Abstract
The disclosure provides systems and related methods for delivering a prosthesis to a target location. Various embodiments of useful valve prostheses are also disclosed.
Claims
1. A valve prosthesis, comprising a generally tubular body adapted for placement proximate a mitral annulus, the tubular body having: a) a generally tubular upper portion adapted to substantially reside in the left atrium above the mitral annulus, the generally tubular upper portion having a first circumferential wall that is outwardly biased to urge against cardiac tissue of the left atrium; b) a lower portion extending downwardly from the generally tubular upper portion, the lower portion being configured to substantially reside in the left ventricle below the mitral annulus, the lower portion being defined by an generally circumferential wall that extends downwardly from the generally tubular upper portion, the generally circumferential wall having a first circumferential end and a second circumferential end defining a circumferential extent therebetween, the generally circumferential wall extending along a posterior portion of the left ventricle, the first and second circumferential ends of the generally circumferential wall defining a circumferential gap therebetween, the circumferential gap being of sufficient circumferential extent to substantially prevent the prosthesis from interfering with the opening and closing of a native anterior mitral valve leaflet; and c) at least one prosthetic valve leaflet disposed within the tubular body, the at least one prosthetic valve leaflet being configured to occupy at least a portion of an opening defined by the generally tubular upper portion and the lower portion.
2. The valve prosthesis of claim 1, wherein the at least one prosthetic valve leaflet includes at least one posterior prosthetic valve leaflet disposed proximate a posterior region of the prosthesis, the at least one posterior prosthetic valve leaflet being configured to coapt with the native anterior mitral valve leaflet to close the mitral valve opening.
3. The valve prosthesis of claim 2, wherein the at least one posterior prosthetic valve leaflet includes a plurality of prosthetic leaflets.
4. The valve prosthesis of claim 3, wherein the plurality of prosthetic leaflets are joined to each other to form a row of leaflets along a posterior portion of the valve prosthesis.
5. The valve prosthesis of claim 2, wherein the at least one posterior prosthetic valve leaflet is substantially fixed.
6. The valve prosthesis of claim 2, wherein the at least one posterior prosthetic valve leaflet is substantially movable.
7. The valve prosthesis of claim 1, wherein the at least one prosthetic valve leaflet includes biological cells residing on the prosthetic material.
8. The valve prosthesis of claim 1, wherein the at least one prosthetic valve leaflet includes fabric.
9. The valve prosthesis of claim 1, wherein the fabric includes at least one of expanded PTFE, Dacron® polyester, and pericardium tissue.
10. The valve prosthesis of claim 1, wherein the at least one prosthetic valve leaflet is substantially formed from living tissue.
11. The valve prosthesis of claim 1, wherein the circumferential extent of the generally circumferential wall of the lower portion is between about 90 degrees and about 270 degrees.
12. The valve prosthesis of claim 1, wherein the circumferential extent of the generally circumferential wall of the lower portion is between about 120 degrees and about 240 degrees.
13. The valve prosthesis of claim 1, wherein the circumferential extent of the generally circumferential wall of the lower portion is between about 150 degrees and about 210 degrees.
14. The valve prosthesis of claim 1, wherein the circumferential extent of the generally circumferential wall of the lower portion is about 180 degrees.
15. The valve prosthesis of claim 1, wherein the circumferential extent of the generally circumferential wall of the lower portion is configured to reside substantially between the commissures of the mitral valve along a posterior extent of the left ventricle.
16. The valve prosthesis of claim 1, wherein the prosthesis forms an open channel in the mitral annulus, and further wherein the at least one prosthetic valve leaflet is provided in a separate mechanism.
17. The valve prosthesis of claim 1, further comprising at least one transverse support extending from a first lateral portion of the prosthesis to an opposing, second lateral portion of the prosthesis to prevent prolapse of an anterior native leaflet during systole.
18. The valve prosthesis of claim 17, wherein the at least transverse support includes at least one of Dacron® polyester material, expanded PTFE and pericardium tissue.
19. The valve prosthesis of claim 1, further comprising at least one circumferential inflatable bladder disposed along a portion of the generally circumferential wall of the lower portion, the bladder being configured to inflate outwardly from the generally circumferential wall of the lower portion and against a surface of the left ventricle to prevent flow around the outside of the valve prosthesis.
