Prosthetic heart valve delivery system: paddle attachment feature

Information

  • Patent Grant
  • 12133797
  • Patent Number
    12,133,797
  • Date Filed
    Thursday, January 28, 2021
    4 years ago
  • Date Issued
    Tuesday, November 5, 2024
    2 months ago
Abstract
Systems, devices and methods for attaching an operator-manipulatable tether(s) to the stent for: loading and/or collapsing the expandable stent into a delivery catheter or sheath, translating the collapsed stent along the delivery catheter or sheath, delivering the expandable stent into the subject heart chamber, repositioning the expandable stent as necessary within the subject heart chamber, recapturing or resheathing the expandable stent within the delivery catheter or sheath if needed, and deploying the expandable stent to, and within, the subject heart chamber.
Description
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not Applicable


BACKGROUND OF THE INVENTION
Field of the Invention

The invention relates to devices and methods for implanting devices within a heart chamber.


Description of the Related Art

The human heart comprises four chambers and four heart valves that assist in the forward (antegrade) flow of blood through the heart. The chambers include the left atrium, left ventricle, right atrium and right ventricle. The four heart valves include the mitral valve, the tricuspid valve, the aortic valve and the pulmonary valve. See generally FIG. 1.


The mitral valve is located between the left atrium and left ventricle and helps control the flow of blood from the left atrium to the left ventricle by acting as a one-way valve to prevent backflow into the left atrium. Similarly, the tricuspid valve is located between the right atrium and the right ventricle, while the aortic valve and the pulmonary valve are semilunar valves located in arteries flowing blood away from the heart. The valves are all one-way valves, with leaflets that open to allow forward (antegrade) blood flow, and are critical in assuring the forward-only flow of an adequate supply of blood through the cardiovascular system. The normally functioning valve leaflets close under the pressure exerted by reverse blood to prevent backflow (retrograde) of the blood into the chamber it just flowed out of. For example, the mitral valve when working properly provides a one-way valving between the left atrium and the left ventricle, opening to allow antegrade flow from the left atrium to the left ventricle and closing to prevent retrograde flow from the left ventricle into the left atrium. This retrograde flow, when present, is known as mitral regurgitation or mitral valve regurgitation.


Native heart valves may be, or become, dysfunctional for a variety of reasons and/or conditions including but not limited to trauma, congenital malformations, inflammatory conditions, infectious conditions, other diseases and conditions, and aging. These types of conditions may cause the valve structure to fail to close properly resulting in regurgitant retrograde flow of blood from the left ventricle to the left atrium in the case of a mitral valve failure.


Mitral valve regurgitation is a specific problem resulting from a dysfunctional mitral valve that allows at least some retrograde blood flow back into the left atrium from the right atrium. In some cases, the dysfunction results from mitral valve leaflet(s) that prolapse up into the left atrial chamber, i.e., above the upper surface of the annulus instead of connecting or coapting to block retrograde flow. This backflow of blood places a burden on the left ventricle with a volume load that may lead to a series of left ventricular compensatory adaptations and adjustments, including remodeling of the ventricular chamber size and shape, that vary considerably during the prolonged clinical course of mitral regurgitation.


Regurgitation can be a problem with native heart valves generally, including tricuspid, aortic and pulmonary valves as well as mitral valves.


Native heart valves generally, e.g., mitral valves, therefore, may require functional repair and/or assistance, including a partial or complete replacement. Such intervention may take several forms including open heart surgery and open heart implantation of a replacement heart valve. See e.g., U.S. Pat. No. 4,106,129 (Carpentier), for a procedure that is highly invasive, fraught with patient risks, and requiring not only an extended hospitalization but also a highly painful recovery period.


Less invasive methods and devices for replacing a dysfunctional heart valve are also known and involve percutaneous access and catheter-facilitated delivery of the replacement valve. Stents in general, and prosthetic cardiac valve and left atrial appendage occluding devices specifically, are well known in the art. Most of these solutions involve a replacement heart valve attached to a structural support such as a stent, commonly known in the art, or other form of wire network designed to expand upon release from a delivery catheter. See, e.g., U.S. Pat. No. 3,657,744 (Ersek); U.S. Pat. No. 5,411,552 (Andersen). The self-expansion variants of the supporting stent assist in positioning the valve, and holding the expanded device in position, within the subject heart chamber or vessel. This self-expanded form also presents problems when, as is often the case, the device is not properly positioned in the first positioning attempt and, therefore, must be recaptured and positionally adjusted. This recapturing process in the case of a fully, or even partially, expanded device requires re-collapsing the device to a point that allows the operator to retract the collapsed device back into a delivery sheath or catheter, adjust the inbound position for the device and then re-expand to the proper position by redeploying the positionally-adjusted device distally out of the delivery sheath or catheter. Collapsing the already expanded device is difficult because the expanded stent or wire network is generally designed to achieve the expanded state which also resists contractive or collapsing forces.


Besides the open heart surgical approach discussed above, gaining access to the valve of interest is achieved percutaneously via one of at least the following known access routes: transapical; transfemoral; transatrial; and transseptal; collectively, transcatheter access routes.


Generally, the art is focused on systems and methods that, using one of the above-described known access routes, allow a partial delivery of the collapsed valve device, wherein one end of the device is released from a delivery sheath or catheter and expanded for an initial positioning followed by full release and expansion when proper positioning is achieved. See. e.g., U.S. Pat. No. 8,852,271 (Murray, III); U.S. Pat. No. 8,747,459 (Nguyen); U.S. Pat. No. 8,814,931 (Wang); U.S. Pat. No. 9,402,720 (Richter); U.S. Pat. No. 8,986,372 (Murray. III); and U.S. Pat. No. 9,277,991 (Salahieh); and U.S. Pat. Pub. Nos. 2015/0272731 (Racchini); and 2016/0235531 (Ciobanu). In such transcatheter techniques, the prosthetic valve is generally mounted within a stented frame that is capable of achieving collapsed and expanded states. The device is collapsed and advanced through a sheath or delivery catheter positioned in a blood vessel of the patient until reaching the implantation site. The stented frame is generally released from the catheter or sheath and, by a variety of means, expanded with the valve to the expanded functional size and orientation within the heart. One of the key issues is ease of delivery of the prosthetic valve, including the stent frame and valve in all access routes, including but not limited to transapical delivery. More specifically, it would be advantageous to have an improved delivery system for attaching, loading, translating, delivering, repositioning and resheathing and deploying an expandable stent to, and within, the subject heart chamber. The present invention addresses these, inter alia, issues.


In addition, known “replacement” prosthetic heart valves are intended for full replacement of the native heart valve. Therefore, these replacement heart valves physically engage tissue within the annular throat, i.e., below the annular plane and upper annular surface, and/or valve leaflets, thereby eliminating all remaining functionality of the native valve and making the patient completely reliant on the replacement valve. Generally speaking, it is a preferred solution that maintains and/or retains the native function of a heart valve, thus supplementation of the valve is preferred rather than full replacement. Obviously, there will be cases when native valve has either lost virtually complete functionality before the interventional implantation procedure, or the native valve continues to lose functionality after the implantation procedure. The preferred solution is delivery and implantation of a valve device that will function both as an adjunctive and/or supplementary functional valve as well as be fully capable of replacing the native function of a valve that has lost, or will lose, most or all of its functionality. However, the inventive solutions described infra will apply generally to all types and forms of heart valve devices, unless otherwise specified. The present disclosure also applies, as the skilled artisan will recognize, to stents generally.


Further, known solutions for, e.g., the mitral valve replacement systems, devices and methods require 2-chamber solutions, i.e., there is involvement and engagement of the implanted replacement valve device in the left atrium and the left ventricle. Generally, these solutions include a radially expanding stent in the left atrium, with anchoring or tethering (disposed downward through the native annulus or annular throat) connected from the stent device down through the annular throat, with the sub-annular surface within the left ventricle, the left ventricular chordae tendineae and even into the left ventricle wall surface(s). See, e.g., the MitraClip® marketed by the Abbott Group and currently the only US approved repair device. With the MitraClip® a catheter containing the MitraClip® is inserted into the femoral vein. The device enters the heart through the inferior vena cava to the right atrium and delivered trans-septally. The MitraClip® passes through the annulus into the left ventricle and sits below the leaflets, clipping the leaflets to decrease regurgitation.


Such 2-chamber and native annulus solutions are unnecessary bulky and therefore more difficult to deliver and to position/recapture/reposition from a strictly structural perspective. Further, the 2-chamber solutions present difficulties in terms of making the ventricular anchoring and/or tethering connections required to hold position. Moreover, these solutions interfere with the native valve functionality as described above because the device portions that are disposed within the left ventricle must be routed through the native annulus and/or annular throat and native mitral valve, thereby disrupting any remaining coaptation capability of the native leaflets. In addition, the 2-chamber solutions generally require an invasive anchoring of some of the native tissue, resulting in unnecessary trauma and potential complication.


It will be further recognized that the 2-chamber mitral valve solutions require sub-annular and/or ventricular engagement with anchors, tethers and the like precisely because the atrial portion of the device fails to adequately anchor itself to the atrial chamber and/or upper portion of the annulus. Again, some of the embodiments, or portions thereof, described herein are readily applicable to single or 2-chamber solutions, unless otherwise indicated.


