Surgery – Diagnostic testing – Structure of body-contacting electrode or electrode inserted...
Reexamination Certificate
1998-06-29
2001-05-15
Dvorak, Linda C. M. (Department: 3739)
Surgery
Diagnostic testing
Structure of body-contacting electrode or electrode inserted...
C600S546000, C600S554000, C600S557000, C607S047000, C607S062000, C607S139000
Reexamination Certificate
active
06233472
ABSTRACT:
FIELD OF THE INVENTION
The following invention relates to devices which are used in the field of assessment of consciousness of a person, electromyography, and specifically for measuring the clinical condition of a patient under anesthesia by noting the muscular activity related to facial micro-expressions. This invention is also concerned with a method for determining the adequacy of anesthesia, and the level of paralysis therefrom, during surgery and otherwise through stimulating and measuring the muscular activity of the face. This method and this device allows for quick application of stimulating and multiple sensing means for the different muscles in the face.
INCORPORATION OF SPECIFICATION BY REFERENCE
U.S. Pat. No. 5,195,531 describing an anesthesia adequacy monitor and method, was issued to Henry L. Bennett on March 23, 1993. The disclosure of U.S. Pat. No. 5,195,531 (the “First Bennett Patent”) is specifically incorporated herein by reference.
BACKGROUND OF THE INVENTION
In the past, when the face was stimulated and monitored for facial expressions to indicate the depth of anesthesia, individual electrodes were often applied one at a time. The time required to apply individual electrodes was significant, especially when a full surgical operating crew was standing by or there were patients waiting for their turn in the surgery operating theater.
Additionally, when individual electrodes are used, there was the problem of multiple wires leading from the patient to any type of signal receiving device. It was, of course, important to keep track of which wire was connected to which electrode and where that electrode was placed on the face or other part of the patient's body. It was also important that the wires be hooked into the proper receptacle in any type of monitor. Again, valuable time was taken up in order to assure that the wires and electrodes had been properly placed on the patient and into the monitoring device.
In addition, as noted in the Background Of The Invention of the First Bennett Patent, there has been no expeditious method of monitoring the depth of unconsciousness of a patient under anesthesia. In this regard, anesthesia often seeks to provide a variety of results for the patient during surgery and invasive medical procedures. One such result is to provide oblivion through a state of unconsciousness. Another is to provide freedom from pain registration, conscious or unconscious. In seeking to achieve oblivion for the patient, however, the anesthesia can and often does paralyze muscle groups in varying degrees from partial paralysis to total paralysis.
In addition to the issues explained about the prior devices and methods explained in the First Bennett Patent, the surface electromyogram devices identified therein did not sense a sufficient number of facial muscle groups to procure sufficient response data. Similarly, they also have not provided a mechanism to readily assess the level of paralysis (neuro muscular blockade) of facial muscle groups brought about by anesthesia and to then quickly process this type of information in order to yield more accurate indicators of the depth of paralysis of the person, if any, and also of the depth of unconsciousness of a person in view of paralysis, if any.
As also shown in the prior art cited in the First Bennett Patent and in this specification, there are many electromyogram devices in the prior art for monitoring neuro muscular blockade during anesthesia (“NMBMs”). Another example of an NMBM is the Datex-Engstrom NeuroMuscular Transmission Module, M-NMT. This NMBM utilizes two stimulator electrodes secured to a patient's wrist, a return electrode secured to the patient's finger, and a sensor mounted on the patient's thumb to monitor the hypothenar muscle stimulated by the ulnar nerve. This NMBM is not designed for easily and reliably mounting on and sensing facial muscle groups and does not include any means of receiving output from the sensors, calculating and reporting consciousness indicators based on the output from the sensors, and also quickly and automatically processing neuro muscular blockade information to more accurately and automatically measure the depth of paralysis, if any, and the depth of consciousness of a person.
The following disclosures reflect the state of the art of which applicant is aware and is included herewith to discharge applicant's acknowledged duty to disclose relevant information available. It is stipulated, however, that none of these references teach singly nor render obvious when considered in any conceivable combination the nexus of the instant invention as disclosed in greater detail hereinafter and as particularly claimed.
