WO2022208120A1 - Système de surveillance non invasive de niveaux de nociception et de conscience de patients sédatés et anesthésiés - Google Patents

Système de surveillance non invasive de niveaux de nociception et de conscience de patients sédatés et anesthésiés Download PDF

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Publication number
WO2022208120A1
WO2022208120A1 PCT/IB2021/000174 IB2021000174W WO2022208120A1 WO 2022208120 A1 WO2022208120 A1 WO 2022208120A1 IB 2021000174 W IB2021000174 W IB 2021000174W WO 2022208120 A1 WO2022208120 A1 WO 2022208120A1
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Prior art keywords
patient
cuff
response
stimulation
muscle
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PCT/IB2021/000174
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English (en)
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Cristina RUIZ NOLASCO
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Ruiz Nolasco Cristina
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Priority to ES202390145A priority Critical patent/ES2957744R1/es
Priority to PCT/IB2021/000174 priority patent/WO2022208120A1/fr
Publication of WO2022208120A1 publication Critical patent/WO2022208120A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4821—Determining level or depth of anaesthesia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
    • A61B5/1104—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb induced by stimuli or drugs
    • A61B5/1106—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb induced by stimuli or drugs to assess neuromuscular blockade, e.g. to estimate depth of anaesthesia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2505/00—Evaluating, monitoring or diagnosing in the context of a particular type of medical care
    • A61B2505/05—Surgical care
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/389—Electromyography [EMG]

Definitions

  • the present disclosure relates to various systems for monitoring the nociception and consciousness level of a person.
  • the application field can range from users carrying out an activity of the daily life that requires attention (e.g. driving a car) up to partially immobilized patients in critical care passing along a continuum from minimal to deep sedation and eventually to general anesthesia.
  • muscular response signals to a verbal or electrical stimulus is proposed as a manner of user or patient feedback for the assessment of consciousness and nociception levels.
  • a patient for nociception and consciousness level -assessment means to communicate with a patient for nociception and consciousness level -assessment according to two types of request assembly components, (1) is the so called Audio Request Module ARM and/or (2) the Muscle Current Stimulation Request Module MCS; These are two components that are present in some of the systems , that serve the purpose of sending commands or stimuli to the patient; On the other side, when the patient reacts to these commands or stimuli, we use a component called the Muscle Movement Detection (MMD) response module.
  • MMD Muscle Movement Detection
  • the present disclosure also relates to the way that each component is implemented;
  • the MMD module operates with a standard NIBP (Non-lnvasive Blood Pressure) Cuff ;
  • the MMD detects response from the patient, which can be caused by the MCS Module.
  • the MCS incorporates in the cuff two electro-stimulation electrodes embedded for stimulating a muscle of a patient; It is the so called “Modified non-invasive Blood Pressure Cuff “ (M-BP Cuff), in which the cuff has hybrid air-signal connectors and a sensor can measure the pressure inside the cuff, for detecting small changes of volume underneath the cuff.
  • M-BP Cuff Modified non-invasive Blood Pressure Cuff
  • the data is correlated with body limb movements;
  • the present disclosure still further relates to another means able to perform stimulation of the patient by means of an Audio Request Module (ARM) which sends voice personalized commands.
  • ARM Audio Request Module
  • All systems are electronically isolated and contain different modules -as will be explained- which can be connected either by wire or wirelessly , i.e. the sensor or actuators with the Console.
  • the air cuff can be used optionally with a sterilized cover to isolate the cuff from the patient ' s limb.
  • the pressure cuff is of the NIBP type, except for the stimulation electrodes, plus additional circuits for cuff authentication and data tracking; It has been designed also to measure BP in a non-invasive way (NIBP), and has different sizes to be arranged around a limb of a patient.
  • NIBP non-invasive way
  • a person can pass along a continuum from no sedation or minimal to deep sedation and eventually to general anesthesia. As a patient passes along this continuum, depression of physiological systems occurs which require intervention to avoid adverse outcomes.
  • the present disclosure relates to various systems for assessing the nociception and the different consciousness levels ranging from “sleepy users” up to sedated or even further up to deeply anesthetized patients.
  • sleepiness or sedation it is not expected that the patient loses consciousness, so he/she can react to voice commands.
  • the patient may lose consciousness, but react to other stimuli such as electrical stimulation.
  • analgesia the patient may react to voice commands, or to electrical stimulus.
  • the intention to move the muscle underneath the cuff should generate detectable IP signals that can allow communication from the patient to the surgical team in order to determine awareness and/or nociception levels.
  • IP signals that can allow communication from the patient to the surgical team in order to determine awareness and/or nociception levels.
  • the mere movement of the patient's finger in the absence of a monitoring device with the cuff in the Arm or ankle is likely to go unnoticed by the surgical team during an operation since (1) the surgical team is likely to be focusing on the surgery and not be monitoring the patient's finger and (2) the patient may be substantially immobilized and have no visible movement.
  • the invention is more sensitive than human vision and can detect such movement intentions.
  • the system is called “SDL” and measures the level of awareness of a person carrying activities of the daily life such as driving a car under no drug infusion or can measure the level of sedated patient subject to hypnotics drugs infusion;
  • SDL measures the level of awareness of a person carrying activities of the daily life such as driving a car under no drug infusion or can measure the level of sedated patient subject to hypnotics drugs infusion;
  • This same system can be used in sedated patients in I.C.U, so that the “S” in SDL stands for “sleepy” or “sedated”.
  • the system measures “anesthesia levels” (ADL) of a patient by means of infusing hypnotics drugs; It can be modified to measure “Deep Anesthesia levels” (DADL).
  • ADL anesthesia levels
  • the system allows measures of the level of nociception of a patient by means of infusing analgesic drugs
  • the system measures simultaneously the level of nociception and sedation of a partially anesthetized patient by means of infusing analgesia and hypnotics drugs, but without infusing paralytic drugs; In a fifth embodiment of the invention, the system measures the level of nociception and sedation of a partially anesthetized or relaxed patient by means of infusing hypnotics and analgesia, but also infusing paralytic drugs.
  • This patent is related to the technology that can be used in order to detect state of awareness in people or consciousness and nociception levels in patients subject to narcotic or analgesic drug infusion.
  • Patients undergoing major surgical procedures are typically anesthetized.
  • General anesthesia has any or all of the three main purposes to achieve using three corresponding types of drugs. These goals are analgesia, unconsciousness, and muscle relaxation.
  • An analgesic reduces or eliminates sensations of pain so that patients do not endure the physical pain of surgery (e.g., having their skin cut). This effect of reducing pain is also known as antinociception.
  • a hypnotic sedative reduces or eliminates consciousness so that patients do not witness or otherwise sense the surgical procedure while undergoing it, which most people would find rather disturbing.
  • a muscle relaxant also called a paralytic
  • a muscle relaxant is used to partially or fully immobilize a patient, so that he/she cannot intentionally or unintentionally move during surgery and thereby injure himself or herself and/or members of the surgical team.
  • Suppressing the autonomous nervous system also provides additional benefits, such as mitigating potentially harmful automatic responses of the body to the surgery.
  • an anesthetic Since each patient is unique, no single dosage of an anesthetic is likely to be appropriate for all patients. In addition, providing an under- or over-dosage of an anesthetic is highly undesirable. An under-dosage fails to achieve the desired anesthetic effect. An over-dosage wastes potentially expensive anesthetic, prolongs recovery, and can harm the patient. I n critical care such as the operating room (O. R), in order to ensure proper dispensation of anesthetics during surgery, a surgical team includes an anesthesiologist who administers the various anesthetics and monitors the patient's vital signs (e.g., pulse, blood pressure, heart activity, oxygen saturation and respiration) in order to determine and adjust dosages as necessary during the surgery. Nevertheless, under and over- dosages of anesthetics do occasionally occur.
  • O. R operating room
  • One first case is for people ' s awareness level while performing daily actions that demand attention. This is the case of e.g. a driver that must be warned if he becomes sleepy.
  • I.C.U. Intensive Care Unit
  • the central nervous system As a whole, including the cortical and subcortical brain areas and the spinal cord.
  • the conscious processes are integrated at the level of the cortical network, while the nonconscious processes such as nociception or implicit memory, which are of particular interest under anesthesia, are integrated in the subcortical areas.
  • the subcortical structures we can mention the limbic system involved in emotional modulation; the thalamus which receives sensory information and relays them to the cortex.
  • the spinal cord is also a major target for the anesthetic agents, mainly responsible for the motor response to nociception [1,2]
  • anesthetic agents induce in a dose dependent manner a loss of consciousness (cortical inhibition), followed by a loss of motor response to nociceptive stimulation (spinal inhibition), and lastly a loss of autonomic response to nociception (subcortical inhibition) [1,3]
  • Nociceptive information is transmitted through the spinal cord to the thalamus and then to the cortex.
  • a number of responses are triggered: firstly, the motor response; then, the cardiovascular autonomic response with a possible emotional component; and, finally, a cognitive response.
  • Anesthetics induce inhibition of these different processes, and this inhibition depends on both the agent and the dose. If the stimulus is greater than expected or the analgesia insufficient, a partial activation of the brain networks may occur with firstly the reappearance of autonomic responses (pupillary or cardiovascular reactivity), then a motor response is possible, and finally a cortical activation may be observed.
