Prosthetic Heart Valves And Apparatus And Methods For Delivery Of Same
Apparatus and methods are described herein for use in the transvascular delivery and deployment of a prosthetic heart valve. In some embodiments, an apparatus includes an outer sheath, a tube member movably disposed within the outer sheath, a retention device coupled to the tube member, and a valve holder. A prosthetic heart valve is disposed within the outer sheath and includes an outer frame and an inner frame that is removably coupled to the valve holder. The outer frame is disposed in an inverted configuration relative to the inner frame. A first actuation wire is releasably coupled to a first portion of the outer frame and releasably coupled to the retention device at a first location on the retention device. A second actuation wire is releasably coupled to a second portion of the outer frame and releasably coupled to the retention device at a second location on the retention device.
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This application is a divisional of U.S. application Ser. No. 16/615,185, filed on Nov. 20, 2019, which application was filed pursuant to 35 U.S.C. § 371 as a United States National Phase Application of International Application No. PCT/US2018/041867 filed Jul. 12, 2018, published in English, which claims the benefit of U.S. Provisional Patent Application No. 62/532,152, entitled “Prosethetic Heart Valves and Apparatus and Methods for Delivery of Same,” filed Jul. 13, 2017 and U.S. Provisional Patent Application No. 62/532,659 entitled “Prosthetic Heart Valves and Apparatus and Methods for Delivery of Same,” filed Jul. 14, 2017, the entire disclosures of which are all incorporated herein by reference in their entireties.
This application is related to U.S. patent application Ser. No. 15/626,607, filed on Jun. 19, 2017, entitled “Prosthetic Mitral Valves and Apparatus and Methods for Delivery of Same,” which is a continuation of International Application No. PCT/US2016/012305, filed on Jan. 6, 2016, which claims priority to and is a continuation-in-part of International Application No. PCT/US15/14572, entitled “Apparatus and Methods for Transfemoral Delivery of Prosthetic Valve,” filed Feb. 5, 2015, which claims priority to and the benefit of U.S. Provisional Patent Application Ser. No. 61/935,899, entitled “Transfemoral Delivery of Prosthetic Mitral Valve,” filed Feb. 5, 2014, and U.S. Provisional Patent Application No. 62/100,548, entitled “Apparatus and Methods for Transfemoral Delivery of Prosthetic Mitral Valve,” filed Jan. 7, 2015. The disclosure of each of the foregoing applications is incorporated herein by reference in its entirety.
International Application No. PCT/US2016/012305 also claims priority to and the benefit of U.S. Provisional Patent Application No. 62/100,548, entitled “Apparatus and Methods for Transfemoral Delivery of Prosthetic Mitral Valve,” filed Jan. 7, 2015. The disclosure of each of the foregoing applications is incorporated herein by reference in its entirety.
International Application No. PCT/US2016/012305 also claims priority to and the benefit of U.S. Provisional Patent Application Ser. No. 62/187,896, entitled “Apparatus and Methods for Delivery of a Prosthetic Mitral Valve,” filed Jul. 2, 2015, and U.S. Provisional Patent Application Ser. No. 62/137,384, entitled “Apparatus and Method for Delivery of a Prosthetic Mitral Valve,” filed Mar. 24, 2015. The disclosure of each of the foregoing applications is incorporated herein by reference in its entirety.
BACKGROUNDEmbodiments are described herein that relate to devices and methods for use in the delivery and deployment of prosthetic valves, and particularly to devices and methods for prosthetic heart valves that provide for delivery of the prosthetic heart valves to within a heart of a patient in an inverted configuration.
Prosthetic heart valves can pose particular challenges for delivery and deployment within a heart. Valvular heart disease, and specifically, aortic and mitral valve disease is a significant health issue in the United States (US); annually approximately 90,000 valve replacements are conducted in the US. Traditional valve replacement surgery involving the orthotopic replacement of a heart valve is considered an “open heart” surgical procedure. Briefly, the procedure necessitates surgical opening of the thorax, the initiation of extra-corporeal circulation with a heart-lung machine, stopping and opening the heart, excision and replacement of the diseased valve, and re-starting of the heart. While valve replacement surgery typically carries a 1-4% mortality risk in otherwise healthy persons, a significantly higher morbidity is associated to the procedure largely due to the necessity for extra-corporeal circulation. Further, open heart surgery is often poorly tolerated in elderly patients. Thus, elimination of the extra-corporeal component of the procedure could result in reduction in morbidities and cost of valve replacement therapies could be significantly reduced.
While replacement of the aortic valve in a transcatheter manner is the subject of intense investigation, lesser attention has been focused on the mitral valve. This is in part reflective of the greater level of complexity associated to the native mitral valve apparatus, and thus, a greater level of difficulty with regards to inserting and anchoring the replacement prosthesis. A need exists for delivery devices and methods for transcatheter mitral valve replacements.
Some known delivery methods include delivering a prosthetic mitral valve through an apical puncture site. In such a procedure, the valve is placed in a compressed configuration within a lumen of a delivery catheter of, for example, 34-36 Fr (i.e. an outer diameter of about 11-12 mm). Delivery of a prosthetic valve to the atrium of the heart can be accomplished, for example, via a transfemoral approach, transatrially directly into the left atrium of the heart or via a jugular approach. In such cases, it is desirable for the prosthetic valve to have a small outer perimeter or profile to allow insertion through a smaller delivery catheter of, for example, 28 Fr (i.e. an outer diameter of about 9 mm). Thus, a need exists for prosthetic heart valves that can have a small profile during delivery while still maintaining the size and characteristics needed to perform their desired function within the heart.
A need also exists for devices and methods for delivering and deploying a prosthetic heart valve within a heart, with the valve disposed within a small diameter delivery sheath and then moving the valve to an expanded configuration within the heart.
SUMMARYApparatus and methods are described herein for various embodiments of a prosthetic heart valve that can be moved to an inverted configuration for delivery of the prosthetic heart valve to within a patient's heart. In some embodiments, an apparatus includes a prosthetic heart valve that includes an inner frame and an outer frame coupled to the inner frame at multiple coupling joints. The prosthetic valve is movable between a first configuration and a second configuration. The multiple coupling joints are configured to allow the outer frame to be moved between a first position relative to the inner frame and a second position relative to inner frame in which the outer frame is inverted relative to the inner frame. The prosthetic valve is in the first configuration when the outer frame is in the first position, and in the second configuration when the outer frame is in the second position.
In some embodiments, an apparatus includes an outer sheath that defines a lumen, a tube member movably disposed within the lumen of the outer sheath and defining a lumen, a retention device coupled to the tube member, a valve holder movably disposed within a lumen defined by the tube member, and a prosthetic heart valve disposed at least partially within the lumen of the outer sheath. The prosthetic heart valve includes an outer frame coupled to an inner frame and the inner frame is removably coupled to a distal end portion of the valve holder. The outer frame is movable between a first configuration relative to the inner frame and a second configuration relative to the inner frame in which the outer frame is inverted relative to the inner frame. The prosthetic heart valve is disposed within the lumen of the outer sheath and the lumen of the tubular member with the outer frame in the second configuration. A first actuation wire is releasably coupled to a first portion of the outer frame and releasably coupled to the retention device at a first location on the retention device. A second actuation wire is releasably coupled to a second portion of the outer frame and releasably coupled to the retention device at a second location on the retention device.
Apparatus and methods are described herein for prosthetic heart valves, such as prosthetic mitral valves, that can be configured to be moved to an inverted configuration for delivery of the prosthetic valve to within a heart of a patient. As described herein, in some embodiments, a prosthetic valve includes an outer frame that can be inverted relative to an inner frame when the prosthetic valve is in a biased expanded configuration. The prosthetic mitral valve can be formed with, for example, a shape-memory material. After inverting the outer frame, the prosthetic valve can be inserted into a lumen of a delivery sheath such that the prosthetic valve is moved to a collapsed configuration.
