HYDROPHILIC SKIRT FOR PARAVALVULAR LEAK MITIGATION AND FIT AND APPOSITION OPTIMIZATION FOR PROSTHETIC HEART VALVE IMPLANTS

Abstract

The present invention provides a prosthetic heart valve device with improved fit, apposition and/or paravalvular leakage mitigation. Thus, the prosthetic device comprises an anchoring structure for supporting prosthetic valve leaflets, wherein the anchoring structure comprises and/or is formed at least partially from a hydrophilic material designed to swell when contacted by the water solute in the patient's blood. Locating the hydrophilic material to provide swelling to improve the fit and/or apposition of the device to the patient's tissues results in, inter alia, improved paravalvular leakage mitigation. Some of the methods and mechanisms described herein may also be used to provide a seal against the septal hole created during transseptal delivery of the device.

Claims

1. A device for expanded implantation into a patient's heart chamber, comprising: an expandable anchoring structure comprising an outer surface; a base section; a valve support adapted for supporting at least one prosthetic valve, and a skirt of single layered material operatively attached to a portion of the outer surface of the anchoring structure and wherein the skirt comprises hydrophilic material that is integrated into, or coated onto, the single layered material of the skirt.

2. The device of claim 1, wherein the hydrophilic material is coated onto an outer surface of the single layered material of the skirt.

3. The device of claim 1, wherein the hydrophilic material is overcoated with a thin film of material that is biodegradeable, dissolvable, bioerodable and/or bioabsorbable when exposed to liquid to enable subsequent exposure of the hydrophilic material to the liquid.

4. The device of claim 1, wherein the hydrophilic material is encased in nanoparticles that are integrated into, or coated onto, the single layered material of the skirt, and wherein the nanoparticles are biodegradeable, dissolvable, bioerodable and/or bioabsorbable when exposed to liquid to enable subsequent exposure of the hydrophilic material to the liquid.

5. The device of claim 1, wherein at least a portion of the skirt comprises two layers of material, wherein at least one pocket is defined between the two layers of material, and wherein the hydrophilic material is disposed within the at least one pocket of the skirt.

6. The device of claim 5, wherein the hydrophilic material is encased in nanoparticles, and wherein the nanoparticle is breakable, biodegradeable, dissolvable, bioerodable and/or bioabsorbable when exposed to liquid to enable subsequent exposure of the hydrophilic material to the liquid.

7. The device of claim 1, wherein the hydrophilic material comprises at least one of a hydrophilic polymer, a hydrophilic metal and/or hydrophilic hydrogel.

8. The device of claim 1, wherein the hydrophilic material is positioned to seal against and/or within the left atrial appendage when the device is implanted into the left atrium.

9. The device of claim 5, wherein the hydrophilic material is positioned to seal against and/or within the left atrial appendage when the device is implanted into the left atrium.

10. The device of claim 1, further comprising at least one ridge, flap or ring operatively attached to the skirt and comprising hydrophilic material.

11. The device of claim 10, wherein the at least one ridge, flap or ring is adapted to seal against or within the left atrial appendage.

12. The device of claim 1, wherein the device is adapted for use as a prosthetic heart valve for one or more of the group consisting of: the mitral valve, tricuspid valve, aortic valve and/or pulmonary valves.

13. A device for expanded implantation within a heart chamber comprising: an expandable anchoring structure comprising a base section and an outer surface; and wherein at least a portion of the anchoring structure comprises a hydrophilic material.

14. The device of claim 13, wherein the hydrophilic material is overcoated with a thin biodegradeable, dissolvable, bioerodable and/or bioabsorbable thin film.

15. The device of claim 13, wherein the hydrophilic material comprises a hydrophilic metal.

16. The device of claim 13, further comprising a valve support operatively connected with the base section and adapted to support at least one prosthetic valve, wherein the base section comprises a hydrophilic metal.

17. The device of 16, wherein the base section comprises a stent formed of struts and wherein at least some of the struts comprise a hydrophilic metal.

18. The device of claim 13, further comprising a valve support integrally formed from the base section and adapted to support at least one prosthetic valve, wherein the base section comprises a hydrophilic metal.

19. The device of claim 18, wherein the base section comprises a stent formed of struts and wherein at least some of the struts comprise a hydrophilic metal.

20. The device of claim 18, further comprising a skirt of single layered material operatively attached to a portion of the outer surface of the anchoring structure.

21. The device of claim 20, wherein the skirt comprises hydrophilic material that is integrated into, or coated onto, the single layered material of the skirt.

