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1. WO2020223663 - WINGED GRAFTS FOR TYMPANIC MEMBRANE REPAIR AND AUGMENTATION

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[ EN ]

WHAT IS CLAIMED

1. A winged graft device for use in repairing or augmenting a tympanic membrane having an opening, comprising

a first graft material layer; and

a second graft material layer,

wherein each of the first and second graft material layers have a shape that corresponds generally to a shape of the opening in the tympanic membrane,

wherein each of the first and second graft material layers has a size that extends beyond a perimeter of the opening in the tympanic membrane,

wherein each of the first and second graft material layers has at least one radial slit that extends from an outer perimeter of the graft material layer towards a center of the graft material layer, wherein if there are two or more radial slits, the two or more slits do not touch, leaving a bridge of graft material at about the center of each graft material layer between the slits, and

wherein the two centers or bridges of graft material in the first and second graft material layers are connected to each other to form a winged graft device comprising at least first and second medial wings that together form an underlay portion of the winged graft device, and at least first and second lateral wings that together form an overlay portion of the winged graft device.

2. The device of claim 1, wherein the opening is a perforation and the shape of the first and second graft material layers comprises a circular shape or other shape that corresponds generally to the shape of the perforation.

3. The device of claim 1 or claim 2, wherein the two centers or bridges of graft material are connected to each other by an adhesive or polymer, by application of heat, or by a mechanical connection element.

4. The device of claim 3, wherein the polymer comprises polyurethane, polylactic acid, silicones, polyurethanes, fluoroplastics, nylon, polyethylene

terephthalate, polycarbonate, acrylonitrile butadiene styrene, poly(p-phenylene oxide), polybutylene terephthalate, polypropylene, polyetheretherketone, polyethylene, polystyrene, polysulfone, polyvinylidene fluoride, polymethylmethacrylate, latex, polyacrylate, polyalkylacrylate, substituted polyalkylacrylate, polystyrene,

poly(divinylbenzene), polyvinylpyrrolidone, poly(vinylalcohol), polyacrylamide, poly(ethylene oxide), polyvinylchloride, polyvinylidene fluoride, polytetrafluoroethylene, polydimethylsiloxane (PDMS), hyaluronic acid (HA), poly(glycolic acid) (PGA), poly (lactic-co-gly colic acid) (PLGA), polylactic acid (PLA), poly(ester urethane)urea

(PEUU), polycarbonate urethane) urea (PECUU), and mixtures thereof.

5. The device of any one of claims 1 to 4, wherein the two centers or bridges of graft material are connected to each other by interdigitating the first graft material layer and the second graft material layer by sliding a slit of the first graft material layer into a slit of the second graft material layer until the center or bridge of graft material of the first graft material layer contacts the center or bridge of graft material in the second graft material layer to connect the two centers or bridges of graft material in the first and second graft material layers.

6. The device of any one of claims 1 to 5, wherein the two centers or bridges of graft material in the first and second graft material layers are sufficiently small, or are connected in such a way, to enable the first and second graft material layers to be rotated with respect to each other, e.g., such that the slits in the first graft material layer do not overlap the slits in the second graft material layer.

7. The device of any one of claims 1 to 6, wherein each of the first and second graft material layers comprise two slits and two wings, and

wherein the first medial wing of the winged graft device comprises a first half of the first graft material layer,

wherein the first lateral wing of the winged graft device comprises a second half of the first graft material layer,

wherein the second medial wing of the winged graft device comprises a first half of the second graft material layer, and

wherein the second lateral wing of the winged graft device comprises a second half of the second graft material layer.

8. The device of any one of claims 1 to 7, wherein the first and second graft material layers are made of the same material.

9. The device of any one of claims 1 to 5, wherein the first and second graft material layers are fabricated in one piece.

10. The device of any one of claims 1 to 7, wherein the first and second graft material layers are made of different materials.

11. The device of any one of claims 1 to 7, wherein each wing comprises the same graft material or a different graft material or wherein both medial wings comprise the same material and both lateral wings comprise the same graft material, which is different from the graft material of the medial wings.

12. The device of any one of claims 1 to 7, wherein the first lateral wing of the first graft material layer and the second lateral wing of the second graft material layer comprise a first material and wherein the first medial wing of the first graft material layer and the second medial wing of the second graft material layer comprise a second material, different from the first material.