Finally, known prosthetic cardiac valves consist of two or three leaflets that are arranged to act as a one-way valve, permitting fluid flow therethrough in the antegrade direction while preventing retrograde flow. The native mitral valve is located retrosternally at the fourth costal cartilage, consisting of an anterior and posterior leaflet, chordae tendineae, papillary muscles, ventricular wall and annulus connected to the atria. Each native leaflet is supported by chordae tendineae that are attached to papillary muscles which become taut with each ventricular contraction preserving valvular competence. Both the anterior and posterior leaflets of the native valve are attached via primary, secondary and tertiary chordae to both the antero-lateral and posterio-medial papillary muscles. A disruption in either papillary muscle in the setting of myocardial injury, can result in dysfunction of either the anterior or posterior leaflet of the mitral valve. Other mechanisms may result in failure of one, or both of the native mitral leaflets. In the case of a single mitral valve leaflet failure, the regurgitation may take the form of a non-central, eccentric jet of blood back into the left atrium. Other leaflet failures may comprise a more centralized regurgitation jet. Known prosthetic valve replacements generally comprise leaflets which are arranged to mimic the native valve structure, which may over time become susceptible to similar regurgitation outcomes.


The applications for collapsible and expandable stents are not limited to prosthetic heart valve implants. Vascular stents are commonly used and are generally collapsible to facilitate delivery through the lumen of a delivery catheter to the working site where the stent is translated out of the lumen of the catheter and it is expanded, either by a self-expanding means or through an expanding mechanism such as, inter alia, an expandable balloon.


As discussed above, known delivery methods and devices comprise expandable prosthetic valve stents and vascular stents that are collapsed during delivery via a delivery catheter. Some issues with known systems, devices and methods include ease of attaching to, and releasing from, an expandable stent for: loading and/or collapsing the expandable stent into a delivery catheter or sheath, translating the collapsed stent along the delivery catheter or sheath, delivering the expandable stent into the subject heart chamber, repositioning the expandable stent as necessary within the subject heart chamber, recapturing or resheathing the expandable stent within the delivery catheter or sheath if needed, and deploying the expandable stent to, and within, the subject heart chamber. The present invention also addresses these, inter alia, issues.


BRIEF SUMMARY OF THE INVENTION

The present invention provides systems, devices and methods for attaching to, and releasing from, at least one tether connected to and extending from an expandable stent for: loading and/or collapsing the expandable stent into a delivery catheter or sheath, translating the collapsed stent along the delivery catheter or sheath, delivering the expandable stent into the subject heart chamber, repositioning the expandable stent as necessary within the subject heart chamber, recapturing or resheathing the expandable stent within the delivery catheter or sheath if needed, and deploying the expandable stent to, and within, the subject heart chamber. The delivery system embodiments described herein apply to stents comprising single-chamber prosthetic heart valves as well as stents comprising prosthetic heart valves that require anchoring outside of a single chamber.


In one embodiment, a delivery system for delivering an expandable prosthetic heart valve comprising a self-expanding stent frame comprises: an operating handle comprising at least one push/pull and release mechanism; at least one tether assembly, wherein each of the at least one tether assembly is operatively connected at its distal end to a corresponding one of the at least one push/pull and release mechanism of the operating handle, wherein each of the at least one tether assembly comprises: an outer tube defining a lumen therethrough; a notched wire configured to be slidingly received within the lumen of the outer tube and defining a T-shaped notch at a distal end of the notched wire, wherein the T-shaped notch is configured to be distally extended from the lumen of the outer tube, wherein the T-shaped notch is configured to releasably engage a corresponding attachment feature extending from a downstream end of the self-expanding stent frame.


In another embodiment, a method for delivering and deploying a prosthetic heart valve to a patient's heart chamber comprises: providing the aforementioned delivery system for delivering the expandable prosthetic heart valve comprising a self-expanding stent frame; loading and/or collapsing the expandable prosthetic heart valve into a lumen defined by a delivery catheter or sheath; translating the collapsed prosthetic heart valve through the lumen of the delivery catheter or sheath; delivering the expandable prosthetic heart valve into the patient's heart chamber; repositioning the expandable prosthetic heart valve as necessary within the patient's heart chamber; deploying the expandable prosthetic heart valve to, and within, the patient's heart chamber; and withdrawing the delivery system from the patient.


Certain inventive embodiments described herein are readily applicable to single or two chamber solutions, unless otherwise indicated. Moreover, certain embodiments discussed herein may be applied to preservation and/or replacement of native valve functionality generally, and are not, therefore, limited to prosthetic mitral valve devices but may be extended to include prosthetic tricuspid valve devices, prosthetic aortic devices, prosthetic pulmonary valves, and methods for the loading, delivery, deployment, and positioning of any such valves.





BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS


FIG. 1 illustrates certain features of the heart in cross-section.



FIG. 2 illustrates a perspective view of an exemplary stent.



FIG. 3A illustrates a bottom view of one embodiment of the exemplary stent of FIG. 2.



FIG. 3B illustrates a bottom view of one embodiment of a transition section of the exemplary stent of FIG. 2.



FIG. 3C illustrates a bottom view of one embodiment of a transition section of the exemplary stent of FIG. 2.



FIG. 4 illustrates one embodiment of an attachment feature defined in an exemplary stent.



FIG. 5 illustrates one embodiment of an attachment feature extending from a lower section, and extending through a paravalvular leakage mitigating fabric cuff, of the exemplary stent of FIG. 2.



FIG. 6 illustrates one embodiment comprising three attachment features extending from a lower section of the exemplary stent of FIG. 2.



FIG. 7 illustrates one embodiment of a notched wire of a tether attachment and release assembly.



FIG. 8 illustrates one embodiment of an outer tube of a tether assembly.



FIG. 9A illustrates one embodiment of a tether assembly in attached engagement with the attachment feature.



FIG. 9B illustrates the embodiment of FIG. 9A wherein the outer tube of the tether assembly is pulled proximally to expose the attachment feature.



FIG. 9C illustrates the embodiment of FIGS. 9A and 9B wherein the attachment feature is detached and released from the tether assembly.



FIG. 10 illustrates one embodiment comprising three (3) tether assemblies extending distally from a delivery catheter or sheath.



FIG. 11 illustrates each of the three tether assemblies of FIG. 10 in attachment with one of the attachment features.



FIG. 12A illustrates three exemplary tether assemblies attached to three attachment features of an exemplary stent, without displacement of the stent from a longitudinal axis of a delivery catheter.



FIG. 12B illustrates three exemplary tether assemblies attached to three attachment features of an exemplary stent with displacement in a first direction relative to a longitudinal axis of a delivery catheter.



FIG. 12C illustrates three exemplary tether assemblies attached to three attachment features of an exemplary stent with displacement in a second direction relative to a longitudinal axis of a delivery catheter.



FIG. 13A illustrates an exemplary handle and mechanism for adjusting (decreasing) the extension of each tether assembly distally from the distal end of the delivery catheter or sheath.



FIG. 13B illustrates an exemplary handle and mechanism for adjusting (increasing) the extension of each tether assembly distally from the distal end of the delivery catheter or sheath.



FIG. 13C illustrates an exemplary handle and mechanism for releasing one of the tether assemblies from attachment to the exemplary attachment features of the stent.





DETAILED DESCRIPTION OF THE INVENTION

Generally, various embodiments of the present invention ae directed to devices and methods for attaching an operator-manipulatable tether(s) to the stent for: loading and/or collapsing the expandable stent into a delivery catheter or sheath, translating the collapsed stent along the delivery catheter or sheath, delivering the expandable stent into the subject heart chamber, repositioning the expandable stent as necessary within the subject heart chamber, recapturing or resheathing the expandable stent within the delivery catheter or sheath if needed, and deploying the expandable stent to, and within, the subject heart chamber.


The support structure or stent has multiple functions to aid with the treatment of cardiac valve regurgitation (mitral or tricuspid). These functions include its function as a scaffold for the functioning prosthetic valve, apposition to the atrial anatomy, optimized radial force for compliance with atrial distension, ability to load and deploy from a minimally invasive delivery system, and geometry to support with mitigating against paravalvular leak (PVL). The design features of the stent are adapted to meet one or more of the functions identified above. Specific design features and attributes for exemplary stents are discussed in detail below to assist in understanding of the utility of the funneling loading device and related methods. As the skilled artisan will recognize, the invention is not limited to prosthetic heart valves comprising stent support structures, but may also be applied to collapsible and expandable stents such as commonly used for intravascular procedures. In addition, the skilled artisan will recognize the utility of the disclosed inventions for use in implanting certain exemplary embodiment stent design concepts that are intended to support minimally invasive procedures for the treatment of valvular regurgitation or other dysfunction in at least mitral, tricuspid, and aortic valves.


The expandable stents of the present invention may be self-expandable (e.g. Nitinol or similar materials) or balloon expandable (e.g. cobalt chromium or similar materials). The stents are typically made of cells that may be open celled diamond like structures or continuous structures that have a working cell element. The stents may also be constructed using tubing, wires, braids or similar structures. Exemplary stent transition sections are described below.


With reference now to FIGS. 2-3C, one embodiment of an exemplary expandable stent 100 for use with the present invention comprises a frame defining an outer section 102 and an inner valve support section 104. FIG. 2 illustrates a perspective view of the stent 100. The outer section 102 may generally be circular but need not be a perfectly round circular structure when fully and/or partially expanded. The inner valve support section 104 may be cylindrical—but need not be a constant-diameter cylinder—and is adapted to support and retain prosthetic valve leaflets (not shown in FIG. 2) within the inner valve support section 104. Most preferably, prosthetic valve leaflets are supported and retained within the inner valve support section 104 at a point that is located above the native annulus; e.g., the mitral valve annulus, though other attachment points for the prosthetic leaflets are within the scope of the present invention. Further, as discussed above, the stent 100 may be configured to supplement and/or replace the function of the tricuspid valve. A preferred construction comprises the prosthetic leaflets disposed above the native leaflets, wherein the prosthetic leaflets are attached and spaced sufficiently away from (i.e., above) the native leaflets so as to not physically interfere or interact with the native leaflets. However, certain embodiments contemplate some interaction with the native leaflets.


