Brachytherapy positioning system

• US 6,607,476 B1
• Filed: 03/17/1999
• Issued: 08/19/2003
• Est. Priority Date: 10/01/1998
• Status: Expired due to Fees

• Current Assignee: University of Iowa Research Foundation
• Original Assignee: University of Iowa Research Foundation
• Inventors: Barnhart, William H.
• Primary Examiner(s): Gilbert, Samuel G.
• Application Number:
  US09/271,176
• Time in Patent Office: 1,616 Days
• Field of Search: 600/1-8, 604/102, 604/108, 604/95-97, 604/160, 604/194, 604/198, 604/22, 604/28, 606/8, 606/159, 606/191, 606/194-198, 606/200
• US Class Current: 600/3
• CPC Class Codes: A61M 2025/1047 having centering means, e.g. balloons having an appropriate shape
• CPC Class Codes: A61N 2005/1003 having means for centering a radioactive source within the lumen, e.g. balloons
• CPC Class Codes: A61N 5/1002 Intraluminal radiation therapy

Abstract

A brachytherapy positioning apparatus and a method of positioning a radiation source within a passageway of a patient'"'"'s body are disclosed. The apparatus is configured to position a radioactive source in the center of the passageway being treated so that all regions of the passageway wall receive the same dosage of radiation. The brachytherapy positioning apparatus may include an elongated member, a distal end cap, a reconfigurable positioning element, and a control member. The positioning element may be positioned between the distal end cap and the elongated member about a portion of the control member and may be selectively changed between a radially expanded state and a retracted state with the control member. In one embodiment, the positioning element includes a plurality of generally parallel wires that each expand and retract along a different radius originating from a centerline axis of the control member.

Claims

1. An apparatus, comprising:

an elongated member defining a lumen extending therethrough;

a control member extending through said lumen and terminating with an end cap, said end cap being distally spaced apart from said elongated member, said control member and said end cap being movable relative to said elongated member;

a positioning element including a plurality of wires each extending from said elongated member to said end cap, said wires being spaced about a centerline axis of said control member and each being predisposed with an arched shape; and

wherein said positioning element is placed in a radially retracted state by applying a force with said control member to push said end cap away from said elongated member, said wires are each at least partially straightened with a longitudinal axis generally parallel to said centerline axis when said positioning element is in said retracted state, and said wires each generally return to said predisposed shape to provide a radially expanded state of said positioning element upon removal of said force to position the apparatus.

2. The apparatus of claim 1, wherein said wires number at least 8 and are generally evenly spaced about a circumference of said control member.

3. The apparatus of claim 1, wherein said wires are each made of a shape memory material.

4. The apparatus of claim 1, wherein said control member has a treatment lumen extending therethrough configured to receive a radiation source.

5. The apparatus of claim 1, wherein said arched shape of each of said wires includes a generally straight central segment.

6. The apparatus of claim 1, wherein said arched shape of each of said wires includes a plurality of arcuate segments.

7. The apparatus of claim 6, wherein said apparatus includes a band disposed about said wires in a region between said distal end cap and said elongated member.

8. The apparatus of claim 1, wherein:

said wires number at least 8 and are generally evenly spaced about said control member, and said wires are each made of an alloy including nickel and titanium and move independent of one another when transitioning between said retracted state and said expanded state;

said control member has a treatment lumen extending therethrough configured to receive a radiation source; and

said end cap is closer to said elongated member when said positioning element is in said expanded state than when said positioning element is in said retracted state.

9. An apparatus, comprising:

an elongated member defining a lumen therethrough, said elongated member being configured for placement in a passageway in a patient'"'"'s body;

a control member disposed in said lumen of said elongated member and terminating with an end cap, said end cap being spaced apart from said elongated member, said control member and said end cap being arranged to be selectively positioned relative to said elongated member;

a positioning element including at least six wires extending from said elongated member to said end cap; and

wherein said positioning element is placed in a radially retracted state by applying a force with said control member to push said end cap away from said elongated member, and said wires each generally assume an arched shape to provide a radially expanded state of said positioning element relative to a centerline axis of said control member upon removal of said force, said wires each being operable to move independent of one another when transitioning between said retracted state and said expanded state.

