Retrievable self-expanding non-thrombogenic low-profile percutaneous atrioventricular valve prosthesis

• US 10,583,004 B2
• Filed: 02/26/2016
• Issued: 03/10/2020
• Est. Priority Date: 02/27/2015
• Status: Active Grant

• Current Assignee: Ri.Med Foundation Co.
• Original Assignee: University of Pittsburgh of The Commonwealth System of Higher Education
• Inventors: Badhwar, Vinay, Chun, Young Jae, D'Amore, Antonio, Schwartzman, David S., Wagner, William R.
• Primary Examiner(s): Stransky, Katrina M
• Application Number:
  US15/553,811
• Publication Number:
  US 20180071088A1
• Time in Patent Office: 1,474 Days
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/0059 temporary
• CPC Class Codes: A61L 2400/16 Materials with shape-memory or superelastic properties
• CPC Class Codes: A61L 27/14 Macromolecular materials
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61N 1/3629 in combination with non-electric therapy

Abstract

An atrioventricular prosthesis device is provided. The device includes a frame at least partially defining and enclosing a central cavity, the frame having a distal portion, a proximal portion, and a middle portion connected therebetween. The device further includes a valve construct formed, at least in part, from a cell growth scaffold, at least partially disposed within the central cavity defined by the frame. The valve construct includes: an annular portion defining an aperture and being connected to the frame for positioning the valve construct within the central cavity of the frame, and a plurality of leaflets extending longitudinally and radially inward from the annular portion. The frame and valve construct are transitionable to a deployed state, in which a diameter of at least a portion of the frame and the valve construct substantially conform to a diameter of a tricuspid and/or mitral valve opening.

Claims

1. An atrioventricular prosthesis device comprising:

a frame disposed on a central member extending along a longitudinal axis thereof, and at least partially defining and enclosing a central cavity, the frame having a distal portion, a proximal portion, and a middle portion connected therebetween, the proximal portion of the frame comprising at least one first collar slidably connected to the central member and a plurality of first elongated members connected to the at least one first collar, the first elongated members extending longitudinally and radially outwardly from the collar to define the central cavity when the frame is in a deployed state; and

a valve construct formed, at least in part, from a cell growth scaffold, at least partially disposed within the central cavity defined by the frame, the valve construct comprising;

an annular portion defining an aperture connected to one or more of the plurality of first elongated members for positioning the valve construct within the central cavity of the frame, and

a plurality of leaflets extending longitudinally and radially inwardly from the annular portion,

wherein the frame and valve construct are transitionable from a contracted state, in which the frame and valve construct are configured to be disposed within a catheter tube, to the deployed state in which a diameter of at least a portion of the frame and the valve construct substantially conforms to a diameter of a tricuspid and/or mitral valve opening.

2. The atrioventricular prosthesis device of claim 1, wherein, when in the deployed state, a diameter of the middle portion of the frame is greater than a diameter of the proximal portion and a diameter of the distal portion of the frame.

3. The atrioventricular prosthesis device of claim 1, wherein the central member comprises one or more of a wire, a catheter guiderail, a catheter tube, and/or a pacemaker lead.

4. The atrioventricular prosthesis device of claim 1, further comprising a protrusion on the distal portion of the frame, the protrusion being configured to engage a corresponding anchor disposed on the central member for advancing the frame and valve construct along the central member.

5. The atrioventricular prosthesis device of claim 1, wherein the distal portion of the frame comprises at least one second collar and a plurality of second elongated members connected to the at least one second collar, the second elongated members extending longitudinally and radially outwardly from the second collar toward the middle portion of the frame to define the central cavity when the frame is in a deployed state.

6. The atrioventricular prosthesis device of claim 5, wherein the plurality of first elongated members and the plurality of second elongated members each comprise a first end mounted to the collar and a second end connected to a second end of an adjacent elongated member, thereby forming an enclosed lattice.

7. The atrioventricular prosthesis device of claim 6, wherein a portion of at least one of the enclosed lattices of the proximal portion of the frame is connected to a corresponding portion of one of the enclosed lattices of the distal portion of the frame to form an enclosed structure.

8. The atrioventricular prosthesis device of claim 5, wherein the first elongated members and/or the second elongated members comprise a super-elastic, temperature-sensitive shape memory material.

9. The atrioventricular prosthesis device of claim 1, wherein the annular portion and/or leaflet of the valve construct comprise a polymer component formed from a biodegradable and biocompatible material, and optionally, the material being selected from a group consisting of one or more of poly(ester urethane) urea (PEUU), poly(ether ester urethane)urea (PEEUU), poly(ester carbonate)urethane urea (PECUU), poly(carbonate)urethane urea (PCUU), a polymer derived from an alpha-hydroxy acid, a polylactide, a poly(lactide-co-glycolide), a poly(L-lactide-co-caprolactone), a polyglycolic acid, a poly(dl-lactide-co-glycolide), a poly(l-lactide-co-dl-lactide), a polymer comprising a lactone monomer, a polycaprolactone, polymer comprising carbonate linkages, a polycarbonate, a polyglyconate, a poly(trimethylene carbonate), a poly(glycolide-co-trimethylene carbonate), a poly(glycolide-co-trimethylene carbonate-co-dioxanone), a polyurethane, a polycarbonate urethane, a polyester urethane, a polymer comprising ester linkages, a polyalkanoate, a polyhydroxybutyrate, a polyhydroxyvalerate, a polydioxanone, a polygalactin, a natural polymer, chitosan, collagen, elastin, alginate, cellulose, hyaluronic acid and gelatin.

10. The atrioventricular prosthesis device of claim 9, wherein the polymer component is formed by electrospinning.

11. The atrioventricular prosthesis device of claim 9, wherein the polymer component is formed by co-electrospinning a polymer suspension comprising a synthetic polymeric material and depositing an extracellular matrix gel by electrospraying.

12. The atrioventricular prosthesis device of claim 11, wherein a blood component and/or a buffer solution are deposited along with the extracellular matrix material by electrospraying.

13. The atrioventricular prosthesis device of claim 1, wherein each of the plurality of leaflets comprises electrospun fibers that are deposited predominantly in a circumferential direction in a central region of the leaflet, and in an axial direction in a commissure region of the leaflet.

14. The atrioventricular prosthesis device of claim 1, wherein the plurality of leaflets have a bending modulus ranging from 500 kPA to 500000 kPa, a mechanical strain ranging from 0 to 100, and/or a stress ranging from 0 to 5000 kPa.

15. A catheter comprising a catheter tube and the atrioventricular prosthesis device of claim 1, wherein the central member extends through at least a portion of the catheter tube and wherein the device is disposed within the catheter tube in its compressed state.

16. A method of implanting an atrioventricular valve prosthesis in a patient in need thereof, the method comprising:

positioning the device of claim 1 to a position adjacent to an atrioventricular valve of a patient;

expanding the frame and valve construct of the device to a deployed state so that the annular portion of the valve construct is aligned with an annulus of an atrioventricular valve of a patient; and

anchoring the central member extending through the device by implanting a distal end of the central member into an interior wall of a ventricle of the patient.

17. The method of claim 16, wherein positioning the device comprises positioning the device by a percutaneous route or by a transseptal route.

18. The method of claim 16, wherein the valve construct comprises at least three leaflets, and wherein the atrioventricular valve is a tricuspid valve.

19. The method of claim 16, wherein the valve construct comprises at least two leaflets, and wherein the atrioventricular valve is a mitral valve.