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: 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 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: 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.

Abstract: The invention relates to kits of supplies and components for the computer assisted IV drug infusion administration device where those supplies and components may be disposable or re-usable. In one embodiment of the present invention single-patient use disposable components are utilized with a computer assisted IV drug infusion administration device to prevent potential cross-contamination and drug carry-over from a previous infusion to a different patient.

Abstract: The present invention comprises a security system integral with a sedation and analgesia system. The invention includes a computer assisted IV drug infusion administration device coupled with a secure user interface, or other security means, that can restrict and monitor user access to prevent unauthorized or improper use of the device. The system can also provide varying levels of access to the device so that different users may have different levels of access to system operations. The variety of access levels may prevent accidental or intentional misuse of the drug delivery system, while still permitting access to the required functionality. Data, such as usage statistics and procedural events associated with drug delivery, may be recorded in association with a user's personal identification information to help identify training needs and to identify possible misuse of access information.

Abstract: The present invention relates to the sterile operation of a sedation and analgesia system. The present invention provides a sedation and analgesia system that can be operated by clinicians involved in medical procedures within a sterile field without contaminating the sterile field. For a variety of systems, the invention provides a sedation and analgesia system that may be accessed within a sterile field by a clinician involved in a medical procedure.

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 invention provides a fail-safe module (FSM) integral with a sedation and analgesia system that meets the high-reliability needs of sedation and/or analgesia delivered by non-anesthetist practitioners. The FSM may operate in “real-time” in order to ensure optimal patient safety. The FSM may deactivate specific patient interfaces, user interfaces, and/or sedation and analgesia delivery in order to ensure patient safety and has redundant safety systems in order to provide the fail-safe module with an accurate assessment of controller functionality.

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: The present invention comprises a printer system integral with a sedation and analgesia system having the capability to display data at spaced intervals, such as, for example, every five minutes, where the data in the previous five minutes is averaged in order to minimize the spurious impact of artifacts on the printed record. The present invention further comprises a printer system integral with a sedation and analgesia system that, upon request, prints a detailed, real time graphical display of critical parameters regarding a patient's physiology. The printer may be used with a brief memory from which an operator may request information that may have already exited an associated visual output device.

Abstract: The present invention comprises a sedation and analgesia system having integrated patient monitoring and drug delivery, where information related to monitored patient parameters and drug delivery is accessible and controllable from a remote location. Information relative to monitored patient parameters and drug delivery may be provided in real-time or near real-time, to an attending nurse, physician, insurance company, billing department, or other suitable party according to the present invention via a computing device, video monitor, over the Internet, over an intranet, or by any other suitable means of transmitting and displaying critical data. The present invention further comprises an integrated in-room monitor, where data related to critical patient parameters and drug delivery may be integrated with other means of communicating data related to a patient, a procedure, or a medical device.

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 clinician's safely and efficaciously providing sedation and analgesia and in some measure, amnesia 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 drug delivery (automated, clinician-controlled or patient-controlled) in correlation with the monitoring of patient health conditions.

Abstract: The present invention comprises a user interface for systems and methods for sedation and analgesia delivery. The user interface receives input from a user of a sedation and analgesia delivery system and relays information regarding the system, the administration of sedation and analgesia, physiological conditions to the user in a context sensitive manner. The information relayed may be displayed to the user on a touch sensitive screen or multi-layer display device. The display may be segregated geographically or may be color coded on the display device where the geographic location and/or color of the displayed information relates further information to the user.

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 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 and the generation of current signals by the patient health monitor device 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 provides apparatuses and methods for marking components, supplies and kits of drug administration devices and other medical systems with quality assurance information. The invention also provides apparatuses and methods for tracking time of use of such components, supplies and kits and various apparatuses and methods for preventing use or reuse of tainted, recalled or unrecognized components, supplies and kits. Quality assurance markers (QAMs) are described which store information regarding the identity and manufacturer of disposable components, supplies and kits. The invention utilizes several QAM modalities, such as, among others, 1-D and 2-D bar codes, 1-D and 2-D symbologies, holograms, written text, radio frequency identification devices (RFIDs), integrated chip smart cards, and EEPROMs.

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: An infusate cassette is described for use with an IV infusion system which controls the process of administering a drug to a patient. The cassette and other aspects of the infusion system may include disposable components, external redundant volume tracking, air removal and automated purge and prime capabilities, component removal lockout mechanisms, and/or redundant automated anti-free flow devices. An IV manifold comprising an imbedded high cracking pressure anti-free flow valve is also described for use with the infusion system. The cassette, IV manifold, and other aspects of the infusion system may be provided with quality assurance mechanisms for use with integrated IV infusion.

Abstract: The present invention relates to capital equipment units, such as systems for providing medical treatment, that are associated with smart supplies. The smart supplies are tagged with data carriers which may encode such information as a unique ID for the supply or component, the identification of the supply or component, the identification of the source of the supply or component, the status of whether said supply or component has been previously used, the expiration date of the supply or component, and in the case where the supply or component contains drug, the purity levels of the drug and the concentration levels of the drug. The capital equipment units or their users then utilize the information to assure quality of any procedure run with the units, by way of improved pre-use checks, certification of the supplies for use, record keeping, inventory control, and charge capture.