Obtaining measurements of muscle reflexes for diagnosis of patient symptoms

• US 8,439,845 B2
• Filed: 09/25/2008
• Issued: 05/14/2013
• Est. Priority Date: 09/25/2007
• Status: Active Grant

• Current Assignee: Uroval, Inc.
• Original Assignee: Uroval, Inc.
• Inventors: Folkerts, Debra Janette, Finstrom McPhee, Karen Louise, Johnson, Gregory Ray, Gack, Timothy Martin
• Primary Examiner(s): Szmal, Brian
• Assistant Examiner(s): Kidanemariam, Mehari
• Application Number:
  US12/238,433
• Publication Number:
  US 20090082830A1
• Time in Patent Office: 1,692 Days
• Field of Search: 600/546, 600/545, 600/550, 600/590, 600521-523, 600/421, 600/449, 600/459, 600/462, 600/493, 600/300, 600/330, 600/340, 600/339, 600/306, 600/591, 600/553, 600/595, 600/592
• US Class Current: 600/557
• CPC Class Codes: A61B 5/0048 Detecting, measuring or recording by applying mechanical forces or stimuli A61B5/021, A61B5/4884 and A61B9/00 take precedence
• CPC Class Codes: A61B 5/0051 by applying vibrations
• CPC Class Codes: A61B 5/1104 induced by stimuli or drugs; A61B5/1102 takes precedence; investigating medicinal preparations G01N33/15
• CPC Class Codes: A61B 5/1106 to assess neuromuscular blockade, e.g. to estimate depth of anaesthesia
• 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 5/227 of constricting muscles, i.e. sphincters
• CPC Class Codes: A61B 5/391 of genito-urinary organs
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition
• CPC Class Codes: A61B 5/4368 Sexual arousal evaluation
• CPC Class Codes: A61B 5/4393 Sexual arousal or erectile dysfunction evaluation, e.g. tumescence evaluation
• CPC Class Codes: A61B 5/4519 Muscles A61B5/389, A61B5/224 take precedence

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 non-surgically implantable method for measuring a bulbocavernosus reflex, comprising:

a probe a patient contacting portion configured for being brought into contact with a predetermined body area of a patient with sufficient force for inducing, via a mechanical stimulation of the predetermined body area from the force, a reflex of bulbocavernosus muscle, said probe comprising;

(i) a housing with a bore there through, said housing containing a piezoelectric disk, said disk electrically connected to an amplifier and activated by a power source;

(iii) a patient contacting portion comprises stimulus plunger having first and second ends and having a shaft that extends through the bore, said shaft being movable along a longitudinal axis and having an expanded portion that prevents the stimulus plunger from sliding our of an opening in the housing; and

(iii) a compression spring that biases said second end of the stimulus plunger away from contact with the piezoelectric disk;

wherein the patient contacting portion is configured to activate, during the contact, the piezoelectric disk in the probe resulting in a signal response that identifies when an onset of the contact of the predetermined body area occurs;

wherein the signal response is used in identifying a subsequent collection of electrical responses from a plurality of electrodes placed on the patient'"'"'s skin, wherein the collection is indicative of the bulbocavernosus muscle reflex or an absence thereof;

wherein the placed plurality of electrodes are spaced apart from each of;

(i) an additional electrode for supplying a voltage to the patient'"'"'s skin, and (ii) the predetermined body area contacted by the patient contacting portion for inducing the bulbocavernosus muscle reflex;

wherein one or more characteristics of the electrical responses in the collection provide information about the bulbocavernosus muscle reflex;

wherein the characteristics are determined using at least one of (a) through (d) following;

(a) a time delay between the response and the collection are output with information, (b) a time duration for the collection, (c) a value indicative of a magnitude of at least one electrical response of the collection, and (d) a voltage differential between the electrical responses of the collection and a voltage indicative of the bulbocavernosus muscle substantially at rest.

2. The apparatus of claim 1, wherein:

(i) the predetermined body area includes the patient'"'"'s penis or the patient'"'"'s clitoris, (ii) the characteristics are determined using at least most of (a) through (d), and (iii) the apparatus includes a computer for determining the characteristics, and an electronic display for displaying a graphical representation of the collection in graphical relation to a time of the signal response.

3. The apparatus of claim 1, wherein the piezoelectric disk is an electrical switch, wherein the signal response is a result of a mechanical effect of the contact on the piezoelectric disk for changing an electrical property thereof.

4. The apparatus of claim 2, wherein the piezoelectric disk is an electrical switch.

5. The apparatus of claim 4, wherein the force affects an electrical property of the piezoelectric disk.

6. The apparatus of claim 2, wherein for determining the characteristics, a voltage difference between two of the plurality of electrodes is determined.

7. The apparatus of claim 1, wherein the contact is non-invasive.

8. The apparatus of claim 1, wherein the first and second of the electrodes are placed on opposite sides of the patient'"'"'s rectum, and adjacent thereto.

9. The apparatus of claim 1, wherein the patient contacting portion is separable from the remainder of the probe so that the probe is operably reusable when a different patient contacting portion is included therein, wherein each one of the patient contacting portion and the different patient contacting portion includes electronics for use in preventing a reuse of the one patient contacting portion;

wherein the electronics includes a data storage for identifying one of;

(i) if the patient contacting portion therefor has been previously used with the probe for contacting a patient for inducing the bulbocavernosus reflex, and (ii) a length of time the patient contacting portion therefor has been activated by the probe.

10. The apparatus of claim 1, wherein the probe includes a data store for storing data indicative of a history of activation of the probe.

11. The apparatus of claim 10, wherein the data store is included in the patient contacting portion, and the patient contacting portion is movable relative to the housing when the force is applied to the predetermined body area.

12. The apparatus of claim 1, further including an analysis process for activating at least one predictive model, wherein upon receiving the characteristics, the at least one predictive model determines a correspondence between (i) the characteristics, and (ii) one of the following disorders:

a neurological disorder, a sexual disorder, and a voiding dysfunction

wherein the correspondence is determined according to a similarity between the characteristics and previously collected data indicative of the disorders.

13. The apparatus of claim 12, wherein the at least one predictive model determines a similarity between the characteristics, and one or more predetermined associations between a patient diagnosis, and collected information representative of (a) through (d) obtained from other patients.

14. The apparatus of claim 1, wherein the information is representative of (a).

15. The apparatus of claim 1, wherein the information is representative of (b).

16. The apparatus of claim 1, wherein the information is representative of (c).

17. The apparatus of claim 1, wherein the information is representative of (d).

18. The apparatus of claim 1, wherein the vibratory assembly vibrates in a range of 2 Hz to 20 Hz.