US20220331102A1 - Delivery system for replacement heart valve - Google Patents

Abstract

Devices, systems and methods are described herein a prosthesis for implantation within a lumen or body cavity and delivery systems for delivering the prosthesis to a location for implantation. A delivery system can include a plurality of components, including a flexible nose cone, multi-layer sheath, and pre-compressed shaft, which can be moveable relative to each other.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This Application is a continuation of U.S. application Ser. No. 16/517,070, filed Jul. 19, 2019, which is a continuation of U.S. application Ser. No. 15/141,684, filed Apr. 28, 2016, now U.S. Pat. No. 10,376,363, 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.
BACKGROUNDField
• 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.
Background
• 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.
SUMMARY
• 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.
• Embodiment 1: 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.
• Embodiment 2: 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.
• Embodiment 3: The flexible delivery system of Embodiment 2, wherein the inner layer and outer layer comprises ePTFE.
• Embodiment 4: The flexible delivery system of Embodiment 2 or 3, wherein the one or more intermediate layers comprises a nitinol hypotube.
• Embodiment 5: The flexible delivery system of any of Embodiments 2-4, wherein the one or more intermediate layers comprises ePTFE.
• Embodiment 6: 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.
• Embodiment 7: The flexible delivery system of Embodiment 6, wherein the second intermediate layer comprises a nitinol hypotube and the first intermediate layer comprises ePTFE.
• Embodiment 8: The flexible delivery system of Embodiment 6, wherein the second intermediate layer comprises ePTFE and the first intermediate layer comprises a nitinol hypotube.
• Embodiment 9: The flexible delivery system of any of Embodiments 6-8, wherein a gap exists between the first intermediate layer and the second intermediate layer.
• Embodiment 10: 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.
• Embodiment 11: The transseptal delivery system ofEmbodiment 10, wherein the outer sheath assembly is configured to slide over the nose cone.
• Embodiment 12: The transseptal delivery system ofEmbodiment 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.
• Embodiment 13: The transseptal delivery system ofEmbodiment 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.
• Embodiment 14: The transseptal delivery system ofEmbodiment 13, wherein the proximal anchors extend distally when in a delivery configuration within the outer sheath assembly.
• Embodiment 15: The transseptal delivery system ofEmbodiment 13 or 14, wherein the distal anchors extend proximally when in a delivery configuration within the outer sheath assembly.
• Embodiment 16: 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.
• Embodiment 17: 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.
• Embodiment 18: The flexible delivery system of Embodiment 17, wherein the distal section has a greater diameter than the proximal section.
• Embodiment 19: The flexible delivery system ofEmbodiment 17 or 18, wherein the inner polymer layer, the outer polymer layer, and the intermediate polymer layer comprise ePTFE.
• Embodiment 20: 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.
• Embodiment 21: The flexible delivery system ofEmbodiment 20, wherein the polymer reinforcement comprises a fluorinated ethylene propylene insert.
• Embodiment 22: 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.
• Embodiment 23: 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.
• Embodiment 24: 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.
• Embodiment 25: 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.
• Embodiment 26: The delivery system of Embodiment 25, wherein the pre-compressed polymer tube comprises a pre-compressed HDPE tube.
• Embodiment 27: The delivery system of Embodiment 25 or 26, wherein the mid shaft provides a distal force on the outer retention ring.
• Embodiment 28: The delivery system of any of Embodiments 25-27, wherein the pre-compressed polymer tube is compressed at least ¼ inch.
• Embodiment 29: 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.
• Embodiment 30: The delivery system of any of Embodiments 25-29, wherein the outer retention ring is at least 15 mm in length.
• Embodiment 31: 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.
• Embodiment 32: 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.
• Embodiment 33: The flexible delivery system ofEmbodiment 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.
• Embodiment 34: The flexible delivery system of Embodiment 33, wherein the inner layer and outer layer comprises ePTFE.
• Embodiment 35: The flexible delivery system ofEmbodiment 33 or 34, wherein the one or more intermediate layers comprises a nitinol hypotube.
• Embodiment 36: The flexible delivery system of any of Embodiments 33-35, wherein the one or more intermediate layers comprises ePTFE.
• Embodiment 37: 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.
• Embodiment 38: The flexible delivery system of Embodiment 37, wherein the second intermediate layer comprises a nitinol hypotube and the first intermediate layer comprises ePTFE.
• Embodiment 39: The flexible delivery system of Embodiment 37, wherein the second intermediate layer comprises ePTFE and the first intermediate layer comprises a nitinol hypotube.
• Embodiment 40: The flexible delivery system of any of Embodiments 37-39, wherein a gap exists between the first intermediate layer and the second intermediate layer.
• Embodiment 41: 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.
• Embodiment 42: 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.
• Embodiment 43: The replacement mitral valve prosthesis ofEmbodiment 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.
• Embodiment 44: The replacement mitral valve prosthesis ofEmbodiment 42 or 43, wherein the frame comprises at least two rows of foreshortening cells.
• Embodiment 45: 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.
• Embodiment 46: 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.
• Embodiment 47: 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.
• Embodiment 48: 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.
• Embodiment 49: 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.
• Embodiment 50: 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.
• Embodiment 51: 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.
• Embodiment 52: The replacement mitral valve prosthesis of any of Embodiments 42-51, wherein at least one of the proximal anchors comprises an eyelet.
• Embodiment 53: 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.
• Embodiment 54: The replacement mitral valve prosthesis of any of Embodiments 42-53, further comprising a valve body attached to the expandable frame.
• Embodiment 55: 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.
• Embodiment 56: 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.
• Embodiment 57: The replacement mitral valve prosthesis ofEmbodiment56, further comprising two rows of diamond-shaped cells.
• Embodiment 58: The replacement mitral valve prosthesis ofEmbodiment 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.
• Embodiment 59: The replacement mitral valve prosthesis of any of Embodiments 56-58, wherein the ends of the distal anchors are parallel to the longitudinal axis.
• Embodiment 60: The replacement mitral valve prosthesis of any of Embodiments 56-59, wherein the plurality of proximal anchors comprises enlarged ends.
• Embodiment 61: The replacement mitral valve prosthesis ofEmbodiment 60, wherein the enlarged ends extend substantially perpendicular to the longitudinal axis.
• Embodiment 62: The replacement mitral valve prosthesis of any of Embodiments 56-61, wherein the proximal portion comprises a single row of hexagonal-shaped cells.
• Embodiment 63: 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.
• Embodiment 64: 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.
• Embodiment 65: 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.
• Embodiment 66: 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.
• Embodiment 67: 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.
• Embodiment 68: 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.
• Embodiment 69: 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
• Embodiment 70: A method of using the guidewire assembly of Embodiment68 or69, 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.
BRIEF DESCRIPTION OF THE DRAWINGS
• 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.
• FIG. 1 shows an embodiment of a delivery system.
• FIG. 2 shows a cross-sectional view of a distal end of the delivery system ofFIG. 1.
• FIG. 3 shows an embodiment of a valve prosthesis that may be delivered using the delivery systems described herein.
• FIG. 4 shows the distal end of the delivery system ofFIG. 2 loaded with the valve prosthesis ofFIG. 3.
• FIGS. 5A-D illustrate a distal end of the delivery system ofFIG. 1 including a spring retention cover.
• FIG. 6 shows a perspective view of the distal end of the delivery system ofFIG. 1.
• FIG. 7 show components of the delivery system ofFIG. 6 with the outer sheath assembly moved proximally.
• FIG. 8 show components of the delivery system ofFIG. 7 with the mid shaft assembly moved proximally.
• FIG. 9 illustrates a schematic, cross-sectional view of an outer sheath assembly.
• FIG. 10 illustrates a hypotube incorporated into the outer sheath assembly ofFIG. 9.
• FIG. 11 shows a hollow nose cone bending upon impact with a surface.
• FIG. 12 illustrates a schematic representation of a transfemoral delivery approach.
• FIG. 13 illustrates a schematic representation of a valve prosthesis positioned within a native mitral valve.
• FIG. 14 illustrates a schematic representation of a distal end of an embodiment of the delivery system utilizing a guide sheath.
• FIG. 15 illustrates an isolated cross-sectional view of a distal end of the guide sheath ofFIG. 14.
• FIG. 16 illustrates a longitudinal sectional view along of the distal end of the guided sheath ofFIG. 14.
• FIG. 17 illustrates an embodiment of a distal tip of a guide sheath in a flat view.
• FIG. 18 illustrates an exploded view of an embodiment of an anchored guidewire which can be incorporated into embodiments of the delivery system.
• FIG. 19 illustrates a cross-sectional view of an embodiment of an anchored guidewire which can be incorporated into embodiments of the delivery system.
• FIG. 20 illustrates a cross-sectional view of another embodiment of an anchored guidewire which can be incorporated into embodiments of the delivery system.
• FIG. 21 shows a side view of an embodiment of a frame that may be delivered using the delivery systems described herein.
• FIG. 22 shows a flat pattern of the frame ofFIG. 21.
• FIG. 23 shows a top perspective view of the frame ofFIG. 21.
• FIG. 24 shows a top view of the frame ofFIG. 21.
• FIG. 25 shows a bottom view of the frame ofFIG. 21.
• FIG. 26 shows a cross-sectional view of the frame ofFIG. 21, through line26-26 ofFIG. 24.
• FIG. 27 shows a cross-sectional view of the frame ofFIG. 21, through line27-27 ofFIG. 24.
• FIG. 28A-B show top and bottom perspective views of an embodiment of a replacement mitral valve comprising the frame ofFIG. 21 and an outer skirt, with the valve body removed.
• FIG. 29 shows a side view of the replacement mitral valve ofFIGS. 28A-28B.
• FIGS. 30A-C illustrate a schematic representation of the replacement mitral valve ofFIGS. 280A-28B positioned within a native mitral valve.
• FIGS. 31A-B illustrates a schematic representation of a valve prosthesis positioned within a native mitral valve.
DETAILED DESCRIPTION
• 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 toFIG. 1, an embodiment of a delivery system orsystem10 is shown. The delivery system can be used deploy a prosthesis, such as a replacement heart valve, within the body. Replacement heart valves can be delivered to a patient's heart mitral valve annulus or other heart valve location in various ways, such as by open surgery, minimally-invasive surgery, and percutaneous or transcatheter delivery through the patient's vasculature. While thedelivery system10 is described in connection with a percutaneous delivery approach, and more specifically a transfemoral delivery approach, it should be understood that features ofdelivery system10 can be applied to any other delivery system described herein, including delivery systems which are described in connection with a transapical delivery approach. Further examples of devices, systems and methods are described in U.S. Provisional Application No. 62/163932, filed May 19, 2015, the entirety of which is incorporated by reference. In particular,delivery system10 as described herein can have components, features, and/or functionality similar to those described with respect to delivery systems, devices and methods described in at least paragraphs [0006]-[0037] and [0078]-[0170] of U.S. Provisional Application No. 62/163932, filed May 19, 2015, including the description relating toFIGS. 1-40B, and all of these descriptions are expressly incorporated by reference herein. Moreover,delivery system10 as described herein can have components, features, and/or functionality similar to those described with respect to the systems, devices and methods described with respect to paragraphs [0171]-[0197] of U.S. Provisional Application No. 62/163932, filed May 19, 2015, including the description relating toFigures A1-A5, B1-B6, C1-C2 and41A-42B, and all of these descriptions are expressly incorporated by reference herein.
• Thedelivery system10 can be used to deploy an expandable prosthesis70 (shown inFIG. 3), such as a replacement heart valve as described elsewhere in this specification, within the body. Thedelivery system10 can receive and/or cover portions of the expandable implant orprosthesis70 such as afirst end301 andsecond end303 of theprosthesis70. For example, thedelivery system10 may be used to deliver aprosthesis70, where theprosthesis70 includes afirst end301 and asecond end303, and wherein the second303 end is configured to be deployed or expanded before thefirst end303. Thedelivery system10 can be relatively flexible. In some embodiments, thedelivery system10 is particularly suitable for delivering a replacement heart valve to a mitral valve location through a transseptal approach (e.g., between the right atrium and left atrium via a transseptal puncture).
• As shown inFIGS. 1 and 2, thedelivery system10 can include anelongate shaft assembly12 comprising aproximal end11 and adistal end13, wherein ahandle14 is coupled to the proximal end of theassembly12. Theelongate shaft assembly12 can be used to hold theprosthesis70 for advancement of the same through the vasculature to a treatment location. Theelongate shaft assembly12 can include animplant retention area16 at its distal end shown inFIG. 2, though it could be in other locations as well, that can be used for this purpose. In some embodiments, theelongate shaft assembly12 can hold anexpandable prosthesis70 in a compressed state at implant retention area16 (shown inFIG. 2) for advancement of theprosthesis70 within the body. Theelongate shaft assembly12 may then be used to allow controlled expansion of theprosthesis70 at the treatment location. Further, thedelivery system10 can have a live-onsheath15. The live-onsheath15 can extend away from thehandle14 partially down a length of theproximal end11 of theelongate shaft assembly12. The live-onsheath15 can be made of a relatively rigid material to provide for structural of theelongate shaft assembly12 while preventing unwanted radial motion or bending of theelongate shaft assembly12.
• As shown in cross-sectional view ofFIG. 2 withoutprosthesis70, theelongate shaft assembly12 can include one or more subassemblies such as aninner assembly18, amid shaft assembly20, anouter sheath assembly22, andnose cone assembly31 as will be described in more detail below.
• As shown, theouter sheath assembly22 can form a radially outer covering, or sheath, to surround animplant retention area16. Moving radially inward, themid shaft assembly20 can be composed of amid shaft50 with its distal end attached toouter retention member40, such as an outer retention ring. Moving further inwards, theinner assembly18 can be composed of aninner retention shaft24 and aninner retention member32. Further, the most radially-inward assembly is thenose cone assembly31 which includes thenose cone shaft30 having the distal end connected to thenose cone28.
• Theelongate shaft assembly12, and more specifically thenose cone assembly31,inner assembly18,mid shaft assembly20, andouter sheath assembly22, can be configured to deliver a prosthesis positioned within theimplant retention area16 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. Thehandle14 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 thedelivery system10 and then later deployed within the body.