  • the assessment of nociception is based on monitoring of these possible responses, especially the autonomic responses which are, up to now, the most investigated.
  • Sedation has become a very popular technique to help patients tolerate unpleasant medical procedures. Sedation has been termed as the actor process of calming. The desired components of this are anxiolysis, amnesia and/or altered conscious level [1,2] Analgesia may also be required if the procedure is painful [3,4] Relaxants are not used.
  • conscious sedation is defined as a technique in which the use of a drug or drugs produces a state of depression of the central nervous system enabling treatment to be carried out, but during which verbal contact with the patient is maintained throughout the period of sedation.
  • the drugs and techniques used “should carry a margin of safety wide enough to render loss of consciousness unlikely” .
  • the end point is clearly defined and wide margins of safety stipulated.
  • the airway is normally unaffected and spontaneous ventilation adequate.
  • the desired target for non-anesthesiologists is always conscious sedation, which relies on the maintenance of verbal contact.
  • Moderate sedation is roughly akin to conscious sedation: it describes a state where there is a purposeful response to verbal commands, either alone, or accompanied by light tactile stimulation. No airway intervention is required, spontaneous ventilation is adequate, and cardiovascular function is usually maintained.
  • the ASA [1,2] makes great emphasis that this is a continuum from minimal to deep sedation and eventually to general anesthesia. As a patient passes along this continuum, depression of physiological systems occurs which require intervention to avoid adverse outcomes. The competency required increases, as does the depth of sedation. The unpredictability of individual patient response means a sedationist may inadvertently take a patient to a level of sedation greater than that intended.
  • anesthesia awareness In a small fraction of surgeries, a patient regains consciousness in the middle of surgery while still anesthetized. This occurrence is known as anesthesia awareness or intraoperative awareness. In an episode of anesthesia awareness, the patient is conscious while being operated on but, because he or she is immobilized, the patient cannot communicate with the surgical team and alert it to this unfortunate circumstance. Regardless of whether or not the patient endures physical pain during such an episode (e.g., if the patient received insufficient analgesic), the patient may suffer psychological trauma from the experience of awaking help- less, immobile, exposed, cut open, and unable to communicate while continuing to be operated on and ignored by the surgical team. The trauma may cause nightmares and/or post- traumatic stress disorder. Even if the patient does not later consciously remember the experience, subconscious trauma may persist.
  • Providing systems to allow an anesthetized, but aware patient to communicate with the surgical team may significantly reduce the trauma of such an event.
  • Communicating with the surgical team by, for example, answering questions through manipulation of his or her own mental state in ways that are neurologically detectable, allows an anesthetized, but aware patient to thereby demonstrate awareness and also provide meaningful information to the surgical team.
  • the Electroencephalogram gives mainly information about cortical inhibition and loss of consciousness.
  • EEG Electroencephalogram
  • pain causes EEG activation in the deeply asleep patient, similar to a startle reaction, with " decrease in slow delta and augmentation of fast alpha and beta activity. This depends on the type of stimulus and on the degree of pain (articular > muscular > cutaneous) [48]
  • the same response is observed, similar to a startle reaction, and is diminished by increasing the depth of anesthesia or by increasing the dose of analgesic agent.
  • This activation of rapid frequencies in response to pain is the basis of the decision algorithms that generate a higher BIS score and indicate a lack of analgesia.
  • CVI composite variability index
  • the EEG-derived parameters can improve our ability to detect consciousness or unconsciousness.
  • the probability of movement in response to a noxious stimulus seems to be much more difficult to assess because it is under the control of brain structures not monitored by the EEG.
  • a simple (and old) way to assess the nociceptive response is to look at the motor response to a painful stimulus; however, we know that the motor response may have disappeared while the autonomic response, including cardiovascular response, persists.
  • Tunstall's isolated forearm technique (I FT) [1] This is a remarkably simple, inexpensive and obvious way to identify consciousness in an otherwise paralyzed patient where neuromuscular blockade is being used during intended general anesthesia.
  • I FT Tunstall's isolated forearm technique
  • a sphygmomanometer cuff is used as a pneumatic tourniquet. It should be applied to the forearm (or below the knee in the case of a leg) and inflated to around 200 mmHg or at least 10 mmHg above the patient's systolic blood pressure.
  • a protective pad of cotton wool should also be placed between the tourniquet and the skin.
  • the tourniquet is applied and the forelimb isolated just before muscle relaxant injection, thus preserving the potential for movement in the forelimb and hand/foot. It is also important to use an NMT monitor (of any kind) with nerve stimulator to allow for periodic monitoring of the presence of motor function of the isolated limb: stimulator electrodes should be placed immediately distal to the tourniquet on the ventral surface of the forelimb, with the ground electrode located near to the antecubital fossa [or knee] A digital audio recorder and headphones are then used to present the instruction "[patient's first name], if you can hear my voice, open and close the fingers of your right/left hand [or move the big toe on your right/left foot]". Typically, the message is presented once every minute during the GA (General Anesthesia).
  • the tourniquet should not be applied for more than 20 min continuously, since after this time typically a functional ischaemia and nerve block occurs, rendering the limb effectively immobile. However, the tourniquet can be released after this period, the blood supply to the limb refreshed for a few minutes, and if further paralysis is required, the tourniquet can be re inflated and more muscle relaxant administered. Provided a non-depolarizing modern muscle relaxant is employed, the limb will continue to be potentially mobile, despite the period of blood flow cessation. This cycle can be repeated for surgeries lasting several hours.
  • I FT involves tying a tourniquet around one arm of the patient before administering the muscle paralytic so that (i) the paralytic does not affect that arm and (ii) that arm remains free to move at the patient's command. Subsequently, during surgery, if the patient regains consciousness, then the patient can move that arm to alert the surgical team to the situation.
  • Use of the tourniquet for even a relatively short length of time can cause tissue damage.
  • using IFT can interfere with regular surgical procedures, such as placement of intravenous (IVs) feeds in the arm.
  • IVs intravenous
  • having a patient suddenly flail his or her arm in the middle of surgery may startle the surgical team and cause surgical mishaps and/or injuries. As a result, IFT is generally limited to use in research studies.
  • EEG electro-encephalogram
  • the EEG changes according to the level of anesthesia.
  • the rapidity of change of consciousness is a major problem because usually an EEG monitor reacts too slowly to be of use. Often the EEG can do no more than confirm the observation that a patient has changed their conscious level.
  • TCI target-controlled infusion
  • a patient may become deeply sedated before the EEG can detect it.
  • a procedure is undertaken on deeply sedated patients, they could awaken before the EEG changes.
  • the EEG is not useful in either situation. In practical terms, therefore, the EEG is not useful for rapid changes in consciousness: propofol sedation is likely to be in this category. Studies have shown a relationship between EEG and conscious level, but there is considerable variation and the association is loose and unreliable.
  • the emerging clinical devices include those which assess peripheral sympathetic response (skin conductance ), cardiac and vascular sympathetic response (surgical pleth index), para-sympathetic cardiac response (analgesia/nociception index), and finally pupillometry which is based on the assessment of the pupillary reflex dilatation (PRD) induced by nociceptive stimuli.
  • PRD pupillary reflex dilatation
  • Anesthesia results from several inhibitory processes, which interact to lead to loss of consciousness, amnesia, immobility, and analgesia.
  • the anesthetic agents act on the whole brain and the cortical and subcortical areas according to their receptor targets.
  • the conscious processes are rather integrated at the level of the cortical neuronal network, while the nonconscious processes such as nociception or implicit memory require subcortical processing.
  • a reliable and meaningful monitor of depth of anesthesia should provide assessment of these different processes.
  • EEG monitoring which gives mainly information on cortical anesthetic effects, it would be relevant to also have feedback on subcortical activity allowing an assessment of nociception.
  • skin conductance may provide a noninvasive and quick assessment of sympathetic activation induced by emotional stress or nociception, in children, and even in neonates, as well as adults. Skin conductance measured in healthy subjects may provide a useful parametric prediction of pain for many experimental settings .
  • the activation of the peripheral sympathetic nervous system induces a distal vasoconstriction.
  • the degree of vasoconstriction is determined by the intensity of the sympathetic stimulation.
  • the photoplethysmographic monitor intends to quantify this distal vasoconstriction and thus to evaluate the peripheral sympathetic nervous activity.
  • the photoplethysmographic pulse wave amplitude (PPGA) inversely correlated to the intensity of sympathetic activation [58]
  • This noninvasive monitor is routinely used in anesthesia because the digital absorption of light also provides vital information about the patient's arterial blood oxygenation (Sp02).
  • Sp02 arterial blood oxygenation
  • the variability of the beat-to -beat amplitude of the plethysmographic signal is often masked by the auto-scaling processes of the monitor.
  • the autonomic response lo noxious stimulation can be investigated at the cardiac level, by studying heart rate variability.
  • heart rate variability results from sympathetic and parasympathetic modulation of the sinus node.
  • This autonomic equilibrium is classically called the sympathovagal balance. Noxious stimulations induce changes in this balance with a shift toward the sympathetic activity associated with a decrease of the parasympathetic influence.
  • the analgesia/nociception index was designed to give an online index calculated from the ECG signal, providing a quantification of the respiratory variability of heart rate. This index is supposed to reflect the cardiac parasympathetic activity and thus to decrease in response to a nociceptive stimulation under general anesthesia .
