Expandable brachytherapy apparatus and methods for using them

• US 9,072,893 B2
• Filed: 06/01/2007
• Issued: 07/07/2015
• Est. Priority Date: 06/02/2006
• 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, Hermann, George D., Nguyen, Tommy G., Ritchart, Mark A., Gex, Steven L., Sutton, Dong S.
• Primary Examiner(s): KUHLMAN, CATHERINE BURK
• Application Number:
  US11/757,231
• Publication Number:
  US 20080221384A1
• Time in Patent Office: 2,958 Days
• Field of Search: 600 1- 8, 604104-109, 604/164.03, 604/509, 378/65, 2504921-4923
• US Class Current: 1/1
• 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 tissue; and

a plurality of elongate members extending between the proximal end and the distal end and comprising pathways that extend from the proximal end to the distal end for receiving a source of radiation therealong, distal portions of the elongate members being movable from a collapsed configuration for introduction through a tissue tract to a target location to an expanded configuration, the distal portions of the elongate members comprising tubular bodies and lateral surfaces extending from the tubular bodies, the lateral surfaces comprising a pair of wings extending laterally from each tubular body, wherein the tubular bodies define an outer cross-sectional dimension and the wings define a substantially uniform thickness that is smaller than the outer cross-sectional dimension, wherein tips of the wings are spaced apart from adjacent elongate members in the expanded configuration, and wherein the wings extend from the tubular bodies such that each elongate member defines an outer surface extending between tips of the wings, the outer surface being substantially flat or arc-shaped and extending substantially continuously between the tips of the wings.

2. The apparatus of claim 1, wherein the wings of each tubular body are flat and lie within the same plane.

3. The apparatus of claim 1, wherein the elongate members comprise tubular extrusions having widths greater then radial depths.

4. The apparatus of claim 1, further comprising a source of radiation introduceable along the pathways for delivering radiation to the target location.

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

6. The apparatus of claim 1, further comprising a proximal hub coupled to proximal ends of the elongate members, the proximal hub being movable relative to the elongate body for moving the elongate members from the collapsed configuration to the expanded configuration.

7. The apparatus of claim 6, wherein the elongate body comprises a core member extending from the proximal end to the distal end and coupled to distal ends of the elongate members, and wherein the proximal hub comprises an outer member coupled to proximal ends of the elongate members, the outer member slidably disposed around the core member.

8. The apparatus of claim 7, wherein the outer member comprises passageways communicating with the pathways of the elongate members.

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

10. The apparatus of claim 6, further comprising a distal hub coupled to distal ends of the elongate members.

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

12. The apparatus of claim 1, wherein the elongate members comprise a three dimensional array in the expanded configuration that provides multiple layers of radiation sources when one or more sources of radiation are introduced into the elongate members.

13. The apparatus of claim 1, wherein the elongate members are formed entirely from non-attenuating material.

14. The apparatus of claim 13, wherein the elongate members are formed entirely from plastic.

15. The apparatus of claim 13, wherein the elongate members are non-metallic.

16. The apparatus of claim 1, the apparatus further comprising a central lumen for receiving a radiation source therein, the central lumen extending distally beyond the pathways of the elongate members, thereby allowing a radiation source to be delivered distally beyond the elongate members for delivering radiation adjacent the distal end of the elongate body.

17. The apparatus of claim 1, wherein the tubular bodies are substantially circular and wherein the outer cross-sectional dimension is an outer diameter.

18. 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 tissue; and

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 to an expanded configuration, the elongate members comprising tubular bodies and wings extending from the tubular bodies, wherein tips of the wings are spaced apart from adjacent elongate members in the expanded configuration, wherein the tubular bodies define an outer cross-sectional dimension and the wings define a substantially uniform thickness that is smaller than the outer cross-sectional dimension,

wherein the elongate members comprise a first inner set of elongate members expandable to define a first diameter in the expanded configuration, the apparatus further comprising a second outer set of elongate members spaced apart about a central axis of the elongate body from the first set of elongate members, the second set of elongate members expandable to define a second diameter in the expanded configuration that is greater than the first diameter.

19. The apparatus of claim 18, wherein the second set of elongate members is angularly offset from the first set of elongate members about the central axis.

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

an elongate tubular extrusion comprising a proximal portion including a plurality of lumens, and a distal portion including a plurality of expandable elongate members formed by separating lumens of the extrusion along the distal portion, each elongate member comprising a tubular body including opposing wings and at least one of the lumens, wherein tips of the wings of each tubular body are spaced apart from tips of the wings of adjacent tubular bodies in the expanded configuration, and wherein each tubular body defines a substantially continuous outer surface extending between the tips of the wings that is substantially flat or arc-shaped,

wherein the expandable members are movable from a collapsed configuration to an expanded configuration, and wherein adjacent wings partially nest together when the expandable members are in the collapsed configuration such that adjacent wings partially overlap one another.