Individual cells CO forming the outer section 102 of stent 100 are visible in FIG. 2 as open cell regions defined by the material used to form the exemplary expandable stent 100.


Individual cells CI forming the inner valve support section 104 are also illustrated as open cells regions formed within an inner region R defined by outer section 102, wherein the inner valve support section extends radially upward into the inner region R. As shown, individual cells CI are of a different size, and may comprise a different shape, than that of individual cells CO.


The region of the frame of stent 100 that facilitates the radially inward transition of the stent 100 from the outer section 102 to the inner valve support section 104 of the stent 100 is a transition section or cell region 106. Transition cell region 106 may comprise cells CT that may comprise a different size and/or shape that either the outer section cells CO and/or the inner section cells CI. The outer section 102, inner valve support section 104, and/or transition cell region 106 of the stent 100 may be constructed from one continuous structure or may combine two or more structures to achieve intended design goals. Transition cell region 106 generally curves radially inward and upward to allow the inner valve support section 104 to reside within the inner region R as shown in FIG. 2. In some embodiments, the lower portion of inner valve support section 104; i.e., the portion of the inner valve support section 104 that is in connection with the cells CT of transition cell region 106, may also comprise a curving shape to facilitate and/or complete the upward turn into the inner region 102.



FIGS. 3A-3C illustrate bottom views of three different embodiments of the exemplary stent of FIG. 2. Exemplary cross-sectional geometry of the transition cell region 106 viewed from the bottom of stent 100 is represented schematically in FIGS. 3A-3C. This transition cell region 106 of the stent 100 may be a strut, completed cell section or a partial cell section. The transition cell region 106 may have any number of struts (minimum of 3) or cell sections as generally required to meet design needs.


The geometry and/or shape of the transition cells CT may be substantially straight segments when expanded, as shown in FIG. 3A. For example, transition cells CT or struts may be evenly spaced and formed by substantially straight and equally spaced apart struts 108 that extend away from the inner valve support section 104 with equal angles α on both sides of the strut 108 and equal angles β on both sides of strut 108 with respect to its intersection or integration with outer support section 102.


In the embodiment of FIG. 3B, the geometry and/or shape of the transition cells CT may incorporate an offset or a twist in the stent cell pattern. As shown in FIG. 3B, the transition cell region 106 may comprise transition cell struts 108′ that comprise transition cells CT that are formed by struts 108′ having an offset, i.e., not straight, are twisted and/or curvilinear. The degree of offset and/or twist and/or curvature of the struts 108′, and therefore the size and/or shape of the resultant expanded cells CT, may be varied dependent on the number of cells/struts in the transition cell region 106, packing density when the stent is collapsed, and stress/strain distribution limitations of the transition cell region 106. In this manner the offset or twist in the geometry and/or shape of the transition cells CT in the embodiment of FIG. 3B may allow for a controlled compression of the stent.


In the embodiment of FIG. 3C, the geometry and/or shape of the transition cells CT may be substantially straight segments as in FIG. 3A, but with non-equal angles relative to the inner valve support section 104 and outer support section 102. As shown in FIG. 3C, the straight struts 108 of this embodiment are slanted so that a smaller angle α and a larger angle α′ are provided relative to the inner valve support section 104. Similarly, a smaller angle β′ and a larger angle β are provided relative to the outer support section 102. This allows a compressed nesting of the slanted struts 108 of transition cell region 106.


Attachment features 402 are illustrated in FIGS. 2 and 3A and will be described further below.



FIG. 4 illustrates one embodiment of an attachment feature 402 defined in an exemplary stent such as the stent 100 of FIG. 2. As shown in FIG. 4, an attachment feature 402 is defined within the stent pattern of the frame of stent 100, preferably within the transition cell region 106 of the stent 100. However, the skilled artisan will recognize that attachment feature 402 may also be defined along strut(s) that are not within the transition cell region 106. In addition, attachment feature 402 may be defined at a point on the frame of stent 100 that is on a downstream (of the normal blood flow within the prosthetic heart valve) side of the stent 100 when implanted. Alternatively, attachment feature 402 may be defined on the lowermost downstream strut of the frame of stent 100. Further, attachment features 402 comprise, as best shown in FIG. 4, a wire portion 401 and an enlarged end portion 403 comprising a diameter that is larger than a diameter of the wire portion 401. Enlarged end portion 403 may be circular as shown, or may comprise any number of shapes as will be discussed further below.



FIG. 5 illustrates one embodiment in which an attachment feature 402 extends from a lower section of the frame of stent 100 of FIG. 2. Attachment feature 402 is, as shown in FIG. 5, adapted to extend outwardly away from the outer section 102 and transition cell region 106. In some cases a paravalvular leakage mitigating fabric skirt or cuff is attached to the outer frame of the stent 100 and at least partially covers the outer section 102 and/or transition cell region 106. In such cases, the attachment feature 402 may pass through the paravalvular leakage mitigating skirt or cuff to outside of the frame of stent 100.


In some embodiments an exemplary stent may comprise one or more of the attachment feature 402. FIG. 6 illustrates the locations around a lower portion of the stent 100 for three (3) of the attachment features 402. As shown, there is a substantially equal spacing or separation between adjacent attachment features 402 along and/or around the transition cell region 106. The skilled artisan will recognize the non-equal spacings or separations between the locations of the attachment features 402 may also be employed. In addition, at least one attachment feature 402 may be used. It is preferable to have at least two, and more preferable to have at least three, attachment features 402 defined as described herein. Further, attachment features 402 comprise, as best shown in FIGS. 4 and 9A-9B, a wire portion 401 and an enlarged end portion 403 comprising a diameter that is larger than a diameter of the wire portion 401.


Turning now to FIGS. 7-9C, one embodiment of a tether assembly 410 that is operationally connected at a proximal end to an operational handle, as will be discussed further, is illustrated. Tether assembly 410 further comprises an outer tube 404, and a notched wire 408. The notched wire 408 defines a distal T-shaped engagement channel 409 adapted to provide a complementary fit for the enlarged distal end portion 403 of attachment feature 402 and a section of the wire portion 401 of attachment feature 402. The inner diameter D1 of the lumen of outer tube 404 is larger than outer diameter D2 of notched wire 408. This relationship between D1 and D2 is maintained when the attachment feature 402 is engaged in T-shaped engagement channel 409. This is because, as shown in FIG. 9A, when attachment feature 402 is engaged in engagement channel 409, the outer tube 404 is advanced to cover the engagement channel 409, holding the attachment feature 402 within engagement channel 409. Outer tube 404 defines a lumen therethrough that is sized to allow sliding reception of notched wire 408 within the lumen of outer tube 404.


The outer tube 404 may be proximally withdrawn to expose the attachment feature 402 while attachment feature 402 is engaged in the engagement channel 409, as shown in FIG. 9B, to enable detachment or release of the attachment feature 402 from the notched wire 408. Detachment or release of the attachment feature 402 from the notched wire 408 is illustrated in FIG. 9C.



FIGS. 10 and 11 provide additional detail for a preferred embodiment comprising three (3) tether assemblies (410). Each of the tether assembly(ies) 410 defines a length that enables proximal connection of the tether assembly 410 with an operating handle (further described below with respect to FIGS. 13A-13C) and provides sufficient extension length from the distal end of a delivery catheter or sheath to facilitate, inter alia, translation and deployment of the subject stent comprising a prosthetic heart valve as will be further discussed herein. Each attachment feature 402 is attached to a distal end of a corresponding tether assembly 410 in the manner discussed above with respect to FIGS. 7-9C.


Thus attached to the stent 100 (e.g., to the outer section 102) as described above, the tether assembly(ies) 410 may be used to collapse the expandable stent 100 into the proximal end of the lumen of a delivery catheter or sheath and assist in translating the collapsed stent 100 distally through the delivery catheter or sheath to the distal end of the delivery catheter of sheath which is pre-positioned at the heart chamber of interest. At this point, the collapsed stent 100 is at least partially released from the delivery catheter or sheath and begins to self-expand. The attached tether assembly(ies) 410 may be used to assist in this process by manipulating the tether assembly(ies) 410 to move the at least partially expanded stent 100 into proper position within the subject heart chamber. In certain cases, it may be advantageous to reposition the at least partially expanded stent 100 (which comprises a prosthetic heart valve) by pulling proximally one or more of the tether assembly(ies) 410 to move the stent 100 in a desired direction and into a desired attitude within the heart valve, relative to anatomical landmarks.



FIGS. 12A-12C illustrate one embodiment comprising three tether assemblies 410 wherein FIG. 12A is a default position and the stent 100 is substantially symmetrically aligned with the longitudinal axis of the delivery sheath. FIGS. 12B and 12C show the result of pulling (or pushing) one or more tether assembly(ies) 410 to cause the connected stent 100 to move away from the symmetrical alignment of the longitudinal axis of the delivery sheath to take on an asymmetrical attitude to assist in positioning and deploying the stent 100.



