Expandable brachytherapy apparatus and methods for using them

• US 9,067,063 B2
• Filed: 11/03/2010
• Issued: 06/30/2015
• Est. Priority Date: 11/03/2010
• 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.
• Primary Examiner(s): Marmor, II, Charles A
• Assistant Examiner(s): COX, THADDEUS B
• Application Number:
  US12/939,121
• Publication Number:
  US 20120108881A1
• Time in Patent Office: 1,700 Days
• Field of Search: 600/3, 600/7, 600/8
• US Class Current: 1/1
• 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: A61N 2005/1004 having expandable radiation sources
• CPC Class Codes: A61N 5/1001 using radiation sources introduced into or applied onto the body; brachytherapy
• CPC Class Codes: A61N 5/1002 Intraluminal radiation therapy
• CPC Class Codes: A61N 5/1007 Arrangements or means for the introduction of sources into the body
• CPC Class Codes: A61N 5/1014 Intracavitary radiation therapy
• 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 core member, a plurality of expandable catheters or other elongate members and a balloon or other expandable member on a distal portion adjacent the core member. Each catheter includes a distal end coupled to the core member distal end, a proximal end movable relative to the core member, and a lumen extending between the proximal and distal ends for receiving a source of radiation therealong. The balloon is expandable independently of the catheters such that the balloon may be expanded after expanding the catheters, e.g., to facilitate imaging and/or dose planning. Optionally, a working channel may be provided for receiving an aspiration catheter or other instrument or at least one of the catheters may include an aspiration lumen and one or more ports, e.g., for aspirating material from a region surrounding the distal portion.

Claims

1. A brachytherapy treatment apparatus, comprising:

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

a plurality of elongate members, each elongate member comprising a distal end coupled to the core member distal end, a proximal end movable relative to the core member, and a pathway extending between the elongate member proximal and distal ends for receiving a source of radiation therealong, the elongate member proximal ends being movable relative to the distal ends for expanding the elongate members from a collapsed configuration to an expanded configuration such that the elongate members are directed radially outwardly away from the distal portion of the core member;

an expandable member comprising a proximal end coupled to the core member adjacent the elongate member proximal ends and a distal end coupled to the distal tip of the core member such that the expandable member surrounds the distal portion of the core member, the elongate members extending along and unsecured to an outer surface of the expandable member in the collapsed configuration; and

an actuator hub coupled to the elongate members and an elongate actuator member extending proximally from the hub that is movable axially relative to the core member for expanding the elongate members independently of the expandable member such that the elongate members are expanded away from the expandable member only by actuating the actuator member independently of the expandable member while the expandable member remains in an unexpanded condition.

2. The apparatus of claim 1, further comprising an inflation lumen extending distally from the proximal portion and communicating with an interior of the expandable member for delivering inflation media into the interior for expanding the expandable member.

3. The apparatus of claim 1, wherein each elongate member comprises a tubular member and an elongate support for biasing the tubular member to maintain a predetermined arcuate shape when the elongate member is directed from the collapsed configuration to the expanded configuration.

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

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

6. The apparatus of claim 1, further comprising a working channel member extending from the proximal end of the core member to the distal portion of the core member, the working channel member comprising a lumen extending from the core member proximal end to an opening adjacent the distal portion and exposed to the outer surface of the expandable member.

7. The apparatus of claim 6, further comprising an aspiration catheter including a proximal end, a distal end sized for introduction through the working channel, and a lumen extending therebetween, the aspiration catheter proximal end coupled to a vacuum source for aspirating material into the aspiration catheter lumen via an opening in the aspiration catheter distal end.

8. The apparatus of claim 6, wherein the working channel member comprises a valve within the lumen for selectively sealing the lumen.

9. The apparatus of claim 8, wherein the valve is biased closed and is configured to be opened when an instrument is introduced through the lumen of the working channel member.

10. The apparatus of claim 1, wherein one of the elongate members comprises an aspiration member including one or more ports adjacent the distal portion communicating with an aspiration lumen extending to a proximal end of the aspiration member.

11. The apparatus of claim 10, further comprising a vacuum source coupled to the proximal end of the aspiration member for aspirating material into the aspiration lumen via the one or more ports.

12. The apparatus of claim 10, wherein the aspiration member is disposed adjacent a tubular member comprising a source lumen therein providing a pathway for receiving a source of radiation therealong.

13. The apparatus of claim 10, wherein the aspiration member comprises a source lumen therein providing a pathway for receiving a source of radiation therealong.

14. The apparatus of claim 1, wherein the actuator member comprises a tubular body disposed around a portion of the core member, the tubular body rotatable relative to the core member to cause the hub to move axially relative to the core member and direct the elongate members to the expanded configuration.

