Abstract: A method and apparatus for reducing the workload of titrating drug to effect while leaving clinician users in control of a related procedure is described. A drug delivery device is controlled to achieve a target drug concentration at a selected site in the patient or a predetermined infusion rate waveform. The time profile of the target drug concentration or a predetermined infusion rate waveform is controlled by a drug state model that uses clinical heuristics to implement safe, pre-defined changes in the target drug concentration or infusion rate and user-commanded changes in target drug concentration or infusion rate. The invention allows time to assess the response of the patient to changes in drug level by making small incremental and conservative changes in drug level over time.

Abstract: Disclosed are devices for facilitating medical and/or procedures that are performed without “general anesthesia,” which is also described in the specification as the state of patient “unconsciousness” resulting from a drug administered by an anesthetist or anesthesiologist. The devices safely and effectively provide and maintain drug infusions that do not push the patient into unconsciousness and/or general anesthesia. Devices according to embodiments of the invention include the use of stored parameters and/or values that correlate to drug delivery during a procedure, and a patient health monitor to measure and send signals regarding a patient health condition to a processor.

Abstract: Disclosed is an apparatus and method for the delivery of inspired gas, e.g., supplemental O2, to a person combined with gas sampling, including for the purpose of monitoring of the ventilation of the person. In the invention, the delivery of inspired gas and gas sampling are accomplished without the use of a sealed face mask. The apparatus of one embodiment of the present invention comprises an oxygen delivery device, nasal airway pressure sampling devices, optionally an oral airway pressure sampling device and at least one pressure analyzer connected to the sampling devices which determine the phase of the person's respiration cycle and the person's primary airway. The oxygen delivery device is connected to a controller such that it delivers a higher flow of oxygen to the person during the inhalation phase of the person s respiratory cycle. The invention thus increases end tidal oxygen concentrations.

Abstract: The invention of this application relates generally to intravenous (IV) infusion of drugs to patients, and more particularly to aspects of an IV infusion system comprising an infusate cassette and an infusate container. The present invention provides a drug infusion cassette that incorporates a strong vial spike that may be non-metal, a means for sheathing the spike when it is not in use, an anti-free flow device, and other beneficial features such as an air entrainment lockout mechanism, quality assurance tags, stopcocks made of soft materials and means of securing tubing to the cassette with a minimum of individual parts. The drug cassette can be used with an automated spiking mechanism comprising a motorized vial holder that holds a vial. The spike remains sheathed if the drug cassette is not fully engaged with a mating surface of devices such as a pumping unit or a sedation and analgesia delivery system.

Abstract: The present invention relates, in general, to prevention of false, annoying, or oversensitive alarms, providing early detection by a sensitive test, generating silent, semi-overt, or overt alarm conditions and/or initiating early passive or active interventions to untoward events. The invention buys time by providing an early intervention in the event that a highly sensitive early detection is later confirmed by a specific test. A particular embodiment of the invention is directed to the early detection of hypoventilation, including apnea and airway obstruction, and the pausing or interrupting of an action such as drug delivery during medical procedures.

Abstract: A care system and associated methods are provided for alleviating patient pain, anxiety and discomfort associated with medical or surgical procedures. The system comprises: at least one patient health monitor device generating a signal reflecting at least one physiological condition of a patient; a drug delivery controller supplying one or more drugs to the patient; a memory device storing a safety data set reflecting parameters of at least one patient physiological condition; and an electronic controller interconnected between the patient health monitor, the drug delivery controller and the safety data set. A method of electronically tracking recurring revenues generated by the use of the care system where the system is at the location of its user is also provided. Additional embodiments of the system and methods are directed to alleviating patient pain or discomfort while enabling safe patient controlled drug delivery in correlation with the monitoring of patient health conditions.

Abstract: The present invention includes systems and methods for decreasing the pain and discomfort commonly associated with endoscopic procedures, where such procedures may be performed with lower dosage levels of sedative and analgesic drugs. The invention includes use of an anesthetic collar coupled to an endoscope with a flexible shaft. The anesthetic collar allows lubricants, local anesthetics, dyes, and/or other desirable fluids to be passed through the existing lumen of the flexible shaft into an annulus, where the fluid may be distributed through expulsion pores into the gastrointestinal tract.

Abstract: Disclosed is an apparatus and method for the delivery of supplemental oxygen gas to a person combined with the monitoring of the ventilation of the person with both being accomplished without the use of a sealed face mask. Preferred embodiments of the present invention combine an oxygen delivery device, a nasal airway pressure sampling device, an oral airway pressure sampling device, and a pressure analyzer connected to the sampling devices to determine the phase of the person's respiration cycle and the person's primary airway. The oxygen delivery device is connected to a controller such that it delivers a higher flow of oxygen to the person during the inhalation phase of the person's respiratory cycle. The invention thus increases end tidal oxygen concentrations with improved efficiency comparative to known open airway devices.

