Patent Application
20230000624
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 or replacement tricuspid heart valves.
Human heart valves, which include the aortic, pulmonary, mitral and tricuspid valves, function essentially as one-way valves operating in synchronization with the pumping heart. The valves allow blood to flow downstream, but block blood from flowing upstream. Diseased heart valves exhibit impairments such as narrowing of the valve or regurgitation, which inhibit the valves' ability to control blood flow. Such impairments reduce the heart's blood-pumping efficiency and can be a debilitating and life-threatening condition. For example, valve insufficiency can lead to conditions such as heart hypertrophy and dilation of the ventricle. Thus, extensive efforts have been made to develop methods and apparatuses to repair or replace impaired heart valves.
Prostheses exist to correct problems associated with impaired heart valves. For example, mechanical and tissue-based heart valve prostheses can be used to replace impaired native heart valves. More recently, substantial effort has been dedicated to developing replacement heart valves, particularly tissue-based replacement heart valves that can be delivered with less trauma to the patient than through open heart surgery. Replacement valves are being designed to be delivered through minimally invasive procedures and even percutaneous procedures. Such replacement valves often include a tissue-based valve body that is connected to an expandable frame that is then delivered to the native valve's annulus.
Development of prostheses including but not limited to replacement heart valves that can be compacted for delivery and then controllably expanded for controlled placement has proven to be particularly challenging. An additional challenge relates to the ability of such prostheses to be secured relative to intralumenal tissue, e.g., tissue within any body lumen or cavity, in an atraumatic manner.
Delivering a prosthesis to a desired location in the human body, for example delivering a replacement heart valve to the mitral valve, can also be challenging. Obtaining access to perform procedures in the heart or in other anatomical locations may require delivery of devices percutaneously through tortuous vasculature or through open or semi-open surgical procedures. The ability to control the deployment of the prosthesis at the desired location can also be challenging.
Embodiments of the present disclosure are directed to a delivery system, such as but not limited to a delivery system for a replacement heart valve. Further embodiments are directed to methods of use to deliver and/or controllably deploy a prosthesis, such as but not limited to a replacement heart valve, to a desired location within the body. 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, an aortic valve, or a tricuspid valve, are provided.
In some embodiments, a delivery system and method are provided for delivering a replacement heart valve to a native mitral valve location. The delivery system and method may utilize a transseptal approach. In some embodiments, components of the delivery system facilitate bending of the delivery system to steer a prosthesis from the septum to a location within the native mitral valve. In some embodiments, a capsule is provided for containing the prosthesis for delivery to the native mitral valve location. In other embodiments, the delivery system and method may be adapted for delivery of implants to locations other than the native mitral valve.
The present disclosure includes, but is not limited to, the following embodiments.
Embodiment 1: A delivery system for a replacement heart valve, the delivery system comprising:
Embodiment 2: The delivery system of Embodiment 1, wherein the at least one aperture of the outer shaft member comprises a plurality of circumferentially-spaced apart apertures.
Embodiment 3: The delivery system of Embodiment 1 or 2, wherein the outer shaft member is configured to be moved proximally relative to the inner shaft to uncover the second looped end of the at least one attachment tether.
Embodiment 4: The delivery system of Embodiment 1 or 2, wherein the inner shaft is configured to be moved distally relative to the outer shaft member to uncover the second looped end of the at least one attachment tether.
Embodiment 5: The delivery system of any of Embodiments 1-4, wherein the outer shaft member comprises a sleeve.
Embodiment 6: The delivery system of any of Embodiments 1-5, wherein the at least one attachment member comprises a plurality of attachment tethers, wherein a first looped end of each of the plurality of attachment tethers is configured to be attached to the distal end of the inner shaft, and wherein a second looped end of each of the plurality of attachment tethers is configured to configured to extend through the at least one eyelet of the replacement heart valve, through the at least one aperture of the outer sleeve into a respective one of the apertures of the manifold, and then looped over a free proximal end of the tooth of the respective one of the apertures of the manifold.
Embodiment 7: A method of facilitating delivery of a replacement heart valve within a body of a patient, the method comprising:
Embodiment 8: The method of Embodiment 7, wherein the desired implantation location is a native mitral valve.
Embodiment 9: The method of Embodiment 7, wherein the desired implantation location is a native tricuspid valve.
Embodiment 10: The method of any of Embodiments 7-9, wherein causing the outer shaft member and the inner shaft to transition from the locked configuration to the unlocked configuration comprises moving the inner shaft in a distal direction.
Embodiment 11: The method of any of embodiments 7-9, wherein causing the outer shaft member and the inner shaft to transition from the locked configuration to the unlocked configuration comprises moving the outer shaft member in a proximal direction.
Embodiment 12: A delivery system for a replacement heart valve, the delivery system comprising a shaft having a proximal end and a distal end, a manifold on a distal end of the shaft, wherein the manifold comprises a plurality of radially extending apertures, each aperture having a tooth, at least one attachment tether configured to releasably connect to the replacement heart valve, wherein looped portions of the at least one attachment tether extend through the radially extending apertures of the manifold to surround the tooth, and a sleeve configured to cover the radially extending apertures in a distal position to prevent release of the looped portions, wherein the sleeve is configured to be proximally translated to a proximal position to uncover the looped portions so that the replacement heart valve is released from the at least one attachment tether.
Embodiment 13: A delivery system for a replacement heart valve, the delivery system comprising:
Embodiment 14: The delivery system of Embodiment 13, wherein the manifold comprises an inner manifold and an outer manifold.
Embodiment 15: The delivery system of Embodiment 14, wherein the outer manifold comprises the radially extending apertures for receiving the looped portions of a distal end of the at least one attachment tether.
Embodiment 16: The delivery system of Embodiment 14 or 15, wherein a proximal end of the at least one attachment tether is attached to the inner manifold.
Embodiment 17: The delivery system of any one of Embodiments 13-15, wherein the at least one attachment tether comprises one and only one attachment tether.
Embodiment 18: The delivery system of any one of Embodiments 13-15, wherein the at least one attachment tether comprises a plurality of attachment tethers.
Embodiment 19: A handle for a replacement heart valve delivery system, the handle comprising, a housing, at least one knob located on the housing, at least one ring gear in communication with the at least one knob, wherein the at least one knob is configured to rotate the at least one ring gear, at least one planet gear located within the at least one ring gear and in communication with the at least one ring gear, wherein the at least one planet gear remains in the same circumferential position with relation to the at least one ring gear during rotation of the at least one ring gear, and a linear travel screw in communication with the at least one planet gear, wherein the linear travel screw is configured to move in an axial direction upon rotation of the at least one knob.
Embodiment 20: The handle of Embodiment 19, wherein the at least one ring gear comprises a plurality of planet gears, each planet gear of the plurality of planet gears in communication with one of a plurality of linear travel screws.
Embodiment 21: A delivery system for use with a replacement heart valve, the system comprising a bendable nose cone shaft having a proximal end and a distal end, a nose cone attached to a distal end of the nose cone shaft; and a rigid shaft at least partially covering the bendable nose cone shaft, wherein the rigid shaft is configured to axially translate with respect to the bendable nose cone shaft to cover or uncover the bendable nose cone shaft, wherein, when the bendable nose cone shaft is uncovered by the rigid shaft, the bendable nose cone shaft is configured to allow the replacement heart valve attached to the system to conform to a native anatomy of a native heart valve.
Embodiment 22: The delivery system of Embodiment 21, wherein the bendable nose cone shaft comprises a bendable polymer.
Embodiment 23: A delivery system for use with a replacement heart valve, the system comprising an inner retention member configured to releasably retain a replacement heart valve, and an outer retention member configured to at least partially cover a portion of the replacement heart valve and the inner retention member, wherein the outer retention member and the inner retention member are configured to have a locked and an unlocked configuration, wherein when in the unlocked configuration the outer retention member is configured to move axially with respect to the inner retention member, and when in the locked configuration the outer retention member is prevented from moving axially with respect to the inner retention member.
Embodiment 24: The delivery system of Embodiment 23, wherein the inner retention member comprises an outer threading and the outer retention member comprises an inner threading, and wherein the locked position occurs when the outer threading is threaded onto the inner threading.
Embodiment 25: The delivery system of Embodiment 23 or 24, wherein the inner retention member and outer retention member comprise locking features that an operator can unlock when the operator wants to move the outer retention member axially with respect to the inner retention member.
Embodiment 26: A delivery system for use with a replacement heart valve, the system comprising an inner shaft having a proximal end and a distal end, the inner shaft having a cut pattern to allow bending of the inner shaft, and a spine, an outer shaft surrounding the inner shaft and having a proximal end and a distal end, the outer shaft having a cut pattern to allow bending of the outer shaft, and a spine, and at least one pull wire configured to bend one or more of the inner shaft and the outer shaft, wherein one of the inner shaft and the outer shaft are configured to rotate with respect to one another between a flexing configuration and an unflexing configuration, wherein, in the flexing configuration, the cut pattern of the inner shaft is aligned with the cut pattern of the outer shaft, and wherein, in the unflexing configuration, the spine of the inner shaft is aligned with the cut pattern of the outer shaft.
Embodiment 27: The delivery system of Embodiment 26, wherein the cut pattern of the inner shaft is the same as the cut pattern of the outer shaft.
Embodiment 28: The delivery system of Embodiment 26, wherein the cut pattern of the inner shaft is different than the cut pattern of the outer shaft.
Embodiment 29: The delivery system of any of Embodiments 26-28, wherein the at least one pull wire comprises a plurality of pull wires, wherein a first pull wire is configured to cause bending of the inner shaft and wherein a second pull wire is configured to cause bending of the outer shaft.
Embodiment 30: A method of facilitating controlled bending of bendable coaxial shafts of a delivery system, the method comprising:
Embodiment 31: The method of Embodiment 30, wherein the cut pattern of the inner shaft is the same as the cut pattern of the outer shaft.
Embodiment 32: The method of Embodiment 31, wherein the cut pattern of the inner shaft is different than the cut pattern of the outer shaft.
Embodiment 33: The method of any of Embodiments 30-32, wherein the at least one pull wire comprises a plurality of pull wires, wherein a first pull wire is configured to cause bending of the inner shaft and wherein a second pull wire is configured to cause bending of the outer shaft.
Embodiment 34: A delivery system for use with a replacement heart valve, the system comprising an inner shaft having a proximal end and a distal end, and an outer shaft surrounding the inner shaft and having a proximal end and a distal end, wherein the inner shaft and the outer shaft are keyed together at the distal end of the outer shaft and the distal end of the inner shaft to prevent rotation of the inner shaft with respect to the outer shaft.
Embodiment 35: The delivery system of Embodiment 34, wherein the inner shaft and the outer shaft each have an ovaloid cross-section.
Embodiment 36: The delivery system of Embodiment 34 or 35, wherein at least the distal end of the inner shaft comprises a locking tab and at least the distal end of the outer shaft comprises a notch or slot configured to receive the locking tab so as to prevent rotation of the inner shaft with respect to the outer shaft.
Embodiment 37: The delivery system of Embodiment 34 or 35, wherein at least the distal end of the outer shaft comprises a locking tab and at least the distal end of the inner shaft comprises a notch or slot configured to receive the locking tab so as to prevent rotation of the inner shaft with respect to the outer shaft.
Embodiment 38: The delivery system of any of Embodiment 34-37, wherein the outer shaft comprises an outer pull wire lumen and wherein the inner shaft comprises an inner pull wire lumen.
Embodiment 39: A delivery system for a replacement heart valve, the delivery system comprising an inner shaft having a proximal end and a distal end, a mid shaft surrounding the inner shaft and having a proximal end and a distal end and a lumen, the mid shaft having a disc on the distal end, the diameter of the disc being greater than a diameter of the inner shaft, wherein the disc comprises a longitudinally extending aperture radially outward of the lumen, and an outer shaft surrounding the mid shaft, the outer shaft comprising a radially extending aperture having a tooth, and an attachment tether configured to releasably connect to the replacement heart valve, wherein the attachment tether has a first end connected to the inner shaft, wherein the attachment tether extends through the lumen of the mid shaft and out the distal end of the mid shaft, and wherein the attachment tether extends proximally through the longitudinally extending aperture and attaches to the tooth of the outer shaft, wherein, when the disc is proximally translated it prevents release of the attachment tether from the tooth, and wherein, when the disc is distally translated it releases the tether from the tooth so that the replacement heart valve is released.
