US20210353413A1 - Prosthetic heart valve delivery - Google Patents

Abstract

A prosthetic heart delivery assembly can provide dynamic control of the components of a valve prosthesis during delivery and placement at a target site. The assembly can permit expansion of a valve anchor and thereafter permit adjustment of the position of the valve anchor using a position control element and/or via a link mechanism coupled to a valve frame of the prosthesis. The assembly can therefore allow a surgeon to adjust the prosthesis's position in both longitudinal and rotational directions at the target site.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• The present application is a continuation of U.S. patent application Ser. No. 16/240,285, filed on Jan. 4, 2019, which claims the benefit of and priority to U.S. Provisional Application No. 62/614,489, filed on Jan. 7, 2018, U.S. Provisional Application No. 62/756,556, filed on Nov. 6, 2018, and U.S. Provisional Application No. 62/781,537, filed on Dec. 18, 2018, the entireties of each of which are incorporated herein by reference.
TECHNICAL FIELD
• The present disclosure relates to devices and methods for the percutaneous delivery and implantation of a cardiac valve prosthesis. The valve prosthesis can be delivered in a compressed state within a sheath to the defective native valve and released in situ.
BACKGROUND
• Prosthetic heart valves are used to replace damaged or diseased heart valves. In vertebrate animals, the heart is a muscular organ with four pumping chambers: the left and right atria and the left and right ventricles, each provided with its own one-way valve. The natural heart valves are identified as the aortic, mitral (or bicuspid), tricuspid and pulmonary valves. Prosthetic heart valves can be used to replace any of these naturally occurring valves, although repair or replacement of the aortic or mitral valves is more common since they reside in the left side of the heart where pressures are the greatest.
• A conventional heart valve replacement surgery involves accessing the heart in the patient's thoracic cavity through a longitudinal incision in the chest. For example, a median sternotomy requires cutting through the sternum and forcing the two opposing halves of the rib cage to be spread apart, allowing access to the thoracic cavity and heart within. The patient is then placed on cardiopulmonary bypass which involves stopping the heart to permit access to the internal chambers. Such open-heart surgery is particularly invasive and involves a lengthy and difficult recovery period.
• The foregoing examples of the related art and limitations related therewith are intended to be illustrative and not exclusive. Other limitations of the related art will become apparent to those of skill in the art upon a reading of the specification and a study of the drawings.
SUMMARY
• The present disclosure relates to heart valve prostheses, delivery devices, and actuation handles that can facilitate delivery of a heart valve prosthesis to a defective native valve structure in a patient, such as the aortic valve. In some embodiments, the delivery can be performed using a transcatheter approach.
• The delivery devices and actuation handles can enable a clinician to more easily maneuver and advance the delivery device through blood vessels leading to the heart, as well as through tortuosities of such vessels, using a transvascular approach, such as a transfemoral approach. Indeed, some embodiments disclosed herein enable components of the heart valve prosthesis to be advanced in tandem, as an axially displaced unit (with or without partial or full overlapping between the components), while still being movably connected, movably attached, flexibly connected, displaceably connected, linked, or coupled to each other, thereby minimizing a passing profile or cross section of the delivery device. Optionally, the distance from which the components of the heart valve prosthesis may be serially displaced may be variable, such that various components are adjacent or potentially inches or feet away. Further, the interconnection of components of the heart valve prosthesis can allow different degrees of motion and can be set into an engaged or retained position that provides a limited range of motion. In some embodiments, the engaged position can also provide a preset relative positioning of the components of the heart valve prosthesis to facilitate proper placement and release of the heart valve prosthesis. Additionally, some embodiments can provide a clinician with a high degree of control and enhance the maneuverability of the heart valve prosthesis when implanting the heart valve prosthesis at the target location.
• In accordance with some embodiments, a procedure is provided for a transcatheter aortic valve implantation (TAVI) and/or a transcatheter aortic valve replacement (TAVR). For example, in the TAVI procedure, a clinician can anchor the anchoring component of the heart valve prosthesis relative to the aortic valve annulus to guide the placement of the prosthetic leaflet structure. The valve prosthesis can comprise prosthetic leaflets, an anchoring component, a valve frame component, and a tethering component, which allows the anchoring component and the frame component to be placed serially in a delivery device in order to reduce the overall crossing profile of the delivery device. The tethering component can be coupled to the anchoring component and the frame component to permit a range of motion and in some embodiments, to restrict other motion. The tethering component can be slidable relative to the anchoring component between a released position and a retained position. In the retained position, the tethering component can allow relative movement of the valve frame component and a preset or predetermined position which the valve frame component is optimally located relative to the anchoring component, which can facilitate placement and release of the valve prosthesis.
• For example, in some embodiments, the interconnection can be implemented using a novel approach of looping the tethering component around “U-shaped” members of the anchoring component. The tethering component can slide along the anchoring component until reaching the end of the travel on the anchoring component. The clinician can exert tension on the tethering component until the tethering component is seated in the engagement area. This action can ratchet the tethering component and engage it to the engagement area of the anchoring component. Thereafter, the tethering component establishes a fixed range of longitudinal travel of the valve frame component relative to the anchoring component, and subsequently a proper position of the valve frame component in the anatomy, based only on the clinician placing the anchoring component into the aortic sinus region (the clinician can see under fluoroscopy and can “feel” the placement).
• Thus, some embodiments disclosed herein advantageously provide a delivery device that has a reduced passing profile or cross section, thereby enabling delivery of a heart valve prosthesis in a safer, less invasive manner than traditional approaches. As such, open-heart surgery can be avoided because the heart valve prosthesis can be advanced to the heart using a catheter via an access point in the blood vessel, such as the femoral artery. This provides enormous benefits to patients, including less trauma to the patient, greater ease of recovery, and potentially fewer surgical risks, to name a few.
• Further, although the in-series arrangement of the anchoring component and the valve frame component overcomes the challenge of creating a low-profile delivery device, the advantageous arrangement of the interconnection overcomes yet another critical challenge: how to optimally position the valve prosthesis within the native valve structure and to reliably anchor it in place. Indeed, some embodiments disclosed herein address this challenge and teach structures and methods for using a tethering component to operatively couple the anchoring component to the valve frame component in a delivery device.
• The delivery device can comprise a proximal sheath that can house at least a portion of the anchoring component and a distal carrier assembly that can house at least a portion of the valve frame component. The tethering component can extend between the anchoring component and the valve frame component when the valve prosthesis is loaded onto the delivery device. The valve prosthesis can be released from the delivery device in a component-by-component manner that allows the clinician to maneuver and position the anchoring component first, followed by the valve frame component.
• In some embodiments, the anchoring component can be coupled to an engagement member or grasper of the delivery device that allows the clinician to push or pull the anchoring component. The grasper can be released from engagement with the anchoring component when the anchoring component is properly seated relative to the native valve annulus.
• In addition, in some embodiments, the distal carrier assembly of the delivery device can comprise two components or be referred to as a two-part nose cone assembly. In accordance with some embodiments is the realization that if a single tubular member or nose cone is used to sheath most of the valve frame component, various problems can arise due to the expansive force and corresponding compressive force required to maintain the valve frame component in its compressed configuration during delivery to a target valve structure. Because the delivery device can be quite long (for example, in some embodiments, up to about 4 to 6 feet or more, although the length can be less than 4, 3, or 2 feet), these forces can create a much stiffer distal section of the delivery device. Further, these forces can require a high degree of longitudinal force to release the valve frame component due to the high frictional forces due to the radial force of the valve implant.
• Thus, the radial and frictional forces of such configurations can cause problems of matching handle actuation and make precise positioning of the distal end of the delivery device quite difficult. For example, the friction tends to be a variable friction that makes it difficult for a clinician to position the components of the valve prosthesis relative to each other, which can lead to unpredictable and/or imprecise component positioning or deployment. Thus, some embodiments herein include the realization that by separating the distal carrier or nose cone assembly into two components (such as a proximal and distal enclosure), the components can cover less surface area of the valve frame component, thus reducing the radial forces exerted on a single component and the resultant friction that would need to be overcome in order to actuate or release the valve frame component. As such, the problems associated with a single tubular member are much more manageable.
• Additionally, in some embodiments, a two-part distal carrier assembly can also enable the clinician to release the valve frame component in an advantageous sequence. For example, during testing and development of the valve prostheses, deployment systems, and handle actuators disclosed herein, some embodiments demonstrate advantageous characteristics by permitting a distal end portion of the valve frame component to open first, before a proximal end portion of the valve frame component is released. In some embodiments, the valve frame component can have one or more anchors at its distal end portion that can supplement the outward expansive force (due to self-expansion of the valve frame component) and its resultant frictional engagement. By opening the distal end portion first (by actuation of distal nose cone or enclosure), the distal end portion can “flower” out and engage with the native valve structure to secure a longitudinal position of the valve frame component relative to the native valve structure. Thereafter, the self-expanding radial outward force of the valve frame component can cause the proximal end portion of the valve frame component to become disengaged and released from the proximal nose cone or enclosure.
• Some embodiments can also provide self-aligning features to allow the components of the delivery assembly to be moved from a releasing state (where the components of the valve prosthesis are released from engagement with the delivery assembly) to a nested or stowed state in which outer surfaces of portions of the delivery assembly are aligned or in an abutting position at a seam. This alignment, abutment, or positioning can provide a smoother outer profile that can reduce the likelihood of having the delivery assembly snag or become entangled with the prosthetic valve after being released or with other vasculature as the delivery assembly is retrieved from the patient's vasculature.
• For example, in some embodiments, the distal carrier or nose cone assembly can include an internal plunger or piston mechanism. The plunger mechanism can be compressed when the valve frame component is loaded into the delivery device. As the valve frame component is released, a spring of the plunger mechanism can push a plunger head to a predetermined position relative to the distal carrier assembly. In accordance with some embodiments, in the predetermined position, the plunger head can be exposed partially from the distal enclosure and be configured to engage with the proximal enclosure to align the proximal and distal enclosures relative to each other in an abutting relationship. The plunger head can therefore engage with both the proximal and distal enclosures to reduce the likelihood of catching or snagging of the delivery device with the prosthetic valve or other vasculature during retrieval of the delivery device. Additionally, such features can also aid in proximal retraction of the delivery device into an introducer sheath. Moreover, the plunger head can also provide a proximal surface that can be in contact with the distal end portion of the valve frame component and not catch or snag with the intricate mesh of the valve frame component, thereby ensuring that the valve frame component can flower open without catching on the delivery device. Accordingly, some embodiments can include one or more of these advantageous features that address the problem of having the valve prosthesis and/or the delivery device catch or snag on each other or surrounding anatomy.
• Furthermore, due to the reduced cross-sectional profile of the delivery device, retrograde delivery of a valve prosthesis through the blood vessel (such as femoral artery in a transfemoral retrograde approach) can be possible with reduced risk of trauma to the surrounding vasculature. For example, retrograde delivery of the valve prosthesis through the femoral artery has been associated with aortofemoral artery injury and/or rupture, and carries a potential risk of stroke as the delivery involves crossing the aortic arch. However, the various features and advantages achieved using some embodiments disclosed herein provide a valve prosthesis and delivery device that minimizes damage along the delivery path of device while also minimizing the invasive nature of the implantation procedure.
• Additional embodiments of the present devices and methods, and the like, will be apparent from the following description, drawings, examples, and claims. As can be appreciated from the foregoing and following description, each and every feature described herein, and each and every combination of two or more of such features, is included within the scope of the present disclosure provided that the features included in such a combination are not mutually inconsistent. In addition, any feature or combination of features may be specifically excluded or omitted from any embodiment of the present disclosure. Additional aspects and advantages of the present disclosure are set forth in the following description and claims, particularly when considered in conjunction with the accompanying examples and drawings.
• Additional features and advantages of the subject technology will be set forth in the description below, and in part will be apparent from the description, or may be learned by practice of the subject technology. The advantages of the subject technology will be realized and attained by the structure particularly pointed out in the written description and embodiments hereof as well as the appended drawings.
• Certain features of valve prostheses, delivery devices, actuation handles, other devices, systems, and methods which can be implemented with the valve prostheses, delivery devices, actuation handles, other devices, systems, and methods discussed in the present disclosure, can implement features of and/or be used in combination with other features of valve prostheses, delivery devices, actuation handles, other devices, systems, and methods described for example in International Application No. PCT/US2019/012406 (Docket No.: 122271-5044), entitled HEART VALVE PROSTHESIS AND DELIVERY, filed on Jan. 4, 2019, by Ji Zhang, Brandon G. Walsh, Cheng Yong Yang, Jinhua Zhu, and Dennis Michael McMahon, and in International Application No. PCT/US2019/012408 (Docket No.: 122271-5048), entitled PROSTHETIC HEART VALVE DELIVERY SYSTEM, filed on Jan. 4, 2019, by Ji Zhang, Brandon G. Walsh, and Cheng Yong Yang, the entirety of each of which is incorporated herein by reference.
• It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the subject technology.
