 9011524 | Eberhardt | Apr 2015 | B2 |
| 9028545 | Taylor | May 2015 | B2 |
| 9034032 | McLean et al. | May 2015 | B2 |
| 9034033 | McLean et al. | May 2015 | B2 |
| 9039757 | McLean et al. | May 2015 | B2 |
| 9055937 | Rowe et al. | Jun 2015 | B2 |
| 9066801 | Kovalsky et al. | Jun 2015 | B2 |
| 9078749 | Lutter et al. | Jul 2015 | B2 |
| 9078751 | Naor | Jul 2015 | B2 |
| 9084676 | Chau et al. | Jul 2015 | B2 |
| 9125738 | Figulla et al. | Sep 2015 | B2 |
| 9138312 | Tuval et al. | Sep 2015 | B2 |
| 9161834 | Taylor et al. | Oct 2015 | B2 |
| 9173737 | Hill et al. | Nov 2015 | B2 |
| 9180004 | Alkhatib | Nov 2015 | B2 |
| 9186249 | Rolando et al. | Nov 2015 | B2 |
| 9220594 | Braido et al. | Dec 2015 | B2 |
| 9241790 | Lane et al. | Jan 2016 | B2 |
| 9248014 | Lane et al. | Feb 2016 | B2 |
| 9277990 | Klima et al. | Mar 2016 | B2 |
| 9277993 | Gamarra et al. | Mar 2016 | B2 |
| 9289291 | Gorman, III et al. | Mar 2016 | B2 |
| 9289296 | Braido et al. | Mar 2016 | B2 |
| 9295551 | Straubinger et al. | Mar 2016 | B2 |
| 9308110 | Newell | Apr 2016 | B2 |
| D755384 | Pesce et al. | May 2016 | S |
| 9326815 | Watson | May 2016 | B2 |
| 9331328 | Eberhardt et al. | May 2016 | B2 |
| 9339382 | Tabor et al. | May 2016 | B2 |
| 9351831 | Braido et al. | May 2016 | B2 |
| 9351832 | Braido et al. | May 2016 | B2 |
| 9364321 | Alkhatib et al. | Jun 2016 | B2 |
| 9439795 | Wang | Sep 2016 | B2 |
| 9445897 | Bishop et al. | Sep 2016 | B2 |
| 9456877 | Weitzner et al. | Oct 2016 | B2 |
| 9675488 | Newell | Jun 2017 | B2 |
| 9681951 | Ratz et al. | Jun 2017 | B2 |
| 9681968 | Goetz et al. | Jun 2017 | B2 |
| 9700329 | Metzger et al. | Jul 2017 | B2 |
| 9700411 | Klima et al. | Jul 2017 | B2 |
| 9724221 | Brown | Aug 2017 | B2 |
| D800908 | Hariton et al. | Oct 2017 | S |
| 9795479 | Lim et al. | Oct 2017 | B2 |
| 9833313 | Board et al. | Dec 2017 | B2 |
| 9861473 | Lafontaine | Jan 2018 | B2 |
| 10130789 | Shimada et al. | Nov 2018 | B2 |
| 20020029046 | Lorentzen Cornelius | Mar 2002 | A1 |
| 20020032481 | Gabbay | Mar 2002 | A1 |
| 20020045929 | Diaz | Apr 2002 | A1 |
| 20020052644 | Shaolian et al. | May 2002 | A1 |
| 20030083654 | Chin | May 2003 | A1 |
| 20030105517 | White et al. | Jun 2003 | A1 |
| 20030120333 | Ouriel et al. | Jun 2003 | A1 |
| 20030130729 | Paniagua et al. | Jul 2003 | A1 |
| 20030176914 | Rabkin et al. | Sep 2003 | A1 |
| 20030199971 | Tower et al. | Oct 2003 | A1 |
| 20030220683 | Minasian et al. | Nov 2003 | A1 |
| 20040117009 | Cali et al. | Jun 2004 | A1 |
| 20040133273 | Cox | Jul 2004 | A1 |
| 20040186561 | McGuckin et al. | Sep 2004 | A1 |
| 20040210304 | Seguin et al. | Oct 2004 | A1 |
| 20040210307 | Khairkhahan | Oct 2004 | A1 |
| 20040215325 | Penn et al. | Oct 2004 | A1 |
| 20040225353 | McGuckin et al. | Nov 2004 | A1 |
| 20040236411 | Sarac et al. | Nov 2004 | A1 |
| 20050033398 | Seguin | Feb 2005 | A1 |
| 20050043682 | Kucklick | Feb 2005 | A1 |
| 20050075727 | Wheatley | Apr 2005 | A1 |
| 20050090887 | Pryor | Apr 2005 | A1 |
| 20050096738 | Cali et al. | May 2005 | A1 |
| 20050107872 | Mensah et al. | May 2005 | A1 |
| 20050137682 | Justino | Jun 2005 | A1 |
| 20050137686 | Salahieh et al. | Jun 2005 | A1 |
| 20050137687 | Salahieh et al. | Jun 2005 | A1 |
| 20050137691 | Salahieh et al. | Jun 2005 | A1 |
| 20050137693 | Haug et al. | Jun 2005 | A1 |
| 20050159811 | Lane | Jul 2005 | A1 |
| 20050182486 | Gabbay | Aug 2005 | A1 |
| 20050216079 | MaCoviak | Sep 2005 | A1 |
| 20050234546 | Nugent et al. | Oct 2005 | A1 |
| 20050283231 | Haug et al. | Dec 2005 | A1 |
| 20060020327 | Lashinski et al. | Jan 2006 | A1 |
