Patent Application
20200261219
Not Applicable
The invention relates to devices and methods for implanting devices within a heart chamber. More specifically, the invention relates to improved mitigation of paravalvular leakage, apposition and fit of the implanted anchoring structure with the heart chamber and related anatomy and closure of the septal hole when trans-septal delivery is used.
The human heart comprises four chambers and four heart valves that assist in the forward (antegrade) flow of blood through the heart. The chambers include the left atrium, left ventricle, right atrium and left ventricle. The four heart valves include the mitral valve, the tricuspid valve, the aortic valve and the pulmonary valve. See generally
The mitral valve is located between the left atrium and left ventricle and helps control the flow of blood from the left atrium to the left ventricle by acting as a one-way valve to prevent backflow into the left atrium. Similarly, the tricuspid valve is located between the right atrium and the right ventricle, while the aortic valve and the pulmonary valve are semilunar valves located in arteries flowing blood away from the heart. The valves are all one-way valves, with leaflets that open to allow forward (antegrade) blood flow. The normally functioning valve leaflets close under the pressure exerted by reverse blood to prevent backflow (retrograde) of the blood into the chamber it just flowed out of. For example, the mitral valve when working properly provides a one-way valving between the left atrium and the left ventricle, opening to allow antegrade flow from the left atrium to the left ventricle and closing to prevent retrograde flow from the left ventricle into the left atrium. This retrograde flow, when present, is known as mitral regurgitation or mitral valve regurgitation.
Native heart valves may be, or become, dysfunctional for a variety of reasons and/or conditions including but not limited to disease, trauma, congenital malformations, and aging. These types of conditions may cause the valve structure to fail to close properly resulting in regurgitant retrograde flow of blood from the left ventricle to the left atrium in the case of a mitral valve failure.
Mitral valve regurgitation is a specific problem resulting from a dysfunctional mitral valve that allows at least some retrograde blood flow back into the left atrium from the right atrium. In some cases, the dysfunction results from mitral valve leaflet(s) that prolapse up into the left atrial chamber, i.e., above the upper surface of the annulus as designated by line or plane A, instead of connecting or coapting to block retrograde flow. This backflow of blood places a burden on the left ventricle with a volume load that may lead to a series of left ventricular compensatory adaptations and adjustments, including remodeling of the ventricular chamber size and shape, that vary considerably during the prolonged clinical course of mitral regurgitation.
Regurgitation can be a problem with native heart valves generally, including tricuspid, aortic and pulmonary valves as well as mitral valves.
Native heart valves generally, e.g., mitral valves, therefore, may require functional repair and/or assistance, including a partial or complete replacement. Such intervention may take several forms including open heart surgery and open heart implantation of a replacement heart valve. See e.g., U.S. Pat. No. 4,106,129 (Carpentier), for a procedure that is highly invasive, fraught with patient risks, and requiring not only an extended hospitalization but also a highly painful recovery period.
Less invasive methods and devices for replacing a dysfunctional heart valve are also known and involve percutaneous access and catheter-facilitated delivery of the replacement valve. Most of these solutions involve a replacement heart valve attached to a structural support such as a stent, commonly known in the art, or other form of wire network designed to expand upon release from a delivery catheter. See, e.g., U.S. Pat. No. 3,657,744 (Ersek); U.S. Pat. No. 5,411,552 (Andersen). The self-expansion variants of the supporting stent assist in positioning the valve, and holding the expanded device in position, within the subject heart chamber or vessel. This self-expanded form also presents problems when, as is often the case, the device is not properly positioned in the first positioning attempt and, therefore, must be recaptured and positionally adjusted. This recapturing process in the case of a fully, or even partially, expanded device requires re-collapsing the device to a point that allows the operator to retract the collapsed device back into a delivery sheath or catheter, adjust the inbound position for the device and then re-expand to the proper position by redeploying the positionally-adjusted device distally out of the delivery sheath or catheter. Collapsing the already expanded device is difficult because the expanded stent or wire network is generally designed to achieve the expanded state which also resists contractive or collapsing forces.
Besides the open heart surgical approach discussed above, gaining access to the valve of interest is achieved percutaneously via one of at least the following known access routes: transapical; transfemoral; transatrial; and trans septal delivery techniques.
Transseptal delivery involves creating an access hole in the septum between the right and left atria. Once the delivery and implantation of the prosthetic heart valve device is achieved, the septal hole either remains open to heal on its own, or is sealed at least partially. However, known sealing techniques require additional tools and manipulation to achieve the at least partial closure. A more efficient and effective septal closure mechanism would be desirable.