BRIEF DESCRIPTION OF THE DRAWINGS
• Various features of illustrative embodiments of the inventions are described below with reference to the drawings. The illustrated embodiments are intended to illustrate, but not to limit, the inventions. The drawings contain the following figures:
• FIG. 1 illustrates delivery of a valve prosthesis using a valve delivery device in a transfemoral retrograde approach, according to some embodiments.
• FIG. 2 shows a valve prosthesis, according to some embodiments.
• FIG. 3 is a side cross-sectional view of the valve prosthesis ofFIG. 2 loaded onto a valve delivery device, according to some embodiments.
• FIG. 4 is a perspective view the valve delivery device ofFIG. 3 showing a grasper mechanism for engaging a valve anchor, according to some embodiments.
• FIGS. 5A and 5B are side cross-sectional views illustrating operation of a distal carrier assembly of the valve delivery device ofFIG. 3 with a nose cone protector, according to some embodiments.
• FIGS. 6A-6I illustrate delivery stages of a method for delivering the valve prosthesis ofFIG. 2 using the delivery device ofFIG. 3 and a handle actuator using a transfemoral retrograde approach, according to some embodiments.
• FIGS. 7A and 7B illustrate delivery stages of a method for delivering the valve prosthesis ofFIG. 2 using the delivery device ofFIG. 3 using a transapical antegrade approach, according to some embodiments.
DETAILED DESCRIPTION
• In the following detailed description, numerous specific details are set forth to provide a full understanding of the subject technology. It should be understood that the subject technology may be practiced without some of these specific details. In other instances, well-known structures and techniques have not been shown in detail so as not to obscure the subject technology.
• Further, while the present disclosure sets forth specific details of various embodiments, it will be appreciated that the description is illustrative only and should not be construed in any way as limiting. Additionally, it is contemplated that although particular embodiments of the present disclosure may be disclosed or shown in the context of aortic valve prostheses, such embodiments may be used in other cardiac valve prosthesis applications. Furthermore, various applications of such embodiments and modifications thereto, which may occur to those who are skilled in the art, are also encompassed by the general concepts described herein.
• Various embodiments will now be described more fully hereinafter. Such embodiments may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey its scope to those skilled in the art. Thus, one or more features shown or otherwise disclosed in an embodiment herein may be interchangeably used or incorporated into another embodiment that may not expressly show or disclose such feature(s). Further, one or more features shown or otherwise disclosed for an embodiment herein may be excluded from such embodiment, unless expressly indicated, using skill in the art.
• As with all cardiac valves, a healthy aortic valve will open to allow blood flow and close to prevent backflow of blood. However, disease and dysfunction of the valve can result in regurgitation or decreased blood flow (stenosis). In such cases, a replacement aortic valve prosthesis must be used to perform the functions of a healthy aortic valve.
• Minimally invasive surgical techniques are evolving, where a valve prosthesis can be introduced into a patient using a catheter that is introduced via a small incision that provides access to, for example, a femoral artery or directly to the heart. These implantation techniques have shown promising results in providing treatment options for patients who are poor open surgical candidates. Nevertheless, challenges still remain in such catheter-based delivery of prosthetic valves.
• For example, in according with an aspect of at least one embodiment disclosed herein is the realization that advancing a conventional tubular delivery device through a vessel exerts stress against the vessel walls and carries the risk of damaging the vessel walls. Further, in according with an aspect of at least one embodiment disclosed herein is the realization that transcatheter prosthetic valves may not be able to treat patients with aortic regurgitation. Additionally, in according with an aspect of at least one embodiment disclosed herein is the realization that conventional prosthetic valves may be difficult to position, may require rapid ventricular pacing, and may have limited expansion. Accordingly, implantation and use of conventional prosthetic valves may result in complications, such as vascular damage, moderate to severe paravalvular leakage, valve thrombosis/migration, coronary artery blockage, and excessive stress due to excessive radial force.
• The present disclosure describes various aspects of heart valve prostheses that can be delivered to a defective heart valve in a patient. The valve prostheses can comprise at least one valve anchor or clasper, which is movably connected, movably attached, flexibly connected, displaceably connected, linked, or coupled to a radially expandable valve support or frame. The valve frame can comprise prosthetic valve leaflets or cusps and provide the functionality of the native heart valve. Certain features of valve prostheses, which can be implemented with the prostheses discussed in the present disclosure, are also further described for example, in U.S. Pat. No. 8,366,768, the entirety of which is incorporated herein by reference.
• Thus, the present disclosure provides a variety of features that can be optionally incorporated or excluded from any of the embodiments explicitly discussed or illustrated herein. These modifications and combinations of features can be performed by a person of skill to achieve advantages and benefits discussed herein. Further, certain modifications or combinations are indicated or suggested herein, but it is contemplated that a person skill can implement or exclude certain aspects or features disclosed herein in developing a suitable embodiment or implementation of these teachings. Advantageously, various embodiments described herein allow for treating patients with aortic regurgitation, permit precise axial, angular, and radial positioning of the valve prosthesis, minimize valve migration and paravalvular leakage while avoiding damage to the valve annulus, minimize the need for a pacemaker, and decrease the likelihood of blocking the coronary artery.
• Some of these features and benefits of the heart valve prosthesis are illustrated with respect toFIGS. 1-5.FIG. 1 illustrates the use of thedelivery device200 in ahuman heart300. Theheart300 can comprise anaorta301 having anaortic arch302 and anaortic valve304. Theaorta valve304 can comprise a plurality ofnative valve leaflets306 and separate theaorta301 from theleft ventricle310. In accordance with some embodiments, thedelivery device200 can be advanced retrograde through theaorta301 until reaching and being positioned through thenative valve leaflets306 of theaortic valve304.
• With reference toFIGS. 1 and 2, during delivery of thevalve prosthesis100 to the native valve site, thevalve anchor104 and thesupport frame102 can be positioned in tandem, as an axially displaced unit (with or without partial or full overlapping between the anchor and the frame) along the longitudinal axis of thedelivery device200. This configuration, as opposed to a concentric arrangement, can allow a more radially compact configuration of the components of thevalve prosthesis100, creating a much smaller cross-section and facilitating a catheter-based delivery. This can improve the flexibility of thedelivery device200, enabling thedelivery device200 to be advanced over a guidewire through the tortuous geometries of the circulatory system, and in particular, theaortic arch302. Indeed, even with guidewire-directed delivery devices, theaortic arch302 represents a difficult obstacle due to its sudden and high-degree of curvature. Often, this is a limiting constraint for some surgeries or delivery devices. However, in accordance with the various benefits and advantages of some embodiments disclosed herein, as illustrated inFIG. 1, thedelivery device200 can be advanced over theaortic arch302 to a target location in the region of theaortic valve304.
• As shown inFIG. 1, once thevalve anchor104 is in the desired position, thesupport frame102 can be released from the distal carrier assembly and expanded into apposition with thenative valve leaflets306 and the internal aspects of thevalve anchor104, thus sandwiching thenative valve leaflets306 between thesupport frame102 and thevalve anchor104. Advantageously, by sandwiching thenative valve leaflets306 between the support frame and the valve anchor, thevalve prosthesis100 can have reduced reliance on radial force retention. Further, by sandwiching thenative valve leaflets306 between the support frame and the valve anchor, the likelihood of thenative valve leaflets306 blocking the opening of the coronary artery is reduced, which may be beneficial for patients with low coronary ostia distance, and in patients with an existing valve prosthesis, who may need a new valve prosthesis inside the existing valve prosthesis (valve-in-valve application). The support frame and the valve anchor can thus expand into contact with theaortic valve304, exerting a chronic outward force against thenative valve leaflets306 andaortic valve annulus320. Thereafter, the prosthetic valve leaflets of theprosthesis100 can begin to function in the manner desired and provide the same operation as a native valve.
• According to some embodiments, the present disclosure also provides a handle actuator that can be used to control the operation of the presently disclosed delivery device and allow a clinician to reliably and accurately control the delivery of the valve prosthesis.FIG. 1 illustrates features and operation of the handle actuator, according to some embodiments, for delivering a valve prosthesis using ahandle actuator500.
• FIG. 1 illustrates thehandle actuator500, which can control one or more functions of a delivery device (e.g., thedelivery device200 discussed herein) for delivering of a valve prosthesis (e.g., theheart valve prosthesis100 discussed herein). Thehandle actuator500 can comprise a plurality of actuators or movable elements, such as knobs or buttons. The movable elements can permit a clinician to control one or more operations of thedelivery device200. Thehandle actuator500 can comprise acontrol handle510 having alongitudinal axis512. Thehandle actuator500 may be also referred to as a control unit. In some embodiments, thehandle actuator500 may be coupled to the second core member222 (shown, e.g., inFIGS. 3 and 5). The control handle510 can support the actuators and be held by the clinician during the procedure.
• In some embodiments, as illustrated inFIG. 1, thehandle actuator500 can comprise a firstmovable element520, a secondmovable element522, a thirdmovable element524, and a fourthmovable element526. The firstmovable element520 can be used to steer thedelivery device200, the secondmovable element522 can be used to release the valve anchor, the thirdmovable element524 can be used to release nosecone or valve frame, and the fourthmovable element526 can be used as a nose cone toggle lock. The firstmovable element520, the secondmovable element522, the thirdmovable element524, and the fourthmovable element526 may be also referred to as thefirst control element520, thesecond control element522, thethird control element524, and thefourth control element526.
• Optionally, in some embodiments, one or more of the movable elements, such as the secondmovable element522 and/or the thirdmovable element524, can include a button orslider safety switch529 that prevent the unintentional rotation of the moveable elements. Thesafety switch529 can be configured as resilient button or slider mechanisms that can be actuated to release a lock that provides resistance to rotational or translational movement of the respective movable element. In some embodiments, the movable elements can have a raised feature that provides a visual indication of rotation and facilitates tactile engagement and actuation by the clinician. Other features of thehandle actuator500 and methods for operating thehandle actuator500 are discussed and illustrated in FIGS. 13A-13H of U.S. Patent Application No. 62/781,537, filed on Dec. 18, 2018, the entirety of which is incorporated herein by reference.
• Referring now toFIG. 2, avalve prosthesis100 and components thereof are shown in various configurations. Thevalve prosthesis100 can be delivered to a patient using a suitable delivery device, including embodiments of the delivery devices disclosed herein. Thevalve prosthesis100 can comprise asupport frame102 and an anchoring component orvalve anchor104 to which thesupport frame102 is movably connected, movably attached, flexibly connected, displaceably connected, linked, or coupled.
• Thevalve prosthesis100 can be configured such that components of thevalve prosthesis100 to be advanced in series while still being movably connected, movably attached, flexibly connected, displaceably connected, linked, or coupled to each other, thereby minimizing a passing profile or cross section of the delivery system. The interconnection of components of thevalve prosthesis100 can allow different degrees of motion and can be set into an engaged or retained position that provides a limited range of motion. In some embodiments, the engaged position can also provide a preset relative positioning of the components of thevalve prosthesis100 to facilitate proper placement and release of thevalve prosthesis100. Additionally, some embodiments can provide a clinician with a high degree of control and enhance the maneuverability of thevalve prosthesis100 when implanting thevalve prosthesis100 at the target location.
• In some embodiments, thevalve anchor104 can be coupled to thesupport frame102 when thesupport frame102 is in the compact configuration prior to delivery and expansion. In some embodiments, thevalve anchor104 is not fixed to thesupport frame102. Further, thevalve anchor104 can be separate from thesupport frame102 or formed separately from and later coupled to thesupport frame102. Thus, although a least a portion of thevalve anchor104, e.g., the anchoring leg, may be in contact with or otherwise reversibly attached or connected to thesupport frame102, no part of thevalve anchor104 is fixed, e.g., welded or otherwise irreversibly adhered, to thesupport frame102. Alternatively stated, thevalve anchor104, which may be in contact with or otherwise reversibly attached to thesupport frame102, is not irreversibly fixed to thesupport frame102.
• Further, upon reaching the target location, thevalve anchor104 can be movably coupled to thesupport frame102 in a manner that prevents theentire valve anchor104 from being radially displaced from thesupport frame102 when thevalve anchor104 is initially expanded. For example, portions of thevalve anchor104 can be radially displaced from the support frame during initial “landing” of thevalve anchor104 against the native valve structure at the target location. In some embodiments, thesupport frame102 can be deployed or expanded within the native heart valve structure, and thevalve anchor104 can become sandwiched between the support frame and the native valve tissue, becoming at least partially, and possibly fully, immobilized. Thevalve anchor104 can function to hold the expandedsupport frame102 in place within the native valve structure.
• Optionally, thesupport frame102 may be referred to as a valve frame or valve support frame.FIG. 2 illustrates thesupport frame102 aligned with and expanded within thevalve anchor104, in a configuration that is achieved when theprosthesis100 is released and expanded within the native valve structure. The native valve structure includes the valve annulus or leaflets. This expanded configuration, serves to secure thevalve prosthesis100 within the native valve annulus by engaging the native valve structure. In some embodiments, the expanded configuration of thevalve prosthesis100 may reduce reliance on securing thevalve prosthesis100 with radial force exerted by thesupport frame102 and thevalve anchor104 via the sandwiching or compression of the native valve leaflets between thesupport frame102 and thevalve anchor104 of thevalve prosthesis100. Further, as discussed further herein, during implantation of thevalve prosthesis100, thesupport frame102 and thevalve anchor104 can be movable relative to each other in expanded and/or compressed states in order to facilitate proper positioning of theprosthesis100 relative to the native valve annulus and surrounding structures. Indeed, various advantages made possible by theprosthesis100 and delivery device disclosed herein allow a clinician to achieve a higher degree of precision in placing theprosthesis100, as well as making such increased precision easier to achieve.