Embodiment 40: A delivery system for a replacement heart valve, the delivery system comprising a capsule configured to surround the replacement heart valve and configured to radially compress the replacement heart valve, wherein the capsule comprises a distal portion, wherein the distal portion comprises a hypotube with an interrupted spiral cut pattern, an outer polymer jacket configured to at least partially cover a radially outwards surface of the hypotube, a fluoropolymer liner on a radially inner surface of the hypotube, and a porous fluoropolymer outer coating on one of the hypotube or the outer polymer jacket, and a proximal portion having a smaller diameter than the distal portion, wherein the proximal portion comprises a hypotube with a cut pattern, the hypotube surrounded by an outer polymer jacket.
Embodiment 41: The delivery system of Embodiment 40, wherein the outer polymer jacket of the distal portion covers greater than 90% of a length of the hypotube of the distal portion.
Embodiment 42: The delivery system of Embodiment 40 or 41, wherein the hypotube of the distal portion is configured to provide compression resistance and the liner and/or outer polymer jacket of the distal portion is configured to provide tension resistance.
Embodiment 43: The delivery system of any of Embodiments 40-42, wherein the liner of the distal portion is porous.
Embodiment 44: The delivery system of any of Embodiments 40-43, wherein the liner of the distal portion is bonded to a metal structure of the hypotube of the distal portion using a reflow process.
Embodiment 45: A handle for a replacement heart valve delivery system, the handle comprising:
Embodiment 46: The handle of Embodiment 45, wherein the first portion comprises a recess and an internal spring within the recess.
Embodiment 47: The handle of Embodiment 46, wherein the second portion comprises a projection configured to be received by the recess of the first portion.
Embodiment 48: The handle of Embodiment 47, wherein the internal spring of the first portion releasably retains the projection of the second portion when the first and second portions are coupled.
Embodiment 49: The handle of Embodiment 45, wherein the first portion comprises a hole and the second portion comprises a spring tab, the hole of the first portion being configured to receive the spring tab of the second portion when the first and second portions are coupled.
Embodiment 50: The handle of Embodiment 49, wherein the spring tab of the second portion is configured to deflect from the hole of the first portion when the threshold force is exerted on the at least one adapter to decouple the first and second portions.
Embodiment 51: The handle of Embodiment 45, wherein the first portion comprises a ramped recess and the second portion comprises a ramped projection, the ramped recess of the first portion being configured to receive the ramped projection of the second portion when the first and second portions are coupled.
Embodiment 52: The handle of Embodiment 51, wherein the ramped projection of the second portion is configured to deflect from the ramped recess of the first portion when the threshold force is exerted on the at least one adapter to decouple the first and second portions.
Embodiment 53: The handle of Embodiment 45, wherein the first portion comprises a recess and the second portion comprises a pin, the recess of the first portion being configured to receive the pin of the second portion when the first and second portions are coupled.
Embodiment 54: The handle of Embodiment 53, wherein the pin of the second portion is configured to break from the second portion when the threshold force is exerted on the at least one adapter to decouple the first and second portions.
Embodiment 55: The handle of Embodiment 45, wherein the first portion comprises a recess and the second portion comprises a spring plunger, the recess of the first portion being configured to receive a portion of the spring plunger of the second portion when the first and second portions are coupled.
Embodiment 56: The handle of Embodiment 55, wherein the portion of the spring plunger of the second portion is configured to decouple from the ramped recess of the first portion when the threshold force is exerted on the at least one adapter to decouple the first and second portions.
Embodiment 57: The handle of any of Embodiments 45-56, wherein the second portion is configured to engage with the threaded portion.
Embodiment 58: A handle for a replacement heart valve delivery system, the handle comprising:
Embodiment 59: The handle of Embodiment 58, wherein the at least one knob further comprises a connector configured to extend between and couple the first and second portions, the connector comprising a distal portion and a proximal portion.
Embodiment 60: The handle of Embodiment 59, wherein the first portion is configured to receive the distal portion of the connector and the second portion is configured to receive the proximal portion of the connector.
Embodiment 61: The handle of Embodiment 59 or 60, wherein the connector comprises one or more indicators.
Embodiment 62: The handle of Embodiment 61, wherein the one or more indicators indicate the force exerted on the adapter.
Embodiment 63: The handle of any of Embodiments 58-62, wherein the distance between the first and second portions increases as the force exerted on the at least one adapter increases.
Embodiment 64: The handle of any of Embodiments 58-63, wherein the distance between the first and second portions decreases as the force exerted on the at least one adapter decreases.
Embodiment 65: The handle of any of Embodiments 58-64, wherein the first and second portions are configured to detach when the force exerted on the adapter reaches a threshold force.
Embodiment 66: The handle of any of Embodiments 58-65, wherein the second portion is configured to engage with the threaded portion.
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, tricuspid, 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 or transjugular 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.
The delivery system 10 can be used to deploy a prosthesis, such as a replacement heart valve as described elsewhere in this specification, within the body. The delivery system 10 can receive and/or cover portions of the prosthesis such as a first end 301 and second end 303 of the prosthesis 70 illustrated in
In some embodiments, the delivery system 10 can be used in conjunction with a replacement aortic valve, such as shown in
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, 2018/0021129, and 2018/0055629, 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. Publication Nos. 2015/0328000 and 2016/0317301 the entirety of each of which is hereby incorporated by reference and made a part of this specification.
The delivery system 10 can be relatively flexible. In some embodiments, the delivery system 10 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 in
As shown in cross-sectional view of
In particular, embodiments of the disclosed delivery system 10 can utilize a steerable rail in the rail assembly 20 for steering the distal end of the delivery system 10, allowing the implant to be properly located in a patient's body. As discussed in detail below, the steerable rail can be, for example, a rail shaft that extends through the delivery system 10 from the handle 14 generally to the distal end. In some embodiments, the steerable rail has a distal end that ends proximal to the implant retention area 16. A user can manipulate the bending of the distal end of the rail, thereby bending the rail in a particular direction. In preferred embodiments, the rail has more than one bend along its length, thereby providing multiple directions of bending. As the rail is bent, it presses against the other assemblies to bend them as well, and thus the other assemblies of the delivery system 10 can be configured to steer along with the rail as a cooperating single unit, thus providing for full steerability of the distal end of the delivery system.
Once the rail is steered into a particular location in a patient's body, the prosthesis 70 can be advanced along or relative to the rail through the movement of the other sheaths/shafts relative to the rail and released into the body. For example, the rail can be bent into a desired position within the body, such as to direct the prosthesis 70 towards the native mitral valve. The other assemblies (e.g., the outer sheath assembly 22, the mid shaft assembly 21, the inner assembly 18, and the nose cone assembly 31) can passively follow the bends of the rail. Further, the other assemblies (e.g., the outer sheath assembly 22, the mid shaft assembly 21, the inner assembly 18, and the nose cone assembly 31) can be advanced together (e.g., relatively together, sequentially with one actuator, simultaneously, almost simultaneously, at the same time, closely at the same time) relative to the rail while maintaining the prosthesis 70 in the compressed position without releasing or expanding the prosthesis 70 (e.g., within the implant retention area 16). The other assemblies (e.g., the outer sheath assembly 22, the mid shaft assembly 21, the inner assembly 18, and the nose cone assembly 31) can be advanced distally or proximally together relative to the rail. In some embodiments, only the outer sheath assembly 22, mid shaft assembly 21, and inner assembly 18 are advanced together over the rail. Thus, the nose cone assembly 31 may remain in the same position. The assemblies can be individually, sequentially, or simultaneously, translated relative to the inner assembly 18 in order to release the implant 70 from the implant retention area 16.
As shown in
The shaft assembly 12, and more specifically the nose cone assembly 31, inner assembly 18, rail assembly 20, mid shaft assembly 21, and outer sheath assembly 22, can be collectively configured to deliver a prosthesis 70 positioned within the implant retention area 16 (shown in
As will be discussed below, the inner retention member 40, the outer retention ring 42, and the outer sheath assembly 22 can cooperate to hold the prosthesis 70 in a compacted configuration. The inner retention member 40 is shown engaging struts 72 at the proximal end 301 of the prosthesis 70 in
The outer retention member 42 may be attached to a distal end of the mid shaft hypotube 43 which can in turn be attached to a proximal tube 44 at a proximal end, which in turn can be attached at a proximal end to the handle 14. The outer retention member 42 can provide further stability to the prosthesis 70 when in the compressed position. The outer retention member 42 can be positioned over the inner retention member 40 so that the proximal end of the prosthesis 70 is trapped therebetween, securely attaching it to the delivery system 10. The outer retention member 42 can encircle a portion of the prosthesis 70, in particular the first end 301, thus preventing the prosthesis 70 from expanding. Further, the mid shaft assembly 21 can be translated proximally with respect to the inner assembly 18 into the outer sheath assembly 22, thus exposing a first end 301 of the prosthesis 70 held within the outer retention member 42. In this way the outer retention member 42 can be used to help secure a prosthesis 70 to or release it from the delivery system 10. The outer retention member 42 can have a cylindrical or elongate tubular shape, and may be referred to as an outer retention ring, though the particular shape is not limiting.
The mid shaft hypotube 43 itself can be made of, for example, high density polyethylene (HDPE), as well as other appropriate materials as described herein. The mid shaft hypotube 43 can be formed of a longitudinally pre-compressed HDPE tube, which can provide certain benefits. For example, the pre-compressed HDPE tube can apply a force distally onto the outer retention member 42, thus preventing accidental, inadvertent, and/or premature release of the prosthesis 70. Specifically, the distal force by the mid shaft hypotube 43 keeps the distal end of the outer retention member 42 distal to the inner retention member 40, thus preventing the outer retention member 42 from moving proximal to the inner retention member 40 before it is desired by a user to release the prosthesis 70. This can remain true even when the delivery system 10 is bent/deflected at a sharp angle. Further disclosure for the outer retention member 42 and mid shaft hypotube 43 can be found in U.S. Pat. Pub. No. 2016/0317301, hereby incorporated by reference in its entirety.
As shown in
The delivery system 10 may be provided to users with a prosthesis 70 preinstalled. In other embodiments, the prosthesis 70 can be loaded onto the delivery system shortly before use, such as by a physician or nurse.
Starting with the outermost assembly shown in
The outer proximal shaft 102 may be a tube and is preferably formed of a plastic, but could also be a metal hypotube or other material. The outer hypotube 104 can be a metal hypotube which in some embodiments may be cut or have slots, as discussed in detail below. The outer hypotube 104 can be covered or encapsulated with a layer of ePTFE, PTFE, or other polymer/material so that the outer surface of the outer hypotube 104 is generally smooth.
A capsule 106 can be located at a distal end of the outer proximal shaft 102. The capsule 106 can be a tube formed of a plastic or metal material. In some embodiments, the capsule 106 is formed of ePTFE or PTFE. In some embodiments, this capsule 106 is relatively thick to prevent tearing and to help maintain a self-expanding implant in a compacted configuration. In some embodiments the material of the capsule 106 is the same material as the coating on the outer hypotube 104. As shown, the capsule 106 can have a diameter larger than the outer hypotube 104, though in some embodiments the capsule 106 may have a similar diameter as the hypotube 104. In some embodiments, the capsule 106 may include a larger diameter distal portion and a smaller diameter proximal portion. In some embodiments, there may be a step or a taper between the two portions. The capsule 106 can be configured to retain the prosthesis 70 in the compressed position within the capsule 106. Further construction details of the capsule 106 are discussed below.
The outer sheath assembly 22 is configured to be individually slidable with respect to the other assemblies. Further, the outer sheath assembly 22 can slide distally and proximally relative to the rail assembly 22 together with the mid shaft assembly 21, inner assembly 18, and nose cone assembly 31.
Moving radially inwardly, the next assembly is the mid shaft assembly 21.
The mid shaft assembly 21 can include a mid shaft hypotube 43 generally attached at its proximal end to a mid shaft proximal tube 44, which in turn can be attached at its proximal end to the handle 14, and an outer retention ring 42 located at the distal end of the mid shaft hypotube 43. Thus, the outer retention ring 42 can be attached generally at the distal end of the mid shaft hypotube 43. These components of the mid shaft assembly 21 can form a lumen for other subassemblies to pass through.
Similar to the other assemblies, the mid shaft hypotube 43 and/or mid shaft proximal tube 44 can comprise a tube, such as a hypodermic tube or hypotube (not shown). The tubes can be made from one of any number of different materials including Nitinol, stainless steel, and medical grade plastics. The tubes 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. The mid shaft hypotube 43 can be a metal hypotube which in some embodiments may be cut or have slots as discussed in detail below. The mid shaft hypotube 43 can be covered or encapsulated with a layer of ePTFE, PTFE, or other material so that the outer surface of the mid shaft hypotube 43 is generally smooth.