  • the main advantage of this monitor is its usability. If the concept is physiologically attractive, its reliability under different anesthetic agents and conditions interacting with the autonomic nervous system activity should be investigated. Indeed, parasympathetic activity could be decreased by stress including nociceptive stress, anxiety, and all the factors or drugs which are known to increase the sympathetic activity. Consequently, ANI may not be considered as a specific and robust measure for assessment of pain intensity .
  • the autonomic response to nociception may be investigated at the level of the pupil. Measurement of the pupillary diameter changes in response to noxious stimulus seems to be a reliable parameter to assess specifically the analgesia/nociception balance in children as well as in adults. This measurement can be performed in routine practice by using a pupillometer which allows intermittent monitoring of the pupil size. Compared to the previously described devices, the pupillometer probably provides more accurate and specific information however its ergonomics may be considered as less simple, especially in infants. There are some references of patents related to nociception technology [11-14] Innovative combination of techniques used in this patent
  • the current invention relates to various systems for implementing a nociception and consciousness Level Detection system For these purposes, it is required means to communicate with a person for nociception and consciousness-assessment according to two types of request assembly components: 1) what is called the Audio Request Module ARM or Muscular Current Stimulation Request Module MCS; These are two components that are present in some of the systems , which serve the purpose of sending commands or stimuli to the patient; On the other side, when the patient reacts to these commands or stimuli, we use a component called the muscle movement detection (MMD) module in the response assembly.
  • MMD muscle movement detection
  • the region between the nerve motor fiber and the muscle cell is the neuromuscular junction.
  • the nerve When the nerve receives a stimulus, it is transmitted to the muscle and produces its contraction.
  • it is usual to block this neuromuscular transmission by using neuromuscular blocking agents.
  • Residual neuromuscular blockade in the postoperative period contributes to significant morbidity and possibly to mortality. The incidence of residual neuromuscular blockade is decreased with the use of neuromuscular monitoring.
  • nerve stimulation allows the clinician to assess the intensity of neuromuscular blockade.
  • the standard monitoring system is based on the electrical stimulation of the motor nerve and the evaluation of an evoked muscle response.
  • the muscular reaction is most often evaluated qualitatively by visual or manual assessment, but it can be quantified more precisely using more sensitive and objective measurement systems.
  • Stimulation of a single nerve fiber follows an all-or-none principle, but, when the whole nerve is stimulated, the response level depends on the number of muscle fibers recruited. It is necessary to apply a supra-maximal stimulus to ensure that all muscle fibers are recruited and derive reliable measurements.
  • a neuromuscular blocking agent By using a neuromuscular blocking agent, the muscle response decreases according to the number of nerve fibers blocked and reflects the extent of neuromuscular blockade.
  • the status of the measurement of muscles is related to neuromuscular block applications, and is evaluated by means of stimulation of a peripheral motor nerve and measurement of the degree of motility of the muscle innervated by said nerve.
  • this type of apparatus might be more sensitive to certain interference or involuntary movements of the patient involves having to immobilize the arm in order to perform a proper registration. For this reason, and the costly equipment, these devices are not very practical for routine use.
  • a standard pressure cuff for a different purpose to muscle relaxation, which is for assessment of consciousness and nociception level of a person in an activity of daily life or in critical care such as O.R. and I.C.U.
  • the stimulation electrodes in the modified (M-BP) cuff are used when movement is not carried out voluntarily, while in all other cases only the cuff with a specific pattern of internal pressure is used to detect the muscle movement.
  • the placement of the cuff in the arm is carried out aligning the stimulation electrodes over the brachial plexus pathway in order to evaluate the muscle evoked response from the changes in cuff pressure generated by the muscular reaction after the electrical stimulus.
  • Other body sites can be used, e.g. the wrist, forearm, or the ankle.
  • the cuff should preferably be placed on the upper arm with the electrodes positioned over the brachial plexus at the middle humeral level as shown in Figure 25. At this position the ulnar and median nerves are mainly stimulated, but other nerves such as the radial and the musculocutaneous can also be stimulated. These innervate various motor muscles of the limb and their responses to stimulation are evaluated through the changes in the cuff pressure, being the main response the one caused by the muscles of the upper arm.
  • the midline of the cuff bladder must be placed over the brachial artery (see Figure 25). There are two marks on the cuff to indicate its midline.
  • the electrodes placed on the patient side must be positioned over the nerve to stimulate. To meet both requirements it is necessary to invert the position of the cuff depending on the arm where it is placed. On the right arm the pneumatic hose should go towards the hand. On the left arm the pneumatic hose should go towards the shoulder.
  • the cuff can also be placed on one of the patient’s legs if, due to the particular conditions of the surgical procedure it cannot be placed on any of the patient’s arms.
  • This condition has been represented in Figure 26 wherein the electrodes should be placed over the posterior tibial nerve near the ankle. The responses of the foot muscles associated with this nerve are monitored.
  • the priority requirement is to place the electrodes over the cited nerve. It is also necessary to invert the position of the cuff depending on the leg where it is placed. On the right leg the pneumatic hose should go towards the hip. On the left leg the pneumatic hose should go towards the foot.
  • the current should be injected through the distal electrode.
  • the distal electrode is also inverted depending on the limb where the cuff is placed.
  • the electronic stimulation circuit can change the current injection electrode. You must select in the monitor the limb which will be used for cuff placement.
  • the invention refers to the system and its components as described herein in detail, for the monitoring of the level of consciousness and nociception of a person performing daily life activities or a partially anesthetized patient.
  • These components are the request modules ARM and MCS, and the response module MMD.
  • the use of these components either alone or in various combinations is applicable in different medical scenarios with patients undergoing critical care.
  • a normal Non Invasive Blood Cuff (BP Cuff) or a modified NIBP cuff (M-BP) that includes stimulation electrodes can be used depending on the specific application.
  • Figure 1 shows a simplified block diagram of a Response Assembly Part for Muscle movement detection with standard NIBP cuff as included in various embodiments of system of the present invention
  • Figure 2 shows a simplified block diagram of a Request Assembly Part-1 MCS for Muscle Current Stimulation
  • Figure 3 shows a simplified block diagram of an alternative embodiment of Response Testing Apparatus consisting of a combination of the Response Assembly Part of Figure land Request Assembly Part 1 of Figure 2;
  • Figure 4 shows a simplified block diagram of a Request Assembly Part 2 intended to communicate to a patient a request generated by a controller
  • Figure 5 shows a simplified block diagram exemplifying the simultaneous utilization of the Response Assembly Part 1 of Figure 1 and the Request Assembly Part 2 of Figure 4 respectively, in accordance with one embodiment of the present invention
  • Figure 6 shows a simplified block diagram of another implementation which comprises a combination of the two previous Request Assembly Parts 1 and 2 and the Response Assembly Part;
  • Figure 7 shows a simplified block diagram of an implementation of the invention comprising a combination of a Request Assembly-2 and a Response Assembly in which a patient is provided with a Cuff acting as pressure sensor and an earphone speaker disposed in the ear of the patient;
  • Figure 8 shows is a simplified block diagram of an implementation of the invention similar to that of Figure 3 which comprises a Request Assembly-2 and a Response Assembly where a Cuff acting as pressure sensor is applied to the patient’s arm and with earphone speaker disposed in the ear of the patient and where a wireless communication is used;
  • Figure 9a is a simplified block diagram of both Request Assembly-1 and Response Assembly in which a Cuff with stimulation electrodes is applied to the patient’s arm;
  • Figure 9b and Figure 9c are schematic views of two implementations including both Request Assembly Parts 1&2 / Response Assembly operating simultaneously and which include a cuff having electrodes for current stimulation and with an earphone speaker disposed in the ear of the patient;
  • Figure 9c shows the case of Figure 9b, in which the patient is also monitored the Neuromuscular Transmission by a device available in the market.
  • Figure 10 shows a simplified block diagram of an implementation of the invention similar to that of Figure 9a, but including respective transmitter and receiver units for each of the Request Assembly-1 and Response Assembly wherein the communication between devices is a wireless communication and with patient being provided with Cuff and stimulation electrodes;
  • Figure 11 and Figure 12 show a simplified block diagram of embodiments similar to that of Figures 9b and 9c including respective transmitter and receiver units using a wireless communication and where a patient is provided with earphone speaker disposed in an ear of the same;
  • Figure 12 shows the case of Figure 11, in which the patient is also monitored the Neuromuscular Transmission by a device available in the market.
