US20200276013A1 - Systems, methods and devices for delivery systems, methods and devices for implanting prosthetic heart valves - Google Patents

Abstract

Embodiments of delivery systems, devices and methods for delivering a prosthetic heart valve device to a heart chamber for expanded implementation are disclosed. More specifically, methods, systems and devices are disclosed for delivering a self-expanding prosthetic mitral valve device to the left atrium, with no engagement of the left ventricle, the native mitral valve leaflets or the annular tissue downstream of the upper annular surface during delivery, and in some embodiments with no engagement of the ventricle, mitral valve leaflets and/or annular tissue located downstream of the upper annular surface by the delivered, positioned and expanded prosthetic mitral valve device.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application is a continuation of U.S. patent application Ser. No. 15/874,376, filed Jan. 18, 2018 and entitled SYSTEMS, METHODS AND DEVICES FOR DELIVERY SYSTEMS, METHODS AND DEVICES FOR IMPLANTING PROSTHETIC HEART VALVES and also claims the benefit of U.S. Provisional Ser. No. 62/448,036, filed Jan. 19, 2017 and entitled SYSTEMS, METHODS AND DEVICES FOR DELIVERY SYSTEMS, METHODS AND DEVICES FOR IMPLANTING PROSTHETIC HEART VALVES, the entirety of which is hereby incorporated by reference.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
• Not Applicable
INCORPORATION BY REFERENCE
• All references, including but not limited to publications, patent applications and patents mentioned in this specification are hereby incorporated by reference to the same extent and with the same effect as if each reference was specifically and individually indicated to be incorporated by reference.
FIELD OF THE INVENTION
• The inventions described herein relate to delivery systems, devices and methods for delivering and/or positioning a cardiac valve.
BACKGROUND OF THE INVENTION
• 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 left ventricle. The four heart valves include the mitral valve, the tricuspid valve, the aortic valve and the pulmonary valve.
• 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. 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.
• Native heart valves may be, or become, dysfunctional for a variety of reasons and/or conditions including but not limited to disease, trauma, congenital malformations, and aging. These types of conditions may cause the valve structure to either fail to properly open (stenotic failure) and/or fail to close properly (regurgitant).
• Mitral valve regurgitation is a specific problem resulting from a dysfunctional mitral valve. Mitral regurgitation results from the mitral valve allowing at least some retrograde blood flow back into the left atrium from the right atrium. 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.
• 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. 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 delivery techniques.
• 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).
• However, known delivery systems, devices and methods still suffer from significant flaws in delivery methodology including, inter alia, positioning and recapture capability and efficiency.
• In addition, known “replacement” heart valves are intended for full replacement of the native heart valve. Therefore, these replacement heart valves physically engage the annular throat 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 a supplementary functional valve as well as be fully capable of replacing the native function of a valve that has lost 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.
• Finally, 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 annular through) 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).
• Such 2-chamber 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 annulus, 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, the inventive solutions described herein are readily applicable to single or 2-chamber solutions, unless otherwise indicated.
• Various embodiments of the several inventions disclosed herein address these, inter alia, issues.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
• FIG. 1 illustrates a side cutaway view of one embodiment of the present invention.
• FIG. 2A illustrates a side view of one embodiment of the present invention.
• FIG. 2B illustrates a side cutaway view of one embodiment of the present invention.
• FIG. 3A illustrates a side cutaway view of one embodiment of the present invention.
• FIG. 3B illustrates a side cutaway view of one embodiment of the present invention.
• FIG. 4 illustrates a side cutaway view of one embodiment of the present invention.
• FIG. 5A illustrates a side cutaway view of one embodiment of the present invention.
• FIG. 5B illustrates a side cutaway view of one embodiment of the present invention.
• FIG. 6A illustrates a side cutaway view of one embodiment of the present invention.
• FIG. 6B illustrates a side cutaway view of one embodiment of the present invention.
• FIG. 6C illustrates a side cutaway view of one embodiment of the present invention.
• FIG. 7A illustrates a side cutaway view of one embodiment of the present invention.
• FIG. 7B illustrates a side cutaway view of one embodiment of the present invention.
• FIG. 8A illustrates a top view of one embodiment of the present invention.
• FIG. 8B illustrates a side and partially exploded view of one embodiment of the present invention.