The outer retention ring 42 can be configured as a prosthesis retention mechanism that can be used to engage with the prosthesis 70, as discussed with respect to
The mid shaft assembly 21 is disposed so as to be individually slidable with respect to the other assemblies. Further, mid shaft assembly 21 can slide distally and proximally relative to the rail assembly 22 together with the outer sheath assembly 22, mid inner assembly 18, and nose cone assembly 31.
Next, radially inwardly of the mid shaft assembly 21 is the rail assembly 20.
As shown in
In some embodiments, a distal pull wire 138 can extend to a distal section of the rail hypotube 136 and two proximal pull wires 140 can extend to a proximal section of the rail hypotube 136, however, other numbers of pull wires can be used, and the particular amount of pull wires is not limiting. For example, a two pull wires can extend to a distal location and a single pull wire can extend to a proximal location. In some embodiments, ring-like structures attached inside the rail hypotube 136, known as pull wire connectors, can be used as attachment locations for the pull wires, such as proximal ring 137 and distal ring 135. In some embodiments, the rail assembly 20 can include a distal pull wire connector 135 and a proximal pull wire connector 139. In some embodiments, the pull wires can directly connect to an inner surface of the rail hypotube 136.
The distal pull wire 138 can be connected (either on its own or through a connector 135) generally at the distal end of the rail hypotube 136. The proximal pull wires 140 can connect (either on its own or through a connector 137) at a location approximately one quarter, one third, or one half of the length up the rail hypotube 136 from the proximal end. In some embodiments, the distal pull wire 138 can pass through a small diameter pull wire lumen 139 (e.g., tube, hypotube, cylinder) attached on the inside of the rail hypotube 136. This can prevent the wires 138 from pulling on the rail hypotube 136 at a location proximal to the distal connection. Further, the lumen 139 can act as compression coils to strengthen the proximal portion of the rail hypotube 136 and prevent unwanted bending. Thus, in some embodiments the lumen 139 is only located on the proximal half of the rail hypotube 136. In some embodiments, multiple lumens 139, such as spaced longitudinally apart or adjacent, can be used per distal wire 139. In some embodiments, a single lumen 139 is used per distal wire 139. In some embodiments, the lumen 139 can extend into the distal half of the rail hypotube 136. In some embodiments, the lumen 139 is attached on an outer surface of the rail hypotube 136. In some embodiments, the lumen 139 is not used.
For the pair of proximal pull wires 140, the wires can be spaced approximately 180° from one another to allow for steering in both directions. Similarly, if a pair of distal pull wires 138 is used, the wires can be spaced approximately 180° from one another to allow for steering in both directions. In some embodiments, the pair of distal pull wires 138 and the pair of proximal pull wires 140 can be spaced approximately 90° from each other. In some embodiments, the pair of distal pull wires 138 and the pair of proximal pull wires 140 can be spaced approximately 0° from each other. However, other locations for the pull wires can be used as well, and the particular location of the pull wires is not limiting. In some embodiments, the distal pull wire 138 can pass through a lumen 139 attached within the lumen of the rail hypotube 136. This can prevent an axial force on the distal pull wire 138 from creating a bend in a proximal section of the rail hypotube 136.
The rail assembly 20 is disposed so as to be slidable over the inner shaft assembly 18 and the nose cone assembly 31. In some embodiments, the outer sheath assembly 22, the mid shaft assembly 21, the inner shaft assembly 22, and the nose cone assembly 31 can be configured to slide together along or relative to the rail assembly 20, such as proximally and distally with or without any bending of the rail assembly 20. In some embodiments, the outer sheath assembly 22, the mid shaft assembly 21, the inner shaft assembly 22, and the nose cone assembly 31 can be configured to retain the implant 70 in a compressed position when they are simultaneously slid along or relative to the rail assembly 20.
Moving radially inwards, the next assembly is the inner shaft assembly 18.
The inner shaft assembly 18 can include an inner shaft 122 generally attached at its proximal end to the handle 14, and an inner retention ring 40 located at the distal end of the inner shaft 122. The inner shaft 122 itself can be made up of an inner proximal shaft 124 directly attached to the handle 14 at a proximal end and a distal section 126 attached to the distal end of the inner proximal shaft 124. Thus, the inner retention ring 40 can be attached generally at the distal end of the distal section 126. These components of the inner shaft assembly 18 can form a lumen for the other subassemblies to pass through.
Similar to the other assemblies, the inner proximal shaft 124 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, cobalt chromium, stainless steel, and medical grade plastics. The tube can be a single piece tube or multiple pieces connected together. A tube comprising multiple pieces can provide different characteristics along different sections of the tube, such as rigidity and flexibility. The distal section 126 can be a metal hypotube which in some embodiments may be cut or have slots as discussed in detail below. The distal section 126 can be covered or encapsulated with a layer of ePTFE, PTFE, or other material so that the outer surface of the distal section 126 is generally smooth.
The inner retention member 40 can be configured as a prosthesis retention mechanism that can be used to engage with the prosthesis 70, as discussed with respect to
The inner shaft assembly 18 is disposed so as to be individually slidable with respect to the other assemblies. Further, the inner assembly 18 can slide distally and proximally relative to the rail assembly 22 together with the outer sheath assembly 22, mid shaft assembly 21, and nose cone assembly 31.
Moving further inwardly from the inner shaft assembly 18 is the nose cone assembly 31 also seen in
The nose cone shaft 27 may include a lumen sized and configured to slidably accommodate a guide wire so that the delivery system 10 can be advanced over the guide wire through the vasculature. However, embodiments of the system 10 discussed herein may not use a guide wire and thus the nose cone shaft 27 can be solid. The nose cone shaft 27 may be connected from the nose cone 28 to the handle, or may be formed of different segments such as the other assemblies. Further, the nose cone shaft 27 can be formed of different materials, such as plastic or metal, similar to those described in detail above.
In some embodiments, the nose cone shaft 27 includes a guide wire shield 1200 located on a portion of the nose cone shaft 27. Examples of such a guide wire shield can be found in
Advantageously, the guide wire shield 1200 can allow for smooth tracking of the guide wire with the implant 70 loaded, and can provide a large axial diameter landing zone for a distal end of the implant so that the distal end of the implant 70 may spread out properly and be arranged in a uniform radial arrangement. This uniformity allows for proper expansion. Furthermore, the guide wire shield 1200 can prevent kinking or damaging of the nose cone shaft 27 during compression/crimping of the prosthesis 70, which can exert a large compressive force on the nose cone shaft 27. As the prosthesis 70 can be crimped onto the guide wire shield 1200 instead of directly on the nose cone shaft 27, the guide wire shield 1200 can provide a protective surface.
As shown, the guide wire shield 1200 can include a lumen 1202 configured to surround the nose cone shaft 27. The guide wire shield 1200 can include a larger diameter distal end 1204 and a smaller diameter proximal end 1206. In some embodiments, the dimension change between the two ends can be tapered, or can be a step 1208 such as shown in
The distal end of the prosthesis 70 can be crimped so that it is radially in contact with the proximal end 1206 of the guide wire shield 1200. This can allow the prosthesis 70 to be properly spread out around an outer circumference of the proximal end 1206 of the guide wire shield 1200. In some embodiments, the distal end of the prosthesis 70 can longitudinally abut against the proximal end of the distal end 1204 (e.g., at the step 1208), thus providing a longitudinal stop.
The nose cone assembly 31 is disposed so as to be individually slidable with respect to the other assemblies. Further, the nose cone assembly 31 can slide distally and proximally relative to the rail assembly 22 together with the outer sheath assembly 22, mid shaft assembly 21, and inner assembly 18.
In some embodiments, one or more spacer sleeves (not shown) can be used between different assemblies of the delivery system 10. For example, a spacer sleeve can be located concentrically between the mid shaft assembly and the rail assembly 20, generally between the mid hypotube 43 and rail hypotube 136. In some embodiments, the spacer sleeve can be generally embedded in the hypotube 43 of the mid shaft assembly 21, such as on an inner surface of the mid shaft assembly 21. In some embodiments, a spacer sleeve can be located concentrically between the rail assembly 20 and the inner assembly 18, generally within the rail hypotube 136. In some embodiments, a spacer sleeve can be used between the outer sheath assembly 22 and the mid shaft assembly 21. In some embodiments, a spacer sleeve can be used between the inner assembly 18 and the nose cone assembly 31. In some embodiments, 4, 3, 2, or 1 of the above-mentioned spacer sleeves can be used. The spacer sleeves can be used in any of the above positions.
The spacer sleeve can be made of a polymer material such as braided Pebax® and can be lined, for example with PTFE, on the inner diameter, though the particular material is not limiting. The spacer sleeve can advantageously reduce friction between the steerable rail assembly 20 and its surrounding assemblies. Thus, the spacer sleeves can act as a buffer between the rail assembly 20 and the inner/nose cone assembly 18/30. Further, the spacer sleeve can take up any gap in radius between the assemblies, preventing compressing or snaking of the assemblies during steering. In some embodiments, the spacer sleeve may include cuts or slots to facilitate bending of the spacer sleeve. In some embodiments, the spacer sleeve may not include any slots, and may be a smooth cylindrical feature.
The spacer sleeve can be mechanically contained by the other lumens and components, and is thus not physically attached to any of the other components, allowing the spacer sleeve to be “floating” in that area. The floating aspect of the spacer sleeve allows it to move where needed during deflection and provide a support and/or lubricious bear surface/surfaces. Accordingly, the floating aspect allows the delivery system 10 to maintain flex forces. However, in some embodiments, the spacer sleeve can be connected to other components.
As discussed above, the outer sheath assembly 22, the mid shaft assembly 21, the inner assembly 18, and the rail assembly 20 can contain an outer hypotube 104, a mid shaft hypotube 43, a distal section 126, and a rail hypotube 136, respectively. Each of these hypotubes/sections/shafts can be laser cut to include a number of slots, thereby creating a bending pathway for the delivery system to follow. While different slot assemblies are discussed below, it will be understood that any of the hypotubes can have any of the slot configurations discussed below.
The outer hypotube 104, shown in
Moving radially inwardly,
For example, the proximal end of the mid shaft hypotube 43 can be a first section 210 having a plurality circumferentially extending slot pairs 213 spaced longitudinally along the first section 211. Generally, two slots are cut around each circumferential location forming almost half of the circumference. Accordingly, two backbones 215 are formed between the slots 213 extending up the length of the first section 211. The slot pairs 213 can be composed of a first thin slot 217. A second slot 221 of each of the slot pairs 213 can be thicker than the first slot 217, such as 1, 2, 3, 4, or 5 times thicker. In some embodiments, the second slot 217 can be generally the same longitudinal thickness throughout the slot. Each of the slots of the slot pair 213 can end in a teardrop shape 219 in some embodiments to facilitate bending.
Moving distally, the mid shaft hypotube 43 can include a second section 220 having a number of slot pairs 222. Similar to the first section 211, the second section 220 can have a plurality of circumferentially extending slots spaced longitudinally along the second section 220. Generally, two slots (e.g., one slot pair 222) are cut around each circumferential location, forming almost half of a circumference. Accordingly, “backbones” 224 can be formed between the slots extending up the length of the second section 220. Each slot pair 222 can include a first slot 226 that is generally thin and has no particular shape (e.g., it can look the same as the slots 213 in the first section 211), and a second slot 228 that is significantly longitudinally thicker than the first slot 226. The second slot 228 can be narrower at its ends and longitudinally thicker in its middle portion, thereby forming a curved slot. Moving longitudinally along the second section 220, each slot pair 222 can be offset approximately 45 or 90 degrees as compared to longitudinally adjacent slot pairs 222. In some embodiments, a second slot pair 222 is offset 90 degrees from an adjacent first slot pair 222, and a third slot pair 222 adjacent the second slot pair 222 can have the same configuration of the first slot pair 222. This repeating pattern can extend along a length of the second section 220, thereby providing a particular bending direction induced by the second slot 228 of the slot pairs 222. Accordingly, the “backbone” 224 shifts circumferential position due to the offsetting of adjacent shifting slot pairs 222. Each of the slots of the slot pair 222 can end in a teardrop shape 229 in some embodiments to facilitate bending.
Moving distally, the mid shaft hypotube 43 can have a third section 230 having a number of slots. The outer retention ring 240 can be attached to a distal end of the third section 230. The third section 230 can have circumferentially extending slot pairs 232, each slot on the slot pair extending about half way along the circumference to form the two backbones 234. The slot pairs 232 can be composed of a first thin slot 236, similar to the slots 213 discussed in the first section 211. A second slot 238 of each of the slot pairs 232 can be thicker than the first slot 236, such as 1, 2, 3, 4, or 5 times thicker. In some embodiments, the second slot 238 can be generally the same longitudinal thickness throughout the slot, unlike the second slot 228 of the second section 220. The first slots 236 and the second slots 238 can be circumferentially aligned along a length of the third section 230 so that all of the first slots 236 are in the same circumferential position and all of the second slots 238 are in the same circumferential position. The second slots 238 can be aligned with one of the circumferential positions of the second slots 228 of the second section 220. Each of the slots of the slot pair 232 can end in a teardrop shape 239 in some embodiments to facilitate bending.