The delivery sheath can be used to deliver the prosthetic valve to within a patient's heart using a variety of different delivery approaches for delivering a prosthetic heart valve (e.g., prosthetic mitral valve) where the inverted prosthetic valve would enter the heart through the atrium of the heart. For example, the prosthetic valves described herein can be delivered using a transfemoral delivery approach as described in PCT International Application No. PCT/US15/14572 (the “'572 PCT application”) and/or in PCT International Application No. PCT/US16/12305 (the “'305 PCT application”), each disclosure of which is incorporated by reference in its entirety herein, or via a transatrial approach, such as described in U.S. Provisional Patent Application Ser. No. 62/220,704, entitled “Apparatus and Methods for Transatrial Delivery of Prosthetic Mitral Valve,” filed Sep. 18, 2015 (the “'704 provisional application”), which is incorporated herein by reference in its entirety. In another example, the prosthetic valves described herein (e.g., an inverted valve as described herein) could be delivered via a transjugular approach, e.g., via the right atrium and through the atrial septum and into the left atrium, as described in U.S. Provisional Patent Application Ser. No. 62/305,678, entitled “Apparatus and Methods for Delivery of Prosthetic Mitral Valve,” (the “'678 provisional application”) and in U.S. Patent Application Pub. No. 2017/0079790, entitled “Apparatus and Methods for Delivery of Prosthetic Mitral Valve,” (the “'790 publication”) each incorporated by reference in its entirety herein. The prosthetic valves described herein can also be delivered apically if desired. With a transapical approach, after the delivery sheath has been disposed within the left atrium of the heart, the prosthetic mitral valve is moved distally out of the delivery sheath such that the inverted outer frame reverts and the prosthetic valve assumes its biased expanded configuration. The prosthetic mitral valve can then be positioned within a mitral annulus of the heart.
In some embodiments, an apparatus includes a prosthetic valve that includes an inner frame and an outer frame coupled to the inner frame at multiple coupling joints. The multiple coupling joints are configured to allow the outer frame to be moved relative to inner frame such that the prosthetic valve can be moved between a first configuration and a second configuration. The outer frame and the inner frame collectively define a first length of the prosthetic valve when the prosthetic valve is in the first configuration and a second length of the prosthetic valve when the prosthetic valve is in the second configuration and the second length is greater than the first length. The inner frame has a length that is the same when the prosthetic valve is in both the first configuration and the second configuration.
In some embodiments, an apparatus includes a prosthetic heart valve that includes an inner frame and an outer frame coupled to the inner frame at multiple coupling joints. The prosthetic valve is movable between a first configuration and a second configuration. The multiple coupling joints are configured to allow the outer frame to be moved between a first position relative to the inner frame and a second position relative to inner frame in which the outer frame is inverted relative to the inner frame. The prosthetic valve is in the first configuration when the outer frame is in the first position, and in the second configuration when the outer frame is in the second position.
In some embodiments, an apparatus includes a prosthetic heart valve that includes an inner frame, and an outer frame coupled to the inner frame at multiple coupling joints. The multiple coupling joints are configured to allow the outer frame to be moved relative to inner frame such that the prosthetic valve can be moved between a first configuration and a second configuration. The outer frame has an outer frame coupling portion coupled to the inner frame at multiple coupling joints and an outer frame free end portion. The inner frame has an inner frame coupling portion coupled to the outer frame at the multiple coupling joints. A first end portion and an inner frame free end portion are on an opposite end of the inner frame from the first end portion. The multiple coupling joints are disposed between the outer frame free end portion and the first end portion of the inner frame when the prosthetic valve is in the first configuration. The multiple coupling joints are disposed between the inner frame free end portion and the outer frame free end portion when the prosthetic valve is in the second configuration.
In some embodiments, an apparatus includes a prosthetic heart valve that includes an inner frame coupled to an outer frame at multiple coupling joints. The multiple coupling joints are configured to allow the outer frame to be moved relative to the inner frame such that the prosthetic valve can be moved between a first configuration and a second configuration. The outer frame has an outer frame coupling portion coupled to the inner frame at the multiple coupling joints and an outer frame free end portion. The inner frame has an inner frame coupling portion coupled to the outer frame at the multiple coupling joints and an inner frame free end portion. The outer frame free end portion and the inner frame free end portion each open in the same direction when the prosthetic valve is in the first configuration. The outer frame free end portion and the inner frame free end portion open in opposite directions when the prosthetic valve is in the second configuration.
In some embodiments, an apparatus includes a delivery sheath that defines a lumen, a valve holder movably disposable within the lumen of the delivery sheath and a prosthetic heart valve disposed at least partially within the lumen of the delivery sheath in a collapsed configuration. The prosthetic heart valve includes an outer frame coupled to an inner frame and the inner frame is removably coupled to a distal end portion of the valve holder. The outer frame is movable between a first configuration relative to the inner frame and a second configuration relative to the inner frame in which the outer frame is inverted relative to the inner frame. The prosthetic heart valve is disposed within the lumen of the delivery sheath with the outer frame in the second configuration. A first actuation wire is releasably coupled to a first portion of the outer frame and a second actuation wire is releasably coupled to a second portion of the outer frame. Each of the first actuation wire and the second actuation wire have a first portion extending proximally from the outer frame and a second portion extending proximally from the outer frame. The first portion and the second portion of each of the first actuation wire and the second actuation wire are configured to be pulled proximally to urge the outer frame from the second configuration towards the first configuration relative to the inner frame.
In some embodiments, an apparatus includes an outer sheath that defines a lumen, a tube member movably disposed within the lumen of the outer sheath and defining a lumen, a retention device coupled to the tube member, a valve holder movably disposed within the lumen of the outer sheath and within a lumen defined by the tube member, and a prosthetic heart valve disposed at least partially within the lumen of the outer sheath. The prosthetic heart valve includes an outer frame coupled to an inner frame and the inner frame is removably coupled to a distal end portion of the valve holder. The outer frame is movable between a first configuration relative to the inner frame and a second configuration relative to the inner frame in which the outer frame is inverted relative to the inner frame. The prosthetic heart valve is disposed within the lumen of the outer sheath and the lumen of the inner sheath with the outer frame in the second configuration. A first actuation wire is releasably coupled to a first portion of the outer frame and releasably coupled to the retention device at a first location on the retention device. A second actuation wire is releasably coupled to a second portion of the outer frame and releasably coupled to the retention device at a second location on the retention device.
In some embodiments, a method includes inserting a distal end portion of a delivery sheath into a left atrium of a heart. The delivery sheath having a prosthetic mitral valve disposed within a lumen of the delivery sheath and the prosthetic mitral valve has an outer frame coupled to an inner frame such that the outer frame can be moved between a first position relative to the inner frame and a second position relative to the inner frame in which the outer frame is inverted relative to the inner frame. The prosthetic valve is disposed within the lumen of the delivery sheath with the outer frame in the second position relative to the inner frame. The prosthetic mitral valve is moved distally out of the delivery sheath causing the outer frame of the prosthetic mitral valve to revert back to the first position relative to the inner frame such that the prosthetic mitral valve at least partially assumes a biased expanded configuration. The prosthetic mitral valve is positioned within a mitral annulus of the heart.
In some embodiments, an apparatus includes an outer sheath that defines a first lumen and is configured to receive a prosthetic heart valve in a compressed configuration and a tube member movably disposed within the first lumen of the outer sheath and defining a second lumen. A valve holder having at least a portion of which movably disposed within the second lumen of the tube member. The valve holder is configured to be releasably coupled to a prosthetic heart valve during delivery of the prosthetic heart valve to a heart. A retention device is coupled to a distal end portion of the tube member and includes a proximal retention member defining a first opening, a center retention member including a first pin and defining a second opening, and a distal retention member including a second pin. The proximal retention member is fixedly coupled to the tube member and the center retention member is axially movable relative to the proximal retention member between a first position in which the first pin is spaced from the proximal retention member and a second position in which the first pin is disposed within the first opening of the proximal retention member. The distal retention member is axially movable relative to the center retention member between a first position in which the second pin is disposed at a spaced distance from the center retention member and a second position in which the second pin is disposed within the second opening. The retention device can be actuated to secure an actuation wire releasably coupled to a prosthetic heart valve to the retention device when at least one of the center retention member is moved to its second positon and the first pin secures a first loop of the actuation wire to the retention member or the distal retention member is moved to its second position and the second pin secures a second loop of the actuation wire to the retention device.
In some embodiments, a method includes placing a first loop of an actuation wire over a first pin of a retention device of a prosthetic heart valve delivery device. The retention device includes a proximal retention member that defines a first opening, a center retention member that includes the first pin and defines a second opening, and a distal retention member that includes a second pin. A first portion of the actuation wire is passed through a first loop on an outer frame of a prosthetic heart valve and a second portion of the actuation wire is passed through a second loop on the outer frame of the prosthetic heart valve. The first portion of the actuation wire has a second loop disposed on a first end of the actuation wire and the second portion of the actuation wire has a third loop on a second end of the actuation wire. The second loop and the third loop of the actuation wire are placed over the second pin of the retention device. The retention device is actuated to move one of the center retention member and the proximal retention member axially such that the first pin is disposed in the first opening and the first loop of the actuation wire is secured to the retention device. The retention member is actuated again to move the distal retention member axially such that the second pin is disposed in the second opening and the second loop and the third loop of the actuation wire are secured to the retention device. The prosthetic valve is placed within a lumen of a sheath of the delivery device.
