BRACHYTHERAPY APPARATUS FOR ASYMMETRICAL BODY CAVITIES

• US 20070270627A1
• Filed: 04/21/2006
• Published: 11/22/2007
• Est. Priority Date: 12/16/2005
• Status: Abandoned Application

• Current Assignee: Portola Medical, Inc. (Huiheng Medical, Inc.)
• Original Assignee: North American Scientific, Inc.
• Inventors: Zhang, John, Bossi, David, Wintch, Fredrick, Ellard, Terence, Higgins, Wayne, Cutrer, L., Terwilliger, Richard
• Application Number:
  US11/379,739
• Publication Number:
  US 20070270627A1
• Time in Patent Office: Days
• US Class Current: 600/7
• 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

Abstract

The present disclosure provides a brachytherapy apparatus, system and method that delivers partial breast irradiation treatment for post-lumpectomy patients via introduction of a catheter-like device through a trocar. The apparatus may be introduced post-surgically with local anesthesia under image guidance into the previous excision site and into a cavity by a surgeon. The brachytherapy apparatus includes one or more thin-walled tubes, each of said thin-walled tubes being configured to contain one or more radioactive sources, at least one radiation source configured to deliver a prescribed dose of radiation, a whisk adjuster configured to permit adjustment of each of the one or more thin-walled tubes so that the tubes substantially conform to a size of the body cavity; and an expansion element configured to expand outwardly said one or more thin-walled tubes within the cavity so that the thin-walled tubes substantially conform to a shape and/or size of the body cavity.

Claims

1. A brachytherapy apparatus for delivery of localized irradiation after surgical tissue removal, the tissue removal resulting in a body cavity surrounded by remaining tissue, the apparatus comprising:

one or more thin-walled tubes, each of said thin-walled tubes being configured to contain one or more radioactive sources;

at least one radiation source configured to deliver a prescribed dose of radiation;

a whisk adjuster configured to permit adjustment of each of the one or more thin-walled tubes so that the tubes substantially conform to a size of the body cavity; and

an expansion element configured to expand outwardly said one or more thin-walled tubes within the cavity so that the thin-walled tubes substantially conform to a shape and/or size of the body cavity.

2. The brachytherapy apparatus of claim 1, further comprising:

an opening corresponding to each of the one or more thin-walled tubes, the opening being configured to permit insertion of the at least one radiation source into each of the one or more thin-walled tubes during or after surgical implantation of the plurality of thin-walled tubes.

3. The brachytherapy apparatus of claim 1, wherein the whisk adjuster includes:

a raised projection and a guide corresponding to each of the one or more thin-walled tubes, each raised projection being configured to be moved within the guide to adjust the length of the corresponding thin-walled tube.

4. The brachytherapy apparatus of claim 1, further comprising:

a sleeve disposed around the plurality of thin-walled tubes, the sleeve being configured to move either in a proximal direction or in a distal direction to accommodate the size of the cavity.

5. The brachytherapy apparatus of claim 4, wherein the sleeve is further configured to receive a trocar therethrough in order to permit entry of the apparatus into the cavity site.

6. The brachytherapy apparatus of claim 1, wherein the expansion element is a center core configured to be pulled in a proximal direction.

7. The brachytherapy apparatus of claim 1, wherein the center core is configured to be gripped and pulled in the proximal direction by a whisk expansion tool.

8. The brachytherapy apparatus of claim 1, further comprising:

a one-way mechanism configured to prevent movement of the center core in a distal direction.

9. The brachytherapy apparatus of claim 8, further comprising:

a release mechanism configured to permit movement of the center core in the distal direction.

10. The brachytherapy apparatus of claim 9, wherein the release mechanism includes two diametrically opposed buttons positioned on the exterior of the whisk adjuster, and wherein the buttons are configured to be pushed, thus permitting movement of the center core in the distal direction.

11. The brachytherapy apparatus of claim 1, further comprising:

at least one whisk clip configured to secure the thin-walled tubes and center core in place to resist a shape and/or size change of thin-walled tubes when expanded.

12. The brachytherapy apparatus of claim 1, wherein the expansion element includes a handle configured to be gripped in order to expand outwardly the plurality of thin-walled tubes.