| 20060030835 | Sherman | Feb 2006 | A1 |
| 20060052867 | Revuelta et al. | Mar 2006 | A1 |
| 20060058872 | Salahieh et al. | Mar 2006 | A1 |
| 20060095115 | Bladillah et al. | May 2006 | A1 |
| 20060173537 | Yang et al. | Aug 2006 | A1 |
| 20060195183 | Navia et al. | Aug 2006 | A1 |
| 20060212110 | Osborne et al. | Sep 2006 | A1 |
| 20060241745 | Solem | Oct 2006 | A1 |
| 20060259135 | Navia et al. | Nov 2006 | A1 |
| 20060265056 | Nguyen et al. | Nov 2006 | A1 |
| 20060287717 | Rowe et al. | Dec 2006 | A1 |
| 20060293745 | Carpentier et al. | Dec 2006 | A1 |
| 20070010876 | Salahieh et al. | Jan 2007 | A1 |
| 20070043435 | Seguin et al. | Feb 2007 | A1 |
| 20070050021 | Johnson | Mar 2007 | A1 |
| 20070100432 | Case et al. | May 2007 | A1 |
| 20070129794 | Realyvasquez | Jun 2007 | A1 |
| 20070142906 | Figulla et al. | Jun 2007 | A1 |
| 20070203560 | Forster et al. | Aug 2007 | A1 |
| 20070213813 | Von Segesser et al. | Sep 2007 | A1 |
| 20070255305 | McMichael | Nov 2007 | A1 |
| 20070255394 | Ryan | Nov 2007 | A1 |
| 20080015569 | Saadat | Jan 2008 | A1 |
| 20080021546 | Patz et al. | Jan 2008 | A1 |
| 20080027528 | Jagger | Jan 2008 | A1 |
| 20080071366 | Tuval et al. | Mar 2008 | A1 |
| 20080082164 | Friedman | Apr 2008 | A1 |
| 20080082165 | Wilson et al. | Apr 2008 | A1 |
| 20080097581 | Shanley | Apr 2008 | A1 |
| 20080114442 | Mitchell | May 2008 | A1 |
| 20080147179 | Cai et al. | Jun 2008 | A1 |
| 20080147183 | Styrc | Jun 2008 | A1 |
| 20080161911 | Revuelta et al. | Jul 2008 | A1 |
| 20080177381 | Navia et al. | Jul 2008 | A1 |
| 20080183273 | Mesana et al. | Jul 2008 | A1 |
| 20080208328 | Antocci et al. | Aug 2008 | A1 |
| 20080228254 | Ryan | Sep 2008 | A1 |
| 20090005863 | Goetz et al. | Jan 2009 | A1 |
| 20090112186 | Adams | Apr 2009 | A1 |
| 20090138079 | Tuval et al. | May 2009 | A1 |
| 20090171456 | Kveen et al. | Jul 2009 | A1 |
| 20090182413 | Burkart et al. | Jul 2009 | A1 |
| 20090188964 | Orlov | Jul 2009 | A1 |
| 20090270972 | Lane | Oct 2009 | A1 |
| 20090275945 | Makower | Nov 2009 | A1 |
| 20090276027 | Glynn | Nov 2009 | A1 |
| 20090276040 | Rowe et al. | Nov 2009 | A1 |
| 20090281618 | Hill et al. | Nov 2009 | A1 |
| 20090287290 | Macaulay | Nov 2009 | A1 |
| 20090287292 | Becking | Nov 2009 | A1 |
| 20090287296 | Manasse | Nov 2009 | A1 |
| 20090292350 | Eberhardt et al. | Nov 2009 | A1 |
| 20090306768 | Quadri | Dec 2009 | A1 |
| 20100114305 | Kang et al. | May 2010 | A1 |
| 20100191326 | Alkhatib | Jul 2010 | A1 |
| 20100217382 | Chau et al. | Aug 2010 | A1 |
| 20100249894 | Oba et al. | Sep 2010 | A1 |
| 20100249911 | Alkhatib | Sep 2010 | A1 |
| 20100249915 | Zhang | Sep 2010 | A1 |
| 20100252470 | Ryan | Oct 2010 | A1 |
| 20100256723 | Murray | Oct 2010 | A1 |
| 20100298931 | Quadri et al. | Nov 2010 | A1 |
| 20100305685 | Millwee et al. | Dec 2010 | A1 |
| 20110004296 | Lutter et al. | Jan 2011 | A1 |
| 20110029067 | McGuckin, Jr. et al. | Feb 2011 | A1 |
| 20110034987 | Kennedy | Feb 2011 | A1 |
| 20110202128 | Duffy | Aug 2011 | A1 |
| 20110208297 | Tuval et al. | Aug 2011 | A1 |
| 20110208298 | Tuval et al. | Aug 2011 | A1 |
| 20110224774 | Silveira et al. | Sep 2011 | A1 |
| 20110224785 | Hacohen | Sep 2011 | A1 |
| 20110257720 | Peterson | Oct 2011 | A1 |
| 20110264196 | Savage et al. | Oct 2011 | A1 |
| 20110313515 | Quadri et al. | Dec 2011 | A1 |
| 20120022639 | Hacohen et al. | Jan 2012 | A1 |
| 20120022640 | Gross et al. | Jan 2012 | A1 |
| 20120041550 | Salahieh et al. | Feb 2012 | A1 |
| 20120059454 | Millwee et al. | Mar 2012 | A1 |
| 20120071969 | Li et al. | Mar 2012 | A1 |