U.S. PAT. NO.
ISSUE DATE
INVENTOR
2,902,030
September 1, 1959
Kennedy et al.
3,572,322
March 23, 1971
Wade
3,774,593
November 27, 1973
Hakata et al.
3,946,723
March 30, 1976
Servos
4,082,087
April 4, 1978
Howson
4,353,372
October 12, 1982
Ayer
4,448,203
May 15, 1984
Williamson et al.
4,583,549
April 22, 1986
Manoli
4,763,660
August 16, 1988
Kroll, et al.
5,195,531
March 23, 1993
Bennett
FOREIGN PATENT DOCUMENTS
GB2, 113,846
August 10, 1983
Rantala, B., et al.
OTHER PRIOR ART
Including Author, Title, Date, Pertinent Pages. Etc.
Ritchie, G., et al., A Microcomputer Based Controller for Neuromuscular Block During Surgery,
Annals of Biomed. Eng.
13:3-15 (1985)
Edmonds, H. L., et al., Quantitative Surface Electromyography in Anesthesia and Critical Care,
Int. J. Clin. Monitoring and Computing
3:135-145 (1986)
Chang, T., et al., Continuous Electromyography for Monitoring Depth of Anesthesia,
Anesth Analg.
67:521-5 (1988)
Edmonds, H. L., et al., Objective Assessment of Opioid Action by Facial Muscle Surface Electromyography (SEMG),
Prog. Neuro-Psychopharmacol. & Biol. Psychiat.
12:727-738 (1988)
Paloheimo, et al.: Comparison of Upper Facial and Hypothenar Block,
J. of Clinical Monitoring
4:256-260 (1988)
Tammisto, T., et al., Assessment of Neuromuscular Block: Comparison of Three Clinical Methods and Evoked Electromyography,
Eur. J. Anaesthesiol.
5:1-8 (1988)
Nielsen, T. A., et al., Effects of Dream Reflection on Waking Affect: Awareness of Feelings, Rorschach Movement, and Facial EMG,
Sleep
12 (3):277-286 (1989)
Paloheimo, M., Assessment of Anaesthetic Adequacy with Upper Facial and Abdominal Wall EMG,
Eur. J. Anaesthiol.
6:111-119 (1989)
Schwilden, H., Surveillance et Conduite de l'Anesthesie a l'Aide de l'EEG, des Potentiels Evoques, de l'EMG du Muscle Frontal ou du Monitorage de la Contractilite Oesophagienne,
Ann. Fr. Anesth. Reanim.
8:162-166 (1989)
McAdams, E. T., et al., Designing Biosignal Monitoring Sensors,
Sensors, :
25-27 (1994)
Datex-Engstrom, NeuroMuscular Transmission Module Product Description, Internet Web Page (1998) (reporting prior art NMBM device by Datex-Engstrom discussed above)
The Kennedy et al. patent, U.S. Pat. No. 2,902,030, described the electrodes at the bottom of column 3 as “small discs of sponge rubber wetted with saline solution or small metal disc attached to the surface of skin with adhesive tape.” A good contact was provided by application of a small amount of “electrode jelly” between the skin and a metal electrode. The electrodes were applied in the supra orbital region of the head of a person. No specific facial muscle group was mentioned.
The Servos patent, U.S. Pat. No. 3,946,723, disclosed attaching a pair of electrodes to opposite temples of a patient for detecting horizontal eyeball movements using the cornea-retina potential. A second pair of electrodes attached to brow and cheek bones detected, at a different time, the cornea-retina potential showing vertical eye movement. Finally, a ground electrode was attached elsewhere on the face. The data gained was used to diagnose the presence of nystagmus as an indicator of vestibular disorders. A patient under anesthesia may not have had reliable eye movements or even any purposeful eye movements at all.
The patent Williamson, et al., U.S. Pat. No. 4,448,203 taught the use of a device for sensing electrica
Bennett Henry L.
Cram Jeffrey R.
Simon Bruce Jay
Dvorak Linda C. M.
Kreten Bernhard
Patient Comfort, L.L.C.
Ruddy David M.
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