Delivery of heart chamber prosthetic valve implant

Abstract

The invention relates to prosthetic heart valves comprising a stent frame with valve support disposed or inverted at least partially within the stent frame, wherein the valve support is at least partially within the interior of the stent frame. The inverted configuration comprises a maximum number of layers of material in cross section where the stent frame and valve support overlap. The maximum number of cross-sectional layers of material structure may be reduced to, e.g., two layers of material to reduce outer diameter during delivery by everting the valve portion to a position located outside of the stent portion, followed by inverted reconfiguration back to the inverted anchoring structure after delivery from the lumen of the delivery catheter to the heart chamber.

Description

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not Applicable

BACKGROUND OF THE INVENTION

Field of the Invention

The invention relates to devices and methods for implanting devices within a heart chamber. More specifically, the invention relates to preferably single-chamber anchoring frames comprising generally a stent portion and a valve portion disposed or inverted at least partially within the stent portion in the inverted, deployed configuration, wherein the inverted valve portion overlaps with at least a portion of the stent portion. The deployed configuration thus comprises a number of layers of material, most preferably more than two layers, along at least a portion of the anchoring frame in cross-section and may include two layers for the stent frame portion and two layers for the valve support portion. The cross-sectional layers of material structure may be reduced to, e.g., two layers of material to reduce outer diameter during delivery by everting the valve portion to a position located outside of the stent portion, followed by inverted reconfiguration back to the anchoring structure with more than two layers in cross section after delivery from the lumen of the delivery catheter and in preparation for implantation.

Description of the Related Art

Prosthetic cardiac valve and left atrial appendage occluding devices are well known in the art. The native heart valves, e.g., aortic, pulmonary, tricuspid and mitral valves, are critical in assuring the forward-only flow of an adequate supply of blood through the cardiovascular system. These heart valves may lose functionality as a result of, inter alia, congenital, inflammatory, infectious diseases or conditions. Early interventions repaired or replaced the dysfunctional valve(s) during open heart surgery. More recently, besides the open heart surgical approach discussed above, gaining access to the valve of interest may be achieved percutaneously via one of at least the following known access routes: transapical; transfemoral; transatrial; and transseptal delivery techniques, collectively transcatheter techniques.

Generally, in a transcatheter technique, the prosthetic valve is mounted within a stented frame that is capable of achieving collapsed and expanded states. The device is collapsed and advanced through a sheath or delivery catheter positioned in a blood vessel of the patient until reaching the implantation site. The stented frame is generally released from the catheter or sheath and, by a variety of means, expanded with the valve to the expanded functional size and orientation within the heart. One of the key issues is ease of delivery of the prosthetic valve, including the stent frame and valve. More specifically the outer diameter of the collapsed device within the catheter is of significant interest. The present invention addresses this issue.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

FIG. 1 illustrates a cross-sectional view of one embodiment of the present invention.

FIG. 2 illustrates a cross-sectional view of one embodiment of the present invention.

FIG. 3 illustrates a cross-sectional view of one embodiment of the present invention.

FIG. 4 illustrates a cross-sectional view of one embodiment of the present invention.

FIG. 5A illustrates a cross-sectional view of one embodiment of the present invention.

FIG. 5B illustrates a cross-sectional view of one embodiment of the present invention.

FIG. 5C illustrates a cross-sectional and partial cutaway view of one embodiment of the present invention.

FIG. 5D illustrates a cross-sectional view of one embodiment of the present invention.

FIG. 5E illustrates a cross-sectional view of one embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Generally, the prosthetic heart valve comprises a collapsible and expandable stent frame as is commonly known in the art and that may be partially manufactured from a shape memory alloy to facilitate biased expansion, and an internally supported one-way valve. The stent frame comprises a lower aperture and is provided with a valve support substantially surrounding the lower aperture and that comprises a first inverted deployed position inside the stent frame and a second everted delivery position outside the stent frame. The stent frame may comprise a central longitudinal axis that the valve support is generally centered around and along which the valve support may translate to achieve the first inverted and second everted positions. The translation from the first inverted position to the second inverted position, and from the second inverted position to the first inverted position occurs by enabling the valve support to move through the lower aperture. The operative connection of the valve support with the stent frame allows flexion, stretching or hinging movement of the valve support relative to the stent frame to achieve the first inverted and second everted positions. Such flexing, stretching and/or hinging connections may be achieved by the expansion and/or collapse of stent frame cells and are well known to the skilled artisan. Therefore, the stent frame and valve support may comprise a stented structure, wherein the stent frame and valve support comprise stent cells and wherein the valve support may be formed from the same material as the stented structure, wherein the valve support structure is turned inside, or inverted within, the interior of the stent frame.

