JP2011005262A - Apparatus and method for automatically assessing and monitoring patient's responsiveness - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an apparatus for safely and efficaciously providing painkiller, analgesic, amnesia agent, or other pharmaceutical substances to a patient with spontaneous respiration, a care system for alleviating patient pain, anxiety and discomfort associated with medical or surgical procedure, and also to provide an apparatus and a method for allowing a doctor to safely control or manage the pain and anxiety.SOLUTION: The care system facilitates a procedural clinician's safely and efficaciously providing painkiller, analgesic, and a certain amount of amnesia agent to a patient by providing a responsiveness monitoring system which monitors the responsiveness of the patient and generates a value representing the level of patient responsiveness. In further aspects of the invention, the responsiveness monitoring system is an automated system which includes patient query and response devices. Additional embodiments of the system and methods are directed so as to alleviate patient pain or discomfort while enabling safe drug delivery in correlation with the monitoring of patient health conditions.

Description

[Field of the Invention]
The present invention relates generally to devices and methods for alleviating patient pain and / or anxiety. In particular, the present invention provides sedation, analgesia, and / or memory loss to conscious patients who are undergoing painful or anxious medical or surgical procedures or who are suffering from post-procedure or other pain or discomfort. The present invention relates to a system and method. The present invention delivers one or more sedatives, analgesics, or memory loss agents while electronically monitoring the physiological symptoms of one or more patients through conservative software management To integrate electronically. In one form, the present invention involves the use of one or more sets of stored data definition parameters that reflect patient and system conditions. This parameter is accessed by the software to conservatively manage and correlate drug delivery to safe and economic optimal values related to conscious patient vital signs and other physiological symptoms.

[Cross-reference of related applications]
This application is a continuation-in-part of US application Ser. No. 09 / 324,759, filed Jun. 3, 1999, which is a US Provisional Patent Application No. 09 / 324,759, filed Jun. 3, 1998. Claims 60 / 087,841 priority and is incorporated herein by reference. This application is based on 35 USC 119 (e), priority from US Provisional Patent Application No. 60 / 342,773, filed Dec. 28, 2001, which is incorporated herein by reference. Also insist.

[Background of the invention]
The present invention provides for conscious patients undergoing painful, uncomfortable, or terrible medical care or surgical procedures, or conscious patients suffering from post-procedure or other pain or discomfort. The safe, effective and economical release of pain and / or anxiety. The focus of the present invention includes, but is not limited to, sedation (induction of sedation), analgesia (eliminating sensation of pain), and / or memory loss (sometimes referred to collectively as “conscious sedation”), To a conscious patient in a safe, effective and economical manner, a non-anesthetic practitioner, ie a doctor or other clinician who is not an anesthesiologist (MDA), or qualified nursing Providing by anesthesiologists (CRNA), providing sedation, analgesia, and / or memory loss to patients in outpatient settings such as hospital laboratories, outpatient surgery centers, and physician offices Enabling the patient's post-operative or other pain to be alleviated in a telemedicine nursing home or home nursing environment. For these purposes, the present invention provides for the delivery of one or more sedatives, analgesics, or memory loss agents to a patient, and electronic monitoring of one or more patient's physiological symptoms. Are integrated mechanically by physical proximity and introduction to the overall structural system, and electronically by software management that makes conservative decisions.

  In a conventional operating room, anesthesiologists free patients from pain, fear, and physiological stress by providing general anesthesia. “Anesthesia” is usually used interchangeably with the state of “loss of consciousness” (also used herein). However, more than 1 billion painful and anxious medical and surgical procedures are performed every year worldwide without anesthesia. As such, there are currently many patients who undergo medical or surgical procedures that do not perform anesthesia and cause considerable distress, deep anxiety, and / or physiological stress while being conscious. Such medical or surgical procedures are frequently performed by doctors (not anesthesiologists) performing treatments in hospital laboratories, doctor offices, and outpatient surgery centers. For example, specialists may provide conscious patients with pacemaker implantation, colonoscopy, various radiological procedures, microlaparoscope, fracture reduction, trauma bandage replacement at burn sites, and central and arterials in pediatric patients Painful procedures such as catheter insertion are performed in a hospital laboratory environment. Leading nursing physicians perform procedures such as flexible sigmoidoscopy, laceration repair, bone marrow biopsy, and other procedures in the physician's office. Many surgical specialists perform painful procedures such as anterior surgery by an ophthalmologist, shaping techniques by a cosmetic surgeon, foreign body removal, transurethral techniques, neck and axillary nodule dissection, and breast biopsy, in a doctor's office or outpatient surgery At the center. Patient requirements for safe and effective pain and anxiety relief during and after such procedures are currently unmet.

  Currently available conscious sedation techniques used by physicians (not anesthesiologists) who perform treatment during the above medical or surgical procedures include analgesics and opioids given orally, rectally or intramuscularly, intravenous administration Analgesics and anesthetics, as well as local anesthetics. However, in most cases, such techniques are not satisfactory.

  When oral, rectal, or intramuscular administration of analgesics and opioids by the physician performing the procedure in providing conscious sedation, ensure that the effects of these drugs can be easily controlled to meet patient requirements There is currently no effective way to do this. This is due in part to the variable interval between administration and the onset and disappearance of the drug effect. Sedation and analgesia can be unreliable because the dose and patient requirements (which can vary depending on the patient's symptoms and the type of procedure being performed) do not match. Administration of such sedatives can also put unconscious patients at risk of causing tracheal injury, pulmonary aspiration, or cardiovascular instability. In an attempt to avoid these complications, the treating physician often administers sedatives and analgesics sparingly. This may reduce the risk of major complications, but may also mean that most patients are not sufficiently free from pain and / or anxiety during medical and surgical procedures that do not perform anesthesia.

  The use of intravenous administration of sedatives and analgesics to conscious patients by physicians performing procedures in hospital laboratories, physician offices, and other ambulatory environments is also unsatisfactory. In the case of intravenous bolus administration, the plasma concentration changes considerably when the drug is injected directly into the blood stream. This can result in excessive (potentially toxic) levels initially and then concentrations below the amount necessary to increase the therapeutic effect. Intravenously administered drugs can be titrated according to patient requirements, but to do this safely and effectively usually requires the constant attendance of a trained nurse (eg, anesthesiologist). This choice is usually ruled out, especially due to cost and schedule adjustment difficulties.

  Because of the above difficulties associated with the administration of sedatives and opioids, many treating physicians rely on local anesthesia for pain relief. However, local anesthesia alone usually does not provide sufficient analgesia (eliminating the sensation of pain) for most medical and surgical procedures, and injections themselves are often relatively painful.

  In short, methods currently available in common for treating physicians to provide effective pain relief to conscious patients without performing anesthesia are usually not attainable. There is insufficient training for such practitioners in the diagnosis and treatment of complications that may or may not result from providing sedatives and analgesics to conscious patients. Inadequate quality management procedures or mechanisms for the care of conscious patients undergoing medical or surgical procedures that are painful and anxious, and the devices and methods used for such care are inadequate It is.

A further focus of the present invention is to integrate and correlate drug delivery with electronic monitoring of physiologic symptoms of conscious patients during drug delivery and electronic feedback values indicative of the patient's physiological symptoms, making it safe and economical Electronic management of drug delivery by software that makes conservative decisions to ensure optimal nursing. Quite often with conscious sedation, the patient's physiological symptoms during drug delivery and recovery are not well monitored and electronically not monitored at all. That is, in most cases there is no electronic monitoring of basic patient vital signs such as blood pressure and blood oxygen saturation (oxygen measurement), and the carbon dioxide level (capnometry) as the patient inhales and exhales gas. There is no electronic monitoring. For example, patients undergoing painful procedures in a dentist office may receive nitrous oxide (N ₂ O) gas to relieve pain, but such drug delivery is often the case for patients Devices that integrate patient electronic monitoring safely and effectively into such drug delivery mechanisms are not currently available to non-anesthetists, without electronic monitoring of other physiological symptoms.

  In other situations that involve providing sedation and analgesia by the treating physician, such as catheterization practiced by a cardiologist in a hospital laboratory, an electronic patient monitor may be used, Currently, electronic patient monitors are integrated safely and effectively into mechanisms for drug delivery, mechanically (by close physical proximity and introduction to the structural system), and electronically (by modest software management). The device is not available to non-anesthetists.

One aspect of the present invention eliminates device features that complicate the provision of patient pain and anxiety, allowing non-anesthetists to provide safe and economical optimal conscious sedation and analgesia. The present invention relates to simplification of a drug delivery machine to alleviate patient suffering and anxiety by including a feature to do so. More specifically, the current anesthesia machine used by anesthesiologists to provide general anesthesia and forms of conscious sedation administered by anesthesiologists known as “monitored anesthesia nursing” (MAC) include: Such as an oxygen (O ₂ ) flush valve that provides a large amount of oxygen to the patient under excessive pressure and can provide a carbon dioxide (CO ₂ ) absorbent that absorbs CO ₂ from the gas exhaled from the patient. Various complex features are included. In addition, anesthesia machines typically deliver halogenated anesthetic gases that can cause malignant hyperthermia. Malignant hyperthermia is a rare but very serious condition that requires rapid training and skill of anesthesiologists for rapid diagnosis and therapy. The tracheal circuit in current anesthesia machines is substantially annular and self-contained, with the patient inhaling an oxygen / anesthetic gas mixture, exhaling the mixture, and the exhaled mixture then passes through the CO ₂ absorber. The patient again inhales the filtered gas mixture (supplemented with further anesthesia and oxygen) and repeats this process.

In particular, these aspects of the anesthesia machine can involve risks for the patient. The risk is that the anesthesia machine requires manipulation by a specialist (eg, anesthesiologist or CRNA) trained through a multi-year training institution for detecting and correcting technical failure modes. And so on. For example, an oxygen flush valve can cause oxygen to enter the patient's stomach and cause vomiting, and the carbon dioxide-absorbing material can fail, but if the failure is not quickly detected and corrected, the patient Will receive the carbon dioxide. Furthermore, by using a self-contained annular trachea circuit, the supply of O ₂ suddenly stops, and the patient breathes under a limited supply of oxygen without the need for additional O ₂ or air. It can happen. Notably, because of these features, non-anesthetists cannot use anesthesia machines. Therefore, the focus of this aspect of the invention is to select and introduce appropriate features so that non-anesthetists can easily perform safe and effective sedation of consciousness. Is to simplify.

  Certain embodiments of the invention also deliver one or more sedatives, analgesics, and / or memory loss agents to conscious, spontaneously ventilated patients who are not intubated into the larynx, etc. The focus is on ensuring that patient awareness is maintained and tracheal obstruction is prevented, including monitoring the patient's level of consciousness while preventing tracheal obstruction. For patients who have not been intubated into the larynx, etc. on the artificial respirator, monitoring the patient's level of consciousness will maintain the patient's trachea, the reflex effects when the trachea is depressed and the possibility of breathing by breathing drive It is important to provide information about the ability to perform and the potential for cardiovascular instability. Integrating such a mechanical and electronic monitoring of a patient's level of consciousness into a drug delivery system, despite the importance of monitoring and maintaining a sufficient level of consciousness in a particular medical environment As a result, no device is currently available to reliably maintain patient awareness. The present invention also relates to such unsatisfied requirements.

  Innovations over the last few decades have introduced non-invasive or minimally invasive techniques for diagnosis, treatment, beauty, and other procedures. These developments involve the transition of non-invasive or minimally invasive clinical procedures from hospital operating rooms to procedure laboratories, outpatient surgery centers, or office based suites. ing. Because these interventions are inherently painful and constrained, or may require organ manipulation, active pain management during the procedure is required. In addition, patient movement as an instinct response to pain, for example, may result in sub-optimal performance of the procedure, and thus less than ideal results.

  Thus, sedative and analgesic administration has evolved into an essential component of such procedures. In addition to the cyclical shortage of anesthesia personnel, the evolutionary nature of sedation and analgesic administration by non-anesthesiologists has allowed many trained clinicians to become independent, sometimes without the supervision of anesthesiologists. The sedation algorithm was developed. Each of these algorithms is usually very variable in quality and has been tailored to inconsistent approaches to preclinical screening, in-process monitoring, and clinician approaches to discharge criteria.

  One problem with using powerful drugs for procedure-based pain management is the risk that the patient will fall into general anesthesia due to negligence. Inexperienced clinicians may give too little sedation and analgesics (lack of pain management, excessive patient movement, poor patient satisfaction). Conversely, too much sedation and anesthetic causes false general anesthesia (GA) with the associated risk of being left to an anesthesiologist who is not trained in airway management and resuscitation. . Clinicians with multiple tasks may not have time to manually assess patient responsiveness as a guide to the depth of sedation or may forget it. Responsiveness is different from unconsciousness. Patients may not respond even if they are conscious. For example, a patient may be conscious and understand a command, but may not respond to the command inadvertently. Thus, loss of responsiveness as a precursor to loss of consciousness can provide a prior warning that loss of consciousness is likely to occur. A system available for automatic and continuous monitoring of responsiveness designed for multi-tasking clinicians currently delivering or supervising sedatives and analgesics during clinical procedures There seems to be no. Accidental general anesthesia has a more serious effect in the office environment and other environments outside the operating room, especially if airway management and resuscitation expertise is not readily available.

  Automated responsive monitors are believed to be most applicable to sedation and analgesia procedures, especially when integrated with a drug delivery system. However, automated responsive monitors can be used in many other environments, such as post-anesthetic treatment rooms, intensive care units, and operating rooms, as stand-alone monitors, or as other physiological monitors or PCA (patient-controlled analgesia) pumps. Is expected to have clinical utility.

  The present invention also relates to reducing pain and / or anxiety of conscious patients in an economical and timely manner. Solutions currently used to relieve patient suffering and anxiety from drug delivery and electronically monitor the patient's physiological symptoms are expensive and take considerable time to set up and remove. In addition, at present, anesthesiologist attendance is required or desired during medical or surgical procedures, which increases costs, especially when nursing within a patient is desired for nursing in an ambulance environment. For conscious patients without sufficient sedation and analgesia because appropriate methods and devices for providing such nursing (eg, replacement of trauma dressings at the burn site) are not currently available In the area where medical procedures are performed, such approaches are performed over a short period of time (because the patient cannot tolerate the level of pain), while doing fewer and clearer techniques, It may need to be done in some cases. When a large number of nursing tasks are required, costs usually increase. The present invention addresses such economic problems and provides a solution to the problems as described.

  The present invention further relates to providing relief from post-operative or post-procedure pain and discomfort in telemedicine nursing homes and home nursing environments. Current devices, for example, allow a particular patient in a home nursing environment to have a patient-controlled drug delivery device (e.g., having the patient press a button or toggle a switch to produce more pain medication (in most cases, By using a device) that allows it to be received (intravenously or transdermally), it may be possible to increase the dose of the analgesic. Such medical practice is sometimes referred to as “PCA” or patient-controlled analgesia. Known commercially available PCA type devices do not consolidate and conservatively manage the delivery of analgesics according to electronic monitoring of the patient's physiological symptoms. The present invention also focuses on this unmet need.

  Other aspects of the invention provide sedatives, analgesics, and / or memory loss agents to conscious patients in a doctor's office, hospital lab, or other ambulance environment, or telemedicine care setting. It relates to the integration of billing / information systems used with devices. Current technology for automated billing and invoicing does not provide a sufficient and efficient way to track the recurring benefits that can be obtained with repeated use of medical devices such as the apparatus of the present invention.

  Other focus of the present invention will become apparent from the following detailed description of the preferred embodiments.

  Known machines or methods managed by a non-anesthetist to provide sedation and analgesia to patients who are conscious, not intubated to the larynx, etc., and voluntarily ventilate are unreliable, economical and It is not satisfactory. Safe and economical sedation, analgesia, and awareness by integrating and correlating the delivery of sedatives, analgesics and / or amnesia to such patients with electronic monitoring of the patient's physiological symptoms Devices that reliably provide memory loss to certain patients are not commercially available. Available drug delivery systems have a safe set of defined data parameters to allow drug delivery to be managed electronically conservatively in relation to the patient's physiological symptoms (including vital signs). Has not been introduced to achieve safe and economical optimal drug delivery to patients. Available drug delivery systems constantly care about the effects and dangers of drug delivery, so that non-anesthetists can be safely and reliably released, and medical tests and techniques intended by non-anesthetists Does not introduce alarm alerts that allow you to focus on. Furthermore, there are no known patient-controlled analgesia devices that mechanically and electronically integrate and correlate electronic monitoring of patient requests for patient dosage adjustments and patient physiologic symptoms (through conservative software management).

