Classifications

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Definitions

• the present disclosure relates generally to systems for monitoring the breathing of sedated patients, especially those receiving narcotic/opioid pain medications that depress or endanger normal breathing, and specifically an apparatus that automatically delivers a narcotic reversal agent to restore normal breathing.
• the apparatus minimizes the delay in rescuing patients with abnormal monitored alarm conditions otherwise at risk of death, irreversible brain damage, or other potentially avoidable outcomes.
• a method for responding to respiratory depression occurring in patients is disclosed.
• PCA pump A common narcotic delivery device used in patients, usually post-operative patients, is known as the patient-controlled analgesia pump ("PCA pump").
• a PCA pump permits the patient to control the dosage of narcotic (typically in response to increased pain) by pressing a button that activates the pump and delivers a certain amount of narcotic.
• PCA pumps from several manufacturers have been recalled by the FDA because of malfunction, tampering and unknown errors, permitting unsafe doses of narcotics to be delivered in a certain period of time.
• various companies, agencies, etc. have focused on trying to improve the efficacy of PCA pumps, in an effort to eliminate the possibility of overdose, user error and/or intentional tampering.
• PCA pumps and associated user error have been implicated in deaths from overdose, even in young (ages 21 -35 years of age), healthy patients.
• PCA pumps and associated user error have been implicated in deaths from overdose, even in young (ages 21 -35 years of age), healthy patients.
• user error and unpredictable patient factors still result in fatal errors and serious complications, and that current narcotic delivery systems still carry a significant risk of patient harm in connection with PCA pumps.
• respiratory depression can lead to stroke, heart attack, brain injury, and death, even in young, healthy patients. If a patient stops breathing, hospital staff or other care providers would prefer to detect it immediately, and common monitoring systems are generally too slow or unresponsive to provide the information necessary to timely respond to respiratory depression (without oxygen, brain death occurs in about three minutes). To complicate this problem further, most patients are not monitored continuously, but rather simply have a nurse periodically visiting a patient's room to count their respirations. Generally, only patients in an operating room are monitored on a continuous basis with an expert in airway management present (Anesthesiologist). Thus, given these conditions, it is impossible for staff or other care providers to sufficiently monitor patients to prevent disasters outside the operating room. In post-operative and many other patient- care situations, there are substantial risks that complications will arise that require attention within seconds, but, appropriate care and intervention is usually minutes away.
• Abnormal breathing and monitoring thereof may provide a valuable indication that serious events are about to occur, have just occurred, or are occurring. Timely warnings can assist in responding to and treating these events as soon as possible to minimize risk of disability or death. Superior monitoring of patients results in better outcomes due to earlier detection of respiratory or breathing-related problems.
• pulse oximetry In contrast to the most commonly used breathing monitor besides occasional visits by staff to count respirations is "pulse oximetry,” which has been in existence for over 20 years and has greatly improved the safety of patients.
• the pulse oximetry apparatus generally consists of a clip-on monitor (typically on a finger or on an earlobe) that detects the amount of oxygen in a patient's blood stream.
• a clip-on monitor typically on a finger or on an earlobe
• pulse oximetry is relatively insensitive and slow in detecting a breathing crisis and leaves less time to correct that problem before irreversible damage begins to occur.
• an acoustic monitor (measuring the sound of breathing) has been used with success in patients to detect air movement in and out of the lungs. It may be an alternative to pulse oximetry in the early detection of cessation or slowing of breathing.
• current technology is limited by ambient noise and not recommended for patients less than twelve years old or larger patients with increased adipose tissue.
• End-tidal CO2 monitors provide the most sensitive means (100% sensitive) for providing the earliest detection of respiratory depression from narcotic overdose and disasters that might follow.
• End-tidal carbon dioxide refers to the amount of carbon dioxide exhaled at the end of a breathing cycle.
• An end-tidal monitor operates on the principle that if sufficient carbon dioxide is not being exhaled, sufficient oxygen is similarly not being inhaled - an obviously life-threatening situation that requires adequate monitoring for hospital and post-hospital settings.
