Delivery devices and methods for heart valve replacement with valvular depth adjustment

Abstract

Heart valve prosthesis delivery devices and methods. The devices include a delivery catheter and stabilization catheter. The stabilization catheter has expandable anchoring segments to anchor the device at a cardiac site superior to the implantation site of the heart valve prosthesis. The stabilization catheter also has a tubular assembly that includes an outer tubular member and an inner tubular member translationally displaceable within the outer tubular member. The outer tubular member defines a longitudinally extending slit and the inner tubular member defines an aperture positionable within the longitudinally extending slot. The device includes a snare and the location of the distal end of the snare adjacent to the distal portion of the delivery catheter is adjustable via translational displacement of the inner tubular member relative to the outer tubular member.

Description

DELIVERY DEVICES AND METHODS FOR HEART VALVE REPLACEMENT WITH VALVULAR DEPTH ADJUSTMENTCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 666,317, filed July 1, 2024, the entire content of which is incorporated herein by reference.TECHNICAL FIELD

[0002] The present technology relates to delivery devices and methods for transcatheter valve replacement with stabilizing or anchoring features to adjust the prosthesis valvular depth.BACKGROUND

[0003] Diseased or otherwise defective heart valves can be repaired or replaced using a variety of different types of heart valve surgeries. One type of heart valve surgery involves an open-heart surgical procedure that is conducted under general anesthesia, during which the heart is stopped and blood flow is controlled by a heart-lung bypass machine. This type of valve surgery is highly invasive and exposes a patient to many potential risks such as infection, stroke, renal failure, and adverse effects associated with using a heart-lung machine.

[0004] Due to the drawback of open-heart surgical procedures, there has been an increased interest in minimally invasive procedures to replace damaged or defective heart valves. A transcatheter aortic valve prosthesis (TAVR) may be used to replace the aortic valve in patients with severe aortic stenosis. A transcatheter tricuspid valve prosthesis (1 1 VR) may be used to replace a malfunctioning tricuspid valve in patients who may not be candidates for open-heart surgery. A transcatheter mitral valve prosthesis (TMVR) may be used to replace a mitral valve that is not working properly and may be a procedural alternative to surgical mitral valve repair or replacement (SMVR).

[0005] When delivering a heart valve prosthesis to a valve or vessel location with complex geometry and navigation, it can be difficult to adjust implant depth accurately without compromising the steered configuration necessary for correct implant orientation and positioning. In many cases, the delivery device is not able to obtain the correct depth,height or orientation due to anatomical complexities or lack of degrees of freedom. Some devices have utilized a guidewire to achieve these additional manipulations by pushing off a ventricular wall. However, a guidewire has a low contact area and can risk vessel perforation.SUMMARY

[0006] In an aspect, a heart valve prosthesis delivery device is provided. The device can comprise a delivery catheter and a stabilization catheter. The delivery catheter can comprise a distal portion sized and configured to receive a heart valve prosthesis. The stabilization catheter can have a central axis and can comprise a catheter body defining one or more inflation lumens. A tubular assembly can be disposed in the catheter body and can include an outer tubular member and an inner tubular member. The outer tubular member can have an outer lumen and can define a longitudinally extending slit offset from the central axis and in fluid communication with the outer lumen. The inner tubular member can be translationally displaceable within the outer lumen. The inner tubular member can have an inner lumen and can define an aperture positionable within the longitudinally extending slot and in fluid communication with the inner lumen. A circumferential array of expandable anchoring segments can be disposed on the catheter body in fluid communication with the one or more inflation lumens and can define an opening sized and configured to permit blood flow through the heart. A snare can extend through the catheter body and have a distal portion that extends through the slit of the outer tubular member and the aperture of the inner tubular member. The snare can also have a distal end positionable adjacent to the distal portion of the heart valve prosthesis delivery catheter. The location of the distal end of the snare adjacent to the distal portion of the delivery catheter can be adjustable via translational displacement of the inner tubular member relative to the outer tubular member.

