Patent Application
20240285858
Currently available devices for providing a user quick administration of a medicament to counteract a medical issue include EpiPen®, AUVI-Q®, and a wearable device that detects apnea patterns and can administer a dose of naloxone based on apnea patterns.
Naloxone is a medicament that can prevent and/or reverse the effects of various opioids including respiratory depression and other indications that result from opioid toxicity if administered in a timely fashion. Since naloxone is typically introduced via injection, naloxone is generally delivered by a healthcare provider or a person trained to deliver the naloxone. However, access to a trained health care provider is not always possible when an individual is suffering from an overdose. When access to a trained professional is not available, a user or other party will need to introduce the naloxone to the affected user. In instances where the user is by themselves, there is a high risk that the naloxone will not be adequately delivered, if at all.
A low cost and reusable means for monitoring an individual that will inject a predetermined amount of naloxone to the individual based on determining the individual may need the naloxone is needed.
Embodiments of the present invention include a medicament delivery system and method(s) of use. Typically, the medicament delivery system can include, but is not limited to, a smart user device and a medicament delivery assembly. The smart user device can include, but is not limited to, one or more sensors, a control module, and a power source. The medicament delivery assembly can be implemented as a cartridge removably received by the smart user device. Typically, each of the components of the smart user device can be contained in a housing that includes a receptacle for removably receiving the medicament delivery assembly therein. The housing can be attached to a strap that can be secured to an arm of a wearer. In some instances, the strap can be coupled to a wearer such that the wearer cannot remove the strap. For instance, a locking mechanism that can be only unlocked by a caregiver can be implemented. It is to be appreciated that the medicament delivery system can be referred to as the “ZEM Band”.
Data from the one or more sensors can be used to determine when to administer a medicament stored in the medicament delivery assembly. In a typical embodiment, the one or more sensors can include a first sensor and a second sensor. For example, the first sensor can be a pulse oximeter sensor and the second sensor can be an inertial sensor. The pulse oximeter sensor can be implemented to determine an oxygen saturation level of a wearer and the inertial sensor can be implemented to detect movement of the wearer. It is to be appreciated that the sensors can be selected from the group including, but not limited to, a pulse oximeter sensor, an inertial sensor, a temperature sensor, a blood pressure sensor, a blood glucose sensor, an electrocardiogram sensor, etc. As will be described hereinafter, a sensor may be located remotely from the smart user device where the sensor can wirelessly (or wired) send data to the smart user device.
In one embodiment, the medicament delivery assembly can include, but is not limited to, an autoinjector and a release mechanism. The autoinjector can include a medicament container, a piston, a spring, and a nozzle. The release mechanism can be operatively connected to the control module and the autoinjector. Typically, the autoinjector and the release mechanism can be housed in a single module and implemented as a cartridge.
The medicament container can be configured to store a medicament for injection into a wearer of the smart user device. For example, the medicament container can store a dose of naloxone. In another example, the medicament container may store one of insulin, epinephrine, atropine, diazepam, and vasopressin. As can be appreciated, an appropriate medicament can be selected based on the needs of a wearer. The autoinjector can be configured to inject the medicament stored in the medicament container into a wearer of the strap. In one example, the autoinjector can include a spring-loaded needle. In another example, the autoinjector can be gas powered. In yet another example, the autoinjector can be a jet injector. It is to be appreciated that one or more means of administering (or injecting) a medicament can be implemented without exceeding a scope of this disclosure. Of significant note, the medicament delivery system can be configured to receive a cartridge storing a medicament that can be injected. The medicament delivery system can be adapted to work with a variety of different medicaments with interchangeable cartridges.
Included hereinafter are a few protocols for when to administer and a how much of a particular medicament. It is to be appreciated that these protocols are a general guidance and not meant to be limiting.
In general, naloxone should be injected if there is a falling oxygen saturation with a good waveform (sine wave), low (or shallow) breathing to no breathing, a slow heartbeat, and/or low blood pressure. One or more of these indicators can be used a parameter by the control module to determine when to administer naloxone. In one example, an initial dose of 0.4 mg to 2.0 mg of naloxone may be administered. A falling oxygen saturation more the 10% below a baseline of a particular wearer, or an absolute value less than 80%, should be a parameter to immediately administer the naloxone. If there is no improvement detected, naloxone injections can be repeated in 2-3 minutes.
For cartridges containing epinephrine, a parameter for determining when to inject epinephrine can be severe bradycardia less than 35 and/or hypotension with systolic pressures below 80. The dose of epinephrine for anaphylaxis can be approximately 0.01 mg/kg (amount of epinephrine/weight of wearer) up to 0.30 mg/kg.
For cartridges containing atropine, a parameter for determining when to inject atropine can be heart rate less than 40 and falling. In another instance, a heart rate more than 10 beats less than normal low rate for the individual if normally around 40. For atropine treatment of organophosphorus poisoning (also for bradycardia from any cause): Adults and children older than 10 years of age weighing more than 41 kilograms-2 milligrams injected into a muscle; Children 4 to 10 years of age weighing 18 to 41 kg-1 mg injected into a muscle.
Vasopressin is a drug that can be used in pulseless arrest or for hypotension. For diabetes insipidus, 10 units can be delivered subcutaneous or intramuscular. The dose for pulseless cardiac arrest is 40 units intravenous.
