SYSTEM AND APPARATUS FOR IMAGING AND TREATING HOLLOW BODY CAVITIES

Abstract

Methods and apparatus for image-guided interstitial radiation are provided. In practicing the subject methods, a catheter is placed in the interstitium in close proximity to the site of tumor. The interstitial catheter is designed to receive an ultrasound imaging probe, and a radioactive source for interstitial radiation therapy. The interstitial catheter may be equipped with a balloon member. Further a system facilitating substance communication with the interstitium is provided.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an interstitial balloon catheter used for both ultrasound imaging and delivery of radiation therapy to the interstitial cavity.

FIG. 2 illustrates an ultrasound imaging probe positioned in a balloon catheter.

FIG. 3 illustrates a radiation therapy delivery device positioned in a balloon catheter.

FIG. 4 is a flowchart illustrating the steps in a treatment protocol in accordance with the principles of the present invention.

FIG. 5 is a flowchart illustrating the steps in an imaging protocol using an ultrasound probe in a balloon catheter in accordance with the principles of the present invention.

FIG. 6 is a flowchart illustrating the steps in a radiation therapy protocol using a radiation source positioned in a balloon catheter in accordance with the principles of the present invention.

FIGS. 7A and 7B illustrate an embodiment of an introducer catheter having a fixed geometry shown both in an enlarged configuration (FIG. 7A) and in a collapsed configuration (FIG. 7B).

FIGS. 8A-8C illustrate an introducer catheter having a biodegradable enlarged structure at its distal end. The catheter comprises at least a shaft structure (FIG. 8B) and a removable, biodegradable enlarged structure (FIG. 8C).

FIGS. 9A-9B illustrate alternative embodiments for ultrasonic imaging tissue characterization devices which may be used in the systems and methods of the present invention.

Claims

1. A method for characterizing tissue surrounding a surgical resection cavity in solid tissue, said method comprising: introducing a tissue characterization device into an interior of the surgical resection cavity; andcharacterizing at least a portion of the surrounding tissue using the tissue characterization device.

2. A method as in claim 1, wherein a tumor had been surgically resected from the solid tissue to create the surgical resection cavity.

3. A method as in claim 2, wherein the solid tissue from which the tumor had been removed is breast tissue.

4. A method as in claim 1, wherein introducing the tissue characterization device comprises positioning an elongate shaft through a transcutaneous opening in tissue overlying the surgical resection cavity.

5. A method as in claim 4, wherein the tissue opening was formed in open surgery.

6. A method as in claim 4, wherein the tissue opening was formed in minimally invasive surgery.

7. A method as in claim 1, further comprising initially positioning a distal end of an introducer catheter in the surgical resection cavity, wherein the tissue characterization device is positioned through a lumen of the introducer catheter.

8. A method as in claim 7, wherein the distal end of the introducer catheter has an enlarged distal structure.

9. A method as in claim 8, further comprising expanding the enlarged distal structure so that an outer surface thereof conforms to the tissue surrounding the surgical resection cavity.

10. A method as in claim 9, further comprising contracting the enlarged distal structure prior to removing the introducer catheter from the surgical resection cavity.

11. A method as in claim 8, wherein the enlarged distal structure has a fixed geometry.

12. A method as in claim 11, wherein the enlarged distal structure is collapsed prior to removing the introducer catheter from the surgical resection cavity.

13. A method as in claim 8, further comprising drawing a vacuum in the interstitial region between the enlarged distal end and the tissue to draw the tissue against an outer surface of the enlarged distal end.

14. A method as in claim 1, wherein characterizing comprises ultrasonically scanning the tissue surrounding the surgical resection cavity.

15. A method as in claim 14, wherein the tissue characterization device comprises one or more ultrasonic transducers, wherein the transducers are rotationally and/or axially scanned within the distal end of the introduced catheter.

16. A method as in claim 1, further comprising treating at least a portion of the tissue surrounding the surgical resection cavity.

17. A method as in claim 16, wherein treatment comprises delivering ionizing or non-ionizing radiation to the tissue.

18. A method as in claim 7, further comprising positioning a treatment device through the lumen of the introducer catheter.

19. A method as in claim 18, wherein the treatment device is adapted to deliver ionizing or non-ionizing radiation.

20. A method for characterizing and treating tissue surrounding a surgical resection cavity, said method comprising: positioning an introducer catheter transcutaneously so that a distal end is in the surgical resection cavity and a proximal end is external to the tissue;introducing a tissue characterization device through the introducer catheter into the distal end;characterizing at least a portion of the tissue surrounding the surgical resection cavity using the tissue characterization device;introducing a tissue treatment device through the introducer catheter; andtreating at least a portion of the tissue surrounding the surgical resection cavity using the tissue treatment device.

