Brachytherapy apparatus and method for treating a target tissue through an external surface of the tissue

• US 7,494,457 B2
• Filed: 11/07/2003
• Issued: 02/24/2009
• Est. Priority Date: 11/07/2003
• Status: Active Grant

• Current Assignee: Cytyc Corporation (Hologic Incorporated)
• Original Assignee: Cytyc Corporation (Hologic Incorporated)
• Inventors: Winkler, Rance A., Salazar, Bartolome J., Patrick, Timothy J., Stubbs, James B.
• Primary Examiner(s): Marmor, II; Charles A.
• Assistant Examiner(s): Hopkins; Christine D
• Application Number:
  US10/704,344
• Publication Number:
  US 20050101825A1
• Time in Patent Office: 1,936 Days
• Field of Search: 600 1- 8, 606/192, 250/519.1, 604/103.1, 604/103.11, 604/103.07
• US Class Current: 600/7
• CPC Class Codes: A61N 2005/1021 Radioactive fluid
• CPC Class Codes: A61N 5/1015 Treatment of resected cavities created by surgery, e.g. lumpectomy

Abstract

A brachytherapy device is provided for treating a target tissue through an external surface area of the target tissue. The device includes an insertion member having a proximal portion, a distal portion, and at least one lumen extending therethrough. A fluid retaining member is mated to the distal portion of the insertion member and has a first surface shaped to conform to a predetermined external surface area of a tissue to be treated, and a cavity formed therein in fluid communication with the at least one lumen in the insertion member. A plurality of anchor members can be distributed about a periphery of the first surface to anchor the first surface to an external surface area of a tissue to be treated.

Claims

1. A brachytherapy device, comprising:

an elongate catheter member having a proximal portion, a distal portion, and at least one lumen extending therethrough;

a balloon member disposed around the distal portion of the elongate catheter member and having a cavity formed therein and in fluid communication with at least one lumen in the elongate catheter, the balloon member having a first tissue contacting surface shaped to conform to a predetermined external surface area of a tissue to be treated; and

a radiation source in the form of a liquid disposed within the cavity of the balloon;

wherein the balloon member includes a plurality of anchor members distributed about a periphery of the first surface to anchor the first surface to an external surface area of the tissue to be treated; and

wherein the balloon member includes a second surface opposed to the first surface, and a peripheral wall extending between the first and second surfaces to define the cavity therein.

2. The device of claim 1, wherein the peripheral wall has a substantially uniform depth.

3. The device of claim 1, wherein the balloon member is substantially disk-shaped.

4. The device of claim 1, wherein at least a portion of at least one of the second surface and the peripheral wall are radio-opaque to protect non-targeted tissue from radiation.

5. The device of claim 1, wherein the balloon member is movable between a closed, deflated position in which the balloon member is disposed adjacent the insertion member, and an open, inflated position in which the balloon member extends outward from the insertion member;

and

wherein the balloon member has a predetermined shape in the open position such that, when inflated, the balloon member is effective to cover a predetermined area of tissue; and

wherein the predetermined shape of the balloon member is substantially disk-shaped.

6. A method for treating a target tissue through an external surface area of the target tissue, comprising:

providing at least one brachytherapy apparatus for delivering radioactive emissions, the apparatus having a catheter member having proximal and distal ends and at least one lumen extending therethrough, at least one fluid retaining member disposed proximate to the distal end of the catheter member, the fluid retaining member including a cavity formed therein in communication with the at least one lumen in the catheter member, a first surface shaped to conform to a predetermined external surface area of a tissue to be treated, and a plurality of anchor members distributed about a periphery of the first surface to anchor the first surface to an external surface area of a tissue to be treated;

intraoperatively placing the at least one brachytherapy apparatus on an external tissue surface of a tissue to be treated; and

introducing a controlled dose of a radiation source through the at least one lumen in the catheter to the fluid retaining member to treat tissue;

wherein the fluid retaining member is movable between a closed position in which the fluid retaining member is disposed adjacent the catheter member, and an open position in which the fluid retaining member extends outward from the catheter member; and

wherein the fluid retaining member is an expandable balloon member that is inflated in the open position and deflated in the closed position; and

wherein the expandable balloon member has a predetermined shape in the open position such that, when inflated, the balloon member is effective to cover the predetermined external surface of a tissue to be treated; and

wherein the predetermined shape of the balloon member is substantially disk-shaped.

7. The method of claim 6,

wherein the fluid retaining member is formed of a shape memory material, and wherein the fluid retaining member has a three-dimensional shape in the open position, and a substantially folded shape in the closed position;

and

wherein the fluid retaining member is substantially disk-shaped in the open position.