Method of utilizing an implant in a human breast

• US 8,680,498 B2
• Filed: 09/09/2013
• Issued: 03/25/2014
• Est. Priority Date: 10/10/1997
• Status: Expired due to Term

• Current Assignee: Senorx Incorporated (Becton, Dickinson & Co)
• Original Assignee: Senorx Incorporated (Becton, Dickinson & Co)
• Inventors: Corbitt, John, Anthony, Lori
• Primary Examiner(s): LOGIE, MICHAEL J
• Application Number:
  US14/021,271
• Publication Number:
  US 20140012376A1
• Time in Patent Office: 197 Days
• Field of Search: 250/515.1, 250/492.1, 600/1, 600/2, 607/108, 623/7, 623/8, 623/23.75, 606/77, 424/400
• US Class Current: 250/515.1
• CPC Class Codes: A61B 2090/3908 Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61N 2005/1061 using an x-ray imaging system having a separate imaging source
• CPC Class Codes: A61N 5/10 X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy A61N5/01 takes precedence
• CPC Class Codes: A61N 5/1049 for verifying the position of the patient with respect to the radiation beam

Abstract

A method for utilizing an implant in a human breast includes forming a breast cavity within the breast at a lumpectomy site, the breast cavity having surrounding tissue; forming a substantially radio-opaque implant constructed of biocompatible and biodegradable material configured to allow for in-growth of fibrous tissue into and replacing the biocompatible and biodegradable material, the biocompatible and biodegradable material being elastically compressible; sizing the substantially radio-opaque implant to occupy the breast cavity; and implanting within the breast cavity the substantially radio-opaque implant to support the tissue surrounding the breast cavity, the step of implanting including compressing the biocompatible and biodegradable material.

Claims

1. A method for utilizing an implant in a human breast, comprising:

forming a breast cavity within the breast at a lumpectomy site, the breast cavity having surrounding tissue;

forming a substantially radio-opaque implant constructed of biocompatible and biodegradable material configured to allow for in-growth of fibrous tissue into and replacing the biocompatible and biodegradable material, the biocompatible and biodegradable material being elastically compressible;

sizing the substantially radio-opaque implant to occupy the breast cavity; and

implanting within the breast cavity the substantially radio-opaque implant to support the tissue surrounding the breast cavity, said implanting including compressing the biocompatible and biodegradable material.

2. The method of claim 1, further comprising:

directing a radiation beam to said substantially radio-opaque implant serving as a target for delivery of radiation therapy to margins around the breast cavity, such that the radiation beam does not materially irradiate the whole of the breast.

3. The method of claim 2, wherein the radiation therapy is delivery of a therapeutically effective dosage of radiation to said breast tissue surrounding the substantially radio-opaque implant via a stereotactic radiation machine.

4. The method of claim 3, wherein the radiation therapy is delivery of multiple therapeutically effective dosages of radiation to said breast tissue surrounding the substantially radio-opaque implant in a single treatment.

5. The method of claim 2, wherein the radiation therapy is delivery of therapeutically effective dosages of radiation to said breast tissue surrounding the substantially radio-opaque implant multiple times in a single treatment.

6. The method of claim 2, wherein the radiation therapy is delivery of a therapeutically effective dosage of radiation to said breast tissue surrounding the substantially radio-opaque implant via multidirectional radiation therapy.

7. The method of claim 2, wherein the radiation therapy is delivery of a therapeutically effective dosage of radiation to said breast tissue surrounding the substantially radio-opaque implant via image guided radiation therapy.

8. The method of claim 2, wherein the radiation therapy is delivery of a therapeutically effective dosage of radiation to said breast tissue surrounding the substantially radio-opaque implant via 3-D conformal radiation therapy.

9. The method of claim 2, wherein the radiation therapy is delivery of a therapeutically effective dosage of radiation to said breast tissue surrounding the substantially radio-opaque implant via intensity modulated radiation therapy.

10. The method of claim 2 comprising initiating targeting of the radiation beam for delivery of the radiation therapy 1 to 120 days subsequent to the placement of the substantially radio-opaque implant in the breast cavity.

11. The method of claim 1, further comprising aspirating air from the breast cavity at any time after implanting the substantially radio-opaque implant.

12. The method of claim 1, wherein the substantially radio-opaque implant is constructed of a porous material.

13. The method of claim 1, wherein said substantially radio-opaque implant has a shape selected to guide delivery of radiation therapy to margins around the breast cavity.

14. A method of partial breast radiation therapy, comprising:

providing a substantially radio-opaque implant constructed of biocompatible and biodegradable material configured to allow for in-growth of fibrous tissue into and replacing the of biocompatible and biodegradable material, the biocompatible and biodegradable material being elastically compressible, the substantially radio-opaque implant being configured to support the tissue surrounding a breast cavity;

implanting the substantially radio-opaque implant within the breast cavity to serve as a target for delivery of radiation therapy to margins around the breast cavity; and

directing a therapeutically effective dosage of radiation to the substantially radio-opaque implant target such that the whole of the breast is not materially irradiated.

15. The method of claim 14 further comprising initiating targeting of the delivery of the radiation therapy 1 to 120 days subsequent to the placement of the substantially radio-opaque implant in the breast cavity.

16. The method of claim 14, wherein the substantially radio-opaque implant is constructed of a porous material.

17. The method of claim 14, wherein said substantially radio-opaque implant has a shape selected to guide the delivery of radiation therapy to the margins around the breast cavity.