22. The device of claim 21, wherein the hydrophilic material is coated onto an outer surface of the single layered material of the skirt.

23. The device of claim 21, wherein the hydrophilic material is overcoated with a thin film of material that is biodegradeable, dissolvable, bioerodable and/or bioabsorbable when exposed to liquid to enable subsequent exposure of the hydrophilic material to the liquid.

24. The device of claim 21, wherein the hydrophilic material is encased in nanoparticles that are integrated into, or coated onto, the single layered material of the skirt, and wherein the nanoparticles are biodegradeable, dissolvable, bioerodable and/or bioabsorbable when exposed to liquid to enable subsequent exposure of the hydrophilic material to the liquid.

25. The device of claim 13, further comprising a skirt of material operatively attached to a portion of the outer surface of the anchoring structure and wherein at least a portion of the skirt comprises two layers of material, wherein at least one pocket is defined between the two layers of material, and wherein the hydrophilic material is disposed within the at least one pocket of the skirt.

26. The device of claim 25, wherein the hydrophilic material is encased in nanoparticles, and wherein the nanoparticle is breakable, biodegradeable, dissolvable, bioerodable and/or bioabsorbable when exposed to liquid to enable subsequent exposure of the hydrophilic material to the liquid.

27. The device of claim 25, wherein the at least one pocket is positioned to seal against and/or within the left atrial appendage when the device is implanted into the left atrium.

28. The device of claim 13, wherein the device is adapted for use as a prosthetic heart valve for one or more of the group consisting of: the mitral valve, tricuspid valve, aortic valve and/or pulmonary valves.

29. (canceled)

30. A device for expanded implantation within a heart chamber comprising: an expandable anchoring structure comprising a base section and an outer surface; a skirt of material operatively attached to a portion of the outer surface of the anchoring structure and wherein at least a portion of the skirt comprises two layers of material, wherein at least one pocket is defined between the two layers of material, and wherein the hydrophilic material is disposed within the at least one pocket of the skirt.

31. The device of claim 30, wherein the hydrophilic material is encased in nanoparticles, and wherein the nanoparticle is breakable, biodegradeable, dissolvable, bioerodable and/or bioabsorbable when exposed to liquid to enable subsequent exposure of the hydrophilic material to the liquid.

32. The device of claim 30, wherein at least one pockets is positioned to mitigate paravalvular leakage.

33. The device of claim 30, wherein at least one pockets is positioned to seal against and/or within the left atrial appendage when the device is implanted into the left atrium.

34. The device of claim 30, wherein when the device is delivered transseptally into a left atrium, at least one pocket is positioned to seal a delivery hole located in the septum between the right and left atria.

35. The device of claim 30, wherein the device is adapted for use as a prosthetic heart valve for one or more of the group consisting of: the mitral valve, tricuspid valve, aortic valve and/or pulmonary valves.

36. (canceled)

Description

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0023] FIG. 1 illustrates certain features of the heart in cross-section.

[0024] FIG. 2 illustrates a cross-sectional perspective view of the left side of the heart.

[0025] FIG. 3 illustrates a cross-sectional view of the heart showing retrograde blood flow resulting from mitral valve regurgitation compared with normal blood flow.

[0026] FIG. 4A illustrates a partial cutaway side view of one embodiment of the present invention.

[0027] FIG. 4B illustrates a side cutaway view of one embodiment of a valve support.

[0028] FIG. 5 illustrates a partial cutaway side view of one embodiment of the present invention.

[0029] FIG. 6 illustrates a partial cutaway side view of one embodiment of the present invention.

[0030] FIG. 7 illustrates a partial cutaway side view of one embodiment of the present invention.

[0031] FIG. 8 illustrates a partial cutaway side view of one embodiment of the present invention.

[0032] FIG. 9 illustrates a partial cutaway side view of one embodiment of the present invention.

[0033] FIG. 10 illustrates a partial cutaway side view of one embodiment of the present invention.

[0034] FIG. 11A illustrates a partial cutaway side view of one embodiment of the present invention.

[0035] FIG. 11B illustrates a top cutaway view of one embodiment of the present invention.

[0036] FIG. 12 illustrates a side cutaway view of one embodiment of the present invention.

[0037] FIG. 13 illustrates a side cutaway view of one embodiment of the present invention.

[0038] FIG. 14 illustrates a side cutaway view of one embodiment of the present invention.

[0039] FIG. 15 illustrates a side cutaway view of one embodiment of the present invention.

[0040] FIG. 16 illustrates a side view of one embodiment of the present invention.