  Known techniques do not fully or electronically monitor the patient's physiological symptoms, including vital signs, and are aware of sedation and analgesia without electronic integration or correlation between such patient monitoring and drug delivery. Focus on delivering to patients with disabilities. Other technologies focus on providing anesthetics to unconscious patients, which require an anesthesiologist to operate an anesthesia machine that is complex and well anticipated to fail. The

  Currently known dinitrogen monoxide delivery systems, such as those manufactured by Matrix Medical, Inc., Accutron, Inc., etc., are mainly used in dentist offices for conscious sedation. Used to provide. Such devices include sources of nitrous oxide and oxygen, gas mixing devices, and system monitors, but do not have mechanical or electronic integration of the patient's physiological condition monitor and drug delivery mechanism. . Similarly, other known drug delivery systems (eg, intravenous infusion or intramuscular delivery mechanisms) used to provide sedatives and analgesics to conscious patients, such as used in hospital laboratories, are well known in the art. There is no mechanical or electronic integration of the physiological symptom monitor and the drug delivery mechanism.

For example, to provide general anesthesia or MAC such as “NARKOMED line” machine manufactured by North American Drager and “EXCEL SE ANESTHESIA SYSTEMS” manufactured by Ohmeda Inc. Anesthesia machines used by anesthesiologists mechanically integrate an electronic patient monitor and physical proximity to a drug delivery mechanism. However, these machines use not only the annular tracheal circuit but also features such as O ₂ flush valves, drugs that cause malignant hyperthermia, CO ₂ absorbents, etc., so as to avoid the occurrence of life-threatening situations. M. D. A. (Or CRNA) is required. These devices do not provide electronic integration or management of drug delivery related to patient physiological condition monitoring and, of course, make conservative decisions to introduce established secure data definition parameters Electronic management through software or logic is not provided.

  US Pat. No. 2,888,922 (Bellville) discloses a servo control for automatically and continuously maintaining a patient's unconscious level based on a voltage indicative of the patient's cortical activity obtained by an electroencephalograph (EEG). A drug delivery device is disclosed. In response to a selected frequency of brain potential, the device continuously and automatically increases and decreases anesthetic gas flow (or IV infusion) in a robotic manner to maintain a constant unconscious level.

  US Pat. No. 4,681,121 (Kobal) provides an anesthetic agent by applying a continuous pain stimulus to the nasal mucosa and adjusting the level of anesthesia in response to an EEG signal indicative of the patient's response to the nasal pain stimulus. Disclosed is a device intended to maintain a sufficient unconscious level to measure the patient's sensitivity to distressing patients.

  In particular, any of the known devices described above delivers drug delivery to conscious patients using software or logic that makes conservative decisions that correlate drug delivery to an electronic patient feedback signal and a set of established safety data parameters. Do not manage.

  Current techniques for ensuring patient awareness during sedation and analgesia include dialogue or conversation between the clinician and the patient. Active participation or response to dialogue or verbal questions indicates to the clinician that the patient is conscious and responding. This is because the patient must be conscious to understand the question and think about the answer, and be responsive to be able to answer the question. In addition to requiring the clinician to speak, for example, not forgetting to speak, this technique is not available if the patient and clinician do not speak the same language.

  Among the non-subjective methods of assessing consciousness in several respects is the Bispectral Index (BIS), which places a sensor on the patient's frontal head and captures an EEG signal, and then EEG The signal is converted to a single number in the range of 100 (wake) to 0 (no brain electrical activity). In principle, BIS monitors help clinicians avoid patient underdose or overdose. The patient's consciousness or arousal level is not speci fi cally part of the actual consciousness monitoring process or method, but is speculative. Therefore, the BIS monitor is only a signal processing algorithm that correlates brain electrical activity with BIS values. When this system was used to monitor patients under general anesthesia, an unexpected arousal event was reported.

  Auditory evoked potential (AEP) is an electrical signal emitted by the brain in response to an audible stimulus and has been used to calculate an index representing the depth of anesthesia. The method includes providing a repetitive auditory stimulus to the patient, monitoring the AEP, and providing a signal corresponding to the roughness of the monitored AEP signal as a number indicating the depth of anesthesia. AEP, like BIS, estimates depth of anesthesia and does not explicitly entail patient cognitive ability in the monitoring process or method.

  Other partially subjective methods of measuring or grading levels of consciousness and / or sedation include the Glasgow Coma Scale, which assesses the level of consciousness after head injury. The Ramsay scale is used to assess the level of sedation, where 1 is “anxiety and excitement” and 6 is “sleep, no response to stimulus”. On the Ramsey scale, the stimulus is variable and irregular intensity and duration, and further, the interpretation of the response can be subjective. Observer's Assessment of Alertness / Sedaton (OAA / S) is also subjective in both stimulus delivery and response interpretation. The patient has four elements: responsiveness (responds instantly and speaks in normal tone-does not respond to light whistling and shaking), utterance (normal-few recognition words), facial expression (normal) Scored based on ~ loose jaws) and eyes (clear ~ stagnation).

[Summary of Invention]
The present invention provides a safe and effective delivery of sedatives, analgesics, memory loss agents, or other medicinal substances (medicines) to conscious, spontaneously ventilated patients who are not intubated into the larynx, etc. An apparatus and method are provided. The present invention alleviates patient pain and anxiety before and / or during a medical or surgical procedure and reduces pain or discomfort after the patient or after other procedures while at the same time allowing the physician to It relates to an apparatus and a method for enabling such pain and / or anxiety to be safely controlled or managed. The cost and time loss often associated with a traditional operating room environment can be avoided, or else the presence of an anesthesiologist may not be required or desired.

  The nursing system according to the present invention has at least one patient health monitor that monitors a patient's physiological symptoms integrated with a drug delivery controller that delivers analgesics or other drugs to the patient. A programmable, microprocessor-based electronic controller is generated from a patient health monitor and indicates an electronic feedback signal indicative of the actual physiological condition of the patient and at least one safe and undesirable parameter of the patient's physiological condition. Is compared to a stored safety data set that reflects and administers medication or delivery to the patient according to the comparison. In a preferred embodiment, the management of drug delivery is performed by the electronic controller via software that makes a conservative decision to access the stored safety data set.

  In another aspect, the present invention also includes at least one system status monitor that monitors at least one operational status of the nursing system, the system status monitor being integrated with a medication delivery controller that delivers medication to the patient. Yes. In this aspect, the electronic controller receives an instruction signal generated from the system monitor and responds conservatively to control (ie, reduce or stop) drug delivery. In a preferred embodiment, this is accomplished by software control of the electronic controller so that the software has access to a stored data set that reflects the safe and undesirable parameters of at least one operating state of the nursing system, Compare the signal generated by the system health monitor with the stored parameter data set and control drug delivery accordingly, reduce drug delivery if the monitored system condition is outside the safe range or Stop. The electronic controller also activates a caution command device, such as a visual or audible alarm, in response to a signal generated by the system status monitor to alert the physician of abnormal or unsafe operating conditions of the nursing system device.

  The present invention further relates to an apparatus having a drug delivery controller for delivering a drug to a patient electronically integrated with an automated consciousness monitoring system that confirms the patient's consciousness and generates a signal value that reflects the patient's consciousness. Also included is an electronic controller that is interconnected to the medication delivery controller and the automated awareness monitor and that manages delivery of the medication according to signal values that reflect patient awareness.

  In another aspect, the invention includes one or more patient health monitors and automated consciousness monitoring systems, such as pulse oximeters or capnometers, where the patient health monitor and consciousness monitoring system is an analgesic or other drug Integrated into a drug delivery controller that delivers to the patient. A microprocessor-based electronic controller is an electronic feedback signal that indicates the patient's actual physiological symptoms, including consciousness levels, and a safety data set that contains parameters that reflect the patient's physiological symptoms (including consciousness levels) In accordance with this comparison, drug delivery is managed while confirming patient awareness. In another aspect of the invention, the automated awareness monitoring system has a patient stimulation or interrogation device and a patient initiation response device.

  This automated awareness monitoring system relies on automated means to monitor patient responsiveness. Unlike other consciousness assessment methods, the design of these tools uses the patient's cognitive ability as an integral part of the monitoring paradigm. The technique of providing a question recognizes and interprets the question or stimulus and confirms that the patient's responsiveness is directly measured in response to the patient's cognitive and psychological actions that consider and describe the response. This responsiveness measurement method minimizes the possibility of false response assessments that can result in drug overdose and unconsciousness. This test is benign and inexpensive and can be repeated if the patient does not respond. Repeating the test reduces the risk of false evaluation of unresponsiveness, which can lead to drug overdose and poor pain management during sedation and analgesia.

  Loss of responsiveness can be a sign of memory loss. If the patient is unresponsive during the painful part of the procedure, the patient is likely not to remember the painful episode, depending on the intensity of the pain and the invasiveness of the procedure. Therefore, memory loss can be facilitated by predicting painful episodes and titrating the drug until the patient becomes unresponsive using an ACQ monitor and ART test. Thus, patient movement may occur involuntarily in response to pain, but if the clinician knows that the patient is likely not to remember the painful episode, clinical Medical concerns can be reduced.

  The present invention also provides an apparatus and method for relieving pain or discomfort after surgery or other procedures in a home nursing environment or telemedicine care location. Here, the nursing system has at least one patient health monitor integrated with patient controlled drug delivery. The electronic controller manages patient controlled drug delivery according to an electronic feedback signal from the patient health monitor. In a preferred embodiment, the electronic controller is responsive to software that provides conservative management of drug delivery according to a stored safety data set.

  Many of the other objects and intended advantages of the present invention will, of course, be further understood by reference to the following detailed description of the preferred embodiments of the invention, considered in conjunction with the accompanying drawings. .

1 is a perspective view of a preferred embodiment of a nursing system device constructed in accordance with the present invention showing the provision of sedatives, analgesics, and / or memory loss agents to a patient conscious by a non-anesthetist. FIG. 1 is a perspective view of a preferred embodiment of a nursing system apparatus constructed in accordance with the present invention showing a user interface and a patient interface device. FIG. 1 is a side view of a preferred embodiment of an apparatus constructed in accordance with the present invention. 1 is a side view of a preferred embodiment of an apparatus constructed in accordance with the present invention. 1 is a schematic block diagram of the present invention. It is a schematic data flow figure showing a medicine delivery management mode of the present invention. It is a figure which shows preferable embodiment of this invention. 1 shows a preferred embodiment of a drug delivery system according to the present invention. FIG. FIG. 2 shows details of a preferred embodiment of a drug source system according to the present invention. FIG. 2 shows details of a preferred embodiment of a drug source system according to the present invention. FIG. 2 shows details of a preferred embodiment of a drug source system according to the present invention. 1 is a diagram showing a preferred embodiment of an electronic mixer system according to the present invention. FIG. FIG. 2 shows one embodiment of a manifold system according to the present invention. It is a figure which shows 2nd Embodiment of the manifold system by this invention. 1 shows a preferred embodiment of a manual bypass system according to the present invention. FIG. 1 shows a preferred embodiment of a scavenger system according to the present invention. FIG. 1 shows a preferred embodiment of a patient interface system according to the present invention. FIG. 1 is a front perspective view of a preferred embodiment of a hand cradle device constructed in accordance with the present invention. FIG. 1 is a side view of a preferred embodiment of a hand cradle device constructed in accordance with the present invention. FIG. 1 is a rear perspective view of a preferred embodiment of a hand cradle device constructed in accordance with the present invention. FIG. 1 is a rear perspective view of a preferred embodiment of a hand cradle device constructed in accordance with the present invention. FIG. FIG. 6 is a front perspective view of another embodiment of a hand cradle device constructed in accordance with the present invention. 1 is a top view of a patient drug dose request device according to the present invention. FIG. 1 is a perspective view of a preferred embodiment of the present invention including a hand cradle device and an earpiece combination oximeter / auditory interrogation device. FIG. 1 is a side view of an ear pad placed in a patient's ear containing a pulse oximetry sensor and an auditory question according to the present invention. FIG. FIG. 6 is a diagram showing another preferred embodiment of a nursing system apparatus constructed according to the present invention. 1 illustrates a user interface system according to a preferred embodiment of the present invention. FIG. 2 illustrates various peripheral devices included in a preferred embodiment of the present invention. FIG. 2 illustrates various peripheral devices included in a preferred embodiment of the present invention. 1 is a diagram illustrating a preferred embodiment of a patient information / billing system according to the present invention. FIG. FIG. 6 illustrates an example of a drug delivery management protocol for a three-stage alarm condition that reflects monitored patient parameters according to the present invention. FIG. 7 illustrates an example of a drug delivery management protocol for a two-stage alarm condition that reflects a monitored system condition parameter according to the present invention. It is a figure which shows 1st Embodiment of the user interface screen display by this invention. It is a figure which shows 2nd Embodiment of the user interface screen display by this invention. FIG. 6 is a data flow diagram illustrating example steps performed by drug delivery management software or logic in response to a patient health monitor according to the present invention. FIG. 6 is a data flow diagram illustrating example steps performed by medication delivery management software or logic in response to a system status monitor according to the present invention. FIG. 4 is a diagram illustrating an example of an ART question cycle according to the present invention. FIG. 6 is a schematic diagram of another embodiment of a handset device constructed in accordance with the present invention. FIG. 6 is an interior view of another embodiment of a handset device constructed in accordance with the present invention. FIG. 6 shows another embodiment of a headset device constructed in accordance with the present invention. It is a figure which shows 3rd Embodiment of the user interface screen display by this invention. It is a figure which shows 4th Embodiment of the user interface screen display by this invention. It is a figure which shows 5th Embodiment of the user interface screen display by this invention.

[Detailed Description of Preferred Embodiments]
The embodiments illustrated below are not exhaustive and do not limit the invention to the disclosed forms. The embodiments are selected and described to illustrate the principles of the invention and its applications and uses, thereby enabling those skilled in the art to make and use the invention.

FIG. 1 shows sedatives, analgesics, and / or memory loss agents for conscious, intubated, spontaneously ventilated patients undergoing medical or surgical procedures by the treating physician. 1 illustrates a nursing system 10 constructed in accordance with the present invention. The system 10 has a generally cylindrical housing 15 with various storage compartments 16 for storing user and patient interface devices, and a base 17 supported on caster wheels 18. The drug delivery system 40 delivers a mixture of one or more gaseous sedatives, analgesics, or amnesia agents in combination with oxygen (O ₂ ) gas to the patient, one end to the face mask 30. A one-way tracheal circuit 20 is connected and connected at the other end to a manifold valve system housed in the housing 15. 3A and 3B show a side perspective view of the trachea circuit 20, the face mask 30, and the exhaust hose 32 that exhausts the patient's exhaled gas to a safe location.

  Referring to FIG. 2, a lead 50 is a microprocessor-based electronic controller or computer (here, the main one or more patient interface devices (eg, 55) disposed within the housing 15). Connected to a logical board (MLB)). Electronic controllers or major logic boards are commercially available programmable types, such as those manufactured by Texas Instruments (eg, XK21E) and National Semiconductor (eg, HKL72), among others. It may include a combination of microprocessors and other “chips”, memory devices and logic devices on various boards. The patient interface device 55 is one that monitors the patient's physiological symptoms, such as a known pulse oximeter, capnometer (not shown), non-invasive blood pressure monitor, EKG, EEG, auditory monitor (not shown). It may include an or more health monitor, an automated awareness monitoring system that includes a query initiation and response device according to the present invention (described below), and a patient drug dose request device (also described below). The main logic board electronically manages the operation of the device 10 by software that makes conservative decisions that integrate and correlate patient feedback signals received from one or more patient health monitors with drug delivery.

  A display device 35 integrated on the upper surface of the apparatus 10 that displays the patient and system parameters and the operating status of the apparatus, for example patient parameters indicating the status of various system alarms with the patient's physiological symptoms and time stamps. Various user interface devices are also shown in FIGS. 1 and 2, including a printer 37 that prints hard copies and a remote control device 45 that allows a physician to interact with the apparatus 10. Various patient and user interface devices are described in further detail below.