13. The device of claim 12, wherein the first material of the first and second lateral wings biodegrades more quickly than the second material of the first and second medial wings.

14. The device of any one of claims 1 to 13, further comprising one or more of a cellular adhesion and a cell invasion-inducing material, e.g., a growth factor, e.g., any one or more of a fibroblast growth factor (FGF), a vascular endothelial growth factor (VEGF), a platelet-derived growth factor (PDGF), a keratinocyte growth factor (KGF), a transforming growth factor (TGF) beta, platelet rich plasma, serum, platelets, or an epidermal growth factor (EGF).

15. The device of any one of claims 1 to 14, further comprising one or more cells, e.g., fibroblasts, chondrocytes, keratinocytes, stem cells, progenitor cells, mesenchymal cells, endothelial cells, platelets, or epithelial cells.

16. The device of claim 15, wherein the cells are harvested from the patient or from different sources, e.g., a transplant from another subject or from cultured cell lines.

17. The device of any one of claims 1 to 16, further comprising one or more antibiotics, steroids, small molecules, cytokines such as IL-10, chemokines, proteins, and biologies.

18. The device of any one of claims 1 to 17, wherein the device comprises one or more of silicones, polyurethanes, fluoroplastics, polyethylene terephthalate, polycarbonate, acrylonitrile butadiene styrene, poly(p-phenylene oxide), polybutylene terephthalate, polypropylene, polyetheretherketone, polyethylene, polystyrene, polysulfone, polyvinylidene fluoride, polymethylmethacrylate, latex, polyacrylate, polyalkylacrylate, substituted polyalkylacrylate, polystyrene, poly(divinylbenzene), polyvinylpyrrolidone, poly(vinylalcohol), polyacrylamide, poly(ethylene oxide), polyvinylchloride, polyvinylidene fluoride, polytetrafluoroethylene,

polydimethylsiloxane (PDMS), hyaluronic acid (HA), poly(glycolic acid) (PGA), poly (lactic-co-gly colic acid) (PLGA), polylactic acid (PLA), poly(ester urethane)urea (PEUU), polycarbonate urethane) urea (PECUU), collagen, fibrin, nylon, silk,

polycaprolactone, porcine or bovine tissues (e.g., submucosa, pericardium, or fascia), human dermal regenerative tissue matrix, collagen, DuraGenĀ® (collagen biologic), absorbable gelatin, elastin, water-insoluble, nonelastic, porous, pliable materials prepared from porcine skin, gelatin, and water, dural matrix, extracellular matrix, temporalis fascia, perichondrium, pericranium, and mucosa.

19. The device of any one of claims 1 to 18, wherein each graft material layer has an outer diameter of about 2.0 to about 12 millimeters, e.g., 3, 4, 5, 6, 7, 8, 9, 10, or 11 mm, and is sized to extend beyond than an outer perimeter of the opening in the tympanic membrane.

20. The device of any one of claims 1 to 19, wherein each of the first and second graft material layers has a thickness of 10 to 750 microns, e.g., 25, 50, 75, 100, 125, 150, 175, 200, 250, 300, 400, 500, 600, or 750 microns.

21. The device of any one of claims 1 to 20, wherein the device is permeable to air, impermeable to air, and/or selectively permeable to one or more drugs or other agents including small molecules, biologies, steroids, and antibiotics, and impermeable to water.

22. A method of repairing or augmenting a tympanic membrane having an opening, e.g., a perforation, the method comprising

obtaining a winged graft device of any one of claims 1 to 21;

applying the winged graft device to a lateral surface of the tympanic membrane with medial wings contacting the lateral surface of the tympanic membrane;

manipulating the medial wings of the winged graft device through the opening to enable the medial wings to contact a medial surface of the tympanic membrane; and arranging and flattening the lateral wings of the winged graft device to contact the lateral surface of the tympanic membrane, thereby securing the graft device to the

tympanic membrane and enabling the medial wings to become secured to the medial surface of the tympanic membrane.

23. The method of claim 22, wherein the tympanic membrane is secured between the lateral wings on the lateral side of the tympanic membrane and the medial wings on the medial side of the tympanic membrane without need of any packing material within the inner ear to hold the medial wings in place against the medial surface of the tympanic membrane.

