Device for ear drum repair
A device for use in the repair of an ear drum in a subject in need of such treatment, said device: having a tensile strength Youngs Modulus between approximately 12.5 and 40 MPa; comprising one or more membrane layers, wherein at least one membrane layer comprises a plurality of pores; and wherein the device can support proliferation, migration and/or adhesion of cells selected from the group comprising at least any one or more of: keratinocytes, fibroblasts, vascular cells, mucosal epithelial cells, and stem cells.
1. A device suitable for repair of a tympanic membrance in a subject in need of such treatment, said device:
(a) having a tensile strength between 12.5 and 40 MPa; and
(b) comprising one or more membrane layers, wherein at least one membrane layer comprises a plurality of pores with a pore diameter of between approximately 0.001 microns and 1 micron, within and on a surface of the device that facilitate cellular adhesion of cells and proliferation of the cells across the device while preventing infiltration of keratinocytes through the device; and
(c) wherein the one or more membrane layers have a combined thickness of between approximately 10 μm and approximately 600 μm; and
wherein
(i) the device transmits sound waves between 20 Hz and 20 kHz;
(ii) the material forming one or more membrane layers is of a source non-autologous to the subject being treated with the device and is biocompatible; and
(iii) the device supports proliferation, migration and/or adhesion of cells selected from the group comprising at least any one or more of: keratinocytes, fibroblasts, vascular cells, mucosal epithelial cells, and stem cells.
2. A device according to claim 1 having a tensile strength between approximately 15 and approximately 37 MPa.
3. A device according to claim 1 having a tensile strength between approximately 25 and approximately 35 MPa.
4. A device according to claim 1 comprising one or more materials that are non-autologous to the subject in need of such treatment; said material being selected from the group comprising: silk fibroin; hyaluronic acid based hydrogels and films; calcium alginate; alginic acid; pluronic 127; poly(glycerol sebacate); collagen (type I/III); water soluble and insoluble chitosan; gelatin; polyethylene glycol; or decellularised tissue from mammalian membranes, including tympanic membrane, pericardium, periosteum, dermis, and muscle fascia.
5. A device according to claim 4 , which incorporates an additive that allows manipulation of the device when in a dry state.
6. A device according to claim 5 wherein the material is silk fibroin.
7. A device according to claim 5 wherein the material is collagen type I/III.
8. A device according to claim 5 comprising bioactive molecules that assist or promote the growth of the cells.
9. The device of claim 8 , wherein the bioactive molecules comprises hyaluronic acid.
10. A device according to claim 5 wherein the additive is one or more materials selected from the group consisting of collagen, gelatin, chitosan, alginic acid, hyaluronic acid hydrogels, pluronic 127 and polyethylene glycol.
11. A device according to claim 1 , wherein the membrane is folded to match the size of the defective portion of the ear canal.
12. A device according to claim 1 that is at least partially translucent.
13. A device according to claim 1 , wherein the surface of one or both faces of the device is scored or grooves are cut to improve the flexibility of the device.
14. A device according to claim 1 wherein the device is formed by at least any one or more of: spinning including electrospinning; weaving including microweaving; or casting.
15. A device according to claim 1 , which is suitable for use in repair of tympanic membrane perforation, reconstruction of the ear canal including a defective pars flaccida, the attic and or the surrounding scutum bone, a mastoidectomy including tympanomastoidectomy.
16. A device according to claim 1 wherein the one or more membrane layers include silk fibroin.
17. A device according to claim 16 wherein the one or more materials also include one or more additives selected from the group consisting of: hyaluronic acid based hydrogels and films; calcium alginate; alginic acid; pluronic 127; poly(glycerol sebacate); collagen (type I/III); water soluble and insoluble chitosan; gelatin; polyethylene glycol; or decellularised tissue from mammalian membranes, including tympanic membrane, pericardium, periosteum, dermis, and muscle fascia.
18. The device according to claim 1 wherein, when the device is employed for use in a subject in need of treatment therefrom, the device effectuates repair of the tympanic membrane in the subject.
19. A kit for use in the repair of a tympanic membrane or reconstruction of an ear canal, said kit comprising the device according to claim 1 .
20. The kit according to claim 19 , further comprising a solution of one or more bioactive molecules that assist or promote the growth of the cells, wherein said solution is applied to the device prior to treatment of a subject with the device.