FIGS. 13A-13C provide embodiments of an operating handle H to which the proximal end of each tether assembly 410 is connected as the skilled artisan will appreciate. As indicated, the length of extension of the tether assembly 410 away from the distal end of the delivery sheath may be manipulated by moving the attached push/pull and release mechanism 430 proximally or distally at the handle H. This may be done as a combined set of tether assemblies, or individual tether assemblies 410 may be selected for selective lengthening (pushing it distally) or shortening (pulling it proximally), relative to the other tether assembly(ies) 410, and/or the components of each tether assembly 410 comprising the outer tube 404, the notched wire 408 and the attachment feature 402 with wire portion 401 and enlarged end portion 403 may each be pushed proximally and/or pulled distally independently. Each tether assembly 410 defines its own length and a release mechanism 430 attached to handle H.


Each push/pull and release mechanism 430 further comprises a lever L that may be locked and unlocked and that allows manipulation of the individual components of the tether assembly 410. When locked, the tether assembly 410 is attached to an attachment feature 402 as described above. Releasing the tether assembly 410 from the attachment feature 402 is achieved, as shown in FIGS. 13C, by unlocking the lever L by actuating it from a locked position to an unlocked position as shown, and then pulling the unlocked portion of the tether assembly 410 proximally (i.e., pulling proximally the notched wire 408 and/or outer tube 404, distally and out of attached engagement with the attachment feature 402). It will be obvious now to the skilled artisan that this same mechanism 430 may be used to advance and/or retract the components of the tether assembly 410. i.e., the outer tube 404, to achieve attachment with, and/or release from, the attachment feature 402.


In some cases, it may be advantageous to at least partially recover, resheath and/or recapture the at least partially expanded stent 100 by pulling it proximally into the lumen of the delivery catheter or sheath, then reinitiating release and deployment steps.


When the stent 100 (comprising the prosthetic heart valve) is properly positioned, the outer tube 404 is pulled proximally to expose the attachment feature 402 engaged within the notched wire 408 for disengagement or release therefrom, thereby disconnecting the tether assembly 410 from the attachment feature 402 and the stent 100. Once each provided tether assembly 410 is similarly disconnected from the stent 100, the tether assembly(ies) 410 may be withdrawn from the heart chamber.


As discussed, a preferred access route for the disclosed delivery system comprises a transapical approach, though all other delivery access routes may be successfully navigated using the disclosed invention(s).


The description of the invention and its applications as set forth herein is illustrative and is not intended to limit the scope of the invention. Features of various embodiments may be combined with other embodiments within the contemplation of this invention. Variations and modifications of the embodiments disclosed herein are possible, and practical alternatives to and equivalents of the various elements of the embodiments would be understood to those of ordinary skill in the art upon study of this patent document. These and other variations and modifications of the embodiments disclosed herein may be made without departing from the scope and spirit of the invention.

Claims
  • 1. A delivery system for delivering an expandable prosthetic heart valve comprising a self-expanding stent frame, the delivery system comprising: an operating handle comprising push/pull and release mechanisms;three tether assemblies, wherein each of the tether assemblies is operatively connected at its distal end to a corresponding one of the push/pull and release mechanisms of the operating handle, wherein each of the tether assemblies comprises: an outer tube defining a lumen therethrough; anda notched wire configured to be slidingly received within the lumen of the outer tube and defining a T-shaped engagement channel at a distal end of the notched wire, wherein the T-shaped engagement channel is configured to be distally extended from the lumen of the outer tube; andthe self-expanding stent frame comprising three attachment features extending from an end of the self-expanding stent frame; wherein: each T-shaped engagement channel is configured to releasably engage a corresponding one of the attachment features extending from the end of the self-expanding stent frame;when the corresponding attachment feature is engaged with the T-shaped engagement channel, the outer tube is configured to be advanced over the entire T-shaped engagement channel, securing the corresponding attachment feature within the engagement channel; andeach attachment feature includes: a wire portion; andan enlarged proximal end portion having a circular shape that is configured to engage a T-shaped engagement channel corresponding to the attachment feature.
  • 2. The delivery system of claim 1, wherein the self-expanding stent frame further comprises: an outer section;an inner valve support section extending upward within the outer section; anda transition cell region at the end of the self-expanding stent frame, the transition cell region extending between the outer section and the inner valve support section; wherein: the three attachment features extend away from the transition cell region of the self-expanding stent frame.
  • 3. The delivery system of claim 1, wherein the stent frame defines a plurality of struts, and wherein each of the attachment features are defined on a corresponding lowermost downstream strut of the stent frame.
  • 4. The delivery system of claim 1, wherein the tether assemblies are configured to be received within a lumen defined by a delivery catheter, and wherein, for each of the tether assemblies, a corresponding one of the push/pull and release mechanisms is adapted to translate a corresponding tether assembly proximally and/or distally relative to a distal end of the delivery catheter when the corresponding tether assembly is received within the lumen of the delivery catheter.
  • 5. The delivery system of claim 4, wherein each of the push/pull and release mechanisms are adapted to selectively translate, for a corresponding tether assembly, a corresponding outer tube and notched wire relative to each other, relative to the distal end of the delivery catheter, and relative to any other one of the tether assemblies.
  • 6. The delivery system of claim 4, wherein each of the push/pull and release mechanisms comprises a lever configured to move between a locked position and an unlocked position.
  • 7. The delivery system of claim 1, wherein delivering the expandable prosthetic heart valve to a heart chamber treats one or more of the group consisting of: a native mitral valve, a native tricuspid valve, and a native aortic valve.
  • 8. The delivery system of claim 7, wherein the expandable prosthetic heart valve is delivered to the heart chamber along one or more of the transcatheter access routes in the group consisting of: transapical, transfemoral, transatrial, and transseptal.
  • 9. The delivery system of claim 1 wherein each of the tether assemblies is configured to be individually manipulated relative to other tether assemblies.
  • 10. A method for delivering and deploying a prosthetic heart valve to a heart chamber, the method comprising: providing the delivery system of claim 1;loading and/or collapsing the expandable prosthetic heart valve into a lumen defined by a delivery catheter or sheath;translating the collapsed prosthetic heart valve through the lumen of the delivery catheter or sheath;delivering the expandable prosthetic heart valve into the heart chamber;repositioning the expandable prosthetic heart valve as necessary within the heart chamber;deploying the expandable prosthetic heart valve to, and within, the heart chamber; andwithdrawing the tether assemblies from the heart chamber.
  • 11. The method of claim 10, further comprising recapturing or resheathing the expandable prosthetic heart valve within the delivery catheter or sheath after delivering the expandable prosthetic heart valve and before withdrawing the tether assemblies from the patient, wherein recapturing or resheathing the expandable prosthetic heart valve within the delivery catheter or sheath comprises proximally moving the push/pull and release mechanisms.
  • 12. The method of claim 10, wherein each of the push/pull and release mechanisms are adapted to selectively translate, for a corresponding tether assembly, a corresponding outer tube and notched wire relative to each other, relative to the distal end of the delivery catheter, and relative to any other one of the tether assemblies.
  • 13. The method of claim 12, wherein each of the push/pull and release mechanisms comprises a lever configured to move between a locked position and an unlocked position, and wherein deploying the expandable prosthetic heart valve comprises releasing each of the attachment features from the corresponding T-shaped notch of the notched wire by moving the corresponding lever to the unlocked position and proximally moving the push/pull and release mechanism.
  • 14. The method of claim 10, wherein the stent frame defines a plurality of struts, and wherein each attachment feature is defined on a corresponding one lowermost downstream strut of the stent frame.
  • 15. The method of claim 10, wherein delivering the expandable prosthetic heart valve into the heart chamber treats one or more of the group consisting of: a native mitral valve, a native tricuspid valve, and a native aortic valve.
  • 16. The method of claim 15, wherein the expandable prosthetic heart valve is delivered to the heart chamber along one or more of the transcatheter access routes in the group consisting of: transapical, transfemoral, transatrial, and transseptal.
CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No. 62/968,220, filed Jan. 31, 2020, and entitled PROSTHETIC HEART VALVE DELIVERY SYSTEM: PADDLE ATTACHMENT FEATURE