• These types of CO2 monitors have been used for anesthesia monitoring during surgery and increasingly for intensive care monitoring, emergency departments and in ambulances.
• the present disclosure involves a system for monitoring patients, and more specifically post-operative patients receiving narcotics, and a novel apparatus for automatically delivering a narcotic-reversing agent, including but not limited to the agent commonly known as naloxone, in response to dangerous respiratory conditions such as respiratory depression or other undesired consequences caused by narcotic over-dosage.
• a narcotic-reversing agent including but not limited to the agent commonly known as naloxone
• naloxone One substance for counteracting the effects of narcotics is a known agent called naloxone, which has been in existence since 1971. Naloxone is frequently used in, for example, emergency and first responder situations to treat/reverse a known or suspected narcotic overdose resulting in impending or actual respiratory arrest. Naloxone is known to take effect within less than one minute and is further known to be both inexpensive and effective at reversing narcotic effects, most importantly restoring normal breathing in patients. There is generally no substantial risk of overdose, side effects, and no reported allergies with the reversal agent. Generally speaking, naloxone is one of the safest drugs on the market. The most significant risk to the patient is that pain being treated will return. However, when weighed against a likelihood of death or brain injury, pain is relatively insignificant as a consequence to critical, life saving benefits provided by naloxone.
• naloxone is provided in proper dosages by the apparatus, automatically, through the patient's pre-existing intravenous line in response to an alarm condition after detection by a monitoring apparatus, such as, by way of example but not limitation, an end-tidal C0 2 monitor.
• the delivery apparatus can be activated by one or more monitors adapted for continuously receiving information from the patient.
• delivery systems of the present invention obviate the need for various levels of unpredictable human interaction, such as dependency on a care-giver being present, human response to various indicia or prompts, and human interaction with a medication dispensing machine, for example. Reliance upon human intervention introduces delays into situations and environments where such delays are unacceptable, and have undisputably resulted in patient deaths and brain damage that are well-known.
• Embodiments of the present invention also address the significant shortcomings of PCA pumps.
• Systems and methods of the present invention provide numerous benefits in the form of redesigned user interfaces, improved hospital operating procedures, minimizing programming errors and enhancing detection before patients are harmed.
• a representation of the three components provided in a preferred embodiment would comprise: (1) an end-tidal C0 2 monitor sampling exhaled C0 2 next to the nose through a small tube alongside the nasal cannula delivering oxygen inside the nose, with the sampled exhaled C0 2 generating a wave form and respiratory rate that is displayed, recorded and sent to (2) a computer or equivalent structure running software that detects alarm conditions that sends a signal to (3) one or more existing syringe pumps that respond by injecting the life-saving naloxone or other drug-reversal agent in the patient's intravenous line and/or through the nasal cannula, the nasal cannula delivery mode being, in fact, a unique and separate embodiment itself.
• the present invention is not limited to a postoperative or any particular type of patient. Indeed, it is contemplated that the device may be used on any hospitalized patient and in various home patient situations. While it is contemplated that the financial cost of the device and associated components is to be relatively low, the risks associated with respiratory depression when compared to any conceivable cost for the device would seem to dictate in favor of widespread and ubiquitous use.
• the present invention has life-saving capability even in patients not being treated with narcotics intravenously with PCA pumps.
• patients receiving oral opiate/narcotic medications may not be connected to a standard PCA or any pump at all.
• features of the present invention may be employed to monitor a patient and/or alert relevant care-givers to over-dose from these oral medications.
• a supply of naloxone given either intravenously or intra- nasally is accompanied by a generally harmless but notable and response-provoking intranasal stimulant.
• a generally harmless but notable and response-provoking intranasal stimulant include, but are not limited to known "smelling salts,” ammonium carbonate, and various other similar substances known to elicit a response from a patient or generally arouse consciousness.
• a drug that specifically reverses the effect of benzodiazepines e.g. Valium, Lorazepam, Versed
• Flumazenil Romazicon may be supplied by the present invention to reverse sedation caused by these benzodiazepines.