[0007] In another aspect, a method of delivering a heart valve prosthesis is provided. The method can comprise advancing a heart valve prosthesis delivery device that through an inferior vena cava. The delivery device includes a deployable heart valve prosthesis. The method further includes advancing an expandable member into the superior vena cava and radially expanding the expandable member such that the expandable member contacts the vessel wall of the superior vena cava to anchor the expandable member to the vessel wall. The method further comprises advancing the heart valve prosthesis delivery device towardsthe tricuspid annulus while the expandable member remains anchored to the vessel wall of the superior vena cava. The method then includes deploying the heart valve prosthesis within the tricuspid annulus and removing the heart valve prosthesis delivery device and the expandable member from the heart.

[0008] In another aspect, a heart valve prosthesis delivery device is provided. The device can comprise a sheath having a proximal end, a distal end and a lumen extending therethrough. A delivery catheter can be extendable from the lumen of the sheath and can comprise a distal portion sized and configured to receive a heart valve prosthesis. A stabilizer can be extendable from the lumen of the sheath and can be operably coupled to the delivery catheter. The stabilizer can comprise a moveable hollow guide having a proximal end and a distal end. An expandable mesh can be operably coupled to the distal end of the moveable hollow guide and can define openings sized and configured to allow blood flow through the heart. A pull wire having a proximal end and a distal end can extend through the moveable hollow guide and the expandable mesh. The distal end of the pull wire can be connected to the expandable mesh. A pull wire actuator can be operably coupled to the proximal end of the pull wire and can be configured to control the transition of the expandable mesh from a collapsed state to an expanded state. A guide actuator can be operably coupled to the proximal end of the moveable hollow guide and can be configured to control axial displacement of the moveable hollow guide from the lumen of the sheath. The location of the distal portion of the delivery catheter can be adjustable via control of the axial displacement of the moveable hollow guide.BRIEF DESCRIPTION OF THE DRAWINGS

[0009] FIG. 1 is a side view of a stabilization catheter of a heart valve prosthesis delivery device according to an aspect of the present disclosure.

[0010] FIG. 2 is a side view and schematic illustration of components of a stabilization catheter of a heart valve prosthesis delivery device according to an aspect of the present disclosure.

[0011] FIG. 3 is a top schematic view of components of a stabilization catheter of a heart valve prosthesis delivery device according to an aspect of the present disclosure.

[0012] FIG. 4 is a side view of an example of a heart valve prosthesis delivery device according to an aspect of the present disclosure.

[0013] FIG. 5 is a schematic illustration of a heart valve prosthesis delivery device during a step of implanting a heart valve prosthesis according to an aspect of the present disclosure.

[0014] FIG. 6 is a schematic illustration of a heart valve prosthesis delivery device during a step of implanting a heart valve prosthesis according to an aspect of the present disclosure.

[0015] FIG. 7 is a schematic illustration of a heart valve prosthesis delivery device during a step of implanting a heart valve prosthesis according to an aspect of the present disclosure.

[0016] FIG. 8 is a schematic illustration of a heart valve prosthesis delivery device during a step of implanting a heart valve prosthesis according to an aspect of the present disclosure.

[0017] FIG. 9 is a schematic illustration of a heart valve prosthesis delivery device during a step of implanting a heart valve prosthesis according to an aspect of the present disclosure.

[0018] FIG. 10 is a side view and schematic illustration of components of a stabilization catheter of a heart valve prosthesis delivery device according to an aspect of the present disclosure.

[0019] FIG. 11 is a schematic illustration of a heart valve prosthesis device during a step of implanting a heart valve prosthesis according to an aspect of the present disclosure.

[0020] FIG. 12 is a side view of a heart valve prosthesis delivery device according to an aspect of the present disclosure.

[0021] FIG. 13 is a side view of a stabilizer of a heart prosthesis delivery device in a collapsed state according to an aspect of the present disclosure.

[0022] FIG. 14 is a side view of the stabilizer of FIG. 13 in an expanded state according to an aspect of the present disclosure.

[0023] FIG. 15 is a side view of a heart valve prosthesis delivery device according to an aspect of the present disclosure.

