Implantable devices and techniques for oncoplastic surgery

Patent metadata

Field	Value
Publication number	US-11534289-B2
Application number	US-201916518139-A
Country	US
Kind code	B2
Filing date	Jul 22, 2019
Priority date	Jul 25, 2014
Publication date	Dec 27, 2022
Grant date	Dec 27, 2022

Abstract

Described herein are devices for placement in surgically created soft tissue spaces, potential spaces, or cavities. The implantable devices generally include a bioabsorbable body having an open framework that facilitates attachment of tissue thereto in a manner that helps avoid post-surgical deformities. Methods for using the implantable devices in oncoplastic surgery are further described.

First claim

The invention claimed is:

1. A method of treating cancer in a partial breast reconstruction, the method comprising:
placing an oncoplastic device within a cavity or space, the cavity or space formed by surgical removal of tissue, wherein the oncoplastic device comprises:
an open framework body formed by one or more framework elements, wherein the one or more framework elements are configured to provide structural support to the tissue forming the cavity or space and allow seroma fluid to pass through the open framework body so that the seroma fluid can promote tissue regrowth within the open framework body of the oncoplastic device to at least partially reconstruct a breast; and
a therapeutic drug for treatment of cancer, or to improve tissue healing, or to prevent infection, or a combination thereof;

dissecting tissue situated under dermal layers of a patient's skin to create one or more tissue flaps in the tissue forming the cavity or space; and
draping the one or more tissue flaps over the open framework body.

2. The method of claim 1 , wherein the therapeutic drug is contained within a plurality of discrete elements spaced about the open framework body.

3. The method of claim 2 , wherein the plurality of discrete elements are symmetrically spaced about the open framework body.

4. The method of claim 2 , wherein the plurality of discrete elements are asymmetrically spaced about the open framework body.

5. The method of claim 2 , wherein the plurality of discrete elements further assist in delineating a three-dimensional region of tissue for subsequent clinical imaging.

6. The method of claim 2 , wherein the plurality of discrete elements further serve as fiducial markers.

7. The method of claim 1 , wherein the open framework body further includes a plurality of discrete radiographically visible elements spaced thereon.

8. The method of claim 1 , further comprising attaching the dissected tissue to the oncoplastic device.

9. The method of claim 8 , wherein attaching the dissected tissue to the oncoplastic device comprises one of:
pulling the dissected tissue through the open framework body;
suturing the dissected tissue through the open framework body;
wrapping the dissected tissue around the open framework body; and
suturing the dissected tissue to the open framework body.

10. The method of claim 1 , wherein after placement of the oncoplastic device, the open framework body has a flattened or low profile-shape.

11. The method of claim 1 , wherein, after placement of the oncoplastic device, a height of the open framework body is substantially less than a width and a length of the open framework body.

12. The method of claim 1 , wherein the one or more framework elements comprise a single, U-shaped framework element.

13. The method of claim 1 , wherein the one or more framework elements comprise a plurality of framework elements.

14. The method of claim 13 , wherein the plurality of framework elements comprises a circular or ovoid base element and one or more curved or arcuate spacer elements.

15. The method of claim 1 , wherein draping the one or more tissue flaps over the open framework body comprises draping the one or more tissue flaps over an anterior region of the open framework body.

16. The method of claim 1 , wherein the open framework body comprises one unitary framework element comprised of a spiral-shape.

17. A method of treating cancer in a partial breast reconstruction, the method comprising:
placing an oncoplastic device within a cavity or space, the cavity or space being formed by surgical removal of tissue of a breast, the oncoplastic device comprising an open framework body formed of a bioabsorbable material;
forming one or more tissue flaps in subcutaneous tissue defining the cavity or space;
draping the one or more tissue flaps over the open framework body; and
restoring a contour of the breast by supporting the one or more tissue flaps with the open framework body, while allowing seroma fluid to pass through the open framework body so that the seroma fluid can promote tissue regrowth within the open framework body.

18. The method of claim 17 , further comprising supporting the tissue defining the cavity or space with the open framework body.

19. The method of claim 18 , further comprising attaching surrounding tissue of the cavity or space to the open framework body.

20. The method of claim 19 , wherein attaching the surrounding tissue of the cavity or space to the open framework body comprises one of:
pulling the surrounding tissue through the open framework body;
suturing the surrounding tissue through the open framework body;
wrapping the surrounding tissue around the open framework body; and
suturing the tissue to the open framework body.

21. The method of claim 17 , further comprising providing cancer treatment to the breast via a therapeutic drug in the open framework body.

22. The method of claim 17 , wherein placing the oncoplastic device within the cavity or space comprises placing the oncoplastic device within a cavity or space having minimal overlying tissue.

23. The method of claim 22 , wherein, after placement of the oncoplastic device, a height of the open framework body is substantially less than a width and a length of the open framework body.

24. The method of claim 17 , wherein forming the one or more tissue flaps in the tissue defining the cavity or space comprises surgically dissecting breast tissue along a mastectomy plane.

25. A method of treating cancer in a partial breast reconstruction, the method comprising:
placing an oncoplastic device within a cavity or space, the cavity or space being formed by surgical removal of tissue of a breast, the oncoplastic device comprising an open framework body formed of a bioabsorbable material;
forming one or more tissue flaps in tissue surrounding the cavity or space;
draping the one or more tissue flaps over the open framework body;
attaching the one or more tissue flaps to the open framework body by pulling the tissue flaps through the open framework body, suturing the tissue flaps through the open framework body, wrapping the tissue flaps around the open framework body, and/or suturing the tissue flaps to the open framework body; and
restoring a contour of the breast by supporting the one or more tissue flaps with the open framework body, while allowing seroma fluid to pass through the open framework body so that the seroma fluid can promote tissue regrowth within the open framework body.

Assignees

• Hologic Inc

Inventors

• Lebovic Gail S
• Willis David B
• Hermann George D
• Olson Jonathan M

Classifications

• A61B17/00

  Surgical instruments, devices or methods (A61B18/00 takes precedence; dental tools A61C3/00; eye surgery A61F9/007; ear surgery A61F11/20) · CPC title

• A61F2210/0004

  bioabsorbable · CPC title

• A61B2090/3908

  Soft tissue, e.g. breast tissue · CPC title

• A61F2230/0008

  elliptical or oval · CPC title

• A61F2230/0013

  Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped · CPC title