OBTAINING MEASUREMENTS OF MUSCLE REFLEXES FOR DIAGNOSIS OF PATIENT SYMPTOMS

• US 20090082830A1
• Filed: 09/25/2008
• Published: 03/26/2009
• Est. Priority Date: 09/25/2007
• Status: Active Grant

• Current Assignee: Uroval, Inc.
• Original Assignee: First Choice for Continence Inc.
• Inventors: Finstrom McPhee, Karen Louise, Gack, Timothy Martin, Johnson, Gregory Ray, Folkerts, Debra Janette
• Granted Patent: US 8,439,845 B2
• Time in Patent Office: Days
• US Class Current: 607/48
• 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. An apparatus for measuring a patient reflex, comprising:

a probe having an electromechanical assembly with a patient contacting portion, and a housing operatively attached to the assembly for contacting the patient contacting portion to a predetermined body area of a patient;

wherein the patient contacting portion is configured for providing a mechanical response when contacting the predetermined body area;

wherein the mechanical response activates a sensor for the probe for generating an electrical response indicative of the contact;

wherein the electrical response is used to identify a collection of electrical responses from a plurality of electrodes placed on the patient'"'"'s skin, the collection being indicative of a patient reflex;

wherein information representative of at least one of (a) through (d) following is determined;

(a) a time delay between the mechanical response and the collection, (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) an attenuation in the electrical responses of the collection.

2. The apparatus of claim 1, wherein the body area includes the patient'"'"'s penis or the patient'"'"'s clitoris.

3. The apparatus of claim 2, wherein the patient reflex includes a bulbocavernosus reflex.

4. The apparatus of claim 3, wherein the assembly includes a piezoelectric disk for generating a vibration communicated to the patient contacting portion.

5. The apparatus of claim 2, wherein the sensor includes the piezoelectric disk.

6. The apparatus of claim 5, wherein the mechanical response affects an electrical property of the piezoelectric disk.

7. The apparatus of claim 2, wherein the probe is handheld.

8. The apparatus of claim 1, wherein the assembly includes an electromechanical element, and a transfer mechanism for contacting the electromechanical element and thereby transferring mechanical movement from the tip to the electromechanical element, wherein the transfer mechanism is forced into contact with the electromechanical element when the patient contacting portion comes into contact with the body area.

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

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

11. The apparatus of claim 1, wherein the contacting portion extends through an opening in the housing, wherein the contacting portion is movable so that when the contacting portion contacts the body area, the contacting portion moves to cause a transfer of vibrations from an electromechanical vibratory element of the assembly to the body area.

12. The apparatus of claim 1, wherein the probe includes a switch for electrically activating the probe, wherein the switch cannot electrically deactivate the probe.

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

14. The apparatus of claim 13, wherein the data store is included in the patient contacting portion.

15. The apparatus of claim 1, further including an analysis process for activating at least one predictive model, wherein upon receiving data derived from the collection, the model uses the data to determine the BCR response of the patient.

16. The apparatus of claim 15, wherein the at least one predictive model uses an association between a patient diagnosis, and at least collected information representative of (a) through (d).

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

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

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

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

21. The apparatus of claim 1, wherein the vibratory assembly vibrates in a range of 410 Hz to 20100 Hz.

22. A method of measuring a patient reflex, comprising:

providing a probe having an electromechanical assembly with a patient contacting portion, and a housing operatively attached to the assembly for positioning contacting the patient contacting portion to a predetermined body area of a patient;

wherein the mechanical response activates a sensor for the probe for generating an electrical response indicative of the contact;

wherein the electrical response is used to identify a collection of electrical responses from a plurality of electrodes placed on the patient'"'"'s skin, the collection being indicative of a patient reflex;

wherein information representative of at least one of (a) through (d) following is determined;

(a) a time delay between the mechanical response and the collection, (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) an attenuation in the electrical responses of the collection.

23. A method of manufacturing a probe for measuring a bulbocavernosus reflex, comprising:

aligning an electromechanical member for detecting a pressure, with a transfer mechanism for transferring mechanical pressure from a patient contacting portion of the transfer mechanism when a force is applied to the patient contacting portion, wherein a housing surrounds at least a portion of transfer mechanism;

providing a biasing component for biasing at least a portion of the transfer mechanism so as to prevent the pressure from being transmitted to the electromechanical member;

wherein the biasing of the biasing component is overcome when the force is applied to the patient contacting portion;

providing a conductor for transmitting, from the electromechanical member a signal indicative of the transfer of the pressure from the patient contacting portion;

wherein when the probe is positioned so that a contact of the patient contacting portion and a predetermined body area of a patient occurs, the contact results in a pressure being applied to the electromechanical member;

wherein the signal is used to identify a collection of electrical responses from a plurality of electrodes placed on the patient'"'"'s skin, the collection being indicative of the bulbocavernosus reflex; and

wherein information representative of at least one of (a) through (d) following is determined;

(a) a time delay between the response and the collection, (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) an attenuation in the electrical responses of the collection.

24. The method of claim 23, wherein the electromechanical member includes a piezoelectric component.

31. The method of claim 24, further including a step of determining each of the characteristics (a) through (d).

25. A method for measuring a bulbocavernosus reflex, comprising:

providing a probe having an electromechanical assembly and a housing operatively attached to the assembly for positioning a patient contacting portion of the electromechanical assembly;

wherein when the probe is positioned so that a contact of the patient contacting portion and a predetermined patient genital area occurs, the contact results in pressure from the electromechanical assembly being transmitted to the genital area for inducing a bulbocavernosus reflex;

activating a sensor for the probe for generating an electromagnetic response indicative of the contact;

using the response to identify a collection of electrical responses from a plurality of electrodes placed on the patient'"'"'s skin adjacent to the genital area, the collection being indicative of the bulbocavernosus reflex;

outputting information representative of at least one of characteristics (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) an attenuation in the electrical responses of the collection; and

storing in the probe data indicative of a history of an activation of the probe.

26. The method of claim 25, wherein the contact causes the patient contacting portion to move relative to the housing.

27. The method of claim 25, further including a step of initiating the activation of the electromechanical assembly by an operator performing a predetermined one or more tasks within a predetermined time period;

wherein after the predetermined time period, a repetition of the tasks does not again operably activate the electromechanical assembly.

28. The method of claim 27, wherein the repetition of the tasks does not provide electrical power due to a battery failure.

29. The method of claim 25, further including a step of activating at least one computational model for diagnosing the patient, wherein the model uses at least one of the characteristics in combination with an identification of patient symptom for determining a diagnosis of the patient.

30. The method of claim 29, wherein the model uses a plurality of the characteristics (a) through (d).