[0024] FIG. 16 is a flow chart depicting steps of a method of implanting a heart valve prosthesis device according to an aspect of the present disclosure.DETAILED DESCRIPTIONDefinitions

[0025] As used herein with respect to a described element, the terms “a,” “an,” and “the” include at least one or more of the described element(s) including combinations thereof unless otherwise indicated. Further the term “a,” “an,” and “the” can refer to one component performing a described functionality or more than one component performing the same functionality. By “substantially” is meant that the shape or configuration of the described element need not have the mathematically exact described shape or configuration of the described element but can have a shape or configuration that is recognizable by one skilled in the art as generally or approximately having the described shape or configuration of the described element. As such “substantially” refers to the complete or nearly complete extent of a configuration, characteristic, property, state, or structure. The exact allowable degree of deviation from the configuration, characteristic, property, state, or structure will be so as to have the same overall result as if the absolute configuration, characteristic, property, state, or structure were obtained. The terms “first,” “second,” etc. are used to distinguish one element from another and not used in a quantitative sense unless indicated otherwise. Thus, a “first” element / state described below could also be termed a “second” element / state. A component operably coupled, connected to or in communication with another component can have intervening components between the components so long as the device can perform the stated purpose. The sequence of operations (or steps) is not limited to the order presented in the claims or figures unless specifically indicated otherwise. As used herein a “patient” includes a mammal such as a human being. All devices as described herein are used for medical purposes and are therefore sterile.Although the drawings show certain elements of a device in combination, it should be noted that such elements can be included (or excluded) in other embodiments or aspects illustrated in other drawings or otherwise described in the specification. In other words, each of the disclosed aspects and embodiments of the present disclosure may be considered individually or in combination with other aspects and embodiments of the disclosure including patent applications incorporated by reference herein.

[0026] The present disclosure generally relates to delivery devices and methods for transcatheter delivery of a heart valve prosthesis. In particular, devices as disclosed herein can leverage the atrial / ventricular or other surrounding tissue walls to allow a heart valveprosthesis to be manipulated (e.g. pushed or pulled into the final position) without disrupting the steered configuration. For example, in an aspect, a device with expandable components is provided that can include features designed to contact vessel wall(s) and apply additional manipulations to position the device to allow for proper depth and orientation of the heart valve prosthesis without the risk of vessel perforation due to an atraumatic design and a large force distribution area.

[0027] In particular and with reference to FIGs. 1-4, a heart valve prosthesis delivery device 10 can comprise delivery catheter 12 and stabilization catheter 16. In certain embodiments, both catheters are insertable in a single lumen or multi-lumen sheath 44. Regarding the delivery catheter, it can have distal portion 14 sized and configured to receive a heart valve prosthesis. As shown in FIG. 4, the distal portion can comprise delivery capsule 39 defining a chamber sized and configured to receive a heart valve prosthesis therein. In certain embodiments, the delivery catheter can include shaft 40 operably coupled to the distal portion thereof. Delivery sheath 42 can be disposable about at least the distal portion of shaft 40 of the delivery catheter.

[0028] Regarding stabilization catheter 16, this catheter can have a central axis and comprise catheter body 18 defining one or more inflation lumens. Tubular assembly 21 can be disposed in the catheter body and can comprise outer tubular member 20 defining outer lumen 24 and inner tubular member 26 defining inner lumen 28. Outer tubular member 20 can define longitudinally extending slit 27 offset from the central axis (such that it is defined by a side wall of the outer tubular member) and that is in fluid communication with outer lumen 24. Inner tubular member 26 can be translationally displaceable within outer lumen 24 and can define aperture 30 positionable within the longitudinal extending slit and in fluid communication with inner lumen 28.

[0029] Circumferential array of expandable anchoring segments 32 can be disposed on a distal portion of catheter body 18 in fluid communication with the one or more inflation lumens and defining opening 34 sized and configured to permit blood flow through the heart. It should be noted that the balloon catheter include a variation of plurality of catheters each connected to a separate expandable anchoring segment. Although FIG. 3 illustrates six balloons, the array can be less than six balloons such as at least three. Further, FIG. 3 illustrates circular shaped balloons but the expandable anchoring segments can have other suitable shapes such as a star-shape or oval shape, for example. Regarding theopening, the opening can be between adjacent expandable anchoring segments (34a) and / or can have a more central location such as the space (34b) between the catheter body and the array.

