Catheter based balloon for therapy modification and positioning of tissue

• US 6,746,465 B2
• Filed: 12/14/2001
• Issued: 06/08/2004
• Est. Priority Date: 12/14/2001
• Status: Expired due to Term

• Current Assignee: Acoustic MedSystems Inc, Regents of the University of California (University of California)
• Original Assignee: Regents of the University of California (University of California)
• Inventors: Diederich, Chris J., Deardorff, Dana L.
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US10/020,583
• Publication Number:
  US 20030114878A1
• Time in Patent Office: 907 Days
• Field of Search: 606/191, 606/192, 606/193, 606/194, 606/197, 606/199, 604/96.01, 604/97.01, 604/97.03, 604/99.01, 604/100.01
• US Class Current: 606/192
• CPC Class Codes: A61B 2017/00092 using thermocouples
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2018/005 Rectum
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61B 2090/0436 Shielding
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/1013 with concentrically mounted balloons, e.g. being independently inflatable
• 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 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61N 2005/1094 Shielding, protecting against radiation
• CPC Class Codes: A61N 5/1027 Interstitial radiation therapy

Abstract

An apparatus and method for shielding non-target tissues and organs during thermotherapy, brachytherapy or other treatment of a diseased target tissue. The apparatus includes a catheter shaft having input and output lumens and at least one inflatable balloon. A plurality of input lumens within the catheter shaft allows the passage of liquid or gas through an input port and into the interior of the balloon thereby inflating the balloon. The gas or liquid can then be cycled through the inflated balloon through an output port and output lumen and out of the catheter shaft. Temperature sensors or other sensors may be attached to the balloon or catheter to monitor temperature or other conditions at the treatment site. The catheter is positioned between the target tissue or organ and sensitive non-target tissues in proximity to the target tissue and inflated causing a physical separation of tissues as well as a physical shield.

Claims

1. A system for minimally invasive therapy modification of tissue to be treated in a localized prostate therapy procedure in a patient, comprising:

an energy source configured to deliver sufficient energy into a region of target tissue associated with a prostate in the patient to provide a therapeutic result;

an elongated shaft having at least one lumen extending therethrough;

inflatable means coupled to an end of said shaft for separating the target tissue from a region of adjacent tissue associated with a rectum in the patient and that is located adjacent to the target tissue, and also for substantially isolating the adjacent tissue from the energy delivered from the energy source and into the target tissue; and

wherein the tissue effects on the adjacent tissue from the energy delivered into the target tissue from the energy source are substantially modified by the inflatable means.

2. A system as recited in claim 1, wherein said inflatable means comprises a balloon.

3. A system as recited in claim 1, further comprising a temperature sensor coupled to said inflatable means and configured to sense temperature of said target tissue and said adjacent tissue.

4. A system as recited in claim 1, further comprising a radiation sensor coupled to said inflatable means and configured to sense exposure of said target tissue and said adjacent tissue to radiation.

5. A system as recited in claim 1, further comprising means for inflating said inflatable means.

6. A system as recited in claim 5, wherein said means for inflating comprises:

a fluid disposed within said at least one lumen; and

means for moving said fluid through said lumen to said inflatable means, wherein said inflatable means is inflated.

7. A system as recited in claim 6, wherein said means for moving said fluid comprises a syringe and a valve.

8. A system as recited in claim 6, wherein said fluid comprises a liquid, or a gas or a mixture of a liquid and a gas.

9. A system as recited in claim 6, wherein said means for moving fluid further comprises means for cycling said fluid through said lumens of said shaft and said inflation means.

10. A system as recited in claim 1, wherein:

the energy source comprises a radiation source adapted to deliver a therapeutic amount of radiation energy into the target tissue; and

the inflatable means comprises means for substantially isolating the adjacent tissue from the therapeutic amount of radiation energy delivered into the target tissue from the radiation source.

11. A system as recited in claim 1, wherein:

said energy source comprises an ultrasound energy source configured to deliver a therapeutic amount of ultrasound energy to the target tissue; and

said inflatable means comprises means for substantially isolating the adjacent tissue from the therapeutic amount of ultrasound energy delivered into the target tissue from the ultrasound energy source.

12. A system for minimally invasive therapy modification of tissue to be treated in a localized prostate therapy procedure in a patient, comprising:

an energy source configured to emit sufficient energy into a region of target tissue associated with a prostate in the patient to provide a therapeutic result;

an elongated shaft having at least one lumen extending therethrough;

an inflatable member coupled to an end of said shaft that is positionable at a location between the target tissue and a region of adjacent tissue associated with a rectum and that is located adjacent to the target tissue; and

wherein said inflatable member when inflated at the location is configured to separate the target tissue from the adjacent tissue; and

wherein said inflatable member when inflated at the location is further adapted to substantially isolate the adjacent tissue from the energy delivered from the energy source and into the target tissue, such that the tissue effects on the adjacent tissue from the energy delivered from the energy source into the target tissue are substantially modified by the inflatable member.