• As mentioned,FIG. 2 illustrates an embodiment of thesystem10 showing the subassemblies, but does not contain theprosthesis70.FIG. 3 shows an example of theprosthesis70 withFIG. 4 showing theprosthesis70 inserted into theimplant retention area16. For ease of understanding, inFIG. 4, theprosthesis70 is shown with only the bare metal frame illustrated. The implant orprosthesis70 can take any number of different forms. A particular example of frame for a prosthesis is shown herein, though it will be understood that other designs can also be used. Theprosthesis70 can include one or more sets of anchors, such as distal (or ventricular) anchors80 extending proximally when the prosthesis frame is in an expanded configuration and proximal (or atrial) anchors82 extending distally when the prosthesis frame is in an expanded configuration. Theprosthesis70 can includestruts72 topped by mushroom-shapedtabs74 on itsfirst end301. Further, theprosthesis70 can include an annular flap surrounding theprosthesis70 generally on thesecond end303.
• 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 theannular flap81 can be found in U.S. Patent Publication No. 2015/0328000, hereby incorporated by reference in its entirety.
• As will be discussed below, theinner retention member32, theouter retention member40, theouter sheath assembly22 as illustrated inFIG. 4 can cooperate to hold thereplacement heart valve70 in a compacted configuration. Theinner retention member32 is shown engagingstruts72 at the proximal end of theheart valve70. For example, slots located between radially extending teeth on theinner retention member32 can receive and engage thestruts72 which may end in mushroom-shapedtabs74 on the proximal end of theheart valve70. The mushroom-shapedtabs74 can be retained within a circumferential gap/ring located proximal to the teeth. Theouter retention member40 can be positioned over theinner retention member32 so that the proximal end of thereplacement heart valve70 is trapped therebetween, securely attaching it to thedelivery system10.
• As shown inFIG. 4, thedistal anchors80 can be located in a delivered configuration where thedistal anchors80 point generally distally (as illustrated, axially away from the main body of the prosthesis frame and away from thehandle14 of the delivery system10). Thedistal anchors80 can be restrained in this delivered configuration by theouter sheath assembly22. Accordingly, when theouter sheath22 is withdrawn proximally, thedistal anchors80 can flip positions to a deployed configuration (e.g., pointing generally proximally).FIG. 4 also shows the proximal anchors82 extending distally in their delivered configuration within theouter sheath assembly22 and within theouter retention member40. In other embodiments, thedistal anchors80 can be held to point generally proximally in the delivered configuration.
• Thedelivery system10 may be provided to users with aprosthesis70 preinstalled. In other embodiments, theprosthesis70 can be loaded onto the delivery system shortly before use, such as by a physician or nurse.
• FIG. 6-8 illustrate further views ofdelivery system10 with different assemblies moved away translated and described in detail.
• Theouter sheath assembly22 will now be described, which is shown inFIG. 6. Specifically,FIG. 6 shows anouter sheath assembly22 in its distal most position relative tonose cone28. Theouter sheath assembly22 is disposed so as to be slidable over theinner assembly18, themid shaft assembly20, and thenose cone assembly31. Like thenose cone assembly31,inner assembly18 and themid shaft assembly20, theouter sheath assembly22 can be a single piece tube or multiple pieces connected together to provide different characteristics along different sections of the tube. As has been mentioned, in some embodiments it can be desirable, and/or needful, for thedelivery system10 to have greater flexibility at the distal end of the device, where flexibility is not as necessary for the proximal end. The illustratedouter sheath assembly22 has afirst segment56, asecond segment58, and athird segment60, where thefirst segment56 is proximal to thesecond segment58, and thesecond segment58 is proximal to thethird segment60. Thethird segment60 of theouter sheath assembly22 is shown in contact with the proximal end of thenose cone28. In this position, theprosthesis70 can be held within theouter shaft assembly22 for advancement of the same through the vasculature to a treatment location.
• Thefirst segment56 may be a tube and is preferably formed plastic, but could also be a metal hypotube or other material. In some embodiments, thetube56 is formed of a polyether block amide (PEBA) or other type of a thermoplastic elastomer (TPE). In particular, thetube56 can be a wire braided reinforced PEBA which can enhance pushability and trackability.
• Thesecond segment58 can be a metal hypotube which in some embodiments may be cut or have slots. Thetube58 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. Thethird segment60 can be a tube formed of a plastic or metal material. In a preferred embodiment, thethird segment60 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 thethird segment60 is the same material as the coating on the cut hypotube1058. The full construction of thesecond segment58 andthird segment60 are discussed in detail below with respect toFIG. 9.
• In some embodiments thethird segment60 can include one or more wings ortabs63, shown inFIG. 6, extending distally from a distal end of thethird segment60. Thetabs63 can be configured to bend, curve, or fold radially outward from thethird segment60. The one ormore tabs63 can facilitate loading of a replacement valve within thethird segment60 when the replacement valve is initially loaded into thedelivery system10. In some embodiments, the one ormore tabs63 can be removed prior to use within a patient, as shown inFIG. 11. The one ormore tabs63 can be formed by cutting thethird segment60 via methods including, but not limited to, laser cutting.
• FIG. 7 illustrates thedelivery system10 with theouter sheath assembly22 pulled back proximally, thus exposing or partially exposing themid shaft assembly20 including a portion of or all of a prosthesis (not shown) in theimplant retention area16. Like thenose cone assembly31,inner assembly18 andouter sheath assembly22, themid shaft assembly20 can be a single piece tube or multiple pieces connected together to provide different characteristics along different sections of the tube. As has been mentioned, in some embodiments it can be desirable, and/or needful, for thedelivery system10 to have greater flexibility at the distal end of the device, where flexibility is not as necessary for the proximal end. The illustratedmid shaft assembly20 has a first segment (not shown) nearhandle14, a second segment ormid shaft50 distal to the first segment, and athird segment40 distal the mid-shaft50 being theouter retention member40. The first segment can extend distally away from thehandle14 and be connected to the second segment ormid shaft50 at the distal end of the first segment. As shown inFIG. 7, the distal end of thesecond segment50 can attach to the outer retention member40 (e.g., third segment). Each of the segments can be a tube, for example a metal or polymer tube, such as described with respect to theouter sheath assembly22.
• Through the use of the handle, themid shaft assembly20 can translate or slide over theinner assembly18, which thereby causes theouter retention member40 to slide over theinner assembly18 and encircle theinner retention member32 described below. As shown inFIG. 4, theouter retention member40 encircles a portion of theprosthesis70, in particular thefirst end301, thus preventing theprosthesis70 from expanding. Further, themid shaft assembly20 can be translated proximally with regards to theinner assembly18 into theouter sheath assembly22, thus exposing afirst end301 of theprosthesis70 held within theouter retention member40. Ataper61 may be provided at the proximal end of theouter retention member40 to allow it to more easily slide into theouter sheath assembly22, specifically thethird segment60. In this way theouter retention member40 can be used to help secure aprosthesis70 to or release it from thedelivery system10. While not shown, themid shaft assembly20 can include an outer retention member lock that may be used to connect theouter retention member40 to themid shaft50. This lock can be located directly proximal to theouter retention member40 and can be attached to both themid shaft50 and theouter retention member40, thus keeping theouter retention member40 in the correct position on themid shaft50. The lock can be located radially inside theouter retention member40. The lock can, for example, be a generally tubular piece having a threaded surface that can thread with theouter retention member40. However, other attachment mechanisms between the lock and theouter retention member40, such as complementary shaped pieces or adhesives, can be used as well. Theouter retention member40 can have a cylindrical or elongate tubular shape, and may sometimes be referred to as an outer retention ring.
• Themid shaft50 itself can be made of, for example, high density polyethylene (HDPE), as well as other appropriate materials as described herein. Themid shaft50 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 theouter retention member40, thus preventing accidental, inadvertent, and/or premature release of theprosthesis70. Specifically, the distal force by themid shaft50 keeps the distal end of theouter retention member40 distal to theinner retention member32, thus preventing theouter retention member40 from moving proximal to theinner retention member32 before it is desired by a user to release theprosthesis70. This can remain true even when thedelivery system10 is being bent at a sharp angle. Further, the pre-compressed HDPE tube allows thedelivery system10 to remain flexible in order to bend to a particular section, while still applying a distally directed force on theouter retention member40. 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, themid shaft50 can comprise a spring to hold theouter retention member40 in place.
• In some embodiments, a spring can be used to cover theprosthesis70 to prevent accidental, inadvertent, and/or premature release of theprosthesis70. 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 toFIGS. 5A-D.
• As shown inFIG. 5A, thespring41 can be attached to an inner surface/diameter of theouter retention member40 and can include a disc or cup-shapedcover43 on its distal end. In some embodiments, thespring41 can be attached to the proximal inner surface of theouter retention member40. In the uncompressed/relaxed position (shown inFIG. 5D), thespring41 may extend to the distal end (or farther) of theouter retention member40. Thespring41 can be configured to curl around the inner surface of theouter retention member40.
• In some embodiments, thespring41 can be designed such that the spring length in the relaxed position is greater than or equal to the length of theouter retention member40. 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 theouter retention member40 for safety, though the particular excess length greater than the length of theouter retention member40 is not limiting.
• As mentioned, acover43 can be attached to a distal end of thespring41. Thecover43 can be generally cylindrical, and shaped in a similar manner as theouter retention member40. In some embodiments, thecover43 can be ring shaped, donut shaped, etc. In particular, thecover43 can be sized and configured to at least partially cover theinner retention member32. Accordingly, thecover43 can have an outer diameter greater than the outer diameter of theinner retention member32. Further, thecover43 can contain a lumen for theinner retention shaft24 to pass through. In some embodiments, thecover43 can abut a proximal surface of theinner retention member32 on a distal surface of thecover43.
• Thecover43 can act as a secondary temporaryouter retention member40 in case theouter retention member40 is prematurely withdrawn proximally, thereby exposing theinner retention member32, in particular the slots in theinner retention member32. Specifically, when theinner retention member32 moves forward or juggles, such as because of slop or bending of thedelivery system10, thecover43 attached to thespring41 can remain forward to cover theinner retention member32, preventing inadvertent release of theprosthesis70. Thus, if theouter retention member40 is accidentally pulled back over theinner retention member32, thecover43 still remains over theinner retention member32 preventing accidental release. It is only on the application of further proximal force to theouter retention member40 that would uncover theinner retention member32, thus allowing release of theprosthesis70.
• FIG. 5B shows a view of thespring41 within theouter retention member40 in the loaded configuration. At this point, thespring41 is compressed and is configured to expand distally upon release, which allows thecover43 to remain over theinner retention member32. In some embodiments, thespring41 can also provide a distal force on theinner retention member32.
• FIG. 5C shows a view where theouter retention member40 is withdrawn backwards due to pending or slop. If this were to occur without thespring41 andcover43, theinner retention member32 would be uncovered, thus causing release of theprosthesis70. However, as shown, thecover43 is still maintained over theinner retention member32, thus preventing release of the prosthesis.
• FIG. 5D shows theouter retention member40 pulled even farther back from the previous position. At this point, thespring41 is in a fully relaxed/uncompressed position/length and is in its expanded condition. Thus, the spring will now translate along with theouter retention member40. As shown in the figure, as theouter retention member40 is now drawn back proximally, theinner retention member32 is uncovered, thus allowing theprosthesis70 to be released.
• Further, in some embodiments, as shown inFIG. 4, theouter retention member40 can cover a substantial length of theprosthesis70 which can help avoid accidental release of theprosthesis70. The longouter retention member40 can be used in conjunction with thespring41 and/or pre-compressed HDPE tube, all of which can be used to prevent inadvertent release. For example, theouter retention member40 can cover over ⅛, ¼, ⅓, or ½ of theprosthesis70. In addition, theouter retention member40 can cover a substantial length of the atrial anchors82. For example, theouter retention member40 can cover over75%, over80%, over85%, or over90% of the atrial anchors82. Theouter retention member40 can be about15,16,17,18,19, or20 mm in length or a range between those lengths. In some embodiments, theouter retention member40 can be between about10 and about30 mm in length.
• FIG. 8 shows approximately the same view asFIG. 7, but with themid shaft assembly20, including theouter retention member40 andmid shaft50, retracted proximally, thereby exposing the inner assembly18 (including theinner retention member32 attached to inner retention shaft42) and nose cone assembly31 (including thenose cone shaft30 attached to the nose cone28).
• As mentioned theinner assembly18 can be composed of theinner retention shaft42 with theinner retention member32 attached to the distal end of theinner retention shaft42. Similar to the assemblies above, theinner retention shaft42 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 theinner assembly18 can be made of a hypotube can extend along a majority of the length of theinner assembly18. For example, metal hypotube extends from within thehandle14 at the proximal end towards the distal end up until a second segment of theinner assembly18 before theimplant retention area16. The hypotube can provide column strength (pushability) to the inner assembly. Asecond segment42 of theinner assembly18 can be made of a more flexible material. For example, thesecond segment42 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 theinner assembly18 with strength, but it can also provide more flexibility to allow for navigating the curvosities of the vasculature, such as within the heart.
• Theinner assembly18 can also include a prosthesis retention mechanism such as aninner retention member32 at a distal end of thesecond segment42 that can be used to engage with the prosthesis, as discussed with respect toFIG. 4. For example, theinner retention member32 may comprise an inner retention ring that includes a plurality of slots configured to engage withstruts72 on theprosthesis70. Theinner retention member32 can also be considered to be part of theimplant retention area16, and may be at the proximal end of theimplant retention area16. Withstruts72 or other parts of aprosthesis70 engaged with theinner retention member32, theouter retention member40 can cover both theprosthesis70 and theinner retention member32 to secure the prosthesis on the delivery system10 (shown inFIG. 4).
• Further, as shown inFIG. 8, thenose cone assembly31 may comprise an elongate member, and in some embodiments, may have anose cone28 on the distal end of anose cone shaft30. Thenose cone28 can be made of Pebax or polyurethane for atraumatic entry and to minimize injury to venous vasculature. Thenose cone28 can also be radiopaque to provide for visibility under fluoroscopy.