[0030] Snare 37 can extend through the catheter body. Snare 37 can have distal portion 36 extending through slit 27 of outer tubular member 20 and aperture 30 of inner tubular member 26. Distal end 38 of snare 37 can be positionable adjacent to the distal portion of delivery catheter 12. In certain embodiments, the distal end can have a loop or hook shaped configuration. The snare 37 may utilize radiopaque materials or markers to aid visualization under fluoroscopy for inserting the distal portion of the delivery catheter 12 through the snare loop. The location of the distal end of snare 37 adjacent to the distal portion of delivery catheter 12 can be adjustable via translational displacement of inner tubular member 26 relative to outer tubular member 20. In other words, the length and exit point of the snare from aperture 30 can be adjusted by such translational displacement. By selectively translating the inner tubular member relative to the outer tubular member (or vice versa), the trajectory and angle at which the distal portion of the delivery catheter enters the valve annulus can be controlled.

[0031] In certain aspects and with reference to FIGs. 5-9, a method of delivering a heart valve prosthesis using heart valve prosthesis delivery device 10 is provided. As depicted in FIG. 5, heart valve prosthesis delivery device 10 can be inserted into the heart with the assistance of a dilator. FIG. 5 illustrates stabilization catheter 16 and delivery catheter 12 as being disposed within a sheath although the catheters could be inserted into the heart using a different structure or separately without a sheath. FIG. 5 also illustrates the heart valve prosthesis delivery device as being inserted through the inferior vena cava, but the device could be inserted through other sites such as the superior vena cava, for example. Circumferential array of expandable anchoring segments 32 can be advanced into a lumen of the heart superior to the implantation site of the heart valve prosthesis such as, for example, the superior vena cava or the atrium. As shown in FIG. 6, the circumferential array of expandable anchoring segments can be radially expanded such that the array contacts the wall defining the lumen of the heart to anchor the array to the wall. Referring to FIG. 7, distal portion of delivery device 12 (which in this instance is illustrated as delivery capsule 39 although the distal portion could have a different configuration) can be advanced toward the implantation site (using fluoro-imaging, for example) and through thedistal end 38 of snare 37. FIG. 7 illustrates the distal portion of the delivery catheter being advanced towards the tricuspid annulus but the delivery catheter could be advanced towards other valve sites such as the mitral annulus, the aortic valve annulus, or the pulmonary valve annulus. With reference to FIG. 8, delivery catheter 12 can be manipulated to position the distal portion thereof into the implantation site. Referring to FIG. 9, distal end 38 of snare 37 can be adjusted to alter the pulling angle of the snare and the snare can then be retracted to pull the delivery catheter laterally. The pulling angle of the snare can be altered by controlling the translational displacement of the inner tubular member relative to the outer tubular member. The heart valve prosthesis can then be released or otherwise deployed from the delivery catheter to the implantation site and the heart valve prosthesis delivery device can be removed from the heart. With respect to the tricuspid valve, achieving the desired trajectory, position, and depth in the tricuspid annulus is a challenge for both repair and replacement devices due to the access path to the tricuspid anatomy. By stabilizing the delivery catheter in the anatomy and biasing it laterally, a stable platform for implantation can be achieved and the available space to maneuver the delivery catheter can be maximized. Together these features provide for a more predictable deployment of the tricuspid valve prosthesis. With respect to a transcatheter mitral valve replacement where the device is inserted in the left hear, the delivery catheter could be placed and anchored in the pulmonary vein achieving a similar effect of gaining height above the valve annulus.

[0032] In certain aspects and with reference to FIGs. 10 and 11, the method of snare angle change can be the same as described above but the snare can be attached to a stiff wire 46 and can be tensions by moving the wire distally rather than pulling the snare through the entire stabilizing catheter. With such a configuration snare 37 traverses aperture 30 of inner tubular member 26 at a shallower angle when the delivery catheter is retracted.

[0033] With reference to FIG. 12, another heart valve prosthesis delivery device 48 is provided according to an aspect of the present disclosure. Heart valve prosthesis delivery device 48 can comprise sheath 50 having a proximal end, distal end 52 and a lumen extending therethrough. The sheath can be a steerable guide catheter or a passive sheath.