• FIG. 9A illustrates a side cutaway view of one embodiment of the present invention.
• FIG. 9B illustrates a side cutaway view of one embodiment of the present invention.
• FIG. 9C illustrates a side cutaway view of one embodiment of the present invention.
• FIG. 9D illustrates a side cutaway view of one embodiment of the present invention.
• FIG. 10A illustrates a side cutaway view of one embodiment of the present invention.
• FIG. 10B illustrates a side cutaway view of one embodiment of the present invention.
• FIG. 10C illustrates a side cutaway view of one embodiment of the present invention.
• FIG. 11 illustrates a side cutaway view of one embodiment of the present invention.
• FIG. 12 illustrates a side view of one embodiment of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
• Various embodiments of the present invention are disclosed in the Figures for providing percutaneous access to the valve of interest via one of at least the following known access routes: transapical; transfemoral; transatrial; and transseptal delivery techniques. Each of these access routes may be used for the embodiments disclosed herein.
• Thus,FIG. 1 illustrates one embodiment of aprosthetic valve device100 with a 2-part frame in collapsed configuration. Thedistal portion102 of the collapsed device comprises the valve with prosthetic leaflets with a portion of the supporting frame, and is longitudinally translatably and rotatably confined within the lumen of anouter sheath104 having a first outer diameter D. Theproximal portion106 of thecollapsed device100 comprises the remaining supporting frame which is in operative connection with thedistal portion102 ofcollapsed device100 and in longitudinally translatably and rotatably confined within the lumen of aninner sheath108 that is at least longitudinally translatable relative to theouter sheath104 and wherein theouter sheath104 is at least longitudinally translatable relative to theinner sheath108. The inner and/orouter sheath108,104 may also be rotationally translatable relative to the other sheath. Theinner sheath108 is disposed within the lumen of theouter sheath104 and, therefore, theinner sheath108 comprises a second outer diameter D′ that is smaller than the outer sheath's outer diameter D.
• The preferred configuration of the device ofFIG. 1 comprises thecollapsed device100 consisting of one unit with a proximal anddistal portion106,102 as shown. Theouter sheath104 may be retracted to release expose firstly thedistal portion102 from thedistal end110 of theouter sheath104 for initial expansion and positioning in the subject chamber of the heart. Alternatively, thedistal portion102 of thedevice100 may be pushed distally to be released from thedistal end110 of theouter sheath104 in response to distal translation of theinner sheath108, e.g., or to a push rod pushing against theproximal portion106 of thedevice100. In the case of a push rod, theproximal portion106 will eventually be pushed distally out of the smaller lumen of theinner sheath106 and into the larger lumen of theouter sheath104 where an interim secondary expansion of theproximal portion106 occurs, followed by the secondary positioning expansion when theproximal portion106 is eventually released from thedistal end110 of theouter sheath104.
• If expanded within the left atrium in connection with a prosthetic mitral valve, the lower portion of thedistal portion102 may be positioned against the upper surface of the annulus within the left atrium.
• In this configuration, if thedistal portion102 is properly positioned and released/expanded, then the secondary release and expansion of theproximal portion106 of thedevice100 may be initiated and achieved according to the alternative methods described above in connection with the initial release and expansion of thedistal portion102. The skilled artisan will recognize that once the initial positioning expansion of thedistal portion102 is accomplished, then the secondary positioning expansion of theproximal portion106 will also be properly located and positioned.
• The configuration ofFIG. 1, in its various embodiments, enables delivery of adevice100 comprising a frame that may be slightly oversized for the chamber, e.g., atrial, dimensions through the two-step frame positioning expansion method. Some frames in collapsed form may be as much as2xin longitudinal length than any chamber, e.g., atrial, dimension. Thus, the staged positioning expansion method is necessary for delivery.
• Turning now toFIGS. 2A and 2B aprosthetic valve device200 comprising a supporting stent frame, with prosthetic valve attached and/or supported therein, is provided wherein the design comprises two portions (distal202 and proximal206, wherein the prosthetic valve withleaflets205 is held/supported within the distal portion202) with expanded diameters that are connected by acentral portion203 that has a smaller diameter than the expanded diameters of the twoportions202,206. As illustrated, the twoportions202,206 comprise an undeformed and fully expanded spherical shape, though other shapes may be used as the skilled artisan will readily understand. Certain embodiments may comprise at least one of the proximal anddistal portions206,202 having an expanded sizing that is slightly larger than the subject chamber's dimensions, e.g., the left atrial dimensions to allow expansion anchoring. Moreover, the aspect ratio of each of the twoportions206,202 may vary.