In some embodiments, a method includes inserting a distal end portion of a delivery sheath of a valve delivery device into a left atrium of a heart, when the delivery sheath has a prosthetic mitral valve disposed within a lumen of the delivery sheath. The prosthetic mitral valve has an outer frame coupled to an inner frame and the outer frame is inverted relative to the inner frame. The prosthetic heart valve is releasably coupled to a retention device that includes a proximal retention member defining a first opening, a center retention member including a first pin and defining a second opening, and a distal retention member including a second pin. An actuation wire is coupled to the prosthetic heart valve and includes a first loop secured to the retention device with the first pin and a second loop secured to the retention device with the second pin. The prosthetic mitral valve is moved distally out the distal end portion of the delivery sheath. The retention device is moved proximally such that the actuation wire pulls the outer frame of the prosthetic heart valve proximally and the outer frame is reverted relative to the inner frame. The retention device is actuated such that the distal retention member moves axially relative to the center retention member and the second pin releases the second loop of the actuation wire. After actuating the retention device, the retention device is moved proximally such that the actuation wire is pulled proximally and is uncoupled from the prosthetic heart valve, allowing the outer frame of the prosthetic heart valve to move to a biased expanded configuration. The prosthetic heart valve is then positioned within a mitral valve annulus of the heart.
In some embodiments, an apparatus includes a prosthetic heart valve that includes an inner frame and an outer frame coupled to the inner frame. The outer frame includes a body portion and a cuff portion and is configured to be moved relative to the inner frame such that the prosthetic valve can be moved between a first biased expanded configuration in which the outer frame is disposed substantially surrounding the inner frame and a second configuration in which the outer frame is inverted relative to the inner frame such that a free end portion of the outer frame opens in an opposite direction than a free end portion of the inner frame. The cuff portion includes a first portion disposed at a transverse angle relative to the body portion and a second portion extending at a transverse angle relative to the first portion of the cuff portion when the prosthetic heart valve is in the biased expanded configuration.
In some embodiments, an actuation wire for use in delivery of a prosthetic heart valve to a heart of a subject includes a first elongate strand having a first end and a second end, a second elongate strand having a first end and a second end. A first loop is disposed at the first end of the first elongate strand, a second loop is disposed at a first end of the second elongate strand, and a third loop is disposed between the second end of the first elongate strand and the second end of the second elongate strand. The first loop, the second loop and the third loop are each configured to be releasably pinned to a delivery device and the first elongate strand and the second elongate strand are each configured to be releasably coupled to the prosthetic heart valve.
The outer frame 120 is configured to have a biased expanded or undeformed shape and can be manipulated and/or deformed (e.g., compressed or constrained) and, when released, return to its original (expanded or undeformed) shape. For example, the outer frame 120 can be formed of materials, such as metals or plastics, which have shape memory properties. With regards to metals, Nitinol® has been found to be especially useful since it can be processed to be austenitic, martensitic or super elastic. Other shape memory alloys, such as Cu—Zn—Al—Ni alloys, and Cu—Al—Ni alloys, may also be used. The inner frame 150 can be formed from a laser-cut tube of Nitinol®. The inner frame 150 can also have a biased expanded or undeformed shape and can be manipulated and/or deformed (e.g., compressed and/or constrained) and, when released, return to its original (expanded or undeformed) shape. Further details regarding the inner frame 150 and the outer frame 120 are described below with respect to valve 200 and
The valve 100 can be delivered and deployed within a left atrium of a heart using a variety of different delivery approaches including, for example, a transfemoral delivery approach, as described in the '572 PCT application, or a transatrial approach, as described in the '704 provisional application. As described above, in some situations, such as when delivering a prosthetic valve to the heart via a transfemoral or transatrial approach, because of the smaller size of the lumen of the delivery sheath, the size of the prosthetic valve during delivery should be sized accordingly. Thus, it is desirable to have a prosthetic valve that can be reconfigured between a biased expanded configuration for implantation in the heart (e.g., within a native mitral annulus) and a delivery configuration that has a smaller outer perimeter or profile to allow for delivery within the lumen of the delivery sheath. The prosthetic valve 100 and the embodiments of a prosthetic valve described herein can be constructed and formed to achieve these desired functions and characteristics.
More specifically, the valve 100 can have a biased expanded configuration (as shown in
To enable the valve 100 to be moved to the inverted configuration, the outer frame 120 can be coupled to the inner frame 150 in such a manner to allow the outer frame 120 to move relative to the inner frame 150. More specifically, the coupling joints 146 can couple the outer frame 120 to the inner frame 150 in such a manner to allow the outer frame 120 to be moved relative to the inner frame 150. For example, in some embodiments, the coupling joints 146 can be configured to allow the outer frame 120 to rotate about the coupling joint 146 relative to the inner frame 150. In some embodiments, coupling joints can provide a pivotal coupling between the outer frame 120 and the inner frame 150. In some embodiments, the coupling joints can provide a flexible attachment between the outer frame 120 and the inner frame 150. The coupling joints 146 can be a variety of different types and configurations as described herein with reference to the various embodiments of a prosthetic valve. For example, the coupling joints 146 can include a living hinge, a flexible member, sutures, a suture wrapped through an opening, a pin or tab inserted through an opening or any combinations thereof.
To move the valve 100 from the expanded configuration (
When in the inverted configuration, an overall length of the valve 100 is increased, but a length of the inner frame 150 and a length of the outer frame 120 remains the same (or substantially the same). For example, as shown in
With the valve 100 in the inverted configuration, the valve 100 can be placed within a lumen of the delivery sheath 126 for delivery of the valve 100 to the left atrium of the heart, as shown in
Thus, by disposing the outer frame 120 in the inverted configuration, the valve 100 can be collapsed into a smaller overall diameter, i.e. placed in a smaller diameter delivery sheath 126, than would be possible if the valve 100 were merely collapsed radially. This is because when the valve is in the biased expanded configuration, the inner frame 150 is nested within an interior of the outer frame 120, and thus the outer frame 120 must be collapsed around the inner frame 150. In some embodiments, the inner frame 150 and the outer frame are disposed concentrically. Whereas in the inverted configuration, the inner frame 150 and the outer frame 120 are arranged axially with respect to each other (i.e., the inner frame is not nested within the outer frame 150), such that the outer frame 120 can be collapsed without needing to accommodate all of the structure of the inner frame 150 inside it. In other words, with the inner frame 150 disposed mostly inside or nested within the outer frame 120, the layers or bulk of the frame structures cannot be compressed to as small a diameter. In addition, if the frames are nested, the structure is less flexible, and therefore, more force is needed to bend the valve, e.g., to pass through tortuous vasculature or to make tight turns in the left atrium after passing through the atrial septum to be properly oriented for insertion into the mitral valve annulus.
As shown, outer frame assembly 210 includes an outer frame 220, covered on all or a portion of its outer face with an outer covering 230, and covered on all or a portion of its inner face by an inner covering 232. Outer frame 220 can provide several functions for prosthetic heart valve 200, including serving as the primary structure, as an anchoring mechanism and/or an attachment point for a separate anchoring mechanism to anchor the valve to the native heart valve apparatus, a support to carry inner valve assembly 240, and/or a seal to inhibit paravalvular leakage between prosthetic heart valve 200 and the native heart valve apparatus.
Outer frame 220 has a biased expanded configuration and can be manipulated and/or deformed (e.g., compressed and/or constrained) and, when released, return to its original unconstrained shape. To achieve this, outer frame 220 can be formed of materials, such as metals or plastics that have shape memory properties. With regards to metals, Nitinol® has been found to be especially useful since it can be processed to be austenitic, martensitic or super elastic. Other shape memory alloys, such as Cu—Zn—Al—Ni alloys, and Cu—Al—Ni alloys, may also be used.
As best shown in
Inner valve assembly 240 includes an inner frame 250, an outer covering (not shown), and leaflets 270. As shown, the inner valve assembly 240 includes an upper portion having a periphery formed with multiple arches. The inner frame 250 includes six axial posts or frame members that support the outer covering of the inner valve assembly and leaflets 270. Leaflets 270 are attached along three of the posts, shown as commissure posts 252 (best illustrated in
Although inner valve assembly 240 is shown as having three leaflets, in other embodiments, an inner valve assembly can include any suitable number of leaflets. The leaflets 270 are movable between an open configuration and a closed configuration in which the leaflets 270 coapt, or meet in a sealing abutment.
Outer covering 230 of the outer frame assembly 210 and inner covering 232 of outer frame assembly 210, outer covering of the inner valve assembly 240 and leaflets 270 of the inner valve assembly 240 may be formed of any suitable material, or combination of materials, such as those discussed above. In this embodiment, the inner covering 232 of the outer frame assembly 210, the outer covering of the inner valve assembly 240, and the leaflets 270 of the inner valve assembly 240 are formed, at least in part, of porcine pericardium. Moreover, in this embodiment, the outer covering 230 of the outer frame assembly 210 is formed, at least in part, of polyester.