  While certain embodiments of the present invention illustrate anesthesia delivery system 40 in a form that delivers one or more sedatives, analgesics, or memory loss agents in a gaseous state, the present invention also includes In particular, it is recognized that such agents also include embodiments where the drug is delivered via veins in a mist, vapor or other inhalation form and / or transdermally, such as using known ion transfer principles. I want to be. Agents that can be delivered by the nursing system include, but are not limited to, nitrous oxide, propofol, remifentanil, dexmedetamidine, epibatadine, and sevoflurane. Other embodiments are described in further detail herein.

  FIG. 4A is a schematic block diagram of a preferred embodiment of the present invention. FIG. 4B is a schematic data flow diagram illustrating drug delivery management steps performed by software / logic control of the microprocessor controller 14 in the preferred embodiment of the present invention. In FIG. 4A, in addition to the patient awareness monitoring system, one or more patient health monitors 12a (pulse oximeters, capnometers, other ventilation monitors, non-invasive blood pressure monitors, EKG, EEG, etc. or Further known patient physiologic condition monitors) are electronically connected to the electronic controller 14 through appropriate A-D converters as needed, as described above. The patient health monitor 12a generates an electronic feedback signal that is converted to an electronic signal and then provided to the controller 14 indicating the actual patient physiological data. Referring now to FIG. 4B, the electronic controller 14 may, for example through appropriate software and / or logic, the received patient electronic feedback signal 13b to be stored in a safety data set stored in a memory device (such as an EPROM device). Compare with 15b.

  The stored safety data set 14a (FIG. 4A) includes at least one set of data parameters indicative of safe and undesirable patient physiological symptoms. Based on the comparison of the actually monitored patient physiological data 13b with the safety data set 14a, the controller 14 determines whether the monitored patient physiological data is outside a safe range (FIG. 4B, 16b). If the monitored patient data is outside the safe range, the electronic controller 14 sends an instruction command (signal) to the drug delivery controller 2a (FIG. 4A) and conservatively manages the drug delivery to the drug delivery controller 2a. (Eg, decrease or stop) (FIG. 4B, 18b). The drug delivery controller 2a may be a standard solenoid valve type electronic flow controller known to those skilled in the art.

  As described below, further embodiments of the present invention also provide an electronic feedback signal that indicates to the controller 14 a patient controlled drug dose increase / decrease request, and the patient's physiological parameters and / or nursing system Consider providing electronic management of drug delivery that takes into account such patient requests with respect to status.

  FIG. 5 shows a block diagram of a preferred embodiment of a nursing system according to the present invention. The analgesic delivery system 2 of FIG. 5 provides a patient with a mixture of gaseous sedatives, analgesics, and / or memory loss agents (such as dinitrogen monoxide, sevoflurane, or nebulized anesthetics) and oxygen gas. Delivered to. A manual bypass circuit 4 (shown in more detail in FIGS. 6 and 10A) is connected to the manifold system portion of the analgesic delivery system 2 and bypasses the analgesic source that allows manual control of atmospheric delivery to the patient. The auxiliary inlet 6 is provided to the analgesic delivery system 2 and allows for the provision of an internal supply of gaseous drug or oxygen to the delivery system 2. The scavenger system 8 (shown in detail in FIG. 10B) is connected to the analgesic delivery system 2 and collects the gas exhaled from the patient and exhausts them to a safe location through the exhaust hose 32 (FIG. 3B).

The patient interface system 12 may be one or more patient health monitors (which may be non-invasive blood pressure monitors or known vital signs monitors such as known pulse oximeters, capnometers, EKGs, etc.), Means for monitoring the patient's level of consciousness and / or means for the patient to communicate with the system 10 (FIG. 1), eg, by requesting an increase or decrease in drug dosage. These one or more patient monitoring and requesting devices are electronically connected to the electronic controller 14 and, via an A-D converter, feedback signals indicating the patient's actual physiologic symptoms and drug dose requests. Is provided to the electronic controller 14. The controller 14 compares the received electronic feedback with data stored in the memory device. This data is a set of one or more safe and undesirable patient physiological symptom parameters (eg, safe and undesirable O ₂ saturation, end-tidal CO ₂ levels, and / or patient awareness levels). Indicates. These sets of parameters are collectively referred to as a safety data set. Based on this comparison, the controller 14 directs a conservative application of drug delivery at a safe and economical optimal value according to the parameter.

  Still referring to FIG. The user interface system 16 (described in further detail in FIGS. 18 and 22) displays electronic signal values that are stored in or provided to the electronic controller 14. Such values reflect one or more patient's physiological condition status, patient awareness level, and / or various nursing system status parameters. User interface system 16 allows non-anesthetists such as keyboard 230 (FIG. 2) and / or remote control unit 45 (FIG. 1) to interact with the nursing system via controller 14 (eg, enter patient information) Including devices that allow presetting doses, stopping alarms). Patient and care system information is displayed by graphical and numerical display devices (eg, 35) (FIG. 1), LEDs provided on housing 15 (FIG. 1), and / or remote control unit 45.

  The external communication device 18 (also described in FIGS. 19A and 19B) allows electronic information signals to be transmitted and / or received to the electronic controller 14 and to external computers at a remote location or on a local network. Peripheral devices 22, such as doors and temperature sensors, among others, electronically communicate with the controller 14 to ensure proper, safe and stable operation of the nursing system 10.

  In the following, the system outlined in FIG. 5 will be described in more detail.

  FIG. 6 provides a patient with a mixture of one or more gaseous sedatives, analgesics, and / or amnesia, oxygen, and air (each provision is independent (manually An overview of the preferred drug delivery system 2 (FIG. 5) (which can be adjusted in and via the electronic controller 14) is shown in more detail. The drug delivery system is comprised of a drug source system 42, an electronic mixer system 44, and a manifold system 46.

  The drug source system 42 includes one or more gaseous drug and oxygen sources and is connected to the electronic mixer system 42 through a pneumatic system. The drug source system 42 is also electronically connected to the electronic controller 14 and monitors one or more operational states of the drug source system 42 as described below (eg, whether the drug is flowing). Sensor). The system information monitored in this manner is converted into an appropriate electronic signal and fed back to the electronic controller 14 via electronic coupling.

The electronic mixer 44 receives one or more gaseous agents, O ₂ , and the atmosphere through the pneumatic system and mixes them electronically. The electronic mixer 44 also has a sensor that is electronically connected to the electronic controller 14 and provides an electronic feedback signal to the electronic controller 14 that reflects the system operating parameters of the mixer 44. The mixer 44 includes an electronic flow controller having a solenoid valve that receives a flow control instruction signal from the controller 14.

The manifold system 46 is connected to the electronic mixer 44 through a pneumatic system and receives a mixture of one or more gaseous agents, O ₂ , and air from the electronic mixer 44 and passes the mixture to the tracheal circuit 20 (FIG. 1) and delivered to the patient via face mask 30 (FIG. 1). The manifold system 46 also has a sensor that is electronically connected to the electronic controller 14 and provides an electronic feedback signal to the controller 14 that reflects the operating parameters of the manifold system 46. The manifold 46 delivers the gas exhaled by the patient to the scavenger system 48 and is exhausted to a safe location via the exhaust hose 32 (FIG. 3B).

  7A-7C show the drug source system 42 in more detail. Referring to FIG. 7A, the analgesic source system includes a drug source system 142 that provides a source of one or more sedatives, analgesics, and / or memory loss agents, and an oxygen source system 144 that provides an oxygen source. Have In embodiments of the invention in which the drug is gaseous, the source of drug and oxygen provides the gas at a low pressure and is designated by reference numeral 54 in FIG. It can be a contained tank. The availability of the nursing system of the present invention is enhanced by the ability to use other sources. This is because the system can function as a source-dependent unit in the room that accesses the internal gas supply or as a self-contained unit in the room that does not have an internal gas connection.

  In a further aspect of the invention, the drug source system 42 may have one or more of the following. That is, known nebulizers 143 that enable delivery of aerosolized drugs such as morphine, meperidine, fentanyl, known evaporators 145 that enable delivery of halogenating agents such as sevoflurane, propofol, remi, by continuous or bolus administration. A known infusion pump-type drug delivery device 147 or a known transdermal drug delivery device 149 that enables delivery of drugs such as fentanyl and other injectable drugs (including devices based on ion transfer). .

FIG. 7B shows the oxygen source system in detail and shows an oxygen tank or other source 104 of oxygen and an air oxygen pressure system 109 for delivering oxygen gas to the electronic mixer system 44 (FIG. 7A). A filter 106 a in the oxygen line 109 removes dirt in the oxygen stream from the oxygen source 104. A pressure sensor 106 (which may be of a known type and currently available) in the oxygen line 109 monitors the pressure in the oxygen source 104 and generates a signal reflecting it, thereby allowing the remaining oxygen to be measured. Measure quantity indirectly. The pressure sensor 106 is electronically connected to the electronic controller 14 and sends a signal to the controller 14 that reflects the pressure measurement in the oxygen source. In the preferred embodiment, the electronic controller 14 receives signals from the pressure sensor 106 and accesses data parameters stored in the memory device through software. The parameters reflect one or more set points that establish safe and undesirable operating conditions of O ₂ operating pressure. The controller 14 compares the actual O ₂ pressure with the stored parameter set point data. This comparison indicates that if the O ₂ pressure is outside the safe range established by the stored data, an alarm or other attention command device is activated and cannot be manually deactivated, The electronic controller 14 instructs the drug delivery flow to be reduced (or stopped) to a preset safe amount. The operation of the software control related to the system status monitor will be described in more detail with reference to FIGS. 21B and 23B.

The signal obtained from the oxygen source pressure sensor 106 is related to the user via a display device (eg, 35 in FIG. 2) for the remaining time currently in use, and the user ascertains whether the procedure can be completed. be able to. The user is immediately notified by an alarm, display device, or other suitable attention command device if the pressure is outside normal operating conditions. The pressure gauge 108 visually displays to the user the oxygen source pressure obtained by the sensor 106. The pressure regulator 110, which can be a known solenoid type or other suitable regulator currently available, can reduce the pressure in the oxygen source 104 to a reasonable operating pressure and provide a flow of O ₂ to the patient. . A check valve 112 in the oxygen line 109 downstream of the regulator 110 (the check valve may be a standard one-way type) prevents reverse flow of patient exhalation, and such reverse flow is Ensure that 110 and oxygen source 104 are not damaged or contaminated. In systems where an internal oxygen source 105 is used, the remote check valve 114 ensures that reverse flow from the patient's exhalation does not damage or contaminate the internal oxygen source 105. The pressure relief valve 116 discharges oxygen to the atmosphere when the pressure in the oxygen line 109 exceeds a safe operating value pre-programmed in the electronic controller 14.

  FIG. 7C shows the drug source system in detail, and in a preferred embodiment, has a tank or other drug source 204 and a pneumatic system 209 for delivering gaseous drug to the electronic mixer 44. Filter 206a in drug line 209 removes dirt in the drug stream from drug source 204. A pressure sensor 206 (which may be of a known type and currently available type) in the drug line 209 monitors the pressure in the drug source 204 and generates a signal reflecting it, thereby measuring the amount of drug. Measure indirectly. The pressure sensor 206 is electronically connected to the electronic controller 14 and sends a signal to the controller 14 reflecting the pressure measurement in the drug source. As described above in connection with the oxygen source pressure sensor 106 and FIGS. 21B and 23B, in a preferred embodiment, the controller 14 receives signals from the sensor 206 and, through software, safe and undesirable drug source pressure. Access stored data parameters reflecting operating conditions and conservatively control drug delivery according to the stored parameters.

  The signal obtained from the drug source pressure sensor 206 is associated with the user via a display device (eg, 35 in FIG. 2) regarding the remaining time currently in use, and the user ascertains whether the procedure can be completed. be able to. The user is immediately notified by an alarm, display device, or other suitable attention command device if the pressure is outside normal operating conditions. The pressure gauge 208 visually displays to the user the drug source pressure obtained by the sensor 206. A pressure regulator 210, which may be a known solenoid type currently available, can reduce the pressure in the drug source 204 to a reasonable operating pressure and provide a flow of drug to the patient. A check valve 212 in the drug line 209 downstream of the regulator 210 prevents a reverse flow of the patient's exhalation so that the reverse flow from the patient's exhalation does not damage or contaminate the regulator 210 and the drug source 204. Make sure. In systems where internal drug source 205 is used, remote check valve 214 ensures that reverse flow from the patient's exhalation does not damage or contaminate internal drug source 205. The pressure relief valve 216 discharges the drug to the atmosphere when the pressure in the drug line 209 exceeds a safe operating value pre-programmed in the electronic controller 14.

To improve safety, known pin indexed safety systems (P.I.S.S.) and / or diameter indexed safety systems (D.I.S.S.) For the source, it can be used for all of the O ₂ sources and line fittings as needed. This prevents, for example, the oxygen source 104 from being accidentally attached to the drug line 209 and the drug line 209 to the oxygen source 104.

  FIG. 8 details a preferred electronic gas mixer system that electronically mixes the gaseous drug and oxygen so that the correct flow rate of the gaseous drug and oxygen is delivered to the patient. By using the electronic mixer system of the present invention, the operational safety of the apparatus of the present invention is improved. This is because, as described below, the drug delivery volume can be electronically controlled in a closed loop manner by currently available electronic flow controllers. The electronic flow controller has a solenoid valve that stops drug flow to the patient when an unsafe patient or system condition occurs in response to a command signal from the electronic controller 14. Or reduce. Specifically, pneumatic oxygen system 109 and drug line 209 from analgesic source system 42 deliver gaseous drug and oxygen to filters 125 and 127 in lines 109 and 209, respectively, and filters 125 and 127 are in line. Filter the filth from 109 and 209. System status monitors, i.e., pressure sensors 129 and 131, monitor the line pressure of oxygen and gaseous drug, respectively, and send a signal reflecting the pressure to the electronic controller 14, which is shown in FIGS. 21B and 23B. The drug delivery is conservatively controlled according to a stored data set that includes parameters reflecting one or more of the safe and undesirable system operating conditions described above. Also, if any pressure deviates from the reference, the electronic controller 14 alerts the user immediately, for example by sending a signal with an alarm device.

  Electronic flow controllers 133 and 135, which can be currently known types with solenoid valves, are electronically connected to the electronic controller 14 and receive instruction signals from the electronic controller 14. The electronic controller 14 is programmed and / or calculated with the desired flow rates of oxygen and drug. The programmed flow rate may be entered by a physician user using conventional selections regarding drug dosages and rates, including, among other things, target controlled infusion principles in IV embodiments. The calculated flow rate can be reached through a software protocol that makes a conservative decision, including a comparison of actual patient physiologic feedback values with stored data indicating safe and undesirable patient physiologic symptoms. . Drug delivery occurs at a rate calculated by the flow controllers 133 and 135 in a closed control loop manner (described in further detail below). Drug administration can be a combination of input by one or more physicians and / or electronic flow rate calculations based on patient and system status parameters. The flow controller may respond to an instruction signal initiated by the electronic controller 14 or a physician.

  Flow controllers 133 and 135 receive instruction signals from controller 14 that reflect the electronic output of the system status monitor (such as pressure sensors 106 and 206 described above) and the patient status monitor. In response to the instruction signal from the controller 14, the flow controllers 133 and 135 indicate that the system status and / or patient health monitor indicates that the malfunction of the nursing system 10 has occurred in the controller 14, and that the system 10 has established safety. Reduce or stop the flow of drug delivery when showing that it is operating in a state other than normal or that the patient's physiological state (eg, vital signs or level of consciousness) has deteriorated to an unsafe state Can do.

  Since the present invention includes intravenous and gaseous delivery in other forms of drug delivery, such embodiments are also connected to the electronic controller 14 and instructions from the controller 14 that reflect both patient and system conditions. A known electronic flow controller responsive to the signal may be included.

  Refer to FIG. 8 again. Solenoid valve 132 is electronically connected to electronic controller 14 and must be actuated by electronic controller 14 before the drug flows through line 209. If system power fails, drug delivery stops due to the fail-closed nature of solenoid valve 132. This is shown, for example, in FIG. 21B. FIG. 21B shows that if the system status monitor indicates a power failure, alarm type “2” sounds, alerts the non-anesthetist, and drug delivery is stopped (ie, reduced to 0%). ing.