• Referring toFIG. 2, thesupport frame102 can comprise an outer or external surface and defines a central orifice about alongitudinal axis120. Thelongitudinal axis120 corresponds to an inflow-outflow axis of theprosthesis100. In some embodiments, thevalve prosthesis100 further comprises a plurality of prosthetic valve leaflets orcusps106 that are coupled to thesupport frame102. Thesupport frame102 can provide a structural support for thevalve leaflets106. Thevalve leaflets106 can have surfaces defining a reversibly sealable opening for unidirectional flow of a liquid through theprosthesis100. Theprosthesis100 can include threevalve leaflets106 for a tri-leaflet configuration. As appreciated, mono-leaflet, bi-leaflet, and/or multi-leaflet configurations are also possible. For example, the valve leaflets can be coupled to thesupport frame102 to span and control fluid flow through the lumen of theprosthesis100. Theprosthetic leaflets106 can comprise one or more synthetic materials, engineered biological tissues, biological valvular leaflet tissues, pericardial tissues, cross-linked pericardial tissues, aortic root tissue, chemically or biologically processed/treated tissue, or combinations thereof. In some embodiments, the pericardial tissue is selected from but not limited to the group consisting of bovine, equine, porcine, ovine, human tissue, or combinations thereof.
• Furthermore, in some embodiments, thevalve prosthesis100 can comprise a sealing component ormembrane108 that can be attached to an inside surface, an outside surface, and/or enclose thesupport frame102, such as by being laminated onto inner and outer surfaces of thesupport frame102. Thus, thevalve leaflets106 can be coupled to thesupport frame102 and/or themembrane108. In some embodiments, themembrane108 can restrict blood flow in areas around thevalve leaflets106 so that blood flow occurs only between thevalve leaflets106 through the lumen of theprosthesis100, as in a healthy native heart valve.
• Thesupport frame102 and/or thevalve anchor104 can comprise a braided frame, a wire frame, or a laser-cut frame (e.g., laser-cut tubular mesh), as shown inFIG. 2. In some embodiments, thesupport frame102 and/or thevalve anchor104 can comprise a shape-memory metal, which can change shape at a designated temperature or temperature range or by inducing stress. Alternatively, the self-expanding frames can include those having a spring-bias. The material from which either thesupport frame102 and/or thevalve anchor104 is fabricated can allow thesupport frame102 and/or thevalve anchor104 to automatically expand to its functional size and shape when deployed but also allows thesupport frame102 and/or thevalve anchor104 to be radially compressed to a smaller profile for delivery through the patient's vasculature. Examples of suitable materials for self-expanding components described herein (e.g., support frames, valve anchors, locking members) include, but are not limited to, medical grade nickel titanium alloys, tantalum, platinum alloys, niobium alloys, cobalt alloys, alginate, or combinations thereof. Shape memory alloys having superelastic properties generally made from ratios of nickel and titanium, commonly known as Nitinol, are preferred materials. In some embodiments, self-expanding components described herein can include materials including, but not limited to shape memory plastics, polymers, and thermoplastic materials which are inert in the body. In an alternative embodiment, either thesupport frame102 and/or thevalve anchor104 is not self-expanding, and may be expanded, for example, using a balloon catheter as is well known in the art. Examples of suitable materials for components described herein include, but are not limited to, stainless steel and titanium. Optionally, either thesupport frame102 and/or thevalve anchor104 can comprise radiopaque materials to allow visualization under fluoroscopy or other imaging techniques.
• Optionally, thesupport frame102 can comprise one ormore hooks109 that can engage with tissue of the native valve annulus, the aortic root, or any other portion of the native valve when thesupport frame102 is expanded within the native valve annulus. Thehooks109 can be engaged with the native valve annulus to secure theprosthesis100 and mitigate any downstream or antegrade migration of theprosthesis100 during operation.
• Thesupport frame102 can comprise afirst end portion110 and asecond end portion112. Thefirst end portion110 can be positioned upstream of thesecond end portion112 when theprosthesis100 is released within the native valve annulus. As illustrated inFIG. 2, thefirst end portion110 of thesupport frame102 can be shaped as a generally flat end of a cylinder, wherefirst apices114 of thesupport frame102 lie generally in a common plane, which can be oriented substantially perpendicular relative to alongitudinal axis120 of theprosthesis100. Further, thesecond end portion112 can be shaped to include a series ofpeaks130 andvalleys132, where second apices orminor peaks136 of thesupport frame102 collectively form contours of thepeaks130 andvalleys132. Thepeaks130 andvalleys132 of thesecond end portion112 can be positioned downstream of thefirst end portion110 when the prosthesis is seated within the native valve annulus.
• In accordance with some embodiments, theprosthetic leaflets106 can be coupled relative to thesupport frame102 at locations circumferentially aligned with thepeaks130 of thesecond end portion112, as shown inFIG. 2. In some embodiments, theprosthetic leaflets106 can be coupled to themembrane108 using ultra-high molecular weight polyethylene sutures. This unique configuration can advantageously enable theprosthesis100 to more fully approximate the native valve structures, permit a more natural blood flow without limiting or otherwise constraining movement of thevalve leaflets106, and more seamlessly integrate with surrounding architecture of the heart. In some embodiments, theprosthetic leaflets106 can comprise features, including, but not limited to, planar features, flat features, three-dimensional features, Bezier curves, or other suitable shapes. Optionally, theprosthetic leaflets106 can be shaped through fixation on a leaflet-shaped mandrel.
• Thevalve anchor104 can comprise at least one U-shaped member, valve clasper, sinus locator, valve positioner, orvalve hanger140 that extends about a longitudinal axis of thevalve anchor104. As illustrated inFIG. 2, thevalve anchor104 can comprise a plurality of lobes orU-shaped members140, such as threeU-shaped members140, but can have fewer or more. In some embodiments,U-shaped members140 can be configured to engage with or fit inside the posterior aortic sinus, the left aortic sinus, and the right aortic sinus of a native aortic valve. TheU-shaped members140 can each have apeak portion142 and abase portion144. TheU-shaped members140 can each comprise first andsecond legs146,148. The first andsecond legs146,148 of the adjacentU-shaped members140 can be interconnected at thepeak portions142 thereof. Further, theU-shaped members140 can comprise shapes other than a U-shape, such as a wave-shape, V-shape, W-shape, or zig-zag. Optionally, multiple valve anchors104 can each comprise one or moreU-shaped members140, wherein the multiple valve anchors104 cooperatively engage with the aortic sinus to anchor the valve prosthesis as described herein.
• Thevalve prosthesis100 can include a link mechanism that interconnects thesupport frame102 to thevalve anchor104. The link mechanism can comprise a single, continuous strand of material or multiple, independent strands of material that interconnects thesupport frame102 to thevalve anchor104. Further, the link mechanism can attach in a sliding, engaged, or fixed manner to one or more locations on thesupport frame102 and/or on thevalve anchor104.
• In accordance with some embodiments, thevalve anchor104 may optionally define one or more engagement areas in one or more portions of thevalve anchor104, where a link mechanism may engage with the one or more engagement areas to restrict relative motion between thesupport frame102 and thevalve anchor104.
• For example, at the interconnection of the respective peak portions, thevalve anchor104 can define anengagement area150. Theengagement area150 may also be referred to as a peak portion engagement area.
• As illustrated inFIG. 2, thesupport frame102 can be flexibly coupled to thevalve anchor104 via one or more tethering components orlink mechanisms160. Thelink mechanism160 can be coupled to thesupport frame102 and to thevalve anchor104, permitting relative movement between thesupport frame102 and thevalve anchor104. However, thelink mechanism160 can be configured to limit relative movement between thesupport frame102 and to thevalve anchor104. In some embodiments, theengagement area150 of thevalve anchor104 can be used to further restrict relative motion of thesupport frame102 with respect to thevalve anchor104 when thelink mechanism160 is engaged in theengagement area150, as discussed herein.
• Thevalve anchor104 can thus be coupled to thesupport frame102 to permit thevalve anchor104 to be moved axially or longitudinally relative to thesupport frame102 while still remaining coupled to thesupport frame102. This advantageous feature of some embodiments can allow a clinician to independently position thevalve anchor104 relative to thesupport frame102. For example, in a transcatheter aortic valve replacement, the clinician can independently position thevalve anchor104 in order to fit thebase portions144 of thevalve anchor104 into the aortic sinus. Portions of the of aortic sinus may include the posterior aortic sinus, the left aortic sinus, and/or the right aortic sinus, of a native aortic valve. In some embodiments, thevalve anchor104 can rotate to be aligned in the respective aortic sinuses. In some embodiments, the interconnection of thevalve anchor104 to thesupport frame102 can allow thevalve anchor104 to self-rotate to be aligned in the aortic sinus. Thereafter, with thevalve anchor104 “landed” in the respective aortic sinuses, the interconnection of thevalve anchor104 to thesupport frame102 further enables thesupport frame102 to translated along thelongitudinal axis120 of thevalve prosthesis100. In some embodiments, during the delivery procedure, thevalve anchor104 can be moved at least axially from a proximal position relative to thesupport frame102, to a distal position relative to thesupport frame102, or from either of such positions to a position in which thesupport frame102 at least partially longitudinally overlaps with or is concentric within thevalve anchor104. A range of various positions are illustrated, for example, inFIGS. 6A-6F.
• For example, when thesupport frame102 is nested within thevalve anchor104, as shown inFIG. 2, thebase portions144 of thevalve anchor104 can be longitudinally spaced apart fromfirst end portion110 of thesupport frame102 along thelongitudinal axis120 at a distance which is about 10% to about 100%, about 25% to about 75%, about 33% to about 100%, about 33% to about 66%, about 25% to about 75%, about 50% to about 75%, or about 60% to about 70% of a length of thesupport frame102. In some embodiments, thesupport frame102 can be contained or otherwise fully overlapping thevalve anchor104. In some embodiments, thesupport frame102 can have minimal or no overlap with thevalve anchor104. Thesupport frame102 can move along thelongitudinal axis120 to overlap thevalve anchor104 by about 10% to about 100%, about 25% to about 75%, about 33% to about 100%, about 33% to about 66%, about 25% to about 75%, or about 50% to about 75% of the length of thesupport frame102. In accordance with some embodiments, theU-shaped members140 of thevalve anchor104 can be in nested positions within the aortic sinuses, and thebase portions144 of thevalve anchor104 can be about longitudinally adjacent to, coplanar with, or spaced apart from thefirst end portion110 of thesupport frame102. For example, thevalve anchor104 can be in a nested position when at least onebase portion144 of thevalve anchor104 is in contact with or adjacent to the basal attachments of the native aortic valvar leaflets. Further, thefirst end portion110 of thesupport frame102 can be longitudinally adjacent to, coplanar with, or spaced apart from the native valve structure (or a virtual ring formed by the basal attachments of the native aortic valvar leaflets) or with the ventriculo-aortic junction.
• Thelink mechanism160 can allow rotational and longitudinal movement of thevalve anchor104 relative to thesupport frame102. Thus, despite the presence of thelink mechanism160, thevalve anchor104 can move rotationally with respect to thesupport frame102. Further, in some embodiments, thelink mechanism160 can be fixedly attached or coupled to thesupport frame102 and fixedly or slidably attached to thevalve anchor104. When thesupport frame102 is moved relative to thevalve anchor104, thelink mechanism160 can slide along theU-shaped members140. In some embodiments, theU-shaped members140 have a generally arcuate or convex shape (as illustrated with the U-shaped members ofFIG. 2) that allows unrestricted movement of thelink mechanism160 along the geometry of the first andsecond legs146,148 of theU-shaped members140. When thelink mechanism160 is allowed to slide along the first andsecond legs146,148 of theU-shaped members140, thevalve prosthesis100 can be in a position referred to as a “slidable” state. In the slidable state, the range of longitudinal and/or rotational movement of thesupport frame102 relative to thevalve anchor104 is variable and may be its greatest because thelink mechanism160 can move along the first andsecond legs146,148 of theU-shaped members140.
• In some embodiments, thelink mechanism160 can be fixedly attached or coupled to thesupport frame102 and fixedly attached to thevalve anchor104. When thesupport frame102 is moved relative to thevalve anchor104, thelink mechanism160 can stretch, flex, deform elastically and/or plastically. As thelink mechanism160 deforms, the range of longitudinal and/or rotational movement of thesupport frame102 relative to thevalve anchor104 is variable as allowed by the deformation of thelink mechanism160.
• In some embodiments, thelink mechanism160 can have multiple link members, where each link member is coupled to and intermittently spaced about a circumference of thesupport frame102. Each link member may be slidably coupled to a respective one of theU-shaped members140. Further, thelink mechanism160 can have multiple link members that are coupled together in an end-to-end manner. Moreover, thelink mechanism160 can have multiple link members that are individually coupled at one and to thesupport frame102 and at another and to thevalve anchor104. Each of the link members can be slidable along thevalve anchor104, as disclosed similarly herein and not described again herein for brevity.
• As noted above, however, thevalve anchor104 can also compriseengagement areas150 that can engage with thelink mechanism160 in order to restrict relative motion between thesupport frame102 and thevalve anchor104. Theengagement areas150 can include one or more local concavities or other geometric shapes that can engage or trap thelink mechanism160 once thelink mechanism160 passes into theengagement area150. Various embodiments ofengagement areas150 can be used to permit theslidable link mechanism160 to enter into theengagement area150, but restrict thelink mechanism160 from exiting theengagement area150, such as those disclosed in FIGS. 2A-2G of U.S. Patent Application No. 62/781,537, filed on Dec. 18, 2018, noted above.
• Referring now toFIG. 3, a side cross-sectional view is provided of thevalve prosthesis100 loaded onto thedelivery device200, according to some embodiments. Among the many features illustrated inFIG. 3,FIG. 3 shows that aproximal enclosure210 ofdelivery device200 can extend over both thevalve anchor104 and thesupport frame102. Thus, in accordance with some embodiments, in the compressed or delivery configuration shown inFIG. 3, the link mechanism (not shown) can extend between thevalve anchor104 and thesupport frame102 and be at least partially enclosed within the proximal enclosure210 (depending on the attachment point of the link mechanism with thesupport frame102 and the longitudinal extent of the proximal enclosure210).
• In addition,FIG. 3 illustrates that thevalve anchor104 can comprise alink motion limiter240. Thelink motion limiter240 can provide an enlarged profile of the wireframe structure of thevalve anchor104 so as to restrict or prevent motion of the link mechanism as the link mechanism slides along the U-shaped member of thevalve anchor104.
• In alternative embodiments of thedelivery device200, thevalve anchor104 and thesupport frame102 can both be enclosed within theproximal sheath component204 prior to and during delivery prior to releasing thevalve anchor104. For example, in some embodiments, thevalve anchor104 can be distal to thesupport frame102 wherein thevalve anchor104 is near the distal end of theproximal sheath component204 and thesupport frame102 can be approximately adjacent to the valve anchor104 (in a serial configuration) and is proximal to thevalve anchor104. In some embodiments of thedelivery device200, thevalve anchor104 and thesupport frame102 can both be enclosed within theproximal sheath component204, with thesupport frame102 near the distal end of theproximal sheath component204 and thevalve anchor104 being approximately adjacent to thesupport frame102 and proximal to thesupport frame102.