| 20120078360 | Rafiee | Mar 2012 | A1 |
| 20120101571 | Thambar et al. | Apr 2012 | A1 |
| 20120101572 | Kovalsky et al. | Apr 2012 | A1 |
| 20120123529 | Levi et al. | May 2012 | A1 |
| 20120215303 | Quadri et al. | Aug 2012 | A1 |
| 20120239142 | Liu | Sep 2012 | A1 |
| 20120271398 | Essinger et al. | Oct 2012 | A1 |
| 20120290062 | McNamara et al. | Nov 2012 | A1 |
| 20120310328 | Olson et al. | Dec 2012 | A1 |
| 20130006294 | Kashkarov et al. | Jan 2013 | A1 |
| 20130035759 | Gross et al. | Feb 2013 | A1 |
| 20130053950 | Rowe et al. | Feb 2013 | A1 |
| 20130131788 | Quadri et al. | May 2013 | A1 |
| 20130144378 | Quadri et al. | Jun 2013 | A1 |
| 20130172851 | Shimada | Jul 2013 | A1 |
| 20130211508 | Lane et al. | Aug 2013 | A1 |
| 20130226276 | Newell | Aug 2013 | A1 |
| 20130226278 | Newell | Aug 2013 | A1 |
| 20130253635 | Straubinger et al. | Sep 2013 | A1 |
| 20130253642 | Brecker | Sep 2013 | A1 |
| 20130282113 | Punga et al. | Oct 2013 | A1 |
| 20130297013 | Klima et al. | Nov 2013 | A1 |
| 20130304185 | Newell | Nov 2013 | A1 |
| 20130310928 | Morriss et al. | Nov 2013 | A1 |
| 20130331929 | Mitra et al. | Dec 2013 | A1 |
| 20130338766 | Hastings et al. | Dec 2013 | A1 |
| 20130345786 | Behan | Dec 2013 | A1 |
| 20140000112 | Braido et al. | Jan 2014 | A1 |
| 20140018912 | Delaloye et al. | Jan 2014 | A1 |
| 20140025150 | Lim | Jan 2014 | A1 |
| 20140025163 | Padala et al. | Jan 2014 | A1 |
| 20140039611 | Lane et al. | Feb 2014 | A1 |
| 20140052237 | Lane et al. | Feb 2014 | A1 |
| 20140052242 | Revuelta et al. | Feb 2014 | A1 |
| 20140081375 | Bardill et al. | Mar 2014 | A1 |
| 20140100651 | Kheradvar et al. | Apr 2014 | A1 |
| 20140100653 | Savage et al. | Apr 2014 | A1 |
| 20140135907 | Gallagher et al. | May 2014 | A1 |
| 20140142694 | Tabor et al. | May 2014 | A1 |
| 20140163668 | Rafiee | Jun 2014 | A1 |
| 20140172077 | Bruchman et al. | Jun 2014 | A1 |
| 20140172083 | Bruchman et al. | Jun 2014 | A1 |
| 20140194981 | Menk et al. | Jul 2014 | A1 |
| 20140200660 | Savage et al. | Jul 2014 | A1 |
| 20140207231 | Hacohen et al. | Jul 2014 | A1 |
| 20140214153 | Ottma et al. | Jul 2014 | A1 |
| 20140214154 | Nguyen et al. | Jul 2014 | A1 |
| 20140214155 | Kelley | Jul 2014 | A1 |
| 20140214160 | Naor | Jul 2014 | A1 |
| 20140222031 | Stack | Aug 2014 | A1 |
| 20140222136 | Geist et al. | Aug 2014 | A1 |
| 20140222139 | Nguyen et al. | Aug 2014 | A1 |
| 20140222142 | Kovalsky et al. | Aug 2014 | A1 |
| 20140222144 | Eberhardt et al. | Aug 2014 | A1 |
| 20140230515 | Tuval et al. | Aug 2014 | A1 |
| 20140236288 | Lambrecht et al. | Aug 2014 | A1 |
| 20140243969 | Venkatasubramanian et al. | Aug 2014 | A1 |
| 20140257240 | Burdulis | Sep 2014 | A1 |
| 20140257467 | Lane et al. | Sep 2014 | A1 |
| 20140277390 | Ratz et al. | Sep 2014 | A1 |
| 20140277402 | Essinger et al. | Sep 2014 | A1 |
| 20140277411 | Bortlein et al. | Sep 2014 | A1 |
| 20140277422 | Ratz et al. | Sep 2014 | A1 |
| 20140277425 | Dakin | Sep 2014 | A1 |
| 20140277426 | Dakin et al. | Sep 2014 | A1 |
| 20140277427 | Ratz et al. | Sep 2014 | A1 |
| 20140296973 | Bergheim et al. | Oct 2014 | A1 |
| 20140296975 | Tegels et al. | Oct 2014 | A1 |
| 20140303719 | Cox et al. | Oct 2014 | A1 |
| 20140309728 | Dehdashtian et al. | Oct 2014 | A1 |
| 20140309732 | Solem | Oct 2014 | A1 |
| 20140324160 | Benichou et al. | Oct 2014 | A1 |
| 20140324164 | Gross et al. | Oct 2014 | A1 |
| 20140330368 | Gloss et al. | Nov 2014 | A1 |
| 20140330371 | Gloss et al. | Nov 2014 | A1 |
| 20140330372 | Weston et al. | Nov 2014 | A1 |
| 20140336754 | Gurskis et al. | Nov 2014 | A1 |
