Helical brachytherapy apparatus and methods of using same

• US 7,887,476 B2
• Filed: 11/08/2006
• Issued: 02/15/2011
• Est. Priority Date: 11/10/2005
• Status: Active Grant

• Current Assignee: Cianna Medical Inc. (Merit Medical Systems, Inc.)
• Original Assignee: Cianna Medical Inc. (Merit Medical Systems, Inc.)
• Inventors: Lebovic, Gail S., Ritchart, Mark A., Hermann, George D.
• Primary Examiner(s): Lacyk; John P
• Application Number:
  US11/557,747
• Publication Number:
  US 20070167665A1
• Time in Patent Office: 1,560 Days
• Field of Search: 600 1- 8, 600/37, 602/79, 604/21, 604/104, 606/15, 606/49, 606/108, 606/159
• US Class Current: 600/3
• CPC Class Codes: A61N 2005/1018 with multiple channels for guiding radioactive sources
• CPC Class Codes: A61N 5/1015 Treatment of resected cavities created by surgery, e.g. lumpectomy
• CPC Class Codes: A61N 5/1027 Interstitial radiation therapy

Abstract

Apparatus, systems, and methods are provided for delivering brachytherapy into a target tissue region, e.g., a breast. In some embodiments, a flexible brachytherapy device is implanted that includes a therapy delivery portion having one or more radioactive sources securely retained thereto, and a tail portion extending from the therapy delivery portion. The brachytherapy device may be implanted in a helical configuration within the target tissue region. To assist in placement and removal of the brachytherapy device, a tubular sheath may be implanted by attaching (e.g., sliding over) a helically coiled needle that is advanced into the body by screw-like rotation. Once implanted, the sheath and the brachytherapy device may extend outside the body, where they may be folded and secured flat against the skin. The device and sheath may be removed at therapy completion.

Claims

1. An apparatus for delivering brachytherapy to breast tissue, the apparatus comprising:

a helically coiled needle removably insertable into the breast tissue, the helically coiled needle operable to define a pathway through the breast tissue for a subsequently delivered brachytherapy source; and

a tubular sheath selectively positionable over an external surface of the needle, wherein the tubular sheath is preformed to substantially the same shape as the helically coiled needle.

2. The apparatus of claim 1, further comprising an elongate brachytherapy device having at least one radioactive source, wherein the brachytherapy device comprises an outer diameter equal to or smaller than an inner diameter of the tubular sheath.

3. The apparatus of claim 2, wherein the brachytherapy device is preformed to substantially the same shape as the helically coiled needle.

4. The apparatus of claim 2, wherein the brachytherapy device comprises:

a therapy delivery portion comprising two or more radioactive sources separated by one or more spacers; and

a casing surrounding the therapy delivery portion to restrain the two or more radioactive sources relative to one another.

5. The apparatus of claim 4, wherein the brachytherapy device further comprises a tail portion extending from at least one end of the therapy delivery portion.

6. The apparatus of claim 5, wherein the tail portion comprises an extension of the casing.

22. The apparatus of claim 1, wherein the tubular sheath comprises relatively rigid material having a helical shape substantially similar to the helically shaped needle.

7. A system for delivering a brachytherapy device to a target tissue region of a body, the system comprising:

a substantially straight alignment needle insertable into the body along a longitudinal axis;

a drive member displaceable along the alignment needle;

a helically coiled needle coupled to the drive member such that a helix axis of the needle is coaxial around the alignment needle; and

a tubular sheath operable to surround at least a portion of the helically coiled needle.

8. The system of claim 7, wherein a distal end of the alignment needle comprises an inflatable balloon.

9. The system of claim 7, further comprising a balloon inflation device coupled to the alignment needle.

10. A method for delivering brachytherapy within a target region of a breast, the method comprising:

rotationally advancing a helically coiled needle into the target region, the needle comprising a sharp tip to penetrate the breast as the needle is advanced, and further wherein the needle is surrounded by a tubular sheath;

withdrawing the needle from the breast, leaving the tubular sheath implanted therein; and

inserting an elongate brachytherapy device into the tubular sheath.

11. The method of claim 10, wherein advancing the helically coiled needle comprises advancing the helically coiled needle completely through a distal side of the breast.

12. The method of claim 11, wherein inserting the elongate brachytherapy device into the tubular sheath comprises inserting the brachytherapy device until a portion of the device extends beyond the distal side of the breast.

13. The method of claim 10, wherein the target region comprises tissue surrounding a lumpectomy cavity.

14. The method of claim 10, wherein advancing the helically coiled needle comprises advancing the helically coiled needle along an alignment member.

15. A method for delivering brachytherapy interstitially to tissue surrounding a lumpectomy cavity of a breast, the method comprising:

advancing a distal tip of a substantially straight alignment needle into the lumpectomy cavity along a longitudinal axis;

inflating a balloon located at the distal tip of the alignment needle within the lumpectomy cavity;

rotationally advancing a helically coiled needle around and along the alignment needle, the helically coiled needle comprising a sharp tip to screw into the breast as the helically coiled needle is advanced, wherein the helically coiled needle is surrounded by a tubular sheath;

withdrawing the helically coiled needle from the breast, leaving the tubular sheath implanted; and

inserting an elongate brachytherapy device into the tubular sheath.

16. The method of claim 15, further comprising deflating the balloon and removing the alignment needle after withdrawing the helically coiled needle from the breast.

17. The method of claim 15, wherein advancing the helically coiled needle comprises advancing the helically coiled needle until the sharp tip of the helically coiled needle penetrates a distal side of the breast.

18. The method of claim 17, wherein withdrawing the helically coiled needle comprises leaving an end of the tubular sheath protruding from both the distal and a proximate side of the breast.

19. A method for providing radiation treatment of target tissue within a breast, the method comprising:

inserting a coiled sheath surrounding a helically coiled needle into the target tissue;

removing the helically coiled needle from the sheath, leaving the sheath in the target tissue;

inserting a brachytherapy device into the sheath for a predetermined period of time; and

removing the brachytherapy device.

20. The method of claim 19, wherein the brachytherapy device comprises a low dose rate brachytherapy device.

21. The method of claim 19, wherein the brachytherapy device comprises a high dose rate brachytherapy device.