Inner frame 250 is shown in more detail in
In this embodiment, inner frame 250 is formed from a laser-cut tube of Nitinol®. Inner frame 250 is illustrated in
Tether connecting portion 244 (also referred to as first end portion of inner frame) includes longitudinal extensions of the struts, connected circumferentially by pairs of opposed, slightly V-shaped connecting members (or “micro-Vs”). Tether connecting portion 244 is configured to be radially collapsed by application of a compressive force, which causes the micro-Vs to become more deeply V-shaped, with the vertices moving closer together longitudinally and the open ends of the V shapes moving closer together circumferentially. Thus, tether connecting portion 244 can be configured to compressively clamp or grip one end of a tether, either connecting directly onto a tether line (e.g. braided filament line) or onto an intermediate structure, such as a polymer or metal piece that is in turn firmly fixed to the tether line.
In contrast to tether connecting portion 244, atrial portion 247 (also referred to as “inner frame free end portion”) and body portion 242 are configured to be expanded radially. Strut portion 243 forms a longitudinal connection and radial transition between the expanded body portion and the compressed tether connecting portion 244. Body portion 242 provides an inner frame coupling portion 245 that includes six longitudinal posts, such as post 242A. The inner frame coupling portion 245 can be used to attach leaflets 270 to inner frame 240, and/or can be used to attach inner assembly 240 to outer assembly 210, such as by connecting inner frame 250 to outer frame 220. In the illustrated embodiment, the posts include openings through which connecting members (such as suture filaments and/or wires) can be passed to couple the posts to other structures.
Inner frame 250 is shown in a fully deformed, i.e. the final, deployed configuration, in side view and bottom view in
Outer frame 220 of valve 200 is shown in more detail in
Outer frame 220 is shown in a fully deformed, i.e. the final, deployed configuration, in side view and top view in
Outer frame 220 and inner frame 250 are shown coupled together in
As shown in
As the valve 300 exits the lumen of the delivery sheath 326, the outer frame assembly 310 exits first in its inverted configuration as shown in the progression of
The delivery sheath 426 can be used to deliver a valve 400 that includes an inner valve assembly 440 including an inner frame (not labeled in
As shown in
In alternative embodiments, the valve holder 438 can be removably coupled to the valve 400 (e.g., the inner frame 450 of the valve 400) via wires or sutures that can be cut after delivery of the valve 400 to the heart. In some cases, the valve holder 438 can be decoupled from the valve 400 when the valve is still disposed within the delivery sheath 426, while in other instances the valve holder 438 can be decoupled from the valve 400 after the valve 400 exits the delivery sheath 426 within the heart.
The actuation wires 474 and 476 can be coupled to the outer frame of the outer frame assembly 410 with a variety of different coupling methods. For example, the outer frame 410 can include loops (as described below, for example, with respect to outer frame 510, and in the '305 PCT application) through which the actuation wires 474 and 476 can be received or threaded. The number of loops on the outer frame can vary and the number of loops through which each actuation wire is connected can vary. For example, in some embodiments, the outer frame includes 12 loops and a first actuation wire is threaded through 6 of the loops and a second actuation wire is threaded through 6 of the loops. In other embodiments, the outer frame can include 12 loops and there can be 4 actuation wires, each coupled to 3 of the loops. In some embodiments, a single actuation wire is coupled through all of the loops of the outer frame.
In this embodiment, the delivery sheath 426 can be used to deliver the valve 400 to the left atrium of the heart using a transvascular approach (e.g., transfemoral, transatrial, transjugular). When the distal end of the delivery sheath 426 is disposed within the left atrium, the valve 400 is moved out of the lumen of the delivery sheath 426 using the actuation wires 474, 476 to assist in pulling the valve 400 out of the delivery sheath 426. In some cases, the valve holder 438 can also be used to push the valve 400 out of the delivery sheath 426. More specifically, the actuation wires 474 and 476 can extend from the outer frame assembly 410 out a distal end of the delivery sheath and extend proximally. In some embodiments, the actuation wires 474, 476 extend proximally outside the delivery sheath 426, then pass back into the lumen of the delivery sheath 426 through side apertures or holes (not shown) and then out a proximal end of the delivery sheath 426. Thus, a user (e.g., physician) can pull the proximal end portions of the actuation wires 474 and 476 to in turn pull the outer frame assembly 410 out of the distal end of the delivery sheath 426. In some embodiments, the actuation wires 474, 476 extend proximally from the outer frame assembly 410, back through the distal end of the delivery sheath 426 (e.g., rather than through side apertures or holes of the delivery sheath) and within the lumen of the delivery sheath, and then out a proximal end of the delivery sheath 426. Various different embodiments and configurations are described in more detail below and in the '305 PCT application.
As the outer frame assembly 410 exits the delivery sheath 426 it will still be in an inverted configuration relative to the inner frame assembly 440. After the outer frame assembly 410 is at least partially outside of the lumen of the delivery sheath 426, the outer frame assembly 410 can begin to revert to its expanded or deployed configuration (not shown in
For example, to dispose the outer frame 520 in its inverted configuration relative to the inner frame 550, the outer frame 520 is folded or inverted distally such that the outer frame 520 is pointed away from the inner frame 550. With the outer frame 520 in the inverted configuration, the valve 500 can be placed within a lumen of the delivery system 505 as shown in
In this embodiment, the delivery system 505 includes an outer delivery sheath 526, an inner sheath 508, a valve holder 538 (also referred to as a “pusher”) and a multi-lumen elongate tube member 503 (also referred to as “tube” or “tube member” or “multi-lumen elongate member”). As shown in
To deploy the valve 500 within a heart, the outer frame 520 of the valve 500 is first moved or placed in its inverted configuration relative to the inner frame 550. As shown in
The inner frame 550 can be releasably coupled to the valve holder 538 via couplers 506 that are received within corresponding recesses 504 defined by the valve holder 538 in the same manner as described above for delivery system 405 (see, e.g.,
In alternative embodiments, the valve holder 538 can be removably coupled to the valve 500 (e.g., the inner frame 550 of the valve 500) via wires or sutures that can be cut after delivery of the valve 500 to the heart. In some cases, the valve holder 538 can be decoupled from the valve 500 when the valve is still disposed within the outer delivery sheath 526, while in other instances the valve holder 538 can be decoupled from the valve 500 after the valve 500 exits the delivery sheath 526 within the heart.
Although not shown, in other embodiments, the valve holder 538 can merely contact and push the valve 500 during deployment, as described for previous embodiments, without securing the inner frame 550 to the valve holder 538. In such embodiments, in some instances, radial expansion of the inner frame 550 can be restricted by the inner sheath 508 when the inner frame 550 is disposed therein.
In this embodiment a first actuation wire 576, a second actuation wire 574, a third actuation wire 576 and a fourth actuation wire 577 are each coupled to the outer frame assembly 510. More specifically, the outer frame 550 of the outer frame assembly 510 includes loops 562 through which the actuation wires 574-577 can be threaded or received therethrough. In this embodiment, the outer frame 520 includes 12 loops 562 and each actuation wire 574-577 is threaded through 3 of the loops 562. In other embodiments, there can be a different number of loops disposed on the outer frame 520 and there can be a different number of actuators. Further, each actuation wire can be threaded or received through a different number of loops than shown for this embodiment.