| 20140343669 | Lane et al. | Nov 2014 | A1 |
| 20140343670 | Bakis et al. | Nov 2014 | A1 |
| 20140343671 | Yohanan et al. | Nov 2014 | A1 |
| 20140350663 | Braido et al. | Nov 2014 | A1 |
| 20140350666 | Righini | Nov 2014 | A1 |
| 20140350668 | Delaloye et al. | Nov 2014 | A1 |
| 20140358223 | Rafiee et al. | Dec 2014 | A1 |
| 20140364939 | Deshmukh et al. | Dec 2014 | A1 |
| 20140364943 | Conklin | Dec 2014 | A1 |
| 20140371842 | Marquez et al. | Dec 2014 | A1 |
| 20140371844 | Dale et al. | Dec 2014 | A1 |
| 20140371845 | Tuval et al. | Dec 2014 | A1 |
| 20140371847 | Madrid et al. | Dec 2014 | A1 |
| 20140371848 | Murray, III et al. | Dec 2014 | A1 |
| 20140379067 | Nguyen et al. | Dec 2014 | A1 |
| 20140379068 | Thielen et al. | Dec 2014 | A1 |
| 20140379077 | Tuval et al. | Dec 2014 | A1 |
| 20150005863 | Para | Jan 2015 | A1 |
| 20150012085 | Salahieh et al. | Jan 2015 | A1 |
| 20150018938 | Von Segesser et al. | Jan 2015 | A1 |
| 20150018944 | O'Connell et al. | Jan 2015 | A1 |
| 20150032198 | Folk | Jan 2015 | A1 |
| 20150039083 | Rafiee | Feb 2015 | A1 |
| 20150045880 | Hacohen | Feb 2015 | A1 |
| 20150142103 | Mdlund | May 2015 | A1 |
| 20150148731 | McNamara et al. | May 2015 | A1 |
| 20150157457 | Hacohen | Jun 2015 | A1 |
| 20150157458 | Thambar et al. | Jun 2015 | A1 |
| 20150173897 | Raanani et al. | Jun 2015 | A1 |
| 20150196390 | Ma et al. | Jul 2015 | A1 |
| 20150209141 | Braido et al. | Jul 2015 | A1 |
| 20150272737 | Dale et al. | Oct 2015 | A1 |
| 20150297346 | Duffy et al. | Oct 2015 | A1 |
| 20150297383 | Brown | Oct 2015 | A1 |
| 20150305943 | Hossainy | Oct 2015 | A1 |
| 20150327994 | Morriss et al. | Nov 2015 | A1 |
| 20150327996 | Fahim et al. | Nov 2015 | A1 |
| 20150328000 | Ratz et al. | Nov 2015 | A1 |
| 20150328001 | McLean et al. | Nov 2015 | A1 |
| 20150335429 | Morriss et al. | Nov 2015 | A1 |
| 20150351903 | Morriss et al. | Dec 2015 | A1 |
| 20150351906 | Hammer et al. | Dec 2015 | A1 |
| 20150359629 | Ganesan et al. | Dec 2015 | A1 |
| 20160000591 | Lei et al. | Jan 2016 | A1 |
| 20160030169 | Shahriari | Feb 2016 | A1 |
| 20160030170 | Alkhatib et al. | Feb 2016 | A1 |
| 20160030171 | Quijano et al. | Feb 2016 | A1 |
| 20160038281 | Delaloye et al. | Feb 2016 | A1 |
| 20160074160 | Christianson et al. | Mar 2016 | A1 |
| 20160106537 | Christianson et al. | Apr 2016 | A1 |
| 20160113765 | Ganesan et al. | Apr 2016 | A1 |
| 20160113766 | Ganesan et al. | Apr 2016 | A1 |
| 20160113768 | Ganesan et al. | Apr 2016 | A1 |
| 20160143732 | Glimsdale | May 2016 | A1 |
| 20160158003 | Wallace et al. | Jun 2016 | A1 |
| 20160158010 | Lim et al. | Jun 2016 | A1 |
| 20160166383 | Lim et al. | Jun 2016 | A1 |
| 20160184097 | Lim et al. | Jun 2016 | A1 |
| 20160199206 | Lim et al. | Jul 2016 | A1 |
| 20160213473 | Hacohen et al. | Jul 2016 | A1 |
| 20160235529 | Ma et al. | Aug 2016 | A1 |
| 20160270910 | Birmingham et al. | Sep 2016 | A1 |
| 20160279386 | Dale et al. | Sep 2016 | A1 |
| 20160310267 | Zeng et al. | Oct 2016 | A1 |
| 20170106166 | Wang | Apr 2017 | A1 |
| 20170128209 | Morriss et al. | May 2017 | A1 |
| 20170216023 | Lane et al. | Aug 2017 | A1 |
| 20170216575 | Asleson et al. | Aug 2017 | A1 |
| 20170258614 | Griffin | Sep 2017 | A1 |
| 20170312075 | Fahim et al. | Nov 2017 | A1 |
| 20170325954 | Perszyk | Nov 2017 | A1 |
| 20170348096 | Anderson | Dec 2017 | A1 |
| 20170367823 | Hariton et al. | Dec 2017 | A1 |
| 20180055636 | Valencia et al. | Mar 2018 | A1 |
| 20180085218 | Eidenschink | Mar 2018 | A1 |
| 20180110534 | Gavala et al. | Apr 2018 | A1 |
| Number | Date | Country |
|---|---|---|
| 2304325 | Oct 2000 | CA |