In addition, the pressure actuated valve 134 in the drug line 209 responds to the magnitude of the pressure in the O ₂ line 109 and allows gaseous drug flow only if sufficient oxygen is flowing through the oxygen line 109. To. A check valve 136a in the drug line 209 ensures that the gaseous drug flow to the manifold system 46 is unidirectional and there is no reverse flow. A check valve 136b in the oxygen line 109 ensures a one-way flow of O ₂ to the manifold system 46 without backflow.

  In the atmospheric line 139, the air inlet solenoid valve 137 is electronically connected to and activated by the electronic controller 14, and when activated, the atmospheric air can be mixed with oxygen gas by the air exhaust 138. The air discharger 138 discharges a fixed ratio of air to the oxygen line 109. The filter 128 removes dirt from the air line 139 and the check valve 136c ensures a one-way flow without backflow of air from the solenoid valve 137 to the exhaust 138.

Reference is made to FIG. 9A, which details one embodiment of the manifold system 46 (FIG. 6). The drug / O ₂ gas mixture from the electronic mixer system 44 (FIG. 6) enters the manifold system 46 and flows to the inspiration plenum 150 and from there through the inspiration line 151 to the main inspiration valve (PIV) 152. To the trachea circuit 20 and finally the mask 30 (FIG. 1). The main inhalation valve 152 allows a one-way flow of the gas mixture, ensuring that the gas exhaled from the patient does not enter the inspiratory side of the manifold system 46 (FIG. 6) and can thereby occur Protect from contamination. Atmosphere can enter the inspiratory line 151 through an inspiratory negative pressure relief valve (INPRV) 154 that draws a considerable negative vacuum to the inspiratory side of the manifold system 46. In some cases (eg, when the patient does not inhale and receive no oxygen or does not inhale and receive enough oxygen), it allows a one-way flow of air to reach the patient. The INPRV 154 thereby substantially allows air on demand of the patient. The INPRV filter 153 removes particles that may be present in the air line 155 or the atmosphere. The INPRV status sensor 156 (which may be a known pressure, temperature, infrared, or other suitable type) monitors the degree of open / closed state of the INPRV 154 and provides a signal that is converted to an appropriate electronic (digital) signal. And the state of the INPRV 154 is transmitted to the electronic controller 14. In the exhalation phase of the patient's respiratory cycle, the inspiratory reservoir bag 149 collects the drug / O ₂ / air mixture that the patient inhales in the next inhalation phase.

Refer to FIG. 9A again. The pressure sensor 166 measures the pressure in the tracheal circuit 20 (FIG. 1) and indicates whether the tracheal flow, ie, the main inspiration valve (PIV) 152 or the main exhalation valve (PEV) 168 is occluded. Used for. For example, sensor 166 reads a high pressure indicating that PEV 168 is blocked, while a low pressure indicates that PIV 152 is blocked. The tracheal circuit 20 (FIG. 1) also includes an inspiratory oxygen fraction (FIO ₂ ) sensor 167 (which may be a known type currently available). The FIO ₂ sensor 167 measures the oxygen percentage of the gas contained in the mixture delivered to the patient and a hypoxic mixture (ie, a drug / O ₂ mixture that does not provide enough O ₂ to the patient) is delivered to the patient. Prevent the possibility of being. The INPRV status sensor 156, pressure / tracheal flow sensor 166, and FIO ₂ sensor 167 are electronically connected to the electronic controller 14 and provide an electronic feedback signal to the electronic controller 14 that reflects system status parameters. As shown in FIGS. 21B and 23B, the controller 14 may, through software and / or logic, setpoints and / or logic types that reflect signals generated by these system monitors and safe and undesirable system operating conditions. Compare with a stored data set of system parameters established by the data, and if this comparison reveals that the nursing system 10 is operating outside the safe range, conservatively control drug delivery (eg, , Decrease or stop).

The tracheal circuit and mask (20 in FIG. 9) are interfaced with the patient and provide a closed circuit for delivering the drug / O ₂ gas mixture to the patient. Embodiments of the invention in which the drug is delivered in a form other than compressed gas (eg, intravenous or transdermal) include face masks, tracheal circuit features, and other aspects related to the delivery of gaseous drugs. It should be recognized that may not be included. When the drug is delivered in gaseous form and tracheal circuits and face masks are used, other features such as face masks, accompanying tracheal circuits, and scavenger systems were issued to Hickle et al. US Pat. No. 5,676,133, entitled “Expiratory Scavenging Method and Apparatus and Oxygen Control System for Post-Anesthesia Care Patients”. (For such embodiments, the specification of Hickle et al. Is incorporated herein by reference).

In a preferred embodiment, the mask is disposable, means for sampling the CO ₂ content of the patient's respiratory airflow, and optionally means for measuring the flow of the patient's airflow and / or auditory monitoring Have means. Sampling of CO ₂ in the patient's airflow can be performed by a capnometer or lumen provided in the mask through the mask inlet and positioned proximate to the patient's trachea. Similarly, a second lumen provided in the mask can also be used to measure the air flow in the patient's airflow. This air flow measurement can be accomplished by various devices currently available. An example of such a device is a device that measures the pressure drop in the airflow over a known resistive element and calculates the air flow using a known equation. The means for auditory monitoring can be a lumen placed in a mask with a microphone attached in the lumen. The microphone allows the audible sound of the patient's breath to be recorded, converted and output using an amplifier. It should be noted that the lumen for auditory monitoring can be a separate lumen or can be combined with a lumen for calculating the flow of the patient's airflow. It is further important to place lumens, particularly CO ₂ sampling lumens, close to the patient's open trachea and to ensure that such lumens are maintained close to the patient's trachea. I want to be.

Refer to FIG. 9A again. A primary exhalation valve (PEV) 168 in the exhalation line 172 ensures a one-way flow of gas exhaled from the patient to the scavenger pump system 48, which reverses the gas exhaled into the scavenger system. Prevent flow back to patient. Importantly, PEV 168 prevents rebreathing of exhaled carbon dioxide. As can be readily appreciated, the manifold 46 and tracheal circuit 20 of the preferred embodiment of the present invention allows only one-way tracheal flow. That is, unlike conventional devices that use an annular tracheal circuit (which requires a CO ₂ absorber to allow rebreathing of exhaled air), in this embodiment of the present invention, exhaled There is no gas rebreathing.

In the embodiment of the invention shown in FIG. 9A, exhalation positive pressure relief valve (EPPRV) 164 in exhalation line 172 is exhaled when sufficient positive pressure is generated on the exhalation side of the manifold system. Gas can escape to the atmosphere. This can occur, for example, if the patient is exhaling but the scavenger system 48 (FIG. 6) is occluded or not operating properly. The EPPRV filter 175, downstream of the EPPRV 164 filter, filters the dirt before the expiratory flow flowing through the EPPRV 164 enters the atmosphere. The expiratory negative pressure relief valve (ENPRV) 178 is a one-way valve that draws air to the expiratory plenum 180 and then to the scavenger system 48 when sufficient vacuum pressure is drawn to the expiratory side of the manifold system 46. Can be made. This can occur, for example, when the scavenger system 48 vacuum pump is set very high or the PEV 168 is blocked. The exhalation storage bag 177 collects gas exhaled from the patient while exhaling via the exhalation plenum 180. These gases are exhausted by the scavenger system 48 in the next patient inhalation phase. As described in detail below, a patient vital signs monitor, such as a capnometer 184, monitors the amount of CO _{2 in} the gas exhaled from the patient and reflects an electronic feedback signal that reflects the CO ₂ level in the patient's exhalation. Is provided to the controller 14. Other types of ventilation monitors such as air flow measurement instruments, IPG devices, or auditory monitors can also be used to provide the controller 14 with an electronic feedback signal that reflects patient health parameters.

  In another preferred embodiment shown in FIG. 9B, ENPRV 164, filter 175, and ENPRV 178 have been removed. Instead, a long pipe or similar conduit 175a interconnected with the storage bag 177 and opened to the atmosphere is used. Removing valves 164 and 175 provides a more economical and simple system, while scavenger system 48 is blocked or set very high by using pipe 175a instead. Even if PEV 168 is occluded or otherwise blocked, patient can be sure to access the atmosphere and patient can exhale into the room or air can enter the system . A highly compatible storage bag 179 also helps capture excess flow of exhaled air. In this simplified embodiment, there are substantially only three valves, PIV152, PEV168, and INPRV154.

  As noted above, system valves PIV152 and PEV168 ensure one-way flow of inspiratory and expiratory gases. The patient cannot rebreath the exhaled gas and impurities cannot enter the source system. The valve systems INPRV 154, EPPRV 164, and ENPRV 178 (or other INPRV 154 and pipes) provide system fail-safety. If the analgesic source system 42 (FIG. 6) or the scavenger system 48 (FIG. 6) is functioning improperly, the valve opens and the patient can breathe without much effort. System status sensors 156, 166, and 167 monitor system operations, such as INPRV valve status, gas pressure, and inspiratory oxygen ratio, and provide signals to microprocessor controller 14 that reflect the operating status of these operations. To ensure safe operation of the device.

It should be noted that the valves and sensors between INPRV 154 and ENPRV 178 in the preferred embodiment of the manifold system 46 can be considered a system condition monitoring system. This is because there is no valve controlled by the software of the electronic controller 14. At this point in the nursing system 10, the gas is already mixed and the volume is determined by the flow controllers 133, 135 (FIG. 8). Manifold system 46 (FIG. 6) provides at least two basic services, sensor inputs for FiO ₂ and CO ₂ (167, 184 in FIG. 9), and flow conditions obtained from flow sensor 166 (FIG. 9). provide.

  The determination of the appropriate drug delivery / flow percentage by the controller 14 can be accomplished by various methods. Initial drug dosages and rates can be selected and entered by a physician using conventional methods. Physicians can also use pharmacokinetic / pharmacodynamic modeling to predict the resulting drug concentration and its efficacy based on the physician's choice, but automatically determine the drug concentration without directing the doctor Is not allowed to change. In an intravenous embodiment, a known target controlled infusion technique allows a physician to determine a desired (target) serum or brain active site concentration based on patient parameters such as height, weight, sex, and / or age. Can be used to select

During operation of the system when an internal or external event occurs, such as activation of a system or patient health monitor alarm, or a request for increased medication by a physician or patient, the electronic controller 14 may receive a desired amount of intravenous medication (or The ratio of O ₂ , gaseous drug, and air in the total gas flow) is determined as a function of such events. The actual IV drug concentration (or gaseous drug / O ₂ / air ratio) is then calculated. These actual calculated quantities are not necessarily the same as requested (eg, by the user, patient, or system). This is because the relationship between drugs or drugs and gas mixtures is often complex. In short, the drug mixture ratio is, for example, when the alarm level changes, when an alarm timeout occurs (eg when the initial alarm is not stopped by the user), when the user requests a change, when the patient requests a change. Usually calculated when the approach begins (the system relies on default values) and when the controller clock is triggered.

In a preferred embodiment of the present invention for delivering a gaseous drug, the flow controller in the mixer 44 (shown in detail in FIG. 8) is for each gas to be controlled (ie, gaseous drug, oxygen, and atmosphere). Determine the total fresh gas flow (FGF), which is the sum of the volumes. Solenoid valves open in unison to achieve the desired FGF and ratio amount of each gas. The flow controllers 133, 135 close the feedback loop on the gas ratio by measuring the ratio of FiO ₂ and inspiratory gaseous drug in the manifold system 46 and adjusting the mixer solenoid valve accordingly.

  In one aspect of the invention, the flow controllers 133, 135 match the FGF to the patient's minute ventilation. Minute ventilation is the volume of breath that a person inhales and exhales in one minute (eg, in cubic centimeters or milliliters). The patient's respiratory physiology is balanced in this minute ventilation. The nursing system optimizes the FGF rate by matching gas delivery to the patient's minute ventilation. This maintains the gas supply, minimizes the release of anesthetic gas to the operating environment and assists in balance of respiratory function. For example, if FGF is smaller than minute ventilation, INPRV 154 opens and replenishes air flow (INPRV 154 becomes a mechanical system that is not under electronic control).

  In a further aspect of the present invention, the nursing system measures and monitors “effective minute ventilation” rather than merely measuring and monitoring minute ventilation as described above, thereby being considered by the system. Improve quantitative information about patient physiology. “Effective minute ventilation”, as used herein (as opposed to “single volume”, which is simply the volume of gas that a person inhales and exhales) It is a term used to mean the amount of gas that is actually involved in the exchange of respiratory gas with other capillary blood. This measurement measures the volume of anatomical space (estimated from the patient's height and weight) placed between the air source (eg, mouth) and the transfer of gas in the alveolar sac once the gas It can be accomplished by subtracting from the volume to obtain an “effective one-time volume”. “Effective minute ventilation” is then obtained by multiplying the effective tidal volume by the respiration rate.

  FIG. 10A shows details of the manual bypass system 4 (FIG. 5) connected to the manifold system 46. The bypass system 4 has a self-inflating resuscitation bag (SIRB) 19a (also shown in FIG. 3B). The SIRB 19a is a manual pump that allows the user to continuously provide air to the patient through the bypass air line 90. A quick cut fixture 91 (as disclosed in Hickle above) connects SIRB 91a to manifold system 46 and can be quickly attached. The manual flow control valve 92 opens and closes the bypass air line 90. When line 90 is open, manual flow control valve 92 can be adjusted to provide the required air flow. The flow meter 94 disposed in the bypass air line 90 visually displays the state of the air flowing through the bypass air line 90 to the user. The manual bypass system 4 described above provides the patient with a manual control flow of air and enables air delivery in the event of a failure of the oxygen source system 144 (FIG. 7A).

  FIG. 10B shows details of the scavenger pump system 48 (FIG. 6). The scavenger pump system 48 is integrated with the nursing system and exhausts the gas exhaled from the manifold system 46 through the scavenger line 85. The filter 86 in the scavenger line 85 removes dirt from the gas exhaled from the patient and flowing through the scavenger line 85. The pressure regulator 87 receives the filtered gas and ensures that the vacuum pressure is maintained in the downstream vacuum pump 95 at a level that will work reasonably. The flow restrictor 88 sets the flow rate through the vacuum pump 95 to a predetermined vacuum pressure. A check valve 89 downstream of the flow restrictor 88 provides a one-way flow of the scavenged gas to ensure that no inadvertent backflow occurs in the scavenger system 48 from the vacuum pump 95 downstream. The vacuum pump 95 provides the vacuum pressure necessary to scavenge the gas exhaled from the patient. The pump can be of an electronic type that can be powered by office standard AC current. Since the vacuum pump is integrated into the nursing system, a wall vacuum source (such as that commonly used in OR) is not required. Once the gas is exhausted, it is exhausted to an appropriate area via the exhaust hose 32 (FIG. 3B). The scavenger system 48 has at least twice the advantage that the system assists the patient in breathing and that the safety of the work environment is improved.

  In a preferred embodiment, the vomiting aspirator 19 (FIG. 3B) can be integrated into the system 10 and stored in the housing 15. The vomiting aspirator 19 is a manually operated device used to suck up from the patient's trachea during vomiting. The vomiting aspirator 19 does not require an external vacuum source (eg, wall suction) or power for operation.

  In order to improve the safety of the present invention, the housing 15 has a structure that is integrated adjacent to or adjacent to where the vomiting aspirator 19 is housed in the housing 15 (FIG. 3B). Holds and prominently displays a container of medication that can reverse the effects of various sedative / analgesic agents. These “reverse drugs” such as naloxone, remazicon, etc. can be administered to the patient immediately upon overdose of sedatives, analgesics, and / or amnesia.