[0034] Delivery catheter 54 can be extendable from the lumen of sheath 50 and can comprise distal portion 56 sized and configured to receive a heart valve prosthesis. Stabilizer 58 can extend from the lumen of sheath 50 and can be operably coupled todelivery catheter 54. FIG. 12 illustrates the stabilizer extending from the distal end of the sheath but as shown in FIG. 15, stabilizer 58A can extend from side port 82 of sheath 50A. Stabilizer 58 can comprise moveable hollow guide 60 having proximal end 62 and distal end 64. Expandable mesh 66 can be operably coupled to distal end 64 of moveable hollow guide 60 and can define openings sized and configured to allow blood flow through the heart. Pull wire 68 can have proximal end 70 and distal end 72 and can extend through moveable hollow guide 60 and expandable mesh 66. Distal end 72 can be connected to expandable mesh 66. Pull wire actuator (and optional lock) 74 can be operably coupled to proximal end 70 of pull wire 68 and can be configured to control the transition of expandable mesh 66 from a collapsed state to an expanded state (as depicted in FIGs. 13 and 14). Guide actuator 76 can be operably coupled to proximal end 62 of moveable hollow guide 60 and can be configured to control axial displacement of moveable hollow guide 60 from the lumen of sheath 50. The location of distal portion 56 of delivery catheter 54 can be adjustable via control of the axial displacement of moveable hollow guide 60. In certain aspects, the guide actuator can be incorporated in handle 78 including knob or dial 80 which can be turned to retract hollow guide 60 and thereby adjust the position of the distal portion of the delivery catheter.

[0035] An exemplary method of delivering a heart valve prosthesis with heart prosthesis delivery device 48 can include inserting the heart valve prosthesis delivery device through an inferior vena cava and advancing the stabilizer into a superior vena cava or an atrium of the heart. The pull wire can be retracted to transition the expandable mesh from a collapsed state to an expanded state such that the expandable mesh contacts the vessel wall of the superior vena cava or the atrial wall of the atrium to anchor the expandable mesh to the vessel wall of the superior vena cava or the atrial wall of the atrium. The method can further include retracting the moveable hollow guide to manipulate the location of the distal portion of the delivery catheter in the tricuspid annulus such that the distal portion is located at the desired site of the tricuspid annulus; The heart valve prosthesis can be deployed and the heart valve prosthesis delivery device removed from the heart.

[0036] Other methods of delivering a heart valve prosthesis are also provided herein. With respect to FIG. 16, such a method 100 can include advancing a heart valve prosthesis delivery device through an inferior vena cava 100. The delivery device includes a deployable heart valve prosthesis disposed therein or thereon. The method further includesadvancing an expandable member into the superior vena cava 102. The expandable member can be part of the heart valve prosthesis delivery device (such as, for example, the device disclosed above) or can be a separate structure. The expandable member can be a balloon, an expandable mesh including a self-expandable mesh, or another suitable structure that can be expanded to contact the wall of the superior vena cava. The method can further comprise radially expanding the expandable member such that the expandable member contacts the vessel wall of the superior vena cava to anchor the expandable member to the vessel wall 104. The method can further include advancing the heart valve prosthesis delivery device towards the tricuspid annulus while the expandable member remains anchored to the vessel wall of the superior vena cava 106. The method can further involve deploying the heart valve prosthesis within the tricuspid annulus 108 and removing the heart valve prosthesis delivery device and the expandable member from the heart 110.

[0037] Each of the disclosed aspects and embodiments of the present disclosure may be considered individually or in combination with other aspects, embodiments, and variations of the disclosure. Further, while certain features of embodiments and aspects of the present disclosure may be shown in only certain figures or otherwise described in the certain parts of the disclosure, such features can be incorporated into other embodiments and aspects shown in other figures or other parts of the disclosure. Along the same lines, certain features of embodiments and aspects of the present disclosure that are shown in certain figures or otherwise described in certain parts of the disclosure can be optional or deleted from such embodiments and aspects. Further, unless otherwise specified, none of the steps of the methods of the present disclosure are confined to any particular order of performance. Furthermore, all references cited herein are incorporated by reference in their entirety.

[0038] The following examples are illustrative of the techniques described herein.