| 2827556 | Jul 2012 | CA |
| 102006052564 | Dec 2007 | DE |
| 1171059 | Jan 2002 | EP |
| 1369098 | Dec 2003 | EP |
| 1259194 | Feb 2005 | EP |
| 1255510 | Apr 2007 | EP |
| 1827558 | Sep 2007 | EP |
| 1239901 | Oct 2007 | EP |
| 1472996 | Sep 2009 | EP |
| 1935377 | Mar 2010 | EP |
| 2238947 | Oct 2010 | EP |
| 2308425 | Apr 2011 | EP |
| 2398543 | Dec 2011 | EP |
| 1281375 | Feb 2012 | EP |
| 2496182 | Sep 2012 | EP |
| 2285317 | Dec 2012 | EP |
| 2566416 | Mar 2013 | EP |
| 2319458 | Apr 2013 | EP |
| 2124826 | Jul 2014 | EP |
| 2750630 | Jul 2014 | EP |
| 2777617 | Sep 2014 | EP |
| 2745805 | Jun 2015 | EP |
| 2749254 | Jun 2015 | EP |
| 2898858 | Jul 2015 | EP |
| 1734903 | Oct 2015 | EP |
| 2967858 | Jan 2016 | EP |
| 2926766 | Feb 2016 | EP |
| 2985006 | Feb 2016 | EP |
| 2168536 | Apr 2016 | EP |
| 2815725 | Apr 2016 | EP |
| 2237746 | May 2016 | EP |
| 2815723 | Jul 2016 | EP |
| 2262451 | May 2017 | EP |
| 3184083 | Jun 2017 | EP |
| 2446915 | Jan 2018 | EP |
| 3057541 | Jan 2018 | EP |
| 3037064 | Mar 2018 | EP |
| 3046511 | Mar 2018 | EP |
| 3142603 | Mar 2018 | EP |
| 3294220 | Mar 2018 | EP |
| 1264471 | Feb 1972 | GB |
| 1315844 | May 1973 | GB |
| 2398245 | Aug 2004 | GB |
| 2002540889 | Dec 2002 | JP |
| 2008541865 | Nov 2008 | JP |
| 0061034 | Oct 2000 | WO |
| 03092554 | Nov 2003 | WO |
| 2004030569 | Apr 2004 | WO |
| 2005011534 | Feb 2005 | WO |
| 2006070372 | Jul 2006 | WO |
| 2006085225 | Aug 2006 | WO |
| 2006089236 | Aug 2006 | WO |
| 2006127765 | Nov 2006 | WO |
| 2007025028 | Mar 2007 | WO |
| 2007058857 | May 2007 | WO |
| 2007123658 | Nov 2007 | WO |
| 2008013915 | Jan 2008 | WO |
| 2008070797 | Jun 2008 | WO |
| 2008103722 | Aug 2008 | WO |
| 2008125153 | Oct 2008 | WO |
| 2008150529 | Dec 2008 | WO |
| 2009026563 | Feb 2009 | WO |
| 2009033469 | Mar 2009 | WO |
| 2009045331 | Apr 2009 | WO |
| 2009053497 | Apr 2009 | WO |
| 2009091509 | Jul 2009 | WO |
| 2009094500 | Jul 2009 | WO |
| 2009134701 | Nov 2009 | WO |
| 2010005524 | Jan 2010 | WO |
| 2010008549 | Jan 2010 | WO |
| 2010022138 | Feb 2010 | WO |
| 2010037141 | Apr 2010 | WO |
| 2010040009 | Apr 2010 | WO |
| 2010057262 | May 2010 | WO |
| 2011025945 | Mar 2011 | WO |
| 2011057087 | May 2011 | WO |
| 2011111047 | Sep 2011 | WO |
| 2011137531 | Nov 2011 | WO |
| 2012177942 | Dec 2012 | WO |
| 2013028387 | Feb 2013 | WO |
| 2013059747 | Apr 2013 | WO |
| 2013075215 | May 2013 | WO |
| 2013120181 | Aug 2013 | WO |
| 2013166356 | Nov 2013 | WO |
| 2013175468 | Nov 2013 | WO |
| 2013192305 | Dec 2013 | WO |
| 2014018432 | Jan 2014 | WO |
| 2014099655 | Jun 2014 | WO |
| 2014110019 | Jul 2014 | WO |
| 2014110171 | Jul 2014 | WO |
| 2014121042 | Aug 2014 | WO |
| 2014139545 | Sep 2014 | WO |
| 2014145338 | Sep 2014 | WO |
| 2014149865 | Sep 2014 | WO |
| 2014163706 | Oct 2014 | WO |
| 2014164364 | Oct 2014 | WO |
| 2014194178 | Dec 2014 | WO |
| 2014204807 | Dec 2014 | WO |
| 2014205064 | Dec 2014 | WO |
| 2015077274 | May 2015 | WO |
| 2015148241 | Oct 2015 | WO |
| 2016016899 | Feb 2016 | WO |
| Entry |
|---|
| Wayback Machine, Cleveland Clinic Lerner Research Institute, Transcatheter Mitral Stent/Valve Prosthetic, https://web.archive.org/web/20130831094624/http://mds.clevelandclinic.org/Portfolio.aspx?n=331, indicated as archived on Aug. 31, 2013. |
| Webb, John G., et al., “Transcatheter Aortic Valve Implantation: The Evolution of Prostheses, Delivery Systems and Approaches,” Archives of Cardiovascular Disease (2012) 105, 153-159. Applicant believes this may have been available as early as Mar. 16, 2012. |