  Please refer to FIG. Preferred embodiments of the present invention include one or more patient health monitors 252 (further health monitors than those shown are also contemplated by the present invention), patient drug dose increase / decrease request device 254 and patient awareness. It has an integrated patient interface system combined with a further automated patient feedback device that has an automated awareness query system 256 for monitoring levels. These health monitors 252 and automated patient feedback devices 254, 256 are electronically connected to the electronic controller 14 via leads (eg, 50 in FIG. 2) to indicate electronic feedback values indicative of the patient's physiological symptoms. (Signal) is provided to the controller 14. In general, if any of the monitored patient parameters are outside the normal range (which can be pre-set by the user or pre-programmed and stored in the memory device, as described above), Be alerted immediately by, for example, an alarm, a display device, or other attention command device. The information obtained from the patient health monitor 252 is displayed on the display device 35 (FIG. 2) by, for example, a continuous waveform or numerical value on the LED, and the treating physician can immediately use the information by examining the display device. Can be obtained. Hereinafter, preferred embodiments of the display considered by the present invention will be described in more detail.

  In a preferred embodiment of one aspect of the invention, drug delivery is integrated into one or more basic patient monitoring systems. These systems interface with the patient and obtain electronic feedback information regarding the patient's physiological symptoms. Referring to FIG. 11, the first patient monitoring system has one or more patient health monitors 252 that monitor the patient's physiological symptoms. Such monitors include a known pulse oximeter 258 (eg, Ohmeda 724) that measures the patient's arterial oxygen saturation and heart rate using an infrared diffusion sensor and a patient's inspiration / expiration using a carbon dioxide sensor. Known capnometers (eg, Nihon Kohden Sj5i2) that measure carbon dioxide levels in the breath flow and measure respiration rate, patient maximum blood pressure, minimum blood pressure, and mean arterial blood pressure, and heart rate inflatable cuff and air pump And a known non-invasive blood pressure monitor 262 (e.g., Criticon First BP). A nursing system constructed in accordance with the present invention may have one or more such patient health monitors. Additional integrated patient health monitors can also be included. These include, for example, flow measuring instruments in patient airflow, IPG ventilation monitoring, standard electrocardiogram (EKG) monitoring electrical activity in the patient's cardiac cycle, electroencephalograph measuring electrical activity in the patient's brain ( EEG) and an audible signal that is processed, provided to the controller 14, amplified, and output for hearing.

  The second patient monitoring system monitors the patient's level of consciousness with an automated consciousness question (ACQ) system 256 that manages the execution of an automated responsiveness test (ART) (FIG. 11). ACQ system 256 includes one or more question initiating devices 264 and one or more question answering devices 266, and communication connections between each of these components. The ACQ system 256 is electronically connected to the electronic controller 14 and the signal generated by the ACQ system 256 is supplied to the controller 14 by appropriate conversion (eg, using an A-D converter). . Preferably, an interface for interacting with and controlling the ACQ system 256 is also provided to the clinician. The clinician can choose to manually operate many of the ART functions or have the ACQ system 256 automatically control those functions. The ACQ system 256 can use the ART results to evaluate the patient's consciousness or responsiveness level according to the procedure described below. The knowledge of the patient's awareness or responsiveness level can then be used to start, stop, or modify the functions of the ACQ system 256 or the care system 10. The ACQ system 256 may itself be provided as a component of any larger medical system, such as the nursing system 10, and its safe and proper use is aided by patient awareness or knowledge of responsiveness level. obtain.

  The query initiating device 264 generates an event that the patient can recognize as being placed near or in contact with the patient or held by the patient and causing the patient to respond with a specific action. An ART query cycle consists of a series of events that occur over a predetermined length of time at predetermined intervals. The question answering device 266 is also configured to be positioned near or in contact with the patient or held by the patient to detect specific actions that the patient can take. Upon detecting a particular action, the question answering device 266 generates a signal that is noticed by the controller 14. (Patients are preferably instructed on how to recognize events and how to respond with specific actions before enforcing ART questions.) Controller 14 is responsible for between event initiation and patient response actions. It is configured to perform a certain evaluation based on the time. This length of time may be referred to as “latency”. The controller 14 is also configured to recognize the lack or delay of any patient response to a given time frame and to make certain assessments based on such lack or delay. If a user interface is provided, the controller 14 may output an evaluation instruction to such a user interface. Controller evaluation may be used by the nursing system 10 or other system or subsystem to change or cause some of the patient's actions.

  The latency is determined by the controller 14 (using software to compare the actual latency to the stored safety data set parameters that reflect safe and undesirable latency parameters). If so, the clinician is informed, for example, by an alarm or other attention command device. If the clinician takes no action within a preset time period, the controller 14 controls and operates the electronic flow controllers 133, 135 of FIG. 8 to reduce the level of sedation / analgesia / memory loss. Instruct. The value of the signal reflecting the latency is displayed on the display device 35 (or an LED device located on the housing 15 or remote control device 45, FIG. 1), and the clinician increases or decreases drug delivery based on the latency. Can do.

  The stimulus generated by the query initiation device 264 can be tactile, visual, or audible. Each event may include one or more types of stimuli. One device may generate any or all of the possible stimuli, or the ACQ system 256 may utilize different devices, each designated to generate a particular type of stimulus. Tactile stimuli may include one or more of vibration, electrical pulses, pressure changes, pinpricks, pinching, or temperature changes. Devices that generate such stimuli are preferably placed near or in contact with the patient's skin or held in the patient's hand. The visual stimulus may include one or more of a sequence of images or text, or simply a pulse or pattern of light. The device that generates such a stimulus is preferably placed near or in contact with the patient's eye. Auditory stimuli may include specific sounds, tones, music samples, or voice messages, and are preferably generated by a device placed in contact with or near the patient's ear.

  Each query initiation device 264 can emit at least one but preferably multiple intensities of stimulation. For example, a vibrator device motor may operate at various revolutions per minute (RPM) and a voice message device may play messages at various levels of urgency and / or volume. The maximum level of tactile stimulation should be generated to maximize the probability of eliciting a response from the patient, and in some applications may include painful stimulation. A voice message is a situation in which the ART question cycle repeats over time, and with regard to the early events of the ART question cycle, the sedation is shallow and responsive, and the patient who is tuned in on the ART monitor The sound may be bright and comfortable so as not to give a feeling of discomfort or frustration. In this case, the tone may become more intense in subsequent events during the ART query cycle if the patient is not responding to the initial audible cause. The last event can include a louder voice message with a more severe tone to maximize response. FIG. 24 shows an example of a voice message for each of these three categories of event stimuli.

  By changing the intensity level of the stimulus, the controller 14 is more likely to elicit responses from patients who are distracted or who are not fully responding at the beginning of the test. For example, if a patient does not respond to a low intensity stimulus because it is diverted to others while the low intensity stimulus is occurring, increase the intensity level of the stimulus to attract the patient's attention If possible, the patient can respond to the test, thereby reducing the risk of false evaluation of no response. Most embodiments of the ART monitor change the intensity of the stimulus, if the strongest stimulus is used immediately at the beginning of the ART query cycle by starting triggering with a low intensity stimulus Ensure that responsive patients do not become excessively frustrated, as can happen. The systems of these embodiments increase the intensity of the stimulus only if the patient does not respond to the cause of the low intensity stimulus. The controller 14 controls which stimulus intensity the device emits. Further, if the patient does not respond to the entire cycle of stimulation, the entire cycle can be repeated one or more times to confirm that the patient is not responsive.

  The question answering device 266 is configured to directly or indirectly detect a patient response to the event. These devices detect the response directly if the response is a physical action on the accepting device itself. Direct question answering device 266 may include buttons, switches, triggers, toggles, or any other element that accepts physical actions on the patient side. For example, a patient can respond to a stimulation event by pressing a button on an acceptance device or by grasping individual parts of the device together. If the patient's response action is not an action given directly to the device, the device may detect the action indirectly or may alternatively detect it indirectly. An indirect response is an audible sound, such as an audio response, detected by a microphone or pressure transducer, movement by any part of the patient's body as detected by a motion sensor, or an aspect of which indicates the patient's response It may include physiological changes (heart rate, blood pressure, brain activity, etc.).

The controller 14 initiates the test by signaling an event as configured by each of the query initiation devices 264 used by the ACQ system 256 that emits each stimulus at each specified time. An event constitutes what causes the patient to respond with a specific action. Event continues to respond during the period t ₁ or the patient causes. If the patient responds within time t ₁ and the question answering device 266 detects the response, the device sends a signal to the controller 14. The controller 14 then registers the elapsed time between the start of the first event or the start and response of the ART question cycle and returns a signal to stop the event to the query start device 264, thereby terminating the stimulus. Can do. If the patient does not respond to the cause within time t ₁ , the controller 14 can send a signal to the query initiation device 264 to initiate a new event. The new event may consist of a stimulus of the same type and intensity as the first event, while the second event is from a stimulus that is stronger or expressed with a higher degree of urgency than the stimulus of the previous event. It is preferable to become. During the second event, the same sequence as the previous event is continued. That is, the patient is given time t ₂ to respond to the second event, and if the patient responds, the event ends and the response time is recorded, but the patient still begins the second event. If no response from the time t _2, the event is stopped. This process can continue for a number of events (which may be prescribed by the clinician) during each ART query cycle. The times t ₁ , t ₂ , t ₃ etc. may be defined by the clinician and need not be the same duration.

When multiple events occur, the ACQ system 256 or monitor can emit each series of events as a continuous flow with increasing stimulus intensity for each event. However, since the pause time between events t _pause can also be provided by the ACQ system 256, the patient does not adapt to the initial low intensity stimulus and therefore does not recognize the high intensity stimulus. Patients who do not recognize low intensity stimuli and therefore do not respond to them are more likely to respond to the next event of increased intensity if there is a pause between events. The pause times t _pause1 , t _pause2 etc. may be defined by the clinician and need not be the same duration. In embodiments having up to three events per test and a pause between each event, the total time of the ART query cycle can be up to t ₁ + t _pause1 + t ₂ + t _pause2 + t ₃ . This total response period is usually short, in one particular embodiment of the ACQ system 256, 14 seconds. Patients can respond at any time during the ART interrogation cycle, including during rest periods. The patient response time is measured and recorded by the controller 14 as the time between the start of the first event or the start of the ART query cycle and the patient response occurring during the ART query cycle. Lack of patient response during the response period (including a patient response after a preset response period, eg, 14 seconds) is recorded as a failed response.

  Certain embodiments of the ACQ system 256 comprise both a tactile stimulus generation device and an auditory stimulus generation device. In some of these embodiments, the auditory stimulation is delayed from the onset of tactile stimulation within the same event. In these and other embodiments, another event includes multiple levels of tactile stimulus intensity, where the tactile stimulus starts at a level and remains at that level for the duration of the auditory stimulus. Then, the remainder of the event period increases at the end of the auditory stimulus.

  As an example of the above embodiment, FIG. 24 shows a delayed auditory (in this case, voice message) stimulus, and the second event has two levels of tactile (in this case, vibration) stimulus within one event. FIG. 4 shows a graphical representation of one ART query cycle with a pause between three events.

  The tactile query initiation device 164 may be placed near the patient's hand or extremity, eg, near the leg or foot, held in the patient's hand, and / or on the patient's hand and / or wrist or leg. It may be included in a wound set. This set may also include a question answering device 266. The set may have one or more straps for securing the set to the patient's hand and / or arm or leg. The handset may also include accessories that are not directly related to performing the ART, such as a drug dose request device 254, a pulse oximeter finger probe 314, and / or a wrist or forearm blood pressure cuff 301. The hand cradle device 55 is described below as a specific embodiment of such a handset.

  FIGS. 25 and 26 show another embodiment of a handset in which the tactile stimulus is generated by a vibrator and the response is directly accepted by a switch that closes when the patient grasps the handset. The vibration mechanism includes a motor 2518 and an eccentric weight 2520 attached to the shaft of the motor. The vibration mechanism is housed in the upper casing 2512 and the lower casing 2510. This mechanism is also electronically connected to controller 14 via lead 2516. The controller 14 can send a signal through the lead to activate the vibration mechanism, which can cause a tactile stimulus that can be felt by a patient holding or in contact with the handset. Generate. Lead wire 2516 or another lead wire is connected to controller 14 and at least one switch 2522 housed in the handset casing. When multiple switches are used, the switches are wired in parallel such that any one of the multiple switches is interpreted as a response. The handset can be held in the patient's hand and the two casings move towards each other when the patient grasps the hand. One or both of casings 2510 and 2512 are constructed to close switch 2522 when the patient grasps the handset. When the switch is closed, a signal is sent to the controller 14, which interprets that the patient has grasped the handset as a direct response to vibration and / or other stimuli. One or both of the casings may have a feature 2514 to which a strap can be attached. There may be a plurality of attachment features 2514 for wrist straps and straps that wrap around the back of the hand or forearm. By grasping the handpiece, tactile and / or audible feedback is generated to inform the patient that the switch has been closed and the stimulation stops immediately.

  The auditory interrogation device 264 may include a headset that is positioned near or in contact with the patient's head to position the stimulation device near the patient's ear. The interrogation start device 264 may be an electrical or pneumatic speaker and is connected to an electrical wire or pneumatic tube that transmits an audible stimulus in the direction of the controller 14. There may be one or more auditory interrogation initiating devices 264 located at or near one or both ears of the patient. The headset may also include a question answering device 266, such as a microphone, to indirectly capture the patient's verbal response to hearing and / or other stimuli. The headset may also include accessories such as devices for oxygen supply, ventilation monitoring, and airway pressure monitoring. As an example of such a headset, an ear clip 450 will be described below.

  FIG. 27 shows another embodiment of a headset, such as comprising a headband 2748 with an adjustment 2750 that secures at least one interrogation device 264 and other attachments to the patient's head along with a retaining plate 2754. Show. In this particular embodiment, the question initiating device is a speaker 2752 positioned in each of the patient's ears. A gas supply and sampling module 2740 is provided as an accessory. The supply and sampling module 2740 is supplied by a hose assembly 2742 that is secured to the headset by at least one hose assembly guide 2756 and connected to the nursing system 10 by a hose connector 2744 and a conduit 2746.

  As described above, the controller 14 performs an ART query cycle that lasts for a fixed number of events and the duration of a pause between events (if the patient does not respond to ART) or until the patient responds to one of the events. Can be enforced. The controller 14 may further be configured to enforce a series of ART query cycles at regular intervals. These intervals may be altered by the clinician and / or controller 14 depending on particular conditions regarding the ACQ system 256, sedation and analgesia system, patient ART response time or poor response, and / or patient physiology, among others. Can be done. Consistent with the user interface of the nursing system 10, the ACQ system 256 may be provided with a user interface (“UI”) that is modified via the above described clinician ART enforcement and display device 35. Allows providing information about ACQ system 256 to the clinician.

  As part of the UI of the ACQ system 256, an ART on / off button is provided as part of the keypad or touch screen 230. The touch screen 230 is overlaid on the display 35. The clinician can use this button to activate an automated response test, or the ART may be activated as part of the initiation sequence at the beginning of the sedation and analgesia procedure for which the ART should be a component . When activated, the ART query cycle is automatically delivered to the patient by default at certain normal intervals (eg, every 3 minutes). The ART setup preference display can be provided as part of the visual display 234 (FIG. 18) and can be accessed by pressing the ART setup button on the UI keypad or by some other button in the UI. The ART setup preference display 28200 (FIG. 28) appears when the ART setup button is pressed and allows the clinician to change preferences regarding the ART delivery mode, interval, and language. The clinician can choose to have the system automatically perform a response test or manually prompt the clinician to assess patient responsiveness. With interval preference, the clinician can select the interval between ART query cycles, and with language preference, the clinician can cause the patient to ask or ask questions in which language voice auditory stimuli are used. You can choose what to do.

  The ACQ system 256 can also automatically provide responsiveness tests at certain intervals (eg, every 15 seconds) more frequently than normal intervals under certain conditions. Conditions under which the ACQ system 256 can be configured to automatically change the interval between ART query cycles are situations where a previous ART result requires retesting, situations where the current medication status is changed, and / or Includes situations where specific patient physiological conditions exist. The clinician can also request an emergency ART ("Emergency (stat ART)") by pressing a button provided on the UI. When the clinician requests an emergency ART, the system resets the timer associated with the interval between ART query cycles and / or if the ACQ system 256 was not activated when the clinician pressed the emergency ART button The ACQ system 256 is activated. The emergency ART function also makes it easier for the patient to learn how to give a specific response to an ART stimulus by allowing the clinician to initiate the test at any time, even for mere guidance.

