Tissue Repair Medical Devices and Methods
Medical devices for repairing defects in tissue, such as perforations in the tympanic membrane of an animal, methods of manufacturing medical devices, methods of implanting a medical device in a defect in a tissue; and methods of repairing a defect in a tissue are described. In one form, a medical device includes an overlay member having multiple arms and defining an overlay member passageway, an underlay member having multiple flaps and defining an underlay member passageway, and a securement member extending through the overlay member passageway and the underlay member passageway. In methods, the multiple flaps of the underlay member can be sequentially advanced into a defect in a tissue, such as a perforation in a tympanic membrane of an animal.
1 . A medical device for repairing a defect in a tissue of an animal, said medical device comprising:
an overlay member comprising an overlay member body having a first overlay member surface, a second, opposing overlay member surface, and at least one arm, the overlay member body defining a first overlay member passageway extending through the overlay member body from the first overlay member surface to the second overlay member surface;
an underlay member comprising an underlay member body having a first underlay member surface and a second, opposing underlay member surface, the underlay member body defining a peripheral edge, at least one slit extending inwardly from the peripheral edge, and a first underlay member passageway extending through the underlay member body from the first underlay member surface to the second underlay member surface; and
a securement member extending through the first overlay member passageway and the first underlay member passageway.
2 . The medical device according to claim 1 , wherein the overlay member body defines a first curvilinear edge disposed between and connecting the first and second arms, a second curvilinear edge disposed between and connecting the second and third arms, a third curvilinear edge disposed between and connecting the third and fourth arms, and a fourth curvilinear edge disposed between and connecting the fourth and first arms.
3 . The medical device according to claim 1 , wherein the underlay member comprises a bioremodelable material.
4 . The medical device according to claim 3 , wherein the underlay member comprises a synthetic material.
5 . The medical device according to claim 3 , wherein the underlay member comprises a natural material.
6 . The medical device according to claim 5 , wherein the underlay member comprises a collagenous material.
7 . The medical device according to claim 6 , wherein the underlay member comprises extracellular matrix.
8 . The medical device according to claim 3 , wherein the overlay member comprises a bioremodelable material.
9 . The medical device according to claim 3 , wherein the overlay member comprises a synthetic material.
10 . The medical device according to claim 9 , wherein the overlay member comprises a foam.
11 . The medical device according to claim 5 , wherein the securement member comprises a bioremodelable material.
12 . The medical device according to claim 1 , wherein the underlay member and the overlay member are formed of the same material.
13 . The medical device according to claim 1 , wherein the overlay member defines a second overlay member passageway extending through the overlay member body from the first overlay member surface to the second overlay member surface;
wherein the underlay member defines a second underlay member passageway extending through the underlay member body from the first underlay member surface to the second underlay member surface; and
wherein the securement member extends through the second overlay member passageway and the second underlay member passageway.
14 . A medical device for repairing a defect in a tissue of an animal, said medical device comprising:
an overlay member comprising an overlay member body having a first overlay member surface, a second, opposing overlay member surface, a first arm, a second arm, a third arm, and a fourth arm, the overlay member body defining a first curvilinear edge disposed between and connecting the first and second arms, a second curvilinear edge disposed between and connecting the second and third arms, a third curvilinear edge disposed between and connecting the third and fourth arms, and a fourth curvilinear edge disposed between and connecting the fourth and first arms, a first overlay member passageway extending through the overlay member body from the first overlay member surface to the second overlay member surface, and a second overlay member passageway extending through the overlay member body from the first overlay member surface to the second overlay member surface;
an underlay member comprising an underlay member body having a first underlay member surface and a second, opposing underlay member surface, the underlay member body defining a peripheral edge, a first slit extending inwardly from the peripheral edge, a second slit extending inwardly from the peripheral edge, a third slit extending inwardly from the peripheral edge, a fourth slit extending inwardly from the peripheral edge, a first underlay member passageway extending through the underlay member body from the first underlay member surface to the second underlay member surface, and a second underlay member passageway extending through the underlay member body from the first underlay member surface to the second underlay member surface; and
a securement member extending through the first overlay member passageway, the first underlay member passageway, the second underlay member passageway, and the second overlay member passageway.
15 . The medical device according to claim 14 , wherein the underlay member comprises a natural material.
16 . The medical device according to claim 15 , wherein the underlay member comprises a bioremodelable material.
17 . The medical device according to claim 16 , wherein the underlay member comprises an extracellular matrix material.
18 . The medical device according to claim 16 , wherein the underlay member comprises small intestine submucosa.
19 . The medical device according to claim 16 , wherein the overlay member comprises a synthetic material.
20 . A medical device for repairing a defect in a tissue of an animal, said medical device comprising:
a cross-shaped overlay member formed of a synthetic material, the overlay member comprising an overlay member body having a first overlay member surface, and a second, opposing overlay member surface, the overlay member body defining a first overlay member passageway extending through the overlay member body from the first overlay member surface to the second overlay member surface;
an underlay member formed of a bioremodelable material, the underlay member comprising an underlay member body having a first underlay member surface and a second, opposing underlay member surface, the underlay member body defining a peripheral edge, a slit extending inwardly from the peripheral edge, and a first underlay member passageway extending through the underlay member body from the first underlay member surface to the second underlay member surface; and
a securement member extending through the first overlay member passageway and the first underlay member passageway.