[0039] EXAMPLES

[0040] Example 1. A heart valve prosthesis delivery device comprising: a delivery catheter comprising: a distal portion sized and configured to receive a heart valve prosthesis; a stabilization catheter having a central axis and comprising: a catheter body defining one or more inflation lumens; a tubular assembly disposed in the catheter body and comprising: an outer tubular member having an outer lumen and defining a longitudinally extending slit offset from the central axis and in fluid communication withthe outer lumen; an inner tubular member translationally displaceable within the outer lumen, the inner tubular member having an inner lumen and defining an aperture positionable within the longitudinally extending slot and in fluid communication with the inner lumen; a circumferential array of expandable anchoring segments disposed on the catheter body in fluid communication with the one or more inflation lumens and defining an opening sized and configured to permit blood flow through the heart; and a snare extending through the catheter body, the snare having a distal portion extending through the slit of the outer tubular member and the aperture of the inner tubular member and having a distal end positionable adjacent to the distal portion of the heart valve prosthesis delivery catheter, wherein the location of the distal end of the snare adjacent to the distal portion of the delivery catheter is adjustable via translational displacement of the inner tubular member relative to the outer tubular member.

[0041] Example 2. The heart valve prosthesis delivery device of Example 1 or 11, wherein the circumferential array of expandable anchoring segments comprises at least three balloons.

[0042] Example 3. The heart valve prosthesis delivery device of Examples 1 or 11, wherein the opening comprises one or more spaces between adjacent expandable anchoring segments.

[0043] Example 4. The heart valve prosthesis delivery device of Examples 1 or 11, wherein the opening comprises a space between the catheter body and the circumferential array of expandable anchoring segments.

[0044] Example 5. The heart valve prosthesis delivery device of Examples 1 or 11, further comprising a multi-lumen sheath having a first lumen through which the stabilization catheter is advanceable and a second lumen through which the delivery catheter is advanceable.

[0045] Example 6. The heart valve prosthesis delivery device of Examples 1 or 11, further comprising a single lumen sheath through which both the stabilization catheter and the delivery catheter are advanceable.

[0046] Example 7. The heart valve prosthesis delivery device of Examples 1 or 11, wherein the distal end of the snare has a loop or hook shaped configuration.

[0047] Example 8. The heart valve prosthesis delivery device of Examples 1 or 11, wherein the distal portion of the delivery catheter comprises a delivery capsule defining a chamber sized and configured to receive a heart valve prosthesis therein.

[0048] Example 9. The heart valve prosthesis delivery device of Example 8, further comprising a shaft having a distal portion operably coupled to the distal portion of the delivery catheter.

[0049] Example 10. The heart valve prosthesis delivery device of Example 9, further comprising a delivery sheath disposable about at least the distal portion of the shaft of the delivery catheter.

[0050] Example 11. The heart valve prosthesis delivery device of Example 1, further comprising a stiff wire extending through the inner lumen of the inner tubular member and attached to the snare.

[0051] Example 12. The heart valve prosthesis delivery device of Example 1, wherein at least the distal portion of the snare comprises a radiopaque material or marker to aid visualization under fluoroscopy for inserting the distal portion of the delivery catheter through the distal portion of the snare.

[0052] Example 13. A method of delivering a heart valve prosthesis comprising: obtaining the heart valve prosthesis delivery device of Example 1; inserting the heart valve prosthesis delivery device into the heart; advancing the circumferential array of expandable anchoring segments into a lumen of the heart superior to the implantation site of the heart valve prosthesis; radially expanding the circumferential array of expandable anchoring segments such that the array contacts the wall defining the lumen of the heart to anchor the array to the wall; advancing the distal portion of the delivery catheter toward the implantation site and through the distal end of the snare; manipulating the delivery catheter to position the distal portion of the delivery catheter into the implantation site; adjusting the distal end of the snare to alter the pulling angle of the snare; retracting the distal end of the snare to pull the delivery catheter laterally; deploying the heart valve prosthesis at the implantation site; and removing the heart valve prosthesis delivery device from the heart.

[0053] Example 14. The method of Example 1, wherein the heart valve prosthesis is a tricuspid valve prosthesis, the implantation site is a tricuspid valve armulus, and the lumen of the heart is an atrium or a superior vena cava.

[0054] Example 15. The method of Example 13, wherein adjusting the distal end of the snare to alter the pulling angle of the snare comprises controlling the translational displacement of the inner tubular member relative to the outer tubular member.