• Thenose cone shaft30 may include a lumen sized and configured to slidably accommodate a guidewire so that thedelivery system10 can be advanced over the guidewire through the vasculature. Thenose cone shaft30 may be connected from thenose cone28 to the handle, or may be formed of different segments such as the other assemblies. Further, thenose cone shaft30 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 shaft36 can be slidably disposed within theinner assembly18, thus allowing the nose cone shaft28 (and thus nose cone28) and theinner retention member32 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. No. 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 ofFIG. 2, theouter sheath assembly22 can include a lumen extending therethrough to allow thesheath assembly22 to be moveable or slideable relative to components contained therein. As shown in more detail inFIG. 9, theouter sheath assembly22 can include athird segment60 and asecond segment58, thesecond segment58 being proximal to thethird segment60. Thethird segment60 may be larger in inner diameter and outer diameter than thesecond segment58, and may be sized in length and inner diameter to receive aprosthesis70 as described herein in a collapsed configuration. These two segments can each have a different diameter, thereby forming the stepped configuration shown inFIG. 9.
• It should be noted that thesecond segment58, relative to the overall length of thedelivery system10, is still generally positioned at a distal portion of thedelivery system10 while thedelivery system10 is being used to deliver the replacement valve towards the in situ implantation site. Moreover, theouter sheath assembly22 may include other segments positioned proximal of thesecond segment58. Such segments may, for example, couple thesecond segment58 to a handle of thedelivery system10. Thethird segment60 can be positioned radially outward from aprosthesis70 when thedelivery system10 is in an initial, delivery configuration such that theprosthesis70 is maintained in thedelivery system10 in an undeployed configuration.
• Theouter sheath assembly22 can include a lumen running therethrough to allow thesheath assembly22 to be moveable or slideable relative to components contained therein. The walls forming thethird segment60 and/or the walls forming thesecond segment58 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, thethird segment60 is formed from one or more materials which allow thethird segment60 to be compliant and flexible while still maintaining a sufficient degree of radial strength to maintain a replacement valve within thethird segment60 without substantial radial deformation which could increase friction between thethird segment60 and a replacement valve contained therein, sufficient column strength to resist buckling of thethird segment60, and sufficient tear resistance to reduce the likelihood that theprosthesis70 causes thethird segment60 to tear. Flexibility of thethird segment60 can be advantageous, particularly for a transseptal approach. For example, while being retracted along a curved member, thethird segment60 can follow the curved member without applying significant forces upon the curved member which may cause the curved member to decrease in radius. Rather, thethird segment60 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 thethird segment60 can cause the distal portion of thedelivery system10 to straighten as thethird segment60 is retracted along the curved member. This straightening could cause thethird segment60 of thedelivery system10 to move thereby placing thethird segment60 in misalignment relative to the in situ implantation site, thereby also moving and placing theprosthesis70 contained in thethird segment60 of thedelivery system10 in misalignment relative to the in situ implantation site.
• In some embodiments, the wall of thethird segment60 and/or the wall of thesecond segment58 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 andsecond segments60,58. In some embodiments, the construction of the walls in the different segments can be the same. As shown in the illustrated embodiment ofFIG. 9, the wall can include aninner layer82 and anouter layer84. Theinner layer82 and/or theouter layer84 can both be formed from ePTFE. The two layers can be two discrete layers bonded together, or can be a single layer that comprises the same material with intermediate layers, discussed below, sandwiched within. One or more additional layers can be positioned between theinner layer82 and/or theouter layer84 to further modify the structural characteristics of the wall. For example, the wall can include a first intermediate layer (e.g., ePTFE insert160), a second intermediate layer (e.g., hypotube150) and a third intermediate layer (e.g., fluorinated ethylene propylene tube164). This can advantageously allow theouter sheath assembly22 to have structural characteristics which differ throughout the length of theassembly22. Moreover, the layered structure described herein can allow theouter sheath assembly22 to be compliant and flexible while still maintaining a sufficient degree of radial strength, column strength, and tear resistance. Examples of the intermediate layers are disclosed below.
• As shown in the embodiment inFIG. 10 showing a flat pattern of thehypotube150, ahypotube150 can have a plurality of spacedslots152 extending along the length from adistal end156 to aproximal end154 of thehypotube150 with the slots increasing in width towards thedistal end156. In this manner, the flexibility of thehypotube150 can be greater near thedistal end156 of thehypotube150 as compared to theproximal end154. In some embodiments, this can be reversed such that the slots increase in width from thedistal end156 towards theproximal end154. In such an embodiment, the flexibility of thehypotube150 can be greater near theproximal end154 of thehypotube150 as compared to thedistal end156. In some embodiments, thehypotube150 can be designed such that a portion between the distal and proximal ends156,154 can have a greater degree of flexibility or a lesser degree of flexibility than the distal and proximal ends156,154. Thehypotube150 can be embedded within any desired portion of theouter sheath assembly22, such as within thesecond segment58, thethird segment60, or both. For example, as shown inFIG. 9, ahypotube150 may be embedded into an ePTFE layer or layers forming thesecond segment58 of theouter sheath assembly22.
• Thehypotube150 can provide structural rigidity, while the cuts can provide for flexibility in the hypotube. For example, they hypotube150 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, thehypotube150 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 offset90 degrees. Other numbers of connecting members such as one, two, three, four, etc. can also be used.
• Further, anePTFE insert160 can be incorporated as an intermediate layer as well. The ePTFE insert160 can have a generally tube like shape or can be formed as a partial tube. The ePTFE insert160 can be located in a section away from thenitinol hypotube150. For example, as shown inFIG. 9, if thenitinol hypotube150 is in thesecond segment58, theePTFE insert160 can be in thethird segment60, though this positioning can be reversed.
• The ePTFE insert160 can be formed of the same material as theinner layer82 and outer layer84 (e.g., ePTFE). However, theePTFE insert160 can be formed so that it has a polymer chain alignment approximately perpendicular to that of the inner andouter layers82/84. For example, if the polymer chains of the inner andouter layers82/84 are aligned distally-to-proximally, the polymer chains of theePTFE insert160 can be aligned radially. This will allow theouter sheath assembly22 to have both tensile and compressive strength, while still allowing theouter sheath assembly22 to remain flexible. In some embodiments, theePTFE insert160 can have polymer chains that have different orientation throughout. The ePTFE insert160 can have a different thickness from the inner/outer layers82/84 as well. For example, as shown in the illustrated embodiment, theePTFE insert160 can be thicker than the ePTFE of theinner layer82 andouter layer84 of the wall. However, other materials and configurations of the insert can be used.
• Further, thethird segment60 can additionally include a reinforcement material, such as fluorinated ethylene propylene (FEP)tube164 between inner andouter layers82/84 as an intermediate layer, as shown inFIG. 9. As shown inFIG. 9, theFEP tube164 can be on top of the ePTFE insert160 orhypotube150, whichever is located in thethird segment60. Further, theFEP tube164 can be adjacent to or spaced apart from the ePTFE insert160 orhypotube150, whichever is located in thethird segment60. TheFEP tube164 can overlap the ePTFE insert160 as well. TheFEP tube164 can be more rigid than theePTFE insert160, and thus can provide for more structural support at the distal end of thethird segment60. For example, theFEP tube164 can provide for strength against the movement of thedistal anchors80 which press outwards against theouter sheath assembly22 in the retracted position. TheFEP tube164 can be located at the far distal end of thethird segment60 or can be spaced away from the distal end of thethird segment60.
• 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 inFIG. 9 which includes ahypotube150 spaced apart from anePTFE insert160. This can be advantageous if the inner andouter layers82/84 provide sufficient structural characteristics, such as radial strength, column strength, and tear resistance along certain portions of thethird segment60 and further flexibility is desired in such portions. For example, in some embodiments, theePTFE insert160 can be positioned along a portion of thethird segment60 which is subject to more stresses, such as axial, radial, and/or hoop stresses, due to components and structures contained within thethird segment60. In embodiments where aprosthesis70 is positioned within thethird segment60, theePTFE insert160 and/orFEP tube164 can be positioned along portions where theprosthesis70 exerts greater amounts of force upon thethird segment60. For example, with respect toprosthesis70, theePTFE insert160 and/orFEP tube164 can be positioned along a portion of thethird segment60 which covers thedistal anchors80 or other portions which extend significantly radially outward relative to other portions of theprosthesis70 as shown inFIG. 9. The portions of the wall which do not have an intermediate layer can serve as bending or kinking points for theouter sheath assembly22. In some embodiments, theinner layer82 and theouter layer84 can be in contact within such gaps. In some embodiments, a gap can be maintained between theinner layer82 and theouter layer84.
• Other types of materials and structures are also contemplated for the intermediate layers, including theFEP tube164 andePTFE insert160, 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 thedelivery system10 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/orouter layers82/84.
• The above intermediate layers can advantageously allow theouter sheath assembly22 to have structural characteristics which differ throughout the length of theassembly22. Moreover, the layered structure described herein can allow theouter sheath assembly22 be compliant and flexible while still maintaining a sufficient degree of radial strength, column strength, and tear resistance.
• In some embodiments, theouter sheath assembly22 can include one or more additional layers applied to an inner surface of theinner layer82 and/or an outer surface of theouter layer84. For example, additional layers can be positioned on an inner surface of theinner layer82. These additional layers can provide additional reinforcement to specific portions of theouter sheath assembly22, 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 theouter sheath assembly22 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 ofFIG. 2, thenose cone28 can have a generally tapered distal end. Thenose cone28 can have an elongated shape. Thenose cone28 can have a length, measured from the distalmost end to a proximalmost end, of between approximately5 mm to50 mm, between approximately10 mm to approximately40 mm, between approximately15 mm to approximately25 mm, approximately20 mm, any other lengths within these ranges, and any other lengths as desired.
• With reference particularly to the embodiment ofFIG. 2, the outer diameter of thenose cone28 at its proximal end can be similar to, or equal to, the inner diameter of anouter sheath assembly22. As shown in the illustrated embodiment ofFIG. 2, thenose cone28 has an outer diameter which is similar to the inner diameter of theouter sheath assembly22. This can form a generally smooth transition in diameter between thenose cone28 and the outer shaft and/or the outer component if and when thenose cone28 is brought into contact with the outer shaft and/or the outer component. In some embodiments, thenose cone28 can have an outer diameter of approximately 30, Fr, 31 Fr or 32 Fr and theouter sheath assembly22 can have an inner diameter of approximately 30 Fr, 31 Fr or32 Fr.
• Moreover, as shown inFIG. 2, thenose cone28 can be generally hollow, e.g., having acavity101 through a portion of thenose cone28. Thecavity101 can extend from adistal tip202 of thenose cone28 to theproximal portion204 of thenose cone28. As shown, thecavity101 can expand in diameter along with thenose cone28 in a distal-to-proximal direction thus keeping thewalls206 of thenose cone28 at approximately the same thickness throughout thenose cone28. In some embodiments, anose cone insert33 can be used to keep thewalls206 of thenose cone28 open at itsproximal end204. Thenose cone insert33 can be connected to thenose cone shaft30 or can be slidable on theshaft30. Further, thenose cone28 can be formed from a lower durometer material such as urethane, PEBAX, polysilicone and any other biocompatible material as desired. In some embodiments, thenose cone28 can include threading201 for attachment to a threaded portion of thenose cone shaft30. In some embodiments, thenose cone28 can be a single unit formed from a single material.
• The hollow andflexible nose cone28 can provide significant advantages while passing through the vasculature of a patient, especially in the transfemoral approach. Specifically, the blood vessels that thesystem10 passes through will not necessarily be straight, and thus it can be advantageous for thesystem10 to follow the blood vessels without any undue damage or catching. As shown inFIG. 11, thecavity101 within thenose cone28 can allow the nose cone to easily kink/bend/deflect/deform103 when thenose cone28 comes in contact with a bodily surface, such as the inner diameter of ablood vessel100. Thisbend103 can allow thenose cone28 to bend and follow along a surface of theblood vessel100 without doing any damage to theblood vessel100.
• Accordingly, as thenose cone28 follows guidewire105 through blood vessels in the body, thehollow nose cone28 will bend103 in order to continue following the blood vessel. This can advantageously reduce damage to theblood vessel100 while still maintaining control of thedevice10 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, thedelivery system10 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 inFIG. 12, in one embodiment aguidewire105 can be placed in the ipsilateralfemoral vein1074 and advanced to the right atrium. A transseptal puncture using known techniques can then be performed to obtain access to the left atrium. Theguidewire105 can then be advanced in to the left atrium and then to the left ventricle.FIG. 12 shows aguidewire105 extending from the ipsilateralfemoral vein1074 to theleft atrium1078. A guidewire snare can be placed in the descending aorta through the ipsilateral femoral artery. Theguidewire105 can be advanced into the ascending aorta and then the snare can be used to snare theguidewire105. The guidewire snare can then be withdrawn to externalize the guidewire from the ipsilateral femoral artery. The physician now has access to both ends of the guidewire. It will be understood that one or more introducer sheaths, catheters and/or guidewires may need to be used to get a guidewire externalized at both the ipsilateral femoral vein and the ipsilateral femoral artery. In addition, theinitial guidewire105 discussed above may not be the same as the ultimate externalized guidewire. As will be explained in more detail below, having an externalized guidewire can be useful for positioning the delivery system, especially the distal end of the delivery system, and for helping the delivery system turn some corners. Some embodiments may not use an externalized guidewire. For example, a steerable catheter may be used instead of the externalized guidewire.
• With theguidewire105 in place, thedelivery system10 can be advanced over the guidewire. Thedelivery system10 can then be advanced to the right atrium, through the septal puncture and theleft atrium1078 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, thenose cone28 can be hollow, as described above, allowing thenose cone28 to follow along the curving path of the body. This can be particularly useful to get thedelivery system10 to make the bend from extending up into the right atrium and then extending down into the left ventricle.