[0041] FIG. 17 illustrates a side view of one embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

[0042] Various embodiments of the present invention comprise a prosthetic heart valve anchoring solution that combines improved PVL mitigation through improved sealing and/or apposition between the implanted device and the heart chamber tissue.

[0043] The invention will be described in the context of an exemplary single-chamber expanded and implanted device structure comprises certain exemplary embodiments as shown in FIGS. 4A-11B and 16-17. As stated above, however, the various embodiments of the invention extend to implanted prosthetic heart valve devices generally including but not limited to 1 and/or 2-chamber solutions.

[0044] With specific reference to FIGS. 4A-11B and 16-17, exemplary embodiments of a collapsible, and expandable, anchoring structure 10 comprising an expandable stent frame 12, or other expandable material such as a wire mesh and/or a shape memory metal or polymer or the equivalent comprising an expandable and collapsible web or interconnected cells as is known in the art. Anchoring structure 10 preferably may be biased to expand to achieve the expanded state from a collapsed state, though other collapsed-to-expanded mechanisms may also be employed. Further, anchoring structure 10 may comprise a base section 20 that may be formed of the expandable stent frame 12 or equivalent and, therefore may achieve a plurality of expanded states in order to expand and contract with the natural movements of the heart chamber walls and the annulus, including the upper annular surface and/or portions of the inner throat of the annulus located between the upper annular surface or floor of the exemplary left atrium and the left ventricle.

[0045] Base section 20 comprises an outer surface 22 and an inner surface 24 and comprises a valve support 30 either integrally formed from the base section or operatively engaged or otherwise attached to base section. Valve support 30 comprises an inner surface 32 and an outer surface 34 wherein valve support 30 is adapted to substantially align with the subject annulus and allow one-way, antegrade blood flow therethrough while preventing retrograde blood flow as a result of prosthetic leaflet(s) 36 disposed on the inner surface 32 of valve support 30.

[0046] Valve support 30 may be disposed wholly or at least partially within base section 20 or may, in alternate embodiments, completely extend away from base section 20 with no part of valve support 30 within the base section 20. Thus, as shown in FIG. 4A, valve support 30 is disposed entirely within base section 20. FIG. 5 illustrates the valve support 30 extending generally entirely outside base section 20. FIG. 6 illustrates the valve support 30 partially within base section 20 and also extending away from, and outside of, base section 20. FIG. 8 illustrates a variation of the valve support 30 of FIG. 4A in that the valve support 30 is formed integrally with base section 20.

[0047] Reference is now made to exemplary boss structure 40 shown in FIG. 7, which when present may be used to align the anchoring structure 10 in the annulus and, in combination with the base section 20, assist with sealing apposition against portions of the annulus including the annular surface and inner throat of the annulus within which boss 40 extends. Boss 40 may be used in combination with any of the structures described herein including, as shown attached to or integrally formed from base section 20 and aligned with, and/or effectively extending, the flow channel defined within valve support 30. In this sense, boss 40 is similar to the extended valve support 30 of FIG. 6. In other embodiments, portions of the anchoring structure, including the valve support 30 and/or boss 40, may extend downstream in the antegrade direction away from the upper surface of the annulus into the inner throat of the annulus. In some cases, the structure may extend downward to pin the native leaflets. In other cases, the structure may extend downward into the annulus but stopping short of pinning the native leaflets.

[0048] Other variations of prosthetic valve devices are known in the art and will also benefit from variations of the present invention.

[0049] It is known to cover at least a portion, typically the lower outer portion, of an anchoring frame for a prosthetic heart valve with some fabric or tissue to help prevent PVL. Known embodiments create bunching and the like of the covering material to form a seal against PVL. These solutions however do not properly solve the fit and/or apposition problems arising from annular calcification and/or the varying and variety of the annular landscape.

[0050] Thus, with reference to the Figures, base section's outer surface 22 may be at least partially covered with a skirt S formed from, or comprising, a material M that conforms and seals with portions of the atrial wall and/or the upper annular surface. In some embodiments as illustrated, portions of the anchoring structure 10 and/or the valve support 30 may extend a distance into the annular throat, i.e., below the annular surface toward the native leaflets, wherein at least some of the anchoring structure 10 and/or valve support 30 may be covered with material M.

[0051] In some embodiment, the material M may seal with at least part of the circumferential region of the wall that encompasses the left atrial appendage (LAA) within the exemplary left atrium in order to seal the LAA.