21. The apparatus of claim 20, wherein first ends of the elongate members extend from the proximal portion and second ends of the elongate members terminate at a distal hub formed as part of the extrusion.

22. The apparatus of claim 20, wherein the opposing wings extend from outer portions of the tubular bodies such that each elongate member defines a substantially flat outer surface extending between the tips of the wings.

23. 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 tissue;

a plurality of expandable 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 to an expanded configuration for providing a three dimensional array of pathways at the target location, at least some of the tubular members comprising a pair of wings extending laterally therefrom, the wings of each tubular member defining flat outer surfaces lying within the same plane, thereby providing an increased outer surface for the tubular members that contacts surrounding tissue when the tubular members are expanded to the expanded configuration, wherein the tubular members define an outer cross-sectional dimension and the wings define a thickness that is smaller than the outer cross-sectional dimension;

a hub coupled to proximal ends of the tubular members, the hub being movable relative to the elongate body for moving the tubular members from the collapsed configuration to the expanded configuration, wherein tips of the wings are spaced apart from adjacent tubular members in the expanded configuration; and

a plurality of tubular bodies extending proximally from the hub, the tubular bodies communicating with respective pathways of the expandable tubular members.

24. The apparatus of claim 23, further comprising an actuator 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.

25. The apparatus of claim 23, further comprising a plurality of pods carrying radioactive elements, the pods being introduceable into the tubular bodies such that the pods may be directed into the respective pathways of the expandable tubular members.

26. The apparatus of claim 23, the tubular members being spaced apart in the expanded configuration such that tissue at the target location invaginates between the tubular members.

27. The apparatus of claim 23, wherein the tubular bodies comprise a length that is longer than the expandable tubular members.

28. The apparatus of claim 23, wherein the tubular bodies are separable from the hub.

29. The apparatus of claim 23, wherein the wings of each tubular member comprise a pair of opposing wings extending tangentially from an outer portion of the tubular member.

30. The apparatus of claim 29, wherein adjacent wings are disposed in a side-by-side arrangement when the tubular members are in the collapsed configuration.

31. The apparatus of claim 23, wherein the wings of each tubular member define a substantially flat inner surface.

32. The apparatus of claim 23, wherein the tubular members comprise a first inner set of tubular members and a second outer set of tubular members spaced apart about a central axis of the elongate body from the first set of tubular members, the second set of tubular members defining a maximum diameter in the expanded configuration that is greater than a maximum diameter of the first set of tubular members.

33. The apparatus of claim 32, wherein each of the tubular members of the first set of tubular members comprises a pair of wings.

34. The apparatus of claim 32, wherein each of the tubular members of the second set of tubular members comprises a pair of wings.

35. The apparatus of claim 32, wherein both the first and second sets of tubular members comprise a pair of wings.

36. The apparatus of claim 23, wherein the elongate body comprises a central lumen extending from the proximal end to the distal end.

37. 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 tissue;

a plurality of elongate members extending between the proximal end and the distal end and comprising pathways that extend from the proximal end to the distal end for receiving a source of radiation therealong, distal portions of the elongate members being movable from a collapsed configuration for introduction through a tissue tract to a target location to 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 adjacent elongate members; and

a pair of opposing wings extending laterally from a plurality of the elongate members for limiting or controlling invagination of tissue at the target location between the elongate members, wherein tips of the wings are spaced apart from adjacent elongate members in the expanded configuration, and wherein the opposing wings of each elongate member are flat and substantially within the same plane.

38. The apparatus of claim 37, further comprising a source of radiation introduceable along the pathways for delivering radiation to the target location.

39. The apparatus of claim 37, wherein the elongate members comprise tubular bodies, the wings extending from the tubular bodies.

40. The apparatus of claim 37, wherein the elongate members comprise tubular members and the pathways comprise lumens within the tubular members, and wherein the tubular members define an outer cross-sectional dimension and the wings define a thickness that is smaller than the outer cross-sectional dimension.