• the present invention comprises Automatic External Defibrillator ("AED") features adapted for communication with additional components (e.g. capnography components) of the present invention.
• AED Automatic External Defibrillator
• additional components e.g. capnography components
• AED devices are becoming more and more common and simplified AED devices are now pervasive in workout facilities, office buildings, nursing homes, as well as hospitals.
• various AEDs are integrated into systems and methods of the present invention.
• a system comprising a monitoring device (e.g. capnography devices, end-tidal C0 2 , pulse oximetry, etc.) which is adapted for communication with an AED device.
• a monitoring device e.g. capnography devices, end-tidal C0 2 , pulse oximetry, etc.
• a monitoring device and/or computer or similar device adapted for receiving information from the monitoring device sends a signal to alert the AED that a detected respiratory arrest may in fact have been caused by a cardiac arrest and need to be evaluated and defibrillated by the AED.
• the AED Upon receiving the signal from a monitoring device, computer, and/or signal processing device, the AED conveys an indication that its services are needed. For example, an AED may be provided with lights and/or the ability to produce audio signals, thus drawing attention and immediately conveying to a first responder or care-giver that the device is needed, thus saving precious time in the presence of emergency circumstances.
• features of an AED such as electrodes are connected to a patient known to be at risk for certain heart conditions.
• the AED is further adapted to receive signals from a monitoring device and/or a signal processing device and, upon the existence of certain predetermined conditions, provide a corrective electrical stimulus to the patient. Accordingly, in this embodiment, AED treatment may be provided to a patient in need of the same without the need for specific human intervention.
• Yet another embodiment of the apparatus might be deployed for home use scenarios, as in post-operative patients being sent home but who continue to need pain medications of the narcotic/opiate class, or in chronic pain or cancer patients requiring high doses of narcotics for pain control. These patients monitored at home could receive narcotic reversal agents through a nasal cannula, and not require an intravenous line to be running.
• narcotic or benzodiazepine reversal agents i.e., smelling salts via nasal cannula, audible or weak electrical stimuli, or even transcutaneous stimulation of the phrenic nerves in the neck that activate the diaphragm, causing artificially-induced inhalation and exhalation in completely unresponsive patients.
• Figure 1 is a system according to one embodiment of the present disclosure, comprising a CC SaC ⁇ monitor, a tamper proof syringe pump and a notebook or laptop computer connected to the C0 2 / Sa0 2 monitor and the syringe pump for monitoring the C0 2 / Sa0 2 associated with a patient's breathing and for initiating the delivery of one or more narcotic reversing agents;
• Figure 2 is a schematic diagram of a system for monitoring a patient according to one particular embodiment of the present disclosure.
• Figure 3 is a flow chart of a method for monitoring a patient according to one particular embodiment of the present disclosure.
• a software-based system can provide the decision making capability to operate syringe pumps, which have been available for many years.
• all these devices shown in Figures 1 -3) can be combined in one device to provide a safer alternative for these patients.
• the system operates in conjunction with a PC A pump apparatus.
• the system replaces the obsolete PCA pump apparatus.
• a representation of the three components provided in a preferred embodiment would comprise: (1 ) an end-tidal CO 2 monitor 2 sampling exhaled C0 2 next to the nose through a small tube alongside the nasal cannula delivering oxygen inside the nose, with the sampled exhaled C0 2 generating a wave form and respiratory rate that is displayed, recorded and sent to (2) a computer 4 or equivalent structure programmed to detect alarm conditions that sends a signal to (3) one or more existing syringe pumps 6 that respond by injecting the life-saving naloxone or other drug-reversal agent in the patient's intravenous line.
• the same naloxone reversal agent is separately and/or simultaneously delivered through a oxygen-supplying nasal cannula tube, as a nasal spray to be absorbed, either as the sole method of supplying the antidote, or as a fail-safe backup mode in the event the intravenous line does not exist or is faulty. All these components could further be connected and made to function with the well-known RS-232 interface, for example.