20. The valve prosthesis of claim 1, further comprising at least one circumferential inflatable bladder disposed within a portion of the generally circumferential wall of the lower portion, the inflatable bladder being configured to inflate outwardly to cause the generally circumferential wall of the lower portion to urge against an inner surface of the left ventricle to prevent flow around an outer portion of the valve prosthesis.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] The foregoing and other objects, aspects, features, and advantages of exemplary embodiments will become more apparent and may be better understood by referring to the following description taken in conjunction with the accompanying drawings, in which:
[0027] FIGS. 1A-1B are front and rear views, respectively, of an exemplary Intercommissural Prosthesis (“IP”) system (for replacement of posterior leaflet) in an expanded configuration.
[0028] FIGS. 2A-2B are front and rear views, respectively, of the underlying framework of an exemplary intercommissural prosthesis system (for replacement of posterior leaflet) in an expanded configuration.
[0029] FIGS. 3A-3D are front, back, side and further back view with intercommisural wings in a closed position of an exemplary IP.
[0030] FIGS. 4A-4B illustrate an exemplary prosthesis in an expanded configuration with a variation of subvalvular multiple inversion anchor(s)/wing(s).
[0031] FIGS. 5A-5C illustrate an exemplary intercommissural prosthesis (“IP”) mounted on a delivery system in a partially expanded condition wherein sub-annular wings are held in an undeployed condition by a tether (FIGS. 5A, 5B) and in a fully expanded condition after the tether is removed (FIG. 5C).
[0032] FIGS. 6A-6D illustrate an exemplary prostheses in partially expanded configurations (FIGS. 6A, 6C) with a tether holding retainers/anchors/wings in an undeployed condition and in a fully expanded configuration wherein the tethers are removed and the retainers/anchors/wings are deployed to hold the prosthesis in place.
[0033] FIGS. 7A-7B illustrate aspects of an exemplary Intercommissural Prosthesis Delivery System (IPDS), ready to be delivered to site with compressed prosthesis mounted therein (FIG. 7A) and ready to attached a prosthesis to be loaded into the delivery system (FIG. 7B).
[0034] FIGS. 8A-8B illustrate an exemplary IPDS with IP mounted thereon advanced to a native mitral site ready to be deployed with the sheath withdrawn to reveal a collapsed undeployed IP, wherein FIG. 8A illustrates a transapical approach and FIG. 8B illustrates a Left Atrial percutaneous approach.
[0035] FIGS. 9A-9B illustrate a further sequence in deployment of the IPDS's illustrated in FIGS. 8A-8B, wherein the intercommissural self-alignment supra-annular frame is expanded by moving the distal delivery control rod with respect to the proximal delivery control rod, wherein FIG. 9A illustrates the transapical approach and FIG. 9B illustrates the Left Atrial approach.
[0036] FIGS. 10A-10B illustrate an exemplary IP in an expanded condition after delivery to a native posterior mitral site, wherein FIG. 10A is a top view showing relative location of the anterior mitral valve leaflet, and FIG. 10B presents a post necropsy view.
[0037] FIGS. 11A-11B illustrate an exemplary Intercommissural Prosthesis (“IP”) in expanded position and placed in a mitral annulus, wherein FIG. 11A illustrates relative positioning of the native anterior leaflet in an open condition, and wherein FIG. 11B illustrates the anterior leaflet is a closed condition against the prosthesis.
[0038] FIG. 12A illustrates an exemplary Intercommissural Prosthesis (“IP”) in an expanded condition with an adjustable drape, and an on demand feature for facilitating rail fixation, expandable wings, and a screw anchor attached to the adjustable drape.
[0039] FIG. 12B illustrates a back view of an exemplary IP configured to be delivered by rail fixation with eyelets for rail fixation, an inter commissural eyelet, a main frame central eyelet, and a sub-annular base eyelet.
[0040] FIG. 13A illustrates an exemplary IPDS advanced to a native mitral site via a transapical approach (side view).
[0041] FIG. 13B illustrates the IPDS of FIG. 13A after implantation. ***
[0042] FIG. 14A illustrates an exemplary full replacement prosthesis system in accordance with the disclosure, side view.
[0043] FIG. 14B illustrates an exemplary full replacement prosthesis system in accordance with the disclosure, front view.
[0044] FIG. 14C illustrates an exemplary full replacement prosthesis system in accordance with the disclosure, further side view.
[0045] FIG. 15A illustrates an exemplary full replacement prosthesis system in accordance with the disclosure.
[0046] FIG. 15B illustrates a further exemplary full replacement prosthesis system in accordance with the disclosure.
