Rectal balloon with radiation sensor and/or markers

• US 8,603,129 B2
• Filed: 04/11/2012
• Issued: 12/10/2013
• Est. Priority Date: 01/16/2007
• Status: Active Grant

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: Radiadyne LLC (AngioDynamics, Inc.)
• Inventors: Isham, John
• Primary Examiner(s): Severson, Ryan
• Assistant Examiner(s): NGUYEN, TIN DUC
• Application Number:
  US13/444,626
• Publication Number:
  US 20120259197A1
• Time in Patent Office: 608 Days
• Field of Search: 606/197, 606/192, 606/193, 606/198, 606/194, 604/96.01, 604/103.06, 604/99.01, 604/99.02, 604/100.01, 604/100.02, 604/101.01, 604/101.02, 604/103.07, 604/103.08
• US Class Current: 606/197
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61N 2005/1097 Means for immobilizing the patient
• CPC Class Codes: A61N 5/10 X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy A61N5/01 takes precedence
• CPC Class Codes: A61N 5/1071 for verifying the dose delivered by the treatment plan

Abstract

A rectal balloon apparatus has a shaft with a fluid passageway extending therethrough. A balloon is affixed over an end of the shaft such that the fluid passageway communicates with an interior of the balloon. The balloon has a laterally flat surface thereon when inflated. The laterally flat surface of the balloon has a longitudinal groove formed thereon. The balloon has a radiation sensor positioned within the groove and a plurality of fiducial markers positioned on a surface of the balloon. A stopper is slidably mounted on the shaft.

Claims

1. A prostate immobilizing rectal balloon, said rectal balloon comprising:

a. a flexible shaft having a fluid passageway extending therethrough and having a distal end and a proximal end,

b. a balloon having an upper surface, a bottom surface, a distal end near said distal end of said shaft and a proximal end that is affixed to the proximal end of said shaft, such that said fluid passageway communicates with an interior of said balloon,

c. wherein said balloon comprises a top layer connected to a bottom layer to form said balloon,

d. said balloon further comprising a middle layer extending between said top layer and said bottom layer, wherein said middle layer is connected to said top layer to form a groove overlying said shaft and making said upper surface generally flattened as compared with said bottom surface,

e. wherein said balloon has a non-inflated condition,

f. wherein said balloon has an inflated condition, wherein said groove has depth and forms a central seating area that is configured to engage with a prostate, and

g. said balloon further comprising i) a radiation sensor in said groove for determining radiation dose from an external beam radiation device, or ii) one or more fiducial markers, or iii) both of i) and ii).

2. The prostate immobilizing rectal balloon of claim 1, wherein a first plurality of fiducial markers are positioned on one side of said groove and a second plurality of fiducial markers are positioned on an opposite side of said groove.

3. The prostate immobilizing rectal balloon of claim 1, wherein said fiducial markers comprise a first set of fiducial markers positioned on said upper surface of said balloon and a second set of fiducial markers positioned on said bottom surface of said balloon.

4. The prostate immobilizing rectal balloon of claim 1, further comprising a stopping means comprising a semispherical member slidably mounted on said shaft, said semispherical member having a curved surface facing said balloon and a locking mechanism to lock said stopping means at a desired location on said shaft.

5. The prostate immobilizing rectal balloon of claim 1, wherein said radiation sensor has an outer surface that is flush with a surface of said balloon or inward of said surface of said balloon.

6. The prostate immobilizing rectal balloon of claim 1, said shaft further comprising indicia formed on an exterior surface thereof.

7. The prostate immobilizing rectal balloon of claim 1, said fiducial markers comprising tungsten.

8. The prostate immobilizing rectal balloon of claim 1, said shaft having a plurality of holes in fluid communication with said balloon, said holes offset from an adjacent hole.

9. A method of treating a prostate, comprising inserting a prostate immobilizing rectal balloon of claim 1 into a rectum of a patient, and inflating said balloon such that a prostate engages with said groove, confirming a position of said balloon via imaging said fiducial markers, treating said prostate with external beam radiation therapy and assessing a radiation dosage via said sensor.