The valve support may be a cylinder with a height and inner and outer diameters that may be constant or that may vary over the height of the cylinder as in FIG. 2, for example. Alternatively, the valve support may comprise a cone-shaped structure as shown in FIG. 1. The valve support may comprise a separately manufactured structure that is operatively connected with the stent frame. Alternatively, the valve support may be formed from the same continuous layer that forms the stent frame, wherein the valve support is inverted within the stent frame in a deployed configuration. The term “operatively engaged” or “operative engagement” relating to the relationship of the valve support and the frame is defined herein to cover both of these possible arrangements. In each embodiment, the valve support is adapted and configured to transition between an inverted position at least partially within the interior of the stent frame and an everted position wherein the valve support is located outside of the stent frame.

The illustrated cone-shaped structure comprises side walls of non-constant diameter wherein the diameter increases from the top of the valve support to the bottom. Such a cone-shaped valve support may also comprise side walls of substantially constant diameter. Still more alternatively, the valve support may comprise other shaping geometries and/or dimensions. What is minimally required is that the valve support be in operative engagement and connection with the frame and valve and amenable to achieving the first inverted and second everted positions. The walls of the valve support must be sufficiently flexible or compliant to enable the valve support to translate through and/or within the lower orifice to achieve the first inverted, deployed position and/or second everted, delivery position. A flexible polymer or mesh or slidable metal frame construction, or similar may be used, as will be well known to the skilled artisan. In addition, the material may be constructed from a laser cut, wire or braided construction of a self-expandable material.

It is noteworthy that the valve support may be at least partially within the interior of the stent frame when deployed in the first inverted position. In other embodiments, the valve support may be entirely within the stent frame when deployed in the first inverted position. Stated differently, the valve support may at least partially overlap with the stent frame within an overlap region as discussed further below.

Further, the position of the valve as supported by the valve support, once deployed in an exemplary left atrium for supplementing and/or replacing the function of native mitral valve leaflets, the left atrium further comprising an upper annular surface or annular plane and an annulus, may be: (1) collinear with the upper annular plane or surface; (2) may be within the annulus or annular throat, i.e., below the upper annular plane or surface; or (3) above the annular plane or surface.

The prosthetic heart valve may in some embodiments be biased towards achieving the first inverted position and may, for example, be subject to a biasing expanding force that urges the valve support to the first inverted position. The biasing expanding force may be generated by the self-expanding stent frame whereby the biasing expanding force may be overcome by a tensile force applied generally and at least partially in the direction of the longitudinal axis and comprising a magnitude greater than the biasing force in order to transition or translate the prosthetic heart valve, specifically the valve support, to the second everted position. In this case, when the tensile force is less than the biasing force, the prosthetic heart valve will transition back to the first inverted position.

It is noteworthy that the necessary tensile force to drive the valve support from the everted second position to the inverted first position may come from the biasing expansion force provided by the expanding stent frame, so that as the stent frame expands, either by virtue of shape memory material or by physical means, the valve support is drawn at least partially into the interior of the stent frame and, therefore, into the inverted first position for deployment by the expansion and/or tensile forces generated by the expanding stent.

In other embodiments, the valve support may not comprise a bias toward either the first inverted or the second everted position, but instead is translatable along the longitudinal axis by application of force. The required force in this embodiment may be provided by an operator with push or pull wires that are inserted during the delivery process. Alternatively, the required force in this embodiment, in particular for the translation of the valve support from the second everted position to the first inverted position may be provided by the expanding deployment of the stent frame itself when released from the delivery catheter lumen. In this case, the expanding stent frame, in operative connection with the valve support and as discussed above, will draw the valve support from the second everted position into the first inverted position to achieve full deployment within the heart chamber as a result of tensile forces and/or expansion forces generated by the expanding stent frame.