US Referenced Citations (786)
Number Name Date Kind
4424833 Spector Jan 1984 A
4503569 Dotter Mar 1985 A
4733665 Palmaz Mar 1988 A
4878906 Lindemann Nov 1989 A
5190528 Fonger Mar 1993 A
5415667 Frater May 1995 A
5441483 Avitall Aug 1995 A
5693083 Baker Dec 1997 A
5693089 Inoue Dec 1997 A
5776188 Shepherd Jul 1998 A
5843090 Schuetz Dec 1998 A
5928258 Khan Jul 1999 A
5957949 Leonhardt Sep 1999 A
5968070 Bley Oct 1999 A
6123723 Konya Sep 2000 A
6152144 Lesh Nov 2000 A
6231602 Carpentier May 2001 B1
6287334 Moll Sep 2001 B1
6319280 Schoon Nov 2001 B1
6319281 Patel Nov 2001 B1
6332893 Mortier Dec 2001 B1
6371983 Lane Apr 2002 B1
6409758 Stobie Jun 2002 B2
6425916 Garrison Jul 2002 B1
6471718 Staehle Oct 2002 B1
6494909 Greenhalgh Dec 2002 B2
6503272 Duerig Jan 2003 B2
6540782 Snyders Apr 2003 B1
6569196 Vesely May 2003 B1
6589275 Ivancev Jul 2003 B1
6702826 Liddicoat Mar 2004 B2
6738655 Sen May 2004 B1
6790231 Liddicoat Sep 2004 B2
6790237 Stinson Sep 2004 B2
6821297 Snyders Nov 2004 B2
6830585 Artof Dec 2004 B1
6840957 Dimatteo Jan 2005 B2
6875231 Anduiza Apr 2005 B2
7011671 Welch Mar 2006 B2
7041132 Quijano May 2006 B2
7044966 Svanidze May 2006 B2
7125420 Rourke Oct 2006 B2
7153324 Case Dec 2006 B2
7252682 Seguin Aug 2007 B2
7276077 Zadno-Azizi Oct 2007 B2
7276078 Spenser Oct 2007 B2
7291168 Macoviak Nov 2007 B2
7364588 Mathis Apr 2008 B2
7381220 Macoviak Jun 2008 B2
7442204 Schwammenthal Oct 2008 B2
7445631 Salahieh Nov 2008 B2
7455689 Johnson Nov 2008 B2
7510572 Gabbay Mar 2009 B2
7524331 Birdsall Apr 2009 B2
7611534 Kapadia Nov 2009 B2
7704277 Zakay Apr 2010 B2
7749266 Forster Jul 2010 B2
7758491 Buckner Jul 2010 B2
7780723 Taylor Aug 2010 B2
7789909 Andersen Sep 2010 B2
7935144 Robin May 2011 B2
7959672 Salahieh Jun 2011 B2
7967853 Eidenschink Jun 2011 B2
7998196 Mathison Aug 2011 B2
8012201 Lashinski Sep 2011 B2
8016877 Seguin Sep 2011 B2
8021420 Dolan Sep 2011 B2
8029556 Rowe Oct 2011 B2
D648854 Braido Nov 2011 S
8052592 Goldfarb Nov 2011 B2
8057493 Goldfarb Nov 2011 B2
8070802 Lamphere Dec 2011 B2
8083793 Lane Dec 2011 B2
D653341 Braido Jan 2012 S
D653342 Braido Jan 2012 S
8092524 Nugent Jan 2012 B2
8142492 Forster Mar 2012 B2
8147541 Forster Apr 2012 B2
D660433 Braido May 2012 S
D660967 Braido May 2012 S
8167932 Bourang May 2012 B2
8236049 Rowe Aug 2012 B2
8246677 Ryan Aug 2012 B2
8252051 Chau Aug 2012 B2
8287538 Brenzel et al. Oct 2012 B2
8308798 Pintor Nov 2012 B2
8348998 Pintor Jan 2013 B2
8348999 Kheradvar Jan 2013 B2
8366768 Zhang Feb 2013 B2
8398708 Meiri Mar 2013 B2
8409275 Matheny Apr 2013 B2
8414644 Quadri Apr 2013 B2
8414645 Dwork Apr 2013 B2
8439970 Jimenez May 2013 B2
8454686 Alkhatib Jun 2013 B2
8465541 Dwork Jun 2013 B2
8491650 Wiemeyer Jul 2013 B2
8512400 Tran Aug 2013 B2
8518106 Duffy Aug 2013 B2
8535373 Stacchino Sep 2013 B2
8562673 Yeung Oct 2013 B2
8568472 Marchand Oct 2013 B2
8579963 Tabor Nov 2013 B2
8579964 Lane Nov 2013 B2
8603159 Seguin Dec 2013 B2
8623075 Murray, III Jan 2014 B2
8636764 Miles Jan 2014 B2
8641757 Pintor Feb 2014 B2
8657870 Turovskiy Feb 2014 B2
8663318 Ho Mar 2014 B2
8679176 Matheny Mar 2014 B2
8721715 Wang May 2014 B2
8740976 Tran Jun 2014 B2
8747459 Nguyen Jun 2014 B2
8747461 Centola Jun 2014 B2
8764793 Lee Jul 2014 B2
8764820 Dehdashtian Jul 2014 B2
8778020 Gregg Jul 2014 B2
8790396 Bergheim Jul 2014 B2
8795354 Benichou Aug 2014 B2
8795357 Yohanan Aug 2014 B2
8805466 Salahieh Aug 2014 B2
8814931 Wang Aug 2014 B2
8828043 Chambers Sep 2014 B2
8828051 Javois Sep 2014 B2
8845711 Miles Sep 2014 B2
8845722 Gabbay Sep 2014 B2
8852271 Murray, III Oct 2014 B2
8852272 Gross Oct 2014 B2
8870949 Rowe Oct 2014 B2
8876897 Kheradvar Nov 2014 B2
8906022 Krinke et al. Dec 2014 B2
8926692 Dwork Jan 2015 B2
8956402 Cohn Feb 2015 B2
8956405 Wang Feb 2015 B2
8961518 Kyle et al. Feb 2015 B2
8986372 Murry, III Mar 2015 B2
8986374 Cao Mar 2015 B2
8986375 Garde Mar 2015 B2
8998980 Shipley Apr 2015 B2
8998982 Richter Apr 2015 B2
9005273 Salahieh Apr 2015 B2
9011527 Li Apr 2015 B2
D730520 Braido May 2015 S
D730521 Braido May 2015 S
9023101 Krahbichler May 2015 B2
9050188 Schweich, Jr. Jun 2015 B2
9060855 Tuval Jun 2015 B2
9060857 Nguyen Jun 2015 B2
9060858 Thornton Jun 2015 B2
9061119 Le Jun 2015 B2
9066800 Clague Jun 2015 B2
9072603 Tuval Jul 2015 B2
9101471 Kleinschrodt Aug 2015 B2
9119717 Wang Sep 2015 B2
9132008 Dwork Sep 2015 B2
9132009 Hacohen Sep 2015 B2
9138313 McGuckin, Jr. Sep 2015 B2
9144493 Carr Sep 2015 B2
9144494 Murray Sep 2015 B2
9155619 Liu Oct 2015 B2
9161835 Rankin Oct 2015 B2
9173737 Hill Nov 2015 B2
9192466 Kovalsky Nov 2015 B2
9226820 Braido Jan 2016 B2
9232942 Seguin Jan 2016 B2
9232996 Sun Jan 2016 B2
9248016 Oba Feb 2016 B2
9259315 Zhou Feb 2016 B2
9271856 Duffy Mar 2016 B2
9277993 Gamarra Mar 2016 B2
9289289 Rolando Mar 2016 B2
9289292 Anderl Mar 2016 B2
9295547 Costello Mar 2016 B2
9295549 Braido Mar 2016 B2
9301836 Buchbinder Apr 2016 B2
9301839 Stante Apr 2016 B2
9320597 Savage Apr 2016 B2
9320599 Salahieh Apr 2016 B2
9326853 Olson May 2016 B2
9326854 Casley May 2016 B2
9333075 Biadillah May 2016 B2
9345572 Cerf May 2016 B2
9351831 Braido May 2016 B2
9358108 Bortlein Jun 2016 B2
9364325 Alon Jun 2016 B2
9364637 Rothstein Jun 2016 B2
9370422 Wang Jun 2016 B2
9387106 Stante Jul 2016 B2
9402720 Richter Aug 2016 B2
9414910 Lim Aug 2016 B2
9414917 Young Aug 2016 B2
9427316 Schweich, Jr. Aug 2016 B2
9439763 Geist Sep 2016 B2
9439795 Wang Sep 2016 B2
9480560 Quadri Nov 2016 B2
9498370 Kyle et al. Nov 2016 B2
9504569 Malewicz Nov 2016 B2
9522062 Tuval Dec 2016 B2
9566152 Schweich, Jr. Feb 2017 B2
9579194 Elizondo Feb 2017 B2
9579197 Duffy Feb 2017 B2
9622863 Karapetian Apr 2017 B2
9717592 Thapliyal Aug 2017 B2
9730791 Ratz Aug 2017 B2
9737400 Fish Aug 2017 B2
9737401 Conklin Aug 2017 B2
9750604 Naor Sep 2017 B2
9763780 Morriss Sep 2017 B2
9795477 Tran Oct 2017 B2
9801711 Gainor Oct 2017 B2
9827093 Cartledge Nov 2017 B2
9839517 Centola et al. Dec 2017 B2
9839765 Morris Dec 2017 B2
9861477 Backus Jan 2018 B2
9872765 Zeng Jan 2018 B2
9877830 Lim Jan 2018 B2
9968443 Bruchman May 2018 B2
10004601 Tuval Jun 2018 B2
10016274 Tabor Jul 2018 B2
10016275 Nyuli Jul 2018 B2
10022132 Wlodarski et al. Jul 2018 B2
10034750 Morriss Jul 2018 B2
10039637 Maimon Aug 2018 B2
10039642 Hillukka Aug 2018 B2
10098735 Lei Oct 2018 B2
10098763 Lei Oct 2018 B2
10117742 Braido Nov 2018 B2
10143551 Braido Dec 2018 B2
10182907 Lapeyre Jan 2019 B2
10195023 Wrobel Feb 2019 B2
10226340 Keren Mar 2019 B2
10231834 Keidar Mar 2019 B2
10238490 Gifford, III Mar 2019 B2
10245145 Mantanus Apr 2019 B2
10258464 Delaloye Apr 2019 B2
10299917 Morriss May 2019 B2
10321990 Braido Jun 2019 B2
10327892 O'Connor Jun 2019 B2
10327893 Maiorano Jun 2019 B2
10350065 Quadri Jul 2019 B2