  • Figure 13 shows an embodiment similar to those of Figures 11, 12 and where a patient is controlled by means of a multiparameter monitor intended to control functions such as BP, HR, sweating, Sp02 and capnography of the patient;
  • Figure 14 shows a response testing apparatus which includes Request Assembly Parts 1 , 2 and Response Assembly Parts with a controller intended to analyze the received responses in order to determine a patient’s nociception level;
  • Figures 15, 16 and 17 are flowcharts to respectively illustrate the Sedation Level Detection SDL, the Anesthesia Level Detection ADL and the Nociception Level Detection NDL of a patient in a system according to the present invention;
  • Figure 18 shows a block diagram of the proposed implementation of a data retrieval system for tracking the use of the M-BP cuff
  • Figure 19 shows a block diagram of the proposed implementation of a data storage system for tracking the use of the M-BP cuff
  • Figure 20 shows a block diagram of the proposed implementation of a data retrieval and storage system for tracking the use of the M-BP cuff
  • Figure 21 shows a new embodiment of the invention with an added functionality of the modified M-NIBP cuff for providing a disposable cuff protector or cover to avoid contact between the cuff and the skin of the patient;
  • the cover can also be adapted accordingly to be used with BP cuffs
  • Figure 22 shows an implementation example of the proposed implementation of a data retrieval and storage system for tracking the use of the M-BP cuff
  • Figure 23 shows a patient in prone and supine position and the location of sensors and actuators
  • Figure 24 shows a pattern of stimulation current impulses with variable number of pulses, amplitude and frequency and time duration of pulses
  • Figure 25 is a schematic representation showing how to place the cuff on the patient's arm with the electrodes on the brachial plexus positioned at the middle humeral level, and
  • Figure 26 is a schematic representation showing the cuff place on one of the patient’s legs when surgical conditions advise against its placement on the arm.
  • the movement detection is carried out with the standard NIBP Cuff called BP-Cuff.
  • BP-Cuff the standard NIBP Cuff
  • the cuff is inflated below diastolic BP for a short time reaching low pressure to guarantee good contact between electrodes and skin and then the cuff senses any changes provoked by the movement of the limb.
  • the BP Cuff is able to detect any volume change caused by the movement in the muscles related to the site where the cuff is placed.
  • the cuff can be placed in the arm, forearm, wrist, thigh, and ankle. As it can be seen in FIG.
  • the pressure inside the cuff is converted by a transducer into an electrical signal; It may be generated and detected as a result of very small volitional muscle movement even in the absence of any visually detectable muscle movement.
  • muscular activity in a particular muscle is typically precipitated by the release of an appropriate neurotransmitter by the corresponding motor neuron, which, in turn, is caused by the propagation of an appropriate neurological signal along the motor neuron and zero or more different connected neurons.
  • the propagation of the neurological signal, the release of the neurotransmitter, and other precursors modify the internal cuff pressure -as a result of muscle activity.
  • the internal pressure inside the cuff is also detectable by various means, and its changes are referred to herein as "internal pressure (IP) signal” changes.
  • IP internal pressure
  • FIG. 1 shows a simplified block diagram of the Response Assembly Part 100, a component of a Consciousness (Sleepiness, Sedation (SLD) , Anesthesia(ALD), deep anesthesia (DALD) and/or nociception (NLD) Level Detection systems in accordance with various embodiment of the present invention.
  • the patient 99 is connected via 99a to the Response Assembly Part 100, which comprises a standard Non-lnvasive Blood Pressure (NIBP) cuff (BP-Cuff) with an internal Pressure (IP) signal generator sensor 101, which provides IP signal 101a to the Muscles Movement Detection (MMD) module 102, which provides the processed data 102a to a controller & display module 103.
  • NIBP Non-lnvasive Blood Pressure
  • BP-Cuff BP-Cuff
  • IP internal Pressure
  • Sensor 101 is connected to MMD 102 via path 101a.
  • MMD 102 is connected to controller &display module 103 via path 102a.
  • Sensor 101 is based on a standard Non-lnvasive Blood Pressure Cuff BP-Cuff for sensing the patient ' s muscle movement underneath the cuff.
  • BP-Cuff Non-lnvasive Blood Pressure Cuff
  • the system is also adapted to non-invasive BP measure (Blood Pressure) using the well-known oscillometric technique. This functionality of BP measurement, however, is not subject to claim in this patent.
  • a faint movement of the muscle underneath the cuff should generate detectable IP signals that can be used to determine consciousness and/or nociception levels and/or allow communication from the patient to the surgical team.
  • IP signals should be generated and detected.
  • anesthetics may be administered such that the patient may retain the ability to fully or partially move the muscle while otherwise substantially immobilized.
  • substantially immobilized describes patients who are immobilized such that they cannot substantially move their limbs and related major muscles. Substantial immobilization may be achieved wholly or partially with anesthetics and/or paralytic drugs or partially with physical restraints. Patients who are partially immobilized but not completely immobilized may be able to move relatively. Note, however, that a completely immobilized patient is completely paralyzed and will not be able to generate an IP signal in a muscle when trying to voluntarily move that muscle.
  • MMD module 102 processes the sensor raw internal cuff pressure signal to determine whether the signal indicates sensed motion or attempted motion.
  • MMD module 102 calculates a metric based on the received signal data, and, if the metric exceeds a set threshold, then MMD module 102 determines that the correct motion occurred or was attempted to a certain degree, while, if the threshold is not exceeded, then processor 102 determines that motion either did not occur or failed to reach a degree of acceptance.
  • the metric is based on average signal amplitude over a defined period of time.
  • the threshold may be pre-programmed or may be set during pre operative preparation, as described elsewhere herein.
  • the degree of correctness in the response or the time delay between the request and the response is used to determine a level of consciousness of the patient.
  • the controller can determine that the patient is in a deeper level of sedation.
  • MMD module 102 indicates the result of that determination and provides th e output to the controller & display module 103.
  • display module 103 comprises a visible light emitting diode (LED) that lights up with a different colour to discriminate if processor 102 determines that motion occurred or was attempted.
  • LED visible light emitting diode
  • FIG.2 shows a simplified block diagram of the Request Assembly Part -1 MCS for Muscle Current Stimulation 104. It is a component of a Sedation / Anesthesia awareness or nociception Level detection system in accordance with various embodiment of the present invention.
  • the controller 103 provides a command via 103a to the Module that generates the Request Assembly Part-1 104, and in particular to one of its components, the generator of a Pattern of Electrical Stimulations (PES) 105, which sends via 105a the electrical stimulations to a Modified Blood pressure (M-BP) Cuff 106.
  • PES Pattern of Electrical Stimulations
  • M-BP Modified Blood pressure
  • the stimuli are given via 106a to the patient 99.
  • Actuator 106 is based on a M-BP Cuff (Modified Blood Pressure Cuff) with two electrodes placed along a nerve for stimulation of the patient.
  • M-BP Cuff Modified Blood Pressure Cuff
  • the M-BP Cuff 106 contains two embedded electrodes to generate a stimulation current to stimulate the nerves or bundle of nerves placed underneath the cuff. This is one of the operational ways of the invention, in which, the patient 99 is stimulated with current from 106 via 106a in order to verify the response to it.
  • the Response Testing Apparatus-1 139 which is a combination of the two previously described modules, Request Assembly-1 MCS 104 and Response Assembly Parts 100 .
  • the same cuff includes the stimulation electrodes and has two functions, one as sensor 101 acting as (1 ) a standard N I BP cuff, with capacity to generate IP signals as described above but (2) it operates also as M-BP Cuff (Modified Blood Pressure Cuff) 106, with two stimulation electrodes.
  • Request and Response assembly parts 104 and 100 may include digital and analog electrical components, such as, for example, resistors, capacitors, and diodes, to condition the raw electrode signals before transmission to controller & display 103.
  • the request assembly 107 is used to activate the speaker or earphones 109 to produce an audible request to the patient 99.
  • This voice command may be generated by the clinical staff itself, when manual operation is activated, or else by synthetized voice from the request assembly part.
  • the speaker is a disposable earphone 109 (such as one which clips on an ear lobe) proximate to an ear of the patient 99, as is within the capabilities of the artisan.
  • the request assembly Part-2 ARM 107 communicates by voice to the patient 99 the request generated by the controller 103.
  • the request assembly can be substituted by the voice of the clinician.
  • FIG.4 shows a simplified block diagram of the Request Assembly Part-2 107, a component of a Consciousness awareness (Sedation or Anesthesia) and/or nociception Level detection system (SLD, ALD, DALD, NLD) in accordance with various embodiment of the present invention.
  • the controller Module 103 provides a command via 103b to the ARM Module that generates an Audio Request Module (ARM) 108, which sends via 108b the acoustic signal to the earphone 109.
  • ARM Audio Request Module
  • the sound stimuli are given via 109b to the patient 99.
  • This is one of the operational ways of the invention, in which, the patient is stimulated with voice sound in order to verify the response to the command.
  • FIG. 5 another implementation is shown, which is a combination of the two previous Request (107) and Response 100 Assembly Part.
  • the response assembly 100 senses the response and communicates the response to the controller 103 by means of the BP Cuff system 101 already described.
  • the ARM is used with earphones while the cuff acts as muscle movement detector only 101, and generates IP signals as described already.
  • Request and Response assembly parts 104 , 107 and 100 may include digital and analog electrical components, such as, for example, resistors, capacitors, and diodes, to condition the raw electrode signals before transmission to controller & display 103.
  • FIG. 5 shows a block diagram 121 for the exemplary simultaneous utilization of the Request 107 and Response 100 Assembly Parts system of FIG. 1 and Fig 4 respectively and in accordance with one embodiment of the present invention.
  • the process starts (step 101) with a determination to assess the level of pain or consciousness of a partially anesthetized patient (step 102).
  • the determination may be triggered by for example, the command of the display & controller module 103, by the output of ARM module 108b and patient stimulation by means of earphones 109, for automated patient-consciousness-monitoring system or at the discretion of the surgical team in manual mode with natural voice.
  • An anesthetized patient who becomes aware may have been trained by the anesthetist to e.g.
