Expandable brachytherapy apparatus and methods for using them

• US 8,814,775 B2
• Filed: 03/18/2010
• Issued: 08/26/2014
• Est. Priority Date: 03/18/2010
• 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., Urquidi, Luis R.
• Primary Examiner(s): Matthews, Christine
• Assistant Examiner(s): Reddy, Sunita
• Application Number:
  US12/727,209
• Publication Number:
  US 20110230700A1
• Time in Patent Office: 1,622 Days
• Field of Search: 600/7, 600/3, 600/1, 424/133.1, 424/450, 424/130.1
• US Class Current: 600/3
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61N 2005/1004 having expandable radiation sources
• CPC Class Codes: A61N 5/1015 Treatment of resected cavities created by surgery, e.g. lumpectomy

Abstract

Brachytherapy treatment apparatus are provided that include an elongate body including a core member and an outer member surrounding and movable relative to the core member. One or more helical catheters are provided on a distal portion of the elongate body, e.g., including distal ends coupled to the core member and proximal ends coupled to the outer member. The outer member is movable relative to the core member, e.g., axially and/or rotationally, to direct the helical catheters between a collapsed configuration for introduction through a tissue tract to a target location, e.g., a lumpectomy cavity, and an expanded configuration. Each helical catheter includes a lumen, and, after expansion to the expanded configuration, a source of radiation may be introduced along the helical catheters and/or a lumen of the core member for delivering radiation to the target location. Optionally, the apparatus may include a balloon surrounding or within the helical members.

Claims

1. A brachytherapy treatment apparatus, comprising:

an elongate core member comprising a proximal end and a distal end configured for introduction into a tract through tissue and terminating in a distal tip;

an outer member surrounding a portion of the core member proximal to the distal tip and movable relative to the core member;

a plurality of helical members, each helical member comprising a distal end coupled to the core member distal end, a proximal end coupled to the outer member, an elongate portion that extends helically in a first helical direction around the core member between the helical member proximal and distal ends such that the helical members do not overlap one another, and a pathway extending between the helical member proximal and distal ends for receiving a source of radiation therealong, the outer member being actuatable for moving the helical members from a collapsed configuration to an expanded configuration such that each elongate portion is directed radially outwardly away from the core member; and

a balloon comprising a proximal end coupled to the outer member and a distal end coupled to the distal tip of the core member such that the balloon surrounds at least a portion of the core member distal end, the helical members extending helically around and outside an outer surface of the balloon and uncoupled from the balloon such that the helical members are expandable independently of the balloon,

wherein the helical members comprise a pair of helical members extending in the first helical direction and offset from one another such that the helical members do not overlap one another in the collapsed configuration.

2. The apparatus of claim 1, further comprising a distal hub coupled to the distal tip of the core member, the distal end of each helical member coupled to the distal hub.

3. The apparatus of claim 1, wherein the outer member comprises a proximal hub movably mounted on the core member and an actuator member extending proximally from the proximal hub, the actuator member movable from adjacent the core member proximal end for actuating the proximal hub to direct the helical members from the collapsed configuration to the expanded configuration.

4. The apparatus of claim 3, wherein the actuator member is movable axially for directing the proximal hub axially to direct the helical members from the collapsed configuration to the expanded configuration.

5. The apparatus of claim 3, wherein the actuator member is movable rotationally for rotating the proximal hub to direct the helical members from the collapsed configuration to the expanded configuration.

6. The apparatus of claim 3, wherein the actuator member comprises a tubular member comprising a distal end coupled to the proximal hub and a proximal end disposed adjacent the core member proximal end.

7. The apparatus of claim 3, wherein the actuator member comprises one or more detents on the actuator member proximal end for releasably securing the actuator member in a first position when the helical members have been directed to the expanded configuration.

8. The apparatus of claim 7, wherein the core member comprises a first detent on the core member proximal end that engages the one or more detents on the actuator member for releasably securing the actuator member in the first position.

9. The apparatus of claim 8, wherein the core member comprises a second detent on the core member proximal end that engages the one or more detents on the actuator member for releasably securing the actuator member in a second position when the helical members have been directed to the collapsed configuration.

10. The apparatus of claim 9, wherein the second detent is located proximal to the first detent on the core member proximal end.

11. The apparatus of claim 8, wherein the first detent limits movement of the actuator member relative to the core member to limit a maximum size of the helical members in the expanded configuration.

12. The apparatus of claim 1, wherein the core member comprises a pathway for receiving a source of radiation.

13. The apparatus of claim 1, further comprising a source of radiation introduceable along the pathway of each helical member for delivering radiation to a target location accessed via the tract through tissue.