• Further, in alternative embodiments of thedelivery device200, thevalve anchor104 can be enclosed within thedistal carrier assembly206 and thesupport frame102 can be enclosed within theproximal sheath component204 prior to and during delivery of the valve prosthesis. For example, in some embodiments of thedelivery device200, both thevalve anchor104 and thesupport frame102 can be enclosed within thedistal carrier assembly206 and thesupport frame102 can be enclosed within theproximal sheath component204 prior to and during delivery of the valve prosthesis. In this configuration, thevalve anchor104 and thesupport frame102 can be approximately adjacent to one another (in a serial configuration) and thevalve anchor104 can be positioned proximal to thesupport frame102. Other details of delivery devices and prostheses are provided in U.S. Patent Application No. 62/781,537, noted above and incorporated herein by reference.
• In addition,FIG. 3 illustrates that ananchor retention component170 can be used to engage theengagement areas150 of thevalve anchor104 with the control member or agrasper224 to facilitate movement and control of the positioning of thevalve anchor104 during delivery. As discussed with regard to FIGS. 7G-7I of U.S. Patent Application No. 62/781,537, noted above, this engagement can maintain theengagement areas150 in acommon plane152, oriented generally perpendicular relative to the longitudinal axis of thedelivery device200.
• FIG. 4 illustrates aspects of thedelivery device200a, according to at least one embodiment. These figures do not illustrate all of the components of the delivery device that can be incorporated into an embodiment. However, the features illustrated in these figures can be incorporated into embodiments of the delivery device to facilitate engagement with the valve anchor and/or facilitate delivery and control of the valve anchor during implantation and release of the valve anchor at the target location.
• For example,FIG. 4 illustrates an embodiment of adelivery device200athat comprises a grasper mechanism. The grasper mechanism can be used to securely couple a portion of the valve anchor with the delivery device to permit the clinician to control movement, operation, and deployment of the valve anchor. The grasper mechanism can engage one or more portions or structures of the valve anchor using a variety of coupling mechanisms, which can use attachment means including mechanical engagement, dissolvable structures, chemically reactive degradable structures, electrolytically degradable structures, and the like.
• In some embodiments, the grasper mechanism can be a tubular grasper mechanism. Thedelivery device200a, shown inFIG. 4, can comprise agrasper224athat can engage with and control the longitudinal position of thevalve anchor104a. Thegrasper224aof thedelivery device200acan comprise an engagement wire that is movable within a lumen of a tubular enclosure. Thevalve anchor104acan be configured to comprise a clasper tang extending from anengagement area150dor150d′ of thevalve anchor104a. The engagement wire can comprise a distal end portion that includes pins, ridges, or protrusions that can be coupled to the engagement structure of the clasper tang at the engagement area of thevalve anchor104a. When engaged together, the engagement wire and the clasper tang can be proximally drawn into the lumen of the tubular enclosure, which secures the engagement wire and the clasper tang relative to each other in both radial and longitudinal directions. However, when the engagement wire and the clasper tang are moved outside of the lumen of the tubular enclosure, the engagement wire and the clasper tang can be disengaged as thevalve anchor104aand the clasper tang expand radially, thereby disengaging the clasper tang from the engagement wire. These and other features are discussed in U.S. Patent Application No. 62/781,537, noted above and incorporated herein by reference.
• During use, after the valve anchor has been released from within the proximal sheath and after the valve anchor and the valve frame have been released from the delivery device, the delivery device can be configured to be compactly reassembled and withdrawn into the introducer sheath in order to minimize any damage to the blood vessel through which the delivery device was advanced.
• For example, in at least one embodiment, as illustrated inFIG. 5A, theproximal enclosure210 can comprise aproximal section250 to facilitate realignment (e.g., radial realignment) of thedistal end portion208 of theproximal sheath component204 with theproximal enclosure210.
• As illustrated inFIG. 5A, theproximal section250 can be coupled to thecore member220. Further, theproximal section250 can optionally be conical or tapered in a proximal direction and/or havecircumferential nodes252 and/orcircumferential cavities254 that can facilitate realignment of theproximal sheath component204 relative to theproximal enclosure210 along a longitudinal axis of thedelivery device200. The tapering of theproximal section250 can allow thedistal end portion208 of theproximal sheath component204 to smoothly advance distally over theproximal section250, and thecircumferential nodes252 can contact an inner surface of thedistal end portion208 of theproximal sheath component204 as thedistal end portion208 approaches theproximal abutment surface214.
• For example, as illustrated inFIG. 5A, thecircumferential nodes252 may gradually taper from theproximal abutment surface214 in the proximal direction. With such a configuration, as theproximal sheath component204 slides distally toward theproximal enclosure210, thecircumferential nodes252 can advantageously guide thedistal end portion208 of theproximal sheath component204 distally toward theproximal abutment surface214 of theproximal enclosure210 so that the outer surface of theproximal sheath component204 is aligned with an outer surface of theproximal enclosure210. Thus, the outer surfaces of theproximal enclosure210 and theproximal sheath component204 can provide a smooth outer profile for thedelivery device200 that can advantageously reduce the likelihood that thedelivery device200 catches or otherwise damages tissue within a body lumen as thedelivery device200 is moved therewithin.
• Optionally, theproximal section250 can comprise threecircumferential nodes252 and threecircumferential cavities254. Thecircumferential nodes252 may extend proximally from theproximal abutment surface214. The threecircumferential cavities254 can correspond to the number of U-shaped members of the valve anchor that are housed within theproximal sheath component204 between theproximal sheath component204 and theproximal section250 of theproximal enclosure210.
• This advantageous feature of some embodiments can allow thedistal enclosure212 to be properly positioned along thedelivery device200 in order to ensure thatdistal enclosure212 does not snag or become caught on any structure during retrieval of thedelivery device200.
• As also shown inFIGS. 5A and 5B, the proximal anddistal enclosures210,212 can collectively house thesupport frame102. The first andsecond core members220,222 can be actuated to separate the proximal anddistal enclosures210,212, thereby permitting thesupport frame102 to self-expand when in position within thevalve anchor104.
• For example, by pushing or pulling thefirst core member220, thesecond core member222, and/or theproximal sheath component204 relative to each other along the longitudinal axis of thedelivery device200, a clinician can control longitudinal movement of each of these components to permit the release of thesupport frame102 and thevalve anchor104 of thevalve prosthesis100.
• Further, in some embodiments, to facilitate delivery of thedelivery device200 to the target location, as shown inFIGS. 5A and 5B, thesecond core member222 can include alumen218 to permit thedelivery device200 to move along a guidewire, which can extend through thelumen218 of thesecond core member222.
• FIGS. 5A and 5B further illustrate positions of the proximal anddistal enclosures210,212 during the release of thesupport frame102. After separating the proximal anddistal enclosures210,212 from the position illustrated inFIG. 5A to the position illustrated inFIG. 5B, thefirst end portion110 of thesupport frame102 can begin to expand from the compressed configuration to an expanded configuration. In some embodiments, thesupport frame102 can have one or more anchors109 (see alsoFIG. 2) at itsfirst end portion110 that, when engaged with the native valve structure can supplement the outward expansive force (due to self-expansion of the support frame102) and its resultant frictional engagement, to mitigate downstream migration of thesupport frame102 relative to the native valve structure. Thus, by opening thefirst end portion110 first (before thesecond end portion112, and via relative movement of the proximal anddistal enclosures210,212), thefirst end portion110 can “flower” out to facilitate release of the support frame and/or to engage with the native anatomy, such as the valve structure itself, to secure a longitudinal position of thesupport frame102 relative to the native valve structure. Thereafter, thesecond end portion112 of thesupport frame102 can be controlled and released to become disengaged and released from theproximal enclosure210.
• In some embodiments, thefirst end portion110 and thesecond end portion112 can open simultaneously, at the same or different rates. For example, in some embodiments, thefirst end portion110 and thesecond end portion112 can open simultaneously, but with thefirst end portion110 opening at a faster rate than thesecond end portion112.
• Advantageously, the use of theproximal enclosure210 and thedistal enclosure212 allows for greater control and enhanced operation of thesupport frame102. For example, by controlling the position and rate of separation of theproximal enclosure210 and thedistal enclosure212, the opening of thesupport frame102 at both thefirst end portion110 and thesecond end portion112 can be controlled. Further, by controlling the movement of thedistal enclosure212, the timing and rate of opening of thefirst end portion110 can be controlled relative to the timing and rate of opening of the second end portion112 (which may be controlled by the movement of the proximal enclosure210).
• Additionally and advantageously, by having separate proximal anddistal enclosures210,212, thedelivery device200 may experience reduced frictional forces and minimize travel of theenclosures210,212 relative to thesupport frame102.
• In particular, in accordance with some embodiments, thedistal carrier assembly206 can comprise aplunger mechanism260 that can facilitate expansion of thesupport frame102. Theplunger mechanism260 can expand from a compressed state (shown inFIG. 5A) to an extended state (shown inFIG. 5A). Theplunger mechanism260 can be biased by a spring or other device in order to move automatically from the compressed state to the extended state. However, theplunger mechanism260 can also be manually actuated by the clinician in some embodiments.
• As illustrated, theplunger mechanism260 can comprise aplunger head262 and a biasing means264. Theplunger head262 can comprise a conical or taperedproximal portion286. The conicalproximal portion286 can be configured to not contact only the first end portion of thesupport frame102 during delivery, but can also help center adistal end portion290 of thetubular portion282 of theproximal enclosure210 relative to a longitudinal axis of thedelivery device200 and help align thedistal end portion290 with aproximal end portion292 of thetubular portion272 of thedistal enclosure212. Theplunger head262 can also comprise an outercircumferential surface294 that can contact not only aninner surface296 of thetubular portion272, but can also contact aninner surface298 of thetubular portion282 when thetubular portion282 is distally advanced over the conicalproximal portion286 of theplunger head262.
• Further, theplunger mechanism260 can be housed within adistal lumen270 of atubular portion272 of thedistal enclosure212. For example, the biasing means264 may be a spring. The biasing means264 can be interposed between an interior structure orwall274 of thedistal lumen270 and a distal surface or structure276 of theplunger head262. Theplunger head262 can move proximally within thedistal lumen270 in order to continue to exert a proximally oriented force on thefirst end portion110 of thesupport frame102 until thesupport frame102 exits thedistal lumen270. Thereafter, in accordance with some embodiments, thesupport frame102 can self-expand until thesecond end portion112 is pulled out of aproximal lumen280 of atubular portion282 of theproximal enclosure210 as thesupport frame102 continues to expand. The expanded state of thesupport frame102 is illustrated inFIGS. 1 and 2, discussed above.
• As discussed above, thedelivery device200 provide several benefits, such as a compact passing profile that allows thedelivery device200 to move through the vasculature with facility, reliable control and positioning of the valve anchor while for within the native valve annulus and sinuses, predictable relative positioning of thesupport frame102 and thevalve anchor104 via thelink mechanism160, and snag-free retrieval of thedelivery device200.
• According to some embodiments, the present disclosure also provides a handle actuator that can be used to control the operation of the presently disclosed delivery device and allow a clinician to reliably and accurately control the delivery of the valve prosthesis.FIGS. 6A-6I illustrate features and operation of the handle actuator, according to some embodiments, for delivering a valve prosthesis using ahandle actuator500. As noted above, the delivery can be performed using a transcatheter approach.
• FIG. 6A illustrates thehandle actuator500. Thehandle actuator500 can control one or more functions of the delivery device (e.g., thedelivery device200 discussed herein) for delivering of a valve prosthesis (e.g., theheart valve prosthesis100 discussed herein). As shown inFIG. 6A, thehandle actuator500 can comprise a plurality of actuators or movable elements, such as knobs or buttons. The movable elements can permit a clinician to control one or more operations of thedelivery device200. Thehandle actuator500 can comprise acontrol handle510 having alongitudinal axis512. Thehandle actuator500 may be also referred to as a control unit. In some embodiments, thehandle actuator500 may be coupled to the second core member222 (shown, e.g., in FIGS. 8A-8D of U.S. Patent Application No. 62/781,537, filed on Dec. 18, 2018, noted above). The control handle510 can support the actuators and be held by the clinician during the procedure.
• FIG. 6A illustrates that thehandle actuator500 can comprise a steering knob or firstmovable element520, an anchor release knob or secondmovable element522, a nosecone/valve release knob or thirdmovable element524, and a nose cone toggle lock or fourthmovable element526. The firstmovable element520, the secondmovable element522, the thirdmovable element524, and the fourthmovable element526 may be also referred to as thefirst control element520, thesecond control element522, thethird control element524, and thefourth control element526.
• Optionally, in some embodiments, one or more of the movable elements, such as the secondmovable element522 and/or the thirdmovable element524, can include a button orslider safety switch529 that prevent the unintentional rotation of the moveable elements. Thesafety switch529 can be configured as resilient button or slider mechanisms that can be actuated to release a lock that provides resistance to rotational or translational movement of the respective movable element. In some embodiments, the movable elements can have a raised feature that provides a visual indication of rotation and facilitates tactile engagement and actuation by the clinician.
• In some embodiments, thehandle actuator500 can further include adeair line514. Thedeair line514 can be in fluid communication with the volume within theproximal sheath component204. Optionally, thedeair line514 can be used to remove or draw air or other gases from theproximal sheath component204 to remove any air or gas bubbles.
• Thehandle actuator500 can be coupled to thedelivery device200. At least a portion of thedelivery device200, such as a catheter portion or adistal tip portion501 thereof, can be steerable in order to facilitate distal advancement and/or coaxial alignment of thedelivery device200 within the vasculature and native anatomy. In this manner, thedelivery device200 can be steered and navigated to the target location within the native valve structure.
• In a first step, the firstmovable element520 can be controlled (e.g., by rotating the first movable element520) to steer adistal tip portion501 of thedelivery device200 in order to maneuver thedelivery device200 through the vasculature. For example, the firstmovable element520 may include a knob that can be rotated about thelongitudinal axis512 in order to cause thedistal tip portion501 to bend in order to maneuver thedelivery device200.
• In some embodiments, thedistal tip portion501 may include theproximal sheath component204 that can be moved by controlling the firstmovable element520. Thus, in some embodiments, the firstmovable element520 may be controlled to bend thedistal tip portion501 by moving theproximal sheath component204. In some embodiments, by moving theproximal sheath component204, the firstmovable element520 may bend thesecond core member222.
• In such embodiments, in some examples, the firstmovable element520 may be controlled to move theproximal sheath component204, thereby axially deflecting thedistal carrier assembly206 and thesecond core member222. Thedelivery device200 can be steered using the firstmovable element520 until reaching the target location within theaortic valve304, as shown inFIG. 6B. In some embodiments, thedelivery device200 can be advanced along a guidewire toward the target location. Further, whether a guidewire is used or not, thedistal tip portion501 can be steered to navigate to thedelivery device200 to the target location. Thedistal tip portion501 can be bent by rotating the firstmovable element520 in either direction. The firstmovable element520 can be operatively coupled to thedelivery device200 via a steering control cable.