41. 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 central lumen extending from the proximal end to the distal end; and

a plurality of elongate tubular members on the distal end surrounding the elongate body distal end and comprising lumens for receiving a source of radiation therealong, the elongate tubular members being movable from a collapsed configuration for introduction through a tissue tract to a target location to an expanded configuration for providing a three dimensional array of pathways at the target location, at least some of the elongate tubular members comprising a pair of wings extending from a tubular portion defining a lumen, wherein the tubular portion defines an outer cross-sectional dimension and the wings define a thickness that is smaller than the outer cross-sectional dimension, wherein tips of the wings are spaced apart from adjacent tubular elongate members in the expanded configuration, and wherein the wings of each elongate tubular member define flat outer surfaces lying within the same plane, thereby providing an increased outer surface for the elongate tubular members that contacts surrounding tissue when the elongate tubular members are expanded to the expanded configuration,

wherein the elongate tubular members comprise a first inner set of elongate tubular members and a second outer set of elongate tubular members spaced apart about a central axis of the elongate body from the first set of elongate tubular members, the second set of elongate tubular members defining a maximum diameter in the expanded configuration that is greater than a maximum diameter of the first set of elongate tubular members.

42. The apparatus of claim 41, wherein the central lumen extends distally beyond the lumens of the elongate tubular members, thereby allowing a radiation source to be delivered distally beyond the elongate tubular members for delivering radiation adjacent the distal end of the elongate body.

43. The apparatus of claim 42, the apparatus further comprising a distal hub on the distal end of the elongate body to which distal ends of the elongate tubular members are attached.

44. The apparatus of claim 41, wherein the wings of each elongate tubular member comprise a pair of opposing wings extending tangentially from an outer portion of the tubular portion.

45. The apparatus of claim 44, wherein adjacent wings are disposed in a side-by-side arrangement when the elongate members are in the collapsed configuration.

46. The apparatus of claim 41, wherein the first set of elongate tubular members comprise tubular bodies including one or more wings and lumens defining respective lumens.

47. The apparatus of claim 41, wherein the second set of elongate tubular members comprise tubular bodies including one or more wings and lumens defining respective lumens.

48. The apparatus of claim 41, wherein both the first and second sets of elongate tubular members comprise tubular bodies including one or more wings and lumens defining respective lumens.

49. 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 central lumen extending from the proximal end to the distal end; and

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 to an expanded configuration for providing a three dimensional array of pathways at the target location, at least some of the elongate members comprising a tubular body including a pair of wings and a lumen defining the pathway, wherein tips of the wings are spaced apart from adjacent elongate members in the expanded configuration, and wherein the wings of each elongate member define outer surfaces lying within the same plane, thereby providing an increased outer surface for the elongate members that contacts surrounding tissue when the tubular members are expanded to the expanded configuration,

wherein adjacent wings partially nest together when the elongate members are in the collapsed configuration such that adjacent wings partially overlap one another.

50. 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 tissue;

a plurality of expandable 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 to an expanded configuration for providing a three dimensional array of pathways at the target location, at least some of the tubular members comprising a pair of wings extending laterally therefrom, the wings of each tubular member defining outer surfaces lying within the same plane, thereby providing an increased outer surface for the tubular members that contacts surrounding tissue when the tubular members are expanded to the expanded configuration;

a hub coupled to proximal ends of the tubular members, the hub being movable relative to the elongate body for moving the tubular members from the collapsed configuration to the expanded configuration, wherein tips of the wings are spaced apart from adjacent tubular members in the expanded configuration; and

a plurality of tubular bodies extending proximally from the hub, the tubular bodies communicating with respective pathways of the expandable tubular members,

wherein adjacent wings partially nest together when the tubular members are in the collapsed configuration such that adjacent wings partially overlap one another.

51. 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 central lumen extending from the proximal end to the distal end; and

a plurality of elongate tubular members on the distal end surrounding the elongate body distal end and comprising lumens for receiving a source of radiation therealong, the elongate tubular members being movable from a collapsed configuration for introduction through a tissue tract to a target location to an expanded configuration for providing a three dimensional array of pathways at the target location, at least some of the elongate tubular members comprising a pair of wings extending from a tubular portion defining a lumen, wherein the tubular portion defines an outer cross-sectional dimension and the wings define a thickness that is smaller than the outer cross-sectional dimension, wherein tips of the wings are spaced apart from adjacent tubular elongate members in the expanded configuration, and wherein the wings of each elongate tubular member define flat outer surfaces lying within the same plane, thereby providing an increased outer surface for the elongate tubular members that contacts surrounding tissue when the elongate tubular members are expanded to the expanded configuration,

wherein the tubular portion of the tubular member is substantially circular, and wherein the outer cross-sectional dimension is an outer diameter of the tubular portion,

wherein the wings of each elongate member comprise a pair of opposing wings extending opposite one another at a substantially widest location on the tubular portion.