Implantable prosthetic or tissue expanding device

• US 6,371,984 B1
• Filed: 09/13/1999
• Issued: 04/16/2002
• Est. Priority Date: 09/13/1999
• Status: Expired due to Term

• Current Assignee: Keraplast Technologies LLC
• Original Assignee: Keraplast Technologies LLC
• Inventors: Van Dyke, Mark E., Smith, Robert A., Blanchard, Cheryl R., Siller-Jackson, Arlene J., Timmons, Scott F.
• Primary Examiner(s): Nguyen, Dinh X.
• Assistant Examiner(s): BARRETT, THOMAS C
• Application Number:
  US09/394,783
• Time in Patent Office: 946 Days
• Field of Search: 623/23.71, 623/8, 424/426
• US Class Current: 623/11.11
• CPC Class Codes: A61F 2/0059 Cosmetic or alloplastic implants A61F2/10 - A61F2/16, A61F2/28 take precedence
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• CPC Class Codes: A61F 2002/30971 Laminates, i.e. layered products
• CPC Class Codes: A61L 2430/04 for mammary reconstruction
• CPC Class Codes: A61L 2430/38 for reconstruction of the spine, vertebrae or intervertebral discs
• CPC Class Codes: A61L 27/227 Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24
• CPC Class Codes: A61L 27/306 Other specific inorganic materials not covered by A61L27/303 - A61L27/32
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/38 containing added animal cells organs or tissue containing native cells A61L27/36
• CPC Class Codes: A61L 27/52 Hydrogels or hydrocolloids
• CPC Class Codes: C08L 83/04 Polysiloxanes

Abstract

A keratin hydrogel-filled implantable prosthetic device. One device is a breast implant for augmenting or reconstructing a human breast including an envelope containing a keratin hydrogel. One keratin hydrogel is formed from a solid precursor which forms a keratin hydrogel upon addition of water. One source of keratin is human hair. In one method, an envelope suitable for implantation and a solid keratin hydrogel precursor are provided. The solid can be in fibrous or powder form. The solid precursor can be inserted into the envelope interior. A small incision near the breast can be made and the envelope inserted into the incision. After insertion, water can be injected into the envelope interior, preferably through the incision and through a self-sealing port in the envelope. In one method, the implant is provided as a kit, with the envelope and keratin hydrogel provided. The hydrogel can be injected into the envelope either before or after insertion into the breast area. One kit has a powdered, keratin hydrogel precursor disposed within the envelope interior, awaiting the addition of water, preferably after insertion of the implant into the body.

Claims

1. A prosthetic implant comprising:

an envelope; and

a keratinous gel contained within said envelope.

2. A prosthetic implant as recited in claim 1, wherein said envelope comprises silicone.

3. A prosthetic implant of claim 1, wherein said envelope comprises a self-sealing port.

4. A prosthetic implant as recited in claim 1, wherein said keratin hydrogel is obtained from hair.

5. A prosthetic implant as recited in claim 4, wherein said keratin hydrogel is obtained from human hair.

6. A prosthetic implant as recited in claim 5, wherein said implant is designated for an intended recipient and sad hydrogel is obtained from human hair from said intended recipient.

7. A prosthetic implant as recited in claim 1, wherein said keratin hydrogel comprises keratin obtained from mammal hair or fur.

8. A prosthetic implant as recited in claim 1, wherein said keratin hydrogel comprises keratin obtained from human hair.

9. A prosthetic implant as recited in claim 1, wherein said cations are potassium, sodium, or ammonium ions.

10. A prosthetic implant as recited in claim 1, wherein said implant is a penile implant, testicular implant, chin implant, breast implant, intervertebral disk implant, or gluteal pad implant.

11. A prosthetic implant comprising:

an envelope; and

a keratin hydrogel contained within said envelope,

wherein said keratin hydrogel is a product made by the process comprising;

oxidizing keratin in a first solution with an oxidizing agent such that at least some of the disulfide bonds of said keratin are oxidized to form sulfonic acid residues;

separating an oxidized solid fraction from said solution;

placing said oxidized keratin solid in a second solution including monovalent cations dissolved in a solvent under conditions effective to allow electrostatic interactions between the sulfonic acid residues of said oxidized keratin and said monovalent cations to obtain a salt of said keratin and said cations;

removing the solvent from said salt to obtain a solid salt; and

hydrating said solid salt.

12. A prosthetic implant as recited in claim 11 wherein said effective conditions comprise adjusting the pH of said second solution, to obtain a substantially neutral solution.

13. A prosthetic implant as recited in claim 11, wherein said oxidizing agent is hydrogen peroxide, peracetic acid, perborates, percarbonates, benzoyl peroxide, or ammnonium sulfate peroxide.

14. A prosthetic implant as recited in claim 11, wherein said oxidizing agent is at a concentration of between about 1 and about 35 weight/volume percent.

15. A prosthetic implant as recited in claim 11, wherein said oxidizing agent is at a concentration of from about 1 to about 20 weight/volume percent.

16. A prosthetic implant as recited in claim 11, wherein said oxidizing agent is at a concentration of from about 2 to about 4 weight/volume percent.

17. A prosthetic implant as recited in claim 11, wherein said oxidizing agent is at a concentration of from about 10 to about 15 weight/volume percent.

18. A prosthetic implant as recited in claim 11, wherein said keratin is oxidized at a temperature between about 0°

C. and about 100°

C.

19. A prosthetic implant as recited in claim 11, wherein keratin is oxidized at a temperature between about 20°

C. and about 100°

C.

20. A prosthetic implant as recited in claim 11, wherein said keratin is oxidized at a temperature between about 80°

C. and about 100°

C.

21. A prosthetic implant as recited in claim 11, wherein said keratin is oxidized for a period of between 0.5 and about 24 hours.

22. A prosthetic implant as recited in claim 11, wherein said keratin is oxidized for a period of between about 1 and about 4 hours.

23. A prosthetic implant as recited in claim 11, wherein the keratin is oxidized by suspending said keratin in a solution of between about 1 percent and about 32 percent peracetic acid at a temperature between about 0°

C. and about 100°

C. for between about 0.5 and about 24 hours.

24. A prosthetic implant as recited in claim 11, wherein the keratin is oxidized by suspending said keratin in a solution of about 4 percent peracetic acid at a temperature of about 4°

C. for about 24 hours.

25. A prosthetic implant as recited in claim 11, wherein the keratin is oxidized by suspending said keratin in a solution of about 4 percent peracetic acid at a temperature between about 20°

C. and about 100°

C. for between about 1 and about 4 hours.

26. A prosthetic implant as recited in claim 11, wherein said effective conditions comprise boiling for between about 0.5 hours and about 12 hours.

27. A prosthetic implant as recited in claim 11, wherein said effective conditions comprise a temperature of between about 15°

C. and about 30°

C. for a period of between about 1 and about 24 hours.

28. A prosthetic implant as recited in claim 11, wherein said effective conditions comprise a temperature of between about 20°

C. and about 25°

C. for a period of between about 1 and about 5 hours.

29. A prosthetic implant as recited in claim 11, wherein said second solution comprising monovalent cations comprises a solvent selected from methanol, ethanol, propanol, ether, tetrahydrofuran or acetone.

30. A prosthetic implant as recited in claim 11, further comprising shredding said solid salt into fibers.

31. A prosthetic implant as recited in claim 11, further comprising grinding said solid salt into powder.