• Optionally, the delivery can be performed using a transcatheter approach. For example, thedelivery device200 can be maneuvered through an introducer sheath (not shown) toward the target area. Further, optionally, in at least one embodiment, thedelivery device200 can be advanced over a guidewire toward the target area.
• FIG. 6B illustrates thedelivery device200 proximal to the target location in ahuman heart300. Theheart300 can comprise anaorta301 having anaortic arch302 and anaortic valve304. Theaorta valve304 can comprise a plurality ofnative valve leaflets306 and separate theaorta301 from theleft ventricle310. In accordance with some embodiments, thedelivery device200 can be advanced retrograde through theaorta301 until reaching and being positioned through thenative valve leaflets306 of theaortic valve304. InFIGS. 6C-6I, the surrounding structure of the heart is removed for clarity.
• With reference toFIG. 6B, during delivery of thevalve prosthesis100 to the native valve site, thevalve anchor104 and thesupport frame102 can be positioned in tandem, as an axially displaced unit (with or without partial or full overlapping between the anchor and the frame) along the longitudinal axis of thedelivery device200. This configuration, as opposed to a concentric arrangement, allows a more radially compact configuration of the components of thevalve prosthesis100, creating a much smaller cross-section and facilitating a catheter-based delivery. This can improve the flexibility of thedelivery device200, enabling thedelivery device200 to be advanced over a guidewire through the tortuous geometries of the circulatory system, and in particular, theaortic arch302. Indeed, even with guidewire-directed delivery devices, theaortic arch302 represents a difficult obstacle due to its sudden and high-degree of curvature. Often, this is a limiting constraint for some surgeries or delivery devices. However, in accordance with the various benefits and advantages of some embodiments disclosed herein, as illustrated inFIG. 6B, thedelivery device200 can be advanced over theaortic arch302 to a target location in the region of theaortic valve304.
• With reference toFIGS. 6B and 6C, the secondmovable element522 and the thirdmovable element524 can be moved together (e.g., by sliding or translating the secondmovable element522 and the third movable element524) to cause thedistal carrier assembly206 of thedelivery device200 to be distally advanced relative to theproximal sheath component204. For example, the secondmovable element522 and the thirdmovable element524 may include knobs that can be translated in a first direction (e.g., distally) to cause thedelivery device200 to be distally advanced relative to theproximal sheath component204. Theproximal sheath component204 can be maintained at a generally constant position while thevalve prosthesis100 is advanced relative to the proximal sheath component204 (i.e., theproximal sheath component204 is retracted proximally relative to the valve prosthesis100). This proximal relative motion of theproximal sheath component204 can be continued until thevalve anchor104 of thevalve prosthesis100 is exposed.
• The secondmovable element522 and the thirdmovable element524 can be operatively coupled to a first control cable to retract theproximal sheath component204 relative to the distal carrier assembly. In some embodiments, theproximal sheath component204 can be operatively coupled to the secondmovable element522 and the thirdmovable element524 via a control wire.
• FIG. 6D illustrates that linearly moving the secondmovable element522 and the thirdmovable element524 away from one another can retract theproximal sheath component204 sufficiently to permit the U-shaped members of thevalve anchor104 to expand within theaortic valve304. Advantageously, thevalve anchor104 can be expanded adjacent to theaortic valve304 to maintain a minimal profile of thedelivery device200 to permit clinicians to locate the desired landing site without blocking blood flow (preventing the need for rapid pacing), prevent snagging or catching on patient anatomy or calcification, and permit manipulation and rotation of thedelivery device200 to allow thevalve anchor104 to be located and positioned in the aortic sinuses. In this position, as discussed above, thegraspers224 can be engaged with the peak portions of thevalve anchor104 to permit the clinician to manipulate the position of thevalve anchor104 relative to thenative valve leaflets306 andaortic sinuses312. The clinician can continue the positional adjustments of thevalve anchor104 until achieving a desired positioning of thevalve anchor104.
• In some embodiments, the continued advancement of the thirdmovable element524 in the distal direction can cause thevalve anchor104 to continue to move distally relative to thesupport frame102, thereby causing thelink mechanism160 to slide along the U-shaped members of thevalve anchor104. In some embodiments, this motion can be driven via thegraspers224. As illustrated, thesupport frame102, thelink mechanism160, and thevalve anchor104 are in the released position, which allows thelink mechanism160 to slide freely. Advantageously, in some embodiments, this flexible connection can allow for thevalve anchor104 to rotate, permitting thevalve anchor104 to self-align with the native cusps of the heart for optimal locating and landing. Eventually, thelink mechanism160 can slide down to be engaged in the engagement areas of thevalve anchor104. The link mechanism will then be in the retained position. In some embodiments, thegraspers224 can be operatively coupled to the thirdmovable element524 via a control wire.
• In some embodiments, the thirdmovable element524 can be translated in a proximal direction while maintaining thesupport frame102 in the desired position, in order to cause thevalve anchor104 to be advanced distally relative to thesupport frame102. As discussed herein, thevalve anchor104 can be advanced distally or otherwise moved relative to thesupport frame102 until thesupport frame102 is in position within thevalve anchor104. In some embodiments, the desired position can be predetermined and achieved once the link mechanism160 (which is captured within the engagement areas of the valve anchor104) becomes taut. For example, the length of thelink mechanism160 can ensure that thevalve anchor104 can advance distally only to a certain predetermined position within thesupport frame102 when thelink mechanism160 is engaged with theengagement areas150 of thevalve anchor104, as discussed herein. Thereafter, thesupport frame102 is properly positioned within thevalve anchor104 and can be expanded.
• Referring toFIG. 6E, thevalve anchor104 is shown in an expanded and rotationally aligned position within theaortic valve304. During the positioning of thevalve anchor104, thevalve anchor104 can be advanced distally along the longitudinal axis relative to thesupport frame102 and become concentric with thesupport frame102. This distal advancement of the valve anchor can be achieved by sliding the thirdmovable element524 along the control handle510 in an axial direction. This motion is allowed in part due to the movable connection of thelink mechanism160 that interconnects thesupport frame102 with thevalve anchor104. Upon reaching the position shown inFIG. 6E, the valve anchor has been advanced in a distal direction until U-shaped members of thevalve anchor104 are in contact with the aortic sinuses of the defectivenative valve leaflets306, between theleaflets306 andvessel wall532.
• In some embodiments, the fourthmovable element526 can comprise a safety switch that engages to lock the axial position of the secondmovable element522 and/or the thirdmovable element524 relative to thehandle actuator500.
• After thesupport frame102 is properly positioned within thevalve anchor104, the thirdmovable element524 may be controlled (e.g., by rotating the third movable element524) in order to separate the proximal and distal enclosures of thedistal carrier assembly206. For example,FIG. 6F illustrates that the thirdmovable element524 may have a knob that can be rotated in a first direction (e.g., clockwise) in order to separate the proximal and distal enclosures of thedistal carrier assembly206, thereby permitting thesupport frame102 to expand within thevalve anchor104. Advantageously, by sandwiching thenative valve leaflets306 between thesupport frame102 and thevalve anchor104, thevalve prosthesis100 can have reduced reliance on radial force retention. Further, by sandwiching thenative valve leaflets306 between thesupport frame102 and thevalve anchor104 the likelihood of thenative valve leaflets306 blocking the opening of the coronary artery is reduced, which may be beneficial for patients with low coronary ostia distance, and in patients with existing valve prosthesis, whom may need a new valve prosthesis inside the existing valve prosthesis (valve-in-valve application). Thesupport frame102 and thevalve anchor104 can thus expand into contact with theaortic valve304, exerting a chronic outward force against thenative valve leaflets306 and aortic valve annulus.
• In some embodiments, the proximal enclosure of thedistal carrier assembly206 can be operatively coupled to the thirdmovable element524 via a control wire.
• Next, as shown inFIG. 6G, after thesupport frame102 has been expanded within thevalve anchor104 to sandwich theleaflets306 between thesupport frame102 and thevalve anchor104, the proximal anddistal enclosures210,212 of thedistal carrier assembly206 can be moved together (for example, until they are in contact, as shown in FIG. 8D of U.S. Patent Application No. 62/781,537, filed on Dec. 18, 2018, noted above). The proximal movement of thedistal enclosure212 relative to theproximal enclosure210 can be achieved by rotating the thirdmovable element524 in a second direction (e.g., counterclockwise) in order to cause the proximal anddistal enclosures210,212 to converge toward each other.
• Referring now toFIG. 6H, after thesupport frame102 has been positioned, expanded, and landed within theaortic valve304, thevalve anchor104 can be detached from thehandle actuator500. Thegraspers224 can be released by controlling the second movable element522 (e.g., by rotating the secondmovable element522 in a first direction). For example, the secondmovable element522 may include a knob that can be rotated to release thegraspers224. In some embodiments, thegraspers224 can be proximally withdrawn into theproximal sheath component204 by linearly moving the secondmovable element522 and the thirdmovable element524 along thehandle actuator500. Thereafter, the catheter530 and thedelivery device200 can be removed from the patient, as shown inFIG. 6I. Thereafter, the prosthetic valve leaflets of theprosthesis100 can begin to function in the manner desired and provide the same operation as a native valve.
• Actions performed with thehandle actuator500 to control thesupport frame102 and thevalve anchor104 can be altered, modified, substituted, or replaced with another function or feature, in some embodiments. For example, instead of rotation, a movable element can be pressed (e.g., as a button), released, or otherwise actuated. Optionally, the third movable element is rotatable to distally engage the grasper mechanism from the valve anchor. In some embodiments, the handle actuator can include additional movable elements, such as a fourth movable element. Optionally, the fourth control element is rotatable to axially translate the proximal enclosure of the distal carrier assembly relative to the core member for exposing the valve frame. In some embodiments, rotation of the fourth movable element in a first direction axially translates the distal enclosure in a proximal direction, while rotation of the fourth movable element in a second direction axially translates the distal enclosure in a distal direction. In some embodiments, rotation of the fourth movable element axially separates the proximal enclosure from the distal enclosure and/or draws the proximal enclosure toward the distal enclosure. Certain features of the handle, which can be implemented with the handle discussed in the present disclosure, are also further described for example, in U.S. Provisional Application No. 62/756,556, the entirety of which is incorporated herein by reference.
• Further, feedback provided to a clinician, such as tactile, auditory, and visual feedback can be altered, modified, substituted, or replaced with another function or feature. In some embodiments, thehandle actuator500 can be manually operated. However, thehandle actuator500 can be motor operated. In some embodiments, thehandle actuator500 can provide electronic control of actuators that are located adjacent to thesupport frame102 and thevalve anchor104.
• In some embodiments, adelivery device200′ can be used to deliver and position thesupport frame102 and thevalve anchor104 utilizing an antegrade, apical, or transapical approach. A transapical approach will be generally illustrated inFIGS. 7A and 7B. Similar toFIGS. 6A-6I, these figures illustrate the use of thedelivery device200′ in ahuman heart300, and more specifically, anaortic valve304 of anaorta301. In accordance with some embodiments, thedelivery device200′ can be advanced antegrade through an apex311 until reaching and being positioned through thenative valve leaflets306 of theaortic valve304. Compared to the transfemoral retrograde approach illustrated inFIGS. 6A-6I, thevalve anchor104 can be positioned to receive the control member or the grasper from an apical approach and to be seated in the sinus structure of theaortic valve304 from an apical approach.
• During delivery of thevalve prosthesis100 to the native valve site, after placement of the delivery catheter530, thedelivery device200′ can be advanced toward the target area. Thevalve anchor104 and thesupport frame102 can be positioned in series (in tandem) along the longitudinal axis of thedelivery device200′. This can improve the flexibility of thedelivery device200′, enabling thedelivery device200′ to be advanced over a guidewire through the tortuous geometries of the circulatory system, and in particular, the apex311. In accordance with the various benefits and advantages of some embodiments disclosed herein, thedelivery device200′ can be advanced through the apex311 to a target location in the region of theaortic valve304.
• Further, theproximal sheath component204 can be proximally retracted relative to theprosthesis100, thereby permitting thevalve anchor104 to expand. Advantageously, thevalve anchor104 can be expanded adjacent to theaortic valve304 to maintain a minimal profile of thedelivery device200′ to permit clinicians to locate the desired landing site without blocking blood flow (preventing the need for rapid pacing), prevent snagging or catching on patient anatomy or calcification, and permit manipulation and rotation of thedelivery device200′ to allow thevalve anchor104 to be located and positioned in the aortic sinuses. Thegraspers224 of thedelivery device200′ can continue to be engaged with theengagement areas150 of thevalve anchor104 after thevalve anchor104 has initially expanded. As shown inFIG. 7A, thegraspers224 of thedelivery device200′ (used in the transapical approach) are coupled to theengagement areas150 of thevalve anchor104 from a direction reverse that of the delivery device200 (used in the transfemoral approach, shown inFIGS. 6A-6I); in the transapical approach, thegraspers224 can extend through or within an inner lumen of thevalve anchor104 whereas the in the transfemoral approach, they do not. However, the interconnection of thegraspers224 and thevalve anchor104 can be reversed in either approach provided that thevalve anchor104 can be properly seated within the nativevalve sinus structure312. Thegraspers224 can allow the clinician to manipulate the position of thevalve anchor104 relative to theaortic valve304 and itssinus structure312. As discussed above, the base portions of thevalve anchor104 can be positioned within the sinuses of theaortic valve304 in order to seat thevalve anchor104 in a proper position within theaortic valve304, as illustrated inFIG. 7A. In the proper position, thenative valve leaflets306 will be positioned in a space between thesupport frame102 and thevalve anchor104.
• Further, as illustrated inFIG. 7A, thelink mechanism160 is coupled to both thevalve anchor104 and thesupport frame102 in a released position which allows thelink mechanism160 to slide freely along thevalve anchor104. Thereafter, the connection between thelink mechanism160 and the tension members198 can be released by proximally retracting thesupport frame102 relative to thevalve anchor104 while maintaining thevalve anchor104 seated within thesinus structure312 of the aortic valve304 (as similarly shown inFIG. 6E). This proximal movement of thesupport frame102 relative to thevalve anchor104 can cause thelink mechanism160 to become taut, thereby stretching and causing the tension members198 to release thelink mechanism160. Further, the proximal movement of thesupport frame102 relative to thevalve anchor104 causes thelink mechanism160 to become engaged in theengagement areas150 of thevalve anchor104.