• FIG 2 is a schematic view of the system components discussed above, wherein a series of steps is provided that typically occurs in a system according to a preferred embodiment.
• the naloxone is delivered by a syringe pump 14 or by way of a nasal cannula 20, or both.
• the nasal cannula 20, which delivers oxygen to the patient also applies slight suction through a separate tube near the patient's nose, for monitoring exhaled C0 2 from the patient.
• the PCA pump is shown in Figure 4, it is expressly understood that the system may operate in conjunction with such an apparatus, or in the complete absence of such an apparatus.
• a patient monitoring unit 2 is provided in communication with a patient 26 and various system components.
• the patient monitoring unit 2 may be connected to a source of oxygen 8 for transmitting oxygen to a patient 26 through a nasal cannula 20.
• the patient monitoring unit 2 may further be connected to and adapted for transmitting patient related data to an interface unit 4, such as a laptop computer.
• an interface unit 4 such as a laptop computer.
• one or more interface units 4 are connected to and in communication with additional system components via known RS-232 cable(s).
• the interface unit 4 may comprise an output 10, such as a wireless signal and/or USB port for transmitting data to, for example, a nurse's station.
• an output 10 such as a wireless signal and/or USB port for transmitting data to, for example, a nurse's station.
• the type of information that may be transmitted through an output 10 is not limited to any particular patient information or distress signal. Rather, the output 10 is adapted to convey any desired information that may be obtained from the patient monitoring unit 2.
• the interface unit 4 performs a detection step 12 wherein data received from the patient interface unit 2 is analyzed to determine whether or not respiratory depression may be occurring.
• the step 12 is performed continuously.
• the step 12 may be performed at predetermined intervals, the predetermined intervals being suitably short to be able to recognize a respiratory depression condition quickly (e.g. at least approximately every 15 seconds).
• the interface unit 4 is further connected to and in communication with an auto- syringe 14 or pump.
• this connection/communication is accomplished through RS-232 cable or similar devices including, for example, wireless devices.
• the auto-syringe pump automatically dispenses a predetermined quantity of naloxone to the patient through a nasal cannula 20 and/or an intravenous line 22.
• a patient 26 may additionally be provided with or connected to a PCA pump 24.
• the interface unit 4 is further adapted for communication with and activation of additional stimulating means.
• the interface unit 4 is in communication with a device 16 for providing an audible signal to a patient, such as an ear piece adapted for producing a spoken and/or pre-recorded command to the patient 26.
• the interface unit 4 may be additional adapted for prompting or initiating additional patient stimulation including, but not limited to activation of a finger-clip electrode 18 and/or dispensing of smelling salts or similar stimulating means.
• features and devices of the present invention as described herein are packaged into a single unitary device.
• components are provided individually such that existing patient care facilities can be modified or updated with features of the present invention.
• Figure 2 depicts various embodiments, systems, and features which may be used alone or in combination with one another. Accordingly, the present invention is not limited to any particular arrangement(s) as shown in Figure 2. For example, where Figure 2 depicts an auto-syringe pump 14, an audible output feature 16, an optional patient stimulator 18, a nasal cannula 20, and an intravenous line 22 for dosing a patient, these and various other features may exist alone or in combination with one another in various embodiments of the present invention.
• Alarm conditions might be, for example, a respiratory rate less than 4 for more than 60 seconds 28, an end-tidal C0 2 absolute level less than 10 (normal 25), apnea (no breathing) for greater than 30 seconds 30, or pulse oximetry less than 85 percent for greater than 15 seconds 32.
• alarm conditions may first trigger the computer to request the patient audibly to take a deep breath 34.
• a response detection step 36 is provided.
• step 40 is initiated wherein hospital staff would be notified to check the patient in any or all of various ways, depending on the alarm conditions initiated actions by the "Apnea Rescue-Bot."
• a weak electrical stimulus may also be delivered by, for example, a separate 9-volt battery via wires connected to ordinary adhesive EKG pads.
• the computer would elevate the severity of the alarm condition and command the syringe pump to inject naloxone to reverse respiratory depression systems before cardio-pulmonary arrest, brain injury or death.