Embodiments are contemplated where the cartridge can include diazepam and the smart user device can include at least an ultrasonic sensor. As known, diazepam can be used to treat seizures. A dose of 5-10 mg of diazepam may be included in a cartridge. Seizure symptoms may be detected by the ultrasonic sensor.
Embodiments are contemplated where sensors specific to a potentially fatal diagnosis can be implemented. The control module can be adapted to analyze data from the one or more sensors to determine when administration of a particular medicament may be needed. For instance, a sensor designed to analyze sweat secreted from a wearer is contemplated. The control module would then be able to analyze the sweat to detect drug and/or alcohol use. The data from the sensor could be analyzed by the control module to determine if a medicament should be administered.
In a typical implementation, the release mechanism can be activated by the control module. In some embodiments, the medicament delivery system can include a means for manually activating the autoinjector by a wearer of the smart user device. For instance, the medicament delivery assembly can include a mechanical actuator to engage the release mechanism that can be actuated by the user. In one example, the smart user device can include a linear actuator that can be activated by the control module. The linear actuator can be adapted to engage the release mechanism to active the autoinjector. In some instances, the smart user device can be connected to a wireless network. The smart user device can be configured to receive a signal (or command) via the wireless network to activate the autoinjector. For example, a caregiver may determine that the medicament needs to be injected and can remotely activate the autoinjector via the wireless network.
In one example embodiment where naloxone is provided as the medicament, the control module can be configured to receive signals from the pulse oximeter sensor and the inertial sensor to determine when to activate the autoinjector of the medicament delivery assembly. For instance, the control module can send a signal to the release mechanism to activate the autoinjector based on determining that an oxygen level is below a predetermined threshold and the inertial sensor has not detected any movement for a predetermined amount of time. Of significant note, by determining an optimum time to inject the medicament by monitoring the two sensors, the wearer of the strap can have the best chance for overcoming an overdose. The control module can be programmed to activate the autoinjector based on data received from one or more of the sensors. For instance, the control module can be configured to activate the autoinjector based on receiving data from the pulse oximeter that indicates an oxygen saturation level has dropped below a critical level. In this instance, the control module may activate the autoinjector even when receiving data from the inertial sensor that there is movement. In another instance, the control module can be configured to send a signal to the release mechanism based on determining there is no movement detected by the inertial sensor for a predetermined amount of time.
In one embodiment, the medicament delivery assembly may be located on a different part of the body than the strap. For instance, where insulin is in the medicament container for a Diabetic, the medicament delivery assembly can be secured to a thigh of a user. The control module can be configured to send a wireless signal to the medicament delivery assembly to activate the autoinjector.
Embodiments are contemplated where the medicament delivery assembly includes more than one medicament. In such an embodiment, the medicament delivery assembly can include, but is not limited to, a first autoinjector, a first release mechanism, a second autoinjector, and a second release mechanism. The first release mechanism can be operatively connected to the first autoinjector and the second release mechanism can be operatively connected to the second autoinjector. The control module can be configured to determine a medicament stored in each of the autoinjectors along with determining one or more protocols to follow based on the medicaments. For instance, the autoinjectors may each contain insulin. A wearer would then have two doses of insulin ready for injection when needed. The control module can be configured to determine that both autoinjectors include insulin in the medicament delivery assembly. The control module may then start a predetermined protocol for a medicament delivery assembly containing two doses of insulin. Instances are contemplated where the dual medicament delivery assembly may include different medicaments. In such an instance, the control module can be configured to run two different protocols simultaneously to determine when to administer either of the medicaments based on data from the sensors.
In some instances, a remotely located database can be implemented to store data from the smart user device. The smart user device can be configured to send data to the remotely located database via a wireless network. For instance, physiological data measured by the one or more sensors, and analyzed by the control module, can be sent to the remote database. Authorized users can access the remote database to monitor physiological data of a wearer. For example, a recently released patient from alcohol and/or drug rehabilitation may be required to wear a medicament delivery system. A caregiver(s) can access data from the remote database via an application or web interface to monitor the patient. Embodiments are contemplated where a caregiver may monitor the data in near real time. The caregiver may have the authority to activate the autoinjector (via the control module) remotely based on monitoring the data from the smart user device. For example, if a wearer is hovering near the thresholds for the autoinjector to be engaged, but not quite getting to the threshold, a caregiver can send a signal to the smart user device to activate the release mechanism to inject the wearer. In another example, a caregiver can be given permission to have the medicament delivery system administer a medicament based on their judgement. Embodiments are contemplated where a caregiver, having access to the remote database, can alter parameters for administrating a medicament for a particular wearer. For example, a caregiver can adjust parameters for injection based on one or more physical characteristics of a wearer.
In one embodiment, a medicament delivery system can include, but is not limited to, a cartridge and a smart user device. The cartridge can include an autoinjector and a release mechanism. The autoinjector can contain a medicament. The release mechanism can be operatively connected to the autoinjector. The smart user device can be adapted to operatively connect to the cartridge and can include a housing, a control module, an inertial sensor, and a pulse oximeter sensor. The housing can (i) be coupled to a strap, and (ii) include a receptacle for removably receiving the cartridge therein. The control module can be (i) operatively connected to the cartridge when the cartridge is inserted into the receptacle, and (ii) adapted to determine the medicament when the cartridge is inserted into the receptacle. The inertial sensor and the pulse oximeter sensor can each be adapted to send data to the control module.
