Surgical implant for marking soft tissue

Patent metadata

Field	Value
Publication number	US-12357418-B2
Application number	US-202418593019-A
Country	US
Kind code	B2
Filing date	Mar 1, 2024
Priority date	Apr 26, 2012
Publication date	Jul 15, 2025
Grant date	Jul 15, 2025

Abstract

An implantable tissue marker device is provided to be placed in a soft tissue site through a surgical incision. The device can include a bioabsorbable body in the form of a spiral and defining a spheroid shape for the device, the spiral having a longitudinal axis, and turns of the spiral being spaced apart from each other in a direction along the longitudinal axis. A plurality of markers can be disposed on the body, the markers being visualizable by a radiographic imaging device. The turns of the spiral are sufficiently spaced apart to form gaps that allow soft tissue to infiltrate between the turns and to allow flexibility in the device along the longitudinal axis in the manner of a spring.

First claim

The invention claimed is:

1. A method of fabricating a surgical implant, the method comprising:
forming a two-dimensional planar structure from a bioabsorbable polymer; and
shaping the two-dimensional planar structure into a three-dimensional, hollow spheroid support structure, the three-dimensional, hollow spheroid support structure having an open architecture and being sized and shaped to fill a surgically created cavity.

2. The method of claim 1 , wherein forming the two-dimensional planar structure comprises injection molding the two-dimensional planar structure.

3. The method of claim 1 , wherein forming the two-dimensional planar structure comprises extruding the two-dimensional planar structure.

4. The method of claim 1 , wherein forming the two-dimensional planar structure comprises forming first and second planar spirals, the first planar spiral being opposite to the second planar spiral and connected to the second planar spiral via a connecting segment.

5. The method of claim 4 , wherein forming the first planar spiral comprises forming a first polar region having a first extension and forming the second planar spiral comprises forming a second polar region having a second extension.

6. The method of claim 5 , wherein the first extension and the second extension each include a pocket or an opening, and further including disposing respective first and second radio-opaque markers in each pocket or opening.

7. The method of claim 5 , wherein shaping the two-dimensional planar structure into the three-dimensional, hollow spheroid support structure comprises forming a three-dimensional spiral having an equatorial region extending between the first polar region and the second polar region, wherein the first extension and the second extension each extend into and terminate within an open center of the three-dimensional spiral.

8. The method of claim 7 , wherein the first extension and the second extension are coaxial with a longitudinal axis of the three-dimensional spiral, and wherein the first extension extends orthogonally from the first polar region at a first end portion of the three-dimensional spiral and the second extension extends orthogonally from the second polar region at a second end portion of the three-dimensional spiral.

9. The method of claim 8 , further comprising connecting a strut between the first extension and the second extension.

10. The method of claim 1 , further comprising, after forming the two-dimensional planar structure, securing a plurality of visualization markers to the two-dimensional planar structure.

11. The method of claim 10 , wherein forming the two-dimensional planar structure includes forming a plurality of pockets in the two-dimensional planar structure, and wherein securing the plurality of visualization markers comprises inserting a respective visualization marker into each of the plurality of pockets.

12. The method of claim 10 , wherein shaping the two-dimensional planar structure into the three-dimensional, hollow spheroid support structure comprises forming the three-dimensional, hollow spheroid support structure, with the plurality of visualization markers secured at various locations along a peripheral surface of the three-dimensional, hollow spheroid support structure.

13. The method of claim 1 , wherein shaping the two-dimensional planar structure into the three-dimensional, hollow spheroid support structure comprises heat molding the two-dimensional planar structure.

14. The method of claim 13 , wherein heat molding the two-dimensional planar structure comprises heat molding the two-dimensional planar structure around a spheroid forming mandrel.

15. The method of claim 1 , wherein forming the two-dimensional planar structure comprises forming the two-dimensional planar structure in a two-part mold.

16. A method of fabricating a surgical implant, the method comprising:
injection molding a two-dimensional body from a bioabsorbable polymer, the two-dimensional body comprising a first planar spiral terminating in a first end portion and a second planar spiral terminating in a second end portion, the first planar spiral being opposite to the second planar spiral and connected to the second planar spiral via a connecting segment; and
heat molding the two-dimensional body into a three-dimensional spiral having an equatorial region extending between the first end portion and the second end portion.

17. The method of claim 16 , wherein forming the first planar spiral comprises forming a first polar region having a first extension at the first end portion and forming the second planar spiral comprises forming a second polar region having a second extension at the second end portion.

18. The method of claim 17 , wherein heat molding the two-dimensional body into the three-dimensional spiral comprises molding the first extension and the second extension to be coaxial with a longitudinal axis of the three-dimensional spiral, such that the first extension extends orthogonally from the first polar region into an open center of the three-dimensional spiral and the second extension extends orthogonally from the second polar region into the open center of the three-dimensional spiral.

19. The method of claim 18 , further comprising connecting a strut between the first extension and the second extension.

20. The method of claim 16 , wherein the first end portion and the second end portion each include a pocket or an opening, and further including disposing respective first and second radio-opaque markers in each pocket or opening.

21. A method of fabricating a surgical implant, the method comprising:
forming a two-dimensional planar structure from a bioabsorbable polymer, the two-dimensional planar structure comprising a first polar region having a first extension and a second polar region having a second extension; and
shaping the two-dimensional planar structure into a three-dimensional support structure having an equatorial region extending between the first polar region and the second polar region, wherein the first extension and the second extension each extend into and terminate within an open center of the three-dimensional support structure, and wherein the three-dimensional support structure has an open architecture and is sized and shaped to fill a surgically created cavity.

Assignees

• Hologic Inc

Inventors

• Hermann George D
• Willis David B
• Drews Michael J
• Lebovic Gail S
• Stubbs James B

Classifications

• A61F2240/005

  Templates · CPC title

• A61F2/12

  Mammary prostheses · CPC title

• A61B2090/3966

  Radiopaque markers visible in an X-ray image · CPC title

• A61B2090/3954

  magnetic, e.g. NMR or MRI · CPC title

• A61B2090/3925

  ultrasonic · CPC title