• an additional monitoring step 42 is provided wherein, in the absence of detection of satisfactory patient conditions, overhead paging for "Code Blue” 44 is accomplished by hard-wired, USB, or wireless connection to the paging system at the hospital. Nurses responding immediately to check would often find the patient waking up and breathing again because of the short time naloxone takes to reverse narcotic effects on breathing and consciousness. Alternatively, if the patient had not responded by the time the nurse reached the patient a "Code Blue" would already have been called, summoning all available help to resuscitate the patient.
• the system provides a notification 38 to nurse, staff, or caregivers to verify the patient's status and take any appropriate actions.
• narcotic delivery is suspended at step 46 and care-givers are notified of the incident.
• notification is provided via a written report produced by the interface or computer.
• the written report may comprise various vital information, such as time of incident, patient conditions which triggered action, actions taken, and advice regarding subsequent patient monitoring and/or treatment.
• the invention described above may come in a number of various configurations. It could be conceived of as a sophisticated PCA infusion pump, such that it would have self- correcting "reverse capability” or narcotic effect reversal, with or without “braking” or stopping of the narcotic delivery itself. These benefits would make stand-alone narcotic infusion pump technology without narcotic reversal capability obsolete, because the invention would include not only the best available monitoring capability to detect respiratory threats, but it would include the first and only automated rescue delivery system to provide emergency administration of the remedy.
• the present invention could include multiple monitoring modalities, such as blood pressure, EKG monitoring, or it could be used in the emergency department or anywhere patients are given sedatives for, by way of example but not limitation, colonoscopies, procedures in radiology, heart cath labs, and any place outside the operating room where they are continuously watched by anesthesiologists, the ultimate experts and inventors of critical care medicine. Even though one of the invention uses would be for addressing problems with patients receiving narcotics, it is to be expressly understood that the invention could also be used in sleep apnea patients not being given narcotics.
• the present invention provides an audible or electrical encouragement to breathe upon detecting the relevant patient condition, and simultaneously employs high-flow oxygen, which is known to provide beneficial and stimulating results.
• the invention receives high-flow oxygen directly from the hospital wall source or a portable oxygen supply, and comprises its own internally adjustable valve.
• the present invention in response to alarm conditions, immediately administers high-flow oxygen both as a stimulus to breath and as a way to deliver the naloxone reversal in spray form through the nasal oxygen supply cannula.
• the invention comprises approximately 6-10 different resuscitation drugs together in a multi-compartment cassette, for use in critical cardiac arrest situations or very unstable patients.
• the cassette contains naloxone, D50 glucose, epinephrine, atropine, phenylephrine, vasopressin, esmolol, cardizem, and adenosine.
• a multi-compartment cassette could address chaotic scenarios in ERs and other places where nurses are scrambling to locate these drugs, potentially rummaging through carts for these drugs, tearing open boxes, assembling syringe cartridge/injectors, looking for needles and syringes to suck drugs out of vials, etc. prior to the patient actually getting the needed drug.
• drugs could come pre-loaded in a manually or automatic multi-injector that could be overridden by physicians, or used before the arrival of higher-level personnel trained in resuscitation.
• Possible drugs include but are not limited to naloxone (reverse narcotic), D 50 (sugar to reverse insulin overdose), NaHCCVbicarb (to reverse high potassium and acidosis), Romazicon/flumazenil (to reverse Versed and Valium), glycopyrrolate (Robinul) or atropine (to speed up a slow heart), phenylephrine (to safely increase blood pressure without speeding up the heart), epinephrine/adrenalin (to raise the blood pressure and speed up the heart, facilitate defibrillation, treat shock and severe allergic reaction and shock), Esmolol (safe short acting drug to slow down the heart), Vasopressin ( powerful drug for severe shock), and Cardizem and Adenosine to slow rapid heart rhythms,
• the device could also permit some or all of the drugs to be delivered intra-nasally.
• naloxone and other drugs are provided through a nasal cannula, either in addition to or in lieu of intravenous delivery.
