Reinforcement device with dissolvable layer and its use
A reinforcement device for reinforcing tissues having one or more structural deficiencies includes a longitudinally-extending reinforcing layer for treating the structural deficiency, a plurality of spiked naps distributed across the reinforcing layer and projecting therefrom for adhering to the tissue, and a dissolvable matrix layer covering at least a portion of the reinforcing layer and a portion of the plurality of spiked naps. The matrix layer increases the time before the spiked naps substantially adhere to the tissue, thereby allowing the practitioner additional time to position the reinforcement device.
1. A reinforcement device for reinforcing tissues having one or more structural deficiencies, comprising:
a longitudinally extending reinforcing layer for treating the structural deficiency, the layer having a first face and a second face;
a plurality of naps distributed across at least the first face and projecting therefrom for adhering to tissue, the plurality of naps having one of an arcuate shape with a flattened ball at the distal end of the plurality of naps, a tapered point, or J-hook shape; and
a dissolvable layer.
2. The device of claim 1 , wherein the plurality of naps have an arcuate shape with a flattened ball at the distal end of the naps.
3. The device of claim 1 , wherein the plurality of naps have a tapered point.
4. The device of claim 1 , wherein the plurality of naps have a J-hook shape.
5. The device of claim 1 , wherein the dissolvable layer covers the plurality of naps, the layer adapted to increase the time before the plurality of naps substantially adhere to the tissue.
6. The device of claim 1 , wherein the dissolvable layer covers at least a portion of at least the second face of the reinforcing layer opposite the plurality of naps.
7. The device of claim 1 , wherein the reinforcing layer includes a three-dimensional and open-worked, porous knit.
8. The device of claim 7 , wherein the knit includes a monofilament polyester yarn.
9. The device of claim 1 , wherein the plurality of naps comprise a biocompatible polymer selected from one or more of polypropylene, polymers of p-dioxanone, polyglycolides, polyorthoesters, polymers of trimethylene carbonate, stereocopolymers of L-lactic acid and D-lactic acid, homopolymers of L-lactic acid, copolymers of lactic acid and a compatible comonomer.
10. The device of claim 1 , wherein the dissolvable layer includes one or more of a biodegradable component, an antibacterial component, an excipient, therapeutic drug, a plasticizer, and a binder component.
11. The device of claim 10 , wherein the biodegradable component is a polymer selected from hydroxy propyl methyl cellulose, hydroxyl propyl cellulose, starch and modified starch, pullulan, pectin, gelatin, and carboxy methyl cellulose, the polymer present in an amount of about 45 percent w/w of the total weight of the dissolvable layer.
12. The device of claim 10 , wherein the antibacterial component includes a non-toxic antibacterial agent present in an amount from about 0 to about 5% w/w of the dissolvable layer.
13. The device of claim 10 , wherein the therapeutic drug component is uniformly distributed in the dissolvable layer.
14. The device of claim 10 , wherein the plasticizer is selected from one or more of glycerol, propylene glycol, low molecular weight polyethylene glycols, phthalate derivatives like dimethyl, diethyl and dibutyl phthalate, and citrate derivatives such as tributyl, triethyl, acetyl citrate, triacetin and castor oil.
15. The device of claim 1 , further comprising a bioadhesive layer of one or more of gelatin, starch, modified starch, proteins, carbohydrates, glycoproteins, mucopolysaccharides, and hydrogels.