• As shown, the collapsed stent with valve is held within the lumen of adelivery sheath204, with a distal portion that holds or supports thedevice200 therein being released from the end210 of thedelivery sheath204 with subsequent positioning expansion of same within the subject chamber, e.g., the left atrium. When proper positioning is confirmed, the remaining central portion203 (if not previously released along with the distal portion202) and/or theproximal portion206 may then be released and positionally expanded by methods described in connection withFIG. 1, including use of an inner sheath as described above and/or a push rod to translate thedevice200 out of the distal end210 of theouter delivery sheath204. As withFIG. 1, this embodiment comprises a two-step or staged delivery mechanism. BothFIG. 1 andFIG. 2A/2B sets of embodiments may comprise a coating or covering on thedistal portion202 while theproximal portion206 may comprise an open frame formed from, e.g., stent cells. In the case ofFIG. 2A/2B, thecentral portion202 may also comprise and open cell construction and uncovered. The dashed lines ofFIG. 2B show an alternate embodiment wherein the expanded deliveredportion202 comprises ahinge point212 to assist in orienting the prosthetic valve and leaflets withindistal portion202 downward toward the native valve.
• FIGS. 3A, 3B, 3C, 5A and 5B provide further disclosure of exemplary prosthetic valve devices with support means, e.g., stented and associated exemplary delivery methods. ThusFIG. 3A shows thecollapsed device300 in the lumen of adelivery sheath304 in operative communication with a push/pull rod308 actuated by the device operator that is capable of distally translating thecollapsed device300 as inFIG. 3A out of thedistal end310 of thedelivery sheath304 for positioning expansion and, conversely, pulling the expandeddevice300 as shown inFIG. 3B back into thedistal end310 of thedelivery sheath304 if necessary. The push/pull rod308 may also allow in certain embodiments the rotation of thecollapsed device300 within the lumen of thedelivery sheath310 to aid in positioning prior to release and expansion. Further, the operative communication of the push/pull rod308 with thecollapsed device300 may comprise a screw orclip release mechanism311 connected with the most proximal portion of thecollapsed device300. The base or lower portion of thedevice300 may be covered with tissue or other biocompatible material while the upper portion of the device may comprise an open cell construction.
• Generally, thecollapsed device300 is loaded and positioned within thedelivery sheath304 with thevalve portion305 oriented in a downward position as shown. This allows the collapsedvalve device305 to be pushed out of thedelivery sheath304 in a sideways orientation as illustrated and enables the expandingvalve device300 upon release from the delivery sheath to be properly oriented to the native valve and subject chamber, e.g., mitral valve and left atrium.
• In certain cases, analignment wire315 may be translated from thedelivery sheath304 into a pulmonary vein, e.g., the left upper pulmonary vein PV to assist in positioning and delivery of thedevice300.
• FIG. 4 illustrates a sideways delivery ofdevice300 during expansion and just after delivery from theouter end310 of thedelivery sheath304, wherein the delivered device is oriented substantially vertically and aligned for positioning over the native valve.
• Thus, as shown best inFIGS. 5A and 5B, theprosthetic valve device500 may be delivered sideways (with thevalve portion505 oriented on the bottom as shown), asymmetrically and may comprise a locatingelement515 in operative connection with theprosthetic valve device500 and that extends from the delivery sheath503 with at least a distal end of the locatingelement515 or push tube disposed within a pulmonary vein PV, e.g., the left upper pulmonary vein as shown. This system provides a self-centering system that may expand upon releasing/translating the collapsedprosthetic valve device500 from the distal end510 of thedelivery sheath504. As shown apush tube508 and associatedconnector511 may be used to assist in manipulating the orientation of theprosthetic valve device500 once it is delivered from the distal end510 of thedelivery sheath504.
• Turning now toFIGS. 6A-6C, a theprosthetic valve device600 is delivered using a delivery catheter orsheath604 comprises either a pre-curveddistal portion620 or a distal portion adapted to be able to be curved620 to present a substantially straight distal section within the atrium.FIG. 6A provides a pre-curved embodiment, curved to enable loading of aprosthetic valve device600 in a configuration that places thevalved bottom portion605 in the proper location on release from thedistal end610 of the pre-curveddistal portion620 of the delivery catheter or sheath, more specifically from the straightened distal section distal to the pre-curveddistal portion620. Thus, as shown, the valve supportedportion605 of the collapsed and expandable frame/stent is distal-most within the lumen of the delivery catheter/sheath604. Thepre-curved portion620 enables easy orienting of thevalved portion605 with an exemplary mitral valve and/or upper surface of the annulus thereof.