In some embodiments, an outer retention ring strengthener 240 which can partially or fully circumferentially surround the outer retention member 40 can have a number of slots/holes/apertures as well, such as shown in
Additionally, the outer retention strengthener 240 can provide strength to lower deployment forces, protect the prosthesis 70 from any metal layers, and can add strength. In some embodiments, the liner can 240 be a polymer, such as PTFE, though the type of polymer or material is not limiting. In some embodiments, the strengthener 240 can be a metal. In some embodiments, the strengthener 240 can further include an outer polymer layer/jacket, such as a Pebax® jacket. This prevents the strengthener 240 from catching on the outer sheath assembly 22.
In certain embodiments, the outer retention ring 42 can further include an inner liner for smoothly transitioning over the prosthesis 70. The inner liner can be PTFE or etched PTFE, though the particular material is not limiting and other reduced friction polymers can be used. As shown in
Next, again moving radially inward,
Distally following the proximal pull wire connection area is the distal slotted hypotube section 235. This section is similar to the proximal slotted hypotube section 233, but has significantly more slots cut out in an equivalent length. Thus, the distally slotted hypotube section 235 provides easier bending than the proximally slotted hypotube section 233. In some embodiments, the proximal slotted section 233 can be configured to experience a bend of approximately 90 degrees with a half inch radius whereas the distal slotted section 135 can bend at approximately 180 degrees within a half inch. Further, as shown in
At the distalmost end of the distal slotted hypotube section 235 is the distal pull wire connection area 241 which is again a non-slotted section of the rail hypotube 136.
Moving radially inwardly in
The capsule 106 can be formed from one or more materials, such as PTFE, ePTFE, polyether block amide (Pebax®), polyetherimide (Ultem®), PEEK, urethane, Nitinol, stainless steel, and/or any other biocompatible material. The capsule 106 is preferably compliant and flexible while still maintaining a sufficient degree of radial strength to maintain a replacement valve 70 within the capsule 106 without substantial radial deformation, which could increase friction between the capsule 106 and a replacement valve 70 contained therein. The capsule 106 also preferably has sufficient column strength to resist buckling of the capsule 106, and sufficient tear resistance to reduce or eliminate the possibility of the replacement valve 70 tearing and/or damaging the capsule 106. Flexibility of the capsule 106 can be advantageous, particularly for a transseptal approach. For example, while being retracted along a curved member, for example while tracking over a rail assembly as described herein, the capsule 106 can flex to follow the curved member without applying significant forces upon the curved member, which may cause the curved member to decrease in radius. More specifically, the capsule 106 can bend and/or kink as it is being retracted along such a curved member such that the radius of the curved member is substantially unaffected.
In particular, a metal hypotube can provide radial strength and compression resistance, while specific slots/cuts in the hypotube can enable the flexibility of the capsule 106. In some embodiments, a thin liner and a jacket can surround the capsule 106, such as a polymer layer, to prevent any negative interactions between the implant 70 and the capsule 106.
In some embodiments, the capsule 106 can have a particular construction to allow for it to achieve advantageous properties, as shown in
In some embodiments, the capsule 106 can be formed of a metal layer 404, which gives the capsule 106 its structure. This metal layer 404 can include the coils discussed with respect to
As mentioned, the metal layer 404 can be, for example, a metal hypotube or laser cut hypotube. In some embodiments, the metal layer 404 can be a metal coil or helix, as discussed in detail above with respect to
If a metal coil, such as shown in
The distalmost end of the metal layer 404 can be formed out of the small coils. Moving proximally, the metal layer 404 may then transition to a section of large coils, followed again by a section of small coils, and then finally the proximalmost section can be the spaced large coils. As an example set of lengths, though not limiting, the distalmost small coil section may have a length of 10 mm (or about 10 mm). Moving proximally, the adjacent large coil section may extend 40 mm (or about 40 mm) to 60 mm (or about 60 mm) in length. These two sections would be found in the distal metal coil 108 shown in
As mentioned, the metal layer 404 (either coil or hypotube) can be covered by an outer polymer layer or jacket 402. In some embodiments, the outer polymer 402 layer is an elastomer, though the particular material is not limiting. In some embodiments, the outer polymer layer 402 can comprise polytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene (ePTFE). The ePTFE can have very different mechanical properties that PTFE. For example, ePTFE can be much more flexible while still maintaining good tensile/elongation properties. In some embodiments, the outer polymer layer 402 can comprise a thermoplastic elastomer, such as PEBAX®. In some embodiments, the outer polymer layer 402 can be pre-axially stressed before applying to the capsule. The outer polymer layer 402 can be approximately 0.006 to 0.008 inches in thickness, but the particular thickness is not limiting.
The outer polymer layer 402 can be applied to the metal layer 404 to form an outer jacket, such as by reflowing the polymer. In some embodiments, the outer polymer layer 402 can be directly applied to the metal layer 404. In some embodiments, an adhesive layer 406 can be disposed between the metal layer 404 and the outer polymer layer 402 to promote attachment of the outer polymer layer to the metal layer. For example, a fluoropolymer, or other soft durometer fluoroelastomer, can be applied between the metal layer 404 and the outer layer 402 in order to attach the two layers together and prevent delamination. In some embodiments, the adhesive layer 406 is not used.
In some implementations, other materials can be included between the metal layer 404 and the outer polymer layer 402 in order to improve properties. For example, fluorinated ethylene propylene (FEP) sections 408 can improve radial strength, in particular when the implant is under compression. While an FEP layer 408 is discussed as a particular material, other high strength polymers, metals, or ceramics can be used as well, and the particular material is not limiting. The FEP layer 408 can also act as an adhesive in some instances.
FEP sections 408 can be included at the distal and proximal ends of the capsule 106. The FEP sections 408 can either overlap the adhesive layer 406. Thus, FEP sections 408 can be located between the adhesive layer 406 and the metal layer 404 or between the adhesive layer 406 and the outer polymer layer 402. In some embodiments, the FEP sections 408 may be located in sections of the capsule 106 that do not include an adhesive layer 406.
The FEP section 408 located at the distal end of the capsule 106 can have a length of 10 mm (or about 10 mm), thought he particular length is not limiting. In some embodiments, the FEP section 408 is approximately 0.003 inches in thickness, but the thickness may vary and is not limited by this disclosure. In some embodiments, different FEP sections 408 (e.g., a proximal section and a distal section) can have different thicknesses. In some embodiments, all FEP 408 layers have the same thickness. Example thicknesses can be 0.006 inches or 0.003 inches.
Moving to the inside of the metal layer 404, a liner 410 can be included on its radially inner surface. The liner 410 can be formed of a low friction and/or high lubricity material that allows for the capsule 106 to be translated over the prosthesis 70 without catching or damaging portions of the prosthesis 70. In some embodiments, the liner 410 can be PTFE, which can resist radial expansion and decrease friction with the prosthesis 70.
In some embodiments, the liner 410 is made from ePTFE. However, it can be difficult to reflow a standard ePTFE liner 410 on the inner layer of the capsule 106. Accordingly, the ePTFE liner layer 410 can be pre-compressed before applying onto the inner layer of the capsule 106. In some embodiments, portions of the outer polymer layer 402 and the liner 410 can be in contact with one another. Thus, prior to bonding the two layers together, the ePTFE liner 410 and/or outer polymer layer 402 can be axially compressed. Then, the layers can be bonded together with reflow techniques during manufacturing. For example, the ePTFE liner 410 can be axially compressed, such as over a mandrel, while the outer polymer layer 402 can be placed over it. These two layers can then be reflowed (e.g., melting under pressure) to connect. The combined layers can be slid into and/or around the metal layer 404 discussed herein, and can be melted under pressure again to form the final capsule 106. This technique can allow for the capsule 106 to maintain flexibility and prevent breakage/tearing.
As mentioned above, the inner liner 410 can be ePTFE in some embodiments. The surface friction of ePTFE can be about 15% less than standard PTFE, and can be about 40% less than standard extruded thermoplastics that are used in the art.
In certain embodiments, the liner layer 410 can extend only along an inner surface of the capsule 106 and terminate at a distal end. However, to prevent delamination during loading of the implant 70, the liner 410 may not be flush at the distal end of the capsule 106. Instead, the liner 410 can be extended and inverted at the distal end in order to cover the distal end of the capsule 106 as well as an outer diameter of a portion of the outer polymer layer 402. This can create a seamless rolled reinforced tip of the liner 410. This solution is advantageous over previously known methods, such as disclosed in U.S. Pat. No. 6,622,367, incorporated by reference in its entirety, as PTFE lined applications do not adhere particularly well to reinforcements or the outer jacket. By inverting the liner 410 and fusing it with the outer polymer layer 402, this creates a seamless reinforced capsule tip that can mitigate delamination. Delamination is a serious concern because the delaminated liner can tear and embolize during deployment, and the delaminated layer can cause extremely high loading and deployment forces. Delaminated layers can also cause lumen translation problems by locking up shafts thereby adding translational force requirements.
In some embodiments, another FEP section 412 can be included between the liner 410 and the metal layer 404. The FEP section 412 can be located on distal metal coil 108, as well as the tube 110 transitioning between the distal metal coil 108 and the proximal metal coil 107. In some embodiments, the FEP section 412 may continue partially or fully into the proximal metal coil 107.
In some embodiments, an FEP section 412 can be included in the proximalmost portion of the proximal metal coil 107. This FEP section 412 be approximately 0.5 inches in length. In some embodiments, there is a longitudinal gap between the proximalmost FEP section 412 and the FEP section 412 that extends over the distal metal coil 108. In some embodiments, the previously mentioned FEP sections 412 are continuous.
As shown in
The handle 14 is located at the proximal end of the delivery system 10 and is shown in
The handle 14 is generally composed of two housings, a rail housing 202 and a delivery housing 204, the rail housing 202 being circumferentially disposed around the delivery housing 204. The inner surface of the rail housing 202 can include a screwable section configured to mate with an outer surface of the delivery housing 204. Thus, the delivery housing 204 is configured to slide (e.g., screw) within the rail housing 202, as detailed below. The rail housing 202 generally surrounds about one half the length of the delivery housing 204, and thus the delivery housing 204 extends both proximally and distally outside of the rail housing 202.
The rail housing 202 can contain two rotatable knobs, a distal pull wire knob 206 and a proximal pull wire knob 208. However, the number of rotatable knobs on the rail housing 202 can vary depending on the number of pull wires used. Rotation of the distal pull wire knob 206 can provide a proximal force, thereby providing axial tension on the distal pull wires 138 and causing the distal slotted section 135 of the rail hypotube 136 to bend. The distal pull wire knob 206 can be rotated in either direction, allowing for bending in either direction, which can control anterior-posterior angles. Rotation of the proximal pull wire knob 208 can provide a proximal force, and thus axial tension, on the proximal pull wires 140, thereby causing the proximal slotted section 133 of the rail hypotube 136 to bend, which can control the medial-lateral angle. The proximal pull wire knob 108 can be rotated in either direction, allowing for bending in either direction. Thus, when both knobs are actuated, there can be two bends in the rail hypotube 136, thereby allowing for three-dimensional steering of the rail shaft 132, and thus the distal end of the delivery system 10. Further, the proximal end of the rail shaft 132 is connected on an internal surface of the rail housing 202.
The bending of the rail shaft 132 can be used to position the system, in particular the distal end, at the desired patient location, such as at the native mitral valve. In some embodiments, rotation of the pull wire knobs 206/208 can help steer the distal end of the delivery system 10 through the septum and left atrium and into the left ventricle so that the prosthesis 70 is located at the native mitral valve.
Moving to the delivery housing 204, the proximal ends of the inner shaft assembly 19, outer sheath assembly 22, mid shaft assembly 21, and nose cone shaft assembly 30 can be connected to an inner surface of the delivery housing 204 of the handle 14. Thus, they can move axially relative to the rail assembly 20 and rail housing 202.
A rotatable outer sheath knob 210 can be located on the distal end of the delivery housing 204, being distal to the rail housing 202. Rotation of the outer sheath knob 210 will pull the outer sheath assembly 22 in an axial direction proximally, thus pulling the capsule 106 away from the implant 70 and releasing the distal end 301 of implant 70. Thus the outer sheath assembly 22 is individually translated with respect to the other shafts in the delivery system 10. The distal end 303 of the implant 70 can be released first, while the proximal end 301 of the implant 70 can remain radially compressed between the inner retention member 40 and the outer retention member 42.