In another embodiment, a medicament delivery system can include, but is not limited to, a cartridge and a smart user device. The cartridge can include a primary autoinjector containing a first medicament, a primary release mechanism operatively connected to the primary autoinjector, a secondary autoinjector containing a second medicament, and a secondary release mechanism operatively connected to the secondary autoinjector. The smart user device can be adapted to operatively receive the cartridge and can include a housing, a control module, an inertial sensor, and a pulse oximeter sensor. The housing can (i) be coupled to a strap, and (ii) include a receptacle for removably receiving the cartridge therein. The control module can be (i) operatively connected to the cartridge when the cartridge is inserted into the receptacle, and (ii) adapted to determine the first medicament and the second medicament when the cartridge is inserted into the receptacle. The inertial sensor and the pulse oximeter sensor can each be adapted to send data to the control module.
In yet another embodiment, a medicament delivery system can include, but is not limited to, a cartridge and a smart user device. The cartridge can include a primary autoinjector containing a first medicament, a primary release mechanism operatively connected to the primary autoinjector, a secondary autoinjector containing a second medicament, and a secondary release mechanism operatively connected to the secondary autoinjector. The smart user device can be adapted to operatively receive the cartridge and can include a housing, a control module, a linear actuator, a first sensor, and a second sensor. The housing can (i) be coupled to a strap, and (ii) include a receptacle for removably receiving the cartridge therein. The linear actuator can be adapted to engage the primary release mechanism and the secondary release mechanism. The control module can be (i) operatively connected to the linear actuator, and (ii) adapted to determine the first medicament and the second medicament when the cartridge is inserted into the receptacle. The first sensor and the second sensor can each be adapted to send data to the control module.
Embodiments are contemplated where the medicament delivery system can be implemented to routinely provide medicament injections based on a predetermined schedule. For instance, where a wearer needs to routinely take a medicament for one or more medical conditions, the medicament delivery system can be implemented to provide the wearer with reminders and administration of the medicament as needed. Generally, the control module can implement a protocol based on a regimen for the medicine to be administered. The smart user device can be adapted to present an alert to a wearer letting them know that a dose of medicament is needed and then administer the medicament to the wearer. Of note, the smart user device can alert a wearer that a new cartridge is needed after the medicament has been administered. Further, the smart user device can alert a wearer if a new cartridge is needed after determining that a loaded cartridge does not have any medicament.
In one instance, the autoinjector can implement a sharp (e.g., a needle) for injection of a medicament in both an emergency and for routine administrations of the medicament. Of note, some medicaments (e.g., nitroglycerin, nicotine, fentanyl, hormones, or others) can be delivered for transcutaneous absorption by expulsion of a cream, emollient, or gel by the medicament delivery assembly. In some instances, the cartridge may be located away from the smart user device. In such an instance, the cartridge may connect to the smart user device via a wireless protocol. The smart user device can be programmed to couple physiological measurement analysis by the smart user device to activate the autoinjector via a Bluetooth signal. For example, a cartridge may be located on a thigh for an injection of Epinephrine for anaphylaxis. In other instances, an implanted device (e.g., for glucose monitoring) can be wirelessly connected to the smart user device for sending data to the smart user device to help determine when to administer a medicament (e.g., injection of insulin). The smart user device may be coupled to an automatic implanted defibrillator device to diagnose arrhythmias and trigger the delivery of an appropriate shock.
Of note, medicaments can be delivered on both an emergency basis and on a scheduled (or routine) basis. The smart user device can be updated via a wireless connection to a local area network to allow for remote adjustments to be programmed by a physician. For example, the physician may want to change the timing or dosing of scheduled medications. Some emergency medications can be delivered based on remote diagnosis by a physician to treat, to change dosage, or change scheduled delivery times. In some instances, a remote emergency alert, a GPS locator, and/or third-party adjustment functions can be facilitated by cell service towers or by satellite.
Embodiments of cartridges configured to store an oral medication to be released for a wearer to take when directed by the smart user device is contemplated. For instance, the smart user device can alert the wearer and allow access to a medicament for the user (or a caregiver) to remove and administer. Cartridges can be preloaded with one or more days' worth of a medicament and can be accessible by the wearer a predetermined times so that patients are less likely to forget or misuse their oral medications. Of note, a size of the cartridge can limit the number of medicaments storable by the cartridge. In some embodiments, a remotely located storage container can be operatively connected to the smart user device. The remotely located storage container can be unlocked (or made accessible) via a wireless signal from the smart user device. As can be appreciated, this could also reduce the possibility of abuse by others of medications contained in typical prescription bottles containing larger quantities of controlled medications.
In a second embodiment of a medicament delivery system, a smart user device can be implemented with one or more smart medicament delivery assemblies. The smart medicament delivery assemblies can be referred to as smart cartridges from hereinafter. The smart cartridge can be similar to the previously described medicament delivery assembly. The smart cartridge may further include a non-volatile storage for storing one or more protocols and information related to a medicament included with the smart cartridge. The smart user device can be configured to receive the data from the smart cartridge.
Embodiments of the smart cartridge can provide the smart user device data to identify how to inject (or deliver) the medicament the smart cartridge is storing. In one example, the smart user device can be implemented as a smart watch with diagnostic capability and emergency alert functionality. The smart cartridge can be an individually prescribed and programmed medical device with medicament delivery capability via the smart user device. Each smart cartridge can store the specific information on how the hardware in the smart user device may activate a distribution (or injection) of a medicament in the smart cartridge. Smart cartridges containing medicaments only available via prescription can be prescribed for each specific need.