In all cases, the prosthetic valve comprising the stent frame, valve support and one-way valve within the valve support, are configured to be extended or everted into the second everted position. As will now be readily understood, the stent frame in the deployed position may comprise at least two cross-sectional layers taken along a longitudinal axis, a right side wall and a left side wall. Further, the valve support also comprises at least two cross-sectional layers along the longitudinal axis when deployed, i.e., in the first inverted position, a right side wall and a left side wall. Thus, when in the first inverted position, the valve support layers and the stent frame layers overlap with at least four layers of material present where the overlap occurs and along the longitudinal axis. These at least four layers of material create a maximum outer diameter that can make delivery to the subject heart chamber difficult.

When the second everted position is achieved, the stent frame and/or valve support no longer overlap, so that there is no longer an area where at least four layers of material is present along the longitudinal axis, thus reducing the maximum outer diameter accordingly.

The device may be further compressed to bring the stent frame's right and left side walls together and the valve support's right and left side walls together, most preferably along a single plane to provide the most compressive reduction in size in preparation for positioning with a lumen of a delivery catheter.

Therefore, in certain embodiments, the deployed first inverted position of the prosthetic heart valve may comprise four cross-sectional layers of material where the stent frame and valve support overlap: (1) the left side of stent frame; (2) the right side of stent frame; (3) the left side of the valve support; and (4) the right side of the valve support. Achieving the second everted position removes the valve support from the interior of the stent frame and when compressed as described above reduces the number of cross-sectional layers for the prosthetic heart valve.

In some embodiments, the overall length of the prosthetic heart valve may be temporarily increased in the everted second position, compared with the length in the first inverted position, during translation through the delivery catheter, but the cross-sectional maximum diameter of the device in the everted second position may also be lessened as compared with the cross-sectional diameter of the device when in the inverted first position.

The extension of the prosthetic valve to the second everted position may occur just before loading into the proximal end of the delivery catheter lumen for easier delivery to the heart chamber of interest, e.g., the left atrium. Once the prosthetic valve exits the distal end of the delivery catheter lumen, the prosthetic valve moves, or is moved, from the second everted position to the deployed and first inverted position. As discussed above, this deployment transformation may occur automatically by virtue of biasing or other forces as the stent frame expands.

With reference to the Figures, a variety of prosthetic heart valve device embodiments are illustrated as deployed within an exemplary left atrium, anchored over the annulus 202 and wherein the valve support 104 and/or one-way valve 106 therein is/are disposed above the upper annular surface 200. In each embodiment, the one-way valve 106 and valve support 104 do not physically interact with the native mitral valve leaflets 204, though in other embodiments the valve support and/or one-way valve may physically interact with the native mitral valve leaflets 204.

FIG. 1 provides a prosthetic heart valve device 100 with an exemplary cone-shaped valve support 104. FIG. 2 illustrates a prosthetic heart valve device 100 with an exemplary cylinder-shaped valve support 104. FIG. 3 illustrates a prosthetic heart valve device 100 with an exemplary tapered curvilinear valve support 104, while FIG. 4 shows a prosthetic heart valve device 100 comprising a valve support 104 formed from the stent frame 102 material and turned inside the stent frame 102. FIG. 4 illustrates a valve support 104 defined by an inversion of the stent frame 102. In each embodiment shown, the valve support 104 may be separately manufactured and attached to the stent frame 102 or the valve support 104 may be formed from the stent frame 102. In all cases, the valve support 104 is at least partially disposed within the interior of the stent frame 102, wherein at least a portion of the valve support 104 overlaps with a portion of the stent frame 102 in the overlap region as shown.

FIG. 5A illustrates the prosthetic valve of FIG. 4 in the first inverted position wherein the valve support 104 is at least partially inside the interior of the stent frame 102 and wherein the stent frame 102 and valve support 104 are at least partially overlapping each other, creating a number of material layers in the overlap region. In the illustrated case, there are six layers of overlapping material as indicated by the numbers 1-6 in FIG. 5A. As shown, force may be applied, either by pushing or pulling or a combination of push/pull to transition the device 100 to the second everted position of FIG. 5B which may then be configured and inserted into the lumen 220 of delivery catheter 222 as shown in FIG. 5C for translation therethrough to the distal end of the delivery catheter and release into the subject heart chamber. A primary advantage of the present invention is the reduction of layers of material by eliminating the overlap region as shown in the transition between FIGS. 4A and 5B. In FIG. 5B, only two of the original six layers are present, greatly increasing the opportunity to deliver the device 100 in a form with a smaller maximum diameter as compared with the device of FIG. 5A.

