Textured breast implant and methods of making same

• US 10,350,055 B2
• Filed: 09/28/2018
• Issued: 07/16/2019
• Est. Priority Date: 05/16/2014
• Status: Active Grant

• Current Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Original Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Inventors: Nieto, Robert, Dominguez, Zachary
• Primary Examiner(s): Sellman, Cachet I
• Application Number:
  US16/147,472
• Publication Number:
  US 20190029807A1
• Time in Patent Office: 291 Days
• Field of Search: 623 8, 427 224, 427180
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: A61F 2002/0081 directly machined on the prosthetic surface, e.g. holes, grooves A61F2/30771 takes precedence
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0026 differing in surface structures
• CPC Class Codes: A61F 2250/0051 differing in tissue ingrowth capacity, e.g. made from both ingrowth-promoting and ingrowth-preventing parts

Abstract

Methods for texturing surgical implants, for example, breast implants, are provided. The methods include the use of computer controlled 3D printing of a sacrificial material to create a textured surface on an unfinished surface of the implant.

Claims

1. A method for creating a textured breast implant, the method comprising:

dipping a mandrel into a liquid elastomer to form a breast implant shell around the mandrel;

depositing, via a three-dimensional printing process, a texturing material onto the breast implant shell to form a first micrometer-scale pattern for creating an imprint on the breast implant shell;

curing the breast implant shell to form a first cured, imprinted layer;

removing the texturing material from the first cured, imprinted layer to form a textured surface;

applying a tacky layer onto the textured surface;

depositing, via three-dimensional printing, additional texturing material onto the tacky layer to form a second micrometer-scale pattern for creating a second imprint on the tacky layer;

curing the tacky layer to form a second cured, imprinted layer; and

removing the additional texturing material from the second cured, imprinted layer to obtain a second textured surface, the first and second cured, imprinted layers being configured to permit ingrowth of cells into the breast implant.

2. The method of claim 1, wherein the step of depositing, via a three-dimensional printing process, the texturing material onto the breast implant shell comprises:

depositing a predetermined number of successive layers of the texturing material; and

applying to one or more predetermined regions of each successive layer of texturing material a binder that will cause the texturing material to become bonded at said one or more predetermined regions.

3. The method of claim 1, wherein the texturing material comprises a sugar.

4. The method of claim 1, wherein the texturing material comprises a sugar and a binder in an aqueous solution or alcohol.

5. The method of claim 1, further comprising obtaining a predetermined thickness of cured, imprinted layers by applying additional alternating layers of a tacky layer and texturing material.

6. The method of claim 5, wherein the predetermined thickness varies in various regions on the textured surface.

7. The method of claim 1, wherein the first or second micrometer-scale patterns is one of a closely packed hexagonal pattern, a nested/tangent circle pattern, or a rectangle pattern.

8. The method of claim 1, wherein the three-dimensional printing process utilizes binder deposition printing.

9. The method of claim 1, wherein the removing the texturing material from the first cured, imprinted layer comprises placing the shell in a water bath and rubbing the texturing material from the breast implant shell.

10. The method of claim 1, wherein the removing the additional texturing material from the second cured, imprinted layer comprises placing the shell in a water bath and rubbing the additional texturing material from the tacky layer.

11. A method for creating a textured breast implant having a plurality of textured layers thereon, method comprising repeatedly, for each textured layer, performing the steps of:

applying a tacky layer onto the implant;

depositing, via a three-dimensional printing process, a texturing material in a predetermined pattern onto the tacky layer of the implant;

curing the tacky layer; and

removing the texturing material from the tacky layer to obtain a textured layer.

12. The method of claim 11, further comprising obtaining a predetermined thickness of the textured layer by applying the tacky layer and the texturing material alternately.

13. The method of claim 12, wherein the predetermined thickness varies in various regions on the textured layer.

14. The method of claim 11, wherein the texturing material comprises a sugar.

15. The method of claim 11, wherein the predetermined pattern comprises a micrometer-scale pattern of a hexagonal pattern, a circle pattern, or a rectangle pattern.

16. A method for creating a textured breast implant, the method comprising:

dipping a mandrel into a liquid elastomer to form a breast implant shell around the mandrel;

forming a first micrometer-scale pattern on the breast implant shell using sugar and a solid freeform fabrication (SFF) or layer manufacturing (LM) technique;

curing the breast implant shell to form a first cured, imprinted surface;

removing the sugar from the first cured, imprinted surface;

after removing the sugar from the first cured, imprinted surface, applying a tacky layer onto the first cured, imprinted surface;

forming a second micrometer-scale pattern on the tacky layer using sugar and a solid freeform fabrication (SFF) or layer manufacturing (LM) technique;

curing the tacky layer to form a second cured, imprinted surface; and

removing the sugar from the second cured, imprinted surface to obtain a second textured surface that facilitates cell ingrowth on the implant.

17. The method of claim 16, wherein the sugar is applied in a liquid binder solution comprising an aqueous solution or alcohol.

18. The method of claim 16, wherein the removing the sugar from the first cured, imprinted surface comprises placing the shell in a water bath and rubbing the sugar from the first cured, imprinted surface.

19. The method of claim 16, wherein the removing the sugar from the second cured, imprinted surface comprises placing the shell in a water bath and rubbing the sugar from the second cured, imprinted surface.

20. The method of claim 16, wherein the breast implant shell comprises silicone.