DETAILED DESCRIPTION
[0047] Reference will now be made in detail to the present preferred embodiments of the disclosure, examples of which are illustrated in the accompanying drawings. The method and corresponding steps of the disclosed embodiments will be described in conjunction with the detailed description of the system.
[0048] Exemplary embodiments provide systems, devices and methods for repairing or replacing elements of the mitral valve. Exemplary elements of the valve prosthesis include the device frame, prosthetic posterior mitral leaflet equivalent and elements to prevent or reduce abnormal prolapse of the native anterior mitral leaflet during systole, as well a full mitral replacement prosthesis. Exemplary methods of implanting the valve prosthesis include direct open surgical placement, minimally invasive surgical placement either with or without the use of cardiopulmonary bypass, and totally catheter based implantation. Exemplary methods for maintaining the valve prosthesis in the preferred mitral annular location include external compression, compression following percutaneous deliver, or rail or suture guided implantation and seating with subsequent active or passive fixation of the valve prosthesis based upon the rail or suture guides.
[0049] In some implementations, the disclosure provides a partial valvular prosthesis for implantation over a native mitral valve. The prosthesis includes a main circumferential frame having a supra annular frame portion for resting above the mitral annulus over a native posterior mitral leaflet and a sub annular frame portion for extending downwardly into a native left ventricle. The main circumferential frame is preferably substantially covered by a curved membrane. The prosthesis also includes at least one deployable anchor attached to the main circumferential frame, the deployable anchor having a body formed from a wire material including at least one stress coil having at least one turn, the at least one stress coil being configured to urge the anchor outwardly to help hold the prosthesis in place upon deployment into a native mitral location.
[0050] For purposes of illustration, and not limitation, embodiments of a partial prosthesis and aspects thereof are illustrated in the embodiments of FIGS. 1-13. Aspects of a full prosthesis are illustrated in FIGS. 14-15. As used herein, the last two digits of a reference number correspond to similar elements in the Figures. For example, element “108” in FIG. 1 is similar to element 208 in FIG. 2.
[0051] FIGS. 1A-1B are front and rear views, respectively, of an exemplary Intercommissural Prosthesis (“IP”) system (for replacement of posterior leaflet) in an expanded configuration. In FIGS. 1A-1B, 102 refers to coaptation depth-supra-annular portion, 104 refers to intercommissural self-alignment expansion fixation, 106 refers to frame depth in LV-sub-annular portion, 108 refers to counter fixation wings-supra-annular portion, 110 refers to anchor-free fixation, intercommissural-sub-annular portion, 112 refers to porcine pericardial tissue membrane, 114 refers to main saddle-shaped frame, 116 refers to the base of the sub-annular portion and attachment mechanism point/location for delivery, 118 refers to attachment mechanism point/location for delivery, 120 refers to subvalvular inversion wing(s)/anchors/retainers which are spring loaded and configured to urge outwardly and upwardly against the mitral annulus and/or ventricular walls, 122 refers to tissue drape attached to the back of 114, which can act to control paravalvular leaks. The prosthesis is illustrated including a membrane, in this case, a porcine tissue membrane as set forth above.
[0052] By way of further illustration, FIGS. 2A-2B are front and rear views, respectively, of the underlying framework of an exemplary intercommissural prosthesis system (for replacement of posterior leaflet) in an expanded configuration. Accordingly, 224 refers to a commissure expanded loop portion to allow for better positioning and coaptation to native anterior leaflet. As is evident from the figure, the frame if principally formed by two loops that overlap along their extent except for the lateral expanded loop portions, thereby defining crescent shaped lateral framework structures on the prosthesis. Also illustrated are eyelets/coils 226 (or stress coils or loops), which are formed into various portions of the prosthesis to minimize stress and to optionally provide guide eyelets for rail fixation techniques. Such coils can be provided with a plurality of turns, thereby permitting the sub-annular anchors to be retracted by a tether, as illustrated herein. Anchors/retainers above and below the mitral annulus can be formed from the same segment of wire, if desired, and include one or more stress loops (stress distribution loops) formed therein. The stress distribution loops distribute stress across the wire, which can be particularly useful in the case of NiTi materials, as such materials can be brittle and prone to fracture when bent excessively.
[0053] FIGS. 3A-3D are front, back, side and further back view with intercommisural wings in a closed position of an exemplary IP. This embodiment differs from the embodiment of FIGS. 1-2 in that the base of the sub-annular portion and attachment mechanism point/location for delivery 316 and the subvalvular inversion wing(s)/anchors/retainers 320 are combined, resulting in the plane of the membrane of the prosthesis being fully pulled back and brought back and under the mitral annulus.