10357360 Hariton Jul 2019 B2
10368982 Weber Aug 2019 B2
10376363 Quadri Aug 2019 B2
10383725 Chambers Aug 2019 B2
10390943 Hernandez Aug 2019 B2
10405974 Hayes Sep 2019 B2
10433961 McLean Oct 2019 B2
10470880 Braido Nov 2019 B2
10492907 Duffy Dec 2019 B2
10500041 Valdez Dec 2019 B2
10507107 Nathe Dec 2019 B2
10512537 Corbett Dec 2019 B2
10512538 Alkhatib Dec 2019 B2
10517726 Chau Dec 2019 B2
10524902 Gründeman Jan 2020 B2
10524910 Hammer Jan 2020 B2
10531951 Spargias Jan 2020 B2
10537427 Zeng Jan 2020 B2
10555809 Hastings Feb 2020 B2
10555812 Duffy Feb 2020 B2
10561495 Chambers Feb 2020 B2
10595992 Chambers Mar 2020 B2
10610362 Quadri Apr 2020 B2
10653523 Chambers May 2020 B2
10667905 Ekvall Jun 2020 B2
10667909 Richter Jun 2020 B2
10702379 Garde Jul 2020 B2
10702380 Morriss Jul 2020 B2
10709560 Kofidis Jul 2020 B2
10751169 Chambers Aug 2020 B2
10751170 Richter Aug 2020 B2
10751172 Para Aug 2020 B2
10758265 Siegel Sep 2020 B2
10758342 Chau Sep 2020 B2
10779935 Scorsin Sep 2020 B2
10779936 Pollak Sep 2020 B2
10779968 Giasolli Sep 2020 B2
10786351 Christianson Sep 2020 B2
10828152 Chambers Nov 2020 B2
10856983 Keränen Dec 2020 B2
10869756 Al-Jilaihawi Dec 2020 B2
10874513 Chambers Dec 2020 B2
10945835 Morriss Mar 2021 B2
10973630 Torrianni Apr 2021 B2
10980636 Delaloye Apr 2021 B2
11000000 Diedering May 2021 B2
11007053 Braido May 2021 B2
11007054 Braido May 2021 B2
11013599 Subramanian May 2021 B2
11026782 Chambers Jun 2021 B2
11033275 Franano et al. Jun 2021 B2
11045202 Amplatz Jun 2021 B2
11065113 Backus Jul 2021 B2
11065116 Tegels Jul 2021 B2
11065138 Schreck Jul 2021 B2
11096781 Gurovich Aug 2021 B2
11147666 Braido Oct 2021 B2
11154239 Toth Oct 2021 B2
11154396 Dibie Oct 2021 B2
11154398 Straubinger Oct 2021 B2
11197754 Saffari Dec 2021 B2
11207176 Delaloye Dec 2021 B2
11278399 Liu Mar 2022 B2
11278406 Straubinger Mar 2022 B2
11351028 Peterson Jun 2022 B2
11389293 Torrianni Jul 2022 B2
11395734 Lee Jul 2022 B2
11413141 Morin Aug 2022 B2
11419716 Braido Aug 2022 B2
11452628 Diedering Sep 2022 B2
11458013 Righini Oct 2022 B2
20010005787 Oz Jun 2001 A1
20020072710 Stewart Jun 2002 A1
20020161377 Rabkin Oct 2002 A1
20030057156 Peterson Mar 2003 A1
20030083730 Stinson May 2003 A1
20030199971 Tower Oct 2003 A1
20030225445 Derus Dec 2003 A1
20030233141 Israel Dec 2003 A1
20040073286 Armstrong Apr 2004 A1
20040088041 Stanford May 2004 A1
20040210307 Khairkhahan Oct 2004 A1
20040243107 Macoviak Dec 2004 A1
20050004641 Pappu Jan 2005 A1
20050075727 Wheatley Apr 2005 A1
20050096739 Cao May 2005 A1
20050113861 Corcoran May 2005 A1
20050137622 Griffin Jun 2005 A1
20050197694 Pai Sep 2005 A1
20050273160 Lashinski Dec 2005 A1
20060142847 Shaknovich Jun 2006 A1
20060184226 Austin Aug 2006 A1
20060224183 Freudenthal Oct 2006 A1
20060229708 Powell Oct 2006 A1
20060259134 Schwammenthal et al. Nov 2006 A1
20060271173 Delgado, III Nov 2006 A1
20060276874 Wilson Dec 2006 A1
20070016288 Gurskis Jan 2007 A1
20070173930 Sogard Jul 2007 A1
20070233223 Styrc Oct 2007 A1
20070238979 Huynh Oct 2007 A1
20070239254 Chia Oct 2007 A1
20070239271 Nguyen Oct 2007 A1
20070270931 Leanna Nov 2007 A1
20070275027 Wen et al. Nov 2007 A1
20070293942 Mirzaee Dec 2007 A1
20080039928 Peacock Feb 2008 A1
20080082166 Styrc Apr 2008 A1
20080262592 Jordan Oct 2008 A1
20080269877 Jenson Oct 2008 A1
20080275540 Wen Nov 2008 A1
20080281398 Koss Nov 2008 A1
20080288042 Purdy Nov 2008 A1
20080288055 Paul, Jr. Nov 2008 A1
20090076585 Hendriksen Mar 2009 A1
20090082840 Rusk Mar 2009 A1
20090099640 Weng Apr 2009 A1
20090099647 Glimsdale Apr 2009 A1
20090125096 Chu May 2009 A1
20090143852 Chambers Jun 2009 A1
20090171447 Von Segesser Jul 2009 A1
20090171456 Kveen Jul 2009 A1
20090198315 Boudjemline Aug 2009 A1
20090248134 Dierking Oct 2009 A1
20090248143 Laham Oct 2009 A1
20090270967 Fleming, III Oct 2009 A1
20090276039 Meretei Nov 2009 A1
20090281609 Benichou Nov 2009 A1
20100021726 Jo Jan 2010 A1
20100057192 Celermajer Mar 2010 A1
20100069948 Veznedaroglu Mar 2010 A1
20100168839 Braido Jul 2010 A1
20100174355 Boyle Jul 2010 A1
20100217260 Aramayo Aug 2010 A1
20100217261 Watson Aug 2010 A1
20100217262 Stevenson Aug 2010 A1
20100217263 Tukulj-Popovic Aug 2010 A1
20100217264 Odom Aug 2010 A1
20100217265 Chen Aug 2010 A1
20100217266 Helevirta Aug 2010 A1
20100217267 Bergin Aug 2010 A1
20100217268 Bloebaum Aug 2010 A1
20100217269 Landes Aug 2010 A1
20100256749 Tran Oct 2010 A1
20100262157 Silver Oct 2010 A1
20100262231 Tuval et al. Oct 2010 A1
20110022151 Shin Jan 2011 A1
20110046712 Melsheimer Feb 2011 A1
20110082539 Suri Apr 2011 A1
20110082540 Forster Apr 2011 A1
20110208293 Tabor Aug 2011 A1
20110218585 Krinke et al. Sep 2011 A1
20110251676 Sweeney Oct 2011 A1
20110269051 Wijenberg Nov 2011 A1
20110301702 Rust Dec 2011 A1
20110319988 Schankereli Dec 2011 A1
20110319991 Hariton Dec 2011 A1
20120016468 Robin Jan 2012 A1
20120035719 Forster Feb 2012 A1
20120078356 Fish Mar 2012 A1
20120083875 Johnson Apr 2012 A1
20120095551 Navia Apr 2012 A1
20120101567 Jansen Apr 2012 A1
20120101571 Thambar Apr 2012 A1
20120109079 Asleson May 2012 A1
20120197193 Krolik Aug 2012 A1
20120197390 Alkhatib Aug 2012 A1
20120209375 Madrid Aug 2012 A1
20120226130 De Graff Sep 2012 A1
20120303048 Manasse Nov 2012 A1
20120323313 Seguin Dec 2012 A1
20130023852 Drasler Jan 2013 A1
20130060329 Agnew Mar 2013 A1
20130066419 Gregg Mar 2013 A1
20130079872 Gallagher Mar 2013 A1
20130090728 Solem Apr 2013 A1
20130096671 Iobbi Apr 2013 A1
20130123911 Chalekian May 2013 A1
20130138138 Clark May 2013 A1
20130150956 Yohanan Jun 2013 A1
20130184811 Rowe Jul 2013 A1
20130190861 Chau Jul 2013 A1
20130204311 Kunis Aug 2013 A1
20130204360 Gainor Aug 2013 A1
20130226286 Hargreaves Aug 2013 A1
20130231736 Essinger Sep 2013 A1
20130238089 Lichtenstein Sep 2013 A1
20130274855 Stante Oct 2013 A1
20130297010 Bishop Nov 2013 A1
20130297012 Willard Nov 2013 A1
20130304197 Buchbinder Nov 2013 A1
20130310917 Richter Nov 2013 A1
20130310923 Kheradvar Nov 2013 A1
20130317598 Rowe Nov 2013 A1
20130331933 Alkhatib Dec 2013 A1
20140005768 Thomas Jan 2014 A1
20140005773 Wheatley Jan 2014 A1
20140005778 Buchbinder Jan 2014 A1
20140012371 Li Jan 2014 A1
20140018841 Peiffer Jan 2014 A1
20140018906 Rafiee Jan 2014 A1
20140031928 Murphy Jan 2014 A1
20140031951 Costello Jan 2014 A1
20140039613 Navia Feb 2014 A1
20140046433 Kovalsky Feb 2014 A1
20140046436 Kheradvar Feb 2014 A1
20140052238 Wang Feb 2014 A1
20140052241 Harks Feb 2014 A1
20140057730 Steinhauser Feb 2014 A1
20140057731 Stephens Feb 2014 A1
20140057732 Gilbert Feb 2014 A1
20140057733 Yamamoto Feb 2014 A1
20140057734 Lu Feb 2014 A1
20140057735 Yu Feb 2014 A1
20140057736 Burnett Feb 2014 A1
20140057737 Solheim Feb 2014 A1
