Brachytherapy apparatus and methods for using them

• US 7,862,496 B2
• Filed: 03/16/2006
• Issued: 01/04/2011
• Est. Priority Date: 11/10/2005
• Status: Active Grant

• Current Assignee: Cianna Medical Inc. (Merit Medical Systems, Inc.)
• Original Assignee: Cianna Medical Inc. (Merit Medical Systems, Inc.)
• Inventors: Cole, Mark A., Chi Sing, Eduardo, Nguyen, Than, Lebovic, Gail S., Hermann, George D., Ritchart, Mark A.
• Primary Examiner(s): Gilbert; Samuel G
• Application Number:
  US11/276,851
• Publication Number:
  US 20070106108A1
• Time in Patent Office: 1,755 Days
• Field of Search: 600 1- 8, 600/37, 602/79, 604/21, 604/104, 606/15, 606/49, 606/108, 606/159, 606/191, 606/194, 606/198
• US Class Current: 600/3
• 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

Apparatus for delivering brachytherapy to a target tissue region includes an elongate body including a proximal end, a distal end sized for introduction into a tissue tract and carrying a plurality of elongate members including pathways for receiving a source of radiation. The elongate members are movable between collapsed and expanded configurations. During use, a tract is created through tissue, and the elongate body carrying the elongate members is advanced through the tract into a target location with the elongate members in the collapsed configuration. The elongate members are directed to the expanded configuration at the target location, and radiation is delivered to treat tissue at the target location, e.g., by introducing one or more radiation sources along the pathways.

Claims

1. A brachytherapy treatment apparatus for treating tissue surrounding a cavity within a body, comprising:

an elongate body comprising a proximal end and a distal end configured for introduction into a tract through tissue, the elongate body comprising a core member and a body member, the core member and body member comprising mating threads for causing the body member to move axially relative to the core member when the body member is rotated relative to the core member;

a plurality of elongate members on the distal end comprising pathways for receiving a source of radiation therealong, the elongate members including distal ends coupled to the core member and proximal ends coupled to the body member, the elongate members being movable from a collapsed configuration for introduction through a tissue tract to a target location, and an expanded configuration for providing a three dimensional array of pathways at the target location;

a source of radiation introduceable along the pathways for delivering radiation to the target location; and

an actuator coupled to one of the core member and body member, the actuator rotatable in a first direction for moving the body member axially relative to the core member to move the elongate members from the collapsed configuration to the expanded configuration and rotatable in a second opposite direction to move the elongate members from the expanded configuration to the collapsed configuration, at least a portion of the actuator being detachable from the elongate body to reduce a profile of the brachytherapy delivery apparatus after implantation, the detachable portion and the elongate body comprising releasable connectors for allowing the detachable portion to be removed after implantation.

2. The brachytherapy treatment apparatus of claim 1, the elongate members being spaced apart in the expanded configuration such that tissue at the target location invaginates between the elongate members.

3. The brachytherapy treatment apparatus of claim 1, further comprising a hub coupled to proximal ends of the elongate members and the body member, the hub being movable axially as the body member is moved axially relative to the core member for moving the elongate members from the collapsed configuration to the expanded configuration.

4. The brachytherapy treatment apparatus of claim 3, wherein the core member is coupled to distal ends of the elongate members, and wherein the hub comprises an outer member coupled to proximal ends of the elongate members, the outer member slidably disposed around the elongate body.

5. The brachytherapy treatment apparatus of claim 4, wherein the outer member comprises passageways communicating with the pathways of the elongate members.

6. The brachytherapy treatment apparatus of claim 3, wherein the hub comprises a plurality of openings communicating with respective pathways for introducing the source of radiation along the pathways.

7. The brachytherapy treatment apparatus of claim 3, wherein the hub comprises one or more indicia for identifying respective pathways of the elongate members.

8. The brachytherapy treatment apparatus of claim 1, wherein each of the elongate members comprises a stiffening member for maintaining the elongate members in a desired orientation when the elongate members are moved from the collapsed configuration to the expanded configuration.

9. The brachytherapy treatment apparatus of claim 1, wherein the source of radiation comprises a plurality of pods carrying radioactive elements that may be introduced along respective pathways of the elongate members.