10. The apparatus of claim 9, wherein said wires number 8 and are generally evenly spaced about said control member.

11. The apparatus of claim 9, wherein said wires are comprised of a shape memory material and are each predisposed to assume said arched shape.

12. The apparatus of claim 9, wherein each of said wires includes at least 3 arcuate segments.

13. The apparatus of claim 12, further comprising a number of bands disposed about said wires in a region between said end cap and said elongated member.

14. The apparatus of claim 9, wherein said wires each include a generally straight central segment when said positioning element is in said expanded state.

15. The apparatus of claim 9, wherein said control member has a treatment lumen extending therethrough configured to receive a radiation source.

16. A method, comprising:

advancing an apparatus having a positioning element through a passageway of a patient'"'"'s body to a treatment site, the positioning element being in a retracted state during said advancing and including a plurality of wires each under tension with a longitudinal axis generally parallel to a centerline axis of the apparatus during said advancing;

expanding the positioning element after reaching the treatment site, the wires each assuming a predisposed shape during said expanding in response to removal of a force applied to the wires with the apparatus, the wires each engaging a surface surrounding the passageway to position the apparatus during said expanding; and

delivering a radiation source with the apparatus to treat the treatment site after said expanding.

17. The method of claim 16, wherein the apparatus includes a guiding catheter, an elongated member extending through the guiding catheter, and a control member extending through the elongated member, a proximal end of the positioning element being coupled to the elongated member and a distal end of the positioning element being coupled to the control member, the wires being positioned about the control member.

18. The method of claim 16, further comprising retracting the positioning element by reapplying the force to the wires with the apparatus and withdrawing the apparatus through the passageway after said delivering.

19. The method of claim 16, wherein said delivering includes advancing the radiation source through a lumen defined by the apparatus.

20. The method of claim 16, wherein the apparatus includes a control member extending through an elongated member, the control member having a distal end portion extending further away from the elongated member when the positioning element is in the retracted state during said advancing than when the positioning element is in an expanded state during said expanding.

21. The method of claim 16, wherein said expanding includes moving the wires independent of one another to transition from the retracted state to an expanded state.

22. The method of claim 16, wherein the predisposed shape of each of the wires is generally arched and includes a generally straight central segment.

23. The method of claim 16, wherein the predisposed shape of each of the wires is generally arched and includes a plurality of arcuate segments.

24. The method of claim 16, wherein the radiation source is generally centered in the passageway by the wires when the positioning element is in the expanded state.

25. A method, comprising:

providing an apparatus including a control member extending through an elongated member, and a positioning element, the control member terminating with an end cap positioned distal to the elongated member, the positioning element including a plurality of wires extending from the elongated member to the end cap;

establishing a radially retracted state of the positioning element by applying a force with the control member to push the end cap away from the elongated member;

advancing the apparatus through a passageway of a patient'"'"'s body to a treatment site;

positioning the apparatus relative to the passageway by releasing the control member to establish a radially expanded state of the positioning element, the wires each radially extending away from the control member in the expanded state a greater distance than in the retracted state to engage a surface surrounding the passageway, the wires each moving independent of one another when transitioning from the retracted state to the expanded state; and

delivering a radiation source with the apparatus to treat the treatment site after said positioning.

26. The method of claim 25, further comprising withdrawing the apparatus through the passageway after treating the treatment site with the radiation source for a predetermined amount of time.

27. The method of claim 25, wherein said delivering includes advancing the radiation source through a lumen defined by the apparatus.

28. The method of claim 25, wherein the wires each assume a predisposed arched shape in the expanded state that includes a generally straight central segment.

29. The method of claim 25, wherein the wires each assume a predisposed arched shape in the expanded state that includes a plurality of arcuate segments.

30. The method of claim 25, wherein the radiation source is generally centered in the passageway by the wires when the positioning element is in the expanded state.