| Backer, Ole De, MD, et al., “Percutaneous Transcatheter Mitral Valve Replacement—An Overview of Devices in Preclinical and Early Clinical Evaluation,” Contemporary Reviews in Interventional Cardiology, Circ Cardiovasc Interv. 2014;7:400-409, Applicant believes this may have been available as early as June of 2014. |
| Banai, Shmeul et al., The Journal of the American College of Cardiology, “Transapical Mitral Implantation of the Tiara Bioprosthesis Pre-Clinical Results,” Feb. 2014, <http://interventions.onlinejacc.org/article.aspx?articleid=1831234>. |
| Bavaria, Joseph E. M.D. et al.: “Transcatheter Mitral Valve Implantation: The Future Gold Standard for MR?,” Applicant requests the Examiner to consider this reference to be prior art as of December of 2010. |
| Bavaria, Joseph E. M.D.: “CardiAQ Valve Technologies: Transcatheter Mitral Valve Implantation,” Sep. 21, 2009. |
| Berreklouw, Eric, PhD, et al., “Sutureless Mitral Valve Replacement With Bioprostheses and Nitinol Attachment Rings: Feasibility in Acute Pig Experiments,” The Journal of Thoracic and Cardiovascular Surgery, vol. 142, No. 2, Aug. 2011 in 7 pages, Applicant believes this may have been available online as early as Feb. 7, 2011. |
| BioSpace, “CardiAQ Valve Technologies (CVT) Reports Cardiovascular Medicine Milestone: First-In-Humannonsurgical Percutaneous Implantation of a Bioprosthetic Mitral Heart Valve,” Jun. 14, 2012, p. 1, http://www.biospace.com/News/cardiaq-valve-technologies-cvt-reports/263900. |
| BioSpace, “CardiAQ Valve Technologies (CVT) Reports First-In-Human Percutaneous Transfemoral, Transseptal Implantation With Its Second Generation Transcatheter Bioprosthetic Mitral Heart Valve,” Jun. 23, 2015, p. 1, http://www.biospace.com/News/cardiaq-valve-technologies-cvt-reports-first-in/382370. |
| Boudjemline, Younes, et al., “Steps Toward the Percutaneous Replacement of Atrioventricular Valves,” JACC, vol. 46, No. 2, Jul. 19, 2005:360-5. |
| CardiAQ Valve Technologies, “Innovations in Heart Valve Therapy,” In3 San Francisco, Jun. 18, 2008, PowerPoint presentation in 19 slides. |
| “CardiAQTM Valve Technologies reports Successful First-in-Human Trans-Apical implantation of its Second Generation Transcatheter Mitral Valve,” CardiAQ Valve Technologies Press Release, May 20, 2014. |
| Chiam, Paul T.L., et al., “Percutaneous Transcatheter Aortic Valve Implantation: Assessing Results, Judging Outcomes, and Planning Trials,” JACC: Cardiovascular Interventions, The American College of Cardiology Foundation, vol. 1, No. 4, Aug. 2008:341-50. |
| Condado, Jose Antonio, et al., “Percutaneous Treatment of Heart Valves,” Rev Esp Cardio. 2006;59(12):1225-31, Applicant believes this may have been available as early as December of 2006. |
| “Company Overview,” at TVT on Jun. 25, 2009. |
| Engager System, Precise Valve Positioning, Transcatheter Aortic Valve Implantation System, Transcatheter Aortic Valve Replacement—Tavr I Medtronic Engager, http://www.medtronic-engager.com/home/transcatheter-aortic-valve-repl., 2014 Medtronic, Inc. in 2 pages Applicant believes this may have been available online as early as Aug. 25, 2013. |
| Fornell, Dave, “Transcatheter Mitral Valve replacement Devices in Development,” Diagnostic and Interventional Cardiology, Dec. 30, 2014, p. 3, <http://www.dicardiology.com/article/transcatheter-mitral-valve-replacement-devices-development>. |
| Fanning, Jonathon P., et al., “Transcatheter Aortic Valve Implantation (TAVI): Valve Design and Evolution,” International Journal of Cardiology 168 (2013) 1822-1831, Applicant believes this may have been available as early as Oct. 3, 2013. |