10. The brachytherapy treatment apparatus of claim 1, wherein the source of radiation comprises a radiation generating device that is introduceable sequentially along each of the pathways of the elongate members.

11. The brachytherapy treatment apparatus of claim 10, wherein the radiation generating device comprises an HDR source of radiation.

12. The brachytherapy treatment apparatus of claim 1, wherein the distal end of the elongate body is sharpened to penetrate through tissue.

13. The brachytherapy treatment apparatus of claim 1, wherein the elongate members comprise tubular members comprising lumens defining the pathways.

14. A brachytherapy treatment apparatus for treating tissue surrounding a cavity within a body, comprising:

an elongate body comprising a proximal end and a distal end sized for introduction into a tract through tissue, the elongate body comprising a core member and a body member surrounding a portion of the core member, the core member and body member comprising mating threads for causing the body member to move axially relative to the core member when the body member is rotated relative to the core member;

a plurality of tubular members on the distal end comprising lumens for receiving a source of radiation therein, the tubular members being movable from a collapsed configuration for introduction through a tissue tract to a target location, and an expanded configuration for providing a three dimensional array of pathways at the target location;

a plurality of openings communicating with respective lumens for inserting the source of radiation into the lumens;

a hub coupled to proximal ends of the tubular members and the body member, the hub being movable axially as the body member is moved axially relative to the core member for moving the tubular members from the collapsed configuration to the expanded configuration; and

an actuator coupled to one of the core member and body member, the actuator rotatable in a first direction for moving the body member axially relative to the core member to move the tubular members from the collapsed configuration to the expanded configuration and rotatable in a second opposite direction for collapsed the tubular members to the collapsed configuration, at least a portion of the actuator extending proximally beyond the hub being detachable from the brachytherapy apparatus to reduce a profile of the brachytherapy delivery apparatus after implantation.

15. The brachytherapy treatment apparatus of claim 14, wherein the actuator is coupled to the body member for moving the hub relative to the distal end of the elongate body for moving the tubular members between the collapsed configuration and the expanded configuration.

16. The brachytherapy treatment apparatus of claim 14, further comprising a plurality of pods carrying radioactive elements, the pods being introduceable into respective lumens of the tubular members.

17. The brachytherapy treatment apparatus of claim 14, the tubular members being spaced apart in the expanded configuration such that tissue at the target location invaginates between the tubular members.

18. The brachytherapy treatment apparatus of claim 14, wherein the tubular members comprise a three dimensional array in the expanded configuration that provides multiple layers of radiation when the source of radiation is introduced into the tubular members.

19. A brachytherapy treatment apparatus for treating tissue surrounding a cavity within a body, comprising:

an elongate body comprising a proximal end and a distal end sized for introduction into a tract through tissue;

a plurality of tubular members on the distal end comprising lumens for receiving a source of radiation therein, the tubular members being movable from a collapsed configuration wherein the elongate members extend substantially parallel to the elongate body for introduction through a tissue tract to a target location, and an expanded configuration for providing a three dimensional array of pathways at the target location;

a plurality of openings communicating with respective lumens for inserting the source of radiation into the lumens;

a proximal hub coupled to proximal ends of the tubular members, the proximal hub being movable relative to the elongate body for moving the tubular members from the collapsed configuration to the expanded configuration;

the tubular members comprising first and second sets of tubular members, the first set of tubular members spaced apart about a central axis of the elongate body such that the first set of tubular members generally define a first maximum diameter in the expanded configuration, the second set of tubular members spaced apart about the central axis such that the second set of tubular members generally define a second maximum diameter in the expanded configuration that is less than the first maximum diameter;

a distal hub coupled to a distal tip of the elongate body and distal ends of the first set of tubular members; and

a floating hub coupled to distal ends of the second set of tubular members, the floating hub contacting the distal hub after the proximal hub has been moved relative to the elongate body to cause the first set of tubular members to bow outwardly without expanding the second set of tubular members, whereupon further movement of the proximal hub relative to the elongate body causes both the first and second sets of tubular members to move outwardly towards the expanded configuration such that the second set of tubular members defines a smaller diameter than the first set of tubular members.