When the valve 500 is disposed within the delivery system 505 as shown, for example, in
As shown in
As shown in
As shown in
As shown in
The distal retention element 686 also defines pinning member lumens 669 that align with the pinning member lumens 679 of the multi-lumen tube member 2603 such that the pinning members 578 can be received therein. A proximal shoulder 688 can be disposed abutting a distal end of the multi-lumen tube member 603. The distal retention element 686 also defines a circumferential recess area 684 defined between the proximal shoulder 688 and a distal end portion of the distal retention element 686. As shown in
The procedure to deliver the valve 500 to the heart can be the same as or similar to any of the procedures described herein, in '572 PCT application or in the '305 PCT application incorporated by reference above. For example, the valve 500, disposed within the delivery system 505 in an inverted configuration, can be delivered to the left atrium of the heart in the same or similar manner as described above with reference to
As described above for previous embodiments, as the outer frame 520 becomes unconstrained by the outer sheath 526, the outer frame 520 can begin to revert to its expanded or uninverted configuration. The actuation wires 575-577 can be used to control the reversion of the outer frame 520. More specifically, the tube member 503 can be pulled proximally such that the actuation wires (pinned to the tube member 503) pull the distally disposed portion of the outer frame 520 proximally (as shown in
In addition, in some instances, the actuation wires 574-577 can assist in the articulation and placement of the valve 500 into its destination (e.g., a native annulus of an atrioventricular valve of a heart). For example, as shown in
Referring back to
The actuation wires 574-577 can also be released or decoupled from the outer frame 520 before or after the inner frame 550 is released from the valve holder 538. To decouple the actuation wires 574-577 from the outer frame 520, one end of each of the actuation wires 574-577 can be unpinned or decoupled from the tubular member 503. For example, as shown in
Although in the above example, the pinning members 578-3 and 578-4 are shown withdrawn to release the ends of the actuation wires 574-577, alternatively, the pinning members 578-1 and 578-2 can be withdrawn leaving the actuation wires 574-577 pinned by pinning members 578-3 and 578-4. Further, the actuation wires 574-577 can be decoupled from the outer frame 520 at any suitable sequence or time period within the procedure. For example, in some instances it may be desirable for the actuation wires 574-577 to be released after the valve 500 has at least partially exited the delivery sheath 526 but before the valve 500 is seated within the native annulus of the atrioventricular valve. In other instances, for example, the actuation wires 574-577 can be released after the valve 500 has at least partially exited the outer delivery sheath 526 and after the valve 500 is seated within the native annulus of the atrioventricular valve.
As with other embodiments described herein and embodiments of the '305 PCT application, the delivery system 805 can be used to deliver the valve 800, which can be moved from a biased expanded configuration to an inverted configuration for delivery of the valve to the heart. To deploy the valve 800 within a heart, the outer frame of the valve 800 can be moved to an inverted configuration relative to the inner frame as described above for previous embodiments and placed within a distal end portion of the lumen 882 of the delivery sheath 826 and/or a lumen of an inner sheath (not shown) that can be movably disposed within the lumen 882 of the outer delivery sheath 826, such that the valve 800 is compressed or collapsed within the delivery sheath 826 as shown schematically in
The inner frame of the valve 800 can be releasably coupled to the valve holder 838 via couplers (not shown) that are received within corresponding recesses (not shown) defined by the valve holder 838 in the same or similar manner as described above for delivery system 405 (see, e.g.,
In this embodiment, the elongate tube member 815 is coupled to a retention device 860 that includes retention components or members that are coupled together coaxially and can be actuated to secure and release actuation wires coupled to the delivery system 805.
The retention device 860 also defines a lumen through which the valve holder 838 can be movably disposed. For example, each of the proximal retention member 864, the center retention member 866 and the distal retention member 868 can define a lumen and the valve holder 838 and elongate member 837 can be movably disposed within each lumen.
Multiple pins 898 are fixedly attached to the center retention member 866 and include a proximal portion 878 (also referred to as “pin” or “pin portion”) that extends proximally from the center retention member 866 and a distal portion 888 (also referred to as “pin” or “pin portion”) that extends distally from the center retention member 866. In some embodiments, the pins 898 extend through lumens (not shown in
As with previous embodiments, multiple actuation wires can be coupled to the outer frame assembly of the prosthetic valve and used to help revert and manipulate the prosthetic valve into a desired position within the heart, and then can be released from the valve when the desired positioning has been achieved. More specifically, the outer frame of the valve can include loops through which the actuation wires 874-877 can be threaded or received therethrough in the same or similar manner as described herein (e.g., with respect to valve 500) and/or in the '305 PCT application. For example, if the outer frame includes 12 loops, each actuation wire 874, 875 and 876 can be threaded through 4 of the loops. In other embodiments, there can be a different number of loops disposed on the outer frame and there can be a different number of actuation wires. Further, each actuation wire can be threaded or received through a different number of loops than shown for this embodiment. In some embodiments, the actuation wires can be coupled to (e.g., threaded through) the outer frame at a second set of loops disposed at a location between the free end of the outer frame and where the outer frame is attached to the inner frame. An example of such an embodiment is shown in
In operation, the loops 809 of the actuation wires 874-876 are placed over the pins 878 (as shown in
With the actuation wires 874-876 pinned to the tube member 815, during deployment of the prosthetic valve 800 within a heart, a user (e.g., physician) can use the tube member 815 to control and/or manipulate movement of the valve (to which the actuation wires are coupled) as described in more detail below. The procedure to deliver the valve to the heart can be the same as or similar to any of the procedures described herein, in the '572 PCT application or in the '305 PCT application incorporated by reference above. For example, a valve, disposed within the delivery system 805 in an inverted configuration, can be delivered to the left atrium of the heart in the same or similar manner as described with reference to
With the distal end portion of the delivery sheath 826 disposed within the left atrium of the heart, the valve 800 can be deployed outside of the delivery sheath 826. For example, the valve holder 838 and tube member 815 can be moved distally relative to the outer sheath 826, moving or pushing the valve 800 outside the lumen 882 of the outer sheath 826. In addition, or alternatively, the outer sheath 826 can be moved or pulled proximally, leaving at least a portion of the valve 800 disposed within the heart. In some cases, a tether coupled to the valve 800 can be used to help pull the valve out of the lumen 882 of the outer sheath 826.
As described above for previous embodiments, as the outer frame of the valve becomes unconstrained by the outer sheath 826, the outer frame can begin to revert to its expanded or uninverted configuration. The actuation wires 874-876 can be used to control the reversion of the outer frame. More specifically, the tube member 815 can be pulled proximally such that the actuation wires (pinned to the tube member 815) pull the distally disposed portion of the outer frame proximally in a controlled manner and such that the reversion of the outer frame from its inverted configuration relative to the inner frame of the valve can be controlled.
In addition, as described above for previous embodiments, in some instances, the actuation wires 874-876 can assist in the articulation and placement of the valve into its destination (e.g., a native annulus of an atrioventricular valve of a heart). For example, the actuation wires 874-876 can also be used to constrain, collapse, or otherwise move the valve (e.g., radially compress the outer frame of the valve) after the valve exits the outer sheath 826 and is in its reverted, expanded or partially expanded configuration. More specifically, in this embodiment, the tube member 815 with the actuation wires 874-876 pinned thereto, can be manipulated by a user to move or urge the outer frame to a more compressed configuration by pulling or moving the tube member 815 proximally. This may be desirable, for example, to reposition the valve within the heart before fully deploying the valve. An example repositioning procedure is shown in
When the outer frame of the valve is disposed in its non-inverted and at least partially expanded configuration, and is in a desired position within the heart, the inner frame can be deployed. As described above for valve 400, in some embodiments, to decouple the inner frame from the valve holder 838, the valve holder 838 can be moved distally and/or an inner sheath (not shown) can be moved proximally such that the valve holder 838 is disposed outside of the lumen of the inner sheath. As such, the couplers (e.g., 406, 506) can be released from the recesses (404, 504) releasing or decoupling the inner frame from the valve holder 838. In some embodiments in which the valve holder 838 includes an inner member that holds the couplers within the valve holder 838, the inner member can be moved distally to release the couplers from the valve holder 838. When the inner frame is released from the valve holder 838 and disposed outside the delivery sheath 826, the inner frame can assume its biased expanded configuration.
The actuation wires 874-876 can also be released or decoupled from the outer frame before or after the inner frame is released from the valve holder 838. In this embodiment, to decouple the actuation wires 874-876 from the outer frame, the end loops 807, 811 of the actuation wires 874-876 can be unpinned or decoupled from the tubular member 815 by actuating the distal retention member 868 to release the loops 807, 811 from the pins 888. The center loops 809 of the actuation wires 874-876 remain pinned by the pins 878 and thus the actuation wires 874-876 remain coupled to the tube member 815. With the center loop 809 of each of the actuation wires 874-876 coupled to the tube member 815 (via pinning members 878 in this example), the tube member 815 can be pulled proximally, which in turn will pull the ends of the actuation wires 874-876 out of the loops of outer frame of the valve. Thus with the actuation wires 874-876 detached from the outer frame, the outer frame can assume a biased expanded or partially expanded configuration.
As described above for previous embodiments, the actuation wires 874-876 can be decoupled from the outer frame at any suitable sequence or time period within the procedure. For example, in some instances it may be desirable for the actuation wires 874-876 to be released after the valve has at least partially exited the delivery sheath 826 but before the valve is seated within the native annulus of the atrioventricular valve. In other instances, for example, the actuation wires 874-876 can be released after the valve has at least partially exited the outer delivery sheath 826 and after the valve is seated within the native annulus of the atrioventricular valve.