  • an automated consciousness-monitoring system may determine and indicate that the patient is actually or likely-to-soon-become aware.
  • the surgical team may choose, for whatever reason, to determine that the patient is potentially aware.
  • FIG. 6 another implementation is shown, which is a combination of the two previous Request (104 and 107) and Response 100 Assembly Parts.
  • the ARM is used with earphones while the cuff acts as muscle movement detector 101, and generates IP signals as described already.
  • Request and Response assembly parts 100, 104 and 107 may include d igital and analog electrical components, such as, for example, resistors, capacitors, and diodes, to condition the raw electrode signals before transmission to controller & display 103.
  • FIG. 6 normally, as the patient moves from no or low sedation or nociception’s levels up to high, the system will make use of the Request assembly Part-2, with voice stimulation.
  • Request Assembly Part-1 When it reaches deep level of sedation and the patient does not respond to the voice command, then Request Assembly Part-1 is used; When used in Deep Anesthesia, if the patient is partially anesthetized, the system may simultaneously combine both types of request, in order to detect AAGA syndromes.
  • the operational implementation is shown, which is a combination of the Request Assembly -2 part 107 and the Response Assembly Part 100.
  • the ARM 108 is used with earphones 109 while the cuff only acts as muscle movement detector 101 and generates IP signals as described already.
  • Request and Response assembly parts 100 and 107 belong to 121 module and may include digital and analog electrical components, such as, for example, resistors, capacitors, and diodes, to condition the raw electrode signals before transmission to controller & display 103.
  • FIG. 6 shows a block diagram 121 for the exemplary simultaneous utilization of the Request 107 and Response 100 Assembly Parts system as described in Fig 5 and with components described in FIG. 1 and Fig 4 respectively and in accordance with one embodiment of the present invention.
  • the process starts (step 101) with a determination to assess the nociception and consciousness (sedation and anesthesia) levels of a patient (step 102).
  • the determination may be triggered by for example, the command of the display & controller module 103, by the output of ARM module 108 and patient stimulation by means of earphones 109, for automated patient-consciousness-monitoring system (not shown), or at the discretion of the surgical team with e.g. natural voice.
  • a partially anesthetized patient who becomes aware may have been trained by the anesthetist to attempt to move the hand three times, when such a voice command is given via 109, and this movement is captured in the cuff 101-102 to inform 103 and causing a determination of potential awareness.
  • the patient that is aware can be asked to move the hands to indicate the level of pain that he/she is feeling.
  • an automated consciousness-monitoring system may determine and indicate that the patient is actually or likely-to-soon-become aware.
  • the surgical team may choose, for whatever reason, to determine that the patient is potentially aware.
  • FIG. 6 it is also shown a second operational mode indicated in module 120; As it has been explained, in some circumstances it can operate simultaneously with the previously explained assembly 121. It is a combination of the Requests-1 104 on one side and of the Response Assembly Part 100.
  • the same cuff includes the stimulation electrodes and has two functions, one as sensor 101 acting as a standard NIBP cuff, and the second as M-BP Cuff (Modified Blood Pressure) Cuff 106, which has two stimulation electrodes.
  • M-BP Cuff Modified Blood Pressure
  • Electrical stimulation patterns come from PES module 105.
  • Request and Response assembly parts 100 and 104 may include digital and analog electrical components, such as, for example, resistors, capacitors, and diodes, to condition the raw electrode signals before transmission to controller & display 103.
  • FIG. 6 shows block diagram 120 for the exemplary simultaneous utilization of The Request assembly-1 104 and Response 100 Assembly Parts system of FIG. 1 and Fig 2 respectively and in accordance with one embodiment of the present invention.
  • the process starts (step 101) with a determination to assess the nociception and/or consciousness (sedation and anesthesia) levels of a patient (step 102).
  • the determination may be triggered by for example, the command of the display & controller module 103, by the output of PES module 105 and patient stimulation by means of electrodes embedded in the cuff 106, for automated patient-consciousness-monitoring system (not shown), or at the discretion of the surgical team.
  • a partially anesthetized patient who becomes aware may make a detectable movement by 100, when an electrical stimulation is provided via 106, and this movement is captured in the cuff 101-102 to inform 103 and causing a determination of potential awareness.
  • an automated consciousness-monitoring system may determine and indicate that the patient is actually or likely-to-soon-become aware.
  • the surgical team may choose, for whatever reason, to determine that the patient is potentially aware.
  • non-disposable earphones have to be cleaned between patient use.
  • Any single-use device eliminates the need for cleaning between patient use.
  • FIG. 9b Examples of two requests 1&2/ one response assemblies operating simultaneously is given in FIG. 9b, which include a cuff having electrodes for current stimulation 106, and an earphone speaker 109 disposed in the ear of the patient 99.
  • FIG. 9c Examples of two request 1&2 /one response assemblies operating simultaneously is given in FIG. 9c, which include a cuff having electrodes for current stimulation 106, and an earphone speaker 109 disposed in the ear of the patient 99.
  • Other response assemblies include an NMT module 119, which can be of any kind in the market.
  • the NMT monitor here is used as a monitoring procedure to guaranty that the patient has substantial mobility as described above.
  • the M-BP Cuff is an accessory connected to the monitor to take the measurements. It is the part of the accessory that comes into contact with the patient and consists of an inflatable chamber with two electrodes. It connects to the console via a male hybrid connector, a part of the measurement accessory. It is hybrid because it has a pneumatic connection (to inflate the chamber with air) and electrical connections for stimulation of the electrodes and terminals for communication with the IDentification Number chip (IDN).
  • IDN chip is a miniature electronic circuit with a unique identification number engraved in its memory which is well known by the artisan; It allows traceability and monitoring of the accessory. It also has memory space that can be read and written.
  • the IDN chip reader / writer is an electronic circuit that can read the identification number of the IDN chip and, in addition, can read and write its memory space enabled for this purpose.
  • the Communication with the IDN chip is done through protective electrical isolation.
  • the M-BP Cuff 101 includes means to be identified and its performance can be evaluated during its Life Cycle.
  • the M-BP Cuff is an accessory connected to the monitor to take the measurements. It is the part of the accessory that comes into contact with the patient and consists of an inflatable chamber with two electrodes 133. It connects to the console 130 via a male hybrid connector 131, a part of the measurement accessory. It is hybrid because it has a pneumatic connection (to inflate the chamber with air) and electrical connections for stimulation of the electrodes and terminals for communication with the IDentification Number chip (IDN) 132.
  • the IDN chip 141 is a miniature electronic circuit with a unique identification number engraved in its memory; It allows traceability and monitoring of the accessory.
  • the IDN chip reader / writer 135 is an electronic circuit that can read the identification number of the IDN chip and, in addition, can read and write its memory space enabled for this purpose.
  • the Communication with the IDN chip is done through protective electrical isolation 136.
  • the type of data managed is:
  • Patient size identifies the patient size for which its use is suitable. For example: child, small adult, standard adult, large adult.
  • Use of the accessory counter to record the number of times the accessory has been used. Data is included in the recordable memory of the chip, which allows to know the number of measurements it has taken and if the accessory has exceeded its useful life.
  • Password security identification code that ensures that the accessory is approved by the manufacturer to measure accurately and safely.
  • the Reader / Writer module reads the information contained in the IDN chip 141. This information is transmitted to the monitor's microcontroller, which processes it to verify the suitability of the accessory. If the information read is correct and indicates that the accessory is in the correct state, then the monitor accepts the accessory and the patient monitoring begins. If the information read is incorrect for any reason, the monitor rejects the accessory and the user is informed on the screen.
  • the modified M-NIBP cuff for providing a disposable cuff protector or cover to avoid contact between the cuff and the skin of the patient.
  • the cover includes two electrodes made of the same material as the ones used in the M-NIBP Cuff.
  • the consumable cover is fixed in the internal side of the inflatable part 133 to avoid contact between the cuff and the skin of the patient and to smooth the contact of skin with cuff when this latter is inflated.
  • the cover may have some sizes, to better adjust to the different cuff sizes.
  • the cover is made of a removable adhesive strip useful as bandage 151.
  • Two perforations 150 are emplaced alongside the short axis of the flexible planar surface.
  • One electrode can be stick to each hole in order to guarantee continuity of voltage transmission and isolation between cuff and skin. In the case of using the BP-Cuff, no perforations or electrodes are implemented.
  • the strip contains an adhesive side using a light adhesive component (sticking material which adhere when pressed against surface) on its rear face. On the frontal face, the strip is attached to the inner surface of the NIBP cuff 133.
  • a light adhesive component sticking material which adhere when pressed against surface
  • the adhesive can be encapsulated in a plastic bag containing several bandages. Each bandage can have a pad that is peelably engaged to the adhesive side of the flexible planar surface.
  • FIG. 7 , FIG 9 and FIG 14, present cabled solutions between 130 and 100, 104 and 107 modules.
  • at least one of the paths 99a, 106a and 109b is in the form of a flexible conductive cable or air hose.
  • FIG. 810, 11, 13 another embodiment of the invention could be in such a way that communication is wireless between 130 and 104,107 and 100, so these devices operate as unitary mobile device in a wireless implementation of system 100, at least one of the paths 109b, 112a, 114a and 116b represents a wireless transmission path, with battery-based power supply.