20140057738 Albertsen Feb 2014 A1
20140057739 Stites Feb 2014 A1
20140067050 Costello Mar 2014 A1
20140074151 Tischler Mar 2014 A1
20140081308 Wondka Mar 2014 A1
20140081375 Bardill et al. Mar 2014 A1
20140088696 Figulla Mar 2014 A1
20140114340 Zhou Apr 2014 A1
20140128963 Quill May 2014 A1
20140134322 Larsen May 2014 A1
20140135817 Tischler May 2014 A1
20140135907 Gallagher May 2014 A1
20140142612 Li May 2014 A1
20140142680 Laske May 2014 A1
20140142688 Duffy May 2014 A1
20140142691 Pouletty May 2014 A1
20140163668 Rafiee Jun 2014 A1
20140172076 Jonsson Jun 2014 A1
20140172083 Bruchman Jun 2014 A1
20140180397 Gerberding Jun 2014 A1
20140180401 Quill Jun 2014 A1
20140188157 Clark Jul 2014 A1
20140194979 Seguin Jul 2014 A1
20140222140 Schreck Aug 2014 A1
20140228944 Paniagua Aug 2014 A1
20140236288 Lambrecht Aug 2014 A1
20140243954 Shannon Aug 2014 A1
20140243967 Salahieh Aug 2014 A1
20140243969 Venkatasubramanian Aug 2014 A1
20140249564 Daly Sep 2014 A1
20140249621 Eidenschink Sep 2014 A1
20140257467 Lane Sep 2014 A1
20140276395 Wilson Sep 2014 A1
20140277074 Kaplan Sep 2014 A1
20140277119 Akpinar Sep 2014 A1
20140277388 Skemp Sep 2014 A1
20140277389 Braido Sep 2014 A1
20140277408 Folan Sep 2014 A1
20140277411 Börtlein Sep 2014 A1
20140277417 Schraut Sep 2014 A1
20140277422 Ratz Sep 2014 A1
20140277424 Oslund Sep 2014 A1
20140277425 Dakin Sep 2014 A1
20140277426 Dakin Sep 2014 A1
20140288634 Shalev Sep 2014 A1
20140288639 Gainor Sep 2014 A1
20140296909 Heipl Oct 2014 A1
20140296969 Tegels Oct 2014 A1
20140296970 Ekvall Oct 2014 A1
20140296975 Tegels Oct 2014 A1
20140309727 Lamelas Oct 2014 A1
20140330366 Dehdashtian Nov 2014 A1
20140330368 Gloss Nov 2014 A1
20140330369 Matheny Nov 2014 A1
20140330370 Matheny Nov 2014 A1
20140331475 Duffy Nov 2014 A1
20140343665 Straubinger Nov 2014 A1
20140343669 Lane Nov 2014 A1
20140343670 Bakis Nov 2014 A1
20140358224 Tegels Dec 2014 A1
20140371844 Dale Dec 2014 A1
20140379020 Campbell Dec 2014 A1
20150005857 Kern Jan 2015 A1
20150018933 Yang Jan 2015 A1
20150025621 Costello Jan 2015 A1
20150025625 Rylski Jan 2015 A1
20150039081 Costello Feb 2015 A1
20150039083 Rafiee Feb 2015 A1
20150066138 Alexander Mar 2015 A1
20150066141 Braido Mar 2015 A1
20150073548 Matheny Mar 2015 A1
20150088248 Scorsin Mar 2015 A1
20150088251 May-Newman Mar 2015 A1
20150094802 Buchbinder Apr 2015 A1
20150094804 Bonhoeffer Apr 2015 A1
20150112428 Daly Apr 2015 A1
20150112430 Creaven Apr 2015 A1
20150119974 Rothstein Apr 2015 A1
20150119978 Tegels Apr 2015 A1
20150119980 Beith Apr 2015 A1
20150119982 Quill Apr 2015 A1
20150127032 Lentz May 2015 A1
20150127093 Hosmer May 2015 A1
20150127097 Neumann May 2015 A1
20150127100 Braido May 2015 A1
20150134054 Morrissey May 2015 A1
20150142103 Vidlund May 2015 A1
20150142104 Braido May 2015 A1
20150148731 McNamara May 2015 A1
20150150678 Brecker Jun 2015 A1
20150157455 Hoang Jun 2015 A1
20150157458 Thambar Jun 2015 A1
20150173770 Warner Jun 2015 A1
20150173897 Raanani Jun 2015 A1
20150173898 Drasler Jun 2015 A1
20150173899 Braido Jun 2015 A1
20150196300 Tischler Jul 2015 A1
20150196390 Ma Jul 2015 A1
20150196393 Vidlund Jul 2015 A1
20150209140 Bell Jul 2015 A1
20150209143 Duffy Jul 2015 A1
20150223729 Balachandran Aug 2015 A1
20150223820 Olson Aug 2015 A1
20150223934 Vidlund Aug 2015 A1
20150230921 Chau Aug 2015 A1
20150238312 Lashinski Aug 2015 A1
20150238313 Spence Aug 2015 A1
20150257879 Bortlein Sep 2015 A1
20150257880 Bortlein Sep 2015 A1
20150257881 Bortlein Sep 2015 A1
20150257882 Bortlein Sep 2015 A1
20150265402 Centola Sep 2015 A1
20150265404 Rankin Sep 2015 A1
20150272730 Melnick Oct 2015 A1
20150272731 Racchini Oct 2015 A1
20150272738 Sievers Oct 2015 A1
20150282931 Brunnett Oct 2015 A1
20150282958 Centola Oct 2015 A1
20150289972 Yang Oct 2015 A1
20150289974 Matheny Oct 2015 A1
20150289977 Kovalsky Oct 2015 A1
20150290007 Aggerholm Oct 2015 A1
20150297346 Duffy Oct 2015 A1
20150297381 Essinger Oct 2015 A1
20150305860 Wang Oct 2015 A1
20150305861 Annest Oct 2015 A1
20150313710 Eberhardt Nov 2015 A1
20150313712 Carpentier Nov 2015 A1
20150320552 Letac Nov 2015 A1
20150320556 Levi Nov 2015 A1
20150327995 Morin Nov 2015 A1
20150327996 Fahim Nov 2015 A1
20150327999 Board Nov 2015 A1
20150328000 Ratz et al. Nov 2015 A1
20150335422 Straka Nov 2015 A1
20150342718 Weber Dec 2015 A1
20150342734 Braido Dec 2015 A1
20150351735 Keranen Dec 2015 A1
20150351904 Cooper Dec 2015 A1
20150351905 Benson Dec 2015 A1
20150359628 Keranen Dec 2015 A1
20150359629 Ganesan Dec 2015 A1
20150366665 Lombardi Dec 2015 A1
20150366667 Bailey Dec 2015 A1
20150366690 Lumauig Dec 2015 A1
20150374490 Alkhatib Dec 2015 A1
20150374906 Forsell Dec 2015 A1
20160000559 Chen Jan 2016 A1
20160000562 Siegel Jan 2016 A1
20160008128 Squara Jan 2016 A1
20160008131 Christianson Jan 2016 A1
20160015512 Zhang Jan 2016 A1
20160015515 Lashinski Jan 2016 A1
20160022417 Karapetian Jan 2016 A1
20160022418 Salahieh Jan 2016 A1
20160030165 Mitra Feb 2016 A1
20160030168 Spenser Feb 2016 A1
20160030169 Shahriari Feb 2016 A1
20160030170 Alkhatib Feb 2016 A1
20160030171 Quijano Feb 2016 A1
20160030173 Cai Feb 2016 A1
20160030175 Madjarov Feb 2016 A1
20160038283 Divekar Feb 2016 A1
20160045306 Agrawal Feb 2016 A1
20160045308 Macoviak Feb 2016 A1
20160045309 Valdez Feb 2016 A1
20160045310 Alkhatib Feb 2016 A1
20160045311 McCann Feb 2016 A1
20160051358 Sutton Feb 2016 A1
20160051362 Cooper Feb 2016 A1
20160051364 Cunningham Feb 2016 A1
20160066922 Bridgeman Mar 2016 A1
20160067038 Park Mar 2016 A1
20160067041 Alkhatib Mar 2016 A1
20160074161 Bennett Mar 2016 A1
20160074164 Naor Mar 2016 A1
20160074165 Spence Mar 2016 A1
20160081799 Leo Mar 2016 A1
20160089234 Gifford, III Mar 2016 A1
20160089235 Yellin Mar 2016 A1
20160089236 Kovalsky Mar 2016 A1
20160095700 Righini Apr 2016 A1
20160095701 Dale Apr 2016 A1
20160095702 Gainor Apr 2016 A1
20160095703 Thomas Apr 2016 A1
20160095704 Whitman Apr 2016 A1
20160100844 Li Apr 2016 A1
20160100939 Armstrong Apr 2016 A1
20160100941 Czyscon Apr 2016 A1
20160100942 Morrissey Apr 2016 A1
20160106539 Buchbinder Apr 2016 A1
20160113764 Sheahan Apr 2016 A1
20160113766 Ganesan Apr 2016 A1
20160113767 Miller Apr 2016 A1
20160113768 Ganesan Apr 2016 A1
20160120642 Shaolian May 2016 A1
20160120643 Kupumbati May 2016 A1
20160120646 Dwork May 2016 A1
20160135951 Salahieh May 2016 A1
20160136412 McKinnon May 2016 A1
20160143730 Kheradvar May 2016 A1
20160143731 Backus May 2016 A1
20160143734 Shaolian May 2016 A1
20160151155 Lutter Jun 2016 A1
20160157998 Bruchman Jun 2016 A1
20160157999 Lane Jun 2016 A1
20160158001 Wallace Jun 2016 A1
20160158004 Kumar Jun 2016 A1
20160158007 Centola Jun 2016 A1
20160158011 De Canniere Jun 2016 A1