| Feldman, Ted, MD. “Prospects for Percutaneous Valve Therapies,” Circulation 2007; 116:2866-2877. Applicant believes that this may be available as early as Dec. 11, 2007. |
| Fitzgerald, Peter J. M.D., “Tomorrow's Technology: Percutaneous Mitral Valve Replacement, Chordal Shortening, and Beyond,” Transcatheter Valve Therapies (TVT) Conference. Seattle, WA. Applicant believes this may have been available as early as Jun. 7, 2010. |
| Grube, E. et al., “Percutaneous aortic valve replacement for severe aortic stenosis in high-risk patients using the second- and current third-generation self-expanding CoreValve prosthesis: device success and 30-day clinical outcome.” J Am Coll Cardiol. Jul. 3, 2007;50(1):69-76. Epub Jun. 6, 2007. |
| Horvath et al.: “Transapical Aortic Valve Replacement under Real-time Magnetic Resonance Imaging Guidance Experimental Results with Balloon-Expandable and Self-Expanding Stents,” http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3038190/. Jun. 2011. |
| Karimi, Houshang, et al., “Percutaneous Valve Therapies,” SIS 2007 Yearbook, Chapter 11, pp. 1-11. |
| Kronemyer, Bob, “CardiAQ Valve Technologies: Percutaneous Mitral Valve Replacement,” Start Up—Windhover Review of Emerging Medical Ventures, vol. 14, Issue No. 6, Jun. 2009, pp. 48-49. |
| Leon, Martin B., et al., “Transcatheter Aortic Valve Replacement in Patients with Critical Aortic Stenosis: Rationale, Device Descriptions, Early Clinical Experiences, and Perspectives,” Semin. Thorac. Cardiovasc. Surg. 18:165-174, 2006 in 10 pages, Applicant believes this may have been available as early as the Summer of 2006. |
| Lutter, Georg, et al., “Off-Pump Transapical Mitral Valve Replacement,” European Journal of Cardio-thoracic Surgery 36 (2009) 124-128, Applicant believes this may have been available as early as Apr. 25, 2009. |
| Ma, Liang, et al., “Double-Crowned Valved Stents for Off-Pump Mitral Valve Replacement,” European Journal of Cardio-thoracic Surgery 28 (2005) 194-199, Applicant believes this may have been available as early as August of 2005. |
| Ostrovsky, Gene, “Transcatheter Mitral Valve Implantation Technology from CardiAQ,” medGadget, Jan. 15, 2010, available at: http://www.medgadget.com/2010/01/transcatheter_mitral_valve_implantation_technology_from_cardiaq.html. |
| Pluth, James R., M.D., et al., “Aortic and Mitral Valve Replacement with Cloth-Covered Braunwald-Cutter Prosthesis, A Three-Year Follow-up,” The Annals of Thoracic Surgery, vol. 20, No. 3, Sep. 1975, pp. 239-248. |
| Mack, Michael, M.D., “Antegrade Transcatheter Mitral valve Implantation: A Short-term Experience in Swine Model,” Applicant believes this may have been presented on May of 2011 at TVT. |
| Mack, Michael, M.D., “Antegrade Transcatheter Mitral valve Implantation: On-Going Experience in Swine Model,” Applicant believes this may have been presented on November of 2011 at TCT. |
| Mack, Michael M.D., “Advantages and Limitations of Surgical Mitral Valve Replacement; Lessons for the Transcatheter Approach,” Applicant believes this may have been available as early as Jun. 7, 2010. Applicant believes this may have been presented at the Texas Cardiovascular Innovative Ventures (TCIV) Conference in Dallas, TX on Dec. 8, 2010. |
| Masson, Jean-Bernard, et al., “Percutaneous Treatment of Mitral Regurgitation,” Circulation: Cardiovascular Interventions, 2:140-146, Applicant believes this may have been available as early as Apr. 14, 2009. |
| NJ350: Vote for Your Favorite New Jersey Innovations, Jun. 27, 2014, http://www.kilmerhouse.com/2014/06/nj350-vote-for-your-favorite-new-jersey-innovations/. |
