BRACHYTHERAPY APPARATUS AND METHODS OF USING SAME

• US 20070167664A1
• Filed: 10/31/2006
• Published: 07/19/2007
• Est. Priority Date: 10/31/2005
• Status: Active Grant

• Current Assignee: Cianna Medical Inc. (Merit Medical Systems, Inc.)
• Original Assignee: Cianna Medical Inc. (Merit Medical Systems, Inc.)
• Inventors: Chi Sing, Eduardo, Lebovic, Gail, Sutton, Doug, Bowes, Robert, Hermann, George
• Granted Patent: US 7,736,292 B2
• Time in Patent Office: Days
• US Class Current: 600/3
• CPC Class Codes: A61N 2005/1005 with asymmetrical radiation pattern
• CPC Class Codes: A61N 2005/1011 Apparatus for permanent insertion of sources
• CPC Class Codes: A61N 2005/1012 Templates or grids for guiding the introduction of sources
• CPC Class Codes: A61N 2005/1023 Means for creating a row of seeds, e.g. spacers
• CPC Class Codes: A61N 2005/1094 Shielding, protecting against radiation
• CPC Class Codes: A61N 5/1007 Arrangements or means for the introduction of sources into the body
• CPC Class Codes: A61N 5/1014 Intracavitary radiation therapy
• CPC Class Codes: A61N 5/1027 Interstitial radiation therapy

Abstract

Apparatus, systems and methods for delivering brachytherapy to a target tissue region of a human or other mammalian body. 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. Once implanted, the tail portion may extend outside the body, where it may be folded and secured flat against the skin. The device may be removed at therapy completion. Other embodiments of the invention are directed to systems and methods for delivering brachytherapy devices to the body.

Claims

1. A brachytherapy treatment device operable for implantation into a target tissue region of a body, the device comprising:

a therapy delivery portion comprising one or more radioactive sources enclosed within a casing;

at least one non-dissolving flexible tail portion extending from the therapy delivery portion and operable to extend outside the body after implantation of the device; and

positioning indicia located along the flexible tail portion.

2-16. -16. (canceled)

17. A brachytherapy treatment device operable for implantation into a target tissue region of a body, the device comprising:

a therapy delivery portion comprising one or more low dose rate radioactive sources constrained within a tubular casing; and

at least one non-dissolving flexible tail portion attached to the therapy delivery portion and operable to extend outside the body after implantation of the device.

18-24. -24. (canceled)

25. A brachytherapy treatment device operable for implantation into a target region of breast tissue, the device comprising:

a therapy delivery portion comprising two or more radioactive seeds, each seed defined by a first end, a second end and a lumen spanning between the first end and the second end; and

a tubular casing surrounding and constraining the two or more radioactive seeds.

26. The device of claim 25, further comprising a hollow spacer located between the two or more radioactive seeds.

27. A kit for delivering brachytherapy to a target region of breast tissue, the kit comprising:

a removably implantable elongate brachytherapy device comprising;

a therapy delivery portion comprising one or more radioactive seeds, wherein each seed defines a through hole;

a casing enclosing the one or more radioactive seeds; and

a device hub coupled to the therapy delivery portion; and

a needle selectively insertable through the through holes of the one or more radioactive seeds, the casing, and the device hub.

28. The kit of claim 27, further comprising an elongate removal tool selectively insertable through the one or more radioactive seeds, the casing, and the device hub, wherein the removal tool comprises a removal tool hub selectively engageable with the device hub.

29. The kit of claim 27, wherein a portion of the device hub is captured by the casing.

30. (canceled)

31. A method of providing brachytherapy to a target region of breast tissue within a body, the method comprising:

inserting an elongate brachytherapy device into the target region, the device comprising a therapy delivery portion having one or more radioactive sources surrounded and restrained by a tubular casing; and

leaving the device implanted within the target region for a period of about four or more days.

32. The method of claim 31, further comprising removing the brachytherapy device from the target region.

33. A method of providing brachytherapy to a target region of breast tissue within a body, the method comprising:

coupling an elongate brachytherapy device to a needle, the device comprising;

a therapy delivery portion comprising one or more radioactive sources; and

a casing surrounding and restraining the one or more radioactive sources;

inserting the needle and associated brachytherapy device into the breast tissue;

immobilizing the brachytherapy device; and

withdrawing the needle from the breast tissue, whereby the brachytherapy device remains implanted.

34-44. -44. (canceled)

45. An apparatus for delivering a plurality of brachytherapy treatment devices into a target tissue region of a body, the apparatus comprising:

a first compression member and a second compression member to compress a portion of the body containing the target tissue region;

a needle guide securable relative to the first compression member and defining an array of guide openings; and

a needle driver for advancing two or more needles simultaneously through the needle guide and the first and second compression members.

46-58. -58. (canceled)

59. A method of delivering a plurality of brachytherapy devices to a target tissue region within a breast, the method comprising:

immobilizing the breast;

locating a needle guide proximate the breast, the needle guide defining an array of guide openings corresponding to the target tissue region;

advancing a plurality of needles simultaneously through the needle guide and the target tissue region, wherein each needle of the plurality of needles includes one of the plurality of brachytherapy devices coupled thereto; and

withdrawing the plurality of needles simultaneously while leaving the plurality of brachytherapy devices implanted in the target tissue region of the breast.

60. The method of claim 59, wherein immobilizing the breast comprises compressing the breast between a first compression member and a second compression member.

61. The method of claim 59, wherein advancing the plurality of needles comprises rotating a screw operatively attached to the plurality of needles.

62. A method of delivering a plurality of brachytherapy devices to a target tissue region within a breast, the method comprising:

immobilizing the breast between first and second compression paddles;

locating a needle guide proximate the first compression paddle, the needle guide defining an array of guide openings corresponding to the target tissue region;

advancing a plurality of needles simultaneously through the needle guide, the first compression paddle, the breast, and the second compression paddle, wherein each needle includes one of the plurality of brachytherapy devices coupled thereto; and

withdrawing the plurality of needles while leaving the plurality of brachytherapy devices implanted in the target tissue region of the breast.

63. The method of claim 62, further comprising:

inserting each needle of the plurality of needles and its associated brachytherapy device through an opening in an anchoring tab positioned adjacent the breast, wherein a tail portion of each brachytherapy device extends outside the breast through the opening in the anchoring tab;

securing the tail portion relative to the anchoring tab.

64. The method of claim 62, wherein securing the tail portion relative to the anchoring tab comprising moving the tail portion from a clearance portion of the opening of the anchoring tab to an interference portion.