• After releasing thelink mechanism160 from the tension members198 and engaging thelink mechanism160 with therespective engagement areas150 of thevalve anchor104, thelink mechanism160 is in the retained position.FIG. 7B illustrates that in the retained position, thesupport frame102 can be distally advanced relative to thevalve anchor104 until thesupport frame102 is positioned within theaortic valve304. In accordance with some embodiments, thelink mechanism160 will become taut when thesupport frame102 is in a desirable position relative to thevalve anchor104. Once thevalve anchor104 is in the desired position, thesupport frame102 can be released from the distal carrier assembly and expanded into apposition with thenative valve leaflets306 and the internal aspects of thevalve anchor104, thus sandwiching thenative valve leaflets306 between thesupport frame102 and the valve anchor104 (as similarly shown inFIG. 6F). Advantageously, by sandwiching thenative valve leaflets306 between thesupport frame102 and thevalve anchor104, thevalve prosthesis100 can have reduced reliance on radial force retention. Further, by sandwiching thenative valve leaflets306 between thesupport frame102 and thevalve anchor104 the likelihood of thenative valve leaflets306 blocking the opening of the coronary artery is reduced, which may be beneficial for patients with low coronary ostia distance, and in patients with existing valve prosthesis, whom may need a new valve prosthesis inside the existing valve prosthesis (valve-in-valve application). Thesupport frame102 and thevalve anchor104 can thus expand into contact with theaortic valve304, exerting a chronic outward force against thenative valve leaflets306 andaortic valve annulus320.
• In addition, as discussed herein, after expanding and releasing thesupport frame102, the hooks of thegraspers224 can be disengaged from thevalve anchor104 to release thevalve anchor104 from thedelivery device200′. Thereafter, the proximal sheath component and the components of the distal carrier assembly can be packed together, as discussed herein, to permit thedelivery device200′ to be withdrawn from the apex311 and retrieved from the patient. The incision through the apex311 can then be closed using a technique known in the art.
• Thereafter, the prosthetic valve leaflets of theprosthesis100 can begin to function in the manner desired and provide the same operation as a native valve.
Illustration of Subject Technology as Clauses
• Various examples of aspects of the disclosure are described as clause sets having numbered clauses (1, 2, 3, etc.) for convenience. These are provided as examples, and do not limit the subject technology. Identifications of the figures and reference numbers are provided below merely as examples and for illustrative purposes, and the clauses are not limited by those identifications.
• Clause Set 1: Control Unit
• Clause 1. A valve delivery device comprising: a distal assembly comprising: a core member extending along a longitudinal axis of the assembly; a distal carrier assembly comprising a distal enclosure and a proximal enclosure, the distal enclosure being coupled to the core member and configured to cover a distal portion of a valve frame of a valve prosthesis, the proximal enclosure being slidably coupled to the core member and configured to cover a proximal portion of the valve frame; a proximal sheath, proximal to the distal carrier assembly, extending along the core member and configured to cover at least a portion of a valve anchor of the valve prosthesis; and a control unit comprising a control handle, coupled to the core member, and configured to control an operation of the distal assembly, the control unit further comprising: a first control element coupled to the control handle and configured to deflect the distal carrier assembly for steering the delivery device during advancement into a body lumen; a second control element coupled to the control handle and configured to actuate the proximal sheath for proximally retracting the proximal sheath relative to the distal carrier assembly and the valve anchor for exposing the valve anchor; and a third control element coupled to the control handle and configured to actuate a grasper mechanism for longitudinally moving the valve anchor relative to the core member and for controlling engagement with the valve anchor and the distal carrier assembly for permitting expansion of the valve frame.
• Clause 2. The delivery device of Clause 1, wherein the core member comprises a hollow shaft.
• Clause 3. The delivery device of Clause 2, wherein the shaft comprises a shaft lumen.
• Clause 4. The delivery device of any preceding Clause, wherein actuation of the first control element axially deflects the distal carrier assembly relative to the core member.
• Clause 5. The delivery device of any preceding Clause, wherein the first control element is actuatable via rotation about a longitudinal axis of the control unit.
• Clause 6. The delivery device of any preceding Clause, wherein the first control element comprises a knob that is rotatable about a longitudinal axis of the control unit.
• Clause 7. The delivery device of any preceding Clause, wherein the second control element is actuatable via rotation about a longitudinal axis of the control unit.
• Clause 8. The delivery device of Clause 7, wherein rotation of the second control element distally disengages the grasper mechanism from the valve anchor.
• Clause 9. The delivery device of any preceding Clause, wherein the second control element comprises a knob that is rotatable about a longitudinal axis of the control unit and translatable along the control handle.
• Clause 10. The delivery device of any preceding Clause, wherein the third control element is actuatable via translation along the control handle.
• Clause 11. The delivery device of Clause 10, wherein distal translation of the third control element distally advances the grasper mechanism relative to the proximal sheath to facilitate manipulation of the valve anchor.
• Clause 12. The delivery device of any preceding Clause, wherein the third control element comprises a knob that is rotatable about and translatable along a longitudinal axis of the control unit to control the grasper mechanism.
• Clause 13. The delivery device of any preceding Clause, wherein the grasper mechanism comprises a plurality of grasper arms coupled to a respective engagement area of the valve anchor.
• Clause 14. The delivery device of any preceding Clause, wherein the valve anchor and the valve frame are movably attached and moveable between a disengaged position and an engaged position, the disengaged position allowing variable range of movement between the valve frame and the valve anchor, the engaged position providing a fixed range of movement between the valve frame and the valve anchor.
• Clause 15. The delivery device of any preceding Clause, wherein rotation of the third control element axially translates the proximal enclosure of the distal carrier assembly relative to the core member for exposing the valve frame.
• Clause 16. The delivery device of Clause 15, wherein the distal enclosure is disposed distal to the proximal enclosure, wherein the rotation of the third control element axially translates the proximal enclosure in a proximal direction relative to the distal enclosure.
• Clause 17. The delivery device of Clause 15, wherein the distal carrier assembly comprises a plunger mechanism and the distal enclosure of the distal carrier assembly has a distal lumen, the plunger mechanism being slidable within the distal lumen of the distal enclosure to urge the distal portion of the valve frame proximally out of the distal lumen after the proximal enclosure is moved proximally relative to the distal enclosure.
• Clause 18. The delivery device of Clause 15, wherein rotation of the third control element in a first direction axially translates the distal enclosure in a first direction relative to the core member.
• Clause 19. The delivery device of Clause 18, wherein the first direction is a proximal relative to the core member.
• Clause 20. The delivery device of Clause 18, wherein rotation of the third control element in a second direction axially translates the distal enclosure in a second direction relative to the core member.
• Clause 21. The delivery device of Clause 20, wherein the second direction is a distal relative to the core member.
• Clause 22. The delivery device of Clause 20, wherein the rotation of the third control element in the first direction axially separates the proximal enclosure from the distal enclosure, and wherein rotation of the third control element in the second direction axially draws the proximal enclosure toward the distal enclosure.
• Clause 23. The delivery device of any preceding Clause, wherein the first, second, and third control elements are positioned along an outer surface of the control handle.
• Clause 24. The delivery device of any preceding Clause, wherein at least one of the first, second, or third control elements comprises a knob.
• Clause 25. The delivery device of any preceding Clause, wherein the first control element is positioned distal to the second control element along the control handle.
• Clause 26. The delivery device of any preceding Clause, further comprising the valve prosthesis having the valve frame and the valve anchor.
• Clause 27. The delivery device of any preceding Clause, wherein in a loaded configuration, a proximal end of the distal enclosure is longitudinally spaced apart from a distal end of the proximal enclosure.
• Clause 28. A method of controlling a valve delivery device for delivering a valve prosthesis using a control unit, comprising: controlling a first control element coupled to the control unit to cause a portion of a core member of the delivery device to bend, wherein a proximal sheath of the valve delivery device extends along the core member and is configured to cover at least a portion of a valve anchor of the valve prosthesis; controlling a second control element coupled to the control unit to proximally retract the proximal sheath relative to the valve anchor to expose the valve anchor and to control engagement with the valve anchor; and controlling a third control element coupled to the control unit to move the valve anchor relative to the core member and to actuate a distal carrier assembly of the valve delivery device for permitting expansion of a valve frame of the valve prosthesis, the distal carrier assembly covering at least a portion of the valve frame to maintain the valve frame in a compressed configuration.
• Clause 29. The method of Clause 28, wherein the controlling of the first control element to cause the portion of the core member of the delivery device to bend comprises controlling the first control element to axially deflect the distal carrier assembly relative to the core member to bend the portion of the core member of the delivery device.
• Clause 30. The method of Clause 28 or 29, wherein the first control element is controllable via rotation about a longitudinal axis of the control unit.
• Clause 31. The method of any of Clauses 28-30, wherein the first control element comprises a knob that is rotatable about a longitudinal axis of the control unit.
• Clause 32. The method of any of Clauses 28-31, wherein the second control element is controllable via rotation about a longitudinal axis of the control unit.
• Clause 33. The method of any of Clauses 28-32, wherein the second control element comprises a knob that is rotatable about a longitudinal axis of the control unit.
• Clause 34. The method of Clause 33, wherein rotation of the second control element distally disengages a grasper mechanism from the valve anchor, the grasper mechanism being used for longitudinally moving the valve anchor relative to the core member and for controlling engagement with the valve anchor.
• Clause 35. The method of Clause 34, wherein the second control element comprises a knob that is rotatable about and translatable along a longitudinal axis of the control unit to control the grasper mechanism.
• Clause 36. The method of Clause 34, wherein the grasper mechanism comprises a plurality of grasper arms coupled to a respective engagement area of the valve anchor.
• Clause 37. The method of any of Clauses 28-36, wherein the valve anchor and the valve frame are movably attached and moveable between a disengaged position and an engaged position, the disengaged position allowing variable range of movement between the valve frame and the valve anchor, the engaged position providing a fixed range of movement between the valve frame and the valve anchor.
• Clause 38. The method of any of Clauses 28-37, wherein the third control element is controllable via translation of the third control element along a control handle coupled to the third control element.
• Clause 39. The method of Clause 38, wherein distal translation of the third control element distally advances a grasper mechanism relative to the proximal sheath to facilitate manipulation of the valve anchor, the grasper mechanism being used for longitudinally moving the valve anchor relative to the core member and for controlling engagement with the valve anchor.
• Clause 40. The method of any of Clauses 28-39, wherein the third control element is controllable via rotation.
• Clause 41. The method of Clause 40, wherein the rotation of the third control element axially translates a proximal enclosure of the distal carrier assembly relative to the core member for exposing the valve frame, the proximal enclosure being slidably coupled to the core member and configured to cover a proximal portion of the valve frame.
• Clause 42. The method of Clause 41, wherein the distal carrier assembly comprises a distal enclosure disposed distal to the proximal enclosure, the distal enclosure being coupled to the core member and configured to cover a distal portion of a valve frame of a valve prosthesis, wherein the rotation of the third control element axially translates the proximal enclosure in a proximal direction relative to the distal enclosure.
• Clause 43. The method of Clause 42, wherein the distal carrier assembly comprises a plunger mechanism and a distal enclosure having a distal lumen, the plunger mechanism being slidable within the distal lumen of the distal enclosure to urge the distal portion of the valve frame proximally out of the distal lumen after the proximal enclosure is moved proximally relative to the distal enclosure.
• Clause 44. The method of Clause 41, wherein rotation of the third control element in a first direction axially translates the distal enclosure in a first direction relative to the core member.
• Clause 45. The method of Clause 44, wherein the first direction is a proximal relative to the core member.
• Clause 46. The method of Clause 44, wherein rotation of the third control element in a second direction axially translates the distal enclosure in a second direction relative to the core member.
• Clause 47. The method of Clause 46, wherein the second direction is a distal relative to the core member.
• Clause 48. The method of Clause 46, wherein the rotation of the third control element in the first direction axially separates the proximal enclosure from the distal enclosure, and wherein rotation of the third control element in the second direction axially draws the proximal enclosure toward the distal enclosure.
• Clause 49. The method of any of Clauses 28-48, wherein the first, second, and third control elements are positioned along an outer surface of a control handle.
• Clause 50. The method of Clause 49, wherein at least one of the first, second, or third control elements comprises a knob.
• Clause 51. The method of Clause 49, wherein the first control element is positioned distal to the second control element along the control handle.
• Clause 52. The method of any of Clauses 28-51, further comprising a valve prosthesis having the valve frame and the valve anchor.
• Clause 53. The method of any of Clauses 28-52, wherein the distal carrier assembly comprises a distal enclosure and a proximal enclosure, and wherein in a loaded configuration, a proximal end of the distal enclosure is longitudinally spaced apart from a distal end of the proximal enclosure.
• Clause 54. A control unit for controlling a valve delivery device to deliver a valve prosthesis, the control unit comprising: a control handle coupled to a core member of the valve delivery device and configured to control an operation of the valve delivery device; a first control element configured to cause a portion of a core member of the delivery device to bend, wherein a proximal sheath of the valve delivery device extends along the core member and is configured to cover at least a portion of a valve anchor of the valve prosthesis; a second control element configured to proximally retract the proximal sheath relative to the valve anchor to expose the valve anchor and to control engagement with the valve anchor; and a third control element configured to move the valve anchor relative to the core member and to actuate a distal carrier assembly of the valve delivery device for permitting expansion of a valve frame of the valve prosthesis by actuating distal carrier assembly covering at least a portion of the valve frame to maintain the valve frame in a compressed configuration.
• Clause 55. The control unit of Clause 54, wherein the core member comprises a hollow shaft.
