Anorectal probe apparatus having at least one muscular activity sensor

• US 5,924,984 A
• Filed: 01/30/1997
• Issued: 07/20/1999
• Est. Priority Date: 01/30/1997
• Status: Expired due to Fees

• Current Assignee: University of Iowa Research Foundation
• Original Assignee: University of Iowa Research Foundation
• Inventors: Rao, Satish
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): MANTIS MERCADER, ELENI M
• Application Number:
  US08/791,313
• Time in Patent Office: 901 Days
• Field of Search: 600/546, 600/373, 600/587, 600/593, 600/560, 600/561, 600/372
• US Class Current: 600/373
• CPC Class Codes: A61B 5/227 of constricting muscles, i.e. sphincters
• CPC Class Codes: A61B 5/392 Detecting gastrointestinal contractions
• CPC Class Codes: A61B 5/42 Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems A61B1/00, A61B5/4857, A61B5/486, A61B5/4866, A61B5/4869 take precedence

Abstract

An apparatus for sensing muscular activity of the rectosigmoid region, rectum, and the anorectal canal of a subject is disclosed. This apparatus includes an elongate probe having a distal end opposing a proximal end which is configured for insertion into the patient'"'"'s anorectal canal and includes a pressure sensor, an electromyography sensor, and a stimulus balloon. Multiple pressure sensors may be included to evaluate muscular activity in the anorectal canal. In addition, pressure sensors may be distributed along the length of the probe to simultaneously measure the response of other portions of the anorectal canal besides the anal sphincter muscle. A pressure sensor is also located inside the stimulus balloon for monitoring intraballoon pressure.

Claims

1. An apparatus configured for sensing muscular activity in an anorectal canal of a patient, comprising:

an elongate probe having a distal end opposing a proximal end, said probe being configured for insertion into the patient'"'"'s anorectal canal, said probe defining a lumen configured for passage of pressurized fluid therethrough, said probe including;

(a) a first pressure sensor configured to provide a pressure signal representative of muscular activity in the anorectal canal;

(b) an electromyography sensor configured to provide an electromyography signal representative of muscular activity in the anorectal canal;

(c) a stimulus balloon carried on said probe, said balloon being in fluid communication with said lumen, said balloon being configured to stimulate muscle activity in the anorectal canal when inflated with pressurized fluid delivered through said lumen; and

wherein said first pressure sensor is positioned on said probe between said distal end and said balloon.

2. The apparatus of claim 1, wherein said electromyography sensor is provided by a pair of opposing electrodes positioned proximal to said balloon.

3. The apparatus of claim 1, further comprising a second pressure sensor positioned along said probe between said balloon and said proximal end.

4. The apparatus of claim 1, wherein said probe is generally cylindrical and further comprising a plurality of second pressure sensors, said second pressure sensors being arranged along a helical path on said probe proximal to said balloon.

5. The apparatus of claim 1, further comprising a plurality of second pressure sensors of at least three in number, said second pressure sensors are spaced apart from one another along a longitudinal portion of said probe, said portion having a length of no more than about two centimeters.

6. The apparatus of claim 1, further comprising a monitoring device responsive to said pressure signal and said electromyography signal to provide a visual output representative of muscular activity in the anorectal canal.

7. The apparatus of claim 1, further comprising a controllable pressurized fluid source in fluid communication with said lumen of said probe to selectively inflate said balloon.

8. An apparatus configured for sensing muscular activity in an anorectal canal of a patient, comprising:

an elongate probe having a distal end portion and a proximal end portion, said probe being configured for insertion into the anorectal canal, said probe defining a lumen configured for passage of pressurized fluid therethrough, said probe including;

(a) a first pressure sensor configured to provide a first pressure signal corresponding to muscular activity in the anorectal canal at a first site; and

(b) a stimulus balloon carried on said probe and proximally spaced apart from said first site, said balloon being in fluid communication with said lumen and being configured to stimulate muscle activity in the anorectal canal when inflated with pressurized fluid delivered through said lumen.

9. The apparatus of claim 8, further comprising a controllable pressurized fluid source in fluid communication with said lumen of said probe to selectively inflate said balloon.

10. The apparatus of claim 8, further comprising a monitoring device responsive to said first signal to provide a visual output representative of muscular activity in the anorectal canal.