[0054] FIGS. 4A-4B illustrate an exemplary prosthesis in an expanded configuration with a variation of subvalvular multiple inversion anchor(s)/wing(s). In FIG. 4A, 430 refers to a first arrangement of subvalvular multiple inversion wings. In FIG. 4B, 432 refers to a second arrangement of subvalvular multiple inversion anchors/wings. As will be appreciated, any desired suitable number of deployable anchors/wings can be used.
[0055] FIGS. 5A-5C illustrate an exemplary intercommissural prosthesis (“IP”) mounted on a delivery system in a partially expanded condition wherein sub-annular wings are held in an undeployed condition by a tether (FIGS. 5A, 5B) and in a fully expanded condition after the tether is removed (FIG. 5C). Accordingly, 532 refers to the illustrated variation of subvalvular multiple inversion anchor(s)/wing(s), 522 refers to a drape, 524 refers to the commissure expanded loop to allow for better positioning and coaptation to the native anterior leaflet, the tissue drape 522 is attached to the back of a redundancy feature to control paravalvular leaks, 536 refers to the eyelet/coil placed along the prosthesis to minimize stresses in the frame, 538 refers to the delivery system distal end, 540 refers to supra-annular expansion loops, 542 refers to the tether, which holds the sub-annular wings/anchors 532 closed allowing simplified loading, individual repositioning and final deployment.
[0056] FIGS. 6A-6D illustrate an exemplary prostheses in partially expanded configurations (FIGS. 6A, 6C) with a tether holding retainers/anchors/wings in an undeployed condition and in a fully expanded configuration wherein the tethers are removed and the retainers/anchors/wings are deployed to hold the prosthesis in place. Specifically, 644 refers to a variation of intercommissural fixation sub-annular, 646 refers to variation of intercommissural fixation sub-annular, 612 refers to porcine pericardial tissue membrane, 614 refers to the main saddle-shaped frame, 616 refers to the base of the sub-annular and attachment mechanism for delivery, 648 refers to a variation of subvalvular inversion anchor(s)/wing(s), 650 refers to a variation of subvalvular inversion anchor(s)/wing(s), 622 refers to a drape, and 642 refers to a tether.
[0057] FIGS. 7A-7B illustrate aspects of an exemplary Intercommissural Prosthesis Delivery System (IPDS) 752, ready to be delivered to site with compressed prosthesis mounted therein (FIG. 7A) and ready to attached a prosthesis to be loaded into the delivery system (FIG. 7B). Accordingly, 754 refers to a back end mechanism for holding the tether, 756 refers to a second shaft back and front end with an injection port and attachment mechanism to the prosthesis, 758 refers to a first shaft back and front end with injection port and attachment mechanism to prosthesis, 760 refers to a third shaft back and with soft front end, 762 refers to a main Catheter, 764 refers to a main hemostasis hub with injection port, and 766 refers to a guidewire access.
[0058] FIGS. 8A-8B illustrate an exemplary IPDS with IP mounted thereon advanced to a native mitral site ready to be deployed with the sheath withdrawn to reveal a collapsed undeployed IP, wherein FIG. 8A illustrates a transapical approach and FIG. 8B illustrates a Left Atrial percutaneous approach. In FIGS. 8, 868 and 870 refer to native mitral valve commissures, 872 refers to a native anterior leaflet, 874 refers to a native posterior leaflet, 876 refers to a collapsed prosthesis in position for transapical access, 878 refers to a second shaft front end, and 880 refers to a first shaft front end.
[0059] FIGS. 9A-9B illustrate a further sequence in deployment of the IPDS's illustrated in FIGS. 8A-8B, wherein the intercommissural self-alignment supra-annular frame is expanded by moving the distal delivery control rod with respect to the proximal delivery control rod, wherein FIG. 9A illustrates the transapical approach and FIG. 9B illustrates the Left Atrial approach, wherein 968 and 970 refer to native mitral valve commissures, 978 refers to the second shaft being released, and 980 refers to the first shaft front end.
[0060] FIGS. 10A-10B illustrate an exemplary IP in an expanded condition after delivery to a native posterior mitral site, wherein FIG. 10A is a top view showing relative location of the anterior mitral valve leaflet, and FIG. 10B presents a post necropsy view, wherein 1068 and 1070 refer to native mitral valve commissures, 1072 refers to the native anterior leaflet, 1074 refers to the native posterior leaflet, and 1082 refers to an exemplary partial replacement (posterior only) prosthesis deployed.