• Clause 56. The control unit of Clause 55, wherein the shaft comprises a shaft lumen.
• Clause 57. The control unit of any of Clauses 54-56, wherein the controlling of the first control element to cause the portion of the core member of the delivery device to bend comprises controlling the first control element to axially deflect the distal carrier assembly relative to the core member to bend the portion of the core member of the delivery device.
• Clause 58. The control unit of any of Clauses 54-57, wherein the first control element is controllable via rotation about a longitudinal axis of the control unit.
• Clause 59. The control unit of any of Clauses 54-58, wherein the first control element comprises a knob that is rotatable about a longitudinal axis of the control unit.
• Clause 60. The control unit of any of Clauses 54-59, wherein the second control element is controllable via rotation about a longitudinal axis of the control unit.
• Clause 61. The control unit of any of Clauses 54-60, wherein the second control element comprises a knob that is rotatable about a longitudinal axis of the control unit.
• Clause 62. The control unit of Clause 61, wherein rotation of the second control element distally disengages a grasper mechanism from the valve anchor, the grasper mechanism being used for longitudinally moving the valve anchor relative to the core member and for controlling engagement with the valve anchor.
• Clause 63. The control unit of Clause 62, wherein the second control element comprises a knob that is rotatable about and translatable along a longitudinal axis of the control unit to control the grasper mechanism.
• Clause 64. The control unit of Clause 62, wherein the grasper mechanism comprises a plurality of grasper arms coupled to a respective engagement area of the valve anchor.
• Clause 65. The control unit of any of Clauses 54-64, wherein the valve anchor and the valve frame are movably attached and moveable between a disengaged position and an engaged position, the disengaged position allowing variable range of movement between the valve frame and the valve anchor, the engaged position providing a fixed range of movement between the valve frame and the valve anchor.
• Clause 66. The control unit of any of Clauses 54-65, wherein the third control element is controllable via translation of the third control element along the control handle.
• Clause 67. The control unit of Clause 66, wherein distal translation of the third control element distally advances a grasper mechanism relative to the proximal sheath to facilitate manipulation of the valve anchor, the grasper mechanism being used for longitudinally moving the valve anchor relative to the core member and for controlling engagement with the valve anchor.
• Clause 68. The control unit of any of Clauses 54-67, wherein the third control element is controllable via rotation about a longitudinal axis of the control unit.
• Clause 69. The control unit of Clause 68, wherein the rotation of the third control element axially translates a proximal enclosure of the distal carrier assembly relative to the core member for exposing the valve frame, the proximal enclosure being slidably coupled to the core member and configured to cover a proximal portion of the valve frame.
• Clause 70. The control unit of Clause 69, wherein the distal carrier assembly comprises a distal enclosure disposed distal to the proximal enclosure, the distal enclosure being coupled to the core member and configured to cover a distal portion of a valve frame of a valve prosthesis, wherein the rotation of the third control element axially translates the proximal enclosure in a proximal direction relative to the distal enclosure.
• Clause 71. The control unit of Clause 70, wherein the distal carrier assembly comprises a plunger mechanism and a distal enclosure having a distal lumen, the plunger mechanism being slidable within the distal lumen of the distal enclosure to urge the distal portion of the valve frame proximally out of the distal lumen after the proximal enclosure is moved proximally relative to the distal enclosure.
• Clause 72. The control unit of Clause 69, wherein rotation of the third control element in a first direction axially translates the distal enclosure in a first direction relative to the core member.
• Clause 73. The control unit of Clause 72, wherein the first direction is a proximal relative to the core member.
• Clause 74. The control unit of Clause 72, wherein rotation of the third control element in a second direction axially translates the distal enclosure in a second direction relative to the core member.
• Clause 75. The control unit of Clause 74, wherein the second direction is a distal relative to the core member.
• Clause 76. The control unit of Clause 74, wherein the rotation of the third control element in the first direction axially separates the proximal enclosure from the distal enclosure, and wherein rotation of the third control element in the second direction axially draws the proximal enclosure toward the distal enclosure.
• Clause 77. The control unit of any of Clauses 54-76, wherein the first, second, and third control elements are positioned along an outer surface of the control handle.
• Clause 78. The control unit of any of Clauses 54-77, wherein at least one of the first, second, or third control elements comprises a knob.
• Clause 79. The control unit of any of Clauses 54-78, wherein the first control element is positioned distal to the second control element along the control handle.
• Clause 80. The control unit of any of Clauses 54-79, further comprising a valve prosthesis having the valve frame and the valve anchor.
• Clause 81. The control unit of any of Clauses 54-80, wherein the distal carrier assembly comprises a distal enclosure and a proximal enclosure, and wherein in a loaded configuration, a proximal end of the distal enclosure is longitudinally spaced apart from a distal end of the proximal enclosure.
• Clause Set 2: Methods for Delivery
• Clause 1. A method for delivering a prosthetic heart valve prosthesis to a native valve structure of a patient, the valve prosthesis comprising a valve frame and a valve anchor, the method comprising: introducing the valve prosthesis into the patient at an implantation site via a valve prosthesis delivery device, the device comprising a proximal sheath component and a distal carrier assembly, the proximal sheath component receiving at least a portion of the valve anchor in a proximal sheath lumen, and the distal carrier assembly comprising a distal enclosure and a proximal enclosure, the distal enclosure being configured to receive at least a distal portion of the valve frame; advancing the valve prosthesis to the implantation site via an aorta; proximally retracting the proximal sheath in a proximal direction to permit expansion of the valve anchor; expanding the distal carrier assembly to permit expansion of the valve frame; and distally urging a base portion of the valve anchor into engagement with a native valve structure.
• Clause 2. The method of Clause 1, further comprising advancing the valve prosthesis in a retrograde direction.
• Clause 3. The method of any preceding Clause, further comprising proximally retracting the valve frame relative to the valve anchor to engage a link mechanism therebetween and restricting a range of movement of the valve frame relative to the valve anchor.
• Clause 4. The method of Clause 3, further comprising distally advancing the valve frame.
• Clause 5. The method of any preceding Clause, wherein the expanding longitudinally separating the distal enclosure from the proximal enclosure to permit expansion of the distal portion of the valve frame.
• Clause 6. The method of any preceding Clause, wherein the expanding comprises distally advancing the distal enclosure relative to the proximal enclosure to permit expansion of the distal portion of the valve frame.
• Clause 7. The method of any preceding Clause, wherein the expanding comprises proximally retracting the proximal enclosure relative to the distal enclosure to permit expansion of a proximal portion of the valve frame.
• Clause 8. The method of any preceding Clause, wherein the expanding comprises proximally retracting the distal enclosure relative to the proximal enclosure and distally advancing the proximal enclosure relative to the distal enclosure to move the distal carrier assembly to a retrieval configuration for retracting the valve prosthesis delivery device from the patient.
• Clause 9. A method for delivering a prosthetic heart valve prosthesis to a native valve structure of a patient, the valve prosthesis comprising a valve frame and a valve anchor, the method comprising: introducing the valve prosthesis into the patient at an implantation site via a valve prosthesis delivery device, the device comprising a proximal sheath component and a distal carrier assembly, the proximal sheath component receiving at least a portion of the valve anchor in a proximal sheath lumen, and the distal carrier assembly comprising a distal enclosure and a proximal enclosure, the distal enclosure being configured to receive at least a distal portion of the valve frame; advancing the valve prosthesis to the implantation site via an apex of a heart of the patient; proximally retracting the proximal sheath in a proximal direction to permit expansion of the valve anchor; expanding the distal carrier assembly to permit expansion of the valve frame; and proximally urging a base portion of the valve anchor into engagement with a native valve structure.
• Clause 10. The method of Clause 9, further comprising advancing the valve prosthesis in a antegrade direction.
• Clause 11. The method of Clause 9 or 10, further comprising proximally retracting the valve frame relative to the valve anchor to engage a link mechanism therebetween and restricting a range of movement of the valve frame relative to the valve anchor.
• Clause 12. The method of Clause 11, further comprising distally advancing the valve frame.
• Clause 13. The method of any of Clauses 9-12, wherein the expanding longitudinally separating the distal enclosure from the proximal enclosure to permit expansion of the distal portion of the valve frame.
• Clause 14. The method of any of Clauses 9-13, wherein the expanding comprises distally advancing the distal enclosure relative to the proximal enclosure to permit expansion of the distal portion of the valve frame.
• Clause 15. The method of any of Clauses 9-14, wherein the expanding comprises proximally retracting the proximal enclosure relative to the distal enclosure to permit expansion of the proximal portion of the valve frame.
• Clause 16. The method of any of Clauses 9-15, wherein the expanding comprises proximally retracting the distal enclosure relative to the proximal enclosure and distally advancing the proximal enclosure relative to the distal enclosure to move the distal carrier assembly to a retrieval configuration for retracting the valve prosthesis delivery device from the patient.
FURTHER CONSIDERATIONS
• In some embodiments, any of the clauses herein may depend from any one of the independent clauses or any one of the dependent clauses. In some embodiments, any of the clauses (e.g., dependent or independent clauses) may be combined with any other one or more clauses (e.g., dependent or independent clauses). In some embodiments, a claim may include some or all of the words (e.g., steps, operations, means or components) recited in a clause, a sentence, a phrase or a paragraph. In some embodiments, a claim may include some or all of the words recited in one or more clauses, sentences, phrases or paragraphs. In some embodiments, some of the words in each of the clauses, sentences, phrases or paragraphs may be removed. In some embodiments, additional words or elements may be added to a clause, a sentence, a phrase or a paragraph. In some embodiments, the subject technology may be implemented without utilizing some of the components, elements, functions or operations described herein. In some embodiments, the subject technology may be implemented utilizing additional components, elements, functions or operations.
• The foregoing description is provided to enable a person skilled in the art to practice the various configurations described herein. While the subject technology has been particularly described with reference to the various figures and configurations, it should be understood that these are for illustration purposes only and should not be taken as limiting the scope of the subject technology.
• There may be many other ways to implement the subject technology. Various functions and elements described herein may be partitioned differently from those shown without departing from the scope of the subject technology. Various modifications to these configurations will be readily apparent to those skilled in the art, and generic principles defined herein may be applied to other configurations. Thus, many changes and modifications may be made to the subject technology, by one having ordinary skill in the art, without departing from the scope of the subject technology.
• It is understood that the specific order or hierarchy of steps in the processes disclosed is an illustration of exemplary approaches. Based upon design preferences, it is understood that the specific order or hierarchy of steps in the processes may be rearranged. Some of the steps may be performed simultaneously. The accompanying method claims present elements of the various steps in a sample order, and are not meant to be limited to the specific order or hierarchy presented.
• As used herein, the term “distal” can denote a location or direction that is away from a point of interest, such as a control unit or region of the delivery system that will be used to deliver a valve prosthesis to a native valve annulus. Additionally, the term “proximal” can denote a location or direction that is closer to a point of interest, such as a control unit or region of the delivery system that will be used to deliver a valve prosthesis.
• As used herein, the phrase “at least one of” preceding a series of items, with the term “and” or “or” to separate any of the items, modifies the list as a whole, rather than each member of the list (i.e., each item). The phrase “at least one of” does not require selection of at least one of each item listed; rather, the phrase allows a meaning that includes at least one of any one of the items, and/or at least one of any combination of the items, and/or at least one of each of the items. By way of example, the phrases “at least one of A, B, and C” or “at least one of A, B, or C” each refer to only A, only B, or only C; any combination of A, B, and C; and/or at least one of each of A, B, and C.
• Terms such as “top,” “bottom,” “front,” “rear” and the like as used in this disclosure should be understood as referring to an arbitrary frame of reference, rather than to the ordinary gravitational frame of reference. Thus, a top surface, a bottom surface, a front surface, and a rear surface may extend upwardly, downwardly, diagonally, or horizontally in a gravitational frame of reference.
• Furthermore, to the extent that the term “include,” “have,” or the like is used in the description or the claims, such term is intended to be inclusive in a manner similar to the term “comprise” as “comprise” is interpreted when employed as a transitional word in a claim.
• The word “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any embodiment described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments.
• A reference to an element in the singular is not intended to mean “one and only one” unless specifically stated, but rather “one or more.” Pronouns in the masculine (e.g., his) include the feminine and neuter gender (e.g., her and its) and vice versa. The term “some” refers to one or more. Underlined and/or italicized headings and subheadings are used for convenience only, do not limit the subject technology, and are not referred to in connection with the interpretation of the description of the subject technology. All structural and functional equivalents to the elements of the various configurations described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and intended to be encompassed by the subject technology. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the above description.
• Although the detailed description contains many specifics, these should not be construed as limiting the scope of the subject technology but merely as illustrating different examples and aspects of the subject technology. It should be appreciated that the scope of the subject technology includes other embodiments not discussed in detail above. Various other modifications, changes and variations may be made in the arrangement, operation and details of the method and apparatus of the subject technology disclosed herein without departing from the scope of the present disclosure. Unless otherwise expressed, reference to an element in the singular is not intended to mean “one and only one” unless explicitly stated, but rather is meant to mean “one or more.” In addition, it is not necessary for a device or method to address every problem that is solvable (or possess every advantage that is achievable) by different embodiments of the disclosure in order to be encompassed within the scope of the disclosure. The use herein of “can” and derivatives thereof shall be understood in the sense of “possibly” or “optionally” as opposed to an affirmative capability.