• Thus, the delivery system with a curved distal portion as inFIG. 6A enables theprosthetic valve device600 to be positioned over the annulus and native valve leaflets. When positioned over the annulus and native valve leaflets, the curved delivery catheter orsheath604 may be withdrawn proximally, alone or in combination with apush rod608 or similar device on the proximal side of theprosthetic valve device600, to release and deliver theprosthetic valve device600 into the left atrium and expand the delivereddevice600. It is noteworthy that the curved delivery catheter orsheath604 comprises in some embodiments a straight distal end within the left atrium and located distal to thecurved section620 wherein the compressedprosthetic valve device600 is translated and manipulated around thecurved portion620 of the curved delivery catheter orsheath604. The compressedprosthetic valve device600 may be assisted in translating around thecurved portion620 of the curved delivery catheter or sheath by including a suture attachment to the distal end of the implant, a pull wire attached to the distal end of the implant extending to the proximal end of the delivery catheter or sheath, or by taking advantage of the natural flexion point in the arrangement ofFIG. 1 between the proximal and the distal portions of the prosthetic valve device and/or by a hinging point as inFIG. 2.
• FIGS. 6B and 6C comprise an alternative approach to creating thecurved portion620 by enabling curving of the distal portion of the delivery sheath orcatheter604 by providing a series of cuts orserrations609 along a bottom portion surface of the sheath or catheter, resulting in a weak region susceptible to bending. As shown apull wire625 is attached to thedistal end610 of thecatheter604 along this bottom weak cut or serrated region and is disposed through the catheter/sheath lumen to an operator who may pull the wire with force F proximally to achieve the desired curvature prior to release of the collapsedprosthetic valve structure600 which is oriented in collapsed form as inFIG. 6A and released for positioning expansion virtually directly on the subject valve or upper annular surface. Thecuts609 may extend through the catheter/sheath wall completely or may only be sections that have a catheter/sheath wall that is thinner than the rest of the catheter/sheath walls. Thecuts609 shown are uniform and generally square, though any depth, shape and uniform or non-uniform spacing of same may be used to achieve the weakened region.
• FIGS. 7A and 7B illustrate delivery systems for an exemplary prosthetic valve, e.g., mitral valve replacement or supplement, to a heart chamber, e.g., the left atrium using a delivery catheter orsheath704 as shown inFIG. 7A with transseptal access and in combination with anadditional guidance tool728 used to help guide the expanding valved device (not shown) as it is released from thedistal end710 of the catheter orsheath704 using methods or devices described herein. Theadditional guidance tool728 may be disposed within the upper pulmonary vein PV, for example. Theguidance tool728 may be hingedly or rotatingly attached to the catheter orsheath704 enabling thetool728 to rotate into position. A pull wire similar to that shown inFIGS. 6B and 6C may be used to connect to and manipulate thetool728 into position.
• FIG. 7B illustrates two delivery systems, afirst delivery system800 for alignment and deployment and asecond delivery system850 for recapture and repositioning if needed. One of the delivery systems, either the first800 or the second850, may access the subject heart chamber via a transfemoral access method while the other delivery system may access the subject heart chamber via another transvenous access method. Thefirst delivery system800 may thus comprise a delivery catheter orsheath804 as described elsewhere herein while the second delivery system may comprise a recapture and repositioning catheter orsheath854, similar in structure to the delivery catheter/sheath804.
• FIGS. 8A and 8B illustrate embodiments designed to facilitate accurate positioning of a prosthetic heart valve within a chamber, e.g., the left atrium, including but not limited to self-centering and fluoroscopy techniques. In this embodiment of a prosthetic stentedvalve device900, with the prosthetic valve andleaflets905 supported proximate the bottom portion of the valve device, the upper portion909 of thedevice900 may be divided into subsections as shown from the top inFIG. 8A. The illustrated case provides 4 subsections, though other numbers of subsections may certainly be useful and are within the scope of the present invention. As shown, opposing subsections are either open cell oropen wire construction907 or are comprised of a fabric in the form of a type ofsail908. Upon delivery of thisdevice900 to a subject heart chamber, the fabric sails908 will catch and use the natural force of blood flow to maneuver thedevice frame900 into proper positioning with subsequent release and expansion when positioning is confirmed.
• FIG. 8B is a related concept, but also includes anannulus spacer919 that may be delivered first via a delivery catheter/sheath as described previously herein and in certain embodiments, the spacer may be directed into position with a guidewire positioned within the lumen of the delivery catheter/sheath and further moved out of the distal end of the delivery catheter/sheath and either proximate to (on the proximal side) of the chamber upper annular surface or may be disposed at least partway within the annular throat. Once released from the lumen and distal end of the delivery catheter/sheath, theannular spacer919 may expand from a delivered collapsed form and positioned on the upper annular surface which may space the prosthetic valve andleaflets905 from the upper annular surface. Subsequently, the prosthetic valve device, as described herein and which may, or may not, comprise sails908 as inFIG. 7A, is delivered from the delivery catheter/sheath and positionally expanded to connect with the previously positionedspacer919.