Once released from the delivery catheter lumen 220, the device 100 may be transitioned from the second everted configuration of FIGS. 5C and 5D to the first inverted position of FIGS. 5A and 5E for subsequent positioning and anchoring within the heart chamber.

The length L of the device in the first inverted position may be less than the length L′ of the device in the second everted position. Moreover, the diameter D of the device 100 in the first inverted position may be greater than the diameter D′ of the device 100 in the second everted position.

The embodiments of FIGS. 1-3 each comprise four layers of material within the overlap region in the first inverted position along longitudinal axis A, but when transitioned to the second everted position, the cross-sectional layers of material are reduced to two, similar to that shown in FIG. 5B.

Various methods are possible using the above-described embodiments.

For example, a method of manipulating the shape of a prosthetic heart valve is possible, the method comprising:

providing a prosthetic heart valve according to this disclosure, the prosthetic heart valve comprising the self-expandable stent frame configured to generate a biasing expanding force, wherein the prosthetic heart valve is in the second everted position;

transitioning the prosthetic heart valve from the second everted position to the first inverted position using at least the biasing expanding force generated by the self-expandable stent frame.

Further, a method of delivering a prosthetic heart valve to a patient's heart chamber using the inventive prosthetic heart valve, comprising:

providing a prosthetic heart valve according to this disclosure, the prosthetic heart valve in the first inverted position;

providing a delivery catheter with a proximal end, a distal end and a lumen therethrough;

positioning the delivery catheter with the distal end within the heart chamber and the proximal end outside of the patient;

transitioning the prosthetic heart valve from the first inverted position to the second everted position;

inserting the prosthetic heart valve in the second everted position into the lumen of the delivery catheter at the proximal end;

translating the prosthetic heart valve through the lumen to the distal end of the delivery catheter;

releasing the prosthetic heart valve from the distal end of the delivery catheter; and

transitioning the prosthetic heart valve from the second everted position to the first inverted position within the heart chamber.

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

Claims

1. A prosthetic heart valve for delivery to and implantation within a heart chamber comprising: a self-expandable, non-braided, stent frame comprising stent cells and an interior;a valve support defined by an inversion of a continuous layer of material formed by the stent cells of the expandable stent frame, wherein the valve support is at least partially disposed in the interior of the stent frame; anda one-way valve supported within the valve support, the one-way valve configured to allow blood flow in a forward direction and prevent regurgitation through the one-way valve in a backward direction; wherein the prosthetic heart valve configured to transition between: a first inverted position wherein the valve support is positioned at least partially within the interior of the stent frame; anda second everted position wherein the valve support is positioned outside of the stent frame in the downstream direction.

2. The prosthetic heart valve of claim 1, wherein the first inverted position comprises a deployed configuration and the second everted position comprises a delivery configuration.

3. The prosthetic heart valve of claim 2, wherein the self-expandable stent frame is configured to generate an expanding biasing force.

4. The prosthetic heart valve of claim 3, wherein when the prosthetic heart valve is in the second everted position, the expanding biasing force generated by the self-expandable stent frame is alone sufficient to at least partially transition the prosthetic heart valve from the second everted position to the first inverted position.

5. The prosthetic heart valve of claim 3, wherein when the prosthetic heart valve is in the second everted position, the expanding biasing force generated by the self-expandable stent frame in combination with an externally applied force is sufficient to transition the prosthetic heart valve from the second everted position to the first inverted position.

6. The prosthetic heart valve of claim 3, wherein externally applied force is required to transition the prosthetic heart valve from the first inverted position to the second everted position.

7. The prosthetic heart valve of claim 3, wherein when the prosthetic heart valve is in the first inverted position, an externally applied force is required to transition the prosthetic heart valve from the first inverted position to the second everted position.

8. The prosthetic heart valve of claim 1, wherein the prosthetic heart valve in the second everted position comprises a length that is greater than a length of the prosthetic heart valve in the first inverted position.

9. The prosthetic heart valve of claim 8, wherein the prosthetic heart valve in the second everted position comprises a maximum diameter that is smaller than a maximum diameter of the prosthetic heart valve in the first everted position.

10. The prosthetic heart valve of claim 1, wherein the prosthetic heart valve in the second everted position comprises a maximum diameter that is smaller than a maximum diameter of the prosthetic heart valve in the first everted position.