In some embodiments, the smart medicament delivery system can include an application that can locate automated external defibrillators (AED) close to the wearer. In some instances, the AED locations may be manually input into the application. Overtime, more and more AED locations can be added to the application. Embodiments of the smart medicament delivery system are contemplated that include blood pressure measuring capabilities and an automatic tourniquet activation system. The smart medicament delivery system can be used in combination with a pre-existing automatic tourniquet system.
Described hereinafter are a plurality of critical events and/or medical emergencies where the medicament delivery system can be implemented. Parameters for determining the critical events and medical emergencies are described along with a type of medicament(s) to treat the emergency. Of note, the smart user device can be configured to determine when to administer a medicament based on one or more predetermined thresholds or parameters. Further, the smart cartridge can provide a protocol for the smart user device to implement to determine when to administer a medicament.
Opioid overdose (e.g., fentanyl and other narcotics) can be detected by falling oxygen saturation, decreasing respiratory rate, slowing heart rate, possible fall, and decreasing movement. Naloxone sodium (e.g., Narcan) 0.4 mg can be administered via subcutaneous (SQ) or intramuscular (IM). Naloxone Sodium is a pure competitive opioid antagonist with a high affinity for the mu-opioid receptor. Naloxone sodium can directly block binding of opioids in the respiratory centers.
Anaphylactic shock can be detected by a severe drop in blood pressure, increasing heart rate, increasing respiratory rate, falling oxygen saturation, possible fall, and/or decreasing movement. In some embodiments, the medicament delivery system can include a self-triggering mechanism for self-administration for self-recognized symptoms prior to changes in vital signs (e.g., airway changes, hives, anxiety, itching, wheezing, etc.). Epinephrine 0.3 mg can be administered via SQ or IM. In some instances, the cartridge can further include Diphenhydramine (Benadryl) 25 mg administered via IM. In some instances, the cartridge can include Glucagon 1 mg to be administered via SQ or IM (instead of epinephrine for patients on beta-blockers). Epinephrine can cause vasoconstriction (alpha effect) and increased contractility of the heart (beta effect) increasing blood pressure. Sympathomimetic catecholamine that acts on alpha and beta receptors. It is the strongest alpha receptor activator. Glucagon may work in patients on beta-blockers where epinephrine does not work by activating adenyl cyclase directly increasing heart rate, contractility and vascular tone bypassing beta blockade.
Septic Shock can be detected by a severe drop in blood pressure, increasing heart rate, rapid respiratory rate, shaking, a possible fall, high or low temperature, and/or heart palpitations. Epinephrine 0.2-0.5 mg can be administered via SQ or IM every 5 minutes as needed. Of note, this can be an acceptable second line until advanced care available to start Norepinephrine. Epinephrine can cause vasoconstriction (alpha effect) and increased contractility of the heart (beta effect) increasing blood pressure. Sympathomimetic catecholamine that acts on alpha and beta receptors. It is the strongest alpha receptor activator.
Cardiogenic shock (e.g., congestive heart failure) can be detected by a severe drop in blood pressure (e.g., a SBP<80), rapid or slow abnormal heart rate, rapid respiratory rate, and/or possible fall. Epinephrine 0.2-0.5 mg can be administered via SQ or IM every 5 minutes as needed to maintain mean arterial pressure between 50-60 mm Hg. Isoproterenol 0.2 mg can be administered via SQ or IM. Epinephrine can cause vasoconstriction (alpha effect) and increased contractility of the heart (beta effect) increasing blood pressure. Sympathomimetic catecholamine that acts on alpha and beta receptors. It is the strongest alpha receptor activator. Isoproterenol can be a non-selective beta agonist analog of epinephrine. Increases heart rate and contractility, relaxes smooth muscle and treats bronchospasm.
Hemorrhagic shock can be detected by a severe drop in blood pressure, increasing heart rate, rapid respiratory rate, shaking, and/or a possible fall. In such an instance, an immediate signal can be sent to emergency services and a GPS location can be provided by the smart device. Epinephrine 0.2-0.5 mg can be administered via SQ or IM every 5 minutes as needed. Of, note, this may increase uncontrolled bleeding if blood pressure is increased. In some instances, the epinephrine can be used if systolic blood pressure less than 80 mm Hg. Fluid resuscitation first line therapy. Epinephrine can cause vasoconstriction (alpha effect) and increased contractility of the heart (beta effect) increasing blood pressure. Sympathomimetic catecholamine that acts on alpha and beta receptors. It is the strongest alpha receptor activator.
Bradycardia can be detected by a heart rate less than 50 with hypotension (blood pressure less than 90/60) and/or a possible fall. Bradycardia can be associated with medications slowing heart rate, have sino-atrial node dysfunction or sleep apnea causing a drop in oxygen saturation and slowing heart rate. Atropine 1 mg can be administered via IM every 3-5 minutes. Epinephrine 0.2-0.5 mg can be administered via SQ or IM every 5 minutes as needed. Atropine can be implemented to increase heart rate by competitively antagonizing acetylcholine receptors, increasing firing of the sinoatrial node in the heart, and increasing conduction through the atrioventricular node. Epinephrine can cause vasoconstriction (alpha effect) and increased contractility of the heart (beta effect) increasing blood pressure. Sympathomimetic catecholamine that acts on alpha and beta receptors. It is the strongest alpha receptor activator.