• The construction and flexibility of thedelivery system10 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 thedelivery system10 especially between the right atrium and the mitral valve are relatively complex and are generally not in a single plane. This part of thedelivery system10 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 thedelivery system10 and releasing an intralumenal frame assembly, such asprosthetic70, 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 asouter sheath assembly22. 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 thedelivery system10. The steps of this method can be used to transeptally deliver a replacement heart valve to a mitral valve location.
• A proximal segment of thedelivery system10 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, thethird segment60 can be oriented in a direction different from that of second58 or third60 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.
• Thedelivery system10 can be in a preliminary configuration with theouter sheath assembly22 covering theprosthesis70. In this configuration, thedelivery system10 has a relatively compact form factor which facilitates delivery of the implant to the in situ target location. As mentioned, theouter sheath assembly22 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, theouter sheath assembly22 can form a curved or rounded configuration thereby allowing the distal portion of thedelivery system10 to remain in proper position relative to the native mitral valve. Thedelivery system10 can retract theouter sheath assembly22 such that the entirety of theprosthesis70 is exposed. Portions of the prosthesis remain attached to thedelivery system70 via mechanisms similar toinner retention member32 andouter retention member40 described in connection withdelivery system10.
• Though the entireelongate shaft assembly12 may be experiencing some bending or flex, typically it is predominantly thesecond segments42,50, and58 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. Thenose cone28 can also be flexible and may be bent during turning and at various other times during the procedure, such as described above with respect toFIG. 11.
• 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, thesecond segment58 of theouter sheath assembly22 can have a bendable length of about 3⅝ inches (9.2 cm), thesecond segment50 of themid shaft assembly20 can have a bendable length of about 4¾ inches (12.1 cm), and thesecond segment42 of theinner assembly18 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 theelongate shaft assembly12.
• Thedelivery system10 can include a radially-compacted replacement mitral valve (e.g., prosthesis70) that has been preloaded within theimplant retention area16. With the distal end of thedelivery system10 within the left ventricle, the operator can begin to deploy theprosthesis70. Throughout the procedure, theprosthesis70 can be allowed to expand partially or in full. Using one or more of thedelivery system10, theguidewire105, and a snare, the distal end of thedelivery system10 can be positioned to be substantially perpendicular to the plane of the mitral annulus. It can also be positioned so that the tips of thedistal anchors80 on theprosthesis70 are midway between a plane formed by the top of themitral annulus106 and a plane formed by the tops of thepapillaries110. The chordae tendineae110 extend between thenative leaflets108 attached to themitral annulus106 and thepapillaries110. The implanted prosthesis, and structures of theheart83, are shown with respect toFIG. 13 and discussed below.
• In some embodiments, ahandle14 can control all or part of the expansion of theprosthesis70. The user can then begin rotating a retraction knob to retract theouter sheath assembly22 until thedistal anchors80 begin to extend out from theouter sheath assembly22. Retracting theouter sheath assembly22 can allow the valve to self-expand. In other embodiments, such as described below, retraction of theouter sheath assembly22 can cause thedistal anchors80 to flip from a delivery orientation where they extend distally to a deployed orientation where they extend proximally. In some embodiments, theouter sheath assembly22 can be at least partially retracted. Thedistal anchors80 can then be positioned between thechordae tendineae110. The angle and depth of thedistal anchors80 then be adjusted to engage one ormore leaflet108 of the mitral valve. Thus, thedistal anchors80 can be move back towards theannulus106 and in some embodiments may engage theleaflet108 and/or the ventricular side of theannulus106. At the same time, thefirst end301 of theprosthesis70 can remain retained by thedelivery system10 in an at least partially radially compacted state. This can allow the position of theprosthesis70 to still be readily adjusted.
• In some embodiments, thedistal anchors80 can be positioned first at one side of the left ventricle to engage thechordae tendineae110 and onevalve leaflet108 before engaging the other side and theother leaflet108. As the mitral valve is a bicuspid valve, thedelivery system10 can be used to attach thedistal anchors80 first to the posterior leaflet and then to anterior leaflet. This second part can be done after theprosthesis70 is expanded or further expanded by further retracting theouter sheath assembly22.
• In some embodiments, the entrance route of thedelivery system10 into the left atrium can bias thedelivery system10 towards one side of the mitral valve. For example, thedelivery system10 may be biased towards the posterior leaflet of the mitral valve. This can facilitate securing thedistal anchors80 to the posterior side or the posterior leaflet first, prior to expanding or further expanding thereplacement heart valve70. Thedistal anchors80 can then be secured to the anterior side of the mitral valve or to the anterior leaflet.
• After thedistal anchors80 are released, thedelivery system10 andprosthesis70 can be moved proximally, which in some embodiments, causes thedistal anchors80 to engage thenative leaflets108 and/ornative valve annulus106. In addition to physically moving the delivery system, this may also be done by pushing theguidewire105 from the venous side towards themitral annulus106. Once thedistal anchors80 are properly placed, thedelivery system10 can then release the proximal anchors82 and the proximal end of theprosthesis70. This can allow further self-expansion of theprosthesis70 so that the proximal anchors82 engage the upstream or atrial side of the native annulus, and theprosthesis70 is deployed in operational condition. This can be by fully retracting theouter sheath assembly22, such as by rotating the control knob, until theprosthesis70 has reached its fully expanded state. However, the proximal anchors82 do not necessarily engage thenative annulus106, and may be positioned above theannulus106 or engage the wall of theatrium102.
• While thedelivery system10 as described above involves retraction of anouter sheath assembly22 to uncover and deploy aprosthesis70 contained therein, in some embodiments thedelivery system10 can deploy aprosthesis70 with little to no proximal retraction of theouter sheath assembly22. For example, components of theouter sheath assembly22 can be designed to separate, as discussed below, to allow for deployment of theprosthesis70.
• For example, in some embodiments, thethird segment60 of theouter sheath assembly22 can incorporate one or more breakaway stitches to allow thethird segment60 to separate. Breakage of the breakaway stitch can be controlled by the user of thedelivery system10. For example, thehandle14 of thedelivery system10 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 thedelivery system10. For example, the breakaway stich can be designed to break after theouter sheath assembly22 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 thedelivery system10 can include similar structures and/or mechanisms.
• In some embodiments, thethird segment60 of theouter sheath assembly22 can be peeled away to uncover the replacement valve (e.g., prosthesis70) 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 thethird segment60 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 thedelivery system10 can include similar structures and/or mechanisms.
• It will be understood that in some embodiments theprosthesis70 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 theinner assembly18 and can positioned at theimplant retention area16 as part of the third segment36.
• Control mechanisms and components at the handle can be used to move different portions of thedevice10. To move theouter sheath assembly22 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 theouter sheath assembly22 to move proximally. Then, to move themid shaft assembly20, the control mechanism is pulled backwards. Springs can be used to give feedback to the user and to better control the movement of themid shaft assembly20 to thereby provide a controlled release of the prosthesis. In addition, the pre-compressedmid shaft50 can maintain a continuous extension force between theinner assembly18 and themid shaft assembly20 to keep theinner retention member32 bottomed out inside theouter retention member40 so that the distal tip of thedelivery system10 maintains maximum flexibility and freedom of motion and the prosthesis does not unlock and prematurely deploy.
• Thehandle14 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 toFIG. 13 which illustrates a schematic representation of an embodiment of a replacement heart valve (prosthesis70) positioned within a native mitral valve of aheart83. Further details regarding how theprosthesis70 may be positioned at the native mitral valve are described in U.S. Patent application Ser. No. 14/716,507, filed May 19, 2015, the entirety of which is hereby incorporated by reference, including but not limited toFIGS. 13A-15 and paragraphs [0036]-[0045]. A portion of the native mitral valve is shown schematically and represents typical anatomy, including aleft atrium102 positioned above anannulus106 and aleft ventricle104 positioned below theannulus106. Theleft atrium102 andleft ventricle104 communicate with one another through amitral annulus106. Also shown schematically inFIG. 13 is a nativemitral leaflet108 havingchordae tendineae110 that connect a downstream end of themitral leaflet108 to the papillary muscle of theleft ventricle104. The portion of theprosthesis70 disposed upstream of the annulus106 (toward the left atrium) can be referred to as being positioned supra-annularly. The portion generally within theannulus106 is referred to as positioned intra-annularly. The portion downstream of theannulus106 is referred to as being positioned sub-annularly (toward the left ventricle).
• As shown in the situation illustrated inFIG. 13, the replacement heart valve (e.g., prosthesis70) can be disposed so that themitral annulus106 is between thedistal anchors80 and the proximal anchors82. In some situations, theprosthesis70 can be positioned such that ends or tips of thedistal anchors80 contact theannulus106 as shown, for example, inFIG. 13. In some situations, theprosthesis10 can be positioned such that ends or tips of thedistal anchors80 do not contact theannulus106. In some situations, theprosthesis70 can be positioned such that thedistal anchors80 do not extend around theleaflet108. Further, theprosthesis70 can be at least partially surrounded by anannular flap81 between thedistal anchors82 and the proximal anchors82. Thisflap81 can wrap around the frame of theprosthesis70 and help position theprosthesis70 in the desired position in the body.
• As illustrated inFIG. 13, thereplacement heart valve70 can be positioned so that the ends or tips of thedistal anchors80 are on a ventricular side of themitral annulus106 and the ends or tips of the proximal anchors82 are on an atrial side of themitral annulus106. Thedistal anchors80 can be positioned such that the ends or tips of thedistal anchors80 are on a ventricular side of the native leaflets beyond a location wherechordae tendineae110 connect to free ends of the native leaflets. Thedistal anchors80 may extend between at least some of thechordae tendineae110 and, in some situations such as those shown inFIG. 13, can contact or engage a ventricular side of theannulus106. It is also contemplated that in some situations, thedistal anchors80 may not contact theannulus106, though thedistal anchors80 may still contact thenative leaflet108. In some situations, thedistal anchors80 can contact tissue of theleft ventricle104 beyond theannulus106 and/or a ventricular side of the leaflets.
• During delivery, the distal anchors80 (along with the frame) can be moved toward the ventricular side of theannulus106 with thedistal anchors80 extending between at least some of thechordae tendineae110 to provide tension on thechordae tendineae110. The degree of tension provided on thechordae tendineae110 can differ. For example, little to no tension may be present in thechordae tendineae110 where theleaflet108 is shorter than or similar in size to the distal anchors80. A greater degree of tension may be present in thechordae tendineae110 where theleaflet108 is longer than thedistal anchors80 and, as such, takes on a compacted form and is pulled proximally. An even greater degree of tension may be present in thechordae tendineae110 where theleaflets108 are even longer relative to the distal anchors80. Theleaflet108 can be sufficiently long such that thedistal anchors80 do not contact theannulus106.
• The proximal anchors82 can be positioned such that the ends or tips of the proximal anchors82 are adjacent the atrial side of theannulus106 and/or tissue of theleft atrium102 beyond theannulus106. In some situations, some or all of the proximal anchors82 may only occasionally contact or engage atrial side of theannulus106 and/or tissue of theleft atrium102 beyond theannulus106. For example, as illustrated inFIG. 13, the proximal anchors82 may be spaced from the atrial side of theannulus106 and/or tissue of theleft atrium102 beyond theannulus106. The proximal anchors82 could provide axial stability for theprosthesis10. In some situations, some or all of the proximal anchors82 may not contact anannular flap81. This may occur when theannular flap81 is in a collapsed configuration although it may also occur when theannular flap81 is in an expanded configuration. In some situations, some or all of the proximal anchors82 may contact theannular flap81. This may occur when theannular flap81 is in an expanded configuration although it may also occur when theannular flap81 is in a collapsed configuration. It is also contemplated that some or all of the proximal anchors82 may contact the atrial side of theannulus106 and/or tissue of theleft atrium102 beyond theannulus106
• Theannular flap81 can be positioned such that a proximal portion of theannular flap81 is positioned along or adjacent an atrial side of theannulus106. The proximal portion can be positioned between the atrial side of theannulus106 and the proximal anchors82. The proximal portion can extend radially outward such that theannular flap81 is positioned along or adjacent tissue of theleft atrium102 beyond theannulus106. Theannular flap81 can create a seal over the atrial side of theannulus106 when theflap81 is in the expanded state.
Guide Sheath
• In some embodiments, a guide sheath can be used in conjunction with thedelivery system10 disclosed herein, such as shown inFIG. 1, to deliver aprosthesis70 into the heart of a patient.FIG. 14 illustrates a schematic representation of an embodiment of such aguide sheath90.
• In particular, theguide sheath90 can be configured to at least partially cover the distal end of thedelivery system10 during insertion of thedelivery system10 into the patient and prevent thedelivery system10 from injuring tissue during its insertion. Thus, in some embodiments theguide sheath90 can be inserted into the proper location, such as by following a guide wire discussed above, and then thedelivery system10 can pass through the lumen of theguide sheath90 and out or along a distal end of theguide sheath90.
• As shown inFIG. 14, in some embodiments theguide sheath90 can comprise a modified distal tip. Theguide sheath90 may be formed of a thin tube, e.g. similar to a catheter, and can include atube portion89 proximal to adistal tip92. In some embodiments, thetube portion89 of theguide sheath90 can comprise 80% to 95% of a length of theguide sheath90. Thedistal tip92 can be attached to the end of thetube portion89, or can be integrally formed with thetube portion89.
• Theguide sheath90 can be formed of a plastic or metal material, and the particular material is not limiting. Thedistal tip92 can be formed of the same or different material than thetube portion89. In some embodiments, thedistal tip92 can be semi-rigid. Thedistal tip92 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 thedistal tip92 can also be covered or encapsulated with alayer99 of ePTFE, PTFE, or other material so that an inner surface of thedistal tip92 is generally smooth. The smooth PTFEinner lining99 of thedistal tip92 can reduce friction when thedelivery system10 is advanced along thedistal tip92. In some embodiments, thelayer99 can be incorporated into the lumen of thetube portion89.
