Rectal balloon with locking stopper

• US 9,707,379 B2
• Filed: 03/04/2016
• Issued: 07/18/2017
• 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): LACYK, JOHN P
• Application Number:
  US15/061,906
• Publication Number:
  US 20160184559A1
• Time in Patent Office: 501 Days
• Field of Search: 606191-199, 604 9601, 60410105, 60410303, 60410001, 60410002, 604117, 604180, 604192, 24 305 R, 24132 A, 24132 AA, 24132 WL, 128DIG 26
• 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 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 2025/0233 specifically adapted for attaching to a body wall by means which are on both sides of the wall, e.g. for attaching to an abdominal wall
• CPC Class Codes: A61M 2202/02 Gases
• CPC Class Codes: A61M 2205/59 Aesthetic features, e.g. distraction means to prevent fears of child patients
• CPC Class Codes: A61M 2210/166 Prostate
• 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 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61N 2005/1072 taking into account movement of the target
• 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
• CPC Class Codes: A61N 5/1078 Fixed beam systems

Abstract

A prostate immobilizing balloon that on full inflation cups the prostate to hold it during treatment is combined with a locking member so that the balloon does not shift during use. Methods of using same are also provided.

Claims

1. A locking device for use on a lumen of a prostate immobilizer comprising:

a) a positioning member having a head portion and a stem portion, said stem portion extending from said head portion, said head portion and said stem portion having a channel formed therein, said channel suitable for receiving a lumen therein; and

b) a locking member connected to said stem portion, said locking member being movable between a locked position and an unlocked position, said locking member having a surface suitable for gripping the lumen when said locking member is in said locked position;

wherein said head portion having a generally hemispherical shape at one end thereof and a generally flat surface at the opposite end thereof, and said locking member positioned adjacent to said generally flat surface.

2. The device of claim 1, said locking member being hingedly connected to said stem portion.

3. The device of claim 2, said stem portion having a lip formed thereon, said locking member having a latch formed thereon, said latch engaging said lip when said locking member is in said locked position.

4. The device of claim 1, said stem portion having an outer surface flush with a surface of said head portion, said locking member having an outer surface flush with another surface of said head portion when in said locked position.

5. The device of claim 1, said head portion having a longitudinal split formed therein so as to open to said channel, said longitudinal split having an opening suitable for allowing the lumen to pass therethrough and into said channel.

7. A prostate immobilizing device, said device comprising:

i) an inflatable balloon having a proximal end and a distal end;

ii) said balloon being sized and shaped for use in a rectum of an adult human male;

iii) a first lumen communicating with an interior of said balloon, said first lumen having a closable valve;

iv) the locking member of claim 1 around said first lumen such that said first lumen is in said channel.

8. The device claim 7, a second lumen extending from past said proximal end of said balloon to past said distal end of said balloon, said second lumen having a closed distal tip and one or more ports adjacent said closed distal tip and distal to said balloon.

9. The device of claim 8, further comprising one or more fiducial markers on a surface thereof.

10. The device of claim 8, further comprising a fiducial marker on a distal tip thereof.

11. A method of treating prostate cancer by external beam radiation therapy (XRT), comprising:

a) inserting a prostate immobilizing balloon of claim 7 into a rectum of a patient with a cancerous prostate;

b) inflating said balloon sufficiently to immobilize said prostate;

c) locking said locking member adjacent an anus; and

d) treating said prostate with XRT.

12. A method of treating prostate cancer by external beam radiation therapy (XRT), comprising:

a) inserting a prostate immobilizing balloon of claim 8 into a rectum of a patient with a cancerous prostate;

b) allowing rectal gas to exit the rectum via said one or more ports until no further exiting gas is evident;

c) inflating said balloon sufficiently to immobilize said prostate in said central seating area;

d) locking said locking member adjacent an anus;

e) treating said prostate with XRT; and

f) allowing rectal gas to exit the rectum via said one or more ports during said treating step.

13. A method of treating prostate cancer by external beam radiation therapy (XRT), comprising:

a) inserting a prostate immobilizing balloon of claim 9 into a rectum of a patient with a cancerous prostate;

b) allowing rectal gas to exit the rectum via said one or more ports until no further exiting gas is evident;

c) inflating said balloon sufficiently to immobilize said prostate in said central seating area;

d) determining the position of said one or more fiducial markers and positioning said balloon such that said fiducial markers are in a desired position;

e) locking said locking member adjacent an anus;

f) treating said prostate with XRT; and

g) allowing rectal gas to exit the rectum via said one or more ports during said treating step.

6. A locking device for use on a lumen of a prostate immobilizer comprising:

a) a positioning member having a head portion and a stem portion, said stem portion extending from said head portion, said head portion and said stem portion having a channel formed therein, said channel suitable for receiving a lumen therein;

b) a locking member connected to said stem portion, said locking member being movable between a locked position and an unlocked position;

c) said locking member having a surface suitable for gripping said lumen when said locking member is in said locked position;

d) said head portion having a generally hemispherical shape at one end thereof and a generally flat surface at the opposite end thereof, and said locking member positioned adjacent to said generally flat surface;

e) said stem portion having a lip formed thereon, said locking member having a latch formed thereon, said latch engaging said lip when said locking member is in said locked position;

f) said stem portion having an outer surface flush with a surface of said head portion, said locking member having an outer surface flush with another surface of said head portion when in said locked position.

14. A prostate immobilizing device, said device comprising:

i) an inflatable balloon having a proximal end and a distal end;

ii) said balloon being sized and shaped for use in a rectum of an adult human male;

iii) a first lumen communicating with an interior of said balloon, said first lumen having a closable valve;

iv) the locking member of claim 6 around said first lumen so that said lumen is in said channel.

15. The device claim 14, a second lumen extending from past said proximal end of said balloon to past said distal end of said balloon, said second lumen having a closed distal tip and one or more ports adjacent said closed distal tip and distal to said balloon.

16. The device of claim 15, further comprising one or more fiducial markers on a surface thereof.

17. The device of claim 15, further comprising a fiducial marker on a distal tip thereof.

18. A method of treating prostate cancer by external beam radiation therapy (XRT), comprising:

a) inserting a prostate immobilizing balloon of claim 14 into a rectum of a patient with a cancerous prostate;

b) inflating said balloon sufficiently to immobilize said prostate;

c) locking said locking member adjacent an anus; and

d) treating said prostate with XRT.

19. A method of treating prostate cancer by external beam radiation therapy (XRT), comprising:

a) inserting a prostate immobilizing balloon of claim 15 into a rectum of a patient with a cancerous prostate;

b) allowing rectal gas to exit the rectum via said one or more ports until no further exiting gas is evident;

c) inflating said balloon sufficiently to immobilize said prostate in said central seating area;

d) locking said locking member adjacent an anus;

e) treating said prostate with XRT; and

f) allowing rectal gas to exit the rectum via said one or more ports during said treating step.

20. A method of treating prostate cancer by external beam radiation therapy (XRT), comprising:

a) inserting a prostate immobilizing balloon of claim 16 into a rectum of a patient with a cancerous prostate;

b) allowing rectal gas to exit the rectum via said one or more ports until no further exiting gas is evident;

c) inflating said balloon sufficiently to immobilize said prostate in said central seating area;

d) determining the position of said one or more fiducial markers and positioning said balloon such that said fiducial markers are in a desired position;

e) locking said locking member adjacent an anus;

f) treating said prostate with XRT; and

g) allowing rectal gas to exit the rectum via said one or more ports during said treating step.