24. The method of claim 22, further comprising applying a vasoconstrictive agent to the ear canal and tympanic membrane.

25. The method of any one of claims 22 to 24, further comprising applying an anesthetic agent, e.g., viscous lidocaine, to the ear canal and tympanic membrane, and optionally filling the ear canal with an antibiotic agent after the perforation is closed with the winged graft device.

26. The method of any one of claims 22 to 25, wherein the opening is a perforation, and the method comprises sealing the perforation with the winged graft device.

27. The method of any one of claims 22 to 25, further comprising creating the opening in the tympanic membrane before applying the winged graft device, wherein the tympanic membrane is overly elastic, thickened, or infected, scarred by tympanosclerosis, thickened or thinned due to disease, replaced by scar tissue, mucosalized, or otherwise abnormal, or wherein the patient has myringosclerosis, and the winged graft device is designed to augment the tympanic membrane.

28. The method of claim 27, wherein the winged graft device is designed to augment the function of the tympanic membrane by changing the elastic properties to

permit a change in passive sound transmission, e.g., wherein a stiffness in radial directions from the center outwards is increased to better enable graft motion across the human range of hearing.

29. A method of fabricating a winged graft device, e.g., a winged graft device of any one of claims 1 to 21, the method comprising:

forming or obtaining a first graft material layer;

forming or obtaining a second graft material layer, wherein each of the first and second graft material layers have a geometric shape, e.g., a circle, or a shape to match a perforation in a tympanic membrane of a subject, and wherein the first and second graft material layers can be formed in one piece or as two separate pieces;

forming one or more radial slits in each of the first and second graft material layers that extend from an outer perimeter of the graft material layer towards a center of the graft material layer, wherein if there are two or more radial slits, the two or more slits do not touch, leaving a bridge of graft material at about the center of each graft material layer between the slits; and

fastening the two centers or bridges of graft material to each other to connect the first and second graft material layers and form a winged graft device comprising at least first and second medial wings that together form an underlay portion of the winged graft device, and at least first and second lateral wings that together form an overlay portion of the winged graft device.

30. The method of claim 29, wherein the two centers or bridges are fastened by interdigitating the first and second graft material layers, e.g., by sliding a slit of the first graft material layer into a slit of the second graft material layer until the center or bridge of material of the first graft material layer contacts the center or bridge of material of the second graft material layer.

31. The method of claim 29, wherein the two centers or bridges of graft material are formed as one piece and are thus fastened to each other.

32. The method of claim 29, wherein the two centers or bridges are fastened to each other by an adhesive, by application of heat, or by a mechanical connection element.

33. The method of any one of claims 29 to 32, wherein the center or bridge of graft material in each of the first and second graft material layers is sufficiently small, or are fastened to enable the first and second graft material layers to be rotated with respect to each other, e.g., such that the slits in the first graft material layer do not overlap the slits in the second graft material layer.

34. The method of any one of claims 29 to 33, wherein each of the first and second graft material layers comprises two slits and two wings, and

wherein the first medial wing of the winged graft device comprises a first half of the first graft material layer,

wherein the first lateral wing of the winged graft device comprises a second half of the first graft material layer,

wherein the second medial wing of the winged graft device comprises a first half of the second graft material layer, and

wherein the second lateral wing of the winged graft device comprises a second half of the second graft material layer.

35 The method of any one of claims 29 to 34, further comprising storing the winged graft device in a saline solution.

36. The method of any one of claims 29 to 34, further comprising seeding the winged graft device with cells or cellular elements, such as platelets, or wherein the winged graft material is a tissue comprising cells, and storing the cell-containing winged graft device in a culture medium under culturing conditions to maintain the living cells.

37. The method of any one of claims 29 to 36, further comprising sterilizing the winged graft device.

38. The method of claim 37, wherein the winged graft device is sterilized chemically, by radiation, by heat, by ultraviolet irradiation, by plasma treatment, by ethylene oxide gas, gamma irradiation, or e-beam irradiation.

39. A method of fabricating the winged graft device of any one of claims 1 to 21, the method comprising injection molding or 3D printing the winged graft device in one piece.

40. A kit comprising two or more of the devices of any one of claims 1 to 21, wherein the kit comprises devices in at least two different sizes and/or two different shapes.

41. The kit of claim 40, further comprising one or more of an anesthetic agent, a vasoconstrictive agent, an antibiotic agent, or a surgical instrument, e.g., curved needle.

42. The kit of claim 40 or claim 41, wherein all components of the kit are enclosed in a single, sterile package.