15. A brachytherapy treatment apparatus, comprising:

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

a distal hub coupled to the distal tip of the core member;

a proximal hub movably mounted on the core member proximal to the distal hub;

a plurality of elongate catheters comprising distal ends coupled to the distal hub, proximal ends coupled to the proximal hub, elongate portions that extend between the proximal and distal hubs, and lumens extending between the respective catheter proximal and distal ends for receiving a source of radiation therealong;

an elongate actuator member coupled to and extending proximally from the proximal hub, the actuator member being actuatable for moving the catheters from a collapsed configuration to an expanded configuration such that the elongate portions are directed radially outwardly away from the core member;

an expandable member comprising a proximal end coupled to the proximal hub and a distal end coupled to the distal hub such that the expandable member surrounds the distal portion of the core member, the catheters extending along and unsecured to an outer surface of the expandable member in the collapsed configuration; and

a working channel member extending between the proximal and distal portions of the core member, the working channel member comprising a proximal end and a distal end disposed between the proximal and distal ends of the expandable member, and a lumen extending therebetween such that an opening in the working channel distal end communicating with the working channel lumen is located outside the outer surface of the expandable member between the proximal and distal ends of the expandable member.

16. The apparatus of claim 15, wherein the actuator member is movable axially relative to the core member to expand the catheters independently of the expandable member such that the catheters may be expanded away from the expandable member before the expandable member is expanded.

17. The apparatus of claim 16, further comprising an inflation lumen extending distally from the proximal portion and communicating with an interior of the expandable member for delivering inflation media into the interior for expanding the expandable member.

18. The apparatus of claim 15, further comprising an aspiration catheter including a proximal end, a distal end sized for introduction through the working channel lumen, and a lumen extending therebetween, the aspiration catheter proximal end coupled to a vacuum source for aspirating material into the aspiration catheter lumen via an opening in the aspiration catheter distal end.

19. The apparatus of claim 15, wherein the working channel member comprises a valve within the working channel lumen for selectively sealing the working channel lumen.

20. A brachytherapy treatment apparatus, comprising:

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

a distal hub coupled to the distal tip of the core member;

a proximal hub movably mounted on the core member proximal to the distal hub;

a plurality of elongate catheters comprising distal ends coupled to the distal hub, proximal ends coupled to the proximal hub, elongate portions that extend between the proximal and distal hubs, and lumens extending between the respective catheter proximal and distal ends for receiving a source of radiation therealong;

an actuator member coupled to and extending proximally from the proximal hub, the actuator member being actuatable for moving the catheters from a collapsed configuration to an expanded configuration such that the elongate portions are directed radially outwardly away from the core member; and

an expandable member comprising a proximal end coupled to the proximal hub and a distal end coupled to the distal hub such that the expandable member surrounds the distal portion of the core member, the catheters extending along and unsecured to an outer surface of the expandable member in the collapsed configuration,

wherein one of the catheters comprises an aspiration member including one or more ports located outside the outer surface of the expandable member between the proximal and distal ends of the expandable member and communicating with an aspiration lumen extending to a proximal end of the aspiration member.

21. A method for brachytherapy treatment of tissue surrounding a cavity within a target location of a body, comprising:

advancing a distal portion of an elongate body comprising a core member defining a central axis and carrying a plurality of elongate members into the cavity with the elongate members in a collapsed configuration such that an elongate actuator member extends from the distal portion and a proximal end of the actuator member is disposed outside the body;

actuating the proximal end of the actuator member to move an actuator hub on the distal portion axially relative to the core member and direct the elongate members to an expanded configuration within the cavity to position portions of the elongate members away from the central axis and adjacent tissue surrounding the cavity while an expandable member on the distal portion between the core member and the elongate members remains in an unexpanded condition;

expanding the expandable member outwardly towards the expanded elongate members without moving the actuator hub; and

delivering radiation to the target location via the elongate members to treat tissue at the target location.

22. The method of claim 21, further comprising:

with the expandable member expanded, imaging at least the distal portion of the elongate body and tissue surrounding the cavity to develop a dose plan; and

collapsing the expandable member after imaging and before delivering radiation to the target location via the elongate members.

23. The method of claim 21, wherein the expandable member remains expanded while radiation is delivered to the target location.

24. The method of claim 21, further comprising:

introducing an aspiration catheter into the cavity outside the expandable member via a working channel on the elongate body; and

aspirating material within the cavity via the aspiration catheter.

25. The method of claim 21, wherein at least one of the elongate members comprises one or more ports on the distal portion, the method further comprising:

aspirating material within the cavity outside the expandable member via the one or more ports.

26. The method of claim 21, wherein the actuator member comprises a tubular body disposed around a portion of the core member, and wherein actuating the proximal end of the actuator member comprises rotating the proximal end of the tubular body to move the actuator axially relative to the core member and direct the elongate members to the expanded configuration.

27. A method for brachytherapy treatment of tissue surrounding a cavity within a target location of a body, comprising:

advancing a distal portion of an elongate body comprising a core member defining a central axis and carrying a plurality of elongate members into the cavity with the elongate members in a collapsed configuration such that an elongate actuator member extends from the distal portion and a proximal end of the actuator member is disposed outside the body;

actuating the proximal end of the actuator member to move an actuator hub on the distal portion axially relative to the core member and direct the elongate members to an expanded configuration within the cavity to position portions of the elongate members away from the central axis and adjacent tissue surrounding the cavity while an expandable member on the distal portion between the core member and the elongate members remains in an unexpanded condition;

expanding the expandable member outwardly towards the expanded elongate members without moving the actuator hub;

imaging at least the distal portion of the elongate body and tissue surrounding the cavity to develop a dose plan;

collapsing the expandable member after imaging while the elongate members remain in the expanded configuration; and

delivering radiation to the target location via the expanded elongate members to treat tissue at the target location while the expandable member remains collapsed.