[0052] Material M may comprise a substance or compound that is hydrophilic, wherein a skirt for base section 20 may be formed, in whole or in part, from at least material M and also be hydrophilic. In this case, the hydrophilic skirt may absorb water from the patient's blood and expand or swell to provide a tightened seal and/or apposition between the base section 20 and relevant regions of the heart chamber, thereby serving as a barrier to retrograde blood flow upon implantation, mitigating and/or preventing PVL.

[0053] The hydrophilic material M may comprise a hydrophilic gel and/or hydrophilic polymer, for example that can be selected with a swelling modulus, or more than one swelling modulus, to help ensure that the swollen material M and/or hydrophilic skirt comprising material M swells to the right size and further ensure that the swelling process occurs slowly and gently to allow for the device to be properly positioned in the heart chamber before substantial swelling occurs. An exemplary hydrophilic hydrogel may comprise poly(vinyl alcohol) (PVA).

[0054] The hydrogel embodiment of material M may comprise hydrophilic polymer(s) that have been chemically, physically and/or ionically crosslinked to form a matrix that swells in water. The degree of swelling of hydrogels in water is determined by a balance between the free energy of polymer/solvent mixing, ionic interactions and elastic forces and is influenced by the extent of crosslinking and the chemical nature of the polymer. The degree of swelling, in turn, determines the mesh size of the hydrogel. Hydrophilic hydrogels and/or polymers may be temperature responsive and/or pH-responsive. Some, such as chitosan and alginate are naturally occurring and offer both natural hydrophilicity and biocompatibility. Still further, swelling may be initiated by mechanical means such as agitation.

[0055] Other hydrophilic materials such as hydrophilic metals may comprise portions of the anchoring structure 10.

[0056] The hydrophilic material M may be encapsulated within easily breakable, or dissolvable or biodegradeable or bioerodable nanoparticles, wherein when the nanoparticles are broken, the hydrophilic material M is exposed to water and begin the swelling process. In this case, the prosthetic heart valve device will be positioned and implanted before any substantial swelling can occur.

[0057] Skirt S may comprise two layers of material, an inner layer I attached to the outer surface 22 of base section 20, and an outer layer 0 wherein the inner and outer layer form a pocket or a series of pockets P. The hydrophilic material M may be disposed or attached or incorporated at designed areas within the pocket or series of pockets to facilitate swelling at the interfacing regions between the expanded device and the patient's anatomy that are most vulnerable to PVL. For example, pocket or pockets may be arranged around the bottom surface of base section 20 and/or at least partially upward therefrom. Exemplary skirts S comprising pocket(s) P are shown in the Figures, with particular reference to FIGS. 12-15. As shown in FIGS. 13-15, subpockets P may be provided within the two-layered skirt to provide discrete locating of the hydrophilic material M at regions particularly susceptible or vulnerable to insufficient apposition and/or PVL.

[0058] In embodiments as in FIGS. 5-7 and 15-17, wherein the valve support 30, or boss 40 or other structure, extends at least partially outwardly from base section 20, the skirt S may cover at least part of the outer surface 34 of the valve support 30, with hydrophilic material M integrated or otherwise comprising the skirt S including but not limited to inclusion in pocket(s) P and/or subpockets P formed as described above.

[0059] In the embodiment comprising a boss structure, or other extension into the inner throat of the annulus, pocket(s) P and/or subpockets P comprising material M may be formed between the boss structure and the base section 20 to swellingly close any gap between the device and the patient's anatomy. This is best shown in FIG. 15.

[0060] Alternatively, in the embodiments comprising encapsulated hydrophilic material M, the nanoparticles or capsules may be integrated, or incorporated into, or coated, attached or adhered to, the skirt in at least the PVL-vulnerable areas discussed above. Still more alternatively, the nanoparticles or capsules carrying hydrophilic material M may be affixed or adhered or coated onto or integrated into the skirt.

[0061] In certain embodiments, therefore, a pocket P formed in skirt S is not required and the skirt S may be formed of, or comprise, a single layer of material, with the hydrophilic material M affixed or adhered or coated thereon, or integrated therein, in either encapsulated or non-encapsulated forms. FIGS. 16 and 17 illustrate exemplary single layer skirts S comprising hydrophilic material M.

