Optic function monitoring process and apparatus

• US 8,862,217 B2
• Filed: 07/09/2009
• Issued: 10/14/2014
• Est. Priority Date: 07/09/2008
• Status: Active Grant

• Current Assignee: Donald Bernstein, Laurence M. Mckinley, Ricardo Bravo
• Original Assignee: Donald Bernstein, Laurence M. Mckinley, Ricardo Bravo
• Inventors: McKinley, Laurence M., Bernstein, Donald, Bravo, Ricardo
• Primary Examiner(s): Kahelin, Michael
• Assistant Examiner(s): TOTH, KAREN E
• Application Number:
  US12/500,216
• Publication Number:
  US 20100056935A1
• Time in Patent Office: 1,923 Days
• Field of Search: 600/558
• US Class Current: 600/544
• CPC Class Codes: A61B 3/0008 provided with illuminating means A61B3/117 takes precedence; goniolenses used for laser treatment A61F9/009; illuminating means for optical instruments G02B27/00
• CPC Class Codes: A61B 3/0025 characterised by electronic signal processing, e.g. eye models
• CPC Class Codes: A61B 3/113 for determining or recording eye movement
• CPC Class Codes: A61B 3/1233 for measuring blood flow, e.g. at the retina
• CPC Class Codes: A61B 3/1241 specially adapted for observation of ocular blood flow, e.g. by fluorescein angiography
• CPC Class Codes: A61B 3/16 for measuring intraocular pressure, e.g. tonometers
• CPC Class Codes: A61B 3/18 Arrangement of plural eye-testing or -examining apparatus
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/378 Visual stimuli
• CPC Class Codes: A61B 5/388 Nerve conduction study, e.g. detecting action potential of peripheral nerves
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition
• CPC Class Codes: A61B 5/4047 afferent nerves, i.e. nerves that relay impulses to the central nervous system
• CPC Class Codes: A61B 5/4076 Diagnosing or monitoring particular conditions of the nervous system A61B5/4821, A61B5/4824 take precedence
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61B 5/4821 Determining level or depth of anaesthesia A61B5/1106 takes precedence
• CPC Class Codes: A61B 5/6803 Head-worn items, e.g. helmets, masks, headphones or goggles
• CPC Class Codes: A61B 5/6843 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61B 5/6844 Monitoring or controlling distance between sensor and tissue
• CPC Class Codes: A61B 5/7225 Details of analog processing, e.g. isolation amplifier, gain or sensitivity adjustment, filtering, baseline or drift compensation A61B5/30, A61B5/316 take precedence; transformers for specific applications H01F38/00; amplifiers H03F
• CPC Class Codes: A61B 5/7282 : Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence

Abstract

A method and apparatus for monitoring optic function is provided. The apparatus and method relies on two principle modes of measuring the function of the optic nerve, namely, monitoring VEPs for neural function, and monitoring at least one additional parameter of optic function such as intraocular pressure, blood flow or location of the eye to provide a multi-variable optic function monitor. The method and apparatus is proposed for the use to diagnose and potentially prevent the incidence of POVL and anaesthesia awareness in patients during medical procedures.

Claims

1. A method of monitoring optic function comprising:

providing at least one sensor and at least one visual evoked potential stimulator;

disposing the at least one sensor and at least one visual evoked potential stimulator in stimulating relation with at least one eye of a patient, and the at least one sensor in monitoring relation with the patient;

activating the stimulator to stimulate at least two portions of the at least one eye selected from the group consisting of the optic nerve, optic chiasma and the optic cortex to produce signals, said signals forming a visual evoked potential, the visual evoked potential being characterized by a waveform;

collecting the waveform of the visual evoked potential in the at least one sensor;

providing a data processor in signal communication with the at least one sensor to collect the waveform from the at least one sensor; and

processing the measured waveform in the data processor such that changes in the waveform of the visual evoked potential over time are monitored for an adverse change in optic function to provide a real-time gauge of the health of the optic nerve of the patient, wherein the processing includes an analysis of at least the temporal interval (TL1) between the onset of stimulation (t₀) and the absolute magnitude of the second measured maximum visual evoked potential (EVP2) after stimulation, and at least one aspect of the waveform of EVP2 selected from the group consisting of the vertical distance (P2) between the maximum value of the upslope of EVP2 to the nadir (N3) of the EVP2, the peak first time-derivative of EVP2, the mean slope of EVP2, and combinations thereof.