• As shown inFIG. 14, unlike thetube portion89 of theguide sheath90 which is fully enclosed, thedistal tip92 of theguide sheath90 can have an open or openable wall/window/section/opening which directs thedelivery system10, and/or an expandingprosthesis70, to the desired location. For example, if thetube portion89 is positioned within a transseptal puncture, thedistal tip92 with open or openable wall may extend to the native mitral valve to provide a bearing surface for the delivery system and/or prosthesis to track along toward the native mitral valve.
• FIG. 15 illustrates a cross-section of thedistal tip92 further illustrating the open wall. As shown, thedistal tip92 may not be a closed circle along at least a portion of thedistal tip92. For example, the cross section of thedistal tip92 can have apartial circle segment94, e.g. a half-circle shape, with an open segment96 (e.g., the open or openable wall/window/section/opening). However, thedistal tip92 may be more or less than a half-circle (such as ¼ circle or % circle), and the particular circumferential distance is not limiting. Thepartial circle segment94 can be rigid or semi-rigid. In some embodiments, the open oropenable segment96 of thedistal tip92 is located along the inner curvature of thedistal tip92. However, the open or openable segment may face other directions as well. In other embodiments, thedistal tip92 may have overlapping sections that open up as a device passes through the distal tip.
• In some embodiments, thepartial circle segment94 can flatten (or unfold) to form an arc with a larger diameter than a diameter of the full circle cross-section of theguide sheath90. Thus, thepartial circle segment94 may be able to change in dimension (e.g., widen out) under certain circumstances.
• In some embodiments, adistalmost segment95 of thedistal tip92 can form a full circle again, and thus theopen segment96 may not extend along the entiredistal tip92. In some embodiments, theopen segment96 may extend along the entiredistal tip92. In some embodiments, thedistalmost segment95 of thedistal tip92 can be tapered. In some embodiments, thedistal tip92 can terminate at a rounded atraumatic end to minimize tissue damage during implantation. In some embodiments, thedistal tip92 can have a lumen which can allow it to pass over a guidewire.
• In some embodiments, thedistal tip92 can be pre-shaped to match a desired anatomical location. For example, thedistal tip92 can comprise a preset nitinol spine, such as discussed below, having a curvature that matches the desired anatomical location. Thus, thedistal tip92 can bend in the same direction as the curvature required for thedelivery system10 to travel from the septum hole to the mitral valve.
• In some embodiments, as shown inFIG. 14, thedistal tip92 of theguide sheath90 can have buckle points93 betweenstiff sections88 allowing theguide sheath90 to conform with a patient's anatomy. The buckle points93 can comprise one or more rings/segments of a weakened wall in thedistal tip92. The buckle points93 can provide for multiple bending points, allowing for thedistal tip92 to bend at the buckle points93 such as when theguide sheath90 abuts against portions of a patient's vasculature system. The bendabledistal tip92 can advantageously allow thedistal tip92 to bend as thedistal tip92 is advanced through the vasculature of the patient, thus reducing or preventing damage to the patient. For example, if thedistalmost segment95 is delivered into the left ventricle or within the native mitral annulus, thedistalmost segment95 may be delivered so that it is supported by the more rigid native anatomical landmarks such as the left ventricle or the mitral annulus, and thedistal tip92 may bend in multiple locations as shown inFIG. 14 between the native mitral valve and the transseptal puncture. This allows for longer, stiffer implants to be utilized because the delivery path does not require as sharp of a turn once crossing the septum in order to reach the mitral valve.
• FIG. 16 illustrates a side cross-section of thedistal tip92 similar to the one shown inFIG. 14.FIG. 16 illustrates some additional components which can be used with theguide sheath90, though may not be included in all embodiments. For example, theguide sheath90 can include apull wire91 attached to ananchor ring97 which can allow for some manipulation of thesheath90 during the insertion through the vasculature of a patient by pulling and releasing thepull wire91. Thepull wire91 can be coupled to the guide sheath90 (either in thetube portion89 or the distal tip92) from a proximal end of theguide sheath90 to the distal end. Theanchor ring97 can be located near the distal end of thedistal tip92 or near the distal end of thetube portion89, though the particular location is not limiting. Thepull wire91 may be used to redirect the guide sheath during advancement of theguide sheath90 through the vasculature of the patient, for example, when passing through an opening of the patient's anatomy or around a sharp turn. For example, theanchor ring97 can transmit the pulling force of thepull wire91 along a circumference of theguide sheath90 to facilitate redirecting of theguide sheath90. Further, thepull wire91 and theanchor ring97 can advantageously allow astraight guide sheath90 instead of a guide sheath with a pre-curved distal tip to be used. The straight guide sheath can be more easily advanced through the patient's anatomy than the guide sheath with the pre-curved distal tip. When thedistal tip92 of thestraight guide sheath90 has been advanced to its desired location, thepull wire91 may be pulled so that thedistal tip92 forms a tightened curve for tracking thedelivery system10. Thepull wire91 may be located on an outer or inner surface of thepartial circle segment94.
• In some embodiments, thedistal tip92 can comprise an articulatedspine98, such as a laser-cut nitinol spine, that is semi-rigid. In some embodiments, thespine98 can have a preset curvature for passing along the patient's vasculature.FIG. 17 illustrates a flat pattern view of the laser-cutspine98. As shown, the laser-cutspine98 can haveslits982 and/or perforations/holes/apertures984. Theslits982 orperforations984 can run in a radial and/or longitudinal direction. Theslits982 can extend from the outer perimeter of thespine98 towards the interior. In some embodiments, theslits982 can be generally triangular in shape, but can include acircular portion983 where theslits982 end at thecentral spine985. In some embodiments, theslits982 can be shaped so that theflanges987 between the slits are angled in a particular direction (such as distal or proximal).
• Theperforations982 can be located on theflanges987. In some embodiments, theflanges987 can each contain twoperforations982, with oneperforation982 located radially outward from theother preformation982.
• In some embodiments, thespine98 can contain twoend portions989 on opposite longitudinal ends of thespine98. Theend portions989 can be generally rectangular in shape, though one or both may be modified to accept one of theslits982. Further, theend portions989 may include a number ofperforations982.
• In other embodiments, the wall of thedistal tip92 can also have cutouts of various shapes not discussed above, and the particular shapes are not limiting.
• The laser-cutspine98 can be rolled up to form a wall of thedistal tip92, which can be open (with an open segment) or openable (with overlapping walls that can be opened by expanding thespine98 to remove the overlap). Specifically, the laser-cutspine98 can be rolled up such that a firstlongitudinal edge986 of thespine98 does not touch a secondlongitudinal edge988 of thespine98, forming a partial circle segment similar to thepartial circle segment94 shown inFIG. 15. The laser-cutspine98 can also be rolled up such that the firstlongitudinal edge986 of the laser-cutspine98 overlap with the secondlongitudinal edge988 of the laser-cutspine98, forming an openable distal tip with an overlapping section. The first and secondlongitudinal edges986,988 can move relative to each other so that thedistal tip92 can contract or expand, e.g. when a device passes through thedistal tip92. In some embodiments, thedistal tip92 may comprise a shape memory alloy or superelastic alloy with a memorized shape. In some embodiments, thedistal tip92 may be articulated by a pull wire, as discussed above. In some embodiments, thespine98 may be covered by a layer of material, such as ePTFE, to form a rectangular shape so theslits982 are covered.
• In some embodiments, an expandable piece of cloth (not shown inFIG. 17) can line theopen segment96 of thedistal tip92 made from the rolled-up laser-cutspine98. The cloth can expand when stiffer sections of thedelivery system10 pass through thedistal tip92. The stiff sections of thedelivery system10 may not bend along the curvature of thedistal tip92 and a portion of the stiff sections can partially protrude outside a lumen formed by the wall of thedistal tip92. The expandable cloth advantageously prevents the stiff sections from getting caught on the heart tissue (or other vascular tissue) and causing trauma.
• Embodiments of the disclosedguide sheath90 can be advantageous for insertion of thedelivery system10 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 thedelivery system10 and by making it easier to track thedelivery system10 andimplant70 to the native mitral valve. Similar to the steps shown inFIG. 12, in one embodiment a guidewire (not shown) can be placed in the ipsilateral femoral vein and advanced to the right atrium. A transseptal puncture using known techniques can then be performed to obtain access to the left atrium. The guidewire can then be advanced in to the left atrium and then to the left ventricle. The guidewire can extend from the ipsilateral femoral vein to the left atrium. Unlike the steps shown inFIG. 12, theguide sheath90 eliminates the need for snares for guidewire manipulation.
• With the guidewire in place, theguide sheath90 can be introduced into the body over the guidewire to the mitral valve from the left atrial septum. Theguide sheath90 can be positioned such that thetube portion89 is positioned and crosses the transseptal puncture. Alternatively, thedistal tip92 may be placed in the transseptal puncture, where the openable wall would be compressed by the septum. Thedistal tip92 can reach before, at or past the mitral valve. In one embodiment, an introducer sheath and/or catheter (not shown inFIGS. 14-17) may retain the semi-rigiddistal tip92 when theguide sheath90 is introduced over the guidewire. In another embodiment, a standard introducer device (not shown inFIGS. 14-17) can be used to aid the introduction of theguide sheath90 with the pre-shaped, such as pre-curved,distal tip92. For example, the introducer device can be a rod or tube that is more rigid than the pre-shapeddistal tip92 and can be inserted into the lumen of theguide sheath90 to hold the pre-shapeddistal tip92 straight before advancing theguide sheath90 into the patient. The introducer device can be retracted after theguide sheath90 has reached the desired location and thedistal tip92 can then resume its preset shape. The introducer device can advantageously allow easier introduction of the pre-shapeddistal tip92 of theguide sheath90 across the septum. Once at its desired location, thedistal tip92 can be supported by more rigid native anatomical landmarks such as the left ventricular wall or the mitral valve annulus. The support from the anatomical landmarks can provide additional rigidity to theguide sheath90 to help thedelivery system10 to make the turn toward the mitral valve after thedelivery system10 passes the septum puncture. In some embodiments, once the guidesheath distalmost segment95 is supported by the native mitral valve or left ventricle, thedistal tip92 would be able to flex or bend as described above to provide a suitable delivery path.
• Theguide sheath90 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, theguide sheath90 can eliminate the need for the distal portion29 of thedelivery system10 to make a sharp turn to reach the desired location. Thedistal tip92 of the guide sheath allows thedelivery system10 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 aguide sheath90 as described herein, thedelivery system10 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, theguide sheath90 also prevents theprosthesis70 or thedelivery system10 from getting caught on the non-uniform heart tissue and potentially causing damage to the heart tissue.
• As shown inFIG. 14, a lumen formed by the wall of thedistal tip92 allows thedelivery system10 to track along a curvature of the inner wall of thedistal tip92 as thedelivery system10 is directed to a desired position. Specifically, the closed segment of thedistal tip92 provides a bearing surface to be pushed against by thedelivery system10 and directs theelongate shaft assembly12 to cross the mitral valve. Theopen segment96 allows stiff sections of thedelivery system10 or theprosthesis70 to pass without bending at the stiff sections. Theopen segment96 also allows thedistal tip92 to flatten to a wider arc to keep thedelivery system10 contained. In embodiments of thedistal tip92 with the overlapping section, the overlapping section also aids in preventing thedelivery system10 from leaving the track.
• Once theprosthesis70 has been delivered to its desired location using thedelivery system10, it can be deployed using the methods described herein. In some embodiments, thedistal tip92 can be an attachment to a conventional catheter used to cross a transseptal puncture and remains during deployment of theprosthesis70. Having thedistal tip92 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, theguide sheath90 is an independent unit. Theguide sheath90 can have a working length of about80 cm and can act as both a femoral sheath and a septal working hole. Theguide sheath90 can advantageously be retracted once thedelivery system10 crosses the mitral valve so as to not avoid interfering with deployment of theprosthesis70.
• In some embodiments, a portion of the openable segment of thedistal tip92 instead of the full-circle section of theguide sheath90 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. Theguide sheath90 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 thedelivery system10 can eliminate the need for snaring as discussed above through the use of an anchored guidewire shown inFIG. 18 instead of theguidewire105.
• For example, an anchoredguidewire500,500′,500″ can comprise one ormore anchors514,514′,514″ attached to a guidewire to form an anchoredguidewire500,500′,500″ as shown inFIGS. 18-20. Theanchors514,514′,514″ can be coupled to the guidewire mechanically or via welding (such as in a lumen of theanchors514,514′,514″ discussed below), or other methods of coupling known in the art. In some embodiments, theanchor514,514′,514″ is made of nitinol, though the particular material is not limiting. Theanchor514,514′,514″ is configured to engage tissue, such as heart tissue in the left ventricular wall at or near the apex of the heart, and provide secure guidewire placement. In some embodiments, theanchor514,514′,514″ can comprise a hook, barb, or other anchoring mechanisms.
• FIG. 18 illustrates an exploded view of an embodiment of an anchoredguidewire500. As shown, theanchor514 can include atorque shaft510, ananchor connector516 having a taperedproximal end526, aretainer ring512 configured to surround the taperedproximal end526 of theanchor connector516, and ananchor portion513. Theanchor portion513 can have one or more hooks520 (or520′ and520″) on a distal end of theanchor portion513 and aring portion522 on a proximal end of theanchor portion513. Further, thetorque shaft510, theretainer ring512, theanchor portion513, and theanchor connector516 can have alumen515 extending through them.
• To assemble theanchor514, theanchor connector516 can slide into the lumen of theanchor portion513 from the distal end of theanchor portion513. Theanchor connector516 can include a plurality of raisedportions517 on an outer surface proximate a distal end of theanchor connector516. The raisedportions517 can abut thering portion522 of theanchor portion513 on a distal end of thering portion522 to stop theanchor connector516 from sliding past theanchor connector516. Theretainer ring512 can then slide past the taperedproximal end526 of theanchor connector516 and abut thering portion522 of theanchor portion513 on a proximal end of thering portion522. Theretainer ring512 can then be secured to theanchor connector516 in a manner described above, for example, by welding. Thetorque shaft510 can also slide into the lumen of theanchor connector516 from the proximal end of theanchor connector516 and be secured to theanchor connector516 in a manner described above, for example, by welding. The guidewire can then be attached to theanchor514, forming the anchoredguidewire500. The anchoredguidewire500 is configured to be used with thedelivery system10. The anchoredguidewire500 is also configured to be used with other delivery devices with a single lumen or multiple lumens.