A rotatable mid shaft knob 214 can be located on the delivery housing 204, in some embodiments proximal to the rotatable outer sheath knob 210, being distal to the rail housing 202. Rotation of the mid shaft knob 214 will pull the mid shaft assembly 21 in an axial direction proximally, thus pulling the outer retention ring 42 away from the implant 70 and uncovering the inner retention member 40 and the proximal end 301 of the implant 70, thereby releasing the implant 70. Thus, the mid shaft assembly 21 is individually translated with respect to the other shafts in the delivery system 10.
Located on the proximal end of the delivery housing 204, and thus proximal to the rail housing 202, can be a rotatable depth knob 212. As the depth knob 212 is rotated, the entirety of the delivery housing 204 moves distally or proximally with respect to the rail housing 202 which will remain in the same location. Thus, at the distal end of the delivery system 10, the inner shaft assembly 18, outer sheath assembly 22, mid shaft assembly 21, and nose cone shaft assembly 31 together (e.g., simultaneously) move proximally or distally with respect to the rail assembly 20 while the implant 70 remains in the compressed configuration. In some embodiments, actuation of the depth knob 212 can sequentially move the inner shaft assembly 18, outer sheath assembly 22, mid shaft assembly 21, and nose cone shaft assembly 31 relative to the rail assembly 20. In some embodiments, actuation of the depth knob 212 can together move the inner shaft assembly 18, outer sheath assembly 22, and mid shaft assembly 21 relative to the rail assembly 20. Accordingly, the rail shaft 132 can be aligned at a particular direction, and the other assemblies can move distally or proximally with respect to the rail shaft 132 for final positioning while not releasing the implant 70. The components can be advanced approximately 1, 2, 3, 5, 6, 7, 8, 9, or 10 cm along the rail shaft 132. The components can be advanced more than approximately 1, 2, 3, 5, 6, 7, 8, 9, or 10 cm along the rail shaft 132. An example of this is shown in
The handle 14 can further include a mechanism (knob, button, handle) 216 for moving the nose cone shaft 27, and thus the nose cone 28. For example, a knob 216 can be a portion of the nose cone assembly 31 that extends from a proximal end of the handle 14. Thus, a user can pull or push on the knob 216 to translate the nose cone shaft 27 distally or proximally individually with respect to the other shafts. This can be advantageous for proximally translating the nose cone 28 into the outer sheath assembly 22/capsule 106, thus facilitating withdraw of the delivery system 10 from the patient.
In some embodiments, the handle 14 can provide a lock 218, such as a spring lock, for preventing translation of the nose cone shaft 27 by the knob 216 discussed above. In some embodiments, the lock 218 can be always active, and thus the nose cone shaft 27 will not move without a user disengaging the lock 218. The lock can be, for example, a spring lock that is always engaged until a button 218 on the handle 14 is pressed, thereby releasing the spring lock and allowing the nose cone shaft 27 to translate proximally/distally. In some embodiments, the spring lock 218 allows one-way motion, either proximal or distal motion, of the nose cone shaft 27 but prevents motion in the opposite direction.
The handle 14 can further include a communicative flush port for flushing out different lumens of the delivery system 10. In some embodiments, a single flush port on the handle 14 can provide fluid connection to multiple assemblies. In some embodiments, the flush port can provide fluid connection to the outer sheath assembly 22. In some embodiments, the flush port can provide fluid connection to the outer sheath assembly 22 and the mid shaft assembly 21. In some embodiments, the flush port can provide fluid connection to the outer sheath assembly 22, the mid shaft assembly 21, and the rail assembly 20. In some embodiments, the flush port can provide fluid connection to the outer sheath assembly 22, the mid shaft assembly 21, the rail assembly 20, and the inner assembly 18. Thus, in some embodiments, the rail shaft 132, the outer retention ring 42, and the capsule 406 can all be flushed by a single flush port.
Methods of using the delivery system 10 in connection with a replacement mitral valve will now be described. In particular, the delivery system 10 can be used in a method for percutaneous delivery of a replacement mitral valve to treat patients with moderate to severe mitral regurgitation. The below methods are merely examples of the how the delivery system may be used. It will be understood that the delivery systems described herein can be used as part of other methods as well.
As shown in
Accordingly, it can be advantageous for a user to be able to steer the delivery system 10 through the complex areas of the heart in order to position a replacement mitral valve in line with the native mitral valve. This task can be performed with or without the use of a guide wire with the above disclosed system. The distal end of the delivery system can be advanced into the left atrium 1078. A user can then manipulate the rail assembly 20 to target the distal end of the delivery system 10 to the appropriate area. A user can then continue to pass the bent delivery system 10 through the transseptal puncture and into the left atrium 1078. A user can then further manipulate the delivery system 10 to create an even greater bend in the rail assembly 20. Further, a user can torque the entire delivery system 10 to further manipulate and control the position of the delivery system 10. In the fully bent configuration, a user can then place the replacement mitral valve in the proper location. This can advantageously allow delivery of a replacement valve to an in-situ implantation site, such as a native mitral valve, via a wider variety of approaches, such as a transseptal approach.
The rail assembly 20 can be particularly advantageous for entering into the native mitral valve. As discussed above, the rail assembly 20 can form two bends, both of which can be located in the left atrium 1078. The bends in the rail assembly 20 can position the prosthesis 70, located in the implant retention area 16, so that it is coaxial with the native mitral valve. Once the prosthesis 70 is coaxial, the outer sheath assembly 22, mid shaft assembly 21, inner assembly 18, and nose cone assembly 31 can together be advanced (e.g., using the depth knob 212 of the handle 14) distally relative to the rail assembly 20. These assemblies advance straight off of the rail assembly 20, thus advancing them coaxial with the native mitral valve until the prosthesis 70 is to be released while maintain the prosthesis 70 in the compressed configuration, as discussed below. Thus, the rail assembly 20 provides the ability for a user to lock the angular position in place, so that the user then has to just longitudinally advance the other assemblies over the rail assembly 20 while not needed to make any angular changes, greatly simplifying the procedure. The rail assembly 20 acts as an independent steering assembly, where all the assembly does is provide steerability and no further prosthesis release functionality. Further, the construction of the rail assembly 20 as described above is sufficiently rigid so that when the rail assembly is actuated to its bent shape, movement of the other components, e.g., the outer sheath assembly 22, mid shaft assembly 21, inner assembly 18, and/or nose cone assembly 31, the rail assembly 20 maintains its shape. Thus, the rail assembly 20 can remain in the desired bent position during the sliding of the other assemblies relative to the rail assembly 20, and the rail assembly 20 can help direct the other assemblies to the final position. The proximal/distal translation of the other assemblies over the rail assembly 20 allows for ventricular-atrial motion. In addition, once the distal anchors 80 of the prosthesis 70 have been released in the left ventricle 1080, but prior to full release, the other assemblies can be proximally retracted over the rail assembly 20 to capture any leaflets or chordae.
Reference is now made to
As shown in
As illustrated in
During delivery, the distal anchors 80 (along with the frame) can be moved toward the ventricular side of the annulus 1106, such as by translating the other assemblies (e.g., outer sheath assembly 22, mid shaft assembly 21, inner assembly 18, and nose cone assembly 31) proximally with respect to the rail assembly 20, with the distal anchors 80 extending between at least some of the chordae tendineae 1110 to provide tension on the chordae tendineae 1110. The degree of tension provided on the chordae tendineae 1110 can differ. For example, little to no tension may be present in the chordae tendineae 1110 where the leaflet 1108 is shorter than or similar in size to the distal anchors 80. A greater degree of tension may be present in the chordae tendineae 1110 where the leaflet 1108 is longer than the distal anchors 80 and, as such, takes on a compacted form and is pulled proximally. An even greater degree of tension may be present in the chordae tendineae 1110 where the leaflets 1108 are even longer relative to the distal anchors 80. The leaflet 1108 can be sufficiently long such that the distal anchors 80 do not contact the annulus 1106.
The proximal anchors 82, if present, can be positioned such that the ends or tips of the proximal anchors 82 are adjacent the atrial side of the annulus 1106 and/or tissue of the left atrium 1078 beyond the annulus 1106. In some situations, some or all of the proximal anchors 82 may only occasionally contact or engage atrial side of the annulus 1106 and/or tissue of the left atrium 1078 beyond the annulus 1106. For example, as illustrate in
The system 10 can first be positioned to a particular location in a patient's body, such as at the native mitral valve, through the use of the steering mechanisms discussed herein or other techniques.
Once the prosthesis 70 is loaded into the delivery system 10, a user can thread a guide wire into a patient to the desired location. The guide wire passes through the lumen of the nose cone assembly 31, and thus the delivery system 10 can be generally advanced through the patient's body following the guide wire. The delivery system 10 can be advanced by the user manually moving the handle 14 in an axial direction. In some embodiments, the delivery system 10 can be placed into a stand while operating the handle 14 controls.
Once generally in heart, the user can begin the steering operation of the rail assembly 20 using the distal pull wire knob 206 and/or the proximal pull wire knob 208. By turning either of the knobs, the user can provide flexing/bending of the rail assembly 20 (either on the distal end or the proximal end), thus bending the distal end of the delivery system 10 in one, two, or more locations into the desired configuration. As discussed above, the user can provide multiple bends in the rail assembly 20 to direct the delivery system 10 towards the mitral valve. In particular, the bends of the rail assembly 20 can direct a distal end of the delivery system 10, and thus the capsule 106, along the center axis passing through the native mitral valve. Thus, when the outer sheath assembly 22, mid shaft assembly 21, inner assembly 18, and nose cone assembly 31 are together advanced over the rail assembly 20 with the compressed prosthesis 70, the capsule 106 proceed directly in line with the axis for proper release of the prosthesis 70.
The user can also rotate and/or move the handle 14 itself in a stand for further fine tuning of the distal end of the delivery system 10. The user can continually turn the proximal and/or distal pull wire knobs 208/206, as well as moving the handle 14 itself, to orient the delivery system 10 for release of the prosthesis 70 in the body. The user can also further move the other assemblies relative to the rail assembly 20, such as proximally or distally.
In a next step, the user can rotate the depth knob 212. As discussed, rotation of this knob 212 together advances the inner shaft assembly 18, mid shaft assembly 21, outer sheath assembly 22, and nose cone assembly 31 over/through the rail assembly 20 while the prosthesis 70 remains in the compressed configuration within the implant retention area 16. Due to the rigidity of, for example, either the inner shaft assembly 18, the mid shaft assembly 21, and/or the outer sheath assembly 22, these assemblies proceed straight forward in the direction aligned by the rail assembly 20.
Once in the release position, the user can rotate the outer sheath knob 210, which individually translates the outer sheath assembly 22 (and thus the capsule 106) with respect to the other assemblies, in particular the inner assembly 18, in a proximal direction towards the handle 14 as shown in
As shown in the illustrated embodiment, the distal end 303 of the prosthesis 70 is expanded outwardly. It should be noted that the proximal end 301 of the prosthesis 70 can remain covered by the outer retention ring during this step such that the proximal end 301 remains in a radially compacted state. At this time, the system 10 may be withdrawn proximally so that the distal anchors 80 capture and engage the leaflets of the mitral valve, or may be moved proximally to reposition the prosthesis 70. For example, the assemblies may be proximally moved relative to the rail assembly 20. Further, the system 10 may be torqued, which may cause the distal anchors 80 to put tension on the chordae through which at least some of the distal anchors may extend between. However, in some embodiments the distal anchors 80 may not put tension on the chordae. In some embodiments, the distal anchors 80 may capture the native leaflet and be between the chordae without any further movement of the system 10 after withdrawing the outer sheath assembly 22.
During this step, the system 10 may be moved proximally or distally to cause the distal or ventricular anchors 80 to properly capture the native mitral valve leaflets. This can be done by moving the outer sheath assembly 22, mid shaft assembly 21, inner assembly 18, and nose cone assembly 31 with respect to the rail assembly 20. In particular, the tips of the ventricular anchors 80 may be moved proximally to engage a ventricular side of the native annulus, so that the native leaflets are positioned between the anchors 80 and the body of the prosthesis 70. When the prosthesis 70 is in its final position, there may or may not be tension on the chordae, though the distal anchors 80 can be located between at least some of the chordae.
The proximal end 301 of the prosthesis 70 will remain in the outer retention ring 42 after retraction of the capsule 106. As shown in
The outer retention ring 42 can be moved proximally such that the proximal end 310 of the prosthesis 70 can radially expand to its fully expanded configuration as shown in
In some embodiments, the prosthesis 70 can be delivered under fluoroscopy so that a user can view certain reference points for proper positioning of the prosthesis 70. Further, echocardiography can be used for proper positioning of the prosthesis 70.