Atrio-ventricular heart block can be detected by an EKG showing heart block-atrio-ventricular dissociation. Drop in blood pressure, falling oxygen saturation, possible fall, decreasing movement can be indicators of atrio-ventricular heart block. Epinephrine 1 mg can be administered via SQ or IM every 5 minutes as needed. Isoproterenol 0.2 mg can be administered via SQ or IM. Atropine 1 mg can be administered via IM every 3-5 minutes. Epinephrine can cause vasoconstriction (alpha effect) and increased contractility of the heart (beta effect) increasing blood pressure. Sympathomimetic catecholamine that acts on alpha and beta receptors. It is the strongest alpha receptor activator. Isoproterenol can be implemented as a non-selective beta agonist analog of epinephrine. Increases heart rate and contractility, relaxes smooth muscle and treats bronchospasm. Atropine can be implemented to increase heart rate by competitively antagonizing acetylcholine receptors, increasing firing of the sinoatrial node in the heart, and increasing conduction through the atrioventricular node. Not for wide-complex bradyarrhthmias or blocks in the bundle of his. Only to be used if low blood pressure or unstable.
Asystole/PEA can be detected by an EKG with electrical activity without pulse or blood pressure, possible fall, and/or lack of movement. Epinephrine 1 mg can be administered via SQ or IM every 5 minutes as needed. In such an instance, an announcement to bystander(s) to start CPR can be made via the smart device. Epinephrine can cause vasoconstriction (alpha effect) and increased contractility of the heart (beta effect) increasing blood pressure. Sympathomimetic catecholamine that acts on alpha and beta receptors. It is the strongest alpha receptor activator.
Ventricular fibrillation (or pulseless ventricular tachycardia) can be detected by an absence of pulse or blood pressure, a V fib EKG with disorganized electrical activity, a V tach EKG with rapid wide complex, a possible fall, and/or lack of movement. Epinephrine 1 mg can be administered via SQ or IM every 5 minutes as needed. A shockable rhythm via an AED or AICD. Bluetooth communication with an implanted defibrillator or identify location of the nearest AED. The medicament delivery system can include an AED locator application or may be in communication with a remotely located AED locator application. In some instances, the smart user device can be configured to make an audible announcement to bystanders to start CPR and find an AED.
Organophosphate poisoning (e.g., insecticides, nerve gases (Sarin, VX, Tabun, Soman)) can be detected by respiratory depression or arrest, irregular heart rate, convulsions, and/or twitching. Atropine 0.5-2 mg can be administered via IM. Pralidoxime chloride 600-1000 mg can be administered via IM. Pralidoxime can be implemented to bind to the acetylcholinesterase-organophosphate complex displacing the phosphate and unbinding it from the acetylcholine, thereby reversing paralysis of respiratory muscles. Does not reverse centrally mediated respiratory depression because it does not cross the blood brain barrier like atropine.
Long QT syndrome (or Torsades de Pointes) can be detected by an EKG with polymorphic ventricular tachycardia, possible increased pulse, decreased blood pressure, a fall, and/or decreased movement. Magnesium 1 gm can be administered via IM. Isoproterenol 0.2 mg can be administered via SQ or IM. Metoprolol can be implemented to bind to beta receptors slowing the heart rate, reducing renin production and reducing cardiac output and blood pressure. Isoproterenol can be implemented as a non-selective beta agonist analog of epinephrine. Increases heart rate and contractility, relaxes smooth muscle and treats bronchospasm. Magnesium can be implemented to function as a calcium channel blocker, suppressing early after depolarizations in torsades de pointes, blocking calcium's ability to activate smooth muscle contraction, and/or relaxing bronchiolar contractions and uterine contractions.
Tonic-clonic seizures (or status epilepticus) can be detected by a fall with repeated jerking or twitching movements, a history of seizure disorder, and/or seizures lasting longer than five minutes. Status epilepticus can be life threatening. Of note, low oxygen saturation, high blood pressure, and high temperature are common. Diazepam (e.g., valium) 10 mg can be administered via IM. The medicament can be administered on repeat in 20 minutes. Valium can enhance the inhibition of GABA by binding to the benzodiazepint, GABA, and barbiturate receptor complex.
Life-threatening Asthma can be detected by a history of asthma, oxygen saturation less than 92%, slow heart rate, arrhythmias, and/or low blood pressure. Epinephrine 0.1-0.2 mg and terbutaline 0.25 mg can be administered via SQ. Isoproterenol 0.2 mg can be administered via SQ or IM. Terbutaline can be implemented as a Beta-2 adrenergic agonist causing bronchodilation, opening airways. Increases heart rate and contractility, relaxes smooth muscle and treats bronchospasm.
Adams-Stokes syndrome can be detected by falling due to fainting, absent or very irregular pulse, breathing usually normal, and/or twitching movements. Isoproterenol 0.2 mg can be administered via SQ or IM.
Acute coronary syndromes (e.g., a heart attack) can be detected by an EKG changes including new ST elevation, V fib EKG with disorganized electrical activity, V tach EKG with rapid wide complex, a possible fall, lack of movement, possible absence of pulse, blood pressure changes. Nitroglycerin 0.5-1 ml 0.1% solution can be administered via SQ or IM. Morphine 5-10 mg can be administered via IM. Heparin 5000 units can be administered vis SQ every 8-12 hours. Morphine can bind to the mu-opioid receptor to decrease heart rate, blood pressure, and venous return. Heparin can bind to an antithrombin inactivating thrombin (Factor IIa) and Factor Xa. Beta-blockers can bind to Beta receptors slowing the heart rate, reducing renin production, and reducing cardiac output and blood pressure.