13. A brachytherapy apparatus for delivery of localized irradiation after surgical tissue removal, the tissue removal resulting in a body cavity surrounded by remaining tissue, the apparatus comprising:

one or more thin-walled tubes, each of said thin-walled tubes being configured to contain one or more radioactive sources;

at least one radiation source configured to deliver a prescribed dose of radiation;

a whisk adjuster configured to permit adjustment of each of the one or more thin-walled tubes so that the tubes substantially conform to a size of the body cavity;

an expansion element configured to be engaged to expand outwardly said one or more thin-walled tubes within the cavity so that the thin-walled tubes substantially conform to a shape and/or size of the body cavity;

a center core; and

wherein, after the expansion element is engaged, the thin-walled tubes are arranged in two substantially concentric circles around the center core; and

an opening corresponding to each thin-walled tube, the opening being configured to permit insertion of the at least one radiation source into each of the one or more thin-walled tubes during or after surgical implantation of the plurality of thin-walled tubes.

14. The brachytherapy apparatus of claim 13, wherein the whisk adjuster includes:

a raised projection and a guide corresponding to each of the one or more thin-walled tubes, each raised projection being configured to be moved within the guide to adjust the length of the corresponding thin-walled tube.

15. The brachytherapy apparatus of claim 13, further comprising:

a sleeve disposed around the plurality of thin-walled tubes, the sleeve being configured to move in either a proximal direction or a distal direction to accommodate the shape and/or the size of the cavity.

16. The brachytherapy apparatus of claim 15, wherein the sleeve is further configured to receive a trocar therethrough in order to permit entry to the cavity site.

17. The brachytherapy apparatus of claim 13, wherein the expansion element is the center core, and said center core is configured to be pulled in a proximal direction.

18. The brachytherapy apparatus of claim 13, wherein the center core is configured to be gripped and pulled in the proximal direction by a whisk expansion tool.

19. The brachytherapy apparatus of claim 13, further comprising:

a one-way mechanism configured to prevent movement of the center core in a distal direction.

20. The brachytherapy apparatus of claim 19, further comprising:

a release mechanism configured to permit movement of the center core in the distal direction.

21. The brachytherapy apparatus of claim 20, wherein the release mechanism includes two diametrically opposed buttons on the exterior of the whisk adjuster, and wherein the buttons are configured to be pushed, thus permitting movement of the center core in the distal direction.

22. The brachytherapy apparatus of claim 13, further comprising:

at least one whisk clip configured to secure the thin-walled tubes and center core in place to resist a shape and/or size change of thin-walled tubes when expanded.

23. The brachytherapy apparatus of claim 13, wherein the expansion element includes a handle configured to be gripped in order to expand outwardly the plurality of thin-walled tubes.

24. A brachytherapy system for delivery of localized irradiation after surgical tissue removal, the tissue removal resulting in a body cavity surrounded by remaining tissue, the system comprising:

one or more thin-walled tubes, each of said thin-walled tubes being configured to contain one or more radioactive sources;

at least one radiation source configured to deliver a prescribed dose of radiation;

a whisk adjuster configured to permit adjustment of each of the one or more thin-walled tubes so that the tubes substantially conform to a size of the body cavity;

an expansion element configured to be engaged to expand outwardly said one or more thin-walled tubes within the cavity so that the thin-walled tubes substantially conform to a shape and/or size of the body cavity; and

at least one whisk clip configured to secure the thin-walled tubes and center core in place to resist a shape and/or size change of thin-walled tubes when expanded, wherein the at least one whisk clip includes a locking mechanism.

25. The brachytherapy system of claim 24, further comprising:

a cutting apparatus configured to cut the thin-walled tubes so as to remove excess tube length that remains beyond the proximal end of the at least one whisk clip after a cavity size and/or shape has been accommodated.

26. The brachytherapy system of claim 24, further comprising:

a center core; and

wherein, after the expansion element is engaged, the thin-walled tubes are arranged in two substantially concentric circles around the center core.

27. The brachytherapy system of claim 26, further comprising:

a seed transport device configured to facilitate insertion of radioactive sources into the thin-walled tubes and/or the center core.