13. A system as recited in claim 12, wherein said inflatable member comprises a balloon.

14. A system as recited in claim 12, further comprising a temperature sensor coupled to said inflatable member and configured to sense temperature of said target tissue or said adjacent tissue.

15. A system as recited in claim 12, further comprising a radiation sensor coupled to said Inflatable member and configured to sense exposure of said target tissue or said adjacent tissue to radiation.

16. A system as recited in claim 12, further comprising means for inflating said inflatable member.

17. A system as recited in claim 16, wherein said means for inflating comprises:

a fluid disposed within said at least one lumen; and

means for moving said fluid through said lumen to said inflatable member, wherein said inflatable member is inflated.

18. A system as recited in claim 17, wherein said means for moving said fluid comprises a syringe and a valve.

19. A system as recited in claim 17, wherein said fluid comprises a liquid, or a gas or a mixture of a liquid and a gas.

20. An apparatus as recited in claim 17, wherein said means for moving fluid further comprises means for cycling said fluid through said lumens of said shaft and said inflatable member.

21. An apparatus as recited in claim 12, wherein said inflatable member further comprises multiple compartments, each compartment capable of inflating independently of the other compartments.

22. A system as recited in claim 12, wherein:

the energy source comprises a radiation source adapted to deliver a therapeutic amount of radiation energy to the target tissue; and

the inflatable member when inflated at the location is substantially non-transmissive to radiation energy such that the inflatable member comprises a radiation shield that is adapted to substantially isolate the adjacent tissue from the therapeutic amount of radiation energy delivered into the target tissue from the radiation source.

23. A system as recited in claim 12, wherein:

said energy source comprises an ultrasound energy source configured to deliver a therapeutic amount of ultrasound energy to the target tissue; and

said inflatable member when inflated at the location is substantially non-transmissive to ultrasound energy such that the inflatable member comprises an ultrasound shield that is adapted to substantially isolate the adjacent tissue from the therapeutic amount of ultrasound energy delivered into the target tissue from the ultrasound energy source.

24. A system for minimally invasive therapy modification of tissue to be treated in a localized prostate therapy procedure in a patient, comprising:

an energy source configured to deliver sufficient energy into a region of target tissue associated with a prostate in the patient to provide a therapeutic result;

an elongate tubular shaft having a proximal end, a distal end and at least one lumen extending therethrough;

said distal end of said shaft having a tip, said tip and said shaft configured for introduction into a body of a patient;

an inflatable member having an interior and an exterior and that is disposed on said distal end of said elongate tubular shaft;

said inflatable member being positionable at a location between the target tissue and an adjacent region of a rectum located adjacent the target tissue upon introduction of the tip and shaft into the patient'"'"'s body;

said interior of said inflatable member being open to at least one lumen;

a source of material coupled to the interior;

means for inflating said inflatable member at least in part with the material at the location;

wherein said material is characterized as being substantially non-transmissive with respect to the energy delivered into the target tissue from the source; and

wherein said inflatable member when inflated with the material at the location is configured to separate the target tissue from the adjacent tissue; and

wherein said inflatable member when inflated with the material at the location is adapted to substantially isolate the adjacent tissue from the energy delivered from the energy source and into the target tissue, such that the tissue effects on the adjacent tissue from the energy emission from the energy source into the target tissue are substantially modified by the material in the inflatable member.

25. A system as recited in claim 24, further comprising a sensor connected to said distal end of said shaft.

26. A system as recited in claim 24, further comprising a sensor connected to said inflatable member.

27. A system as recited in claim 26, wherein said sensor is selected from the group of sensors consisting essentially of a thermocouple, a fiber optic sensor, a thermistor, and a radiation dosimeter.

28. A system as recited in claim 25, wherein said sensor is selected from the group of sensors consisting essentially of a thermocouple, a fiber optic sensor, a thermistor, and a radiation dosimeter.

29. A system as recited in claim 24, wherein said inflatable member comprises a plurality of balloons connected to said distal end of said shaft and configured for substantially simultaneous inflation or deflation.

30. A system as recited in claim 24, wherein:

said inflatable member comprises a plurality of balloons connected to said distal end of said shaft;

each of said balloons is in fluid communication with at least one of said lumens; and

each of said balloons can be selectively inflated or deflated.

31. A system as recited in claim 24, further comprising:

a fluid disposed in said lumen of said shaft;

wherein fluid flow into said lumen causes said inflatable member to inflate; and

wherein said fluid flow delivers the material into the inflatable member.