Abstract: A care system and associated methods are provided for alleviating patient pain, anxiety and discomfort associated with medical or surgical procedures. Embodiments of the system include a health monitor device coupled to a patient and generating a signal reflecting at least one physiological condition of the patient; a drug delivery controller supplying one or more drugs to the patient; a memory device storing a safety data set reflecting parameters of at least one patient physiological condition; and an electronic controller interconnected between the patient health monitor, the drug delivery controller and the safety data set. The electronic controller is capable of effecting a change in the drug supply delivered to the patient by the drug controller, said change depending on a comparison between at least one patient physiological condition at its corresponding value reflected in the safety data set.

Abstract: The present invention includes a respiratory monitor that improves patient safety through the use of highly responsive monitors and displays highly visible to all clinical personnel even in the absence or failure of an alarm display. The display can be positioned so that clinicians do not have to look away from the patient to view the output of the respiratory monitor. The respiratory monitoring system alerts clinicians of potential problems while automatically taking steps to gather additional information and place an integrated drug delivery system in a safe state (e.g., step down or deactivation) in addition to providing a real-time visual indicator of respiratory rate and estimated tidal volume or respiratory effort and effect. Multiple thresholds that trigger corresponding indicators such as color-coded LEDs provide a quantized display of respiratory effort and effect while also providing a certain level of redundancy. The respiratory effort and effect can also be displayed by the intensity of the LEDs.

Abstract: The present invention includes systems and methods for decreasing the pain and discomfort commonly associated with endoscopic procedures, where such procedures may be performed with lower dosage levels of sedative and analgesic drugs. The invention includes use of an anesthetic collar coupled to an endoscope with a flexible shaft. The anesthetic collar allows lubricants, local anesthetics, dyes, and/or other desirable fluids to be passed through the existing lumen of the flexible shaft into an annulus, where the fluid may be distributed through expulsion pores into the gastrointestinal tract.

Abstract: The present invention provides a sedation and analgesia system having a bite block configured for integration and use with the system. The bite block facilitates access to the mouth while allowing the monitoring and delivery of gas via the oral and/or the nasal cavity where the monitoring and delivery are integrated with a sedation and analgesia system.

Abstract: The present invention includes a sedation and analgesia system having a high sensitivity and specificity for diagnostic and therapeutic algorithms, where the high sensitivity and specificity may be gained by providing multiple monitors for a single patient parameter. The invention also comprises multiple monitors for a single patient parameter, where the monitored data from each monitor is compared with that of the others by a controller in order to ascertain whether monitored data is reliable.

Abstract: The present invention comprises systems and methods for handling large amounts of data prone to ambiguity and artifact in real-time in order to ensure patient safety while performing a procedure involving a sedation and analgesia system. The invention utilizes neural networks to weight data which may be more accurate or more indicative of true patient condition such that the patient condition reported to the controller and the user of a sedation and analgesia system will have increased accuracy and the incidence of false positive alarms will be reduced.

Abstract: A battery backup system is provided for use in a sedation and analgesia system. The battery backup system can include a battery, a power source, and a battery controller connected to power source and the battery. The power source can be connected to the battery controller unidirectional. In addition, the battery can be connected to the battery controller bidirectional. The battery controller can help determine whether the sedation and analgesia system should be run with the power source or the battery.

Abstract: The present invention comprises a system that incorporates the natural relationships of patient parameters into a medical monitoring system in order to increase monitoring specificity by reducing false positive alarms resulting from spurious data and inconclusive data. The invention also comprises a system that incorporates the natural relationships of patient parameters in order to use the data obtained from those parameters to non-invasively monitor a patient parameter that typically precludes direct monitoring.

Abstract: A gas supply and monitoring system is provided for use in many medical system which can include, but is not limited to, a sedation and analgesia system, anesthesia machines, dental gas systems, and veterinary systems which deliver gasses. The gas supply and monitoring system can include a gas source; a variable size orifice system connected to the gas source wherein the variable size orifice system has a gas output supply opposite of the gas source; and a sensor system connected to the gas output supply wherein the sensor system can be used to verify a patient receives the appropriate gas output supply.

Abstract: A care system and associated methods are provided for alleviating patient pain, anxiety and discomfort associated with medical or surgical procedures. The care system facilitates a procedural physician's safely and efficaciously providing conscious sedation 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 to alleviating patient pain or discomfort while enabling safe patient controlled drug delivery in correlation with the monitoring of patient health conditions.

Abstract: A drug delivery system is provided for use in a sedation and analgesia system. The drug delivery system can include a first bolus interface, a second bolus interface wherein the second bolus interface appears after the first bolus interface, a third bolus interface wherein the third bolus interface can appear after the second bolus interface, and a drug delivery display. The first bolus interface asks a user if he or she wants to give the patient a bolus from the drug delivery. If the user answers yes, then the second bolus interface asks the user to confirm the bolus. The third bolus interface can appear if the bolus is outside a predetermined range flagging the user that the bolus is outside a specific range asking for confirmation to continue.

Abstract: The present invention provides a sedation and analgesia system having an emergency medical kit, where the medical kit is designed to meet the specific needs of medical emergencies related to the delivery of sedatives, analgesics, and/or amnestics. The invention further provides a sedation and analgesia system with an emergency medical kit having policies along with automated and semi-automated pre-use checks necessary to ensure that components of the kit are present, functioning properly, and that perishable components within the kit have not expired.