| Neovasc corporate presentation, Oct. 2009, available at http://www.neovasc.com/investors/documents/Neovasc-Corporate-Presentation-October-2009.pdf. |
| Piazza, Nicoló, MD, et al., “Anatomy of the Aortic Valvar Complex and Its Implications for Transcatheter Implantation of the Aortic Valve,” Contemporary Reviews in Interventional Cardiology, Circ. Cardiovasc. Intervent., 2008;1:74-81, Applicant believes this may have been available as early as August of 2008. |
| Preston-Maher, Georgia L., et al., “A Technical Review of Minimally Invasive Mitral Valve Replacements,” Cardiovascular Engineering and Technology, vol. 6, No. 2, Jun. 2015, pp. 174-184. Applicant believes this may have been available as early as Nov. 25, 2014. |
| Quadri, Arshad M.D., “Transcatheter Mitral Valve Implantation (TMVI) (An Acute In Vivo Study),” Applicant believes this may have been presented on Sep. 22, 2010 at TCT. |
| Ratz, J. Brent, “LSI EMT Spotlight,” May 15, 2009. |
| Ratz, J. Brent, “In3 Company Overview,” Jun. 24, 2009. |
| Ruiz, Carlos E., “Overview of Novel Transcatheter Valve Technologies,” Applicant believes this may have been presented on May 27, 2010 at EuroPCR. |
| Ratz, J. Brent et al., “Any experiences making an expandable stent frame?” Arch-Pub.com, Architecture Forums: Modeling, Multiple forum postings from Feb. 3, 2009 to Feb. 4, 2009, http://www.arch-pub.com. |
| Seidel, Wolfgang, et al., “A Mitral Valve Prosthesis and a Study of Thrombosis on Heart Valves in Dogs,” JSR—vol. II, No. 3—May 1962, submitted for publication Oct. 9, 1961. |
| Spillner, J. et al., “New Sutureless ‘Atrial-Mitral-Valve Prosthesis’ for Minimally Invasive Mitral Valve Therapy,” Textile Research Journal, 2010, in 7 pages, Applicant believes this may have been available as early as Aug. 9, 2010. |
| Sondergaard, Lars, et al., “Transcatheter Mitral Valve Implantation: CardiAQ™,” Applicant believes this may have been presented at TCT 2013. |
| Sondergaard, Lars, et al., “Transcatheter Mitral Valve Implantation: CardiAQ™,” Applicant believes this may have been presented at EuroPCR 2013. |
| Sondergaard, Lars, “CardiAQ TMVR FIH—Generation 2,” Applicants believe this may have been presented in 2014 at the TVT symposium. |
| Treede et al.: “Transapical transcatheter aortic valve implantation using the JenaValve™ system: acute and 30-day results of the multicentre CE-mark study” http://ejcts.oxfordjournals.org/content/41/6/e131.long Apr. 16, 2012. |
| Taramasso et al.: “New devices for TAVI: technologies and initial clinical experiences” http://www.nature.com/nrcardio/journal/v11/n3/full/nrcardio.2013.221.html?message-global=remove#access. Jan. 21, 2014. |
| “Update,” Applicant believes this may have been presented on Jun. 6, 2010 at TVT. |
| Van Mieghem, et al., “Anatomy of the Mitral Valvular Complez and Its Implications for Transcatheter Interventions for Mitral Regurgitation,” J. Am. Coll. Cardiol., 56:617-626 (Aug. 17, 2010). |
| Vu, Duc-Thang, et al., “Novel Sutureless Mitral Valve Implantation Method Involving a Bayonet Insertion and Release Mechanism: A Proof of Concept Study in Pigs,” The Journal of Thoracic and Cardiovascular Surgery, vol. 143, No. 4, 985-988, Apr. 2012, Applicant believes this may have been available online as early as Feb. 13, 2012. |
| Number | Date | Country | |
|---|---|---|---|
| 20190336285 A1 | Nov 2019 | US |
| Number | Date | Country | |
|---|---|---|---|
| 62300478 | Feb 2016 | US | |
| 62210165 | Aug 2015 | US | |
| 62163932 | May 2015 | US | |
| 62155405 | Apr 2015 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15141684 | Apr 2016 | US |
| Child | 16517070 | US |