20160158013 Carpentier Jun 2016 A1
20160166381 Sugimoto Jun 2016 A1
20160166382 Nguyen Jun 2016 A1
20160166384 Olson Jun 2016 A1
20160175096 Dienno Jun 2016 A1
20160193044 Achiluzzi Jul 2016 A1
20160193045 Pollak Jul 2016 A1
20160193047 Delaloye Jul 2016 A1
20160199177 Spence Jul 2016 A1
20160199178 Venkatasubramanian Jul 2016 A1
20160199180 Zeng Jul 2016 A1
20160199182 Gorman, III Jul 2016 A1
20160213470 Ahlberg Jul 2016 A1
20160220363 Peter Aug 2016 A1
20160235525 Rothstein Aug 2016 A1
20160235530 Thomas Aug 2016 A1
20160235531 Ciobanu Aug 2016 A1
20160250022 Braido Sep 2016 A1
20160250051 Lim Sep 2016 A1
20160256168 Nielsen Sep 2016 A1
20160256270 Folan Sep 2016 A1
20160262884 Lombardi Sep 2016 A1
20160270910 Birmingham Sep 2016 A1
20160270911 Ganesan Sep 2016 A1
20160278922 Braido Sep 2016 A1
20160296323 Wulfman Oct 2016 A1
20160296333 Balachandran Oct 2016 A1
20160302920 Al-Jilaihawi Oct 2016 A1
20160302921 Gosal Oct 2016 A1
20160302922 Keidar Oct 2016 A1
20160310268 Oba Oct 2016 A1
20160324640 Gifford, III Nov 2016 A1
20160331529 Marchand Nov 2016 A1
20160346081 Zeng Dec 2016 A1
20160354203 Tuval et al. Dec 2016 A1
20160361161 Braido Dec 2016 A1
20160374790 Jacinto Dec 2016 A1
20160374801 Jimenez Dec 2016 A1
20160374802 Levi Dec 2016 A1
20160374803 Figulla Dec 2016 A1
20160374842 Havel Dec 2016 A1
20170079781 Lim Mar 2017 A1
20170079785 Li Mar 2017 A1
20170079787 Benson Mar 2017 A1
20170079790 Vidlund Mar 2017 A1
20170086973 Zeng Mar 2017 A1
20170095256 Lindgren Apr 2017 A1
20170100241 Modine Apr 2017 A1
20170105839 Subramanian Apr 2017 A1
20170165066 Rothstein Jun 2017 A1
20170172737 Kuetting Jun 2017 A1
20170202525 Piazza Jul 2017 A1
20170231761 Cohen-Tzemach et al. Aug 2017 A1
20170252191 Pacetti Sep 2017 A1
20170281193 Asirvatham Oct 2017 A1
20170348098 Rowe Dec 2017 A1
20170360570 Berndt et al. Dec 2017 A1
20180014830 Neumann Jan 2018 A1
20180049873 Manash et al. Feb 2018 A1
20180055629 Oba et al. Mar 2018 A1
20180092744 Von Oepen Apr 2018 A1
20180110622 Gregg et al. Apr 2018 A1
20180116843 Schreck May 2018 A1
20180116848 McHugo May 2018 A1
20180133012 Nathe May 2018 A1
20180185184 Christakis Jul 2018 A1
20180193153 Brenzel et al. Jul 2018 A1
20180206983 Noe Jul 2018 A1
20180256329 Chambers Sep 2018 A1
20180296335 Miyashiro Oct 2018 A1
20180311039 Cohen Nov 2018 A1
20180325664 Gonda Nov 2018 A1
20180333102 De Haan et al. Nov 2018 A1
20180360602 Kumar Dec 2018 A1
20180369006 Zhang Dec 2018 A1
20190053898 Maimon et al. Feb 2019 A1
20190099265 Braido Apr 2019 A1
20190105088 Peterson et al. Apr 2019 A1
20190151067 Zucker May 2019 A1
20190201192 Kruse Jul 2019 A1
20190224028 Finn Jul 2019 A1
20190247189 Dale Aug 2019 A1
20190247190 Nathe Aug 2019 A1
20190321530 Cambronne Oct 2019 A1
20190321531 Cambronne Oct 2019 A1
20190365534 Kramer Dec 2019 A1
20190365538 Chambers Dec 2019 A1
20200000592 Lee Jan 2020 A1
20200030088 Vidlund Jan 2020 A1
20200030507 Higgins Jan 2020 A1
20200069423 Peterson Mar 2020 A1
20200069449 Diedering Mar 2020 A1
20200100897 McLean Apr 2020 A1
20200113682 Chang Apr 2020 A1
20200113719 Desrosiers Apr 2020 A1
20200129294 Hariton Apr 2020 A1
20200155306 Bonyuet May 2020 A1
20200163765 Christianson May 2020 A1
20200179111 Vidlund Jun 2020 A1
20200179115 Chambers Jun 2020 A1
20200188101 Chambers Jun 2020 A1
20200222179 Chambers Jul 2020 A1
20200253733 Subramanian Aug 2020 A1
20200261219 Kumar Aug 2020 A1
20200276013 Chambers Sep 2020 A1
20200315678 Mazzio et al. Oct 2020 A1
20200337765 Smith Oct 2020 A1
20200368023 Kheradvar Nov 2020 A1
20200375733 Diedering Dec 2020 A1
20210236274 Benson Aug 2021 A1
20210236276 Diedering Aug 2021 A1
20210275297 Berndt Sep 2021 A1
20210275301 Kumar Sep 2021 A1
20210290383 Chambers Sep 2021 A1
20220031451 Spence Feb 2022 A1
20220338979 Benichou Oct 2022 A1
20230218397 Chambers et al. Jul 2023 A1
20230372089 Kumar Nov 2023 A1
20240138976 Berndt et al. May 2024 A1
Foreign Referenced Citations (53)
Number Date Country
2014203064 Jun 2015 AU
2015230879 Oct 2015 AU
2013201970 Mar 2016 AU
2820130 Sep 2006 CN
100413471 Aug 2008 CN
100444811 Dec 2008 CN
101953723 Jan 2011 CN
101953724 Jan 2011 CN
101953725 Jan 2011 CN
101953728 Jan 2011 CN
101953729 Jan 2011 CN
101961269 Feb 2011 CN
101961273 Feb 2011 CN
102036622 Apr 2011 CN
201870772 Jun 2011 CN
203290964 Nov 2013 CN
103431931 Dec 2013 CN
203379235 Jan 2014 CN
103598939 Feb 2014 CN
103610520 Mar 2014 CN
203619728 Jun 2014 CN
203677318 Jul 2014 CN
104287804 Jan 2015 CN
104352261 Feb 2015 CN
204133530 Feb 2015 CN
204181679 Mar 2015 CN
204246182 Apr 2015 CN
204318826 May 2015 CN
104688292 Jun 2015 CN
102985033 Aug 2015 CN
204581598 Aug 2015 CN
204581599 Aug 2015 CN
204683686 Oct 2015 CN
105596052 May 2016 CN
105615936 Jun 2016 CN
205286438 Jun 2016 CN
108348270 Jul 2018 CN
107252363 Apr 2020 CN
106913909 Sep 2020 CN
107007887 Oct 2020 CN
102010021345 Nov 2011 DE
2596754 May 2013 EP
2967858 Jan 2016 EP
2982336 Feb 2016 EP
2967845 Aug 2018 EP
2950752 Jul 2022 EP
2016531722 Oct 2016 JP
WO1995016476 Jun 1995 WO
WO2009127973 Oct 2009 WO
WO2014210299 Dec 2014 WO
WO2015004173 Jan 2015 WO
WO2016100806 Jun 2016 WO
WO2019006387 Jan 2019 WO
Non-Patent Literature Citations (9)
Entry
International Search Report and Written Opinion issued in PCT/US2021/15623, mailed Apr. 20, 2021.
The AltaValve™. Attributes, Challenges, and Future Programs, Dr. Philippe Genereux, MD, Jun. 22, 2018.
4C Medical' s AltaValve: The First-in-Human Experience, Joep Rodes-Cabau, MD, Sep. 21, 2018.
Ferreira-Neto et al., “Transcatheter Mitral Valve Replacement With a New Supra-Annular Valve-First-in-Human Experience with the AltaValve System,” https://doi.org/10.1016/j.jcin.2018.10.056, by the American College of Cardiology Foundation Published by Elsevier, Jan. 28, 2019.
Goel et al., “Transcatheter Mitral Valve Therapy with Novel Supra-Annular AltaValve,” https://doi.org/10.1016/j.jaccas.2019.10.034, Published by Elsevier on behalf of the American College of Cardiology Foundation, Dec. 18, 2019.
Hatamifar et al., “MRI Evaluation of an Atrial-Anchored Transcatheter Mitral Valve Replacement Implant,” https://www.ajronline.org/doi/10.2214/AJR.19.22206 American Roentgen Ray Society, Jan. 15, 2020.
Alperi et al., “Device profile of the AltaValve System for Transcatheter Mitral Valve Replacement: Overview of its safety and Efficacy,” https://doi.org/10.1080/17434440.2020.1781616, Informa UK Limited, Jun. 25, 2020.
Extended European Search Report in Application No. 21748274.4, Jan. 22, 2024.
Taiwanese Office Action received in Application No. 110103581, Aug. 7, 2024.
Related Publications (1)
Number Date Country
20210236274 A1 Aug 2021 US
Provisional Applications (1)
Number Date Country
62968220 Jan 2020 US