  • the request assembly-2 107b includes a cableless communication means with Transmitter in Console and Receiver in 117, which communicates the request from the controller 103 vi a Request Assembly Transmitter 116, and sends the voice command message via the Request Assembly Receiver 117, the ARM 108 and Earphone 109 to the patient 99 (this can also be wireless).
  • the response assembly 100 includes a wi reless communication T ransmission device 114 which communicates the response from the patient 99, NIBP Cuff 101, MMD module 102 to the controller 103, via the response assembly transmitter 114 and the receiver 115.
  • the transmitter 116 of the wireless communication transmitter of the request assembly-2 is disposed on or in the console 130
  • the receiver of the wireless communication device 115 of the response assembly 100 is disposed on or in the console 130. It must be understood here that the terms transmitter /receiver are referred only to the direction of the main information, while all communications are bidirectional, so that status information can be known of every component by any other one.
  • the request assembly-1 104b includes a wi rel ess communication means with Transmitter in Console and Receiver, which communicates the request from the controller 103 via Request Assembly Transmitter 112, and sends the electrical stimulation command message via the Request Assembly Receiver 113, the PES 105 and M-BP Cuff 106 to the patient 99;
  • the response assembly 100b includes a wi rel ess communication Transmission device 114 which communicates the response from the patient 99a, NIBP Cuff pressure sensor 101, MMD module 102 to the controller 103, via the response assembly transmitter 114 and receiver 115.
  • the transmitter 112 of the wi rel ess communication transmitter of the request assembly-1 is disposed on or in the console 130, and the receiver of the wireless communication device 115 of the response assembly 100b is disposed on or in the console 130.
  • transmitter /receiver are referred only to the direction of the main information, while all communications are bidirectional, so that status information can be known of every component by any other one.
  • wireless communication devices 112 and 113 and/or 1 14 and1 15 include, without limitation, communication devices using a standard type of communication based on Bluetooth (BT), WIFI or any other form such as a radio frequency (RF) transmitter and receiver (such as those operating in the range of 0.1 megahertz to 3 gigahertz), an ultrasonic transmitter and receiver, an infrared transmitter and receiver, and/or a visible-light transmitter and receiver, etc.
  • BT Bluetooth
  • WIFI wireless RF transmitter and receiver
  • RF radio frequency
  • ultrasonic transmitter and receiver such as those operating in the range of 0.1 megahertz to 3 gigahertz
  • infrared transmitter and receiver such as those operating in the range of 0.1 megahertz to 3 gigahertz
  • visible-light transmitter and receiver etc.
  • one implementation of the request assembly 107 and 107b is disposed within or on the earphone housing.
  • the console 130 generates the voice commands from a synthesizer;
  • the wireless connection is disposed on a headset and the receiver is wired to the earphone which is supported by the headset.
  • the request assembly is a mobile phone with an APP that wirelessly communicates with the console 130. The voice commands are triggered from the system in accordance to a predefined sequence of a protocol.
  • manual SLD 200 and ALD systems 210 or NLD 220 make use of modules in FIG. 1,2, and 4 implemented in such a way that during surgery, if the alarm of console module 130 lights up, then the surgical team would be alerted to the fact that the patient may be aware. The patient would then be able to communicate with the surgical team by consciously manipulating his arm and, thereby, activating the output module via the controller and display 103.
  • the communication could be as simple as outlined by flowcharts 200, 210 and 220 of FIG. 15, 16 and 17 and could comprise more complex communication, such as responding to commands, answering questions, or volunteering some other information of the patient's choosing.
  • SLD 200 and ALD systems 210 or NLD 220 of FIG. 1, 2, 4, 8, 10, 11 is programmable to allow for more-complex communication by the patient with the surgical team.
  • the programming might require a particular pattern of actions by the patient, which are detectable by response assembly 100, in order to have response assembly 100 trigger a corresponding audible/ visible output alarm from controller/display m od u l e 103.
  • the nociception or conscious awareness (sedation /Anesthesia) systems 100b, 104b and 107b are wirelessly connected to a console 130, wherein the controller 103 is disposed in the console 130.
  • the console 130 is connected to a pen-drive, desktop or portable computer or central station designed to stay near the console 130.
  • the desktop or portable computer can be connected and used as processing means to enhance capabilities of system.
  • the console 130 is connected to a central station designed to supervise a plurality of patients in an ICU. It is noted that the console is disposed proximate the patient.
  • the present invention may be implemented as circuit-based processes, including possible implementation as a single integrated circuit (such as an ASIC or an FPGA), a multi chip module, a single card, or a multi-card circuit pack.
  • a single integrated circuit such as an ASIC or an FPGA
  • multi chip module such as an ASIC or an FPGA
  • a single card such as an ASIC or an FPGA
  • various functions of circuit elements may also be implemented as processing steps in a software program.
  • Such software may be employed in, for example, a digital signal processor, micro- controller, or general-purpose computer.
  • the present invention can also be embodied in the form of program code embodied in tangible media, such as solid-state memory, pen-drives, hard drives, or any other non- transitory machine-readable storage medium, wherein, when the program code is loaded into and executed by a machine, such as a computer, the machine becomes an apparatus for practicing the invention.
  • the present invention can also be embodied in the form of program code, for example, stored in a non-transitory machine-readable storage medium including being loaded into and/or executed by a machine, wherein, when the program code is loaded into and executed by a machine, such as a computer, the machine becomes an apparatus for practicing the invention.
  • the program code segments combine with the processor to provide a unique device that operates analogously to specific logic circuits.
  • controller includes one controller and includes two or more spaced- apart sub-controllers, etc.
  • sensors for the assembly in FIG. 13 and Fig. 14 include a cuff having electrodes for current sti mulation , and an earphone speaker disposed in the ear of the patient 99.
  • Other request assemblies include a pulse oximeter disposable on a finger or ear lobe of the patient, or supported by another medical device.
  • Yet other assemblies include a cannula;
  • a cannula is a well-known medical device which is used for monitoring the breathing of a patient and which is placed on the face of the patient proximate the nose and/or mouth of the patient, to monitor the inhalation and exhalation of carbon dioxide levels (capnometry).
  • the multiparameter monitor 118 includes a breathing sensor (such as a bioimpedance sensor or capnograph). In the same or a different modification, the breathing sensor detects the changes of bioimpedance of the breathing of the patient 99.
  • An expression of the embodiment of FIG. 5 is for a sleepiness or sedation level detection SLD 200 including a controller 103 and a response testing apparatus 138.
  • the controller 103 generates a request for e.g. a predetermined hand motion response from a patient 99, analyses at least a hand motion response made by the patient 99 to the request to determine a level of sedation of the patient 99, and generates a feedback signal which is communicated (in one example by a response Assembly 100) to the patient 99 when the hand motion response from the patient 99 meets a predetermined criterion.
  • the response testing apparatus 138 includes a request generated by a nurse in manual mode or a controller 107 in automatic mode of the conscious sedation system 200 and 210 for a predetermined hand motion response from the patient 99.
  • the request assembly 107 communicates to the patient 99 the request generated by the controller 103.
  • the response assembly 100 senses the hand motion response and communicates the hand motion response to the controller 103 to determine a level of sedation of the patient 99.
  • IP internal pressure
  • the care nursing or ARM system may generate voice command telling the patient, "If you can hear me, please try to press the button (or move the finger, the hand, close the fist, etc.” Each action has a degree of response that can be used to evaluate the corresponding response. If the patient is aware and responsive, then the patient can volitionally attempt to move his or her part of the body. It is then determined whether corresponding "Internal pressure” (IP) cuff signals are detected (step 204) by, for example, SDL system 200.
  • IP Internal pressure
  • step 204 If corresponding signals are detected in step 204, then it is determined the level of awareness of the patient (step 205) based on time delay of the response, the procedure terminates (step 207), and appropriate follow-up action is undertaken (not shown), such as, for example, explaining the situation to the patient, providing comforting reassurance, and administering additional anesthetics to bring the patient to higher levels of unconsciousness. If corresponding signals are not detected in step 204, then no new determination is made regarding the patient's state of awareness (step 206), and the procedure terminates (step 207). Note that, although step 206 makes no new determination regarding the patient's state of awareness, the patient is most likely not aware, and the surgical team will likely continue with the surgery, if autonomic system does not show changes to be considered.
  • sensor 101 also comprises two stimulating electrodes, that (a) are adapted to be placed over a muscle, (b) can stimulate and provoke the movements of the muscle, and (e) are adapted to generate sensor output signal 101a indicative of the movements of the muscle.
  • an Anesthesia level detection ADL 210 including a controller 103 and a response testing apparatus 138.
  • the controller 103 generates a request for a predetermined hand motion response from a patient 99, analyses at least a hand motion response made by the patient 99 to the request to determine a level of sedation of the patient 99, and generates a feedback signal which is communicated (in one example by a response Assembly 100) to the patient 99 when the hand motion response from the patient 99 meets a predetermined criterion.
  • the response testing apparatus 138 includes a request generated by a nurse in manual mode or a controller 107 in automatic mode of the conscious sedation system 200 and 210 for a predetermined hand motion response from the patient 99.
  • the request assembly 107 communicates to the patient 99 the request generated by the controller 103.
  • the response assembly 100 senses the hand motion response and communicates the hand motion response to the controller 103 to determine a level of sedation of the patient 99.