[0055] Example 16. A method of delivering a heart valve prosthesis comprising: obtaining the heart valve prosthesis delivery device of Example 1; inserting the stabilization catheter and the delivery catheter through an inferior vena cava; advancing the circumferential array of expandable anchoring segments into a superior vena cava or an atrium; radially expanding the circumferential array of expandable anchoring segments such that the array contacts the vessel wall of the superior vena cava or the atrial wall of the atrium to anchor the array to the vessel wall of the superior vena cava or the atrial wall of the atrium; advancing the distal portion of the delivery catheter toward a tricuspid annulus and through the distal end of the snare; manipulating the delivery catheter to position the distal portion of the delivery catheter in the tricuspid annulus; adjusting the distal end of the snare to alter the pulling angle of the snare; retracting the distal end of the snare to pull the delivery catheter laterally; deploying the heart valve prosthesis; and removing the heart valve prosthesis delivery device from the heart.

[0056] Example 17. A heart valve prosthesis delivery device comprising: a sheath having a proximal end, a distal end and a lumen extending therethrough; a delivery catheter extendable from the lumen of the sheath and comprising a distal portion sized and configured to receive a heart valve prosthesis; a stabilizer extendable from the lumen of the sheath and operably coupled to the delivery catheter, the stabilizer comprising: a moveable hollow guide having a proximal end and a distal end; an expandable mesh operably coupled to the distal end of the moveable hollow guide and defining openings sized and configured to allow blood flow through the heart; a pull wire having a proximal end and a distal end and extending through the moveable hollow guide and the expandable mesh, the distal end connected to the expandable mesh; a pull wire actuator operably coupled to the proximal end of the pull wire and configured to control the transition of the expandable mesh from a collapsed state to an expanded state; a guide actuator operably coupled to the proximal end of the moveable hollow guide and configured to control axial displacement of the moveable hollow guide from the lumen of the sheath, wherein the location of the distal portion of the delivery catheter is adjustable via control of the axial displacement of the moveable hollow guide.

[0057] Example 18. The heart valve prosthesis delivery device of Example 17, further comprising a handle, the guide actuator located on the handle.

[0058] Example 19. The heart valve prosthesis delivery device of Example 17, wherein the stabilizer is extendable from the distal end of the sheath.

[0059] Example 20. The heart valve prosthesis delivery device of Example 17, wherein the sheath comprises a side port in fluid communication with the lumen and the stabilizer is extendable from the side port of the sheath.

[0060] Example 21. A method of delivering a heart valve prosthesis comprising: obtaining the heart valve prosthesis delivery device of Example 17, 19 or 20; inserting the heart valve prosthesis delivery device through an inferior vena cava; advancing the stabilizer into a superior vena cava or an atrium; retracting the pull wire to transition the expandable mesh from a collapsed state to an expanded state such that the expandable mesh contacts the vessel wall of the superior vena cava or the atrial wall of the atrium to anchor the expandable mesh to the vessel wall of the superior vena cava or the atrial wall of the atrium; retracting the moveable hollow guide to manipulate the location of the the distal portion of the delivery catheter in the tricuspid annulus such that the distal portion is located at the desired site of the tricuspid annulus; deploying the heart valve prosthesis; and removing the heart valve prosthesis delivery device from the heart.

[0061] Example 22. A method of delivering a heart valve prosthesis comprising: advancing a heart valve prosthesis delivery device through an inferior vena cava, the delivery device including a deployable heart valve prosthesis; advancing an expandable member into a superior vena cava; radially expanding the expandable member such that the expandable member contacts the vessel wall of the superior vena cava to anchor the expandable member to the vessel wall, advancing the heart valve prosthesis delivery device towards a tricuspid annulus while the expandable member remains anchored to the vessel wall of the superior vena cava; deploying the heart valve prosthesis within the tricuspid armulus; and removing the heart valve prosthesis delivery device and the expandable member from the heart.

[0062] Example 23. The method of Example 22, wherein the expandable member is an expandable mesh defining openings sized and configured to permit blood flow through the heart.

[0063] Example 24. The method of Example 22, wherein the expandable member is a circumferential array of expandable anchoring segments collectively sized and configured to contact the vessel wall of the superior vena cava to anchor the expandable anchoring segments to the vessel wall.