20. The brachytherapy treatment apparatus of claim 19, wherein the second set of tubular members is angularly offset from the first set of tubular members about the central axis.

21. The brachytherapy treatment apparatus of claim 19, wherein the second set consists of a single tubular member.

22. The brachytherapy treatment apparatus of claim 19, wherein a tubular member of the second set of tubular members is disposed between two adjacent tubular members in the first set of tubular members and closer to the central axis in the expanded configuration.

23. The brachytherapy treatment apparatus of claim 22, wherein at least one of the two adjacent tubular members in the first set of tubular members has one or more portions with no radiation source.

24. The brachytherapy treatment apparatus of claim 19, wherein the distal hub comprises a pocket that receives the floating hub when the proximal hub has been moved partially relative to the elongate body to cause the first set of tubular members to bow outwardly without expanding the second set of tubular members, thereby preventing further movement of the floating hub relative to the distal hub.

25. A brachytherapy treatment apparatus for treating tissue surrounding a cavity within a body, comprising:

an elongate body comprising a proximal end and a distal end sized for introduction into a tract through tissue, the elongate body comprising a core member and a body member surrounding a portion of the core member, the core member and body member comprising mating threads for causing the body member to move axially relative to the core member when the body member is rotated relative to the core member;

a plurality of elongate members on the distal end comprising pathways for receiving a source of radiation therealong, the elongate members being movable from a collapsed configuration for introduction through a tissue tract to a target location, and an expanded configuration for providing a three dimensional array of pathways at the target location, the elongate members being spaced apart in the expanded configuration such that tissue at the target location invaginates between the elongate members; and

an actuator coupled to one of the core member and body member, the actuator rotatable in a first direction for moving the body member axially relative to the core member to move the elongate members from the collapsed configuration to the expanded configuration and rotatable in a second opposite direction for collapsed the elongate members to the collapsed configuration, at least a portion of the actuator being detachable from the brachytherapy apparatus to reduce a profile of the brachytherapy delivery apparatus after implantation, the detachable portion and the elongate body comprising releasable connectors for allowing the detachable portion to be removed after implantation.

26. The brachytherapy treatment apparatus of claim 25, further comprising a source of radiation introduceable along the pathways for delivering radiation to the target location.

27. A method for brachytherapy treatment of tissue within a body, comprising:

creating a tract through tissue to a target location including a cavity;

advancing an elongate body carrying a plurality of elongate members through the tract into the target location with the elongate members in a collapsed configuration such that an actuator extends from the tract out of the body and the elongate body is disposed within the body, the elongate body comprising a core member and a body member, the core member and body member comprising mating threads for causing the body member to move axially relative to the core member when the body member is rotated relative to the core member;

rotating the actuator to rotate and cause the body member to move axially relative to the core member and thereby direct the elongate members to an expanded configuration at the target location to position the elongate members away from a central axis such that tissue surrounding the cavity extends between at least a portion of adjacent elongate members;

detaching at least a detachable portion of the actuator from the elongate body;

removing the detachable portion of the actuator from the body after expanding the elongate members to the expanded configuration; and

delivering radiation to the target location to treat tissue at the target location.

28. The method of claim 27, wherein the elongate members secure the elongate body at the target location when the elongate members are directed to the expanded configuration.

29. The method of claim 27, wherein tissue at the target location invaginates between the elongate members when the elongate members are directed to the expanded configuration.

30. The method of claim 27, wherein the elongate members direct tissue surrounding the cavity outwardly when the elongate members are directed to the expanded configuration.

31. The method of claim 30, wherein one or more of the elongate members extend into tissue surrounding the cavity such that at least a portion of the one or more elongate members is substantially surrounded by tissue.

32. The method of claim 27, wherein one or more of the elongate members penetrate into the tissue surrounding the cavity when the elongate members are directed to the expanded configuration.

33. The method of claim 27, wherein one or more of the elongate members cut into the tissue surrounding the cavity when the elongate members are directed to the expanded configuration.

34. The method of claim 27, wherein the elongate members carry one or more radioactive elements, and wherein radiation is delivered to the target location by leaving the elongate body at the target location for a predetermined time, thereby exposing the tissue to radiation emitted by the one or more radioactive elements.