In some embodiments, the pins 898 of the retention device 860 can have different lengths resulting in different lengths for the pin portions 878 and 888 (see, e.g., pins 1298 in
The delivery system 905 can include the same or similar components as delivery systems 505 or 805 described above. The delivery system 905 includes an outer delivery sheath 926, a valve holder 938 (also referred to as a “pusher”), and an elongate tube member 915 (also referred to as “tube” or “tube member”) which can be slidably disposed within a lumen 982 of the delivery sheath 926 and can be coupled to retention components that can be used to secure and release actuation wires 974, 975 and 976 in the same or similar manner as described above for delivery system 805. The valve holder 938 can be coupled to an elongate member 937 (see, e.g.,
As with other embodiments described herein and embodiments of the '305 PCT application, the delivery system 905 can be used to deliver a valve that can be moved from a biased expanded configuration to an inverted configuration for delivery of the valve to the heart. To deploy the valve within a heart, the outer frame 920 of the valve 900 can be moved to an inverted configuration (as shown in
The inner frame 950 of the valve 900 can be releasably coupled to the valve holder 938 via couplers (not shown) that are received within corresponding recesses (not shown) defined by the valve holder 938 in the same or similar manner as described above for delivery system 405 (see, e.g.,
As with the previous embodiment, the elongate tube member 915 is coupled to a retention device 960 that includes retention components or members that are coupled together coaxially and can be actuated to secure and release actuation wires coupled to the delivery system 905. The retention device 960 includes a first or proximal retention member 964 fixedly coupled to a distal end portion of the tube member 915, a second or center retention member 966 movably coupled to the proximal retention member 964 and a third or distal retention member 968 movably coupled to the center retention member 966. The center retention member 966 can be coupled to the proximal retention member 964 via an actuation rod 965 (
As with previous embodiments, multiple actuation wires can be coupled to the outer frame assembly 910 of the prosthetic valve 900 and used to help revert and manipulate the prosthetic valve 900 into a desired position within the heart, and then can be released from the valve when the desired positioning has been achieved. More specifically, the outer frame 920 of the valve 900 includes loops 962 (see
In addition, when the outer frame is being reverted by pulling the actuation wires proximally, the routing of the actuation wires through two rows of loops on the outer frame helps reduce the profile of the outer frame during the reverting/flipping. When the outer frame has been reverted and the inner frame is released from the valve holder, and when tension is applied to the actuation wires they can function as purse strings at both the cuff tips of the outer frame and the middle portion of the outer frame to pull in or reduce the outer profile of the outer frame and the valve overall. The reduced profile helps during the positioning of the valve within an annulus (e.g., mitral valve annulus) of the heart.
The actuation wires 974, 975, 976 are also routed through apertures 935 (see
In operation, the loops 909 of the actuation wires 974-876 are placed over the pins 978 (as shown in
With the actuation wires 974-976 pinned to the tube member 915, during deployment of the prosthetic valve within a heart, a user (e.g., physician) can use the tube member 915 to control and/or manipulate movement of the valve (to which the actuation wires are coupled) as described in more detail below. The procedure to deliver the valve 900 to the heart can be the same as or similar to any of the procedures described herein, in '572 PCT application or in the '305 PCT application incorporated by reference above. For example, the valve 900, disposed within the delivery system 905 in an inverted configuration, can be delivered to the left atrium of the heart in the same or similar manner as described with reference to
With the distal end portion of the delivery sheath 926 disposed within the left atrium of the heart, the valve 900 can be deployed outside of the delivery sheath 926 as shown in
As described above for previous embodiments, as the outer frame 920 of the valve 900 becomes unconstrained by the outer sheath 926, the outer frame 920 can begin to revert to its expanded or uninverted configuration. The actuation wires 974-976 can be used to control the reversion of the outer frame 920. More specifically, the tube member 915 can be pulled proximally such that the actuation wires (pinned to the tube member 915) pull the distally disposed portion of the outer frame 920 proximally in a controlled manner and such that the reversion of the outer frame 920 from its inverted configuration (
In addition, as described above for previous embodiments, in some instances, the actuation wires 974-976 can assist in the articulation and placement of the valve into its destination (e.g., a native annulus of an atrioventricular valve of a heart). For example, the actuation wires 974-976 can also be used to constrain, collapse, or otherwise move the valve (e.g., radially compress the outer frame of the valve) after the valve exits the outer sheath 926 and is in its reverted, expanded or partially expanded configuration. More specifically, in this embodiment, the tube member 915 with the actuation wires 974-976 pinned thereto, can be manipulated by a user to move or urge the outer frame to a more compressed configuration by pulling or moving the tube member 915 proximally. This may be desirable, for example, to reposition the valve within the heart before fully deploying the valve. Such a repositioning procedure is shown and described with respect to
When the outer frame 920 of the valve 900 is disposed in its non-inverted and at least partially expanded configuration, and is in a desired position within the heart, the inner frame 950 can be deployed. As described above, in some embodiments, to decouple the inner frame 950 from the valve holder 938, the inner member (not shown) of the valve holder 938 can be moved distally to release the couplers (e.g., 406, 506) from the recesses (404, 504) of the valve holder 938, releasing or decoupling the inner frame 950 from the valve holder 938. When the inner frame 950 is released from the valve holder 938 and disposed outside the delivery sheath 926, the inner frame can assume its biased expanded configuration.
The actuation wires 974-976 can be released or decoupled from the outer frame 920 before or after the inner frame 950 is released from the valve holder 938. As with the previous embodiment, to decouple the actuation wires 974-976 from the outer frame 920, the end loops 907, 911 of the actuation wires 974-976 can be unpinned or decoupled from the tubular member 915 by actuating the distal retention member 968 to release the loops 907, 911 from the pins 988. The center loops 909 of the actuation wires 974-976 remain pinned by the pins 978 and thus the actuation wires 974-976 remain coupled to the tube member 915. With the center loop 909 of each of the actuation wires 974-976 coupled to the tube member 915 (via pinning members 978 in this example), the tube member 915 can be pulled proximally, which in turn will pull the ends of the actuation wires 974-976 out of the loops 962, 958 of outer frame 920 of the valve 900. Thus with the actuation wires 974-976 detached from the outer frame 920, the outer frame 920 can assume a biased expanded or partially expanded configuration.
As described above for previous embodiments, the actuation wires 974-976 can be decoupled from the outer frame 920 at any suitable sequence or time period within the procedure. For example, in some instances it may be desirable for the actuation wires 974-976 to be released after the valve 900 has at least partially exited the delivery sheath 926 but before the valve 900 is seated within the native annulus of the atrioventricular valve. In other instances, for example, the actuation wires 974-976 can be released after the valve 900 has at least partially exited the outer delivery sheath 926 and after the valve is seated within the native annulus of the atrioventricular valve.
The configurations of the actuation wires described herein and used with the delivery devices to deploy a prosthetic valve are constructed such that the loops can be easily released from the delivery system when needed, and can smoothly route through the valve to disengage after deployment of the valve. The loops of the actuation wires can be constructed by various processes including a bifurcation process, a sewing process or both. The actuation wires can be formed with, for example a fiber material or a braided material, such as used with sutures. The delivery devices described herein can also be used with actuation wires formed and constructed by different methods and have various configurations, such as, for example, the actuation wires described above with reference to
As shown in
The retention device 1260 includes a first or proximal retention member 1264 that is fixedly coupled to a distal end portion of the tube member (not shown) as described above for previous embodiments, a second or center retention member 1266 that is movably coupled to the proximal retention member 1264 and a third or distal retention member 1268 that is movably coupled to the center retention member 1266 and the proximal retention member 1264. The center retention member 1266 can be coupled to the proximal retention member 1264 via a first actuation rod (not shown), and the distal retention member 1268 can be coupled to the center retention member 1266 and to the proximal retention member 1264 via two second actuation rods (not shown) in the same or similar manner as described above for previous embodiments.
The actuation rods can extend to a proximal end of the delivery device to which the retention member 1260 is attached and be operably coupled to a handle assembly (not shown). For example, the second actuation rods can extend into apertures/lumens 1241 defined by the distal retention member 1268 and be fixedly attached to the distal retention member 1268, slidably extend through apertures/lumens 1248 defined by the center retention member 1266 and through apertures/lumens 1249 defined by the proximal retention member 1264 such that the distal retention member 1268 can be slidably moved relative to the center retention member 1266 and the proximal retention member 1264. The first actuation rod can extend within an aperture 1248 of the center retention member 1266 and be fixedly attached thereto, and slidably extend through an aperture 1249 of the proximal retention member 1264 such that the center retention member 1266 can be slidably moved relative to the proximal retention member 1264. The proximal retention member 1264 can be fixedly attached to the tube member (not shown) with a connecting rod (not shown). For example, the connecting rod can extend into an aperture 1257 defined at the proximal end of the proximal retention member 1264 and be fixedly attached thereto such that the proximal retention member 1264 can move with the tube member.