• FIG. 19 shows an embodiment of the anchoredguidewire500′. Similar to the anchoredguidewire500 inFIG. 18, the anchoredguidewire500′ also can include ananchor portion513′ similar to theanchor portion513. Unlike the anchoredguidewire500 inFIG. 18, the anchoredguidewire500′ can also comprise a standard guidewire instead of thetorque shaft510 shown inFIG. 18. A distal end of the standard guidewire can be welded (or otherwise attached) to ahousing518 at a proximal end of thehousing518. Theanchor portion513′ can be coupled to a distal end of thehousing518. Thehousing518 can therefore replace theanchor connector516, thetorque shaft510, and theretainer ring512 shown inFIG. 18. In some embodiments, thehousing518 can be made of CoCr, though the particular material is not limiting. The anchored guidewire500′ is configured to be used with thedelivery system10. The anchored guidewire500′ is also configured to be used with other delivery devices with a single lumen or multiple lumens.
• FIG. 20 shows yet another embodiment of the anchoredguidewire500″. Similar to the anchoredguidewire500 inFIG. 18, the anchoredguidewire500″ can include ananchor portion513″ similar to theanchor portion513 inFIG. 18. The anchored guidewire500″ can also include atorque shaft510″ similar to thetorque shaft510 inFIG. 18 except that a distal end of thetorque shaft510″ has an increased outer diameter so that theanchor portion513″ can be directly coupled to the distal end of thetorque shaft510″ without theanchor connector516 and theretainer ring512 inFIG. 18. The anchored guidewire500″ is configured to be used with thedelivery system10. The anchored guidewire500″ is also configured to be used with other delivery devices with a single lumen or multiple lumens.
• During a surgical procedure, acatheter540, such as an articulating catheter (the distal end of which is shown inFIGS. 19 and 20) can first be introduced through a septum puncture, through the left atrium and then into the left ventricle until a distal tip of thecatheter540 presses against the wall of the left ventricle. For example, the distal tip of thecatheter540 presses against the wall of the left ventricle near the apex of the heart. Thecatheter540 can have features that enable thecatheter540 to bend in one direction such that thecatheter540 can pass the septum puncture and then bend to cross the mitral valve.
• The anchoredguidewire500,500′,500″ can then be inserted through thecatheter540 to reach the left ventricle. Thehooks520,520′,520″ of theanchor portions513,513′,513″ can be deflected distally when theanchor portions513,513′,513″ travel inside thecatheter540. Thus, as the anchoredguidewire500,500′,500″ is translated distally, thehooks520,520′,520″ can pierce the heart tissue. Thehooks520,520′,520″ of theanchor portions513,513′,513″ can then deflect radially outward and back proximally once outside of thecatheter540 to catch the wall of the left ventricle, thus keeping the anchoredguidewire500,500′,500″ stable.
• In some embodiments, the anchoredguidewire500,500′,500″ can be pre-loaded into a lumen of thecatheter540, such as an articulating catheter (the distal end of which is shown inFIGS. 19 and 20), before thecatheter540 is introduced into the patient. For example, the anchoredguidewire500,500′,500″ can be pre-loaded such that theanchor portions513,513′,513″ are located at a small distance, such as 2 mm-10 mm, proximally from a distal end of thecatheter540. Pre-loading the anchoredguidewire500,500′,500″ can advantageously allow the user, such as a surgeon, to advance the anchoredguidewire500,500′,500″ distally over a smaller distance for theanchor portions513,513′,513″ to be pushed out of thecatheter540 and anchored into the wall of the left ventricle than having to advance the anchoredguidewire500,500′,500″ through an entire length of thecatheter540.
• For the anchoredguidewire500,500′,500″ that has alumen515,515″, a separate guidewire can be inserted through thelumen515,515″ prior to deploying theprosthesis70. A balloon loaded on the separate guidewire can be inflated to detect any chordae tendineae when crossing the mitral valve. In some embodiments, thecatheter540 can have a balloon (not shown inFIGS. 19 and 20) on an outer wall of thecatheter540. Instead of having to insert the separate guidewire with the balloon, the balloon on the outer wall of thecatheter540 can be inflated to check for the presence of entangled chordae tendineae. Thecatheter540 can then be removed and thedelivery system10, with the valve prosthesis70 (with or without guide sheath90), can be introduced over the anchoredguidewire500,500′,500″. When thedelivery system10 is about to cross the mitral valve, a user can apply tension on the anchor guidewire500,500′,500″, such as by pulling on the anchoredguidewire500,500′,500″. Theanchor portions513,513′,513″ can provide an opposing force and cause a straightening of the anchoredguidewire500,500′,500″. The straightening can cause thedelivery system10 to bend downward toward theanchor portions513,513′,513″ along the anchoredguidewire500,500′,500″. Thetorque shaft510,510″ of the anchoredguidewire500,500″ or the standard guidewire of the anchoredguidewire500′ can act as a rail, allowing thedelivery system10 to glide across the mitral valve.
• Following deployment of theprosthesis70, thecatheter540 can be reintroduced to abut against the heart tissue around the anchoredguidewire500,500′,500″. The anchoredguidewire500,500′,500″ can then be pulled into thecatheter540, compressing thehooks520,520′,520″ within thecatheter540 to disengage thehooks520,520′,520″ from the heart tissue and retract the anchoredguidewire500,500′,500″.
• The anchoredguidewire500,500′,500″ allow for a recapturable method of gaining secure guidewire placement. Thecatheter540 ensures that the user is able to place theanchor portions513,513′,513″ in a desired location. Thetorque shaft510,510″ of the anchoredguidewire500,500″ or the standard guidewire of the anchoredguidewire500′ can act as a rail as opposed to other methods such as snaring, where the user must manipulate multiple devices in order for thedelivery system10 to cross the mitral valve.
Additional Embodiments of Prostheses and Replacement Valves
• With reference toFIGS. 21-27, an embodiment of aprosthesis1010 is shown. The illustratedprosthesis1010 includes aframe1020 that may be self-expanding or balloon expandable. Theprosthesis1010 may be a replacement valve that can be designed to replace a damaged or diseased native heart valve such as a mitral valve, as discussed above. The additional features of the replacement valve are not shown inFIGS. 21-27 in order to more clearly illustrate features of theframe1020. It will also be understood that theprosthesis1010 is not limited to being a replacement valve. In addition, it will be understood inFIG. 21, that only a front portion of theframe1020 is shown for further ease of illustration.
• Theframe1020 can be made of many different materials, but is preferably made from metal. In some embodiments, theframe1020 can be made from a shape memory material, such as nitinol. A wire frame or a metal tube can be used to make theframe1020. 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 theframe1020.FIG. 22 illustrates the flat cut pattern of the frame shown inFIG. 22. As shown, one of theanchors1022 can include an eyelet, which can help manufacturing with alignment. As theframe1020 can be generally round and symmetric, the eyelet can serve as a reference position for frame dimensional measurements as well as alignment. However, the eyelet may not be included in all embodiments. Further, more eyelets can be included on theanchors1022 as well, and the particular number of eyelets is not limiting. The flat pattern can be cut from a metal tube and then the tube can be shaped and/or bent to the expanded shape shown inFIG. 21. In some embodiments, theframe1020 is self-expanding so that it naturally assumes the expanded shape or configuration. Theframe1020 can further be expanded and/or compressed and/or otherwise worked to have the desired shape or shapes, such as for introduction and implantation.
• As shown, the frame when in an expanded configuration, such as in a fully expanded configuration, has a bulbous or slightly bulbous shape, with amiddle portion1033 being larger than the proximal1032 and distal1034 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 amiddle portion1033 larger than both the proximal anddistal ends1032/1034. In some embodiments, the effective diameter of thedistal frame end1034 is smaller than the effective diameter of themiddle portion1033. The bulbous shape of theframe1020 can advantageously allow theframe1020 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, theframe1020 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. Theprosthesis1010 andframe1020 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 theframe1020.FIG. 21 illustrates the frame in an expanded configuration with a number ofproximal struts1012 that extend substantially longitudinally to enlarged proximal ends1013. A proximal row of circumferentially-expansible struts1017 connects theproximal struts1012, having a zig-zag or undulating shape such that between eachproximal strut1012, thestruts1017 form a V-shape. From the distal ends of each of the V's,vertical struts1015 extend substantially longitudinally in a distal direction. The distal ends of thevertical struts1015 then connect to a row of diamond-shapedcells1023 formed by a plurality of circumferentially-expansible struts1014 having a zig-zag or undulating shape. As illustrated, the proximalmost row ofstruts1014 extend distally away from the distal ends of thevertical struts1015 in a V-shape, thereby forming hexagonal-shapedcells1021 bounded by the proximal row ofstruts1017, thevertical struts1015, and the proximalmost row ofstruts1014. The embodiment ofFIG. 21 further comprises a second, distal row of diamond-shapedcells1023 further defined by additional circumferentially-expansible struts1014, wherein the proximalmost corner of the second row of diamond-shapedcells1023 coincides with the distalmost corner of the hexagonal-shapedcells1021 and the side corners of the diamond-shaped cells in the first, proximal row.
• The proximal struts1012 and thevertical struts1015 may be arranged so that they are parallel or generally or substantially parallel to a longitudinal axis of the frame. The proximal struts1012 and thevertical struts1015 can further be inclined relative to the longitudinal axis so that the proximal ends of theproximal struts1012 are closer to the longitudinal axis than distal ends of theproximal struts1012. The longitudinal axis of theframe1020 may be defined as the central axis that extends through the center of theframe1020 between the proximal1032 and distal1034 ends.
• The illustrated embodiment includes one ring, or row of hexagonal or generallyhexagonal cells1021 shown inproximal portion1016 of theframe1020, and two rows of diamond-shapedcells1023 shown indistal portion1018. As discussed in more detail below, theproximal portion1016 includes the portion of thehexagonal cells1021 extending proximally from the distal end ofvertical struts1015 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. Thedistal portion1018 includes the diamond-shapedcells1023 extending distally from the distal ends of thevertical struts1015 and may be considered a foreshortening portion. In some embodiments, thehexagonal cells1021 can be irregular hexagons. For example, thehexagonal cells1021 can be symmetrical about a vertical axis extending from proximal to distal ends of thehexagonal cell1021.Vertical struts1015 can form opposite sides, while circumferentially-expansible struts1014 of two adjacent diamond-shapedcells1023 in the proximalmost row can form a base of thehexagonal cell1021 ending at a distalmost corner that is distal to the distal ends of thevertical struts1015. These circumferentially-expansible struts1014 can connect to thevertical struts1015. Further, the proximal row of circumferentially-expansible struts1017 can form the upper sides of thehexagonal cell1021 that extend to a proximalmost corner of thehexagonal cell1021 that is proximal to the proximal ends ofvertical struts1015. These circumferentially-expansible struts1017 can connect to the proximal ends of thevertical struts1015. In some embodiments, two of the sides of thehexagonal cells1021 can be one length, while the other four sides of thehexagonal cells1021 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, theframe1020 has aproximal portion1016 and adistal portion1018. InFIG. 21 it can be seen that theproximal struts1012 and the majority of thehexagonal cells1021 are included in theproximal portion1016, while circumferentially-expansible struts1014 form thedistal portion1018 having a first, proximal row of diamond-shapedcells1023 and a second, distal row of diamond-shapedcells1023. As illustrated, adjacent cells between the proximal row and the distal row may share common struts. In some embodiments, the diamond-shapedcells1023 in the second, distal row may have a larger longitudinal height than the diamond-shapedcells1023 in the first, proximal row. When the frame is radially collapsed or compacted, thestruts1014 become more parallel with respect to the longitudinal axis of the frame, causing an outer diameter of the frame to decrease and the longitudinal length of the frame to increase in thedistal portion1018. As the frame moves from a compacted position to an expanded position, the longitudinal length of the frame can decrease due to foreshortening of the diamond-shapedcells1023 indistal portion1018. But, the frame length does not substantially change length in theproximal portion1016 due to thevertical struts1015, although the proximal row of circumferentially-expansible struts1017 in theproximal portion1016 may allow for some foreshortening.
• Theframe1020 shown inFIG. 21 can have a relatively squat configuration, as opposed to, for example, the frame shown inFIG. 3. For example, the ratio of the width of the largest portion of theframe1020 to the height (e.g., extending from the proximal1032 to distal end1034) of theframe1020 when the frame is in its expanded configuration can be about 3:1, about 2.5:1, about 2.0:1, about 1.5:1, about 4:3, about 1.3:1, about 1.25:1, or about 1.0:1. Thus, in some embodiments the width at the largest portion of theframe1020 can be greater than the height. Generally, theframe1020 can have a larger aspect ratio than theprosthesis70 shown inFIG. 3. In some embodiments, the height ofportion1016 can be greater than, equal to, or less than the height ofportion1018. In some embodiments, the height ofproximal portion1016 can be approximately ½ the height ofdistal portion1018. In some embodiments, theframe1020 can have an overall height of about 32 mm (or about 32 mm), which can be shorter than the height of theprosthesis70 shown inFIG. 3 having a height of 37 mm (or about 37 mm). Theframe1020 can have an inner diameter of 40 mm (or about 40 mm). In some embodiments, theframe1020 can have a height of 29, 30, 31, 33, 34, 35, or 36 mm (or about 29, about 30, about 31, about 33, about 34, about 35, or about 36 mm).
• Foreshortening of theframe1020 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. Opposinganchors1022,1024 can be constructed on theframe1020 so that portions of the anchors, such as tips or ends1026,1028, move closer together as the frame foreshortens. As one example, this can allow theanchors1022,1024 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 anchors1024) are secured to or grasp tissue, while the other set of anchors (such as anchors1022) are used to provide stabilization and help align the prosthesis, and may or may not directly engage tissue, as described further below.
• Theanchors1022,1024 andanchor tips1026,1028 are preferably located along theframe1020 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 anchors1024 are connected to thedistal portion1018, and may extend from distalmost corners of the diamond-shapedcells1023. As illustrated, thedistal anchors1024 extend distally from distalmost corners of the proximal row of diamond-shapedcells1023, such that the second, distal row of diamond-shapedcells1023 extend longitudinally alongside a portion of the distal anchors.
• Preferably, each of theanchors1022,1024 is positioned or extends generally radially outwardly from theframe1020 so that theanchor tips1026,1028 are generally spaced away or radially outward from the rest of theframe1020 and from where the base of the anchors connect to the frame. For example, the anchor tips may be located radially outward from themiddle portion1033 of the frame, with thetips1026 and1028 being axially spaced from one another. Themiddle portion1033, which has the largest cross-sectional dimension when the frame is radially expanded, can be defined by the proximalmost row of diamond-shapedcells1023. Theanchors1022,1024 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 theframe1020.
• Proximal anchors1022 are shown having a single strut extending into thehexagonal cells1021 ofportion1016. Thus, theanchor1022 extends from a proximal intersection of two segments of thehexagonal cell1021, for example, from the proximalmost corner of thehexagonal cells1021. As shown, theproximal anchors1022 extend generally distally into thehexagonal cells1021 while curving outwards away from theframe1020. Thus, theanchor1022 extends radially outwardly from theframe1020 as it extends generally distally towards thetip1026. Thetips1026 of theproximal anchors1022 can end after extending approximately half the length or more of thehexagonal cells1021. Further, thetips1026 can extend farther outwards than the main body of theframe1020.
