Method and apparatus for quantifying nerve and neural-muscular integrity related to pelvic organs or pelvic floor functions

• US 7,079,882 B1
• Filed: 01/22/2000
• Issued: 07/18/2006
• Est. Priority Date: 01/22/2000
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Schmidt, Richard
• Primary Examiner(s): Dvorak, Linda C. M.
• Assistant Examiner(s): Ruddy, David M.
• Application Number:
  US09/490,175
• Time in Patent Office: 2,369 Days
• Field of Search: 713/8, 128/DIG.25, 600/373, 600/377, 600/546, 600/547, 600/554, 600/591
• US Class Current: 600/373
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/296 for electromyography [EMG]
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/392 Detecting gastrointestinal contractions
• CPC Class Codes: A61B 5/395 Details of stimulation, e.g. nerve stimulation to elicit EMG response
• CPC Class Codes: A61B 5/4029 for evaluating the peripheral nervous systems A61B5/24 takes precedence
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition

Abstract

The present invention is a method and apparatus for quantifying nerve and neural-muscular integrity related to pelvic organs or pelvic floor functions. In one embodiment, the invention is a method and device to measure muscle or nerve activity in the pelvis or pelvic floor. In a modification of this embodiment, the invention includes means for inducing an efferent nerve signal in the spinal cord or sacral nerves and then measuring the resulting nerve activity of the nerves of the pelvic floor region. In a preferred embodiment, the invention includes placing a probe in the anal canal or vagina, the probe having proximal recording electrodes along its outer surface. In one possible embodiment, the probe has a distensible sheath having recording electrodes located on its outside surface. In another embodiment, the probe has an inflatable balloon at its distal end with recording electrodes located on the outside surface of the inflatable balloon. In a further embodiment, the proximal recording electrodes will be located on the outside of the distal end of the probe itself. In yet another embodiment, a disk having recording electrodes is placed in the rectum in contact with the tissue above the submucous space. In yet another embodiment of the invention, an essentially “C” shaped clip is provided having a core made of a spring-like material.

Claims

1. A method of quantifying nerve and neural-muscular integrity related to pelvic organs or pelvic floor functions comprising:

providing a probe comprising a body, a distensible member, and a recording electrode, wherein the distensible member has a first end connected to the body and a distal end movable relative to the body, and wherein the recording electrode is attached to the distensible member adjacent the distal end;

placing the probe into the anal canal or vagina;

moving the distal end of the distensible member away from the body to engage tissue of the anal canal or vagina with the recording electrode;

placing a stimulation electrode, connected to a pulse generator, near the spinal cord or sacral nerves;

producing electrical stimulation pulses at the stimulation electrode; and

detecting the resulting electrical activity in the pelvic organs or pelvic floor by the recording electrode.

2. The method of claim 1 further comprising the step of timing the time between the application of a stimulation pulse by the stimulation electrode and the detection of the resulting electrical activity in the pelvic organs or pelvic floor by the recording electrode.

3. The method of claim 1 wherein moving the distal end of the distensible member away from the body to engage tissue of the anal canal or vagina comprises moving the distensible member away from the body to engage the mucosal tissue of the rectal wall, wherein the mucosal tissue of the rectal wall is pushed against the levator ani muscles.

4. The method of claim 1 wherein the distensible member comprises two or more wings each comprising a distal end, and wherein the moving step comprises moving the distal ends of the wings away from the body.

5. The method of claim 4 further comprising one or more additional recording electrodes, wherein a recording electrode is adjacent each wing, and wherein the moving step comprises moving each of the wings away from the body to engage tissue of the anal canal or vagina with the recording electrodes.

6. The method of claim 1 wherein the probe further comprises a distending member, wherein at least a portion of the distending member is positioned between the body and the distensible member, and wherein the moving step comprises distending the distending member thereby causing the distensible member to move away from the body.

7. The method of claim 6 wherein the distending member comprises a balloon, and wherein the moving step comprises expanding the balloon, wherein the balloon exerts pressure on the distensible member thereby causing the distensible member to move away from the body.

8. A method of quantifying nerve and neural-muscular integrity related to pelvic organs or pelvic floor functions comprising:

providing a probe comprising a body, a distensible member, and a recording electrode, wherein the distensible member has a first end connected so he body and a distal end movable relative to the body, and wherein the recording electrode is attached to the distensible member adjacent the distal end;

placing the probe into the anal canal or vagina;

moving the distal end of the distensible member away from the body to engage tissue of the anal canal or vagina with the recording electrode; and

detecting the electrical activity in the pelvic organs or pelvic floor by the recording electrode.

9. A method of quantifying nerve and neural-muscular integrity related to pelvic organs or pelvic floor functions comprising:

providing a probe comprising a body, a plurality of wings, and at least one recording electrode, wherein each of the plurality of wings has a first end connected to the body and a distal end movable relative to the body, and wherein the at least one recording electrode is attached to one of the plurality of wings adjacent the distal end;

placing the probe into the anal canal or vagina;

moving the distal end of the plurality of wings away from the body to engage tissue of the anal canal or vagina with the at least one recording electrode; and

detecting the electrical activity in the pelvic organs or pelvic floor by the at least one recording electrode.

10. The method of claim 9 wherein the plurality of wings comprises four wings, and the at least one recording electrode comprises four recording electrodes, wherein there is a recording electrode adjacent the distal end of each of the four wings, and wherein the moving step comprises moving the distal ends of the four recording electrodes away from the body to engage the tissue of the anal canal or vagina with the four recording electrodes.

11. The method of claim 9 wherein the probe further comprises a distending member, wherein at least a portion of the distending member is positioned between the body and one or more of the plurality of wings, and wherein the moving step comprises distending the distending member thereby causing one or more of the plurality of wings to move away from the body.

12. The method of claim 11 wherein the distending member comprises a balloon, and wherein the moving step comprises expanding the balloon, wherein the balloon exerts pressure on one or more wings thereby causing one or more wings to move away from the body.

13. The method of claim 12 wherein the step of expanding the balloon comprises forcing a fluid into the balloon.

14. The method of claim 13 wherein the body includes a lumen and the fluid is forced into the balloon through the lumen.

15. A method of quantifying nerve and neural-muscular integrity related to pelvic organs or pelvic floor functions comprising:

providing a probe comprising a body, a plurality of wings, and at least one recording electrode, wherein each of the plurality of wings has a first end connected to the body and a distal end movable relative to the body, and wherein the at least one recording electrode is attached to one of the plurality of wings adjacent the distal end;

placing the probe into the anal canal or vagina;

moving the distal end of the plurality of wings away from the body to engage tissue of the anal canal or vagina with the at least one recording electrode;

placing a stimulation electrode, connected to a pulse generator, near the spinal cord or sacral nerves;

producing electrical stimulation pulses at the stimulation electrode;

detecting the resulting electrical activity caused by the stimulation pulses at the stimulation electrode in the pelvic organs or pelvic floor by the at least one recording electrode.