Systems and methods for mastopexy

• US 10,258,460 B2
• Filed: 02/09/2017
• Issued: 04/16/2019
• Est. Priority Date: 03/09/2011
• Status: Active Grant

• Current Assignee: Tepha Incorporated (Becton, Dickinson & Co)
• Original Assignee: Tepha Incorporated (Becton, Dickinson & Co)
• Inventors: Moses, Arikha, Stires, Emily, Natale, Anthony
• Primary Examiner(s): Gherbi, Suzette J
• Application Number:
  US15/428,268
• Publication Number:
  US 20170143475A1
• Time in Patent Office: 796 Days
• Field of Search: 623 7- 8
• CPC Class Codes: A61B 17/32 Surgical cutting instruments A61B18/042 takes precedence; suture cutters A61B17/0467; instruments for ligaturing or cutting A61B17/128; instruments for rupturing the amniotic membrane A61B17/4208; specially adapted knives for eye surgery A61F9/0133
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00792 Plastic surgery
• CPC Class Codes: A61B 2017/00796 Breast surgery
• CPC Class Codes: A61B 2017/320048 Balloon dissectors
• CPC Class Codes: A61B 2018/00333 Breast
• CPC Class Codes: A61B 2018/00595 Cauterization
• CPC Class Codes: A61B 2018/00601 Cutting
• CPC Class Codes: A61B 2090/3908 Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 2090/3937 Visible markers
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: A61F 2002/0068 having a special mesh pattern
• CPC Class Codes: A61F 2002/0072 Delivery tools therefor
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0058 : X-shaped
• CPC Class Codes: A61F 2230/0076 : ellipsoidal or ovoid
• CPC Class Codes: A61L 31/06 : obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/146 : Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/148 : Materials at least partially resorbable by the body

Abstract

A mastopexy implant for maintaining the breast in an elevated and aesthetically pleasing position includes a lower pole support comprising end portions which may be affixed to the chest wall or to a previously installed upper suspension strut. The implant is loaded in an insertion device. The insertion device is inserted through a small incision and into a subcutaneous pocket created in an inferior half of the breast. The lower pole support may have various constructs and in one embodiment includes a unitary conformable mesh having a plurality of arm or band members which are attached across the breast parenchyma and to the chest wall.

Claims

1. An implant for securing a breast of a patient in a lifted position, the implant comprising:

a lower pole support comprising a body having a low-profile configuration, and a self-deploying 3D pre-determined configuration larger than the low-profile configuration, and wherein said 3D pre-determined configuration is sized such that the body substantially spans a lower pole of the breast when deployed wherein the body comprises a shape-memory material that imparts the 3D pre-determined configuration onto the breast when unconstrained.

2. The implant of claim 1 further comprising a plurality of sutures extending through said straps and for securing the straps to supportive tissue, causing the breast to be secured in the lifted position.

3. The implant of claim 1 wherein the body is a composite of different materials.

4. The implant of claim 3 wherein each of the materials of the body is biodegradable.

5. The implant of claim 4 wherein the body comprises a polymer.

6. The implant of claim 5 wherein the body comprises a porous structure.

7. The implant of claim 1 wherein the body has a canoe-like shape.

8. The implant of claim 1 wherein the body has a radius of 4.5 or 5.5 cm.

9. The implant of claim 1 wherein the body has a length of 22 cm.

10. The implant of claim 1 further comprising a plurality of flexible straps extending in the upwards direction and lower direction from the body.

11. The implant of claim 10 wherein each of the straps has a width between 0.25 to 5 cm.

12. The implant of claim 10 wherein the plurality of flexible straps comprises more than five straps including at least two upper straps and two lower straps.

13. The implant of claim 10 wherein the body and straps comprises a silk-based material.

14. The implant of claim 10 wherein the body and straps comprises poly-4-hydroxybutyrate (P4HB).

15. The implant of claim 10 wherein at least one of the straps extends in a lateral direction.

16. The implant of claim 10 wherein the straps are extendable.

17. The implant of claim 16 wherein the straps are extendable up to 10%.

18. The implant of claim 1 wherein the low-profile configuration comprises the body in a rolled state.

19. An implant for securing a breast of a patient in a lifted position, the implant comprising:

a lower pole support comprising a body having a low-profile configuration, and a self-deploying 3D pre-determined configuration larger than the low-profile configuration, and wherein said 3D pre-determined configuration is sized such that the body substantially spans a lower pole of the breast when deployed; and

wherein the body further comprises a mesh, sheet, fabric, woven construct, knitted construct, braided construct, porous scaffold, nanospun, electrospun, or melt-blown construct, and wherein the body is made of a shape-memory material to impart the 3D pre-determined configuration onto the breast.

20. A breast implant comprising a 3D shaped body made of a soft-tissue promoting resorbable scaffold and support or a long-lasting resorbable matrix, said soft-tissue promoting resorbable scaffold adapted to allow tissue ingrowth thereby imparting a fuller contour to the breast.

21. The breast implant of claim 20 wherein the soft-tissue promoting resorbable scaffold is porous.

22. The breast implant of claim 21 wherein the soft-tissue promoting resorbable scaffold comprises a synthetically derived product.

23. The breast implant of claim 20 further comprising a naturally derived product, and wherein the naturally derived product is protein-based.

24. The breast implant of claim 20 further comprising a naturally derived product, and wherein the naturally derived product is allograft, autograft, or xenograft-based.

25. The breast implant of claim 20 wherein the 3D shaped body includes a cavity for facilitating tissue remodeling.