• a particular embodiment contemplates administering naloxone or similar agents through an intravenous and intra-nasally.
• naloxone is pre-loaded in a proprietary tamper-proof cassette or syringe-injector.
• the preferred way to use the injector would be with the proprietary naloxone loads, to avoid it being used for any other purpose (naloxone is harmless if injected rapidly, and other medications could be harmful if delivered fast in a non-proprietary user-accessible device).
• the injector could deliver intravenously and/or intra-nasally through nasal oxygen cannula plugged into the Apnea Rescue-Bot in response to Apnea Condition.
• the device could provide further an assessment of pain control based on respiratory rate or quality of end-tidal C0 2 tracing, and advise whether the patient could safely tolerate more narcotic without respiratory depression, thus improving both comfort and the safety of patients. For example, respiratory rates greater than 20 with a high quality capnograph tracing would allow an increase in narcotic dosing, and could advise the nurse, or alternately allow the patient more frequent opportunities to self- medicate safely, without demanding more of nursing personnel. Voice-activated patient requests could be evaluated and decided upon by the device if respiratory parameters were reasonable and no alarm conditions were being approached. According to this embodiment, all actions, alarms, and adjustments would be recorded, displayed, automatically entered into the EMR (Electronic Medical Record) or wirelessly relayed to the nursing station if desired.
• EMR Electronic Medical Record
• naloxone in another embodiment, other therapeutic medications besides naloxone could be given intravenously or intra-nasally.
• phenylephrine used commonly as a vaso-constrictor to relieve nasal congestion is well known to have the side- effect of elevating blood pressure. This side effect could be exploited as a remedy for dangerously low blood pressure with nasal administration of the antidote, at least until an intravenous line could be established for the best support of low blood pressure.
• the invention has another embodiment as a "Critical Care Rescue-Bot,” which may supply the necessary dosages either intravenously or intra-nasally (in the event of intravenous line failure or prior to establishing an intravenous line, which occurs commonly).
• control system such as a programmable logic controller or relay-based control system, with accompanying algorithms to govern the relationship between the monitoring inputs, the events or conditions and subsequent reporting or alarming for notification to hospital staff or other caregivers, as well as the actual automation of the various drugs being supplied to the patient.
• control systems that are now known or developed in the future are contemplated with and considered within the scope of the present disclosure.
• capnography monitoring devices and its rescue-oriented technology are contemplated for use with the apparatus and method of the present disclosure.
• the device could easily be used in home health scenarios, for example.
• CPAP machines continuous positive airway pressure machines
• CPAP machines continuous positive airway pressure machines
• CPAP machines continuous positive airway pressure machines
• less severe types of sleep apnea are treated with extra oxygen by nasal cannula, and built-in monitoring is provided with presently available CO 2 , monitoring nasal cannula.
• CO 2 monitoring nasal cannula.
• home health systems and features are provided.
• patients who may generally qualify for discharge from a primary care facility e.g. hospital
• a primary care facility e.g. hospital
• patients who may generally qualify for discharge from a primary care facility yet mat still be at risk for over-sedation with prescribed narcotic-opiate pain pills, and chronic pain or cancer patients requiring administration of narcotics
• a scaled-down version of the invention may be provided wherein an oxygen source comprises a portable oxygen tank rather than a wall-source, and various additional system components as shown and described herein are provided in sizes and formats adapted for home use.
• a system comprising the ability to meter, monitor, and/or detect the amount of a narcotic dispensed to a patient.
• data related to the amount of a narcotic or pain-relieving drug provided to a patient is continuously monitored and automatically compared with relevant patient information such as age, weight, gender, etc.
• Relevant patient information may be manually input into the system, such as through manual data entry at a terminal or interface upon check-in or admittance to a hospital. Alternatively, relevant patient information may be automatically obtained from pre-existing medical records.
• a system is provided with predetermined limits for various types of dispensed drugs and related patient information. In this embodiment, when the predetermined limits are exceeded, dispensing of drugs is at least temporarily prevented and/or naloxone or other reversal agents are dispensed to the patient.

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