  The controller 14 may register an ART response failure for the patient not responding to an ART query cycle during the response period. However, in situations where the patient is simply distracted during an ART query cycle (rather than subject to a condition that makes the patient unresponsive) To avoid registration as a failure, the controller 14 can enforce an emergency ART when the first ART is defective. Thus, the controller 14 may register the patient's first poor response to ART or the subsequent second poor response as an ART poor response. Enrollment by ART response failure or latency controller outside the stored safety data set is used to manage other ACQ systems 256 or nursing system 10 (eg, reduce drug delivery, change ART query cycle frequency) .

A portion of the UI display may include an ART information box that includes an ART status 2880 and an ART history 2878 section. The ACQ system 256 may display a symbol of the patient's response to each ART question cycle in the ART history section 2878, which is the first event or ART question of the ART question cycle along the y-axis of the graph. Plots the time interval between the start of the cycle and the patient's response to the ART question versus the time at which each ART question cycle was enforced along the x-axis. Patient responses that occur within a response period (eg, 14 seconds) are displayed on the graph as a symbol of one color (eg, green). Patient responses that occurred after the response period or did not fully respond to the test are displayed as symbols of another color (eg, blue). All of these poor responses can be displayed on the y-axis for some maximum time on the axis scale (eg, 1 second longer than the acceptable response period, ie 15 seconds in the example above). FIG. 29 shows an example display of the ART history section 2878, where five consecutive ART results are registered as bad by the ACQ system 256 and are all displayed in 15 seconds on the y-axis. Acknowledgments to triggered manual ART tests are always recorded and displayed for a specific time t _manual (eg, 5 seconds). As time progresses, symbols representing recent ART results are scrolled to one side of the ART history section 2878 and are removed from the display after they are older than a given elapsed time. The range of the x-axis (time) scale determines when past ART results are removed from the display. The scale exists as a default (eg, 20 minutes) in the ACQ system 256, but may be changed by the clinician.

  The ART status section 2880 of the UI display shows the words “in response test” or “in response test” on a green background for the duration of the ART response period or question cycle. The ART status section 2880 shows a solid fill of a particular color (eg, green) following the patient's response within the response period of the most recently implemented ART query cycle. The ART status section 2880 shows a different color (eg, blue) background and an appropriate message, eg, “no patient response” if the patient is not responding within the response period. Also, when the ART response is poor, an auditory message can be played back to the clinician at the time of the first failure. The same auditory message can be played during consecutive ART failures, but is preferably only played after the system first records an ART response failure to reduce discomfort and redundant information. This audible message may be in the form of a voice message such as “loss of patient response” or another sound that suggests to the clinician that the patient is not responding to the question. If the patient responds in a timely manner to the next question but does not respond at some later time, the auditory message can be replayed. The ART status section can also display a message if the question is currently enforced. If the clinician has specified ART mode for manual check of the patient caused, a message is displayed at each normal or change interval to alert the clinician to assess the patient's condition. An audible tone can also be played by the system to prompt the clinician to manually check the patient. In that case, the clinician will input an assessment of the patient's responsiveness using the UI instead of the actual patient's response. If the clinician does not provide the system with information about patient responsiveness within a time limit specified by the clinician (eg 45 seconds), the system assumes that the patient is not responding and that no patient response has been received. The above message can be displayed. The response period is longer than the automated question answering period, which is that in a manual manner, the response time of the clinician included in the total response time registered by the system can be variable, and the intermediate This is because it takes into account that it takes more time to get a response. The clinician's input that the patient is responding is recorded with a certain default value (eg 5 seconds). The clinician may choose to be prompted to do a manual response test in the ART setup preference display. This manual ART mode feature may be appropriate if the clinician specifies that the patient is not capable or cooperating to follow an automated responsiveness test procedure. If the ART is not available, an appropriate atrium (eg, a red “X”) is displayed in the status section 2880. FIG. 30 shows examples of the above-mentioned ART status section format.

  The ART monitor concept can be combined with the concept of target controlled injection (“TCI”) of intravenous medication to increase its safety and efficiency. Possible when the clinician or the controller 14 changes from one drug administration state to another (for example, from drug discontinuation to drug increase) by performing ART question cycles at more frequent intervals than normal It may be advantageous to get a current assessment of patient responsiveness as close to real time as possible. This is because the active site concentration of the drug can change rapidly. The sedative and analgesic administration system 10 may be configured such that whenever a poor ART response is registered by the ACQ system 256, the drug state is automatically changed, for example, to a gradual decrease in site concentration. The clinician has the opportunity to override the automatic reduction in some cases. If the patient recovers responsiveness to subsequent ART query cycles after enrollment of ART failure, the ART status section 2880 can indicate an appropriate message and the target site concentration is stabilized or changed by the clinician Unless automatically done, any automatic reduction in drug level continues. If the clinician shuts down the ACQ system 256 while the sedation and analgesic administration system is still in decline because the patient is not responding to the previous question, the clinician Unless reset or stabilized, the dosing system continues to decrease.

  The patient interface system of FIG. 11 also includes a drug dose request device 254 that allows the patient to directly control the drug dose. This is accomplished by the patient operating a switch or button to request the electronic controller 14 to increase or decrease the amount of medication the patient is receiving. For example, if the patient feels that the pain is getting stronger, he activates the increment of switch 254, whereas if he begins to feel nauseous, confused or uncomfortable, he requests a decrease in the drug dose. obtain. In embodiments where drug delivery is performed intravenously, such delivery can be by continuous infusion or bolus. A feedback signal from the analgesic request 254 indicating the patient's drug dose increase / decrease request is electronically communicated to the controller 14, which stores the monitored patient's symptoms and the patient's physiological symptoms. Using conservative decision-making software, including comparisons with established safety parameters, provide safe optimal drug delivery in response to patient requests. The amount of increase / decrease managed by the controller 14 can be preset by the physician through a user access device such as the keyboard 230 (FIG. 2). For example, if the drug being delivered is nitrous oxide, the allowed increase or decrease can be an increment of ± 10%. When not activated by the patient, the medication request device 254 remains in a neutral position. Thus, the present invention integrates and correlates patient-controlled drug delivery with electronic monitoring of the patient's physiological symptoms.

  In another embodiment, the physician is informed of the patient's drug dose increase / decrease request via the user interface system 16 (display device 30 or LED remote control device 45) (FIG. 1) and the patient's current life. Considering signs and other monitored physiological symptoms, including the level of consciousness obtained from various patient interface system monitors 252, 256 (FIG. 11), the requested increase or decrease can be recognized.

  In a preferred embodiment of the present invention, the patient controlled drug dose request system 254 has a lockout capability that prevents drug self-management by the patient under certain circumstances. For example, access to self-management is electronic when the patient's physiological parameters or machine condition parameters are outside of the stored safety data set parameters, or in situations where it is expected to be outside of the safety data set parameters. It is prevented by the controller 14. Access to drug self-management may be prevented at a specific or expected target level of the drug or at the combination level of the drug. For example, if the requested drug combination effect is expected to be too strong, drug delivery in response to a patient request is prohibited. It should be noted that the expected effect of such agents can be determined by using various mathematical modeling, expert system type analysis or neural networks, among other applications. In short, the present invention is designed to dynamically change drug dosage and dose variables, nursing system status, and patient physiological predictive elements as a function of patient physiology.

  Furthermore, it is possible that patient self-administration of drugs may be prohibited when drug levels are changing rapidly. For example, if the patient feels pain and is apparent to the doctor, the doctor may increase the target level of the drug at the same time as the patient requests more drug. The present invention continuously responds to physician and patient requests for drug increases and prevents any increase requested by the patient that exceeds the programmed parameters.

  In a further aspect of the invention, the patient may be stimulated or urged to administer the drug based on electronic feedback from the patient's physiological monitoring system. For example, if the analgesic is at an inadequate dose and the patient is suffering from pain, as indicated by the high respiratory rate or high blood pressure reflected in the electronic feedback to the electronic controller, the controller May encourage self-management of growth. This can be accomplished, for example, by providing audio suggestions to the patient's ear. Therefore, it is considered that the present invention has a prediction function when a demand for an increase in drug of a patient is predicted.

  In a preferred embodiment of the present invention, one or more patient vital sign monitoring devices 252, ACQ system device 256, and drug dose request device 254 house the patient's hand and wrist, or the patient's hand. And mechanically integrated into a cradle or glove-like bandage device 55 (FIG. 2) constructed to be attached around the wrist. FIG. 2 generally illustrates a hand cradle device 55 that is electronically connected to the nursing system 10 by a lead 50. 12A and 12B show in more detail one embodiment of a hand cradle device according to the present invention.

  FIG. 12A shows a blood pressure cuff 301 that can be wrapped around a patient's wrist and attached so that it can be held in place. The cuff 301 is attached to the palm support portion 303. Alternatively, the cuff is separated from the palm support 303 and placed on the upper arm at the physician's discretion. A generally oval depression or round 305 is supported by the upper edge of the palm support 303 and can accommodate and support the bottom surface of the patient's thumb. A depressible question answering switch 307 is disposed in the thumb support 305, and the switch 307 can be depressed by the patient's thumb. The thumb support 305 can be constructed to have a housing, frame, raised wall, or other guide. This allows the patient's thumb to be guided more easily to depress or move a button or switch (here switch 307) in portion 305, or by an effective movement of the patient's thumb to the switch, A button or switch may be activated. The thumb support part 305 and the abutting palm part 303 are supported by a finger support part 309 for accommodating a patient's finger so that it can be wrapped. The drug dose request switch 311 is integrated into the finger support 309 and takes the form of a rocker switch so that when the upper portion 310a of the switch is depressed, a sedative, analgesic and / or amnesia agent While the delivery of the rocker switch is depressed, drug delivery is reduced by an appropriate set percentage (eg, ± 10%, FIG. 12B). The rocker switch 311 is constructed to be in the neutral position when not activated by the patient.

  13A and 13B show another embodiment of the hand cradle device of the present invention. In particular, the pulse oximetry sensor 314 is mechanically attached to and electronically connected to the hand cradle device 55 that abuts the upper end of the finger support 309 and is substantially flat with respect to the outer edge of the thumb support 305. . The pulse oximeter 314 is constructed as a clip that can be placed on the patient's finger. The transmitter and receiver portions of sensor 314 are housed on opposite sides 315a, 315b (FIG. 13B) of finger clip 314, so that when placed on the finger, infrared light passes through the finger and spectrum The analysis determines the percentage of oxygenated hemoglobin molecules. In the present embodiment of the hand cradle device 55, the question start device 313 is in the form of a small vibrator disposed on the palm support 303. Alternatively, the vibrator can be placed adjacent to the question answering switch 307 to improve patient attention to the question initiating device and increase the accuracy when the patient depresses the answering switch, or the implementation of FIG. 14A In this case, it may be arranged adjacent to the response switch 407.

  In another embodiment of the hand cradle device 55, referring now to FIGS. 14A and 14B, the drug dose request device 409 is disposed within the thumb 405 and takes the form of a slidable member 409, wherein Thus, the sliding member 409 achieves a forward effect of increasing the dose of the analgesic and a backward effect of decreasing the dose of the analgesic (FIG. 14B). In the present embodiment of the present invention, the question answering device 407 is a depressible part integrated in the finger support 409.

  All embodiments of the hand cradle device 55 are constructed to be substantially ambidextrous. That is, these embodiments accommodate the patient's right or left hand and are operable with the right or left hand. For example, in FIG. 12A and FIG. 13A, the second question answering switch 307 b is disposed in a symmetrically opposing thumb portion 305 b attached to the opposite end of the finger portion 309. Similarly, the device of FIG. 14A is also constructed using symmetrically opposed thumbs 405b and drug dose request device 409b. The pulse oximeter clip 314 is fastened mechanically and electronically and is attached to the finger support 309 to allow reversibility when used with the opposite hand. The pulse oximeter clip 314 can be anchored rather than mechanically attached to the hand cradle device 55, or the blood pressure cuff 301 and oximeter clip 314 can be mechanically separated from the cradle device 55 and allowed It should also be appreciated that the flexible lead may be electronically connected to the controller 14.

  Referring to FIG. 15, yet another embodiment of the present invention is shown. In this embodiment, similar to the above, the hand cradle device 55 includes a mechanically integrated blood pressure cuff 301, question answering device 307, and analgesic request device 309. However, the present embodiment has an ear clip device 450 that can be clipped to the patient's earlobe and can be electronically connected to the electronic controller 14 via a lead 456. Still referring to FIG. 16, the ear clip 450 has a question initiation device 452 in the form of a speaker that provides an audible command to the patient to activate a response switch. Such speakers can also instruct the patient to self-manage the medication and allow the patient to listen to music during the procedure. The pulse oximeter 454 is a clip that can be attached to the patient's earlobe. One side of the clip is a transmitter and the other side of the clip is a receiver, which performs infrared spectral analysis of oxygen saturation levels in the patient's blood.

In another aspect of the present invention, it is envisaged to synchronize the automated monitoring of one patient's health care system with the monitoring of one or more other patient health conditions. For example, in a preferred embodiment, when the controller 14 receives low O ₂ saturation, low heart rate, or low perfusion index feedback information from a pulse oximeter (eg, the actual received parameters for these parameters are Such feedback may trigger the controller 14 to automatically inflate the blood pressure cuff and check the patient's blood pressure (if within an undesired range of the stored safety data set set by the user). (This is because low O ₂ saturation is caused by hypotension, low heart rate causes hypotension, low blood pressure causes low heart rate, etc.). Thus, under normal operating conditions, a preferred embodiment of the present invention is that the patient's blood pressure changes every 3 to 5 minutes and whenever there are changes in other parameters of the patient such as O ₂ saturation or heart rate in the blood. Is automatically checked. In another example, the electronic blood pressure check is synchronized with an automated awareness question. This is because the cuff actuation stimulates the patient and affects the question response time. Thus, the present invention considers “orthogonal redundancy” in patient health monitoring to ensure maximum safety and effectiveness.

As noted above, one aspect of the preferred embodiment of the present invention includes electronic management of drug delivery via a software / logic controlled electronic controller 14, including system monitors, one or more patient monitors / The drug delivery is integrated and correlated with an electronic feedback signal from the interface device and / or the user interface device. Specifically, the electronic signal value may be a nursing system condition monitor, a patient monitor / interface device (one or more vital signs or other patient health monitors 252, an ACQ system 256, and / or a patient drug dose request device. 254 (which may include FIG. 11)), as well as possibly from one or more user interface devices. All of these are electronically connected to the electronic controller 14 through standard A-D converters as needed. The controller 14 receives the feedback signal values and, via software and programmed logic, these values indicative of the monitored patient's physiological symptoms, as well as known safe and undesirable patient physiological symptoms. Compare the stored data parameters (safety data set). In response, the controller 14 then generates instructions to maintain or reduce the level of sedation, analgesics, and / or memory loss being provided to the conscious patient, Manage and correlate drug delivery to safe and economical optimal values (FIG. 2B). The controller 14 is operatively and electronically connected to the electronic flow controllers 133, 135 (FIG. 8) of the electronic mixer 44, which (via a solenoid valve) provides a gaseous agent and O ₂ . The flow is adjusted in a closed loop manner as described above. In an intravenous embodiment, such a flow controller regulates the flow of one or more combinations of IV medications. The electronic values provided to the microprocessor controller 14 to manage and correlate drug delivery need not necessarily include a signal indicative of the patient's level of consciousness, but may indicate other health conditions such as patient vital signs and pulse oximetry. It will be appreciated that one or more of the signals shown may be included and vice versa.

  Also, as described above, the software that performs electronic management of drug delivery by the controller 14 uses the “conservative decision” or “negative feedback” principle. This is, for example, that electronic management of drug delivery substantially only maintains or decreases drug delivery overall (increasing drug to raise sedation / analgesic overall) No). For example, if the ACQ system 256 (FIG. 11) indicates that the potential period is outside of an acceptable range, the controller 14 may flow oxygen to the manifold system 48 relative to the electronic flow controller 133 (FIG. 8). And / or instruct the flow controller 135 to reduce the flow of gaseous drug to the manifold system 48.