Claims (17)

What is claimed is:

1. A valve delivery device assembly comprising:

a valve prosthesis having a valve frame that is coupled a valve anchor via a link mechanism; and

a distal carrier assembly configured to support the valve frame in a collapsed configuration during delivery; and

a sheath configured to support the valve anchor in a collapsed configuration during delivery, the sheath being movable relative to the distal carrier assembly to release the valve anchor such that when the valve anchor is released from the assembly, the distal carrier assembly can be moved relative to the valve anchor to engage the link mechanism with the valve anchor and thereafter limit motion of the valve frame relative to the valve anchor.

2. The assembly ofclaim 1, wherein the link mechanism is slidable along the valve anchor, the valve anchor comprising an engagement area whereat the link mechanism can be engaged and constrained from further sliding movement.

3. The assembly ofclaim 1, wherein the link mechanism comprises a suture that is slidably coupled to the valve anchor and fixedly coupled to the valve frame.

4. The assembly ofclaim 1, wherein distal carrier assembly comprises a distal enclosure and a proximal enclosure that are movable relative to each other for collectively supporting the valve frame during delivery and release therefrom.

5. The assembly ofclaim 1, wherein the link mechanism is coupled to the valve frame at a substantially fixed position when the valve frame is engaged by the distal carrier assembly, prior to release of the valve frame therefrom.

6. The assembly ofclaim 1, wherein assembly comprises a system length of less than 4 feet.

7. The assembly ofclaim 1, wherein assembly comprises a system length of less than 3 feet.

8. The assembly ofclaim 1, further comprising a sheath control element configured to enable a surgeon to permit expansion the valve anchor and a position control element configured to enable the surgeon to control a rotational or longitudinal position of the valve anchor during placement of the valve anchor in a patient.

9. A method for delivering a prosthetic heart valve prosthesis, the method comprising:

introducing the valve prosthesis into a patient, the valve prosthesis including a valve anchor that is coupled to a valve frame via a link mechanism;

actuating a sheath control element to permit expansion of the valve anchor;

actuating a position control element to adjust a rotational or longitudinal position of the valve anchor relative to a target location;

releasing the valve anchor at the target location; and

moving the valve frame relative to the valve anchor to cause the link mechanism to engage with the valve anchor and thereby restrict a range of movement of the valve frame relative to the valve anchor.

10. The method ofclaim 9, wherein the moving comprises urging the valve frame in an anterograde direction to cause the link mechanism to engage with respective peak portions of the valve anchor.

11. The method ofclaim 9, wherein the target location comprises an aortic valve.

12. The method ofclaim 9, wherein the moving comprises causing the link mechanism to slide along at least a portion of the valve anchor.

13. The method ofclaim 9, further comprising permitting expansion of the valve frame into engagement with the valve anchor.

14. The method ofclaim 13, wherein prior to the permitting expansion of the valve frame, the method further comprises moving the valve frame into a lumen of the valve anchor.

15. The method ofclaim 14, wherein the moving the valve frame into the valve anchor comprises moving the valve frame until further movement of the valve frame relative to the valve anchor is restricted by the link mechanism.

16. The method ofclaim 9, further comprising applying tension to the link mechanism until the link mechanism is taut and exerting a force via the link mechanism on the valve anchor to pull the valve anchor distally relative to the target location.

17. The method ofclaim 9, further comprising applying tension to the link mechanism until the link mechanism is taut and exerting a force via the link mechanism to rotate a position of the valve anchor relative to the target location.

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