  • the M-BP Cuff can be used to measure the level at deep relaxation; Otherwise, some additional means such as autonomic system monitoring must be incorporated as indicated in Fig 14.
  • IP internal pressure
  • the anesthetized patient is asked to perform an activity that would generate detectable "internal pressure (IP)” cuff signal (step 213).
  • IP internal pressure
  • the anesthesiologist in manual mode
  • the ARM Automatic
  • Each action has a degree of response that can be used to evaluate the corresponding response. If the patient is aware and responsive, then the patient can volitionally attempt to move his or her arm.
  • step 214 It is then determined whether corresponding signals are detected (step 214) by the ALD system 210. If corresponding signals are detected in step 214, then it is determined that the patient is aware (step 215), the procedure terminates (step 217), and appropriate follow-up action is undertaken (not shown), such as, for example, explaining the situation to the patient, providing comforting reassurance, and administering additional anesthetics to return the patient to unconsciousness. If corresponding signals are not detected in step 214, then no new determination is made regarding the patient's state of awareness (step 216), and the procedure terminates (step 217). Note that, although step 216 makes no new determination regarding the patient's state of awareness, the patient is most likely not aware, and the surgical team will likely continue with the surgery, if autonomic system does not show changes to be considered.
  • sensor 101 also comprises two stimulating electrodes, that (a) are adapted to be placed over a muscle, (b) can stimulate and provoke the movements of the muscle, and (c) are adapted to generate sensor output signal 101a indicative of the movements of the muscle.
  • a Nociception level detection SLD 220 including a controller 103 and a response testing apparatus 138.
  • the controller 103 generates a request for a predetermined hand motion response from a patient 99, analyses at least a hand motion response made by the patient 99 to the request to determine a level of sedation of the patient 99, and generates a feedback signal which is communicated (in one example by a response Assembly 100) to the patient 99 when the hand motion response from the patient 99 meets a predetermined criterion.
  • the response testing apparatus 138 includes a request generated by a nurse in manual mode or a controller 107 in automatic mode of the conscious sedation system 200 and 210 for a predetermined hand motion response from the patient 99.
  • the request assembly 107 communicates to the patient 99 the request generated by the controller 103.
  • the response assembly 100 senses the hand motion response and communicates the hand motion response to the controller 103 to determine a level of sedation of the patient 99.
  • IP internal pressure
  • the care nursing or ARM system may generate a voice command telling the patient, "If you feel pain, please move the finger (the hand, close the fist, etc.) ”. Each action has a degree of response that can be used to evaluate the corresponding response. If the patient is responsive, then the patient can volitionally attempt to move his or her part of the body. It is then determined whether corresponding "Internal pressure” (IP) cuff signals are detected (step 224) by, for example, SDL system 220.
  • IP Internal pressure
  • step 224 If corresponding signals are detected in step 224, then it is determined the level of pain of the patient (step 225), the procedure terminates (step 227), and appropriate follow-up action is undertaken (not shown), such as, for example, explaining the situation to the patient, providing comforting reassurance, and administering additional nociception drugs to bring the patient to lower levels of pain. If corresponding signals are not detected in step 224, then no new determination is made regarding the patient's state of awareness (step 226), and the procedure terminates (step 227). Note that, although step 226 makes no new determination regarding the patient's state of pain, the patient is most likely not aware, and the surgical team will likely continue with the surgery, if autonomic system does not show changes to be considered.
  • sensor 101 also comprises two stimulating electrodes, that (a) are adapted to be placed over a muscle, (b) can stimulate and provoke the movements of the muscle, and (e) are adapted to generate sensor output signal 101a indicative of the movements of the muscle.
  • the stimulation 106a is a stimulus in the form of current injection between the two electrodes placed in the cuff as shown in FIG. 2.
  • the request assembly 104 includes a modified cuff 106, with pneumatic cuff and two electrodes which are used as in the case of a muscle stimulator to pass current of variable and predetermined amplitude 106a to produce a muscle response to the patient 99 which is captured by the 101 BP cuff.
  • the invention is a system of applying discrete amplitude current pulses and altering the time intervals between pulses and the duration of the pulses to determine the level of awareness by narcosis effect in a patient.
  • the level of sedation in a patient is determined by applying a current stimulus (e.g. such as single or pattern of single stimulations or twitches or even a tetanic stimulation) to the sedated patient and assessing the patient's response to the stimuli. If the patient does not respond, the intensity of the stimuli (in mA) is increased until the patient responds to the stimuli. The intensity of the stimuli required to generate the patient's response is correlated with the patient's level of sedation.
  • the current stimulation will be carried out in accordance to medical standards.
  • a system for determining the level of sedation in a patient utilizes the time interval of the current stimuli thereby obviating the need to use the intensity stepping approach used in the prior art.
  • the patient's ability to discern current stimulation time-dependent patterns can be used to determine the patient's level of sedation.
  • a set of current stimulation stimuli comprises several stimulation pulses which are applied to the patient with a predetermined time interval between each pulse.
  • a sample set of three pulses is applied with a predetermined time spaced in between each pulse.
  • the time between the first pulse and the second pulse is T1 and the time between the second pulse and third pulse is T2.
  • T1 the time between the first pulse and the second pulse
  • T2 the time between the second pulse and third pulse
  • the time interval between each distinct pulse correlates with the patient's level of sedation.
  • the time interval ranges will vary with the patient, as an exemplary approach, the interval may range from 0.05 to 15.0 seconds. More typically, the interval ranges from 0.3 to 1.0 seconds. Starting from 0,4 seconds, if the patient detects the distinct pulses, the time interval between the pulses is decreased to 0.2 seconds. If the patient does not detect the distinct pulses, the time interval between the pulses is increased to 0.6 seconds.
  • both the time interval and the duration of the pulse sets may be used in conjunction to assess the patient's response and determine the level of sedation of the patient.
  • a set of current stimuli comprising current pulses of predetermined duration for each pulse and predetermined time intervals between each pulse is applied to the patient.
  • the patient then responds to the set of stimuli.
  • a subsequent set of cu rrent stimuli can be applied to generate a subsequent response by the patient.
  • the subsequent set of current stimuli can be the same or modified from the previous set by either altering the duration and/or time interval.
  • the individual current pulses can be intensity modulation or frequency modulation pulses.
  • an intensity modulation pulse is a current pulse that has a variable amplitude within the individual pulse itself.
  • a frequency modulation pulse is a current pulse that has a variable frequency within the individual pulse itself. Either intensity and frequency modulation pulses may be incorporated in order to assess the level of sedation of a patient.
  • the 24 comprises applying a first stimuli to a patient who has received, is receiving or is about to receive a conscious sedation drug, instructing the patient to respond to the stimuli, monitoring a patient's response to the stimuli, applying an additional stimuli to the patient when the patient has received, is receiving or is about to receive a dose of a conscious sedation drug, wherein the additional stimuli can be the same or different as the first stimuli, monitoring the patient's response to the additional stimuli, repeating the steps of applying the additional stimuli and monitoring the patient's response to the additional stimuli to determine the patient's level of sedation.
  • the patient's initial or previous response may be used as a baseline for comparison to calibrate the patient's baseline level based on the level of stimulus to which the patient responded. Once the patient's baseline level is established and recorded by the sub controller, the baseline is used as the initial stimulus level in assessing the level of sedation of the patient.
  • the programming might vary the output of module 103 depending on the detected pattern so that each particular detected pattern corresponds to a different output of output module 103.
  • SLD system 200 might indicate one arm movement as a "no” and three as a "yes,” where "yes” and “no” may be indicated by differently colored LEDs of display module 103. Enabling an anesthetized but aware patient to respond to questions with a "yes” or “no” allows the surgical team to better assess and handle an occurrence of anesthesia awareness. For example, the surgical team might ask the anesthetized but aware patient whether he or she is feeling any pain.
  • Anesthesia Level Detection system 210 may be programmed to also account for the temporal lengths of arm movements and/or pauses.
  • Embodiments of the invention have been described where sensor 101 of FIG. 1 is placed on substantially one location on the body.
  • the cuff with electrodes of sensor 101 are placed on substantially different locations on the patient.
  • it is placed on the patient's right or left arm forearm or legs and feet, but then it must be considered the active electrode to be placed in the distal part always.
  • Pflueger’s Law defines the conditions under which an active electrode and a passive electrode arranged on a path of a motor nerve ensure that an evoked muscle response induced by a current transmitted by the active electrode to the nerve is reliable.
  • FIG. 4 Another expression of the embodiment of FIG. 4 is for a Nociception level detection system 220, sedation level detection SLD system 200 or anesthesia level detection ADL system 210 including a controller 103 and a response testing apparatus 138.
  • the controller 103 generates a request for a predetermined hand motion response from a patient 99, analyses at least a hand motion response made by the patient 99 to the request to determine a level of sedation of the patient 99, and generates a feedback signal which is communicated (in one example by a response Assembly 100) to the patient 99 when the hand motion response from the patient 99 meets a predetermined criterion.
  • the response testing apparatus 138 includes a request generated by a nurse in manual mode or a controller 107 in automatic mode of the conscious sedation system 200 and 210 and the nociception system 220 for a predetermined hand motion response from the patient 99.
  • the request assembly 107 communicates to the patient 99 the request generated by the controller 103.
  • the response assembly 100 senses the hand motion response and communicates the hand motion response to the controller 103 to determine a level of sedation of the patient 99.
