Body implant and method of implanting

• US 6,146,418 A
• Filed: 09/28/1998
• Issued: 11/14/2000
• Est. Priority Date: 02/28/1997
• Status: Expired due to Term

• Current Assignee: Medico Holdings, Inc.
• Original Assignee: Mark Berman
• Inventors: Berman, Mark
• Primary Examiner(s): Hirsch, Paul J.
• Application Number:
  US09/162,477
• Time in Patent Office: 778 Days
• Field of Search: 623/7, 623/8
• US Class Current: 623/8
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008

Abstract

A human body implant has a separate bladder made from a bio-compatible flexible polymer into which a mobile device or prosthesis is placed after the bladder has been introduced into a subcutaneous body pocket. The bladder completely forms an artificial scar by ingrowth of body tissue into pores in the bladder to form an artificial scar. In the case of a breast implant, a breast prosthesis of many different types can be used. The prosthesis is isolated from but is mobile in the bladder. Fluids can be withdrawn from the prosthesis without contaminating the body.

Claims

1. A human body implant comprising, in combination:

a bio-compatible flexible thermoplastic polymer bladder with at least its outer surface being microporous so that after implant in a subcutaneous pocket, body tissue will grow into the pores to form an artificial scar with minimal spherical capsular contracture;

said bladder having an inlet; and

apparatus including one of a body prosthesis and a physiological device introduced through said bladder inlet into said bladder after implant of said bladder, said inlet being subsequently sealed.

15. The implant as defined in claim 1 and in which said bladder has an inner surface, said inner surface being coated with a non-porous material.

2. A breast prosthesis implant comprising, in combination:

a bio-compatible flexible thermoplastic polymer bladder being microporous with a pore size between 15 and 100 microns so that after implant in a subcutaneous pocket, body tissue will grow into the pores to form an artificial scar with minimal spherical capsular contracture;

said bladder being formed of the same material throughout and having a thin enough wall thickness so as to be non-palpable under subcutaneous tissue;

said bladder further having an inlet and being expandable to a generally tear-drop shape; and

a soft pliable breast prosthesis introduced into said bladder through said bladder inlet after implant of said bladder, said inlet being subsequently sealed and said prosthesis expanding said bladder to a desired shape.

3. The breast prosthesis implant according to claim 2 wherein at least the outer surface of said bladder has a pore size between 15 and 100 microns.

4. The breast prosthesis implant according to claim 2 wherein said bladder is formed of expanded polytetrafluoroethylene.

5. The breast prosthesis implant according to claim 2 wherein said bladder comprises a plurality of pieces which are joined together.

6. The breast prosthesis according to claim 5 wherein said pieces are stitched together.

7. The breast prosthesis implant according to claim 2 wherein said bladder has a wall thickness between 0.2 mm and 0.4 mm.

8. The breast prosthesis implant according to claim 2 wherein said breast prosthesis comprises an outer polymer shell filled with a liquid.

9. The breast prosthesis implant according to claim 8 wherein said outer shell is a silicone rubber filled with a silicone gel.

10. The breast prosthesis implant according to claim 8 wherein said outer shell is filled with a saline solution.

11. The breast prosthesis implant according to claim 2 wherein said bladder has a peripheral attachment area.

12. The breast prosthesis implant according to claim 8 wherein said breast prosthesis is constructed with a double lumen, having an outer polymer lumen shell and an inner polymer lumen shell.

13. The breast prosthesis implant according to claim 12 wherein at least the inner lumen shell is filled with a liquid.

14. The breast prosthesis according to claim 13 wherein said outer lumen shell is filled with a liquid.

20. The method according to claim 6 wherein the inlet is cut and opened in the bladder in step G) after the bladder has been introduced into the breast pocket in step D).

16. A method of performing a breast prosthesis implant comprising the following steps:

A) making an incision and creating a subglandular or submuscular breast pocket by dissection followed by hemostasis;

B) irrigating said breast pocket with an antibiotic solution;

C) providing a bio-compatible thermoplastic polymer bladder with at least its outer surface being microporous, the bladder having a wall thickness between 0.2 mm and 1.2 mm and being expandable to a tear drop shape;

D) introducing the bladder into the breast pocket created in step A);

E) securing said bladder in said breast pocket;

F) providing a soft pliable smooth surface breast prosthesis;

G) opening an inlet in the bladder;

H) introducing the breast prosthesis into the bladder through said opened inlet, and expanding the bladder to a desired shape with the prosthesis remaining at least partially mobile within said bladder;

I) closing the inlet in the bladder, and

J) allowing host body tissue to grow into said pores forming an artificial scar in a manner which prevents or minimizes spherical capsular contracture.

17. The method according to claim 16 wherein in step C) said bladder comprises a plurality of pieces which are stitched together.

18. The method according to claim 17 wherein said bladder as provided in step C) has an inlet which is opened in steps G) and is closed in step I).

19. The method according to claim 18 wherein a seam between two pieces is left unstitched to provide said inlet in said bladder.

21. The method according to claim 16 wherein the bladder provided in step C) has a peripherally located attachment area and the bladder is secured in step E) by stitching through the attachment area.

22. The method according to claim 16 wherein the breast prosthesis provided in step F) has an outer shell of silicone rubber filled with silicone gel.

23. The method according to claim 16 wherein in step F) a double lumen breast prosthesis is provided, and after it has been introduced into the bladder in step H), an inner lumen of the prosthesis is filled by a catheter with a bio-compatible liquid, and an outer lumen of the prosthesis is filled by a catheter with a bio-compatible liquid, the filling of the outer lumen expanding the bladder to temporarily secure the bladder in the breast pocket in step E) with final securing being obtained in step J) by the formation of the artificial scar, after which the bio-compatible liquid is removed from the outer lumen by a catheter, and the bladder assumes a desired final shape with the breast prosthesis being at least partially mobile within the bladder so as to not cause wrinkling of the skin.