• In some embodiments, thetip1026 of theanchor1022 also includes an enlarged orbulbed portion1026, which can be generally circular in shape, though the particular shape is not limiting. As illustrated, thebulbed portion1026 is located at the distal end, though thebulbed portion1026 can be positioned in other locations along theanchor1022. Thebulbed portion1026 can have a radius greater than the width of the rest of theanchor1022, making thebulbed portion1026 larger than the rest of theanchor1022. 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 theanchor1022 distally and radially outwardly.
• As another example, thedistal anchors1024 are shown having looped ends1048. The looped ends can be larger near the tip to form a type of elongated teardrop. In some embodiments, thetips1028 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.
• Eachdistal anchor1024 is connected to the frame at abase1042. As illustrated inFIG. 21, the base of the distal anchor may be at a location where the corners of adjacent cells meet, such that the base is proximal to thedistal end1034 of the frame. In other embodiments, the base of the distal anchor may be at a distal most corner of a cell, which corresponds to a distal most point on the frame The distal anchors as illustrated extend from thebase1042 generally distally before bending back around in an arcuate and/or bent segment where the distal anchor extends generally proximally and radially outwardly from the frame. As shown, theanchors1024 may also extend generally distally and radially inwardly from the base with respect to the frame such that the distal most point on the prosthesis has a smaller inside diameter than where thebase1042 connects to the frame. The inside diameter at the distal most point can be the same or substantially the same as the inside diameter of the proximal end, or may be smaller. As illustrated, theanchors1024 may extend distally from thebase1042 and bend or curve radially inwardly and then curve approximately in a half-circle first further radially inwardly, and then around so that the anchor extends radially outwardly. This half-circle can provide a space for the distal ends of the leaflets to be stored, such as in the configurations described below. The anchors may then extend in a linear segment radially outwardly and proximally. Finally, the anchor may extend towards thetip1028 in a direction parallel or substantially parallel to the longitudinal axis. Thus, the anchor as illustrated is bent around about180 degrees from its base so that thetip1028 extends in the opposite, proximal direction, which may be parallel or substantially parallel to the longitudinal axis of the frame. For example, inFIG. 21 it can be seen that thedistal anchors1024 are bent near thetips1028 such that the ends of the anchors point proximally and are generally parallel with the longitudinal axis of the frame. Alternatively, thetip1028 may extend generally proximally but still extend radially outwardly inclined or at an acute angle relative to the longitudinal axis of the frame
• 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 ends1013 ofproximal struts1012 can be enlarged relative to other portions of the tips1013. For example, the ends of tips1013 can have a generally “mushroom” shape. The proximal struts1012 and enlarged tips1013 can form locking tabs used to engage a locking mechanism of a delivery system for the prosthesis. In some embodiments, thelongitudinal extensions1012 and the mushroom tips1013 can be inclined generally radially inward.
• In the illustrated embodiment ofFIGS. 23-27 there are twelve distal anchors positioned circumferentially around frame and twelve proximal anchors positioned circumferentially around the frame. In some embodiments there may be6 proximal anchors and12 distal anchors, or vice versa. Some embodiments may include different numbers of anchors.
• 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 inFIGS. 26-27, which illustrate cross-sectional cuts for theframe1020, theproximal anchors1022 anddistal anchors1024 are not directly aligned with one another. For example,FIG. 26 illustrates a cross section throughproximal anchors1022 extending to the left and right of theframe1020. As shown, while theproximal anchors1022 are cut, thedistal anchors1024 are not.FIG. 27 illustrates theframe1020 rotated so that thedistal anchors1024 are cut on the left and right sides of theframe1020. Again, theproximal anchors1022 are located circumferentially offset from thedistal anchors1024.
• Theanchor tips1026 and1028 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, theproximal anchors tips1026 anddistal anchor tips1028 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 ofFIGS. 28A-29, a replacement heart valve such as a replacementmitral valve1010 can include anannular flap1050 which can be positioned around and secured to an exterior of theframe1020. In the embodiments described herein, the valve body that includes the artificial valve leaflets that would be attached to the frame is not illustrated, but may be similar to the embodiments shown in U.S. Patent Publication No. 2015/0328000, hereby incorporated by reference. Further in the embodiments described herein, the flap that is discussed below may be similar to embodiments shown in U.S. Patent Publication No. 2015/0328000, hereby incorporated by reference. For example, the valve body can start from the proximalmost ends of thehexagonal cells1021 described above, and can extend below theannular flap1050. Theannular flap1050 can have a distal edge1036 (shown inFIG. 29) secured at or proximate thedistal end1034 of theframe1020 and extend to a proximal edge1040 (shown inFIG. 28A) secured at or proximate an intermediate location on theframe1020 between the proximal anddistal ends1032,1034. In some embodiments, thedistal edge1036 of theannular flap1050 can be provided with a shape that generally corresponds to the shape of theframe1020. This can facilitate the securement of theflap1050 to theframe1020. For example, thedistal edge1036 can include a generally triangular pattern which follows the generally triangular, zig-zag or undulating pattern of the struts offrame1020 along thedistal end1034 offrame1010. Other shapes and/or patterns can be used along thedistal edge1036 of theannular flap1050. In some embodiments, thedistal edge1036 of theannular flap1050 can have no pattern. In some embodiments thedistal edge1036 does not follow the pattern of the struts of theframe1020 and/or can have a different pattern from that of the struts.
• In some embodiments, covers/cushions can be used to surround or partially surround thedistal anchors1024, specifically thetips1028 of thedistal anchors1024, 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 thetips1028 or can have extra padding so that the covers extend radially away from theframe1020. In some embodiments, all of thedistal anchors1024 have the snug fitting covers. In some embodiments, all of thedistal anchors1024 have the padded covers. In some embodiments, some of thedistal anchors1024 have the padded covers and some have the snug covers. In some embodiments, not all of thedistal anchors1024 can have covers. In some embodiments, all of thedistal anchors1024 can have some sort of cover.
• Reference is now made toFIGS. 30A-31B which illustrate schematic representations of an embodiment of areplacement heart valve1010 positioned within a native mitral valve of aheart83. A portion of the native mitral valve is shown schematically and represents typical anatomy, including aleft atrium102 positioned above anannulus106 and aleft ventricle104 positioned below theannulus106. Theleft atrium102 andleft ventricle104 communicate with one another through amitral annulus106. Also shown schematically inFIGS. 30A-31B is a nativemitral leaflet108 havingchordae tendineae110 that connect a downstream end of themitral leaflet108 to the papillary muscle of theleft ventricle104. The portion of thereplacement heart valve1010 disposed upstream of the annulus106 (toward the left atrium) can be referred to as being positioned supra-annularly. The portion generally within theannulus106 is referred to as positioned intra-annularly. The portion downstream of theannulus106 is referred to as being positioned sub-annularly (toward the left ventricle). In the illustrated embodiment, only a part of the foreshortening portion is positioned intra-annularly or sub-annularly, and the rest of thereplacement heart valve1010 is supra-annular. In some embodiments, all of theproximal portion1016 can be super-annular, with thedistal portion1018 being intra-annular and/or sub-annular.
• As shown in the situations illustrated inFIGS. 30A-31B, thereplacement heart valve1010 can be disposed so that themitral annulus106 is between thedistal anchors1024 and the proximal anchors1022. In some situations, theprosthesis1010 can be positioned such that ends ortips1028 of thedistal anchors1024 contact the ventricular side of theannulus106 as shown, for example, inFIGS. 30A-C. In some situations, theprosthesis1010 can be positioned such that ends ortips1028 of thedistal anchors1024 do not contact theannulus106 as shown, for example, inFIGS. 31A-B, and may just contact a downstream side of theleaflet108. In some situations, theprosthesis1010 can be positioned such that thedistal anchors1024 do not extend around theleaflet108 as illustrated, but rather are positioned radially inward of the leaflet. WhileFIGS. 30A-31B are described separately below, it should be understood that one or more of the situations illustrated inFIGS. 30A-31B may be present when theprosthesis1010 is positioned at the implantation location, such as a native mitral valve. For example, in some situations theprosthesis1010 may be positioned such that somedistal anchors1024 may contact theannulus106 while otherdistal anchors1024 may not.
• With reference first to the situations illustrated inFIGS. 30A-31B, thereplacement heart valve1010 can be positioned so that the ends ortips1028 of thedistal anchors1024 are on a ventricular side of themitral annulus106 and the ends or tips of1026 theproximal anchors1022 are on an atrial side of themitral annulus106. Thedistal anchors1024 can be positioned such that the ends ortips1028 of thedistal anchors1024 are on a ventricular side of the native leaflets radially outwardly beyond a location wherechordae tendineae110 connect to free ends of the native leaflets. Thedistal anchors1024 may extend between at least some of thechordae tendineae110 and, in some situations such as those shown inFIGS. 30A-C, can contact or engage a ventricular side of theannulus106. It is also contemplated that in some situations, such as those shown inFIGS. 31A-B, thedistal anchors1024 may not contact theannulus106, though thedistal anchors1024 may still contact thenative leaflet108. In some situations, thedistal anchors1024 can contact tissue of theleft ventricle104 beyond theannulus106 and/or a ventricular side of the leaflets.
• During delivery, the distal anchors1024 (along with the frame1010) can be moved toward the ventricular side of theannulus106 with thedistal anchors1024 extending between at least some of thechordae tendineae110 to provide tension on thechordae tendineae110 after theprosthesis1010 is finally delivered. The degree of tension provided on thechordae tendineae110 can differ. For example, little to no tension may be present in thechordae tendineae110 as shown inFIG. 30C where theleaflet108 is shorter than or similar in size to thedistal anchors1024. A greater degree of tension may be present in thechordae tendineae110 as shown inFIG. 30A and 30B where theleaflet108 is longer than thedistal anchors1024 and, as such, takes on a compacted form and is pulled proximally. An even greater degree of tension may be present in thechordae tendineae110 as shown inFIGS. 31A-B where theleaflets108 are even longer relative to thedistal anchors1024. As shown inFIGS. 31A-B, theleaflet108 is sufficiently long such that thedistal anchors1024 do not contact theannulus106.
• Theproximal anchors1022 can be positioned such that the ends ortips1026 of theproximal anchors1022 are on or adjacent the atrial side of theannulus106 and/or tissue of theleft atrium102 beyond theannulus106. In some situations, some or all of theproximal anchors1022 may only occasionally contact or engage atrial side of theannulus106 and/or tissue of theleft atrium102 beyond theannulus106. For example, as shown inFIGS. 30A-B, theproximal anchors1022 may be spaced from the atrial side of theannulus106 and/or tissue of theleft atrium102 beyond theannulus106. Theproximal anchors1022 may be utilized to provide axial stability for theprosthesis1010 and prevent off-axis orientation. Further, theproximal anchors1022 can act as a safety feature with our without utilizing them for axial stability and off-axis orientation. For example, if theprosthesis1010 is improperly deployed so that the valve body is deployed too low toward theleft ventricle104, theanchors1022 can prevent the valve body from falling into theleft ventricle104. In some situations, such as those shown inFIGS. 30A and 31A, some or all of theproximal anchors1022 may not contact theannular flap1050. This may occur when theannular flap1050 is in a collapsed configuration although it may also occur when theannular flap1050 is in an expanded configuration. It is also contemplated that some or all of theproximal anchors1022 may contact the atrial side of theannulus106 and/or tissue of theleft atrium102 beyond theannulus106. The particular curve of theanchors1022 discussed above can prevent trauma to tissue of theheart83, and can also help with stabilization of theprosthesis1010 in theheart83. [0134]
• With continued reference to the situations illustrated inFIGS. 30A-31B, theannular flap1050 can be positioned such that aproximal portion1051 of theannular flap1050 is positioned along or adjacent an atrial side of theannulus106. Theproximal portion1051 can be positioned between the atrial side of theannulus106 and the proximal anchors1022. Theproximal portion1051 can extend radially outward such that theannular flap1050 is positioned along or adjacent tissue of theleft atrium102 beyond theannulus106. Theannular flap1050 can create a seal over the atrial side of theannulus106 when theflap1050 is in the expanded state.
• Theflap1050 can transition from the collapsed state to the expanded state during systole when pressure in theleft ventricle104 increases. This increased pressure within theleft ventricle104 can cause blood within theleft ventricle104 to be directed to areas of lower pressure, such as the aorta (not shown) and theleft atrium102. During systole the valve body may be closed to prevent blood from flowing back into theleft atrium102. A substantial portion of blood can be forced around theframe1020 and valve body and into theannular flap1050 such that theflap1050 can expand. Sealing along an atrial side of theannulus106 can be particularly effective. Theleft atrium102 can be at a lower pressure in comparison to the pressure of the space between theannular flap1050 and thevalve body1020, which is closer to the pressure of theleft ventricle104. The existence of such a pressure differential between theleft atrium102 and the space during systole can allow theflap1050 to apply a greater force to surrounding tissue within theleft atrium102. During diastole, where blood flows from theleft atrium102 towards theleft ventricle104, theflap1050 can transition from the expanded state back to the collapsed state.
• In some situations such as those shown inFIG. 30A and 31A, theannular flap1050 may not contact the wall of theheart83. This may occur when theannular flap1050 is in a collapsed configuration although it may also occur when theannular flap1050 is in an expanded configuration. In some situations, such as those shown inFIGS. 30B, 30C and 31B, theannular flap1050 may contact the wall of theheart83. This may occur when theannular flap1050 is in an expanded configuration although it may also occur when theannular flap1050 is in a collapsed configuration. As shown inFIG. 30A-31B, theannular flap1050 can also assist in filling gaps which exist between theleaflet108 and the frame1020 (portions of which are illustrated in dashed lines).
• As noted above, although the in vivo situations ofFIG. 30A-31B have been described separately, it should be understood that one or more of these situations may be present when a prosthesis is positioned at the implantation location, such as a native mitral valve. For example, one or more of thedistal anchors1024 may not capture theleaflet108 whereas the remaininganchors1024 may capture theleaflet108. As another example, when theprosthesis1010 is positioned within the native mitral valve, theannular flap1050 can contact the wall of theheart83 along one or more portions of an outermost circumference of theproximal portion1051 and may not contact the wall of theheart83 along other portions of the outermost circumference of theproximal portion1051. For example, theannular flap1050 may contact the wall of theheart83 along an approximately180-degree portion of the outermost circumference of theproximal portion1051 and may not contact the wall of theheart83 along the remaining, approximately 180-degree portion of the outermost circumference of theproximal portion1051.
• 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.