• We next describe positional orienting delivery structures inFIGS. 9A-9D. Generally, each of these prosthetic valved devices are designed for use in the left atrium and make use of the left atrial appendage (LAA) as an orienting mechanism.FIG. 9A therefore comprises anLAA plug1006 disposed on a side surface of thecollapsed device100 within thedelivery sheath1004 lumen and, inFIG. 9B, theLAA plug1006 is positioned at least partially within the LAA. Once the LAA is engaged by theLAA plug1006, the operator has confirmation that the valvedprosthetic device1000 is in correct position. This device may be used in combination with any of the previously described devices and methods, including but not limited to the staged 2-step delivery devices and methods, whereby an initial positioning expansion would result in orienting the LAA plug into the LAA, then the secondary positioning expansion of the rest of the device initiated by release from the distal end of a delivery sheath.
• An additional benefit of certain embodiments ofFIGS. 9A and 9B may be to employ theLAA plug1006 as a device to prevent clotting within the LAA, wherein theLAA plug1006 fills the LAA entirely and/or anouter flange1008 covers the LAA opening entirely to prevent any blood clots from forming and/or moving out of the heart to potentially cause a stroke.
• FIG. 9D shows a slightly different mechanism whereby aguidewire1020 is disposed through adelivery sheath1004 and into the LAA to provide orienting guidance for the positioning expansion (1 step or staged) of the collapsed prosthetic valved device (not shown) within the lumen ofdelivery sheath1004. Thesheath1004 may be pulled back to deploy/release the valved device (not shown) from the distal end of thesheath1004 for positioning expansion or a push rod may be used to push the valved device out of the sheath's distal end as previously described. In these cases, theguidewire1020 positioned within the LAA provides a key orienting guidance parameter so that the operator knows positioning will be proper on expansion. Theguidewire1020 may comprise an atraumatic tip to prevent damaging the tissue of the LAA.
• FIG. 9C illustrates another alignment/orienting system wherein the delivery catheter/sheath1004 is introduced via a pulmonary vein PV, e.g., the upper pulmonary vein, into the left atrium and aguidewire1020 disposed through the lumen of the delivery catheter/sheath1004 and into, or proximate, the annulus, i.e., the annular throat, as a guide for the to-be-delivered valved device (not shown but compressed and self-expanding as previously described). When thesheath1004 is pulled back, or a push rod is used to push the collapsed valved device out of the distal end of the delivery catheter orsheath1004, the expanding valved device may slide down over thepre-positioned guidewire1020 to a proper position when fully expanded.
• FIG. 10A illustrates a partially expanded stentedvalved device1100 released from the delivery catheter sheath. At least one capture wire1030 (shown radially wrapped around thedevice1100, but may take other wrapping positions) is shown and which restrains theexpandable device1100 from fully expanding until properly positioned within the subject heart chamber, e.g., the left atrium. When proper position is confirmed, thecapture wire1030 may be removed by cutting and withdrawal distally through thedelivery sheath1004 lumen or by disconnecting a connector pin orlatch1032 or equivalent to enable full expansion of thedevice1100 at the proper positional location.FIG. 10B is similar with analignment wire1130 that assists in positional orientation as it feeds out of the distal end of the delivery catheter/sheath1104 while in connection with the partially expanding sheath at 2 or 3 or more stabilization points1034 until proper position is confirmed. Thestabilization point1134 connections may hold the partially expanded device in that state until proper position is confirmed, then the connections may be removed, either by cutting (as in the case of a releasable suture) or by disconnecting a connector pin or latch, to enable the full expansion at the proper positional location or by provision of a secondary over the wire cutter introduced via the delivery catheter/sheath1104 to clipalignment wire1130.
• FIG. 10C provides an alternative prosthetic heart valve device shown in a positionally expanded position after release from the distal end of the delivery catheter/sheath1104 and comprising at least oneattachment point1032 located within the stented heart valve device as well as two or more pull/push wires1130 with a first end connected to the at least oneattachment point1032 and a second end attached topoints1033 around the stent frame. This arrangement may function in several different ways to facilitate recapture, repositioning and/or redeployment.
• First, one embodiment may comprise the two or more pull/push wires1130 of a length that is slightly smaller than the chamber, e.g., left atriam, dimensions to ensure proper positioning. Once position is confirmed as proper, the pull/push wires1130 may be released by, e.g., a secondary over the wire cutter or other means to disengage the pull/push wire connection between the at least oneattachment point1032 and the two or more pull/push wires1130, thereby enabling the full expansion of the properly positioned frame within the chamber. As with other embodiments described herein, the fully expanded frame may be slightly larger than at least one dimension to facilitate anchoring.