Described hereinafter are multiple critical events that can be treated with same medicament.
Torsades de Pointes, asthma, eclampsia, and pre-term labor can be treated with Magnesium 1 gm administered via IM. Magnesium can function as a calcium channel blocker, suppressing early after depolarizations in Torsades, and blocking calcium's ability to activate smooth muscle contraction, relaxing bronchiolar contractions and uterine contractions.
Anticoagulation requirement including, but not limited to, deep venous thrombosis, pulmonary embolus, atrial fibrillation, cardiac stents, cardiac valve replacements, vascular stents, and ischemic strokes can be treated with Lovenox 40-80 mg administered via SQ and heparin 5000 units administered via SQ every 8-12 hour. Lovenox can be implemented to bind and potentiates antithrombin III, irreversibly inactivates clotting factor Xa. Heparin can bind to an antithrombin inactivating thrombin (Factor IIa) and Factor Xa.
Anaphylactic shock, septic shock, cardiogenic shock, hemorrhagic shock, bradycardia, atrio-ventricular heart block, asystole/PEA, ventricular fibrillation, pulseless ventricular tachycardia, and life-threatening asthma can be treated with epinephrine.
Hypoglycemia and anaphylaxis in patients on beta-blockers can be treated with glucagon. Glucagon can activate adenyl cyclase directly increasing heart rate, contractility and vascular tone bypassing beta blockade. Glucagon is a hormone that signals the liver to release stored glucose.
Congestive heart failure (cardiogenic shock), atrio-venticular heart blocklong-qt syndrome, adams-stokes syndrome, bronchospasm can be treated with isoproterenol.
Bradycardia and organophosphate poisoning (e.g., insecticides, nerve gases including, but not limited to, Sarin, VX, Tabun, and Soman) can be treated with atropine.
Pain control for trauma, battlefield injuries, cancer treatment, palliative/end of life care, sickle crises, heart attacks, etc. can be treated with morphine.
Described hereinafter are examples of critical events that can be treated with IV medicaments.
The medicament delivery system can be implemented for military applications including, but not limited to, pain control, hemorrhage control, nerve gas, and performance enhancement. In some instances, medicaments can be configured to be administered by a third party (e.g., via satellite signals). For example, vitals of a soldier can be remotely monitored and a medicament can be administered based on a third party reviewing and analyzing the vitals. The medicament delivery system can be configured to activate one or more tourniquets contained within clothing for hemorrhagic shock.
Medicaments to be administered can include morphine, epinephrine, and atropine.
Supra-ventricular tachycardia, atrial fibrillation (or atrial flutter with rapid ventricular response), rapid rate control in aortic dissection, acute coronary syndromes, non-ST elevation myocardial infarction, hypertensive crisis, thyrotoxicosis, refractory ventricular tachycardia, and ventricular defibrillation can be treated with esmolol. Esmolol can be implemented as a short acting cardio-selective beta blocker to rapidly decrease atrio-ventricular conduction slowing heart rate. Presently for IV use.
Hypertensive crisis including, but not limited to, angina, myocardial infarction, atrial fibrillation, atrial flutter, supraventricular tachycardia, and thyroid storm can be treated with metoprolol, nitroglycerin. Metoprolol can bind to beta receptors slowing the heart rate, reducing renin production and reducing cardiac output and blood pressure. Presently for IV use.
Myocardial infarction can be treated with aspirin, lidocaine, and/or metoprolol.
Described hereinafter are conditions requiring routinely scheduled medicaments for injection. Of note, the medicament delivery system can be configured to determine when to administer a medicament based on a schedule provided by a caregiver.
The medicament delivery system can be implemented to administer medicaments for diabetes. For hyperglycemia, insulin can be administered by the system based on a predetermined schedule or may be activated by wireless communication with Libre (or another implanted glucose detection system). For hypoglycemia, glucagon can be administered by the system based on a predetermined schedule or may be activated by wireless communication with Libre (or another implanted glucose detection system).
The medicament delivery system can be implemented to administer medicaments for weight loss on a weekly basis. Semaglutide injections can include, but are not limited to, Mounjaro, Wegovy, Ozempic, Rybelsus, Trulicity, and/or Victoza.
The medicament delivery system can be implemented to administer medicaments to help with fertility. Medicaments can include, but are not limited to, human menopausal gonadotropin (hMG), follicle stimulating hormone (FSH), human chorionic gonadotropin (HCG), gonadotropin releasing hormone agonists (GnRHA) (e.g., Lupron, Zoladex, Synarel, etc.), and antagonists (e.g., Antagon, Ganirelix, Cetrotide, etc.). hMG can be administered via injection daily for 7-12 days in the first half of the menstrual cycle. FSH can be administered via injections daily for 7-12 days in the first half of the menstrual cycle. hCG can be injected to trigger ovulation. GnRHA agonists and antagonists can be used prior month to shut down natural hormone production to precisely control egg production.
The medicament delivery system can be implemented to administer medicaments for schizophrenia. Medicaments can include, but are not limited to, Respiridone, Zyprexa, Invega, Abilify, Aristada, Uzedy, Haldol, and Prolixin. Of note, in some instances, the smart device may be locked allowing another person to control administration of a medicament for a wearer of the smart device. For example, a wearer may have a court order or patient or parent requested locked band. Injections for schizophrenia can be administered 1-2 times per month.