The retention device 1260 defines a lumen through which a valve holder (as described herein) can be movably disposed. For example, each of the distal retention members 1268 defines a lumen 1251, the center retention member 1266 defines a lumen 1253 and the proximal retention member 1264 defines a lumen 1255. A valve holder and elongate member coupled thereto can be movably disposed within each lumen of the retention device 1260.
In this embodiment, the retention device 1260 includes three pins 1298 that are fixedly attached to the center retention member 1266 and that can be used to releasably hold actuation wires to a delivery device in the same or similar manner as described above for previous embodiments. The pins 1298 can be, for example, welded to the center retention member 1266. In this embodiment, the pins 1298 extend through apertures/lumens 1272 defined by the center retention member 1266 and are fixedly attached thereto. The pins 1298 include a proximal pin portion 1278 that extends between the center retention member 1266 and the proximal retention member 1264, and a distal pin portion that extends between the center retention member 1266 and the distal retention member 1268. As shown in
The insert 1322 defines recesses 1304 to which corresponding couplers (e.g., couplers 406) of the inner frame (not shown) of a prosthetic valve (not shown) can be releasably coupled in the same or similar manner as described above for delivery system 405 (see, e.g.,
In an embodiment with the capsule 1324 movable relative to the insert 1322, the capsule 1324 can be moved proximally relative to the insert 1322 such that the recesses 1304 are disposed outside the capsule 1324 (as shown in
The capsule 1324 defines apertures 1335 through which actuation wires can be routed as described above for previous embodiments. For example, as shown for valve holder 938, each strand (e.g., 913, 917) of an actuation wire (e.g., 974) can be pinned by the retention device (e.g., 960) and routed through an aperture 1335 of the capsule 1324, pass through a loop or loops of the prosthetic valve and then pass back through the aperture 1335 and be pinned by the retention device. Thus, in an embodiment with three actuation wires and six strands, the capsule 1324 can include six apertures 1335.
In this embodiment, the outer frame 1420 can include two rows of loops 1462 and 1458 (shown in
The outer frame 1420 includes a cuff portion 1472 and a body portion 1473 as described above, for example, with respect to valve 200 and outer frame 220. In this embodiment, the cuff portion 1472 has a shape and length that can assist the reverting process during delivery of the prosthetic valve 1400. More specifically, as shown in
With the cuff portion 1472 having an additional segment 1434 disposed perpendicular or near perpendicular to the remaining cuff portion 1472, during reversion or flipping (using the actuation wires) of the outer frame 1420 during delivery of the valve 1400, the cuff portion 1472 of the outer frame 1420 will “roll outward” from delivery sheath 1426, as shown in
As shown in
The delivery system 1505 can include the same or similar components as delivery systems 505 or 805 described above. The delivery system 1505 can include an outer delivery sheath (not shown) and an elongate tubular member, which can be slidably disposed within a lumen of the delivery sheath. In some embodiments, the delivery system 1505 may not include such an elongate member. The delivery system 1505 includes a valve holder 1538 and a retention device 1560 as described in more detail below.
As with other embodiments described herein and embodiments of the '305 PCT application, the delivery system 1505 can be used to deliver a valve that can be moved from a biased expanded configuration to an inverted configuration for delivery of the valve to the heart. To deploy the valve within a heart, the outer frame of the valve can be moved to an inverted configuration relative to the inner frame as described above for previous embodiments and placed within a distal end portion of the lumen of the delivery sheath.
The valve holder 1538 can be coupled to an elongate member 1537 that can be movably disposed within the lumen of the delivery sheath and/or a lumen of an elongate tubular member as described above for previous embodiments. In this embodiment the valve holder 1538 includes an insert or inner member 1522 that can be movably disposed within an interior region 1528 defined by an outer capsule 1524. For example, the insert 1522 of the valve holder 1538 can be operably coupled to a handle assembly (not shown) via an actuation rod that extends through a lumen of the elongate member 1537 that can be actuated to move the insert 1522 proximally and distally relative to the outer capsule 1524. In an alternative embodiment, the capsule 1524 of the valve holder 1538 can be actuated to move proximally and distally relative to the inner insert 1522.
The insert 1522 defines recesses 1504 to which corresponding couplers (e.g., couplers 406 described above) of the inner frame (not shown) of a prosthetic valve (not shown) can be releasably coupled in the same or similar manner as described above for delivery system 405 (see, e.g.,
The capsule 1524 defines apertures 1535 through which actuation wires can be routed as described above for previous embodiments. For example, as shown and described above for valve holder 938, each strand of an actuation wire can be pinned by the retention device 1560 and routed through an aperture 1535 of the capsule 1524, pass through a loop or loops of the prosthetic valve and then pass back through the aperture 1535 and be pinned by the retention device 1560. Thus, in an embodiment with three actuation wires and six strands, the capsule 1524 can include six apertures 1535. In this embodiment, the capsule 1524 also includes a ring 1559 that can provide a radiused, smooth surface/contact point for actuation wires routed through the apertures 1535.
The delivery system 1505 also includes a retention device 1560 that defines a lumen through which the elongate member 1537 can be slidably disposed. As described above for previous embodiments, the retention device 1560 can be used to secure and release actuation wires (not shown) in the same or similar manner as described above for delivery system 805 and 905. The retention device 1560 includes retention components or members that are coupled together coaxially and can be actuated to secure and release actuation wires (not shown) coupled to the delivery system 1505. More specifically, the retention device 1560 includes a first or proximal retention member 1564, a second or center retention member and a third or distal retention member 1568. In this embodiment, the center retention member 1566 is fixedly coupled to a proximal portion of the delivery device 1505 such as a handle assembly (not shown). For example, as shown in
An axial wire 1555 is attached to the elongate member 1537 and each of the proximal retention member 1564, the center retention member 1566 and the distal retention member 1568 include a cutout 1531 keyed to ride along the axial wire 1555. In other words, the keyed coupling of the retention members 1564, 1566, 1568 allows them to slide along the axial wire 1555, and thus the elongate member 1537, in an axial direction (proximal an distal), but prevents them from rotating relative to the elongate member 1537. This allows the retention device 1560 (e.g., retention members 1564, 1566, 1568) and the elongate member 1537 to be rotated together in unison and prevents actuation wires attached to the retention device 1560 (e.g., 1564, 1566, 1568) from becoming entangled and wrapping around the elongate member 1537 during use to deliver and deploy a prosthetic heart valve. Multiple cutouts 1531 can be included, as shown in
Three pins 1598 are fixedly attached to the center retention member 1566 and extend through openings in the center retention member 1566 such that proximal pins or pin portions 1578 extend proximally from the center retention member 1566, and distal pins or pin portions 1588 extend distally from the center retention member 1566. The pins 1578 and 1588 can be used to releasably hold actuation wires to the delivery device 1505 in the same or similar manner as described above for delivery system 805 or 905. The actuation wires can be any of the actuation wires described herein. The pins 1578 can be received within apertures/lumens defined by the proximal retention member 1564 and the pins 1588 can be received within apertures/lumens defined by the distal retention member 1568. In this embodiment, the pins 1578 each extend proximally at different lengths from the center retention member 1566, and the pins 1588 each extend distally at different lengths from the center retention member 1566. In this embodiment, the center retention member 1566 also includes one or more spacers 1533 on each side (proximal and distal) of the center retention member 1566 (only one spacer 1533 is shown in
As with previous embodiments, multiple actuation wires can be coupled to the outer frame assembly of the prosthetic valve to be delivered to a heart and used to help revert and manipulate the prosthetic valve into a desired position within the heart, and then can be released from the valve when the desired positioning has been achieved. More specifically, the outer frame of the valve can include loops at a free end portion of the outer frame and/or at a second location on the outer frame as described above for valve 900, through which the actuation wires can be threaded or received therethrough in the same or similar manner as described herein (e.g., with respect to valve 500) and/or in the '305 PCT application.
To prepare the delivery device to deliver a prosthetic valve to a heart of a patient, the actuation wires can be coupled to the valve as described above, and loops of the actuation wires can be secured to the retention device 1560 in a similar manner as described above for delivery devices 805 and 905. In this embodiment, to secure the loops to the retention device 1560, the proximal retention member 1564 is actuated to move distally toward the center retention member such that the pins 1578 are received within apertures 1563 (see, e.g.,
In some embodiments, a delivery system described herein (e.g., 505, 805, 905) can include a dilator device or member (not shown). The dilator can be, for example, a balloon dilator and can be configured to expand an opening or passage, for example, during delivery of the prosthetic valve. The dilator device can be the same as or similar to and used in the same or similar manner as dilator device 1711 described in the '305 PCT application with respect to
Further, although not shown, any of the embodiments of a delivery device or system can include a handle or handle assembly to which the various delivery sheaths and components can be operatively coupled and which a user (e.g., physician) can grasp and use to manipulate the delivery device or system. The handle or handle assembly can include actuators to actuate the various components of the delivery system.