• Another embodiment may further comprise a push rod disposed translationally within the delivery catheter/sheath1104 lumen and that also provides a distally extending releasable connector attached to the at least oneattachment point1032 within the stented heart valve frame for disengaging the attachment between the at least oneattachment point1032 and the two or more push/pull wires1130 once proper positioning is confirmed. This embodiment provides the further benefit of using a distally extending releasable connector tool to pull proximally on the at least one attachment point wherein the attachment point and the push/pull wires are connected to points on the stent frame that, when proximal force is applied to the attachment point, cause the stent frame to collapse slightly or fully, to enable repositioning. Once repositioned, distal force is applied to the releasable connector tool to fully expand the prosthetic valve frame.
• Yet another embodiment may comprise the attachment point1132, push/pullwires1130, and/or the connection of the push/pull wires to the stent frame to be formed of a material that dissolves over a short time period.
• FIG. 11 illustrates aprosthetic valve device1200 comprising a ball and socket relationship between the support frame (socket or partial socket), with the prosthetic valve andleaflets1253 disposed therein (ball or partial ball). In this embodiment, theouter frame1250 is, as illustrated, a partial sphere having a radiusing and acentral point1252, with thecentral point1252 disposed generally around the native valve and annulus. Theouter frame1250 may comprise aradially extending flange1254 to connect and seal with the upper annular surface and may further comprisewall elements1256 extending upward from at least portions of theradially extending flange1252 to connect with and seal against the chamber, e.g., left atrial, walls. Theradially extending flange1252 may comprise an expandable stent-like construction to provide radial expansive force to assist in anchoring thedevice1200. Alternative constructions may comprise any of the prosthetic stented valve frames described herein, e.g. and without limitation, an upper open expandable frame with a lower expandable frame covered with tissue.
• The prosthetic valve further comprises an innerpartial sphere1253 with a radiusing that matches, or is complementary with, the radiusing of the outer frame'spartial sphere1250, but with a smaller radius that theouter frame1250 as the innerpartial sphere1253 resides within the outer frame'spartial sphere1250. The prosthetic leaflets are supported within the innerpartial sphere1253. The innerpartial sphere1253 may comprise a friction fit with the outer frame'spartial sphere1250 so that some movement is possible in all dimensions, including rotational, without losing the proper valve position relative to the native valve and/or annulus. Alternatives may allow a looser friction fit so that the inner partial sphere essentially floats within the outer frame's partial sphere, thereby allowing a fuller range of motion than a tighter friction fit.
• FIG. 12 illustrates an implant frame withprosthetic valve device1300 attached thereto connected via aconnector element1302 to alasso structure1304 that is, in turn, operatively connected with a manipulation wire1306, that may comprise a single wire or two wires, that extends proximally to the operator who is then able to manipulate thelasso1304 andconnector element1302. Thelasso structure1304 may comprise two distal wires, W1, W2, or more than two distal wires, in operative connection with theconnector element1302. If the manipulation wire1306 comprises two wires W1, W2, then a first of the two wires may be connected with wire1 and the second of the two wires may be connected with wire1. Wires W1, W2 may be disconnected from theconnector element1302 by the operator's pulling of one, or both, of the manipulation wire(s) W1, W2. Thelasso structure1304 may, as shown, be expandable to a diameter that is larger than the inner diameter of the catheter's1305 lumen and is disposed through the implant frame structure with theconnector element1302 in operative connection with thelasso1304 and thedevice frame1300 generally in the middle of the implant structure. This configuration allows the operator to steer thedevice1300 with thelasso structure1304 during deployment and also allows retrieval back into the catheter's1305 lumen if necessary. Theconnector element1302 may be configured together with the device's1300 frame structure to enable collapsing of the device's1300 frame structure to allow pullback of the device's1300 structure into the catheter's1305 lumen. Theconnector element1302 may also be disconnected by the operator from the device's1300 frame, whereby one, or both, of the wires W1, W2 are disconnected and thelasso structure1304 retracted proximally through thecatheter1305. In other embodiments, theconnector element1302 may remain attached to the device's1300 frame structure when the operator disconnects wires W1, W2 from theconnector element1302 and pulls thelasso structure1304 proximally through thecatheter sheath1305.
• The description of the various inventions, embodiments thereof and 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 these inventions. 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 inventions.

