Brachytherapy apparatus, systems, and methods for using them

• US 8,636,635 B2
• Filed: 08/18/2009
• Issued: 01/28/2014
• 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: Chi Sing, Eduardo, Nguyen, Tommy G.
• Primary Examiner(s): Matthews, Christine
• Assistant Examiner(s): Reddy, Sunita
• Application Number:
  US12/543,469
• Publication Number:
  US 20100048978A1
• Time in Patent Office: 1,624 Days
• Field of Search: 600 1- 15, 600 19- 41, 604/915, 604/912, 606/198, 606/41.46, 606/41, 606/46
• US Class Current: 600/1
• 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 system for brachytherapy treatment within a body cavity within a patient accessed via a passage through tissue, comprising:

an access port device comprising a tubular member comprising a proximal end, a distal end sized for introduction through a passage through tissue into a body cavity, and an expandable member comprising a proximal end attached to the tubular member distal end and a distal end extending distally beyond the tubular member distal end, the tubular member further comprising a working channel extending between the tubular member proximal end and the tubular member distal end and communicating with the interior of the expandable member, the expandable member comprising a substantially enclosed interior in communication with the working channel and an inflation lumen extending between the tubular member proximal end and the tubular member distal end and communicating with the interior of the expandable member for delivering inflation media into the interior for expanding the expandable member; and

an expandable brachytherapy applicator comprising an applicator proximal end, an applicator distal end sized for introduction through the working channel of the access port device into the interior of the expandable member, the applicator comprising a plurality of elongate members extending between the applicator proximal and distal ends and comprising pathways for delivering a source of radiation from the applicator proximal end to a distal portion of the applicator, the elongate members movable from a collapsed configuration to an expanded configuration to expand the applicator distal end within the interior of the expandable member.

2. The system of claim 1, further comprising a source of radiation receivable along the pathways of the applicator elongate members.

3. The system of claim 1, wherein the applicator elongate members comprise catheters comprising lumens extending between the applicator proximal end and the applicator distal end for receiving a source of radiation therein, thereby defining the pathways.

4. The system of claim 1, wherein the access port device further comprises a valve disposed within the working channel adjacent the tubular member proximal end and configured to allow the applicator to be inserted through the working channel into the interior of the expandable member without inflation media within the interior escaping substantially through the working channel.

5. The system of claim 4, wherein the valve comprises one or more duck bill valves in the working channel for substantially preventing fluid flow proximally out of the working channel while accommodating the applicator to be introduced therethrough.

6. The system of claim 1, further comprising a hub on the tubular member proximal end, the hub comprising an index thereon for determining a rotational orientation of the applicator when inserted into the working channel.

7. The system of claim 6, wherein the index comprises a plurality of position labels and a respective plurality of grooves associated with respective position labels.

8. The system of claim 7, wherein the applicator comprises an indexing bushing and a tab, the tab configured to be slidably received in one of the grooves when the applicator is inserted into the working channel to prevent rotational movement of the applicator relative to the access port device.

9. The system of claim 8, wherein the indexing bushing comprises a plurality of catheter labels, the catheter labels matching the position labels on the index.

10. The system of claim 1, wherein the applicator comprises an elongate core member, a distal tip coupled to the elongate core member, and an actuator coupled to the elongate members and axially movable relative to the distal tip for directing the elongate members between the collapsed and expanded configurations.

11. The system of claim 10, wherein the elongate members extend substantially parallel to the elongate core member in the collapsed configuration.

12. The system of claim 11, wherein the elongate members bow radially outwardly in the expanded configuration to form a pear shape that bulges near the distal tip of the elongate core member and tapers towards the actuator.

13. The system of claim 10, wherein the elongate members comprise a pair of elongate members that expand outwardly away from one another substantially within a plane in the expanded configuration.

14. The system of claim 1, wherein the working channel terminates at the proximal end of the expandable member such that, when the applicator is introduced through the working channel, the distal portion is located within the interior of the expandable member beyond the tubular member distal end.

15. The system of claim 1, wherein there are no pathways for receiving a source of radiation on the expandable member such that the elongate members provide a single layer of pathways for receiving a source of radiation.

16. An access port device for accessing a body cavity of a patient via a passage through tissue, comprising:

a tubular member comprising a proximal end, a distal end sized for introduction through a passage through tissue into a body cavity, and an inflation lumen and a working channel within the tubular member extending between the proximal end and the distal end;

an expandable member comprising a proximal end attached to the tubular member distal end and a distal end extending distally beyond the tubular member distal end and terminating in a closed distal tip, the expandable member configured for delineating or dilating tissue surrounding a body cavity within which the expandable member is expanded, the expandable member comprising a substantially enclosed interior in communication with the inflation lumen and the working channel; and

a valve disposed within the working channel adjacent the tubular member proximal end and configured to allow a device to be inserted through the working channel into the interior of the expandable member without inflation media within the interior escaping substantially through the working channel.

17. The access port device of claim 16, wherein the inflation lumen is disposed within the tubular member adjacent the working channel.

18. The access port device of claim 16, wherein the working channel terminates at the proximal end of the expandable member.