2. The method of claim 1, wherein the stimulating and monitoring of the function of at least two portions of the eye includes producing a visual evoked potential in the nasal and temporal halves of the optic nerve.

3. The method of claim 1, wherein the stimulating and monitoring the function of the eye includes positioning at least two sensors and two visual evoked potential stimulators proximate to the eye.

4. The method of claim 1, wherein the at least one stimulator is a light emitting diode.

5. The method of claim 1, further comprising providing at least one pressure sensor and disposing said at least one pressure sensor in monitoring relation with the at least one eye for measuring the intraocular pressure of the at least one eye and evaluating the intraocular pressure for an adverse change in optic function of the patient.

6. The method of claim 5, wherein the at least one pressure sensor is a tonometer.

7. The method of claim 1, further comprising providing at least one blood flow sensor and disposing said at least one blow flow sensor in monitoring relation with the at least one eye for measuring one of either the retinal or the optic blood flow within the at least one eye and evaluating the one of either the retinal or optic blood flow for an adverse change in optic function of the patient.

8. The method of claim 7, wherein the blood flow sensor is selected from one of either a near-infrared spectrometer or a laser Doppler velocimeter.

9. The method of claim 1, further comprising placing a location sensor proximate to said eye;

and

monitoring said location sensor to determine the placement of said eye in relation to the eye socket.

10. The method of claim 9, wherein said location sensor further comprises a pressure transducer such that the location of the eye may be adjusted based on an output from the location sensor.

11. The method of claim 1, wherein the adverse change is one of either perioperative vision loss (POVL) or anesthesia awareness.

12. The method of claim 1, wherein the processing includes producing an evaluation number from the waveform of the VEP, said evaluation number being indicative of at least the level of optic function.

13. The method of claim 1, further comprising computing an anesthesia evaluation number from the VEP waveform in accordance with an equation selected from the group consisting of:

P2/TL1, where P2 is the vertical distance between the maximum value of the upslope of a second and largest maximum visual evoked potential (EVP2) measured by the waveform to the nadir (N3) of the EVP2, and TL1 is the temporal interval between the onset of stimulation (t₀) and the absolute magnitude of the second evoked potential (EVP2);

(P2/TL1)ⁿ, wherein n is an exponent between 0.333 and 3;

(P2)^x/(TL1)^y, where P2 is the vertical distance between the maximum value of the upslope of a second and largest maximum visual evoked potential (EVP2) measured by the waveform to the nadir (N3) of the EVP2, and TL1 is the temporal interval between the onset of stimulation (t₀) and the absolute magnitude of the EVP2, and wherein x and v are an exponents between 0.333 and 3;

((P2)^x/(TL1)^y)ⁿ where n is an exponent between 0.333 and 3;

((P2)^x/(TL1)^y)ⁿ where n is an exponent between 0.5 and 2;

(δ

(EVP2)/δ

_max)/TL1, where (EVP2) is a second and largest maximum visual evoked potential, δ

(EVP2)/δ

t_max is the peak forward upslope of EVP2, and TL1 is the temporal interval between the onset of stimulation (t₀) and the absolute magnitude of EVP2;

(δ

(EVP2)/δ

t_max)^x/(TL1)^y, where (EVP2) is a second and largest maximum visual evoked potential, δ

(EVP2)/δ

t_max is the peak forward upslope of EVP2, TL1 is the temporal interval between the onset of stimulation (t₀) and the absolute magnitude of EVP2, and wherein x and y are an exponents between 0.333 and 3;

((δ

(EVP2)/δ

t_max)^x/(TL1)^y)ⁿ where n is an exponent between 0.333 and 3;

(δ

(EVP2)/δ

t_mean)/TL1, where (EVP2) is a second and largest maximum visual evoked potential, δ

(EVP2)/δ

t_mean is the mean sloe of EVP2 and P2, and TL1 is the temporal interval between the onset of stimulation (t₀) and the absolute magnitude of EVP2, and where P2 is the vertical distance between the maximum value of the upslope of a second and largest maximum visual evoked potential (EVP2) measured by the waveform to the nadir (N3) of the EVP2;

(δ

(EVP2)/δ

t_mean)^x/(TL1)^y, where (EVP2) is a second and largest maximum visual evoked potential, (δ

(EVP2)/δ

t_mean is the mean sloe of EVP2 and P2, TL1 is the temporal interval between the onset of stimulation (t₀) and the absolute maqnitude of EVP2, and wherein x and y are an exponents between 0.333 and 3, and where P2 is the vertical distance between the maximum value of the upslope of a second and largest maximum visual evoked potential (EVP2) measured by the waveform to the nadir (N3) of the EVP2;