Claims (31)

What is claimed is:

1. A method of delivering a self-expanding prosthetic mitral valve device comprising prosthetic mitral valve leaflets to an implantation site within a left atrium of a patient's heart, comprising:

accessing the left atrium with a delivery catheter having a proximal end, a distal end and a lumen therethrough, wherein the delivery catheter comprises a curved distal portion adapted to facilitate positioning of the self-expanding prosthetic mitral valve device within the left atrium;

loading the self-expanding prosthetic mitral valve device in a collapsed configuration into the lumen of the delivery catheter at the proximal end thereof, wherein the collapsed configuration of the prosthetic mitral valve device comprises a prosthetic mitral valve attached thereto;

delivering the collapsed prosthetic valve out of the distal end of the delivery catheter and into the left atrium at a location proximate the implantation site; and

allowing the delivered self-expanding prosthetic mitral valve device to expand within the left atrium at the implantation site, wherein at least a portion of the expanded device engages at least a portion of the upper annular surface within the left atrium.

2. The method ofclaim 1, further comprising:

providing a pull wire that is attached to the distal end of the delivery catheter and extends proximally out of the proximal end of the delivery catheter, wherein the curved distal portion of the delivery catheter is adapted to be curved by pulling the pull wire proximally during at least the delivery of the prosthetic mitral valve device; and

pulling the pull wire proximally during at least the delivery of the prosthetic mitral valve device to curve the distal portion of the delivery catheter.

3. The method ofclaim 2, further comprising providing a weakened section around at least a portion of the distal portion of the delivery catheter and proximate to the attachment of the pull wire to the distal end of the delivery catheter.

4. The method ofclaim 3, wherein the weakened section comprises a series of cuts or serrations that extend partially through the catheter wall of the distal portion of the delivery catheter.

5. The method ofclaim 3, wherein the weakened section comprises a series of cuts or serrations that extend fully through the catheter wall of the distal portion of the delivery catheter.

6. The method ofclaim 1, wherein the curved distal portion of the delivery catheter is pre-curved.

7. The method ofclaim 1, further comprising:

providing a plug attached to a side of the distal portion of the collapsed self-expanding prosthetic mitral valve device;

aligning the plug with the left atrial appendage; and

engaging the left atrial appendage with the plug when the self-expanding mitral valve device is expanded.

8. The method ofclaim 7, wherein the plug further comprises a flange that engages and seals the atrial wall around the left atrial appendage.

9. The method ofclaim 1, further comprising:

providing a push rod that is connected to the collapsed prosthetic mitral valve device; and

pushing the collapsed prosthetic mitral valve device with the push rod through the lumen of the delivery catheter for delivery and expansion within the left atrium.

10. The method ofclaim 9, further comprising at least partially collapsing the expanded prosthetic mitral valve within the lumen of the delivery catheter by pulling proximally on the push rod.

11. The method ofclaim 9, further comprising:

translating a locating element through the lumen of the catheter;

engaging an open frame portion of the prosthetic mitral valve device with the locating element; and

engaging the lumen of the left upper pulmonary vein with a distal end of the locating element before delivering the prosthetic mitral valve device into the left atrium.

12. The method ofclaim 11, wherein the locating element extends through an open frame section of the prosthetic mitral valve device.

13. The method ofclaim 1, wherein the collapsed self-expanding prosthetic mitral valve device further comprises:

a proximal portion;

a distal portion, wherein the prosthetic mitral valve leaflets are disposed within the distal portion; and

a central portion disposed between the proximal portion and the distal portion, the central portion having a maximum diameter that is smaller than a maximum diameter of the proximal portion and a maximum diameter of the distal portion.

14. The method ofclaim 13, further comprising:

providing a hinge on the central portion;

delivering the central portion out of the distal end of the delivery catheter lumen to expose the hinge to the left atrium; and

rotating the distal portion toward the upper annular surface of the left atrium; and

delivering the proximal portion out of the distal end of the delivery catheter lumen and into the left atrium.