19. A system for brachytherapy treatment within a target tissue region within a patient accessed via a passage through tissue, comprising:

an access sheath comprising a proximal portion, a distal section sized for introduction into a passage through tissue to access a target tissue region, and a bendable intermediate section between the proximal portion and the distal portion, the access sheath comprising a “

C”

shaped cross-section including longitudinal edges that at least partially define a lumen extending from the proximal portion to the distal portion;

an expandable device comprising a tubular member including a tubular member proximal end, a tubular member distal end sized for introduction through the lumen of the access sheath, an expandable member comprising a proximal end attached to the tubular member distal end, a distal end extending distally beyond the tubular member distal end, and an inflation lumen extending between the tubular member proximal end and the tubular member distal end that communicates with an interior of the expandable member; and

an expandable brachytherapy applicator comprising an applicator proximal end, an applicator distal end sized for introduction through the lumen of the access sheath, the expandable brachytherapy applicator comprising a plurality of elongate members extending between the applicator proximal end and applicator distal end and comprising pathways for delivering a source of radiation from the applicator proximal end to a distal portion of the expandable brachytherapy applicator, the distal portion movable from a collapsed configuration to an expanded configuration,

wherein the longitudinal edges of the access sheath are spaced apart from one another to define a gap extending between the proximal portion and the distal portion of the access sheath, the longitudinal edges being sufficiently flexible to be directed apart from one another to increase a width of the gap to accommodate removing the access sheath from around at least one of the expandable device and the expandable brachytherapy applicator.

20. The system of claim 19, wherein the bendable section of the access sheath is bendable up to an angle of at least about ninety degrees.

21. The system of claim 19, wherein the tubular member further comprises a working channel extending between the tubular member proximal end and the tubular member distal end and communicating with the interior of the expandable member, the working channel comprising a valve to accommodate introducing the applicator through the working channel without substantial leakage of fluid from within the expandable member.

22. The system of claim 19, wherein the tubular member is substantially flexible such that, when the bendable section of the access sheath is bent with the tubular member within the access sheath lumen, the tubular member does not substantially restrict bending of the bendable section.

23. The system of claim 19, wherein the bendable section of the access sheath comprises a plurality of corrugations that accommodate bending of the bendable section.

24. The system of claim 19, wherein the bendable section of the access sheath comprises a plurality of slots that accommodate bending of the bendable section.

25. The system of claim 19, wherein the access sheath has a “

C”

shaped cross-section that extends from a proximal end of the access sheath through the proximal and distal portions to a distal end of the access sheath.

26. A method for brachytherapy treatment of a target tissue region within a patient'"'"'s body, comprising:

introducing a distal portion of an access sheath having a “

C”

shaped cross-section into a passage through tissue to access a target tissue region such that a proximal portion of the access sheath remains outside the patient'"'"'s body;

introducing a distal end of an expandable device through the passage through tissue until a balloon on the distal end is disposed within the target tissue region;

expanding the balloon to dilate or manipulate tissue within the target tissue region;

collapsing the balloon;

withdrawing the expandable device from the target tissue region through the access sheath, leaving the access sheath within the passage through tissue; and

introducing a distal portion of an applicator through the access sheath into the target tissue region to treat tissue within the target tissue region.

27. The method of claim 26, further comprising bending a proximal portion of the access sheath relative to the distal portion to minimize a profile of the access sheath outside the patient'"'"'s body.

28. The method of claim 26, wherein the expandable device is inserted into the access sheath before the access sheath is introduced into the passage through tissue, and wherein the access sheath and the expandable device are introduced into the passage through tissue with the expandable device inserted into the access sheath.

29. The method of claim 26, wherein the access sheath is introduced into the passage through tissue before the expandable device, and wherein the expandable device is introduced into the passage through tissue through a lumen of the access sheath.

30. A method for brachytherapy treatment of tissue within a patient'"'"'s body, comprising:

introducing a distal end of an access port device into a body cavity;

expanding an expandable member extending beyond the distal end of the access port device within the body cavity;

introducing a distal portion of an applicator through the access port device into the body cavity with the distal portion of the applicator in a collapsed configuration;

directing the distal portion of the applicator to an expanded configuration within the expandable member after expanding the expandable member within the body cavity and introducing the distal portion of the applicator into the body cavity; and

deflating the expandable member after directing the distal portion of the applicator to the expanded configuration;

after deflating the expandable member, delivering radiation to a target location adjacent the body cavity via the distal portion of the applicator.

31. The method of claim 30, wherein the body cavity comprises a vaginal cavity.

32. The method of claim 30, further comprising:

directing the distal portion of the applicator to the collapsed configuration; and

withdrawing the applicator from the body cavity while leaving the distal end of the access port device within the body cavity.

33. The method of claim 32, wherein the distal end of the access port device is left within the body cavity for at least twenty four (24) hours.

34. The method of claim 33, further comprising:

advancing a distal portion of a second applicator through the access port device into the body cavity with the distal portion of the second applicator in a collapsed configuration;

directing the distal portion of the second applicator to an expanded configuration within the body cavity; and

delivering radiation to the target location via the distal portion of the second applicator.