IP Library Granted Patent US 11,337,772
Granted Patent B2
US 11,337,772 · App. 15/982,903 · Granted May 24, 2022

Implant for targeting therapeutic procedure

Inventor: James B. Stubbs (Palo Alto, CA)
Assignee: HOLOGIC, INC.
A61B90/39A61B17/22A61F2/12A61L31/044A61L31/148A61M31/002A61N5/02A61N5/1039A61N5/1045A61N5/1049A61N5/1067A61N5/1069A61N5/1077A61N7/02A61B2017/00004A61B2090/363A61B2090/3908A61B2090/3925A61B2090/3966A61B2090/3995A61N5/107A61N5/1042A61N2005/1051A61N2005/1089A61N2005/1091A61N2005/1096
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Quick Facts
Patent No.
US 11,337,772
App. No.
15/982,903
Granted
May 24, 2022
Kind
B2
Abstract

An implantable device has a body that is substantially rigid and has a predetermined shape. The body is further bioabsorbable and has a density less than or equal to about 1.03 g/cc. When the device is implanted in a resected cavity in soft tissue, it causes the cavity to conform to the predetermined shape. The implantable device is further imageable due to its density being less than that of soft tissue such that the boundaries of the tissue corresponding to the predetermined shape can be determined.

Claims (28)

1. A method for treating a proliferative tissue disease in a patient comprising:

excising diseased tissue from the patient and thereby creating a tissue cavity;

placing a bioabsorbable implant within the tissue cavity, the implant having a body that is rigid and has a predetermined size and shape that remains constant prior to implantation, during implantation, and after implantation, the body being configured to exhibit negative contrast under ultrasonic or x-ray visualization;

determining a location of the implant within the patient using ultrasonic or x-ray imaging apparatuses; and

treating tissue surrounding the tissue cavity with therapeutic energy sources, wherein the implant remains within the tissue cavity following treatment.

2. The method of claim 1 , wherein the implant comprises collagen.

3. The method of claim 1 , wherein the treating of tissue with energy sources comprises applying external beam radiation.

4. The method of claim 1 , wherein the implant is sized to fill the tissue cavity.

5. The method of claim 1 , wherein the implant maintains its predetermined shape for a period of about at least six weeks.

6. The method of claim 1 , wherein a diameter of the implant is approximately 2 to 4 centimeters.

7. The method of claim 1 , wherein the body comprises a rigid spherical shape including a core and an outer layer, wherein the outer layer is manufactured from a stiffer material as compared to the core.

8. The method of claim 7 , wherein the outer layer further comprises one or more of air, gas pockets, or bubbles to facilitate visualization under ultrasound.

9. The method of claim 1 , wherein the body comprises a core and an outer layer, wherein the outer layer is manufactured from a stiffer material as compared to the core.

10. The method of claim 9 , wherein the outer layer further comprises one or more of air, gas pockets, or bubbles to facilitate visualization under ultrasound.

11. A method for targeting and delivering therapeutic rays to a patient's soft tissue, comprising:

(a) preparing a treatment plan for a patient, the treatment plan including one or more sessions of radiation treatment;

(b) imaging an implanted device within soft tissue in the patient, the implanted device comprising a body that is rigid and has a predetermined size and shape that remains constant prior to implantation, during implantation, and after implantation, wherein the implanted device has a density that is lower than a density of the patient's soft tissue, wherein the shape of the body comprises a rigid spherical shape;

(c) determining a region of target tissue surrounding the implanted device;

(d) targeting an energy dose from an energy source external to the patient to the region of target tissue; and

(e) delivering the targeted energy dose, wherein the implanted device remains within the patient's soft tissue following completion of the treatment plan.

12. The method of claim 11 , further comprising:

without removing the implanted device or acting to alter its configuration, repeating, following a passage of time, steps (b) through (e).

13. The method of claim 11 , wherein the implanted device has a density of less than or equal to about 1.03 g/cc.

14. The method of claim 11 , wherein the implanted device is implanted in a patient's breast.

15. The method of claim 12 , wherein the implanted device is bioabsorbable.

16. The method of claim 15 , wherein the implanted device remains substantially rigid during the delivery of the targeted energy doses before absorbing.

17. The method of claim 11 , further comprising providing fiducial markers in or on the device in order to track the device's position.

18. The method of claim 11 , further comprising delivering to the patient a treatment material from the implanted device.

Assignments (5)
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 →
Continuity (5)
Continuation 15466619 · Mar 22, 2017
Continuation 14581807 · Dec 23, 2014
Continuation 12173881 · Jul 16, 2008
Provisional Application 60949963 · Jul 16, 2007
Related Publication 20190110858A1 · Apr 18, 2019
Cited By (1)
US 12,357,418