(δ

(EVP2)/δ

t_mean)^x/(t₁^y/P2^z)^m in (μ

V/ms), where (EVP2) is a second and largest maximum visual evoked potential, δ

(EVP2)/δ

t_mean is the quotient of P2 and the temporal interval occurring between the onset of the upslope of EVP2 and P2, t₁ is the absolute magnitude of EVP2, P2 is the vertical distance between the maximum value of the upslope of a second and largest maximum visual evoked potential (EVP2) measured by the waveform to the nadir (N3) of the EVP2, and wherein x and v are an exponents between 0.333 and 3;

((δ

(EVP2)/δ

t_mean)^x/(t₁^y/P2^z)^m)ⁿ where n is an exponent between 0.333 and 3;

δ

(EVP2)/δ

t_max/t₁/P2 in (μ

V/ms), where(EVP2)is a second and largest maximum visual evoked potential, δ

(EVP2/δ

t_max is the peak forward upslope of EVP2, t₁ is the absolute magnitude of EVP2, and P2 is the vertical distance between the maximum value of the upslope of a second and larqest maximum visual evoked potential (EVP2) measured by the waveform to the nadir (N3) of the EVP2;

δ

(EVP2)/δ

t_max/t₁/P2 in (μ

V/ms), where (EVP2) is a second and largest maximum visual evoked potential, t_max δ

(EVP2)/δ

t_max is the peak forward upslope of EVP2, t₁ is the absolute magnitude of EVP2, P2 is the vertical distance between the maximum value of the upslope of a second and largest maximum visual evoked potential (EVP2) measured by the waveform to the nadir (N3) of the EVP2, and wherein x, y and z are an exponents between 0.333 and 3;

(δ

(EVP2)/δ

t_mean)^x/(t₁^y/P2^z)^m in (μ

V/ms), where (EVP2) is a second and largest maximum visual evoked potential, δ

(EVP2)/δ

t_mean is the mean slope of EVP2 and P2, t₁ is the absolute magnitude of EVP2, P2 is the vertical distance between the maximum value of the upslope of a second and largest maximum visual evoked potential (EVP2) measured by the waveform to the nadir (N3) of the EVP2, and wherein x, y, z and m are an exponents between 0.333 and 3;

((δ

(EVP2)/δ

t_mean)^x(t₁^y/P2^z)^m)ⁿ where n is an exponent between 0.333 and 3;

(δ

(EVP2)/δ

t_max)^x/(t₁^y/P2^z)^m in (μ

V/ms), where n (EVP2) is a second and largest maximum visual evoked potential δ

(EVP2)/δ

t_max is the peak forward upslope of EVP2, t₁ is the absolute magnitude of EVP2), P2 is the vertical distance between the maximum value of the upslope of a second and largest maximum visual evoked potential (EVP2) measured by the waveform to the nadir (N3) of the EVP2, and wherein x, y, z and m are an exponents between 0.333 and 3; and

((δ

(EVP2)/δ

t_max)^x/(t₁^y/P2^z)^m)ⁿ where n is an exponent between 0.333 and 3.

14. The method as in claim 13, further comprising computing a dimensionless anesthesia evaluation index, obtained by dividing the anesthesia evaluation number by a static control value defined as the value of the anesthesia evaluation number measured at a time before the induction of anesthesia.

15. The method of claim 1, further comprising computing two anesthesia evaluation numbers from the VEP waveform in accordance with the equation, (P2)^x/(TL1)^y, where P2 is the vertical distance between the maximum value of the upslope of a second and largest maximum visual evoked potential (EVP2) measured by the waveform to the nadir (N3) of the EVP2, and TL1 is the temporal interval between the onset of stimulation (t₀) and the absolute magnitude of the EVP2, and wherein x and y are an exponents between 0.333 and 3;

computing a third anesthesia evaluation number according to the equation ((P2)^x/(TL1)^y)ⁿ where n is an exponent between 0.333 and 3; and

further comprising computing a dimensionless anesthesia evaluation index obtained by dividing the third anesthesia evaluation number by a static control value defined as the value of the third anesthesia evaluation number measured at a time before the induction of anesthesia.

16. The method as in one of claim 13, further comprising calibrating the anesthesia evaluation number by measuring the anesthesia evaluation number prior to the administration of an anesthesia.