Claims (20)

What is claimed is:

1. A transseptal delivery system for replacement heart 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 heart 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 heart 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 heart valve prosthesis when the proximal portion of the replacement heart valve prosthesis is held by the outer retention ring within the inner retention ring,

wherein the outer sheath assembly comprises a proximal segment and a distal segment,

wherein the distal segment is configured to cover the replacement heart valve prosthesis, and

wherein the distal segment is formed from an inner polymer layer and an outer polymer layer.

2. The transseptal delivery system ofclaim 1, wherein the outer sheath assembly is configured to slide over the nose cone.

3. The transseptal delivery system ofclaim 1, 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.

4. The transseptal delivery system ofclaim 3, wherein the distal section has a greater diameter than the proximal section.

5. The transseptal delivery system ofclaim 3, further comprising a polymer reinforcement in the distal section that at least partially overlaps the intermediate polymer layer.

6. The transseptal delivery system ofclaim 3, 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.

7. The transseptal delivery system ofclaim 3, wherein the hypotube comprises a plurality of circumferentially extending cuts along a longitudinal length thereof

8. The transseptal delivery system ofclaim 1, wherein the mid shaft comprises a longitudinally pre-compressed polymer tube located within the outer sheath assembly, 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 ring.

9. The transseptal delivery system ofclaim 1, 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.

10. A flexible delivery system for replacement heart valve implantation, the delivery system comprising:

an outer sheath comprising a distal segment configured to cover a replacement heart valve, wherein the distal segment is formed from an inner polymer wall and an outer polymer wall, and wherein the distal segment further comprises:

a proximal section comprising a hypotube sandwiched between the inner polymer wall and the outer polymer wall; and

a distal section comprising an intermediate polymer layer sandwiched between the inner polymer wall and the outer polymer wall.

11. The delivery system ofclaim 10, wherein a proximalmost end of the intermediate polymer layer is distal from a distal most end of the hypotube

12. The delivery system ofclaim 10, wherein the distal section has a greater diameter than the proximal section.

13. The delivery system ofclaim 10, wherein the inner polymer wall, the outer polymer wall, and the intermediate polymer layer comprise ePTFE.

14. The delivery system ofclaim 10, further comprising a polymer reinforcement in the distal section that at least partially overlaps the intermediate polymer layer.

15. The delivery system ofclaim 14, wherein the polymer reinforcement comprises a fluorinated ethylene propylene insert.

16. The delivery system ofclaim 10, further comprising a replacement heart valve loaded within the distal section of the distal segment, wherein the replacement heart valve comprises ventricular anchors that apply a radially outward force to the distal section of the distal segment.

17. A flexible delivery system for replacement heart 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 heart valve,

wherein the distal segment is formed from two or more layers,

wherein the two or more layers comprise an inner layer, an outer layer, and one or more intermediate layers positioned between the inner and outer layers, and

wherein the one or more intermediate layers comprises a nitinol hypotube.

18. The flexible delivery system ofclaim 17, wherein the inner layer comprises ePTFE.

19. The flexible delivery system ofclaim 17, wherein the outer layer comprises ePTFE.

20. The flexible delivery system ofclaim 17, wherein the distal segment comprises a proximal portion and a distal portion, wherein the proximal portion comprises a first intermediate layer of the one or more intermediate layers and the distal portion comprises a second intermediate layer of the one or more intermediate layers located distal to the first intermediate layer, and wherein a gap exists between the first intermediate layer and the second intermediate layer.

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