BRACHYTHERAPY APPARATUS, SYSTEMS, AND METHODS FOR USING THEM

• US 20100048977A1
• Filed: 08/18/2009
• Published: 02/25/2010
• Est. Priority Date: 08/18/2008
• Status: Active Grant

• Current Assignee: Cianna Medical Inc. (Merit Medical Systems, Inc.)
• Original Assignee: Cianna Medical Inc. (Merit Medical Systems, Inc.)
• Inventors: Nguyen, Tommy G., Sing, Eduardo Chi
• Granted Patent: US 8,475,353 B2
• Time in Patent Office: Days
• US Class Current: 600/6
• CPC Class Codes: A61N 5/1015 Treatment of resected cavities created by surgery, e.g. lumpectomy
• CPC Class Codes: A61N 5/1016 Gynaecological radiation therapy

Abstract

An applicator for delivering brachytherapy includes elongate members movable between collapsed and expanded configurations for delivering brachytherapy within a lumpectomy cavity, a vaginal cavity, or other target region. The elongate members may be expandable into a symmetrical or asymmetrical expanded configuration, e.g., into a generally spherical, pear-shaped, or planar configuration. A system for delivering brachytherapy includes the applicator and an access device for lining and/or dilating a body cavity and/or for receiving the applicator therein. The access device is advanced into a body cavity, an expandable member on the access device is inflated, the applicator is advanced into the access device, and the elongate members are expanded to deliver radiation to the target region. Alternatively, the access device carries an expandable device into the target region, the expandable device is removed after dilating the target region, and the applicator is introduced through the access device to deliver radiation.

Claims

1. A brachytherapy treatment apparatus, comprising:

an elongate core member comprising proximal and distal ends defining a central longitudinal axis therebetween;

a pair of elongate members comprising proximal and distal ends and pathways extending between the elongate member proximal and distal ends for receiving a source of radiation therealong, the elongate member distal ends coupled to the distal end of the core member;

an actuator coupled to the elongate members adjacent distal portions of the elongate members and movable axially relative to the core member for moving the distal portions of the elongate members between a collapsed configuration wherein the distal portions extend substantially parallel to the core member and an expanded configuration wherein the distal portions bow away from one another substantially within a plane.

2. The apparatus of claim 1, further comprising a distal tip coupled to and extending beyond the distal ends of the elongate members and the distal end of the core member, the distal tip having a size to be received within an os of a cervix.

3. The apparatus of claim 1, wherein the core member comprises a central catheter having a lumen for receiving a source of radiation therein, and the elongate members comprise expandable catheters including lumens defining the pathways for receiving a source of radiation.

4. The apparatus of claim 1, wherein the actuator comprises a hub fixed to the elongate members adjacent the distal portions and a handle adjacent the elongate member proximal ends that is coupled to the hub.

5. The apparatus of claim 4, wherein the actuator further comprises a plunger coupled to the core member that is movable relative to the handle between a distal position in which the distal portions of the elongate members are in the collapsed configuration and a proximal position in which the core member is pulled proximally to cause the distal portions of the elongate members to bow outwardly towards the expanded configuration.

6. The apparatus of claim 5, wherein the plunger is biased to one of the distal and proximal positions.

7. The apparatus of claim 5, further comprising a locking mechanism for locking the plunger relative to the handle at one or more positions between the distal and proximal positions.

8. The apparatus of claim 7, wherein the plunger is biased to the proximal position, and wherein the locking mechanism is configured for locking the plunger in the distal position.

9. The apparatus of claim 1, wherein the elongate members are offset from core member such that the plane does not intersect the core member.

10. The apparatus of claim 1, further comprising a third elongate member comprising a proximal end, a distal end coupled to the core member distal end, and a pathway for receiving a source of radiation therealong, the actuator coupled to the third elongate member adjacent a distal portion of the third elongate member such that, when the actuator is moved axially relative to the core member, the distal portion of the third elongate member is also directed between a collapsed configuration wherein the distal portion extends substantially parallel to the core member and an expanded configuration wherein the distal portion bows away from the core member out of the plane defined by the pair of elongate members.

11. A brachytherapy treatment apparatus, comprising:

an elongate core member comprising proximal and distal ends defining a central longitudinal axis therebetween;

an actuator adjacent the core member proximal end and movable axially relative to the core member; and

a plurality of elongate members comprising proximal and distal ends and pathways extending between the elongate member proximal and distal ends for receiving a source of radiation therealong, the elongate member proximal ends coupled to the actuator and the elongate member distal ends coupled to the core member distal end such that the elongate members are movable from a collapsed configuration extending substantially parallel to the core member and an expanded configuration when the actuator is directed distally relative to the core member distal end, the elongate members arranged asymmetrically around the core member.

12. The apparatus of claim 11, wherein the elongate members are disposed adjacent the core member on one side of a plane extending substantially parallel to the central longitudinal axis in the expanded configuration.

13. The apparatus of claim 11, wherein the elongate members are disposed adjacent the core member such that the elongate members lie within or above a plane that intersects the central longitudinal axis in the expanded configuration.

14. The apparatus of claim 11, wherein the elongate members form a pear shape that bulges near the distal end of the core member and tapers towards the actuator in the expanded configuration.

15. The apparatus of claim 11, wherein the plurality of elongate members consists of three elongate members.

16. The apparatus of claim 15, wherein the three elongate members are disposed substantially on one side of a plane extending substantially parallel to the central longitudinal axis.

17. The apparatus of claim 15, wherein two of the three elongate members lie within a plane that intersects the central longitudinal axis, and one of the three elongate members lies above the plane.

18. The apparatus of claim 11, further comprising a plurality of support members attached to respective elongate members for biasing the elongate members to expand into a predetermined shape in the expanded configuration.

19. A brachytherapy treatment apparatus, comprising:

an elongate core member comprising proximal and distal ends defining a central longitudinal axis therebetween;

an actuator adjacent the core member proximal end and movable axially relative to the core member; and

a plurality of elongate members comprising proximal and distal ends and pathways extending between the elongate member proximal and distal ends for receiving a source of radiation therealong, the elongate member proximal ends coupled to the actuator and the elongate member distal ends coupled to the core member distal end such that the elongate members are movable from a collapsed configuration extending substantially parallel to the core member and an expanded configuration when the actuator is directed distally relative to the core member distal end, the elongate members forming a shape that bulges near the distal end of the core member and tapers towards the actuator in the expanded configuration.

20-24. -24. (canceled)

25. A method for brachytherapy treatment of tissue within a body cavity of a patient, comprising:

introducing a distal portion of an applicator through a passage through tissue into the body cavity with the distal portion of the applicator in a collapsed configuration, the applicator comprising a plurality of pathways extending from outside the patient'"'"'s body to the distal portion;

directing the distal portion of the applicator to an expanded configuration within the body cavity such that the pathways are directed away from a central longitudinal axis of the applicator, the pathways disposed asymmetrically about the central longitudinal axis; and

delivering radiation to a target location adjacent the body cavity via the distal portion of the applicator.

26-32. -32. (canceled)