11. The prosthetic heart valve of claim 8, wherein the prosthetic heart valve in the second everted position is further compressible to fit within a lumen of a delivery catheter.

12. The prosthetic heart valve of claim 1, wherein: the prosthetic heart valve in the first inverted position comprises a number of layers of material along a longitudinal cross-section of the prosthetic heart valve;the prosthetic heart valve in the second everted position comprises a number of layers of material along a longitudinal cross-section of the prosthetic heart valve; andthe number of layers of material in the second everted position is less than the number of layers in the first everted position.

13. The prosthetic heart valve of claim 12, further comprising two layers of material along the longitudinal cross-section of the prosthetic heart valve in the second everted position.

14. The prosthetic heart valve of claim 1, wherein the prosthetic heart valve is configured to be delivered via a delivery catheter to the heart chamber using a transcatheter access and delivery technique.

15. The prosthetic heart valve of claim 1, wherein the prosthetic heart valve is configured to be delivered via a delivery catheter to the heart chamber using a transcatheter access and delivery technique selected from the group consisting of: transfemoral, transapical, transseptal, transapical and transatrial.

16. The prosthetic heart valve of claim 1, wherein the prosthetic heart valve is configured to be delivered by surgical implantation.

17. The prosthetic heart valve of claim 1, wherein the prosthetic heart valve is configured to at least one of supplement and replace the function of native valve leaflets from the group consisting of: native mitral valve leaflets, native tricuspid valve leaflets, native aortic valve leaflets, and native pulmonary valve leaflets.

18. The prosthetic heart valve of claim 17, wherein when the prosthetic heart valve is in the first inverted configuration and implanted in the heart chamber, the implanted prosthetic heart valve does not physically interact with the native valve leaflets.

19. The prosthetic heart valve of claim 17, wherein when the prosthetic heart valve is in the first inverted configuration and implanted in the heart chamber, the implanted prosthetic heart valve does physically interact with the native valve leaflets.

20. A prosthetic heart valve for implantation in the left atrium of a patient, with at least partial anchoring on the upper annular surface of the left atrium, for at least one of supplementation and replacement of the function of the patient's native mitral valve, the prosthetic heart valve comprising: a self-expandable, non-braided, stent frame comprising stent cells and an interior;a valve support defined by an inversion of a continuous layer of material forming the stent cells of the expandable stent frame, wherein the valve support is at least partially disposed in the interior of the stent frame; anda one-way valve supported within the valve support, the one-way valve configured to allow blood flow in a downstream direction and prevent regurgitation through the one-way valve in an upstream direction, the prosthetic heart valve configured to transition between: a first inverted deployed position wherein the valve support is positioned at least partially within the interior of the stent frame; anda second everted delivery position wherein the valve support is positioned outside of the stent frame in the downstream direction; wherein:when the prosthetic heart valve is implanted within the left atrium, the one-way valve is positioned in one of the locations in the group consisting of: collinear with the upper annular surface, below the upper annular surface, or above the upper annular surface.

21. A method of manipulating a shape of a prosthetic heart valve, the method comprising: providing a prosthetic heart valve according to claim 1, wherein the self-expandable stent frame is configured to generate a biasing expanding force, wherein the providing is performed when the prosthetic heart valve is in the second everted position; andtransitioning the prosthetic heart valve from the second everted position to the first inverted position using at least the biasing expanding force generated by the self-expandable stent frame.

22. The method of claim 21, wherein the prosthetic heart valve has a length in the second everted position that is less than a length of the prosthetic heart valve in the first everted position.

23. A method of delivering a prosthetic heart valve to a patient's heart chamber, the method comprising providing a prosthetic heart valve according to claim 1 in the first inverted position;providing a delivery catheter with a proximal end, a distal end and a lumen therethrough;positioning the delivery catheter with the distal end within the heart chamber and the proximal end outside of the patient;transitioning the prosthetic heart valve from the first inverted position to the second everted position;inserting the prosthetic heart valve in the second everted position into the lumen of the delivery catheter at the proximal end;translating the prosthetic heart valve through the lumen to the distal end of the delivery catheter;releasing the prosthetic heart valve from the distal end of the delivery catheter; andtransitioning the prosthetic heart valve from the second everted position to the first inverted position within the heart chamber.