Reinforcement device with dissolvable layer and its use

• US 8,435,307 B2
• Filed: 05/20/2010
• Issued: 05/07/2013
• Est. Priority Date: 05/20/2010
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: CES Advancements, LLC
• Inventors: Paul, Martin G.
• Primary Examiner(s): Severson, Ryan
• Assistant Examiner(s): Cronin, Ashley
• Application Number:
  US12/783,936
• Publication Number:
  US 20120259348A1
• Time in Patent Office: 1,083 Days
• Field of Search: 602 41- 59, 623 2372- 2374
• US Class Current: 623/23.72
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2002/0068 having a special mesh pattern
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures

Abstract

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.

Claims

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 an upper and a lower face, a flap portion, a slit portion, and a cut-out portion;

a plurality of naps distributed across one or both of the faces and the flap portion and projecting therefrom for adhering to the tissue; and

a first dissolvable layer covering at least a portion of the plurality of naps and optionally a portion of the reinforcing layer, the layer adapted to increase the time before the naps substantially adhere to the tissue.

2. The device of claim 1, wherein the reinforcing layer comprises a three-dimensional and open-worked, porous knit.

3. The device of claim 2, wherein the knit comprises a monofilament polyester yarn.

4. The device of claim 1, wherein the naps comprise a biocompatible polymer.

5. The device of claim 4, wherein the biocompatible polymer is 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.

6. The device of claim 4, wherein the dissolvable layer comprises one or more of a biodegradable component, an antibacterial component, an excipient, a therapeutic drug, a plasticizer, and a binder component.

7. The device of claim 6, wherein the biodegradable component is a polymers selected from hydroxy propyl methyl cellulose (HPMC), hydroxyl propyl cellulose (HPC), starch and modified starch, Pullulan, Pectin, Gelatin, and carboxy methyl cellulose (MC).

8. The device of claim 7, wherein the amount of the polymer is about 45-percent w/w of the total weight of the dissolvable layer.

9. The device of claim 6, wherein the antibacterial component comprises a non-toxic antibacterial agent.

10. The device of claim 9, wherein the amount of the antibacterial component is about 0 to about 5% w/w of the dissolvable layer.

11. The device of claim 6, wherein the therapeutic drug component is uniformly distributed in the dissolvable layer.

12. The device of claim 6, 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.

13. The device of claim 1, further comprising a bioadhesive layer.

14. The device of claim 13, wherein the bioadhesive layer comprises one or more of gelatin, starch, modified starch, proteins, carbohydrates, glycoproteins, and mucopolysaccharides, and hydrogels.

15. The device in claim 1, wherein the dissolvable layer covers at least a portion of the upper or lower face of the reinforcing layer.

16. A method for reinforcing tissues having one or more structural deficiencies, comprising the steps of:

providing a reinforcement device comprising a longitudinally-extending reinforcing layer for treating the structural deficiency, the layer having an upper and a lower face, a flap portion, a slit portion, and a cut-out portion;

a plurality of naps distributed across one or both of the faces and the flap portion and projecting therefrom for adhering to the tissue; and

a first dissolvable layer covering at least a portion of the plurality of naps and optionally a portion of the reinforcing layer, the layer adapted to increase the time before the naps substantially adhere to the tissue; and

holding the reinforcement device on the tissue until at least a portion of the dissolvable layer dissolves.

17. The method of claim 16, further comprising the step of adding a liquid solvent at the same time the reinforcement device is being held on the tissue.

18. The method of claim 17, wherein the liquid solvent is saline.