Following is a discussion of an alternative implantation method for delivering a replacement mitral valve to a mitral valve location. Elements of the below can be incorporated into the above discussion and vice versa. Prior to insertion of the delivery system 10, the access site into the patient can be dilated. Further, a dilator can be flushed with, for example, heparinized saline prior to use. The delivery system 10 can then be inserted over a guide wire. In some embodiments, any flush ports on the delivery system 10 can be pointed vertically. Further, if an introducer tube is used, integrated or otherwise, this can be stabilized. The delivery system 10 can be advanced through the septum until a distal end of the delivery system 10 is positioned across the septum into the left atrium 1078. Thus, the distal end of the delivery system 10 can be located in the left atrium 1078. In some embodiments, the delivery system 10 can be rotated, such as under fluoroscopy, into a desired position. The rail can be flex so that direct a distal end of the delivery system 10 towards the septum and mitral valve. The position of the delivery system 10, and the prosthesis 70 inside, can be verified using echocardiography and fluoroscopic guidance.
In some embodiments, the prosthesis 70 can be located, prior to release, above the mitral annulus 1106, in line with the mitral annulus 1106, or below the mitral annulus 1106. In some embodiments, the prosthesis 70 can be located, prior to expansion, fully above the mitral annulus 1106, in line with the mitral annulus 1106, just below the mitral annulus 1106, or fully below the mitral annulus 1106. In some embodiments, the prosthesis 70 can be located, prior to expansion, partially above the mitral annulus 1106, in line with the mitral annulus 1106, or partially below the mitral annulus 1106. In some embodiments, a pigtail catheter can be introduced into the heart to perform a ventriculogram for proper viewing.
In some embodiments, the position of the mitral plane and the height of any papillary muscles on the fluoroscopy monitor can be marked to indicate an example target landing zone. If needed, the delivery system 10 can be unflexed, reduced in rotation, and retracted to reduce tension on the delivery system 10 as well as reduce contact with the left ventricular wall, the left atrial wall, and/or the mitral annulus 1106.
Further, the delivery system 10 can be positioned to be coaxial to the mitral annulus 1106, or at least as much as possible, while still reducing contact with the left ventricular wall, the left atrial wall, and/or the mitral annulus 1106 and reducing delivery system tension. An echo probe can be positioned to view the anterior mitral leaflet (AML), the posterior mitral leaflet (PML) (leaflets 1108), mitral annulus 1106, and outflow tract. Using fluoroscopy and echo imaging, the prosthesis 1010 can be confirmed to be positioned at a particular depth and coaxiality with the mitral annulus 1106.
Afterwards, the outer sheath assembly 22 can be retracted to expose the ventricular anchors 80, thereby releasing them. In some embodiments, once exposed, the outer sheath assembly 22 can be reversed in direction to relieve tension on the outer sheath assembly 22. In some embodiments, reversing the direction could also serve to partially or fully capture the prosthesis 70.
The distal anchors 80 can be released in the left atrium 1078. Further, the proximal anchors 82, if included in the prosthesis 70, are not yet exposed. Moreover, the body of the prosthesis 70 has not undergone any expansion at this point. However, in some embodiments, one or more of the distal anchors 80 can be released in either the left atrium 1078 (e.g., super-annular release) or generally aligned with the mitral valve annulus 1106 (e.g., intra-annular release), or just below the mitral valve annulus 1106 (e.g., sub-annular release). In some embodiments, all of the distal anchors 80 can be released together. In other embodiments, a subset of the distal anchors 80 can be released while at a first position and another subset of the distal anchors 80 can be released while at a second position. For example, some of the distal anchors 80 can be released in the left atrium 1078 and some of the distal anchors 80 can be released while generally aligned with the mitral valve annulus 1106 or just below the mitral valve annulus 1106.
If the distal anchors 80 are released “just below” the mitral valve annulus 1106, the may be released at 1 inch, ¾ inch, ½ inch, ¼ inch, ⅛ inch, 1/10 inch or 1/20 inch below the mitral valve annulus 1106. In some embodiments, the distal anchors 80 the may be released at less than 1 inch, ¾ inch, ½ inch, ¼ inch, ⅛ inch, 1/10 inch or 1/20 inch below the mitral valve annulus 1106. This may allow the distal anchors 80 to snake through the chordae upon release. This can advantageously allow the prosthesis 70 to slightly contract when making the sharp turn down toward the mitral valve. In some embodiments, this may eliminate the need for a guide wire assisting to cross the mitral valve. In some embodiments, the guide wire may be withdrawn into the delivery system 10 before or following release of the distal anchors 80.
In some embodiments, the distal anchors 80 can be released immediately after crossing the septum, and then the final trajectory of the delivery system 10 can be determined. Thus, the delivery system 10 can cross the septum, release the ventricular anchors 80, establish a trajectory, and move into the left ventricle to capture the leaflets.
As discussed in detail above, upon release from the delivery system 10, the distal anchors 80 can flip from extending distally to extending proximally. This flip can be approximately 180°. Accordingly, in some embodiments, the distal anchors 80 can be flipped in either the left atrium 1078 (e.g., super-annular flip), generally aligned with the mitral valve annulus 1106 (e.g., intra-annular flip), or just below the mitral valve annulus 1106 (e.g., sub-annular flip). The proximal anchors 82, if any, can remain within the delivery system 10. In some embodiments, all of the distal anchors 80 can be flipped together. In other embodiments, a subset of the distal anchors 80 can be flipped while at a first position and another subset of the distal anchors 80 can be released while at a second position. For example, some of the distal anchors 80 can be flipped in the left atrium 1078 and some of the distal anchors 80 can be flipped while generally aligned with the mitral valve annulus 1106 or just below the mitral valve annulus 1106.
In some embodiments, the distal anchors 80 may be positioned in line with the annulus 1106 or just below the annulus 1106 in the non-flipped position. In some embodiments, the distal anchors 80 may be position in line with the annulus 1106 or just below the annulus 1106 in the flipped position. In some embodiments, prior to flipping the distalmost portion of the prosthesis 70 can be located within or below the mitral valve annulus 1106, such as just below the mitral valve annulus 1106. However, flipping the anchors can cause, without any other movement of the delivery system 10, the distalmost portion of the prosthesis 70/anchors 80 to move upwards, moving it into the left atrium 1078 or moving it in line with the mitral annulus 1106. Thus, in some embodiments the distal anchors 80 can begin flipping at the annulus 1106 but be fully within the left atrium 1078 upon flipping. In some embodiments the distal anchors 80 can begin flipping below the annulus 1106 but be fully within the annulus 1106 upon flipping.
In some embodiments, the distal anchors 80 can be proximal (e.g., toward the left atrium 1078) of a free edge of the mitral leaflets 1108 upon release and flipping. In some embodiments, the distal anchors 80 can be aligned with (e.g., toward the left atrium 1078) a free edge of the mitral leaflets 1108 upon release and flipping. In some embodiments, the distal anchors 80 can be proximal (e.g., toward the left atrium 1078) of a free edge of the mitral valve annulus 1106 upon release and flipping. In some embodiments, the distal anchors 80 can be aligned with (e.g., toward the left atrium 1078) a free edge of the mitral valve annulus 1106 upon release and flipping.
Thus, in some embodiments the distal anchors 80 can be released/flipped above where the chordae 1110 attach to the free edge of the native leaflets 1108. In some embodiments the distal anchors 80 can be released/flipped above where some the chordae 1110 attach to the free edge of the native leaflets 1108. In some embodiments the distal anchors 80 can be released/flipped above where all the chordae 1110 attach to the free edge of the native leaflets 1108. In some embodiments, the distal anchors 80 can be released/flipped above the mitral valve annulus 1106. In some embodiments, the distal anchors 80 can be released/flipped above the mitral valve leaflets 1108. In some embodiments, the distal anchors 80 can be released/flipped generally in line with the mitral valve annulus 1106. In some embodiments, the distal anchors 80 can be released/flipped generally in line with the mitral valve leaflets 1108. In some embodiments, the tips of the distal anchors 80 can be released/flipped generally in line with the mitral valve annulus 1106. In some embodiments, the tips of the distal anchors 80 can be released/flipped generally in line with the mitral valve leaflets 1108. In some embodiments the distal anchors 80 can be released/flipped below where some the chordae 1110 attach to the free edge of the native leaflets 1108. In some embodiments the distal anchors 80 can be released/flipped below where all the chordae 1110 attach to the free edge of the native leaflets 1108. In some embodiments, the distal anchors 80 can be released/flipped below the mitral valve annulus 1106. In some embodiments, the distal anchors 1024 can be released/flipped below the mitral valve leaflets 1108.
Once the distal anchors 80 are released and flipped, the delivery system 10 can be translated towards the left ventricle 1080 through the mitral valve annulus 1106 so that the distal anchors 80 enter the left ventricle 1080. In some embodiments, the distal anchors 80 can compress when passing through the mitral valve annulus 1106. In some embodiments, the prosthesis 70 can compress when passing through the mitral valve annulus 1106. In some embodiments, the prosthesis 70 does not compress when it passes through the mitral annulus 1106. The distal anchors 80 can be delivered anywhere in the left ventricle 1080 between the leaflets 1108 and the papillary heads.
In some embodiments, the distal anchors 80 are fully expanded prior to passing through the mitral valve annulus 1106. In some embodiments, the distal anchors 80 are partially expanded prior to passing through the mitral valve annulus 1106 and continued operation of the delivery system 10 can fully expand the distal anchors 80 in the left ventricle 1080.
When the distal anchors 80 enter the left ventricle 1080, the distal anchors 80 can pass through the chordae 1110 and move behind the mitral valve leaflets 1108, thereby capturing the leaflets 1108. In some embodiments, the distal anchors 80 and/or other parts of the prosthesis 1010 can push the chordae 1110 and/or the mitral valve leaflets 1108 outwards.
Thus, after release of the distal anchors 80, the delivery system 10 can then be repositioned as needed so that the ends of the left distal anchors 80 are at the same level of the free edge of the native mitral valve leaflets 1108. The delivery system 10 can also be positioned to be coaxial to the mitral annulus 1106 if possible while still reducing contact with the left ventricular wall, the left atrial wall, and/or the annulus 1106.
In some embodiments, only the distal anchors 80 are released in the left atrium 1078 before the prosthesis 70 is move to a position within, or below, the annulus. In some alternate embodiments, the distal end of the prosthesis 70 can be further expanded in the left atrium 1078. Thus, instead of the distal anchors 80 flipping and no portion of the prosthesis 70 body expanding, a portion of the prosthesis 70 can be exposed and allowed to expand in the left atrium 1078. This partially exposed prosthesis 1010 can then be passed through the annulus 1106 into the left ventricle 1080. Further, the proximal anchors, if any, can be exposed. In some embodiments, the entirety of the prosthesis 70 can be expanded within the left atrium 1078.
To facilitate passage through the annulus 1106, the delivery system 10 can include a leader element (not shown) which passes through the annulus 1106 prior to the prosthesis 70 passing through the annulus 1106. For example, the leader element can include an expandable member, such as an expandable balloon, which can help maintain the shape, or expand, the annulus 1106. The leader element can have a tapered or rounded shape (e.g., conical, frustoconical, semispherical) to facilitate positioning through and expansion of the annulus 1106. In some embodiments, the delivery system 10 can include an engagement element (not shown) which can apply a force on the prosthesis 70 to force the prosthesis 70 through the annulus 1106. For example, the engagement element can include an expandable member, such as an expandable balloon, positioned within or above the prosthesis 70.
In some embodiments, to facilitate passage through the annulus 1106, a user can re-orient the prosthesis 70 prior to passing the prosthesis 70 through the annulus 1106. For example, a user can re-orient the prosthesis 70 such that it passes through the annulus 1106 sideways.
However, if only the distal anchors 80 are flipped, and no other expansion occurs, the prosthesis can be partially expanded in the ventricle 1080. Thus, when the prosthesis 70 is in the proper location, the distal end can be allowed to expand to capture the leaflets 1108. If the distal end is already expanded, no more expansion may take place or the distal end can be further expanded.
Further, the PML and AML 1106 can be captured, for example by adjusting the depth and angle of the prosthesis 70. If a larger prosthesis diameter is needed to capture the leaflets 1106, the outer sheath assembly 22 can be retracted until the desired diameter of the prosthesis 70 is achieved. Capture of the leaflets 1106 can be confirmed through echo imaging. In some embodiments, a user can confirm that the prosthesis 70 is still in the appropriate depth and has not advanced into the left ventricle 1080. The position can be adjusted as needed.
