Diagnosis of brain and spinal cord injury by bulbocavernosus reflex measurement

• US 9,730,605 B2
• Filed: 07/19/2016
• Issued: 08/15/2017
• Est. Priority Date: 09/25/2007
• Status: Active Grant

• Current Assignee: Uroval, Inc.
• Original Assignee: Uroval, Inc.
• Inventors: Folkerts, Debra J., Finstrom McPhee, Karen Louise, Gack, Timothy Martin, Johnson, Gregory Ray
• Primary Examiner(s): Eiseman, Adam J
• Assistant Examiner(s): Warsi, Yasmeen S
• Application Number:
  US15/213,696
• Publication Number:
  US 20160324437A1
• Time in Patent Office: 392 Days
• CPC Class Codes: A61B 5/1107 Measuring contraction of parts of the body, e.g. organ, muscle apparatus for measuring work or force in general G01L
• CPC Class Codes: A61B 5/202 Assessing bladder functions, e.g. incontinence assessment
• CPC Class Codes: A61B 5/296 for electromyography [EMG]
• CPC Class Codes: A61B 5/391 of genito-urinary organs
• CPC Class Codes: A61B 5/4064 Evaluating the brain A61B5/031, A61B5/369, A61B5/14553 take precedence
• CPC Class Codes: A61B 5/407 Evaluating the spinal cord A61B5/4896 takes precedence
• CPC Class Codes: A61B 5/4368 Sexual arousal evaluation
• CPC Class Codes: A61H 19/30 Devices for external stimulation of the genitals
• CPC Class Codes: A61H 19/34 For clitoral stimulation
• CPC Class Codes: A61H 19/40 Devices insertable in the genitals
• CPC Class Codes: A61H 2201/10 with further special therapeutic means, e.g. electrotherapy, magneto therapy or radiation therapy, chromo therapy, infrared or ultraviolet therapy
• CPC Class Codes: A61H 2201/1207 with electric or magnetic drive
• CPC Class Codes: A61H 2201/501 connected to external computer devices or networks
• CPC Class Codes: A61H 2201/5043 Displays
• CPC Class Codes: A61H 2201/5048 Audio interfaces, e.g. voice or music controlled
• CPC Class Codes: A61H 2230/605 used as a control parameter for the apparatus
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

A system and method is disclosed for measuring muscle reflexes (e.g., a bulbocavernosus reflex) as a tool for identifying/diagnosing dysfunctions (e.g., spinal cord abnormalities, bladder voiding dysfunction, and sexual organ dysfunction) non-invasively by using mechanical stimulation. The system and method includes a probe having a predetermined patient contacting portion, wherein when the contacting portion is moved into contact with a particular area of the patient (e.g., the patient'"'"'s genitals), the contact induces a muscle reflex. The probe detects the pressure resulting from the contacting portion being abruptly and forcibly brought into contact with the particular area. Such detection is used to electronically initiate capture of electrical responses from a plurality of electrodes placed on the patient'"'"'s skin in proximity to the particular area. Such electrical responses are processed to determine characteristics of the patient'"'"'s reflexes of one or more muscles adjacent to the electrodes.

Claims

1. A method for diagnosing at least one of a brain injury and a spinal cord injury, comprising:

providing a probe comprising;

a housing with a bore therethrough, the housing comprising a piezoelectric disk, the disk electrically connected to an amplifier and activated by a power source;

a stimulus plunger having first and second ends and a shaft that extends through the bore, the shaft being movable along a longitudinal axis and having an expanded portion that prevents the stimulus plunger from sliding out of an opening in the housing; and

a compression spring that biases the second end of the stimulus plunger away from contact with the piezoelectric disk,

wherein, when the stimulus plunger makes non-invasive contact with a patient'"'"'s genital area, pressure from the stimulus plunger is transmitted to the genital area to induce a bulbocavernosus reflex;

placing the stimulus plunger in non-invasive contact with the patient'"'"'s genital area;

activating the piezoelectric disk to generate an electromagnetic response indicative of the non-invasive contact;

using the electromagnetic response to identify at least one electrical response indicative of the bulbocavernosus reflex from a plurality of electrodes placed on the patient'"'"'s skin adjacent to the genital area;

determining at least one quantity selected from the group of a time delay between the electromagnetic response and the at least one electrical response, a time duration of the at least one electrical response, a value indicative of a magnitude of the at least one electrical response, and an attenuation in the at least one electrical response; and

comparing the quantity to a predetermined baseline.

2. The method of claim 1, further comprising storing data indicative of a history of activation of the probe.

3. The method of claim 1, wherein the piezoelectric disk comprises an electrical switch.

4. The method of claim 1, further comprising determining a voltage difference between the plurality of electrodes.

5. The method of claim 1, wherein the electrodes are placed on opposite sides of the patient'"'"'s rectum.

6. The method of claim 1, further comprising identifying a length of time of the placing step.

7. A method for diagnosing at least one of a brain injury and a spinal cord injury, comprising:

providing a probe comprising;

a housing with an opening therethrough, the housing operably associated with a probe tip;

a patient contact shield cap, adapted to cover the probe tip and having a shaft with an expanded portion that prevents the shaft from sliding out of the opening in the housing; and

a single electrical conductor attached to the expanded portion and concentric to the shaft,

wherein the shaft of the cap is slidable along an axis within a bore through the cap, extends through the bore, is movable along a longitudinal axis, and has an inner end attached to an elastomeric component, the elastomeric component adapted to fit within the recess and exert a force effective to cause the expanded portion to contact the interior of the cap, and

wherein the inner end of the shaft and the elastomeric component are received in a recess within the probe and the shaft is slidable along the axis within the recess;

abruptly contacting the cap with a patient'"'"'s genital area, wherein the shaft slides along the axis and thereby compresses the elastomeric component by an amount effective to cause the conductor to contact a pair of electrodes that are spaced apart;

detecting current flow between the electrodes to identify a time indicative of the cap contacting the patient for inducing a bulbocavernosus reflex;

measuring a time delay of the bulbocavernosus reflex in the patient; and

comparing the time delay of the bulbocavernosus reflex to a predetermined baseline,

wherein, as a result of the abruptly contacting step, the electrical conductor moves toward the probe tip and slides past the pair of electrodes so that the flow of current between the electrodes ceases, and wherein the detecting step provides a signal effective for commencing the measuring step.

8. The method of claim 7, further comprising storing data indicative of a history of activation of the probe.

9. The method of claim 7, wherein the cap further comprises a flat spring provided along the shaft, the flat spring adapted to fold against the shaft in a first position and move toward the probe tip in a second position.

10. The method of claim 7, further comprising determining at least one of a duration of the bulbocavernosus reflex, a value indicative of a magnitude of at least one electrical response of the bulbocavernosus reflex, and an attenuation in the at least one electrical response of the bulbocavernosus reflex.

11. The method of claim 7, wherein the electrical conductor comprises an electrical switch.

12. The method of claim 7, further comprising determining a voltage difference between the electrodes.

13. The method of claim 7, wherein the electrodes are placed on opposite sides of the patient'"'"'s rectum.

14. The method of claim 7, further comprising identifying a length of time of the abruptly contacting step.