In addition, the systems and methods described herein can also be adapted for use with a prosthetic tricuspid valve. For example, in such a case, a procedural catheter can be inserted into the right ventricle of the heart, and the delivery sheath delivered to the right atrium of the heart either directly (transatrial), or via the jugular or femoral vein.
While various embodiments have been described above, it should be understood that they have been presented by way of example only, and not limitation. Where methods described above indicate certain events occurring in certain order, the ordering of certain events may be modified. Additionally, certain of the events may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above.
Where schematics and/or embodiments described above indicate certain components arranged in certain orientations or positions, the arrangement of components may be modified. While the embodiments have been particularly shown and described, it will be understood that various changes in form and details may be made. Any portion of the apparatus and/or methods described herein may be combined in any combination, except mutually exclusive combinations. The embodiments described herein can include various combinations and/or sub-combinations of the functions, components, and/or features of the different embodiments described.
Claims
1. A method, comprising:
- inserting a distal end portion of a delivery sheath of a valve delivery device into a left atrium of a heart, the delivery sheath having a prosthetic heart valve disposed within a lumen of the delivery sheath, the prosthetic heart valve having an outer frame coupled to an inner frame, the outer frame being inverted relative to the inner frame, the prosthetic heart valve being releasably coupled to a retention device, the retention device including a proximal retention member defining a first opening, a center retention member including a first pin and a second pin, and a distal retention member defining a second opening, an actuation wire being coupled to the prosthetic heart valve and including a first loop secured to the retention device with the first pin and a second loop secured to the retention device with the second pin;
- moving the prosthetic heart valve distally out of the distal end portion of the delivery sheath;
- moving the retention device proximally such that the actuation wire pulls the outer frame of the prosthetic heart valve proximally and the outer frame is reverted relative to the inner frame;
- actuating the retention device such that the distal retention member moves axially relative to the center retention member and the second pin releases the second loop of the actuation wire;
- after actuating the retention device, moving the retention device proximally such that the actuation wire is pulled proximally and is uncoupled from the prosthetic heart valve; and
- positioning the prosthetic heart valve within a mitral valve annulus of the heart.
2. The method of claim 1, further comprising;
- after positioning the prosthetic heart valve within the mitral valve annulus of the heart, releasing the inner frame of the prosthetic heart valve from a valve holder of the delivery device.
3. The method of claim 1, wherein the actuation wire includes a third loop secured to the retention device with a third pin of the retention device, and when the retention device is actuated and the distal retention member moves axially relative to the center retention member, the third pin releases the third loop of the actuation wire.
4. The method of claim 1, further comprising:
- prior to actuating the retention device such that the distal retention member moves axially relative to the center retention member and the second pin releases the second loop of the actuation wire, moving the retention device further proximally such that outer open ends of the outer frame are pulled in closer to the retention device.
5. The method of claim 1, further comprising loading the prosthetic heart valve into the delivery sheath prior to inserting the distal end portion of the delivery sheath of the valve delivery device into the left atrium of the heart, the loading comprising:
- placing the first loop of the actuation wire over the first pin of the retention device of the prosthetic heart valve delivery device;
- passing a first portion of the actuation wire through a first frame loop on the outer frame of the prosthetic heart valve and passing a second portion of the actuation wire through a second frame loop on the outer frame of the prosthetic heart valve, the first portion of the actuation wire having the second loop disposed on a first end of the actuation wire and the second portion of the actuation wire having a third loop on a second end of the actuation wire;
- placing the second loop and the third loop of the actuation wire over the second pin of the retention device;
- actuating the retention member to move one of the center retention member and the proximal retention member axially such that the first pin is disposed in the first opening and the first loop of the actuation wire is secured to the retention device;
- actuating the retention member to move the distal retention member axially such that the second pin is disposed in the second opening and the second loop and the third loop of the actuation wire are secured to the retention device;
- placing the prosthetic heart valve within the lumen of the delivery sheath of the delivery device.
6. The method of claim 5, further comprising:
- prior to placing the prosthetic heart valve within the lumen of the delivery sheath, moving the prosthetic heart valve from a first configuration in which the outer frame of the prosthetic heart valve is disposed substantially surrounding the inner frame of the prosthetic heart valve to a second configuration in which the outer frame is inverted relative to the inner frame and a free end portion of the outer frame points in a direction away from the inner frame.
7. The method of claim 6, wherein the prosthetic heart valve is in the second configuration when placing the prosthetic heart valve within the lumen of the delivery sheath.
8. The method of claim 5, further comprising:
- prior to placing the prosthetic heart valve within the lumen of the delivery sheath, releasably coupling a portion of the prosthetic heart valve to a valve holder of the prosthetic heart valve delivery device, the valve holder being movably disposed within a tube member, the tube member being fixedly coupled to the retention device.
9. The method of claim 8, wherein prior to placing the prosthetic heart valve within the lumen of the delivery sheath, routing a portion of the actuation wire through an aperture defined by the valve holder.
10. The method of claim 5, wherein the actuation wire is a first actuation wire, the method further comprising:
- placing a first loop of a second actuation wire over a third pin of the retention device, the center retention member including the third pin and a fourth pin, the distal retention member defining a third opening, the proximal retention member defining a fourth opening;
- passing a first portion of the second actuation wire through a third frame loop on the outer frame of the prosthetic heart valve and passing a second portion of the second actuation wire through a fourth frame loop on the outer frame of the prosthetic heart valve, the first portion of the second actuation wire having a second loop disposed on a first end of the second actuation wire and the second portion of the second actuation wire having a third loop on a second end of the second actuation wire; and
- placing the second loop and the third loop of the second actuation wire over the fourth pin of the retention device; wherein
- when the retention member is actuated to move one of the center retention member and the proximal retention member axially, the third pin is disposed in the fourth opening and the first loop of the second actuation wire is secured to the retention device; and
- when the retention member is actuated to move the distal retention member axially, the fourth pin is disposed in the third opening and the second loop and the third loop of the second actuation wire are secured to the retention device.
11. The method of claim 1, wherein the second pin extends a first length from the center retention member and the center retention member includes a third pin extending toward the distal retention member having a second length greater than the first length, and wherein actuating the retention device such that the distal retention member moves axially includes disengaging the second pin from the second opening before disengaging the third pin from a third opening of the distal retention member.
12. The method of claim 11, wherein actuating the retention device such that the distal retention member moves axially includes releasing the second loop from the second pin before releasing a third loop from the third pin.
13. The method of claim 1, wherein positioning the prosthetic heart valve within the mitral valve annulus includes manipulating a tube member with the actuation wire pinned thereto to control the outer frame.
14. The method of claim 1, wherein while actuating the retention device such that the distal retention member moves axially relative to the center retention member, the distal retention member is rotationally fixed to the center retention member.
15. The method of claim 14, wherein the proximal retention member is rotationally fixed to the center retention member and the distal retention member.
16. The method of claim 1, wherein prior to positioning the prosthetic heart valve within the mitral valve annulus, moving the retention device proximally to tension the actuation wire and pull outer free end portions of the outer frame, hinging the outer frame about the valve holder to reduce a profile of the prosthetic heart valve.
17. The method of claim 16, wherein after moving the retention device proximally to tension the actuation wire, the positioning includes releasing the tension on the actuation wire to allow the outer frame to radially expand in the mitral valve annulus.
18. The method of claim 17, wherein after releasing the tension on the actuation wire, the positioning includes reapplying the tension on the actuation wire to reposition the prosthetic heart valve within the mitral valve annulus.
19. The method of claim 1, wherein the outer frame includes a first row of frame loops at a first longitudinal location and a second row of frame loops at a second longitudinal location, the actuation wire passing through at least one frame loop in each of the first and second rows such that tensioning the actuation wire causes an end portion of the outer frame to hinge about the first row of frame loops.
20. The method of claim 1, wherein the actuation wire is passed through an aperture on a valve holder, the aperture surrounded by a ring providing a radiused smooth surface for the actuation wire to abut while the actuation wire is translated relative to the valve holder.
Type: Application
Filed: Sep 20, 2021
Publication Date: Jan 6, 2022
Applicant: Tendyne Holdings, Inc. (St. Paul, MN)
Inventors: Zachary Vidlund (Robbinsdale, MN), Zachary Robert Kowalski (Maple Grove, MN), Son Mai (North Branch, MN)
Application Number: 17/479,166