Generally, the art is focused on systems and methods that, using one of the above-described known access routes, allow a partial delivery of the collapsed valve device, wherein one end of the device is released from a delivery sheath or catheter and expanded for an initial positioning followed by full release and expansion when proper positioning is achieved. See, e.g., U.S. Pat. No. 8,852,271 (Murray, III); U.S. Pat. No. 8,747,459 (Nguyen); U.S. Pat. No. 8,814,931 (Wang); U.S. Pat. No. 9,402,720 (Richter); U.S. Pat. No. 8,986,372 (Murray, III); and U.S. Pat. No. 9,277,991 (Salahieh); and U.S. Pat. Pub. Nos. 2015/0272731 (Racchini); and 2016/0235531 (Ciobanu).
In addition, all known prosthetic heart valves are intended for full replacement of the native heart valve. Therefore, these replacement heart valves, and/or anchoring or tethering structures, physically extend out of the left atrial chamber, in the case of mitral valves, and engage the inner annulus and/or valve leaflets, in many cases pinning the native leaflets against the walls of the inner annulus, thereby permanently eliminating all remaining functionality of the native valve and making the patient completely reliant on the replacement valve. In other cases, the anchoring structures extend into the left ventricle and may anchor into the left ventricle wall tissue and/or the sub-annular surface at the top of the left ventricle. Others may comprise a presence in, or engagement with, a pulmonary artery.
Obviously, there will be cases when native valve has lost virtually complete functionality before the interventional implantation procedure. In this case the preferred solution will comprise an implant that does not extent outside of, e.g., the left atrium, and that functions to completely replace the native valve function. However, in many other cases, the native valve remains functional to an extent and may, or may not, continue to lose functionality after the implantation procedure. A preferred solution in this case comprises delivery and implantation of a valve device that will function both as a supplemental or augmentation valve without damaging the native leaflets in order to retain native valve leaflet functionality as long as present, while also being fully capable of replacing the native function of a valve that slowly loses most or all of its functionality post-implantation of the prosthetic valve.
In all cases, including two-chamber solutions, paravalvular leakage (PVL) may develop as a result of insufficient sealing or apposition of the prosthetic valve device and the native chamber tissue, including but not limited to annular sealing. In the case of the exemplary mitral valve, PVL results in a retrograde leak of blood from the left ventricle to the left atrium, reducing the efficiency of the heart. Lack of sealing apposition may occur for several reasons.
For example, patients may have at least some calcification in the heart chamber, particularly in the annular surface which works to reduce compliance of that calcified tissue. This reduced compliance reduces the ability of the tissue and the prosthetic heart valve device to seal together on implantation, leaving gaps between tissue and device. The mitral valve annulus and the tricuspid valve annulus may be affected by calcification, leading to poor sealing apposition with the implanted prosthetic heart valve device and PVL.
Further, as seen in
Certain inventive embodiments described herein are readily applicable to single or two chamber solutions, unless otherwise indicated. Moreover, certain embodiments discussed herein may be applied to preservation and/or replacement of native valve functionality generally, with improved PVL mitigation, and are not, therefore, limited to the mitral valve and may be extended to include devices and methods for treating the tricuspid valve, the aortic valve and/or pulmonary valves.
Various embodiments of the several inventions disclosed herein address these, inter alia, issues.
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 hold created during transseptal delivery of the device.
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.
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
With specific reference to
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.
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
Reference is now made to exemplary boss structure 40 shown in
Other variations of prosthetic valve devices are known in the art and will also benefit from variations of the present invention.
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.
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.
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.
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.
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).
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.
Other hydrophilic materials such as hydrophilic metals may comprise portions of the anchoring structure 10.
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.
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
In embodiments as in
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
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.
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.
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.
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.
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.
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
In some embodiments, sealing of the left atrial appendage (LAA) may be an objective. In these cases, as shown in
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.
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.
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.
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.
This application claims the benefit of U.S. Provisional Application Serial No. 62/805662, filed Sep. 4, 2018 and entitled HYDROPHILIC SHIRT FOR PARAVALVULAR LEAK MITIGATION AND FIT AND APPOSITION OPTIMIZATION FOR PROSTHETIC HEART VALVE IMPLANTS, the entire contents of which are incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 62805662 | Feb 2019 | US |