In some embodiments, once the distal anchors 80 enter the left ventricle 1080 the system 10 can be pulled backwards (e.g., towards the left atrium 1078) to fully capture the leaflets 1108. In some embodiments, the system 10 does not need to be pulled backwards to capture the leaflets 1108. In some embodiments, systolic pressure can push the leaflets 1108 upwards to be captured by the distal anchors 80. In some embodiments, systolic pressure can push the entire prosthesis 70 up towards the mitral annulus 1106 after the leaflets 1108 are captured and the prosthesis 70 is fully or partially released. In some embodiments, a user can rotate the delivery system 10 and/or prosthesis 70 prior to and/or while pulling the delivery system 10 backwards. In some instances, this can beneficially engage a greater number of chordae tendineae.
The outer sheath assembly 22 can be further retracted to fully expand the prosthesis. Once the prosthesis 70 is fully exposed, the delivery system 10 can be maneuvered to be coaxial and height relative to the mitral annulus 1106, such as by flexing, translating, or rotating the delivery system 10. As needed, the prosthesis 70 can be repositioned to capture the free edge of the native mitral valve leaflets 1108. Once full engagement of the leaflets 1108 is confirmed, the prosthesis 70 can be set perpendicular (or generally perpendicular) to the mitral annular plane.
Following, the mid shaft assembly 21 can be withdrawn. The mid shaft assembly 21 can then be reversed in direction to relieve any tension on the delivery system 10.
Below is a discussion of proximal anchors 82, though some embodiments of the prosthesis 70 may not include them. In some embodiments, proximal anchors 82 may not be released from the system 10 until the distal anchors 80 have captured the leaflets 1108. In some embodiments, proximal anchors 82 may be released from the system 10 prior to the distal anchors 80 capturing the leaflets 1108. In some embodiments, the proximal anchors 82 can be released when the distal anchors 80 are super or intra annular and the expanded prosthesis 70 (either partially or fully expanded) can be translated through the mitral annulus 1106. In some embodiments, the proximal anchors 82 could be released when the distal anchors 80 are sub-annular and the entire prosthesis 70 can be pulled up into the left atrium 1078 such that the proximal anchors 82 are supra-annular prior to release. In some embodiments, the proximal anchors 82 could be intra-annular prior to release and the systolic pressure could push the prosthesis 70 atrially such that the proximal anchors 82 end up supra-annular.
After, the leaflet capture and positioning of the prosthesis 70 can be confirmed, along with the relatively perpendicular position with respect to the mitral annular plane. In some embodiments, the nosecone 28 can then be withdrawn until it is within the prosthesis 70. The mid shaft assembly 21 can be further retracted until the prosthesis 70 is released from the delivery system 10. Proper positioning of the prosthesis 70 can be confirmed using TEE and fluoroscopic imaging.
Following, the delivery system 10 can be centralized within the prosthesis 70. The nosecone 28 and delivery system 10 can then be retracted into the left atrium 1078 and removed.
This intra-super annulus release can have a number of advantages. For example, this allows the distal anchors 82 to be properly aligned when contacting the chordae 1110. If the distal anchors 82 were released in the left ventricle 1080, this could cause misalignment or damage to heart tissue, such as the leaflets 1108 or chordae 1110.
In an alternate delivery approach, the delivery system 10 can be translated into the left ventricle 1080 prior to release of the prosthesis 70. Thus, the distal end of the prosthesis 70, and thus the distal anchors 82, can be released and flipped partially, or fully within the left ventricle 1080. Accordingly, in some embodiments the anchors 70 can be released/flipped below the mitral annulus 1106, just below the mitral annulus 1106, and/or below the free edges of the leaflets 1108. Further, the anchors 70 can be released above the papillary heads. Similar methodology as discussed above can then be used to properly position the prosthesis 70 and remove the delivery system 10 to deliver the prosthesis 1010. Further, in some embodiments the distal anchors 82 can be released without expanding the prosthesis initially in the ventricle 1080.
As discussed above, the delivery system 10 can include multiple shafts and one or more pull wires, some or all of which may be translated longitudinally/axially with respect to one another. However, having more movable components requires some sort of axial translation, which means that the handle 14 tends to become longer. This occurs because the different components within the handle 14 are generally moving in series, and thus there must be sufficient longitudinal space between handle components.
In order to prevent further lengthening of the handle 14, or even to provide a reduction in size of the handle 14, a planetary gear system can be used in the handle 14. This planetary handle gear system can be used in conjunction with, or instead of, the current linear screws in the delivery system 10. Embodiments of the planetary gears are shown in
In some embodiments, the handle 14 may include one or more outermost gears (e.g., ring gear 2502), which can be connected to a rotatable knob on the handle 14 such as disclosed above. The ring gear 2502 can encompass an entire circumference or substantially an entire circumference of the handle 14 and thus be connected directly to a knob. Alternatively, the ring gear 2502 may be smaller than the handle 14 and connected to a knob by one or more intermediate components.
Further, the handle 14 can include one or more planet gears 2504 within the ring gear 2502. The planet gears 2504 can be smaller in circumference/diameter than the ring gear 2502 and may be interlocked within an inner surface of the ring gear 2504. The planet gear 2504 can be axially and circumferentially fixed in place, though in some embodiments it may not be. If fixed in place, the planet gear 2504 is only allowed to rotate in place by rotation of the ring gear 2504, and thus does not translate around a circumference of the ring gear 2502. This can prevent any components attached to the gear system from circumferentially moving around the ring gear 2504.
Additionally, the planet gear 2504 can have an internal thread which can mate with a linear travel screw 2506, which can be attached to any of the axially translating components (e.g., shaft assemblies such as the outer sheath assembly 22, the mid shaft assembly 21, the inner assembly 18, and/or the nose cone assembly 31) discussed above. Thus, as the ring gear 2502 is rotated by the handle 14, the ring gear 2502 will rotate the planet gear 2504 in place, which will each in turn translate the linear travel screw 2506 in an axial direction. Thus, the rotational motion of the ring gear 2502 can be converted into linear translation of the travel screw 2506, providing the linear translation discussed above.
As shown in
As discussed above, the delivery system 10 (or other delivery system) can include a rigid component attached to the prosthesis 70 prior to full implant deployment. For example, the prosthesis 70 generally surrounds nose cone shaft 27, which can be a generally rigid shaft. When still partially or fully within the delivery system 10, the prosthesis 70 may be forced into the proper position by the delivery system 10, which may be against the natural anatomy of the valve area. However, the prosthesis 70 can jump or move inside the patient's anatomy once detached from the delivery system 10, such as when uncovered by the outer retention ring 42 or capsule 106. This can occur because when the prosthesis 70 is removed from the delivery system 10, it loses the support of the delivery system 10 and moves to a non-resistant position inside the natural valve anatomy.
Thus, if the prosthesis 70 is not co-axial with the native anatomy, or perpendicular to the native annulus, when the prosthesis 70 is deployed, the prosthesis 70 loses the rigid support the delivery system 10 is exerting. If the prosthesis 70 does not capture the leaflets, then the valve can move into a position where a paravalvular leak forms around the prosthetic valve leaflets.
For example, as shown in
As shown, the rigid shaft 2602 can surround the bendable shaft 2604 so that the bendable shaft 2604 extends within a lumen of the rigid shaft 2602. Thus, the rigid shaft 2602 prevents significant bending of the bendable shaft 2604. The rigid shaft 2602 can extend all the way to the nosecone 2606, or may extend only partially over the bendable shaft 2604. The bendable shaft 2604 may attach to the nosecone 2606 as discussed in conjunction with the nose cone shaft 27. The bendable shaft 2604 may be, for example, wires, cut shafts, a bendable polymer, or other materials and the particular material is not limiting.
As shown in
In some embodiments, instead of using a rigid shaft 2602, the bendable shaft 2604 can transition from a “rigid” structure to a less rigid “bendable” structure. In some embodiments, the rigid shaft 2602 may be located within a lumen of the bendable shaft 2604.
While the above-disclosed delivery system 10 includes a number of shafts and components that are fixed at their proximal end until movement of different actuators, such as at the handle 14, it can be advantageous for the components to be locked (or fixed) instead at their distal end. In order to engage/disengage with one another, the layers can be rotated relative to one another.
Specifically, the inner retention member 40 and the outer retention member 42 can be locked together until any motion is desired. In some embodiments, the members 40/42 can be threaded together. In some embodiments, the components can have additional locking features, which an operator can unlock when the operator wants to move the outer retention member 42 axially with respect to the inner retention member 40.
As shown in
Thus, an operator can translate the prosthesis 70 within the delivery system 10 to a location while the inner retention member 40 and the outer retention member 42 are locked together (e.g., threaded together). The operator can torque or rotate either one of the inner retention member 40 and the outer retention member 42, or both in some embodiments, in order to unlock the members 40/42 from one another. The operator can then axially withdraw the outer retention ring 42 to release the prosthesis 70. By connecting the two components at their distal ends, the risk of unintentional release is mitigated as the members 40/42 cannot move with respect to one another when locked together.
While the inner retention member 40 and the outer retention member 42 are disclosed with the torqueing features discussed herein, other components such as the rail assembly 20, nose cone assembly 31, or outer sheath assembly 22 may additionally include such features to connect different shaft assemblies.
In some embodiments, it can be advantageous to further include additional structural elements that can be configured to reduce deflection about a flex plane of certain shafts in the delivery system 10. This can improve the delivery system 10 under compressive loads by preventing uncontrolled deflection. For example, the delivery system 10 can inadvertently deflect in the direction of a flex plane during advancement of the delivery system 10 or when the delivery system 10 is under a compressive load, which can lead to procedural complications or accidental release of the prosthesis 70.
In order to avoid the uncontrolled bend shown in
The above disclosed shaft configuration can be used in the inner assembly 18, mid shaft assembly 21, the rail assembly 20, nose cone assembly 31, and/or outer sheath assembly 22 and may additionally include such features to connect different shaft assemblies of other delivery systems not specifically illustrated herein.
In some delivery systems, inner and outer shafts/lumens are not “keyed”, meaning that the shafts or lumens can rotate with respect to one another, as shown in
Accordingly, in some embodiments, the shafts or lumens (e.g., pull wire lumens 139 of the rail assembly 20) disclosed herein may be “keyed” as shown in
As shown in
Additionally, other keying embodiments can be used as well. For example, as illustrated in
The above disclosed keying shaft configurations can be used in the inner assembly 18, mid shaft assembly 21, the rail assembly 20, nose cone assembly 31, and/or outer sheath assembly 22 or other shafts or lumens of a delivery system and may additionally include such features to connect different shaft assemblies or lumens. The keying shaft configurations can also be used in pull wire lumens (e.g., pull wire lumens 139 of the rail assembly 20) of the delivery system (e.g., delivery system 10).
In some embodiments, tethers/sutures can be used as attachment mechanisms between a valve delivery system (e.g., delivery systems disclosed herein or delivery systems configured for delivery of replacement heart valves to replace an atrioventricular valve, a mitral valve, a tricuspid valve or other heart valve) instead of, or in conjunction with, the particular prosthesis 70 attachment mechanisms disclosed above.
As shown in
The manifold 3204 can include a number of apertures 3201 extending radially for loops 3208 (such as looped ends) of the tethers 3202 to extend through. Thus, the tethers 3202 can extend into an inner lumen of the manifold 3204 (e.g., from a distal direction) and partially extend through the apertures 3201 to an outer surface (e.g., radial or side surface) of the manifold 3204. A release (or locking) tether/suture 3206 can extend through the loops 3208, thus preventing the prosthesis (e.g., valve) 70 from being released from the manifold 3204 until ready.
The release tether 3206 can be withdrawn so that a free end 3210 of the release tether 3206 can pass through the loops 3208, thus releasing the prosthesis (e.g., valve) 70 from the tethered attachment to the manifold 3204, as shown in
Advantageously, natural tension that the prosthesis 70 exerts on the suture loops 3208 when the prosthesis 70 is loaded also cinches the release (or locking) tether 3206, so there is no need for a catheter or user to keep a constant tension on the release (or locking) tether 3206. At a time when the prosthesis 70 is ready for release, a user may pull one end of the release (or locking) tether 3206 until it is unthreaded from all of the loops 3208, thereby enabling the loops 3208 to detach from the prosthesis 70 and the prosthesis 70 to thereby separate from the manifold 3204 of the delivery system.