[0061] FIGS. 11A-11B illustrate an exemplary Intercommissural Prosthesis (“IP”) in expanded position and placed in a mitral annulus, wherein FIG. 11A illustrates relative positioning of the native anterior leaflet 1172 in an open condition, and wherein FIG. 11B illustrates the anterior leaflet 1172 is a closed condition against the prosthesis, wherein 1184 refers to a partial replacement (posterior only) prosthesis deployed.
[0062] FIG. 12A illustrates an exemplary Intercommissural Prosthesis (“IP”) in an expanded condition with an adjustable drape, and an on demand feature for facilitating rail fixation, expandable wings, and a screw anchor attached to the adjustable drape. Specifically, FIG. 12A illustrating an exemplary Intercommissural Prosthesis System in an expanded position with adjustable drape 1288, and an “on demand” version of rail fixation 1286, expandable wings 1286-1, screw anchor 1286-2, attachment of the on demand fixation to the adjustable drape. FIG. 12B illustrates an exemplary prosthesis system in an expanded state with eyelets for rail fixation, inter commissural eyelet 1290, main frame center eyelet 1292, and sub-annular base eyelet 1294.
[0063] FIG. 13A illustrates an exemplary IPDS advanced to a native mitral site via a transapical approach (side view) and FIG. 13B illustrates the IPDS of FIG. 13A after implantation. Both prosthesis and on demand fixation 1388 are delivered to the site at the same time in this embodiment. While the base 1380 of prosthesis, and on demand fixation 1388, are held and ready to be deployed, the prosthesis main frame supra annular is deployed and self aligned to the commissures 1368 and 1370. Then, the on demand fixation 1388 is placed to the LV wall and/or posterior sub-annulus. After confirming the essential signs (e.g., under fluoroscopy) the prosthesis base is released. Prior to full release the system can be retrieved. While sutures can be used to hold devices depicted herein in place, this is not necessary. Also, while implantation using surgical techniques with a bypass machine are possible, it is preferred to deliver and implant the prosthesis and adjust its positioning while the heart is still beating under visualization (e.g., fluoroscopy) to ensure acceptable coaptation between the native anterior leaflet and the prosthesis.
[0064] FIG. 14A illustrates an exemplary full replacement prosthesis system in accordance with the disclosure, side view. FIG. 14B illustrates an exemplary full replacement prosthesis system in accordance with the disclosure, front view. FIG. 14C illustrates an exemplary full replacement prosthesis system in accordance with the disclosure, further side view. Both sub-annular loops 1497 and supra-annular loops 1491 and 1493 are used for attaching the full tissue valve and support of the full prosthesis to mitral valve annulus. FIG. 14A-14C illustrate a version of the on-demand anchors 1499, in that the prosthesis and the on demand anchors are delivered to the site. In FIGS. 14A-14C, 1495 refers to the sub-annular base. After full deployment of the prosthesis the on demand anchors 1499 are deployed. The system can be used for both Transapical and Left Atrium approaches. It will be appreciated that all variations of rail fixation from this application and others incorporated by reference herein can be used to deliver the illustrated full prosthesis as well to fixate the prosthesis.
[0065] FIG. 15A illustrates an exemplary full replacement prosthesis system in accordance with the disclosure. FIG. 15b illustrates a further exemplary full replacement prosthesis system in accordance with the disclosure. It will be appreciated that the embodiment of FIG. 15B can utilize the delivery system illustrated in FIGS. 7A and 7B. The system can be deployed both by transapical and Left Atrium approaches, in that the prosthesis is inverted for one approach versus the other by attaching the prosthesis to the opposing control rods. This prosthesis is also repositionable and retrievable prior to full release.
[0066] All statements herein reciting principles, aspects, and embodiments of the invention, as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents as well as equivalents developed in the future, i.e., any elements developed that perform the same function, regardless of structure.
[0067] The methods and systems of the present disclosure, as described above and shown in the drawings, provide for improved techniques for treating mitral valves of patients. It will be apparent to those skilled in the art that various modifications and variations can be made in the devices, methods and systems of the present disclosure without departing from the spirit or scope of the disclosure. Thus, it is intended that the present disclosure include modifications and variations that are within the scope of the subject disclosure and equivalents.