  • An expression of the embodiment is an example of the response assembly 100 includes a M-BP Cuff system 106, as shown in FIG. 3, wherein the cuff is first inflated so that when the patient 99 moves the muscle, it sends a signal to the controller 103 when the cuff 101 is moved.
  • the cuff 101 is attached to the arm, but it can be attached in other muscles as described in use.
  • the controller 103 analyzes the pressure inside the cuff and correlates to the movement of the muscle and thereafter determines the level of sedation of the patient 99.
  • the predetermined hand motion response is the patient 99 moving a hand .
  • the predetermined hand motion response is the patient 99 moving a hand to trace out an IP expression.
  • the controller 103 makes two requests. One request is for the patient 99 to make a certain movement of the body. The other request is for the patient 99 to make another movement.
  • the controller 103 at least analyzes the responses from the two requests to determine the level of sedation of the patient. Discrimination is carried out in analyzing the correct or false response of one or any combined response, i.e. a patient who passes the first movement request but fails the second one request is considered by the controller 103 (with other inputs used by the controller for determining the level of sedation being equal) to be at a deeper level of sedation than a patient who passes both requests. It is noted that hand motion responses do not require grip strength and are easier for patients to make whose grip strength is impaired. Eliminating switches provides for greater reliability as switches need to be sealed against moisture and debris.
  • the response is not limited to a hand motion response but includes a series of requests for different types of predetermined responses.
  • such series is in an ascending or a descending order of difficulty for a patient to give an acceptable (i.e., acceptable as determined by the controller 103) response.
  • the acceptable response for different types of predetermined responses corresponds (with other inputs used by the controller for determining the level of sedation being equal) to different levels of sedation of the patient.
  • An expression of the embodiment is for a conscious sedation system 200 and 210 and a Nociception system 220 including a controller 103 and a response testing apparatus 138 (wherein parts 101 and 102 are parts of the response testing apparatus 100).
  • the controller 103 generates a request for a predetermined hand grip response from a patient 99 and analyses at least a dynamic variable of a hand grip response made by the patient 99 to the request 107 to determine a level of sedation of the patient.
  • the response testing apparatus 138 includes a request assembly 107 and a response assembly 100.
  • the request assembly 107 communicates to the patient 99 the request generated by the controller 103.
  • the response assembly 100 senses the dynamic variable of the hand grip response and communicates the dynamic variable to the controller 103.
  • Other examples are left to the artisan.
  • hand grip response is meant the response of a patient using a hand, or one or more fingers and/or a thumb thereof, to squeeze or exert pressure.
  • a hand grip response is meant a patient using a hand to squeeze the hand like one can try to squeeze a handpiece.
  • sensing a dynamic variable is meant sensing the varying value of a dynamic variable.
  • a “dynamic variable” includes, without limitation, applied force (or pressure), the time rate of the applied force (or pressure), the change of pressure in the cuff caused by a finger or several fingers moved, the elbow bent, the forearm moved, the arm moved.
  • the response assembly 100 senses a nerve signal sent by the brain of the patient 99 to activate a muscle which is used by the patient 99 to make a hand grip response.
  • one or more electrodes are applied to the arm, ankle etc. and are monitored by the BP Cuff system, wherein, in one embodiment, the electrodes are part of a modified cuff.
  • the internal cuff pressure signal (IP) changes are measured, when the patient squeezes a handpiece.
  • IP internal cuff pressure signal
  • the controller 103 estimates the time response to be correlated to the level of sedation of the patient (with other inputs used by the controller in determining the level of sedation being equal), as can be appreciated by those skilled in the art.
  • the pressure inside the cuff can detect a weak attempt of the patient when he/she intends to make a hand grip response, including a patient response with no detectable movement but detectable via small muscle fiber contraction by the system.
  • the pressure inside the cuff can be correlated with the movement of the body part.
  • the pressure inside the cuff 101 is adjustable (or automatically adapts) in compliance and/or size to respond to one of a lower hand grip force and/or size and a higher hand grip force and/or size. This enables the same cuff to be used by a patient having a weak grip and by a patient having a strong grip.
  • a voice message is made to take place when the patient 99 reaches an acceptable hand grip response so that voice acts as a feedback to the patient 99 indicating a successful hand grip response.
  • FIG. 5 illustrates an embodiment of this aspect of the invention.
  • An embodiment of the invention is for a conscious sedation system 200 or 210 including a controller 103 and a response testing apparatus 138.
  • the controller 103 generates a reguest for a predetermined response from a patient 99 to the reguest to determine a level of sedation of the patient 99
  • the response testing apparatus 138 includes a request assembly 107 and a response assembly 100.
  • either the response assembly 100 includes a cuff in the arm or forearm for finger movement detection.
  • each numerical value and range should be interpreted as being approximate as if the word “about” or “approximately” preceded the value of the value or range.
  • the term “connected” is intended to cover both direct and indirect connections between elements.
  • the terms “couple,” “coupling,” “coupled,” “connect,” “connecting,” or “connected” refer to any manner known in the art or later developed in which energy is allowed to be transferred between two or more elements, and the interposition of one or more additional elements is contemplated, although not required.
  • figure numbers and/or figure reference labels in the claims is intended to identify one or more possible embodiments of the claimed subject matter in order to facilitate the interpretation of the claims. Such use is not to be construed as limiting the scope of those claims to the embodiments shown in the corresponding figures.
  • transmitter /receiver are referred only to the direction of the main information, while all communications are bidirectional, so that status information can be known of every component by any other one.
  • the terms "receive" and its variants can refer to receipt of the actual data, or the receipt of one or more pointers to the actual data, wherein the receiving entity can access the actual data using the one or more pointers.
  • Exemplary embodiments have been described with data flows between entities in particular directions. Such data flows do not preclude data flows in the reverse direction on the same path or on alternative paths that have not been shown or described. Paths that have been drawn as bidirectional do not have to be used to pass data in both directions.
  • conscious and unconscious sedation has the capability to bring the patient into unconscious sedation, to bring the patient into and out of conscious sedation, and/or to assess the patient as the patient moves into and out of deep sedation or consciousness.
  • a deep sedation level or unconsciousness is indicated if a patient response to a stimulus is not detected.
  • conscious sedation also encompasses the conscious sedation portion of a system and/or system which provides both conscious and unconscious sedation. It is noted that conscious sedation includes conscious sedation where the patient is not responsive to stimuli (which is also known as deep sedation) and conscious sedation where the patient is responsive to stimuli.
  • EEG signal data is obtained from electrodes placed on a patient's scalp, where the EEG may be contaminated by electromyographic (EMG) signals which indicate muscular activity underneath the electrodes.
  • EEG signal data is filtered to remove the EMG signals (based on their different frequency bandwidth), since the EMG signals are considered artifacts with respect to the EEG signals.
  • Korhonen then teaches using cardiovascular, EEG, EMG, and/or other signals to derive parameter values for use in a mathematical formula to calculate probability of patient comfort.
  • EP 0408 483 A1 published on 16 th January 1991 is intended to improve vasoactive drugs by suitable infusion devices, controlled by a computerized device which controls and adjusts automatically in a closed loop, establishing the dosage in order to maintain blood pressure with a predefined set of values.
  • These improvements involve the use of equipment to automatically control and dose for the different vasoactive medicine infusion pumps.
  • This equipment is comprised of a controller (1), a monitor (2) and a high pressure infusion pump (3), the main part of this equipment being the controller (1) which includes programmed logic units to carry out this function, as well as the necessary input and control devices.

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Abstract

L'invention concerne un système de surveillance non invasive de niveaux de nociception et de conscience de patients sédatés et anesthésiés, le système étant conçu pour déterminer et indiquer si un patient est (i) conscient et/ou a une douleur ou (ii) susceptible de devenir rapidement conscient, le système comprenant des moyens (102, 103) pour effectuer une telle détermination sur la base de signaux de mouvement musculaire produits par un patient (99), et le système comprenant également des détecteurs (101) qui peuvent être utilisés pour mettre en œuvre un système de détection de niveau de nociception (NLD) et des détecteurs de niveaux de conscience basés sur un système de détection de niveau de sédation (SLD), un système de détection de niveau d'anesthésie (ALD), et un système de une détection de niveau d'anesthésie profonde (DALD), et lesdits systèmes SLD, ALD et DALD étant aptes à fonctionner simultanément de manière combinée ; le système étant également conçu pour mesurer la conscience ou la somnolence pendant qu'une personne effectue une activité de la vie quotidienne.
PCT/IB2021/000174 2021-03-30 2021-03-30 Système de surveillance non invasive de niveaux de nociception et de conscience de patients sédatés et anesthésiés WO2022208120A1 (fr)

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EP1694386A1 (fr) 2003-12-05 2006-08-30 Cardinal Health 303, Inc. Analgesie regulee par le patient au moyen d'un systeme de surveillance du patient
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US5957860A (en) * 1995-08-04 1999-09-28 Rodiera Olive; Jose J Method and apparatus for monitoring and/or controlling the neuromuscular blocking, specially the blocking produced by muscular relaxing pharmaceuticals during anaesthesia
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EP1694386A1 (fr) 2003-12-05 2006-08-30 Cardinal Health 303, Inc. Analgesie regulee par le patient au moyen d'un systeme de surveillance du patient
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