32. A system as recited in claim 31, wherein said fluid comprises a gas.

33. A system as recited in claim 31, wherein said fluid comprises a mixture of a gas and a liquid.

34. A system as recited in claim 31, wherein said fluid comprises air, water, oil, perfluorocarbons, diagnostic imaging contrast agent, or saline solution.

35. A system as recited in claim 31, wherein said fluid comprises a liquid.

36. A system as recited in claim 24, wherein said elongate shaft comprises stainless steel hypodermic tubing, polyimide, polyethylene, polystyrene, polycarbonate, extrudable polymer, thermoplastic, silicone, rubber, composite, brass, titanium, aluminum, or ceramic.

37. A system according to claim 24, wherein said tip of said shaft is pointed to allow direct insertion of the tip and shaft into body tissue.

38. A system as recited in claim 24:

wherein said elongate shaft is dimensioned to be coupled with a catheter placement device having a slightly larger diameter than said shaft;

wherein said catheter placement device is placed over the tip and distal end of said shaft and inflatable member during insertion and placement; and

wherein said catheter placement device is configured to decouple from said shaft after insertion and placement of the shaft into the body.

39. A system as recited in claim 24:

wherein said elongate shaft and said inflatable member is placed within a catheter placement device having a slightly larger diameter than said shaft and is placed over the distal portion;

wherein said catheter placement device is placed over the tip and distal end of said shaft and inflatable member during insertion and placement; and

wherein said catheter placement device is configured to slide back on said shaft after insertion and placement of the shaft into the body.

40. A system as recited in claim 24, wherein said inflatable member is made of an elastic material that is configured to expand during inflation.

41. A system as recited in claim 40, wherein said inflatable member is configured to take a shape when inflated at the location that is adapted to either correspond to a shape along at least one of the adjacent tissue, the target tissue, or a space at the location between the adjacent tissue and the target tissue, or to displace one of the adjacent tissue or target tissue to a predetermined position relative to the other.

42. A system asd recited in claim 24, wherein said inflatable member is made of an inelastic material that is configured to inflate to a predetermined volume and shape.

43. A system as recited in claim 42, wherein said predetermined shape is configured to either substantially correspond with a shape along at least one of the adjacent tissue, the target tissue, or a space at the location between the adjacent tissue and the target tissue, or to displace one of the adjacent or target tissue to a predetermined position relative to the other.

44. A system as recited in claim 24, wherein said inflatable member is made at least in part of a porous material that is configured to allow the transfer of fluid from the interior of said inflatable member to the exterior of said inflatable member.

45. A system as recited in claim 24, wherein said inflatable member has a metallized surface that is capable of conducting an electric current.

46. A system as recited in claim 24, wherein said inflatable member is optically transparent.

47. A system as recited in claim 24, wherein said inflatable member is optically opaque.

48. A system as recited in claim 24, wherein said inflatable member has a generally spherical shape when inflated.

49. A system as recited in claim 24, wherein said inflatable member has a generally ovoid shape when inflated.

50. A system as recited in claim 24, wherein said inflatable member has a generally spoon shape when inflated.

51. A system as recited in claim 24, wherein said inflatable member has a generally elliptical shape when inflated.

52. An apparatus as recited in claim 24, wherein said inflatable member has a generally cylindrical shape when inflated.

53. A system as recited in claim 24:

wherein said inflatable member includes a plurality of chambers; and

each of said chambers is in fluid communication with at least one other chamber.

54. A system as recited in claim 24, wherein said inflatable member further comprises:

a plurality of partitions compartmentalizing the interior of said inflatable member; and

each compartment is configured to inflate independently of the other compartments.

55. A system as recited in claim 24, wherein said inflatable member is made from a material comprising silastic, silicone, c-flex, polyester, Mylar, polyurethane, polyethylene, polyvinyl, latex, or rubber.

56. A system as recited in claim 24, wherein:

the energy source comprises a radiation source adapted to deliver a therapeutic amount of radiation energy to the target tissue; and

the inflatable member when inflated at least in part with the material at the location comprises a substantial radiation shield that is adapted to substantially isolate the adjacent tissue from the therapeutic amount radiation energy delivered into the target tissue from the radiation source.

57. A system as recited in claim 24, wherein:

said energy source comprises an ultrasound energy source configured to deliver a therapeutic amount of ultrasound energy to the target tissue; and

said material is characterized as having an acoustic impedance such that the inflatable member when inflated at least in part with the material comprises an ultrasound energy shield that is adapted to substantially isolate the adjacent tissue from the therapeutic amount of ultrasound energy delivered into the target tissue from the ultrasound energy source.