14. The apparatus of claim 1, wherein each helical member comprises a tubular member and an elongate support for biasing the tubular member to maintain a helical shape when the helical member is directed between the collapsed and expanded configurations.

15. The apparatus of claim 14, wherein the elongate support is biased to a helical shape corresponding to the expanded configuration, the elongate support being elastically compressible inwardly when the helical member is directed towards the collapsed configuration.

16. The apparatus of claim 14, wherein the elongate support is biased to a helical shape corresponding to the collapsed configuration, the elongate support being elastically expandable outwardly when the helical member is directed towards the expanded configuration.

17. The apparatus of claim 14, wherein the support extends along an outer surface of the tubular member.

18. The apparatus of claim 17, wherein the support is attached to the outer surface of the tubular member using shrink tubing.

19. The apparatus of claim 1, wherein the pair of helical members are offset from one another about one hundred eight degrees around a perimeter of the core member.

20. A brachytherapy treatment apparatus comprising:

an elongate core member comprising a proximal end and a distal end configured for introduction into a tract through tissue and terminating in a distal tip;

an outer member surrounding a portion of the core member proximal to the distal tip and movable relative to the core member;

a plurality of helical members, each helical member comprising a distal end coupled to the core member distal end, a proximal end coupled to the outer member, an elongate portion that extends helically around the core member between the helical member proximal and distal ends, and a pathway extending between the helical member proximal and distal ends for receiving a source of radiation therealong;

an expandable member comprising a proximal end coupled to the outer member and a distal end coupled to the distal tip of the core member such that the expandable member surrounds at least a portion of the core member distal end, the expandable member uncoupled from the helical members; and

an elongate actuator member coupled to the outer member and movable axially to move the helical members independent of the expandable member from a collapsed configuration where the helical members extend helically around and outside an outer surface of the expandable member to an expanded configuration such that the elongate portions of the helical members are directed radially outwardly away from the expandable member,

wherein the helical members comprise a pair of helical members extending in a first helical direction and offset from one another such that the helical members do not overlap one another in the collapsed configuration.

21. The apparatus of claim 20, wherein the expandable member is expandable independently of the helical members such that the helical members may be expanded away from the expandable member before the expandable member is expanded.

22. The apparatus of claim 20, wherein the core member comprises an inflation lumen extending distally from the core member proximal end and communicating with an interior of the expandable member for delivering inflation media into the interior for expanding the expandable member.

23. The apparatus of claim 20, wherein the pair of helical members are offset from one another about one hundred eight degrees around a perimeter of the core member.

24. The apparatus of claim 20, wherein the expandable member is a balloon.

25. The apparatus of claim 20, further comprising a source of radiation introduceable along the pathway of each helical member for delivering radiation to a target location accessed via the tract through tissue.

26. A brachytherapy treatment apparatus, comprising:

an elongate core member comprising a proximal end and a distal end configured for introduction into a tract through tissue and terminating in a distal tip;

an outer member surrounding a portion of the core member proximal to the distal tip and movable relative to the core member;

a plurality of helical members, each helical member comprising a distal end coupled to the core member distal end, a proximal end coupled to the outer member, an elongate portion that extends helically around the core member between the helical member proximal and distal ends, and a pathway extending between the helical member proximal and distal ends for receiving a source of radiation therealong; and

the outer member being actuatable for moving the helical members from a collapsed configuration to an expanded configuration such that each elongate portion is directed radially outwardly away from the core member,

wherein the helical members are configured such that adjacent windings of the helical members are spaced apart axially from one another by no more than one and a half centimeters.

27. The apparatus of claim 26, further comprising a distal hub coupled to the distal tip of the core member, the distal end of each helical member coupled to the distal hub.

28. The apparatus of claim 26, wherein the outer member comprises a proximal hub movably mounted on the core member and an actuator member extending proximally from the proximal hub, the actuator member movable from adjacent the core member proximal end for actuating the proximal hub to direct the helical members from the collapsed configuration to the expanded configuration.

29. The apparatus of claim 28, wherein the actuator member is movable axially for directing the proximal hub axially to direct the helical members from the collapsed configuration to the expanded configuration.

30. The apparatus of claim 28, wherein the actuator member is movable rotationally for rotating the proximal hub to direct the helical members from the collapsed configuration to the expanded configuration.

31. The apparatus of claim 26, wherein the core member comprises a pathway for receiving a source of radiation.

32. The apparatus of claim 26, wherein each helical member comprises a tubular member and an elongate support for biasing the tubular member to maintain a helical shape when the helical member is directed between the collapsed and expanded configurations.

33. The apparatus of claim 26, further comprising a source of radiation introduceable along the pathway of each helical member for delivering radiation to a target location accessed via the tract through tissue.