21. A method as in claim 20, wherein a tumor had been surgically resected from the solid tissue to create the surgical resection cavity.

22. A method as in claim 21, wherein the solid tissue from which the tumor had been removed is breast tissue.

23. A method as in claim 20, wherein introducing the introducer catheter comprises positioning the introducer catheter through a transcutaneous opening in tissue overlying the surgical resection cavity.

24. A method as in claim 23, wherein the tissue opening was formed in open surgery.

25. A method as in claim 23, wherein the tissue opening was formed in minimally invasive surgery.

26. A method as in claim 20, wherein the distal end of the introducer catheter has an enlarged distal structure.

27. A method as in claim 26, further comprising expanding the enlarged distal structure so that an outer surface thereof conforms to the tissue surrounding the surgical resection cavity.

28. A method as in claim 27, further comprising contracting the enlarged distal structure prior to removing the introducer catheter from the surgical resection cavity.

29. A method as in claim 26, wherein the enlarged distal structure has a fixed geometry.

30. A method as in claim 29, wherein the enlarged distal structure is collapsed prior to removing the introducer catheter from the surgical resection cavity.

31. A method as in claim 26, further comprising drawing a vacuum in the interstitial region between the enlarged distal end and the tissue to draw the tissue against an outer surface of the enlarged distal end.

32. A method as in claim 20, wherein characterizing comprises ultrasonically scanning the tissue surrounding the surgical resection cavity.

33. A method as in claim 32, wherein the tissue characterization device comprises one or more ultrasonic transducers, wherein the transducers are rotationally and/or axially scanned within the distal end of the introduced catheter.

34. A method as in claim 20, wherein treatment comprises delivering ionizing or non-ionizing radiation to the tissue from the treatment device.

35. A system comprising: an introducer catheter including a shaft having a proximal end, a distal end, a central lumen therethrough, and a distal structure positionable in a surgical resection cavity in solid tissue; andat least one tissue characterization element insertable through the central lumen and having an active component which is positionable within the distal structure.

36. A system as in claim 35, wherein the at least one tissue characterization element is adapted to detect residual tumor cells in cavity wall tissue.

37. A system as in claim 36, wherein the tissue characterization element comprises an ultrasonic imaging transducer or array.

38. A system as in claim 35, further comprising at least one tissue treatment element adapted to treat residual tumor cells in cavity wall tissue.

39. A system as in claim 38, wherein the tissue treatment element comprises an ionizing or non-ionizing radiation source.

40. A system as in claim 35, wherein the distal structure is enlarged or enlargeable.

41. A system as in claim 40, wherein the distal structure is inflatable and deflatable.

42. A system as in claim 41, wherein the distal structure has a fixed geometry and is collapsible to a smaller diameter.

43. A system as in claim 42, wherein the distal structure is biodegradable.

44. A method for treating tissue surrounding a surgical resection cavity, said method comprising: positioning a collapsible fixed geometry radiation delivery apparatus transcutaneously so that a distal end is in the surgical resection cavity and a proximal end is external to the tissue;introducing a tissue treatment device through the introducer catheter; andtreating at least a portion of the tissue surrounding the surgical resection cavity using the tissue treatment device.

45. A method for treating tissue surrounding a surgical resection cavity, said method comprising: positioning a bioresorbable radiation delivery apparatus transcutaneously so that a distal end is in the surgical resection cavity and a proximal end is external to the tissue;introducing a tissue treatment device through the introducer catheter; andtreating at least a portion of the tissue surrounding the surgical resection cavity using the tissue treatment device.

46. An interstitial brachytherapy apparatus for delivering ionizing radiation to an internal body location comprising: a catheter body member having a proximal end and distal end;a volume defined by the uncollapsed state of a collapsible membera radiation source within the apparatus generating a three-dimensional isodose profile that is substantially similar in shape to the uncollapsed shape of the collapsible member.

47. An interstitial brachytherapy apparatus for delivering ionizing radiation to an internal body location comprising: a catheter body member having a proximal end and distal end;a volume defined by a bioresorbable membera radiation source within the apparatus generating a three-dimensional isodose profile that is substantially similar in shape to the bioresorbable member