35. The method of claim 27, wherein delivering radiation to the target location comprises introducing a source of radiation along pathways provided along the elongate members.

36. The method of claim 35, wherein the source of radiation comprises an HDR radiation source that is introduced sequentially into successive pathways of the elongate members.

37. The method of claim 35, wherein the source of radiation comprises a plurality of pods that are introduced along respective pathways provided along the elongate members.

38. The method of claim 37, wherein the elongate members comprise a plurality of tubular members comprising lumens defining respective pathways, and wherein introducing a source of radiation along pathways comprises introducing pods into respective lumens.

39. The method of claim 38, wherein each pod comprises a plurality of radioactive seeds located based upon a predetermined dose plan, and wherein the pods are introduced into the respective lumens to provide a three-dimensional array that is substantially asymmetrical about the central axis.

40. The method of claim 37, wherein the pods comprise seeds, the seeds having different radioactive intensities at predetermined locations in the three dimensional array.

41. The method of claim 40, wherein the radioactive intensities of the seeds are selected to deliver a relatively lower dose of radiation to one or more regions of the target location than to other regions of the target location.

42. The method of claim 41, wherein the one or more regions comprise tissue adjacent skin of the body.

43. The method of claim 41, wherein the one or more regions correspond to one or more specific pathways of the three dimensional array.

44. The method of claim 41, wherein one or more specific pathways include no radioactive seeds.

45. The method of claim 27, wherein the elongate body comprises a sharpened distal tip, and wherein the tract is created when the elongate body is advanced through tissue to the target location.

46. The method of claim 27, further comprising:

directing the elongate members to the collapsed configuration after delivering radiation to the target location; and

removing the elongate body from the target location.

47. The method of claim 27, wherein creating the tract through tissue comprises advancing a tubular member through tissue to the target location, and wherein the elongate body is advanced through the tubular member.

48. The method of claim 47, wherein a piercing member is disposed within the tubular member when the tubular member is advanced through tissue, the piercing member comprising a sharpened distal tip extending beyond the tubular member for penetrating through tissue to create the tract, and wherein the piercing member is removed before the elongate body is advanced through the tubular member.

49. The method of claim 27, wherein the elongate members are directed towards the expanded configuration such that the elongate members contact tissue surrounding the cavity, thereby causing the tissue to invaginate between the elongate members.

50. The method of claim 27, wherein the elongate members carry a plurality of radioactive elements, and wherein the elongate members position the radioactive elements in a three dimensional array when the elongate members are directed to the expanded configuration.

51. The method of claim 50, wherein the radioactive elements define multiple layers of radiation in the expanded configuration.

52. The method of claim 50, wherein the radioactive elements are fixed to the elongate members such that the three dimensional array defined by the radioactive elements corresponds to a predetermined dose plan for treating the tissue at the target location.

53. The method of claim 27, wherein delivering radiation to the target location comprises:

determining a dose plan based upon the expanded configuration within the target location; and

delivering radiation according to the determined dose plan.

54. The method of claim 53, wherein delivering radiation according to the determined dose plan comprises introducing an HDR source sequentially along successive pathways of the elongate members.

55. The method of claim 53, wherein delivering radiation according to the determined dose plan comprises introducing a plurality of pods along respective pathways provided along the elongate members.

56. The method of claim 55, wherein a first set of the elongate members is disposed towards a relatively thin tissue region adjacent the cavity, the pods comprising a first set of pods introduced along the first set of the elongate members, the first set of pods having a lower radiation intensity than other pods.

57. The method of claim 56, wherein the first set of the elongate members comprises an outer layer of pathways, and wherein a second set of the elongate members is disposed below the first set of the elongate members such that second set of the elongate members comprises an inner layer of pathways in the expanded configuration.

58. The method of claim 56, wherein the first set comprises a pair of adjacent elongate members, and wherein the second set comprises an elongate member disposed between the pair of adjacent elongate members and closer to a central axis of the elongate body.

59. The method of claim 27, further comprising removing at least a portion of the actuator after directing the elongate members to the expanded configuration at the target location to reduce a profile of the actuator extending from the body after implantation.