  In another example of such electronic management of drug delivery according to the principle of making conservative decisions, the ACQ system 256 (FIG. 11) is out of acceptable range in response to a patient question given every three minutes. The electronic controller 14 may immediately stop drug delivery, but at the same time increase the frequency at which the patient is queried (eg, every 15 seconds). If the patient does not respond to the question, drug delivery is started again, but again at an overall lower concentration, such as 20% less than the original concentration of the drug being given.

  Another example of electronic management of drug delivery through software instructions that make a conservative decision of the present invention is based on patient physical parameters such as age, gender, weight, height, etc. using known target control infusion software routines. Calculate the appropriate dose of the IV drug. Here, the practitioner provides the patient's physiological parameters through the user interface system, and the electronic controller 14 calculates the appropriate drug dose based on these parameters, and drug delivery is initiated as a bolus, for example. Then, the target level of the pre-calculated injection is returned. Later, if significant changes occur in the monitored patient parameters (eg, if pulse oximetry or latency is outside the desired range), controller 14 may be responsible for overall drug delivery as described above. Reduce to.

  One of the problems that the present invention addresses with respect to target controlled infusion of IV drugs is the nature and speed with which the nursing system reaches the target level of drug stability. For example, it is important for the physician to consider that once the medication has been initiated, the physician will take action when the patient is adequately dosed (eg, sedated or anesthetized). Is that you can start. It is often desirable for the patient to reach the target steady state level of the drug as soon as possible so that the procedure can be started as soon as possible. It has been determined that one way to quickly reach the appropriate level of drug effect is to administer at an initial level that is in excess of the final steady state target drug level. This reduces the time between the start of drug delivery and the start of the clinical drug effect and the procedure can be started. Typically, the expected target level has an error of plus or minus 20%, so one approach to quickly reaching the clinical effect state is to try to reach at least 80% of the final target level However, overdose above the 80% level is done initially by giving a drug infusion that is increased by 15% beyond the 80% target. One way to accomplish this is to use currently available PDI controllers. The PDI controller uses an error condition (here, the difference between the expected drug level in the blood flow and the target level) to reach the infusion rate. However, other control systems are also suitable that allow an initial overdose of the drug to reach the clinical effect level more quickly than the target blood level.

  The ACQ system 256 allows the clinician to find the site concentration of a drug that automatically causes the patient to lose responsiveness. To find the site concentration, the clinician begins to increase the site concentration and waits for the ACQ system 256 to register for an ART response failure. The clinician can consider the site concentration expected by the TCI algorithm when the controller registers an ART response failure as the site concentration of the drug for the intended procedure. In certain embodiments, taking into account the above features of the ACQ system 256, ART questions are administered to the patient every 15 seconds during the drug augmentation state. At some point along the rising drug action site concentration curve, sedatives and / or analgesics cause the patient to lose responsiveness. It is at this point that the clinician can accurately calibrate the calculated action site concentration of the sedative to the patient's response. The ACQ system 256 may be configured to automatically signal the drug delivery system to stabilize the drug site concentration, or may be administered by the clinician manually stopping the site increase. The active site concentration may be stabilized. The clinician can then perform a medical procedure while the drug site concentration is maintained at this site concentration target, or the site concentration can be determined by the patient's response to the procedure and the pain level during the procedure. Further adjustments may be made based on the expected change in. Then, at the end of the procedure, the clinician can stop the drug infusion pump to end the case.

  In other embodiments, the clinician can deduce which concentration of the site of action results in no response to a given patient's procedure with a given drug. The clinician suddenly changes the drug action site concentration to its estimated level (stat) and then assesses the patient's condition, including responsiveness, for indications that a medical procedure should be started. If the clinician's guess is too low, the clinician must suddenly change the drug to another higher site of action concentration and wait and observe again. Because it is safer to overdosage the site of action at which the patient loses responsiveness, rather than overdosing by the clinician, the clinician must find an ideal steady state site of action concentration for treatment. A great deal of time may be spent on this type of trial and error method. By automating the process site concentration at which a patient loses responsiveness using the ACQ system 256, the clinician has the freedom to perform other pre-procedural activities.

  Other useful information provided by the ACQ system 256 is derived from the response time progression (ie, 14 seconds) during the event and pause response windows. Response time depends on some function of the current drug site concentration. As the drug action site concentration increases and approaches the point where the patient loses responsiveness, the patient's response time begins to rise along a curve. The ACQ system 256 can utilize a mathematical model derived from this curve if it matches or correlates with this curve and / or an increasing drug action site concentration curve. Possible applications include the prediction of drug action site concentrations at which patients lose responsiveness. This ability allows the use of a more aggressive increase in drug action site concentration and / or stabilization of drug action site concentration prior to the actual loss of responsiveness, minimizing overestimation of drug action site concentration . The ACQ system 256 may communicate a response time progress curve to the system that is administering the drug so that the drug system can change the current drug state based on this curve. The ACQ system 256 may also display a message to the clinician via the UI regarding the patient response time displaying a progress curve with a specific function. The clinician can then make his own decision as to whether to change the drug status before the patient completely loses responsiveness.

  In the above situation, the ART results provide useful information prior to the start of the procedure. The ART question can continue during the duration of the procedure and when changing the drug increase or decrease status at the end of the procedure. The clinician or drug delivery system can utilize the information provided by the ACQ system 256 during these periods, including the time the patient recovers responsiveness and responds to the ART in a timely manner and the drug site concentration. .

The interval between ART query cycles is determined by the ACQ system 256 during certain situations where certain patient condition parameters (eg, low SpO ₂ , low heart rate, hypotension, or low respiratory rate) have reached a pre-specified alarm limit. May be changed. These parameters can be monitored and alarms can be evaluated by the controller 14 of any larger system to which the ACQ system 256 is connected. In this case, these ART results may serve as a basis for comparison or checking of the assessment regarding patient status alarms made by the clinician or larger system controller 14.

  Loss of memory can also be facilitated using the ACQ system 256 by titrating the drug until the patient becomes unresponsive according to the ART results. For example, if the clinician is concerned that the procedure will be a painful episode for the patient, the user may choose to increase the drug until the ESC reaches a result that results in poor ART response by the patient. Good. Thus, the clinician can intentionally cause loss of responsiveness during a painful episode to encourage memory loss and faint memory of the painful episode.

FIG. 17 is a schematic diagram of another embodiment of an apparatus constructed in accordance with the present invention. This device is particularly suitable for telemedicine nursing homes and home nursing-type environments for signs of pain and / or discomfort after surgery or other procedures, including, for example, nausea associated with tumor chemotherapy It is. In this embodiment, the drug source system 442 provides the drug (propofol, morphine, morphine, etc.) to the patient intravenously, for example by using a known syringe pump type device that the patient can wear or attach to the patient. Which can be a drug such as remifentanil), or such a drug is transdermally delivered, for example, by using, inter alia, known ion transfer devices. Drug delivery is performed by either or agent bolus is continuous, integrated supply of O ₂ is not. If desired, oxygen can be supplied to the patient from a separate tank or internal field oxygen source. The resulting apparatus is simplified and does not require the integrated O ₂ source, electronic mixer, manifold or tracheal circuit, and face mask device described above.

One or more patient health monitors 412, such as a known pulse oximeter, blood pressure cuff, end-tidal CO ₂ monitor, EKG, and / or consciousness monitor, or other monitor as described herein, Monitor the physiological symptoms. The drug dosage can be preset by the physician prior to or during application of drug delivery and / or thereafter controlled by the patient generally using a patient drug dose increase / decrease request device of the type described above. It will also be appreciated that intravenous delivery of the drug can be by continuous infusion, target controlled infusion, pure bolus, patient selected bolus or a combination thereof.

  Still referring to FIG. Electronic management of drug delivery in this embodiment of the invention is provided by an electronic controller 414 that may be of the type described above. The controller 414 performs drug delivery by the drug source system 442 (which may have a known solenoid type or other electronic flow controller) using software and / or logic devices that make conservative decisions. Integrated and correlated with electronic feedback values from patient health monitor 412. The value (signal) from patient health monitor 412 indicates one or more actually monitored patient physiological symptoms. The controller 414 uses software using a comparison protocol as described herein to access a stored safety data set 410 that includes data reflecting safe and undesirable patient physiologic symptoms, A signal reflecting actual monitored patient symptoms is compared to the safety data set. As described above, the safety data set 410 can be stored in a memory device such as an EPROM. Based on the results of this comparison, the controller 414 generates a signal that instructs the drug delivery controller of the drug source system 442 to manage the drug application to a safe optimal level, or to instruct the drug delivery system 442 to not change. .

  In certain aspects of the invention, the controller 414 may also be configured with preset parameters stored in a memory device indicating lockout of the initial or target drug dose and patient drug administration request via software, as described above. Accessible. In these environments, the instruction signal generated by the controller 414 also considers and controls medication delivery in response to these preset parameters.

  This embodiment of the present invention also typically includes a system status monitor, such as an electronic sensor, that indicates whether power is being supplied to the system or at which measurements drug flow is being delivered. Such a system status monitor is electronically connected to the controller 414 and provides a feedback signal to the controller 414. The drug delivery control in response to the feedback signal by the controller 414 electronically connected to the drug source system 442 is similar to that described herein with respect to other embodiments.

In another aspect of the present invention, the electronic controller 414 is located in a remote computer system and electronically manages field drug delivery as described above, and drug delivery is field monitored of the patient's physiological symptoms and nursing system status. Here, it is integrated and correlated with an instruction signal generated from a remote place. In some embodiments, the controller 414 may monitor the patient parameter, such as the percentage of oxygen absorbed into the blood (S _P O ₂ ), by a safe established value or stored safety data set. If outside the established value range, it is conceivable to send an electronic alarm alert to a remote location using a modem or electronic pager or cellular or other wired or wireless technology. This allows such remote locations to call ambulances or other trained nurses and respond to alarm warnings.

  FIG. 18 shows details of the user interface system of the preferred embodiment of the present invention. This system allows a physician to deliver one or more sedatives, analgesics, or memory loss agents to a patient safely and effectively, while simultaneously performing multiple tasks. it can. The user interface allows the physician to interact with the nursing system and informs the user of the patient and system status with passive display devices and various active audio / visual alarms, thereby improving safety and abnormal Allows immediate response times to conditions (including “modest” responses, eg, detailed drug delivery as described above).

  Specifically, the keypad and / or touch screen 230 (FIGS. 2 and 18) allows the physician to interact with the electronic controller 14 to enter patient background and set drug delivery and oxygen levels. Remote control device 45 (FIGS. 1 and 18) provides the physician with remote interaction with nursing system 10 and allows the physician to remotely control the functions of the system. The remote control device 45 is removably integrated with the top surface of the housing 15 and can be clipped to the material in close proximity to the physician and / or patient. In one aspect of the invention, the remote control device 45 itself includes a display device, such as an LED, to advise the physician on patient and system parameters. The panic switch 232 (FIG. 18) is the on-board housing 15 (FIG. 1) or housed in the remote control device 45 and is electronically connected to the controller 14 so that the physician can stop the nursing system 10 from operating. , Allowing the nursing system 10 to be maintained in a preprogrammed safe state in the controller 14.

  The visual display device 234 (FIGS. 2, 35) displays the actual and expected or target patient and system parameters and the overall operating status of the nursing system.

  FIG. 22A shows one version of the preferred embodiment of the visual display 234. Display 2230 is a first portion of display 2234 for displaying to the user the current status of system operation and monitored patient symptoms, including the status of alarms caused by changes in the monitored system or patient symptoms. including. For example, if a patient's response to a consciousness question (latency) after a certain time is outside the established range and the alarm is triggered, the query latency is displayed in this first portion 2234 of the visual display. , Thereby allowing the physician to immediately understand the cause of the alarm.

  The visual display device 2230 of this embodiment also has a second portion of the display 2236 for indicating actions taken or soon to be taken by the nursing system. For example, if the device reduces drug flow to the patient in response to an alarm indicating a potential period that is outside the established safe range, this second portion 2236 may be reduced in the affected drug dose. Display percentage.

  The visual display 2230 facilitates interaction between the physician and the device by allowing the physician to walk through various system operation software subprograms. Such subprograms may have system startups and patient setups where various system self-checks are performed to ensure that the system is fully functional. To start the procedure, a nursing system monitor is placed on the patient, the doctor powers it on, and the user ID (such a user ID is trained and credentialed to the certified doctor). The system is started by entering (which is considered to be issued only). The visual display then prompts the physician to initiate a pre-operative assessment that includes entering patient ID information and taking patient history and / or physical information. In preoperative evaluation, the physician asks the patient a series of questions (such as age, weight, height, and gender) aimed at determining an appropriate drug dosage, including factors that indicate high sensitivity to the disease or drug. Against. Responses to such questions are entered into the nursing system and are used by the system to help the physician select an appropriate dose. For example, a nursing system would allow a physician to obtain a single dosage unit range for healthy people and a narrower dosage unit range for sick or elderly people. Can be. The physician must make a clear decision to exceed the recommended range. In addition to the preoperative assessment performed by the physician described above, it is also conceivable that the nursing system can perform an automated preoperative assessment of the patient's physiology. For example, when the monitor is placed in place, the nursing system evaluates such parameters as the oxygenation function of the patient's lungs and / or the ventilation function of the patient's lungs. Oxygenation function can be determined, for example, by considering the Aa gradient, ie, the level of oxygen in the alveoli or lungs compared to the level of oxygen in the arteries or blood. Lung ventilation function can be determined from, among other things, a lung function test (PFT). This is a measure of air volume and pressure per breath or every minute as air enters and leaves the lungs. (These assessments may also be performed as dynamic intraoperative assessments before and during the procedure.) Also, during the pre-operative (or as a continuous intraoperative) assessment, Cardiac function can be assessed by looking at the output of EKG to determine if there is evidence of ischemia or arrhythmia. Alternatively, an automated algorithm can be applied to the EKG signal to diagnose ischemia or arrhythmia. Further automated patient health assessments can also be made.

  During patient setup, current patient and system parameters are also evaluated and displayed, and consciousness questioning systems and patient drug increase / decrease systems are tested and standardized. The set drug subprogram considers the selection of drugs and / or drug mixtures (or drugs, oxygen, and air), considers selection of drug target levels, and / or within a specific range of drugs Allows patient self-management. The present invention also contemplates determining a sedation threshold limit for a given patient in an unstimulated state during preoperative evaluation. This can be done as a manual check, i.e. by simply raising the drug level and observing the patient manually. Or this approach can be automated. In this case, as the drug is increased and the concentration of the drug effect site increases, safe set parameters such as latency (consciousness questions) are tested.

System and patient status, and system actions can be displayed, for example, during a sedation subprogram. The visual display device 2230 is a graphical and numerical display (2238) showing the monitored patient status, such as patient breathing and ventilation status, consciousness, O ₂ saturation in blood, heart rate, and blood pressure, from the start of drug delivery. Display of elapsed time (2239), drug and / or O ₂ concentration (2241), and patient request for drug increase / decrease (2243). The calculated actual ratio of inspired oxygen can also be displayed. Silence the alarm (2240), change the concentration of the delivered drug (2242), turn on / off the mixing of oxygen flow and atmosphere (2244), and turn on / off the automated awareness query system Or a command “button” to make (2246) other changes to it. Once the procedure is complete, set the device to “recovery” mode (patient parameters are monitored but disabled during drug delivery) (2248), and exit the current case and a new case A command button for initiating (2250) or shutting down the system may also be included.

FIG. 22B shows another version of the preferred embodiment of the visual display portion of the present invention. Portions 2202, 2204, 2206, and 2208 of display device 2200 show the current patient's O ₂ saturation, blood pressure, heart rate, and end-tidal CO ₂ level, respectively. These parts, which indicate the patient's physiological state, are encoded in a unique color. A smart alarm box portion 2212 that may be encoded in a color that draws attention, such as red, indicates to the physician the specific alarm that makes the sound. For example, if the O ₂ saturation level in the patient's blood falls below a safe level, the O ₂ saturation alarm will sound, the O ₂ saturation level will appear in the smart alarm box portion 2212, and the physician can easily see it. it can. In short, all the parameters informed by the alarm are moved to the smart alarm box part, and the specific alarm indicator is moved to the same position every time the alarm sounds. Also, as described below, in a preferred embodiment, the critical level of the alarm, which can be shown in either yellow or red, is displayed in the patient's physiological parameter portion of the display. For example, when a red level O ₂ saturation alarm sounds, the background portion of the O ₂ saturation portion 2202 appears in red.