28. The brachytherapy system of claim 27, wherein the seed transport device includes:

a substantially cylindrical body having a distal end and a proximal end, and

an obturator cavity disposed at the distal end;

wherein the distal end of the seed transport device is configured to engage with the locking mechanism of the at least one whisk clip,

wherein the proximal end of the seed transport device includes openings corresponding to each of the plurality of thin-walled tubes and the center core in order to permit one or more radiation sources to be inserted through the openings; and

wherein the obturator cavity is configured to permit an obturator to be stored therein, the obturator being capable of inserting one or more radiation sources into the thin-walled tubes and center core.

29. The brachytherapy system of claim 24, wherein the radiation source is a high dose rate radiation source, and the system further comprises:

a high dose rate adapter configured to permit a computer-based afterloader machine to insert the at least one high dose rate radiation source into the one or more thin-walled tubes and/or a center core, and wherein the high dose rate adapter is further configured to permit the computer-based afterloader machine to control the movement of the at least one high dose rate radiation source within the body cavity.

30. The brachytherapy system of claim 29, wherein the high dose rate adapter includes:

a plurality of substantially flexible tubes, the substantially flexible tubes corresponding to each of the plurality of thin-walled tubes and the center core;

an opening at the distal end of each substantially flexible tube.

31. The brachytherapy system of claim 24, further comprising:

a whisk removal tool configured to remove a brachytherapy catheter after treatment is complete.

32. A method for delivering localized irradiation after surgical tissue removal, the tissue removal resulting in a body cavity, the method comprising:

creating access to the cavity;

providing an interstitial brachytherapy apparatus, comprising;

one or more thin-walled tubes, each of said thin-walled tubes being configured to contain one or more radiation sources;

at least one radiation source configured to deliver a prescribed dose of radiation;

a whisk adjuster configured to permit adjustment of each of the one or more thin-walled tubes so that the tubes substantially conform to a size of the body cavity; and

an expansion element configured to expand outwardly said one or more thin-walled tubes within the cavity so that the thin-walled tubes substantially conform to the shape and/or size of the body cavity;

placing the interstitial brachytherapy apparatus into the cavity;

expanding outwardly the interstitial brachytherapy apparatus so that it substantially conforms to the shape and/or size of the cavity;

inserting the at least one radiation source into the outwardly expanded thin-walled tubes;

clamping the interstitial brachytherapy apparatus onto the patient;

leaving the interstitial brachytherapy apparatus inside the cavity for a sufficient time to deliver the prescribed radiation dose to remaining tissue that surrounds the cavity; and

removing the interstitial brachytherapy apparatus.

33. A method for delivering localized irradiation after surgical tissue removal, the tissue removal resulting in a cavity, the method comprising:

creating access to the cavity;

providing an interstitial brachytherapy apparatus, comprising;

one or more thin-walled tubes, each of said thin-walled tubes being configured to contain one or more radioactive sources;

at least one radiation source configured to deliver a prescribed dose of radiation;

a whisk adjuster configured to permit adjustment of each of the one or more thin-walled tubes so that the tubes substantially conform to a size of the body cavity;

an expansion element configured to be engaged to expand outwardly said one or more thin-walled tubes within the cavity so that the thin-walled tubes substantially conform to a shape and/or size of the body cavity;

a center core; and

wherein, after the expansion element is engaged, the thin-walled tubes are arranged in two substantially concentric circles around the center core; and

an opening corresponding to each thin-walled tube, the opening being configured to permit insertion of the at least one radiation source into each of the one or more thin-walled tubes and/or center core during or after surgical implantation of the plurality of thin-walled tubes.

placing the interstitial brachytherapy apparatus into the cavity;

expanding outwardly the interstitial brachytherapy apparatus so that it substantially conforms to the shape and/or size of the cavity;

inserting the at least one radiation source into the outwardly expanded thin-walled tubes and/or center core;

clamping the interstitial brachytherapy apparatus onto the patient;

leaving the interstitial brachytherapy apparatus inside the cavity for a sufficient time to deliver the prescribed radiation dose to remaining tissue that surrounds the cavity; and

removing the interstitial brachytherapy apparatus.