Non-rotating breast implant

• US 20030205846A1
• Filed: 06/16/2003
• Published: 11/06/2003
• Est. Priority Date: 12/01/1999
• Status: Active Grant

• Current Assignee: Howard T. Bellin
• Original Assignee: Howard T. Bellin
• Inventors: Bellin, Howard T., Kredovski, Kenneth C., Campbell, Ruairidh W.
• Granted Patent: US 7,105,116 B2
• Time in Patent Office: Days
• US Class Current: 264/305
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: B29C 2791/001 Shaping in several steps
• CPC Class Codes: B29C 37/0053 Moulding articles characterised by the shape of the surface, e.g. ribs, high polish mould construction therefor B29C33/42; surface shaping of articles B29C59/00; by incorporating filler in or near the surface B29C70/64
• CPC Class Codes: B29C 41/14 Dipping a core B29C41/10 takes precedence
• CPC Class Codes: B29L 2031/7532 Artificial members, protheses

Abstract

A non-rotating anatomical-shaped breast implant having a front side with a smooth surface and a rear side with a textured surface. A smooth surface ripples or wrinkles little, if at all. Rippling or wrinkling of the implant may undesirably produce a visible or palpable waviness on the skin of the breast. A smooth surface is more likely to produce the look and feel of a natural breast. A rear side with a textured surface is desirable because tissue growth of the body, after the implant has been implanted, engages the textured surface to anchor the implant in place such that the front side with the smooth surface remains matched with the front side of the body and such that the anatomical-shaped breast implant with its tear drop shaped fullness remains at a natural position within the breast. The disclosure further includes a method for minimizing the rotation of an implant within the body and a method for making an implant envelope that has different thicknesses.

Claims

1. A breast implant for being implanted within a body, wherein the body includes front, rear, right and left sides, wherein the breast implant comprises:

a) an envelope having at least two sides, wherein the envelope is fillable with fluid to provide a three-dimensional shape to the envelope;

b) wherein one of the sides of the envelope comprises a relatively smooth surface; and

c) wherein the other of the sides of the envelope comprises a relatively rough surface, wherein tissue growth by the body engages the relatively rough surface after the envelope has been implanted such that the envelope is restrained from rotating and such that the relatively smooth surface may be oriented as desired within the body.

2. The breast implant according to claim 1, wherein one of the sides of the envelope is thicker than the other of the sides of the envelope, wherein the thicker side of the envelope comprises the relatively rough surface, and wherein the thinner side of the envelope comprises said relatively smooth surface.

3. The breast implant according to claim 1, wherein one of the sides of the envelope has been cured once, wherein the other side of the envelope has been cured twice, and wherein the side that has been cured once comprises said relatively smooth surface.

4. The breast implant according to claim 1, wherein the envelope is anatomically-shaped in the form of a breast and comprises front, rear, right and left sides, wherein the front, rear, right and left sides of the envelope are oriented toward the front, rear, right and left sides of the body, wherein the rear side of the anatomically-shaped envelope comprises the relatively rough surface, wherein the front side of the envelope comprises the relatively smooth surface, and wherein each of the right and left sides comprises the relatively smooth surface.

5. The breast implant according to claim 1, wherein the envelope has a total surface area, wherein the relatively smooth surface runs over about 50% of the total surface area, and wherein the relatively rough surface runs over about 50% of the total surface area.

6. The breast implant according to claim 1, wherein the envelope includes an opening through which a mandrel had been removed, wherein the envelope is sealed with a patch engaged over the opening and to the envelope, and wherein the patch includes an exterior surface which includes the relatively rough surface.

7. A non-rotating anatomical-shaped breast implant for being implanted within a body, wherein the body includes front, rear, right and left sides, with the non-rotating anatomical-shaped breast implant comprising:

a) an envelope formed in the anatomical shape of a breast, wherein the envelope comprises front, rear, right and left sides;

b) wherein the envelope is fillable with fill material;

c) wherein the front side of the envelope comprises a relatively smooth surface; and

d) wherein the rear side of the envelope comprises a relatively rough surface, wherein tissue growth by the body engages the relatively rough surface after the implant has been implanted such that the envelope is restrained from rotating and such that the front, rear, right and left sides of the envelope remain respectively oriented toward the front, rear, right and left sides of the body.

8. The non-rotating anatomical-shaped breast implant according to claim 7, wherein the envelope includes fill material prior to the envelope being implanted.

9. A breast implant comprising:

a) an envelope having an anterior side, posterior side, superior pole, inferior pole and a nipple position, with the nipple position being on the anterior side near the inferior pole;

b) wherein the anterior side has a first thickness;

c) wherein the posterior side has a second thickness; and

d) wherein the first thickness of the anterior side is less than the second thickness of the posterior side.

10. The breast implant of claim 9 wherein the posterior side comprises a textured exterior surface portion.

11. The breast implant of claim 9 wherein the anterior side comprises a smooth exterior surface portion.

12. The breast implant of claim 9 wherein the anterior side comprises a relatively smooth exterior surface portion and wherein the posterior side comprises a relatively rough exterior surface portion.

13. The breast implant of claim 9 wherein the posterior side has been cured twice and the anterior side has been once cured.

14. The breast implant of claim 9 wherein the envelope is an anatomical-shaped breast envelope.

15. A method for minimizing rotation of a breast implant within a body, comprising the steps of:

a) selecting a breast implant;

b) forming a relatively rough surface on an exterior portion of the breast implant and forming a relatively smooth surface on another exterior portion of the breast implant;

c) implanting the breast implant within the body so as to orient the relatively smooth surface in a desired direction;

then

d) permitting tissue growth to engage the relatively rough surface so as to anchor the breast implant in place, thereby minimizing rotation of the breast implant and holding the relatively smooth surface in the desired direction.

16. The method according to claim 15, wherein the step of forming the relatively rough surface comprises the step of forming a relatively rough surface over about 5% to about 50% of a total surface area of the breast implant.

17. The method according to claim 15, wherein the step of selecting a breast implant comprises the step of selecting an anatomical-shaped breast implant, wherein the anatomical-shaped breast implant comprises front, rear, right and left sides, wherein the front side of the anatomical-shaped breast implant comprises the relatively smooth surface, wherein the right side of the anatomical-shaped breast implant comprises the relatively smooth surface, wherein the left side of the anatomical-shaped breast implant comprises the relatively smooth surface, and wherein the rear side of the anatomical-shaped breast implant comprises the relatively rough surface.

18. A method of making an envelope for a breast implant, comprising the steps of:

a) selecting a mandrel;

b) selecting a dispersion into which the mandrel is dipped;

c) fully submerging the mandrel in the dispersion such that an envelope is formed, withdrawing the mandrel from the dispersion and thereby picking up a first envelope layer on the mandrel, and permitting the first envelope layer to at least partially stabilize; and

d) partially submerging the mandrel in the dispersion such that a portion of the mandrel remains exposed to the atmosphere, withdrawing the mandrel from the dispersion and thereby picking up a second envelope layer on the mandrel and permitting the second envelope layer to at least partially stabilize, whereby an envelope coating of a first thickness is disposed over one portion of the mandrel and whereby an envelope coating of a second thickness is disposed over another portion of the mandrel.

19. The method of claim 18 wherein the step of fully submerging the mandrel occurs prior to the step of partially submerging the mandrel.

20. The method of claim 18 and further comprising:

e) curing the envelope between the steps of fully submerging the mandrel and partially submerging the mandrel; and

f) curing the envelope after the step of partially submerging the mandrel.