11. The apparatus of claim 8, further comprising a second pressure sensor configured to provide a second pressure signal corresponding to muscle activity at a second site, said second site being proximal to said balloon.

12. The apparatus of claim 8, further comprising a pair of electrodes located proximal to said balloon to monitor muscle activity in the anorectal canal.

13. An apparatus configured for sensing muscular activity in an anorectal canal of a patient, comprising:

(a) an elongate probe having a longitudinal axis with a distal end and a proximal end oppositely disposed therealong, said probe being configured for insertion into the patient'"'"'s anorectal canal;

(b) at least three proximal pressure sensors each coupled to said probe, said proximal pressure sensors being configured to simultaneously monitor anal sphincter activity of the patient at each of a corresponding number of different positions, said positions each being within about a three centimeter length along said longitudinal axis and being circumferentially and longitudinally spaced apart from each other; and

(c) an electromyography sensor coupled to said probe, said electromyography sensor being configured to monitor anal sphincter activity simultaneously with said proximal pressure sensors at a site on said probe located within about one centimeter of at least one of said positions.

14. The apparatus of claim 13, wherein said probe includes a lumen and further comprising:

a stimulus balloon carried on said probe between said distal end and said proximal end, said balloon being in fluid communication with said lumen; and

a controllable pressurized fluid source in fluid communication with said lumen of said probe to selectively inflate said balloon to stimulate anal sphincter activity.

15. The apparatus of claim 13, further comprising a first distal pressure sensor coupled to said probe, said first distal pressure sensor being configured to measure muscle activity in the anorectal canal at a first location on said probe distally displaced along said longitudinal axis from said positions by at least about nine centimeters.

16. The apparatus of claim 15, further comprising:

a second distal pressure sensor coupled to said probe, said second distal pressure sensor being configured to measure muscle activity in the anorectal canal at a second location on said probe between said first distal pressure sensor and said proximal pressure sensors; and

a stimulus balloon carried on said probe between said first distal pressure sensor and said proximal pressure sensors.

17. The apparatus of claim 13, wherein:

said proximal pressure sensors and said corresponding positions number at least four;

said corresponding positions include a first one centered about 0.5 centimeter distal to said site, a second one centered about 1.0 centimeter distal to said site, a third one centered about 1.5 centimeters distal to said site, and a fourth one centered about 2.5 centimeters distal to said site.

18. The apparatus of claim 17, wherein said probe includes an anal margin mark located about 0.5 centimeter proximal to said site, said positions are generally located along a helical path about said probe;

and further comprising;

a first distal pressure sensor coupled to said probe, said first distal pressure sensor being configured to measure muscle activity in the anorectal canal at a first location centered about 9 centimeters from said mark;

a second distal pressure sensor coupled to said probe, said second distal pressure sensor being configured to measure muscle activity in the anorectal canal at a second location centered about 14 centimeters from said mark; and

a stimulus balloon carried on said probe between said second distal pressure sensor and said proximal pressure sensors.

19. An apparatus configured for sensing muscular activity in an anorectal canal of a patient, comprising:

an elongate probe having a distal end opposing a proximal end, said probe being configured for insertion into the patient'"'"'s anorectal canal, said probe defining a lumen configured for passage of pressurized fluid therethrough, said probe including;

(a) a stimulus balloon carried on said probe to stimulate muscle activity in the anorectal canal when inflated with pressurized fluid delivered through said lumen;

(b) a first sensor positioned along said probe distal to said balloon to provide a first signal representative of muscular activity in the anorectal canal;

(c) a second sensor positioned along said probe proximal to said balloon to provide a second signal representative of muscular activity in the anorectal canal; and

(d) a monitoring device responsive to said first and second signals to provide an output simultaneously representing muscular activity of the anorectal canal at a distal site and a proximal site relative to a location stimulated by said balloon to facilitate diagnosis of defecation disorders.

20. The apparatus of claim 19, wherein said first sensor is a pressure sensor.

21. The apparatus of claim 19, wherein said second sensor is an electromyography sensor including a pair of opposing electrodes.

22. The apparatus of claim 19, further comprising at least three pressure sensors coupled to said probe, said pressure sensors being positioned proximal to said stimulus balloon along said probe.

23. The apparatus of claim 22, wherein said pressure sensors are generally arranged along a helical path about said probe.

24. The apparatus of claim 22, wherein said probe includes an anal margin mark located proximal to said stimulus balloon.