The medicament delivery system can be implemented to administer medicaments for snake bites (e.g., cobras, kraits, mambas). Medicaments can include synthetic snake antivenom.
The medicament delivery system can be implemented to administer medicaments via IM including antibiotics, corticosteroids, and vitamin B12.
In one embodiment, a medicament delivery system can include, but is not limited to, a first smart cartridge and a smart user device. The first smart cartridge can include an autoinjector containing a first medicament, a release mechanism operatively connected to the autoinjector, and non-volatile storage storing a first protocol and one or more predetermined thresholds related to the first medicament. The smart user device can be adapted to operatively connect to the first smart cartridge. The smart user device can include a housing, a control module, and one or more sensors. The housing can be coupled to a strap and can include a receptacle for removably receiving the first smart cartridge therein. The control module can be (i) operatively connected to the first smart cartridge when the first smart cartridge is inserted into the receptacle, (ii) adapted to receive the first protocol from the first smart cartridge including the one or more predetermined thresholds, and (iii) adapted to determine when to administer the first medicament based on the first protocol provided by the first smart cartridge. The one or more sensors can be adapted to send data to the control module.
In another embodiment, a medicament delivery system can include a plurality of smart cartridges and a smart user device. The plurality of smart cartridges can each include a medicament, a delivery mechanism, and non-volatile storage storing a protocol and one or more predetermined thresholds related to the medicament. The smart user device can be adapted to operatively connect to each of the plurality of smart cartridges. The smart user device can include a housing, a control module, and one or more sensors. The housing can be coupled to a strap and include a receptacle for removably receiving the plurality of smart cartridges therein. The control module can be (i) operatively connected to each of the plurality of smart cartridges inserted into the receptacle, (ii) adapted to receive the protocol from each of the plurality of smart cartridges operatively connected to the control module, and (iii) adapted to determine when to administer the medicament of each of the plurality of smart cartridges. The one or more sensors can be adapted to send data related to physiological measurements to the control module.
In yet another embodiment, a medicament delivery system can include a smart cartridge and a smart user device. The smart cartridge can include a medicament and non-volatile storage storing a protocol and one or more predetermined thresholds related to the medicament. The smart user device can be adapted to operatively connect to the smart cartridge. The smart user device can include a housing, a control module, and one or more sensors. The housing can be coupled to a strap and can include a receptacle for removably receiving the smart cartridge therein. The control module can be (i) operatively connected to the smart cartridge when the smart cartridge is inserted into the receptacle, (ii) adapted to receive the protocol from the smart cartridge including the one or more predetermined thresholds, and (iii) adapted to determine when to administer the medicament based on the protocol provided by the smart cartridge. The one or more sensors can be adapted to send data related to physiological measurements to the control module.
Embodiments are contemplated with the medicament delivery system being configured to work with infants and small children. As can be appreciated, there are many infant-related conditions the medicament delivery system can help protect children against. For instance, SIDS, apnea, and many more. The medicament delivery system can be modified to transmit data to a parent (or doctor) and can be configured to administer a medicament if needed. In some instances, the medicament delivery system can be configured to send a signal to a user device (e.g., parent smart phone) and initiate an alarm or other emergency signal to alert the parent of an issue detected by the medicament delivery system. The medicament delivery system can be configured to be worn on an arm and/or a leg. Typically, the smart user device can further include a temperature sensor or can be wirelessly connected to a temperature sensor. Of significant note, medicaments used for infants/children can be appropriate for their age and weight.
Embodiments are contemplated where the medicament delivery system can be configured to be implemented with animals. For instance, a dog collar can be implemented to couple to the smart user device and cartridges storing animal medicine can be administered. In another instance, a strap configured to couple to a cow can be implemented with the medicament delivery system to administer medicine to the cow. It is to be appreciated that the smart user device and medicament delivery assembly can be configured to work with a variety of different animals. Of note, the smart user device may be modified to work with an animal. For example, the smart user device may be manufactured from more rugged materials to withstand more abuse. In another example, the smart user device may not include a display. In one example, a cow can be fitted with a collar that includes the smart user device and one or more cartridges. In one instance, the cartridges can include follicle-stimulating hormone (FSH) as a hormone reproduction ovulation drug. In another instance, the cartridges can include progesterone which is a heat production drug for animals. In another instance, the cartridges may include tranquilizers to be injected on command from a remotely located smart device operatively connected to the medicament delivery system. In other instances, antibiotics can be included in the cartridges.
The present invention can be embodied as devices, systems, methods, and/or computer program products. Accordingly, the present invention can be embodied in hardware and/or in software (including firmware, resident software, micro-code, etc.). Furthermore, the present invention can take the form of a computer program product on a computer-usable or computer-readable storage medium having computer-usable or computer-readable program code embodied in the medium for use by or in connection with an instruction execution system. In one embodiment, the present invention can be embodied as non-transitory computer-readable media. In the context of this document, a computer-usable or computer-readable medium can include, but is not limited to, any medium that can contain, store, communicate, propagate, or transport the program for use by or in connection with the instruction execution system, apparatus, or device.
The computer-usable or computer-readable medium can be, but is not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, device, or propagation medium.
