IP Library Granted Patent US 9,199,092
Granted Patent B2
US 9,199,092 · App. 14/581,146 · Granted Dec 1, 2015

Diagnostic or therapeutic procedure using implantable targets

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Quick Facts
Patent No.
US 9,199,092
App. No.
14/581,146
Granted
Dec 1, 2015
Kind
B2
Abstract

An implantable device has a body that is substantially rigid and has an imageable shape. The body is further bioabsorbable and may contain permanent metallic elements to aid in its imaging. When the device is implanted in a resected cavity in soft tissue, it can cause the cavity to conform substantially to a known imageable shape. The implantable device is further imageable due to its attenuation properties being different from those of soft tissue such that the boundaries of the tissue corresponding to the predetermined shape can be determined.

Claims (46)

1. A method, comprising:

creating a cavity by removing soft tissue through an open surgical incision from a location within the body;

inserting into the cavity by an open surgical method a bioabsorbable implant having an open architecture;

threading a suture around a portion of the open architecture of the bioabsorbable implant, the suture threaded around the portion of the open architecture via the open surgical incision; and

inserting the suture through a portion of soft tissue defining the cavity such that the implant is secured to a periphery of the cavity.

2. The method of claim 1 , wherein the cavity is created in a breast.

3. The method of claim 1 , wherein the cavity is created during a lumpectomy procedure.

4. The method of claim 1 , wherein the implant includes radiopaque marker elements.

5. The method of claim 1 , wherein the implant provides an overall volumetric shape.

6. The method of claim 1 , wherein the implant is used to determine a target tissue region.

7. The method of claim 1 , further comprising closing the surgical site after inserting the suture through the portion of the soft tissue defining the cavity.

8. The method of claim 1 , further comprising imaging the implanted device within the soft tissue defining the cavity.

9. The method of claim 1 , further comprising planning external radiation to the body based on a position of the implant.

10. The method of claim 1 , further comprising targeting radiation to the body based on a position of the implant.

11. The method of claim 1 , further comprising delivering radiation to the body based on a position of the implant.

12. The method of claim 1 , wherein the suture is a first suture, the method further comprising:

closing the open surgical incision with a second suture.

13. A method, comprising:

creating an open surgical incision in a breast;

removing a volume of soft tissue of the breast through the surgical incision;

inserting through the open surgical incision a bioabsorbable implant having an open three-dimensional framework, an attachment portion, and a plurality of radiopaque markers;

suturing the attachment portion of the bioabsorbable implant to the breast tissue via the surgical incision such that the bioabsorbable implant is secured in place within the breast; and

closing the open surgical incision after suturing the attachment portion of the bioabsorbable implant to the breast.

14. The method of claim 13 , wherein the volume of soft tissue is removed to create a tumor resection cavity in the breast.

15. The method of claim 13 , further comprising imaging the breast after surgical insertion of the implant.

16. The method of claim 13 , further comprising planning external radiation to the breast based on a position of the bioabsorbable implant.

17. The method of claim 13 , further comprising targeting radiation to the breast based on a position of the bioabsorbable implant.

18. The method of claim 13 , further comprising delivering radiation to the breast based on a position of the bioabsorbable implant.

19. The method of claim 13 , wherein the bioabsorbable implant has a size and a shape when inserted through the surgical incision, the bioabsorbable implant having the size and the shape after the surgical site is closed.

20. A method of treatment, comprising:

creating a tumor resection cavity in subcutaneous tissue in a body, the tumor resection cavity defined by subcutaneous tissue, the tumor resection cavity open to an exterior of the body via an open surgical incision;

implanting a plurality of radiopaque markers into the tumor resection cavity through the open surgical incision, the plurality of radiopaque markers coupled to a structure that positions the markers in a spaced-apart array that defines a three dimensional volume associated with at least a known portion of the tumor resection cavity;

securing the structure to the subcutaneous tissue via the surgical incision such that the spaced-apart array that defines the three dimensional volume associated with at least the known portion of the tumor resection cavity is fixed in place within the body; and

closing the open surgical incision.

21. The method of claim 20 , wherein the structure is a three dimensional, open architecture, bioabsorbable implant.

22. The method of claim 20 , further comprising imaging the plurality of radiopaque markers.

23. The method of claim 20 , further comprising planning radiation to the body based on a position of the plurality of radiopaque markers.

24. The method of claim 20 , further comprising targeting radiation to the body based on a position of the plurality of radiopaque markers.

25. The method of claim 20 , further comprising delivering radiation to the body based on a position of the plurality of radiopaque markers.

26. The method of claim 20 , wherein securing the structure to the subcutaneous tissue includes suturing the structure to the subcutaneous tissue.

27. The method of claim 20 , wherein:

the structure includes a plurality of suture attachment portions; and

securing the structure to the subcutaneous tissue includes threading a suture around a suture attachment portion from the plurality of suture attachment portions.

28. The method of claim 27 , wherein:

the suture is a first suture; and

closing the incision includes closing the incision with a second suture, the second suture not being disposed through any attachment portion from the plurality of attachment portions.

Assignments (6)
RELEASE OF SECURITY INTEREST RECORDED AT REEL/FRAME 047582/0020 Recorded Apr 24, 2026
From: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
To: HOLOGIC, INC., AS SUCCESSOR-BY-MERGER TO FOCAL THERAPEUTICS, INC.
Reel/Frame 075455/0555 →
SECURITY INTEREST Recorded Apr 8, 2026
From: BIOTHERANOSTICS, INC.; GEN-PROBE INCORPORATED; GEN-PROBE PRODESSE, INC.; CYTYC CORPORATION; SUROS SURGICAL SYSTEMS, INC.; GYNESONICS, INC.; BOLDER SURGICAL, LLC; FAXITRON BIOPTICS, LLC; HEALTH BEACONS, INC.; HOLOGIC, INC.
To: ROYAL BANK OF CANADA, AS COLLATERAL AGENT
Reel/Frame 075462/0440 →
MERGER AND CHANGE OF NAME Recorded Jul 13, 2021
From: FOCAL THERAPEUTICS, INC.; HOLOGIC, INC.
To: HOLOGIC, INC.
Reel/Frame 056835/0532 →
SECURITY INTEREST Recorded Oct 14, 2019
From: HOLOGIC, INC.; CYNOSURE, LLC; CYTYC CORPORATION; FAXITRON BIOPTICS, LLC; FOCAL THERAPEUTICS, INC.; GEN-PROBE INCORPORATED
To: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
Reel/Frame 050719/0701 →
SECURITY INTEREST Recorded Nov 26, 2018
From: FOCAL THERAPEUTICS, INC.
To: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
Reel/Frame 047582/0020 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 5, 2015
From: STUBBS, JAMES B.; HERMANN, GEORGE D.; LEBOVIC, GAIL S.; DREWS, MICHAEL J.
To: FOCAL THERAPEUTICS, INC.
Reel/Frame 034633/0974 →