Claims

WHAT IS CLAIMED IS:

1. A heart valve prosthesis delivery device comprising: a delivery catheter comprising: a distal portion sized and configured to receive a heart valve prosthesis; a stabilization catheter having a central axis and comprising: a catheter body defining one or more inflation lumens; a tubular assembly disposed in the catheter body and comprising: an outer tubular member having an outer lumen and defining a longitudinally extending slit offset from the central axis and in fluid communication with the outer lumen; an inner tubular member translationally displaceable within the outer lumen, the inner tubular member having an inner lumen and defining an aperture positionable within the longitudinally extending slot and in fluid communication with the inner lumen; a circumferential array of expandable anchoring segments disposed on the catheter body in fluid communication with the one or more inflation lumens and defining an opening sized and configured to permit blood flow through the heart; and a snare extending through the catheter body, the snare having a distal portion extending through the slit of the outer tubular member and the aperture of the inner tubular member and having a distal end positionable adjacent to the distal portion of the heart valve prosthesis delivery catheter, wherein the location of the distal end of the snare adjacent to the distal portion of the delivery catheter is adjustable via translational displacement of the inner tubular member relative to the outer tubular member.

2. The heart valve prosthesis delivery device of claim 1 or 11, wherein the circumferential array of expandable anchoring segments comprises at least three balloons.

3. The heart valve prosthesis delivery device of claims 1 or 11, wherein the opening comprises one or more spaces between adjacent expandable anchoring segments.

4. The heart valve prosthesis delivery device of claims 1 or 11, wherein the opening comprises a space between the catheter body and the circumferential array of expandable anchoring segments.

5. The heart valve prosthesis delivery device of claims 1 or 11, further comprising a multi-lumen sheath having a first lumen through which the stabilization catheter is advanceable and a second lumen through which the delivery catheter is advanceable.

6. The heart valve prosthesis delivery device of claims 1 or 11, further comprising a single lumen sheath through which both the stabilization catheter and the delivery catheter are advanceable.

7. The heart valve prosthesis delivery device of claims 1 or 11, wherein the distal end of the snare has a loop or hook shaped configuration.

8. The heart valve prosthesis delivery device of claims 1 or 11, wherein the distal portion of the delivery catheter comprises a delivery capsule defining a chamber sized and configured to receive a heart valve prosthesis therein.

9. The heart valve prosthesis delivery device of claim 8, further comprising a shaft having a distal portion operably coupled to the distal portion of the delivery catheter.

10. The heart valve prosthesis delivery device of claim 9, further comprising a delivery sheath disposable about at least the distal portion of the shaft of the delivery catheter.

11. The heart valve prosthesis delivery device of claim 1, further comprising a stiff wire extending through the inner lumen of the inner tubular member and attached to the snare.

12. A heart valve prosthesis delivery device comprising: a sheath having a proximal end, a distal end and a lumen extending therethrough; a delivery catheter extendable from the lumen of the sheath and comprising a distal portion sized and configured to receive a heart valve prosthesis; a stabilizer extendable from the lumen of the sheath and operably coupled to the delivery catheter, the stabilizer comprising: a moveable hollow guide having a proximal end and a distal end; an expandable mesh operably coupled to the distal end of the moveable hollow guide and defining openings sized and configured to allow blood flow through the heart; a pull wire having a proximal end and a distal end and extending through the moveable hollow guide and the expandable mesh, the distal end connected to the expandable mesh; a pull wire actuator operably coupled to the proximal end of the pull wire and configured to control the transition of the expandable mesh from a collapsed state to an expanded state; a guide actuator operably coupled to the proximal end of the moveable hollow guide and configured to control axial displacement of the moveable hollow guide from the lumen of the sheath, wherein the location of the distal portion ofthe delivery catheter is adjustable via control of the axial displacement of the moveable hollow guide.

13. The heart valve prosthesis delivery device of claim 10, wherein the stabilizer is extendable from the distal end of the sheath.

14. The heart valve prosthesis delivery device of claim 12, wherein the sheath comprises a side port in fluid communication with the lumen and the stabilizer is extendable from the side port of the sheath.

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