15. The method ofclaim 1, wherein the collapsed self-expanding prosthetic mitral valve device further comprises a proximal portion and a distal portion, wherein the prosthetic mitral valve leaflets are disposed within the distal portion, the method further comprising;

loading an inner sheath into the catheter lumen, the inner sheath having a distal end that engages the collapsed self-expanding prosthetic mitral valve, wherein translation of the inner sheath through the catheter lumen results in translation of the collapsed self-expanding stented valve through the catheter lumen; and

wherein the inner sheath comprises a lumen therethrough sized to receive the proximal portion of the collapsed self-expanding prosthetic mitral valve device.

16. The method ofclaim 14, wherein the distal end of the inner sheath engages the distal portion of the collapsed self-expanding prosthetic mitral valve device, wherein the distal portion is not received within the lumen of the inner sheath.

17. The method ofclaim 14, wherein the distal portion is delivered, positioned proximate the implantation site and expanded before the proximal portion of the collapsed self-expanding prosthetic mitral valve device is delivered and expanded.

18. The method ofclaim 1, further comprising:

translating an alignment wire disposed through the lumen of the delivery catheter;

engaging an open frame portion of the prosthetic mitral valve device with the alignment wire; and

engaging the left upper pulmonary vein with the alignment wire before delivering the prosthetic mitral valve device into the left atrium along the alignment wire.

19. The method ofclaim 1, further comprising at least one capture wire extending through the delivery catheter lumen and engaging the self-expanding prosthetic mitral valve device adapted to restrain the expansion of the device to a partially expanded configuration.

20. The method ofclaim 19, further comprising the at least one capture wire further adapted to positionally orient the partially expanded device by manipulating the at least one capture wire at the proximal end of the delivery catheter.

21. The method ofclaim 20, further comprising:

positionally orienting the partially expanded device within the left atrium;

confirming proper orientation of the partially expanded device;

removing the at least one capture wire; and

allowing the partially expanded device to fully expand.

22. The method ofclaim 21, further comprising providing a push/pull rod through the lumen of the delivery catheter adapted to assist in positionally orienting the partially expanded device.

23. The method ofclaim 1, further comprising a lasso element attached to the prosthetic mitral valve device adapted to be manipulated at the proximal end of the delivery catheter; manipulating the lasso element to positionally orient, prevent full expansion of the prosthetic mitral device and/or allow full expansion of the prosthetic mitral valve device within the left atrium.

24. The method ofclaim 1, wherein the self-expanding prosthetic mitral valve device further comprises an upper portion formed from a stent comprising at least two sets of opposing subsections, at least one set of the opposing subsections comprising a fabric covering.

25. The method ofclaim 24, further comprising using the fabric covering to capture blood flow to position the self-expanding prosthetic mitral valve device and expanding the positioned self-expanding prosthetic mitral valve device.

26. The method ofclaim 1, further comprising ensuring that the left ventricle is not touched at any point by the expanded prosthetic mitral valve device.

27. The method ofclaim 1, further comprising ensuring that the native mitral valve leaflets are not touched at any point by the expanded prosthetic mitral valve device.

28. The method ofclaim 1, wherein the left atrium is accessed through the septum between the right and left atria.

29. The method ofclaim 1, further comprising:

translating an alignment wire through the lumen of the catheter and engaging an open frame portion of the prosthetic mitral valve device; and

engaging the lumen of the left upper pulmonary vein with a distal end of the alignment wire before delivering the prosthetic mitral valve device into the left atrium along the alignment wire.

30. The method ofclaim 1, further comprising an alignment guide wire disposed through the lumen of the catheter and engaging the left atrial appendage.

31. A system suitable for use in a method of delivering a self-expanding prosthetic mitral valve device to an implantation site within a left atrium of a patient's heart, the system comprising:

the self-expanding prosthetic mitral valve device, comprising prosthetic mitral valve leaflets; and

a delivery catheter having a proximal end, a distal end and a lumen therethrough, wherein the delivery catheter comprises a curved distal portion adapted to facilitate positioning of the self-expanding prosthetic mitral valve device within the left atrium,

wherein the method comprises:

accessing the left atrium with the delivery catheter;

loading the self-expanding prosthetic mitral valve device in a collapsed configuration into the lumen of the delivery catheter at the proximal end thereof, wherein the collapsed configuration of the prosthetic mitral valve device comprises a prosthetic mitral valve attached thereto;

delivering the collapsed prosthetic valve out of the distal end of the delivery catheter and into the left atrium at a location proximate the implantation site; and

allowing the delivered self-expanding prosthetic mitral valve device to expand within the left atrium at the implantation site, wherein at least a portion of the expanded device engages at least a portion of the upper annular surface within the left atrium.

Images