In the locked position, or configuration, shown in
The tether/suture attachment mechanisms described herein can be used in conjunction with any prosthesis (e.g., replacement heart valve) that includes retention components (e.g., eyelets) through which one or more tethers can be looped. For example, the prosthesis could be a modified version of the prosthesis 70 illustrated in
In some embodiments, the capsule 106 may have an alternate construction than discussed above, which are shown in
Advantageously, this alternative construction may allow for repositioning or retrieval of the implant (e.g., replacement heart valve). To do so, the capsule 3702 may be flexible, be good in compression, and good in tension. Thus, embodiments of the capsule 3702 may be universally flexible, able to deliver high compressive and tensile forces, and a low profile.
As shown in
Further, the distal section 3704 can include an outer jacket 3804 which can partially or fully surround the hypotube 3802, as shown in
Further, the hypotube 3802 can have an inner liner. In some embodiments, the inner liner is a fluoropolymer. In certain embodiments, the inner liner may be porous. The inner liner can then be bonded to a metal structure of the hypotube 3802, such as using a reflow process. A polymer can be used which bonds the inner liner to the metal. For example, a low durometer thermoplastic elastomer or a thermoplastic polyurethane can be used.
The proximal section 3706 can further include a lasercut hypotube 3902, shown in
Another embodiment of the handle 14′ is shown in
The failsafe knob 500 can be configured to decouple a lumen or shaft of the delivery system 10 from the handle 14′ when a threshold force is applied to the shaft assembly 12 (e.g., to one or more lumens or shafts) of the delivery system 10. For example, the failsafe knob 500 can include a first portion 502 and a second portion 506. In some embodiments, the first portion 502 can be positioned distally of the second portion 506 on the handle 14′. In a first configuration, as shown in
The first portion 502 of the failsafe knob 500 can be coupled to an adapter 510 of or within the handle 14′. The adapter 510 can be positioned radially inward of the failsafe knob 500 and engage with the delivery housing 204. The second portion 506 of the failsafe knob 506 can include an engagement portion configured to engage with the delivery housing 204. For example, the delivery housing 204 can be threaded and the engagement portion can be a projection (e.g., a v-shaped projection or tab) configured to engage the threading in the delivery housing 204.
In use, a force F can be applied to the adapter 510 that can be correlated to a force exerted on the shaft assembly 12 (e.g., one or more lumens or shafts) of the delivery system 10 when the user navigates the shaft assembly 12 using the failsafe knob 500. When the force F reaches a threshold force, the first portion 502 may move distally until the projection 508 of the second portion 506 detaches from the spring 504 of the first portion 502. When the first portion 502 and the second portion 506 decouple, the user may no longer be able to rotate the failsafe knob 500 (either permanently or temporarily until the user reduces the force exerted on the shaft assembly 12 such that the force F is less than the threshold force). If temporary, once the force F is reduced, the user may couple the first portion 502 with the second portion 506 and resume the procedure. Advantageously, the failsafe knob 500 may prevent the delivery system 10 from failing due to excess forces or loads (e.g., (e.g., shear force or load) being exerted on the delivery system 10 (e.g., one or more shafts or lumens of the delivery system 10). The threshold force may be a level of force or load substantially below a calculated failure level during testing so that risk of failure is reduced. For example, if the one or more lumens or shafts of the shaft assembly 12 have an ultimate tensile strength of 20 lbs., the threshold force can be 10 lbs. for a safety factor of 2 or can be 15 lbs. for a safety factor of 1.5. In some configurations, the threshold force can be between about 1 lb. and about 50 lbs., about 10 lbs. and about 40 lbs., or about 20 lbs. and about 30 lbs. In some configurations, the threshold force can be configured for a safety factor of between about 1.0 and about 5.0, about 1.5 and about 4.5, about 2.0 and about 4.0, or about 2.5 and about 3.5.
In some embodiments, the second portion 506 can be positioned distally of the first portion 502 on the handle 14′. When the force F is applied to the adapter 510, the first portion 502 may move distally toward the second portion 506 such that the spring 504 is increasingly compressed. When the force F reaches the threshold force, the compressive forces may cause the first and second portions 502, 506 to decouple. Any of the releasable coupling mechanisms described herein can be configured to decouple the first and second portions 502, 506 based on the compressive forces applied to the first and second portions 502, 506.
In some embodiments, a knob may not mechanically separate or decouple into two components but may instead provide a visual indicator of an amount of force being exerted on or by one or more shafts or lumens controlled by the knob. An embodiment of an indicator knob 600 is shown in
The indicator knob 600 can be configured to indicate (e.g., visually) when a force being applied to the shaft assembly 12 (e.g., one or more lumens or shafts controlled by, or operatively coupled to, the indicator knob 600) of the delivery system 10 increases and/or decreases, a “real-time” amount of force being applied, or when a threshold amount of force has been reached. For example, the indicator knob 600 can include a first portion 602 and a second portion 606. The first portion 602 can be positioned distally from the second portion 606. The first portion 602 can be connected to the second portion 606 via a connector 604. A first or distal end of the connector 604 can be moveably secured in the first portion 602 and a second or proximal end of the connector 604 can be moveably secured in the second portion 606. For example, the first and second portions 602, 606 can have a recess (e.g., groove, notch, slot) that extends from an opening of the first portion 602 or the second portion 606. The recess of the first portion 602 can be configured to receive the first end and/or a distal portion of the connector 604. The recess of the second portion 606 can be configured to receive the second end and/or a proximal portion of the connector 604. The second portion 606 can include a spring 608 that surrounds the connector 604 within the second portion 606.
As shown in
The first portion 602 of the indicator knob 600 can be coupled to an adapter 610 of or within the handle 14′. The adapter 610 can be positioned radially inward of the indicator knob 600 and engage with the delivery housing 204. The second portion 606 of the indicator knob 606 can include an engagement portion configured to engage with the delivery housing 204. For example, the delivery housing 204 can be threaded and the engagement portion can be a projection (e.g., a v-shaped projection) that can be configured to engage the threading in the delivery housing 204.
In use, a force F can be applied to the adapter 610 that is correlated to a force exerted on the shaft assembly 12 of the delivery system 10 when the user navigates the shaft assembly 12 (e.g., one or more shafts or lumens of the shaft assembly 12) using the indicator knob 600. When a force is exerted on the shaft assembly 12 (e.g., one or more shafts or lumens of the shaft assembly 12), the force F applied to the adapter 610 may cause the first portion 602 to move distally while the position of the second portion 604 can remain unchanged. In some embodiments, both portions 602, 606 can be configured to move in response to the applied force F. As the force exerted on the shaft assembly 12 (e.g., one or more shafts or lumens of the shaft assembly 12 operatively coupled to the indicator knob 600) increases, the increasing force F applied to the adapter 610 may cause the distance between the first and second portions 602, 606 to increase. The increasing force F may cause an increasing length of the connector 604 to be uncovered. The distance between the first and second portions 602, 606 and the length of the connector 604 that is uncovered can correlate (e.g., be proportional) with the amount of force F that is being exerted on the adapter 610. For example, the shorter the distance between the first and second portions 602, 606 and the greater length of the connector 604 that is covered, the less force F that may be applied to the adapter 610. Moreover, the greater the distance between the first and second portions 602, 606 and the greater length of the connector 604 is uncovered, the greater the force F that may be applied to the adapter 610. Accordingly, as the force F is reduced, the distance between the first and second portions 602, 606 and the length of the connector 604 that is uncovered may decrease. In some embodiments, the distance between the first and second portions 602, 606 may be inversely related to the force F being applied.
The connector 604 may include indicators along the length of the connector 604 that can correlate with the force F being applied to the delivery system 10. For example, the indicators can include colors, bands, stripes, numbers, shapes, symbols, or the like. The connector 604 can include any number of indicator(s). For example, the connector 604 can include one, two, three, four, five, six, or more than six indicator(s). In some embodiments, the connector 604 may include three indicators. The three indicators can include a band of different colors. For example, the three indicators can include one or more red bands, one or more yellow bands, and one or more green bands. The one or more green bands can include a single green band at or near the middle of the connector 604. The one or more red bands can include two red bands that can be positioned adjacent the first and second portions 602, 606. The one or more yellow bands can include two yellow bands that can be positioned between the green band and the red bands. The green band can indicate that the amount of force being applied to the delivery system 10 is within an acceptable range or a preferred range. The red bands can indicate that the amount of force being exerted on the delivery system 10 is in an unacceptable range and the user should reduce the amount of force. The yellow bands can indicate the amount of force being applied to the delivery system 10 is within an acceptable range but the amount of force is increasing to the unacceptable range or the amount of force is decreasing to the preferred range.
In some embodiments, the second portion 606 can be positioned distally of the first portion 602 on the handle 14′. The distance between the first and second portions 602, 606 may be inversely related to the force F being exerted on the delivery system 10. For example, the greater the distance between the first and second portions 602, 606 and the greater length of the connector 604 is uncovered, the less the force F that may be applied to the adapter 610. Accordingly, as the force F is increased, the distance between the first and second portions 602, 606 and the length of the connector 604 that is uncovered may decrease.
In some embodiments, the indicator knob 600 can include the same or similar functionality as the failsafe knob 500. For example, a distance between the first and second portions 602, 606 of the indicator knob 600 may increase as the force F being exerted on the delivery system 10 increases, as described above. Once the force F reaches a threshold force, the first and second portions 602, 606 may decouple.
From the foregoing description, it will be appreciated that an inventive product and approaches for implant delivery systems are disclosed. While several components, techniques and aspects have been described with a certain degree of particularity, it is manifest that many changes can be made in the specific designs, constructions and methodology herein above described without departing from the spirit and scope of this disclosure.
Certain features that are described in this disclosure in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable subcombination. Moreover, although features may be described above as acting in certain combinations, one or more features from a claimed combination can, in some cases, be excised from the combination, and the combination may be claimed as any subcombination or variation of any subcombination.
Moreover, while methods may be depicted in the drawings or described in the specification in a particular order, such methods need not be performed in the particular order shown or in sequential order, and that all methods need not be performed, to achieve desirable results. Other methods that are not depicted or described can be incorporated in the example methods and processes. For example, one or more additional methods can be performed before, after, simultaneously, or between any of the described methods. Further, the methods may be rearranged or reordered in other implementations. Also, the separation of various system components in the implementations described above should not be understood as requiring such separation in all implementations, and it should be understood that the described components and systems can generally be integrated together in a single product or packaged into multiple products. Additionally, other implementations are within the scope of this disclosure.
Conditional language, such as “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include or do not include, certain features, elements, and/or steps. Thus, such conditional language is not generally intended to imply that features, elements, and/or steps are in any way required for one or more embodiments.
Conjunctive language such as the phrase “at least one of X, Y, and Z,” unless specifically stated otherwise, is otherwise understood with the context as used in general to convey that an item, term, etc. may be either X, Y, or Z. Thus, such conjunctive language is not generally intended to imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z.
Language of degree used herein, such as the terms “approximately,” “about,” “generally,” and “substantially” as used herein represent a value, amount, or characteristic close to the stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms “approximately”, “about”, “generally,” and “substantially” may refer to an amount that is within less than or equal to 10% of, within less than or equal to 5% of, within less than or equal to 1% of, within less than or equal to 0.1% of, and within less than or equal to 0.01% of the stated amount. If the stated amount is 0 (e.g., none, having no), the above recited ranges can be specific ranges, and not within a particular % of the value. For example, within less than or equal to 10 wt./vol. % of, within less than or equal to 5 wt./vol. % of, within less than or equal to 1 wt./vol. % of, within less than or equal to 0.1 wt./vol. % of, and within less than or equal to 0.01 wt./vol. % of the stated amount.
Some embodiments have been described in connection with the accompanying drawings. The figures are drawn to scale, but such scale should not be limiting, since dimensions and proportions other than what are shown are contemplated and are within the scope of the disclosed inventions. Distances, angles, etc. are merely illustrative and do not necessarily bear an exact relationship to actual dimensions and layout of the devices illustrated. Components can be added, removed, and/or rearranged. Further, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like in connection with various embodiments can be used in all other embodiments set forth herein. Additionally, it will be recognized that any methods described herein may be practiced using any device suitable for performing the recited steps.
While a number of embodiments and variations thereof have been described in detail, other modifications and methods of using the same will be apparent to those of skill in the art. Accordingly, it should be understood that various applications, modifications, materials, and substitutions can be made of equivalents without departing from the unique and inventive disclosure herein or the scope of the claims.
This application is a continuation of International Application No. PCT/US2021/023303, filed Mar. 19, 2021, which designates the United States and was published in English by the International Bureau on Sep. 30, 2021 as WO2021/194899, which claims priority to U.S. Provisional App. No. 62/993,885, filed Mar. 24, 2020, the entire contents of each of which are hereby incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| 62993885 | Mar 2020 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US2021/023303 | Mar 2021 | US |
| Child | 17940868 | US |