  Portion 2214 of display 2200 shows the past, present, and expected levels (2215) of drug administration (the drug levels shown in FIG. 22B are those of dinitrogen monoxide, remifentanil and propofol). In a preferred embodiment, the past, present and expected levels of target control infusion starting from the past 30 minutes and over the future 30 minutes are shown graphically. The present invention also contemplates integrating the range of accuracy (not shown) of the target control injection level.

Display portions 2220 and 2224 show, among other things, a graphical display of patient health parameters such as lung Aa gradient (oxygenation function), lung function test results, electrocardiogram, blood O ₂ saturation.

  In another aspect of the present invention, the visual display 35 (FIG. 1) is removably integrated with the top surface of the housing 15 and can be removed from the housing 15 on a frame such as a gurney rail or test table near the patient. Can be attached. Alternatively, or in addition, a head-up visual display device can be easily used by non-anesthetists in medical or surgical procedures, while simultaneously providing system status and patient monitored value status, as well as alarm status details. It is provided so that it can be seen. In this case, the display device is miniaturized and mounted on a wearable headset or spectacles table, or on a wall display that can be easily viewed.

  Reference is again made to FIG. In a preferred embodiment, the audible alarm 236 alerts the physician when patient or system parameters are outside the normal range. In a preferred embodiment, the alarm may have two or three stages with different tones to indicate different levels of problem or criticality. As described above, when an alarm sounds, the user can immediately know the cause of the alarm. This is because the smart alarm box portion 2212 of the visual display 2200 shows the value of the monitored system or patient parameter that triggered the alarm.

FIG. 21A illustrates drug delivery management for a three-stage alarm in response to a patient monitor (ie, alarms “1”, “2” and “3”), according to a preferred embodiment of one aspect of the present invention. An example protocol is shown. These alarms may have different tones or other indicators to indicate different levels of problems or criticalities. The data flow diagram of FIG. 23A shows one such protocol, a pulse oxygen concentration that the electronic controller 14 described above monitors the actual amount of oxygen saturation in the patient's blood (the value indicated by “SpO ₂ ”). FIG. 6 illustrates an example of steps performed by drug delivery management software or logic for a protocol that receives an electronic feedback signal from a meter. As shown, the SpO ₂ value is compared to a stored safety data set 220 that includes parameter values or ranges of parameter values that reflect safe and undesirable patient blood oxygen saturation. Or SpO ₂ value is greater than the parameter 90% stored, or if equal to it, the alarm does not sound, not performed the adjustment of drug delivery (221a). If the SpO ₂ value is less than 90% but greater than 85% (221b), alarm 1 sounds for 15 seconds (222). If alarm 1 is manually stopped (222a), no further action is taken by the system. If alarm 1 does not stop, the amount of drug delivered (in this example, gaseous N ₂ O) is reduced to a concentration of 45% or 10% less than the current (223). The software / logic approach operates in the same way as for intravenous and nebulized drug forms, and the instructions provided (eg, as in 223) are specified for a safe dose of such drugs. The

Furthermore, if the value of oxygen saturation (SpO ₂ ) is less than 85% but greater than or equal to 80% (221c), alarm 2 sounds and the amount of N ₂ O delivered is immediately 45% Or to a concentration that is 10% less than current (224). If the feedback value SpO ₂ from the pulse oximeter indicates that oxygen saturation in the blood is less than 80%, alarm 3 sounds and the amount of N ₂ O being delivered is immediately reduced to 0%. (225).

  FIG. 21A is similar for an electronic feedback signal from a patient health monitor showing pulse rate, amount of carbon dioxide in the patient's end-expiration, respiratory rate, maximal blood pressure, and feedback from an automated consciousness monitoring system constructed in accordance with the present invention. Shows the protocol. These protocols are implemented in software (and / or logic) that operates in the same manner as described in the data flow diagram of FIG. 23A. That is, the protocol shown in FIG. 23A is an example using one monitored patient parameter, but the operation of the present invention is similar to implementing the remaining protocols in FIG. 21A.

Of course, the system response to the alarm (described above with respect to decreasing or stopping the drug concentration) may also include the onset and / or increase of administration of oxygen according to patient and system status parameters as described above. If the drug is stopped and pure oxygen (or O ₂ atmospheric mixing) is provided, for example if the feedback signal indicates that the patient has low blood O ₂ saturation, the preferred system is LIFO (“ Designed to work in a “last-in-first-out” manner. This is because when the controller 14 receives feedback signaling the reverse patient or machine condition and instructs the flow controller to turn on oxygen, the next breath that the patient exhales is not a drug / air mixture. Mean pure O ₂ (and / or atmosphere). This may be accomplished, for example, by supplying oxygen instead of air directly to the PIV 152 (FIG. 9A) and bypassing the storage bag 149.

FIG. 21B illustrates an example medication delivery management protocol for a two-stage alarm (ie, alarms “1” and “2”) in response to a system status monitor, according to a preferred embodiment of one aspect of the present invention. These alarms may have different tones or other indicators to indicate different levels of problems or criticalities. The data flow diagram of FIG. 23B shows that one such protocol, the electronic controller 14 (eg, FIG. 2A), shows the amount of oxygen remaining in the onboard oxygen tank (the value indicated as “O ₂ remaining”). ) Shows an example of steps performed by drug delivery management software and / or logic for a protocol that receives an electronic feedback value from an O ₂ tank pressure sensor (519) that indirectly measures. As shown, the remaining O ₂ value is compared to an established data set of secure system parameters stored in the memory device as described above. The data set includes “set points” that reflect known safe and undesirable oxygen tank pressure conditions (520). If the oxygen pressure is greater than the set point, no alarm will sound and no adjustment will be made to drug delivery (521). If the O ₂ % value is below the set point, alarm “1” sounds (522). If alarm “1” stops manually within 15 seconds, no further action is taken by the system (523). If alarm “1” does not stop within 15 seconds, the amount of drug being delivered (in this example, gaseous N ₂ O) is reduced to a concentration of 45% or 10% less than current. (524). The software or logic approach operates in the same way as for intravenous and nebulized drug forms, and the instructions provided (eg, as in 524) are specified for a safe dose of such drugs. The

  In another example of FIG. 21B that includes a system status monitor that indicates whether power is being supplied to the device 10, logic operations determine whether the power has been shut off. If the system status monitor for the power signal indicates that power has been cut off, alarm “2” will sound and drug delivery will be reduced to 0%.

FIG. 21B shows a system status monitor showing the O ₂ cutoff failsafe, total gas flow, drug tank pressure, ratio of inspired oxygen (FIO ₂ ), and vacuum pump operation for scavenging system 48 (FIG. 6). A similar protocol is shown. These protocols are implemented in software (and / or logic) that operates in the same manner as described in the data flow diagram of FIG. 23B. That is, the protocol shown in FIG. 23B is an example using the storage parameters of one system state monitor, but the operation is similar to implementing the remaining protocols in FIG. 21B.

  In the above example involving the response to the patient's physiological condition, there is a time lapse between the alarm sounding and the delivery of the drug to the patient being reduced. In other protocols contemplated by the present invention, the electronic controller 14 stops or reduces drug administration as soon as the alarm sounds. For less serious ("yellow") alarms, drug delivery is reduced to 80% when an alarm occurs, and for more severe ("red") alarms, drug delivery is stopped when the alarm sounds. In any case, the physician is then given, for example, 30 seconds to instruct the controller 14 to resume medication delivery (eg, the physician needs to override the reduction in medication delivery). If the physician disables the controller 14, the medication is restarted, for example with a bolus amount. This method prevents the patient from decaying while the physician is waiting for a response to the alarm at the current medication level, and is insufficient by allowing the physician sufficient time to begin delivering the medication again. Dosing is avoided.

  Refer to FIGS. 2 and 18 again. The printer 238 (FIGS. 2, 37) not only detects alarm types with time stamps that indicate what type of alarm was sounded and when, but also monitored patient health parameters (eg, one or more patients). Provide on-site hard copy of feedback value from health monitor. A diagnostic LED 240 attached to the outside of the device 10 (eg, FIG. 1) and electronically connected to the controller 14 allows physicians typically involved in the procedure to see system status at a glance and connects to the microprocessor controller 14 The rendered LED also allows the technician to assess the defect status.

The preferred embodiment of the present invention is on a board of various peripheral electronic devices, ie, a group within or integrated within housing 15 of apparatus 10 (eg, FIG. 1), and electronic controller 14. Has a second group. These electronic devices provide hardware state feedback through the sensors to ensure proper operation of various aspects of the system 10, including ensuring that the apparatus is operating within the desired parameters. 19A and 19B show various peripheral devices according to the present invention, such devices may be of the known off-the-shelf type currently available. In particular, the internal solenoid type actuating door lock 190 restricts access to the interior of the device 10. The door lock 190 is disposed within the housing 15 (FIG. 1), is electronically connected to the controller 14, and is controlled by the controller 14 by software including a protocol for password protection. In this way, access to the interior of the device 10 is limited to authorized personnel with passwords. This is intended, among other things, to minimize the opportunity for abuse of “medicine pursuit” of the pharmaceuticals contained therein (eg N ₂ O). An internal door condition sensor 191 disposed within the housing 15 and electronically connected to the controller 14 generates a signal indicating whether the access door to the interior of the device 10 is open or closed. The real time clock 192 on the board of the controller 14 allows the controller 14 to provide a time stamp for the entire system and patient activity, thereby enabling accurate logging of the operation of the nursing system 10. An on-board ambient temperature sensor 193 monitors the external temperature and signals this to the controller 14, which is operating under desired conditions with respect to ambient temperature through a software comparison type protocol. Make sure. An internal battery temperature sensor 194 located within the housing 15 and electronically connected to the controller 14 generates a signal to the controller 14 indicating whether the backup battery power system is functioning properly and is not overcharged. To do. A tilt sensor 195 located on the board of the controller 14 signals to the controller 14 whether the device 10 is operating at an angle beyond its designed conditions.

  In the preferred embodiment, the software control process of electronic controller 14 is stored in standard flash memory 196, and SRAM type battery support memory 197 stores system, patient, and other status information upon AC power loss. The on-board defect detection processor (FDP) 198 is based on a secondary microprocessor that signals a fault to the controller 14 and frees the controller 14 from its control obligation if a defect is detected during operation. Computing system. Onboard watchdog timer 199 indicates to controller 14 that device 10 is functioning and resets controller 14 if system 10 does not respond.

  The preferred embodiment of the present invention also has a standard serial port interface, such as an RS-232C serial port, for transferring data to the electronic controller 14. The port allows, for example, downloading software updates to the system and transferring system and patient log data from the controller 14. Interfaces such as PC type III slots can also be used, for example, to transfer billing information to a remote site or to enable remote diagnosis of problems, thereby minimizing the time required for troubleshooting and closing Provided to allow a computer support device such as a modem or LAN to be added to the system 10.

  Needless to say, the nursing system of the present invention is essentially modular and its functions are separated into separable, portable, plug-in units. For example, the electronic controller 14, display device (FIGS. 2, 35), and one or more patient health monitors are included in one module, and the pneumatic system (flow controller, pressure regulator, manifold) is the second The base (FIG. 3B, 17), oxygen and drug tank (FIG. 2, 54), scavenger system, and vacuum pump (FIG. 3B, 32) are included in the third module. Furthermore, each patient health monitor or drug delivery aspect of the system can be its own plug-in module. For example, the system may provide a pluggable ventilator module. This modularity not only makes the system easier to carry, but also allows certain features of the system (such as certain patient health monitors) to be used without having to use others.

  FIG. 20 is an interface to the nursing system 10 (FIG. 1) and allows patient information and billing to allow billing or other patient information collection to occur locally at the point of use or at a remote billing office. 1 shows a preferred embodiment of a system. Specifically, the information / billing storage system 280, which can be a known type of microprocessor-based computing system controlled by software, includes start time, usage time, usage frequency, duration of patient monitoring, consumption As well as measured system operating data 282 generated during operation of the device 10 and stored in the controller 14, such as the amount of gas and other such parameters, the patient's name, address, and other accounts Collect and store patient data 281 such as information. The user access device 283, which can be a standard keyboard type, allows the physician to interact with the information / billing storage system 280 and enter additional data, such as predetermined treatment or billing parameters, and state the status of these data. It is possible to read (for example, read the state of the measured system operating parameter 282). Preferably, a password is provided to allow access to information / billing system 280.

  At the end of the medical or surgical procedure or other desirable time, the information / billing storage system 280 processes the received data and sends it to the remote profit / billing processing center 286. Profit / billing processing center 286 may be a known mainframe computing system such as manufactured by International Business Machines (IBM) or a known client-server computer network system. At a remote location, the patient's invoice is created by the printer 287, as well as other profit records used for payment to the merchant.

  The present invention also contemplates that an automated record of the details of the system operation is printed on the user site printer 285 (preferably located on the board of the device 10 (FIG. 1)). Details of such system operation may include, for example, all alarms and actual system operating conditions, drug flow, and / or actually monitored patient physiologic symptoms supplied by electronic controller 14. A modem or LAN may be used to remotely send and receive billing and other information and communicate with remote clients / servers or other networks 288 as described above.

Claims (18)

In an automated system that monitors patient responsiveness,
(A) at least one triggering means that triggers a response from the patient;
(B) at least one sensor for sensing a patient's response to the cause from the at least one cause means;
(C) an electronic controller in communication with the at least one triggering means and the at least one sensor, initiating triggering by the at least one triggering means, receiving a response detected by the at least one sensor; An electronic controller that calculates the time between the cause and the response;
(D) at least one display for displaying at least one time delay indicator, wherein the at least one time delay indicator reflects a time between the cause and the response;
(E) A system comprising a user interface through which a user of the system interacts with the function of the system and monitors the function of the system.   The system of claim 1, wherein if the at least one sensor does not detect a response after a first predetermined time, the at least one trigger means changes the trigger of the at least one trigger means.   The at least one time delay indicator is green if the response is detected within a predetermined time and blue if the response is detected after the predetermined time or not detected at all. The described system.   The system of claim 1, wherein the at least one display graphically displays two or more time delay indicators simultaneously, and the electronic controller calculates a trend in patient response based on the graphical display. A drug delivery system in communication with the electronic controller;
The system of claim 4, wherein the electronic controller compares a trend in the patient response with a rate of drug delivery.   The at least one display is responsive to whether the at least one trigger means is generating a trigger, the patient has responded, the at least one trigger means is on or off, The system of claim 1, wherein one or more of whether to be manually confirmed for gender or whether the patient responded within a predetermined time.   The system of claim 1, wherein the at least one sensor directly measures the patient response via a button, switch, trigger toggle, or any other element that directly senses a physical action on the patient side. .   The at least one sensor indirectly measures the patient's response by sensing audible sounds, movements of a part of the patient's body, or physiological changes indirectly related to patient responsiveness. Item 4. The system according to Item 1. A feedback generating means;
The feedback generating means is configured to inform the patient that the patient response has been detected by the at least one sensor and that the at least one triggering means is to stop generating a trigger. The system of claim 1, wherein the system generates a separate signal. The at least one triggering means is
Generate tactile triggers,
Combining the tactile trigger with the auditory trigger,
Stop for a certain amount of time, do not generate any cause,
Then, in a state stronger than before the stop, resume the generation of the haptic trigger,
The system of claim 1, wherein the generation of the auditory trigger is resumed in a stronger state than before the stop.   The system of claim 1, wherein the at least one response-causing device can be part of a handset or headset.   The system of claim 1, wherein the cause is of variable intensity, urgency, and duration.   The system of claim 1, wherein the system is integrated with a system for delivering or monitoring medication during a medical procedure.   14. The system of claim 13, wherein the system for delivering or monitoring the medication is partially automated.   14. The system of claim 13, wherein the medicament is for sedation and analgesia.   A system for delivering or monitoring a drug during the medical procedure delivers a drug to the patient, the rate of drug delivery being varied based on the time between the trigger and the response. Item 14. The system according to Item 13.   The system of claim 1, wherein a user of the system manually initiates the at least one triggering means by interaction with the user interface.   The method of claim 1, further comprising a manual responsiveness test function that allows a user to manually assess patient responsiveness and manually enter results of the manual assessment into the user interface. system.

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