[0062] In alternative embodiments, portions of the anchoring structure 10 may be at least partially formed from hydrophilic material M and may be covered or overcoated by a thin film of biodegradeable, dissolvable, bioerodable and/or bioabsorbable material to delay solute interaction, and resulting swelling, with hydrophilic material M. For example, and without limitation, boss structure 40, or other extension into the inner throat of the annulus, may comprise a hydrophilic polymer that swells when contacted with a solute, e.g., water within blood. In this embodiment, a biodegradeable, bioerodable and/ bioabsorbable thin coating layer may be applied over the boss structure 40 to appropriately delay swelling until after implantation is achieved. The outer portions of the boss structure 40, i.e., those portions that are juxtaposed by and/or within the annulus and/or inner throat of the annulus, may comprise the hydrophilic material, e.g., polymer, so that only the outer portion of boss structure 40 swells in response to solute contact, leaving the dimensions of the inner boss structure 40 unaltered. Other areas of the anchoring structure 10 may also be formed from hydrophilic material M, e.g., a polymer(s), e.g., key struts or cells of the anchor 10 may comprise hydrophilic polymer that swells on solute contact.

[0063] Further, portions of anchoring structure 10 may also comprise a skirt S comprising a thin film of hydrophilic material M that may also be covered, or overcoated, temporarily during delivery and implantation by a biodegradeable, dissolvable, bioerodable and/or bioabsorbable thin film layer as described above.

[0064] Moreover, nanoparticles encapsulating hydrophilic material M as described above may be adhered or coated onto portions of anchoring structure 10 to comprise skirt S. These nanoparticles may be overcoated with a thin biodegradeable, dissolvable, bioerodable and/or bioabsorbable thin film to ensure adherence to the anchoring structure during delivery and implantation.

[0065] Each of the possible embodiments described above for implementing hydrophilic skirt comprising or incorporating hydrophilic material M may be used to cover portions of various configurations of prosthetic heart valve devices. Exemplary embodiments wherein the valve support 30 is formed from, or otherwise integrated or attached with, base section 20 are shown in FIGS. 4A, 8-10, 11A and 16-17. In this case, hydrophilic skirt S comprising hydrophilic material M as discussed above may cover the outer surface 22 of base section 20, extending to cover the bottom of base section 20 and extending further upward within base section 20 to cover the inner surface 32 of valve support 30.

[0066] In some embodiments, sealing of the left atrial appendage (LAA) may be an objective. In these cases, as shown in FIG. 15, a hydrophilic skirt S comprising hydrophilic material M may comprise a reserve pocket 100 of hydrophilic material M in the region of the LAA, wherein upon implantation, the hydrophilic material M swells to enlarge pocket 100 to cover and/or fill the LAA. The hydrophilic material M reserve may comprise a ring or gasket 102 of material M around the circumference of the skirt S so that locating the LAA is achieved no matter the rotational position of the implanted anchoring structure 10. Alternatively, the specific pocket 102 may be provided as described above that is located to the LAA for swelling sealing and/or filling of the LAA. The hydrophilic material M reserve may be formed according to the various embodiments discussed herein, including pocket(s) and/or nanoparticles and/or coating.

[0067] Generally, the improved sealing and/or apposition may therefore be improved by including hydrophilic material M at one or more locations on an anchoring structure 10. The hydrophilic material M may be associated or integrated with or incorporated with a skirt S, but this is just one embodiment. Nanoparticles, when employed, may comprise an easily breakable material and/or biodegradeable, bioerodable or dissolving material to provide the desired delay in exposing the hydrophilic material M to blood.

[0068] Still more alternatively, hydrophilic material-containing nanoparticles may be injected or otherwise delivered to the relevant regions of the implanted device, either after expansion and implantation is fully achieved, or just prior to full expansion and implantation. Further, hydrophilic material M may be injected or otherwise delivered without encapsulation to the relevant regions of the implanted device, either after expansion and implantation is fully achieved or just prior to full expansion and implantation. The injection or delivery of the hydrophilic material M, whether or not encapsulated, may be achieved by providing a reservoir of hydrophilic material M (encapsulated or not) that is, by known techniques, delivered through a delivery device comprising a lumen in fluid communication with the reservoir. The distal tip of delivery device may be manipulated by the operator, by e.g., use of a push/pull wire(s) or the like, to enable delivery at the discreet regions of interest at or around the device and related anatomy. The delivery device described here may be a modification of the delivery catheter and related mechanisms for delivery of the prosthetic device to the subject heart chamber.

[0069] Moreover, the device may comprise at least one ridge, flap or ring operatively attached to the skirt and comprising hydrophilic material M as discussed herein, wherein the at least one ridge, flap or ring may in some cases be adapted to seal against or within the left atrial appendage and/or against the annulus of the subject heart chamber.

[0070] 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.