The terms and phrases as indicated in quotation marks (“ ”) in this section are intended to have the meaning ascribed to them in this Terminology section applied to them throughout this document, including in the claims, unless clearly indicated otherwise in context. Further, as applicable, the stated definitions are to apply, regardless of the word or phrase's case, to the singular and plural variations of the defined word or phrase.
The term “or” as used in this specification and the appended claims is not meant to be exclusive; rather the term is inclusive, meaning either or both.
References in the specification to “one embodiment”, “an embodiment”, “another embodiment, “a preferred embodiment”, “an alternative embodiment”, “one variation”, “a variation” and similar phrases mean that a particular feature, structure, or characteristic described in connection with the embodiment or variation, is included in at least an embodiment or variation of the invention. The phrase “in one embodiment”, “in one variation” or similar phrases, as used in various places in the specification, are not necessarily meant to refer to the same embodiment or the same variation.
The term “couple” or “coupled” as used in this specification and appended claims refers to an indirect or direct physical connection between the identified elements, components, or objects. Often the manner of the coupling will be related specifically to the manner in which the two coupled elements interact.
The term “directly coupled” or “coupled directly,” as used in this specification and appended claims, refers to a physical connection between identified elements, components, or objects, in which no other element, component, or object resides between those identified as being directly coupled.
The term “approximately,” as used in this specification and appended claims, refers to plus or minus 10% of the value given.
The term “about,” as used in this specification and appended claims, refers to plus or minus 20% of the value given.
The terms “generally” and “substantially,” as used in this specification and appended claims, mean mostly, or for the most part.
Directional and/or relationary terms such as, but not limited to, left, right, nadir, apex, top, bottom, vertical, horizontal, back, front and lateral are relative to each other and are dependent on the specific orientation of a applicable element or article, and are used accordingly to aid in the description of the various embodiments and are not necessarily intended to be construed as limiting.
The term “software,” as used in this specification and the appended claims, refers to programs, procedures, rules, instructions, and any associated documentation pertaining to the operation of a system.
The term “firmware,” as used in this specification and the appended claims, refers to computer programs, procedures, rules, instructions, and any associated documentation contained permanently in a hardware device and can also be flashware.
The term “hardware,” as used in this specification and the appended claims, refers to the physical, electrical, and mechanical parts of a system.
The terms “computer-usable medium” or “computer-readable medium,” as used in this specification and the appended claims, refers to any medium that can contain, store, communicate, propagate, or transport the program for use by or in connection with the instruction execution system, apparatus, or device. The computer-usable or computer-readable medium may be, for example but not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, device, or propagation medium. By way of example, and not limitation, computer readable media may comprise computer storage media and communication media.
The term “signal,” as used in this specification and the appended claims, refers to a signal that has one or more of its characteristics set or changed in such a manner as to encode information in the signal. It is to be appreciated that wireless means of sending signals can be implemented including, but not limited to, Bluetooth, Wi-Fi, acoustic, RF, infrared and other wireless means.
Referring to
As shown in
The smart user device 102 can have a hardware platform and software components. In general, the hardware platform can include a processor, a user interface, storage, and a display. The processor can be a single microprocessor, multi-core processor, or a group of processors. The user interface can include one or more buttons and the display when implemented as a touch display. The storage can include random access memory and nonvolatile storage. The random access memory can store executable code as well as data that can be immediately accessible to the processor. The nonvolatile storage can store executable code and data in a persistent state. Typically, the display can be a touch display configured to receive input from a user. The software components of the smart user device 102 can include one or more databases which can store information related to various medicaments that the smart user device 102 may be used to administer. The one or more databases can also store methodologies (or protocols) for determining when to administer a particular medicament based on data received from the sensors 110/112. The software components can also include an operating system on which various applications can execute.
As shown generally in
As shown in
The control module 106 can include a means for determining a type of medicament in a particular cartridge 104. For instance, a first cartridge containing naloxone can be inserted into the smart user device 102. The control module 106 can determine a naloxone cartridge has been inserted and can automatically update how the control module 106 will determine when to inject the naloxone. For instance, a predetermined protocol can be implemented once the control module 106 determines the inserted cartridge includes naloxone. In another instance, a second cartridge can be inserted that contains Insulin. The control module 106 can determine the second cartridge contains Insulin and implement a new protocol predetermined for an Insulin containing cartridge.
Referring back to
Typically, the power source 108 can be a rechargeable power source. Embodiments are contemplated where the power source 108 is removable and replaceable with a second power source. For instance, a small rechargeable battery bank can be implemented such that the strap 116 can be worn while replacing the power source 108.
The first sensor 110 and the second sensor 112 can be implemented to measure one or more physiological conditions and provide data to the control module 106. Typically, the sensors 110/112 can be adapted for a specific purpose and send appropriate signals to the control module 106 to analyze. In one instance, the first sensor 110 can be a pulse oximeter sensor configured to measure an oxygen saturation level in a wearer and the second sensor 112 can be an inertial sensor configured to determine if a wearer is moving. For example, the control module 106 can receive data from the first sensor 110 and determine a current oxygen saturation level for the wearer. In some instances, the control module 106 may continuously analyze the data from the first sensor 110. In other instances, the control module 106 may analyze data in predetermined intervals. The control module 106 can be configured to determine when to administer the medicament in the medicament delivery assembly 104 based on data received from the first sensor 110 and the second sensor 112. In some instances, the control module 106 may determine to administer the medicament based solely on one of the sensors 110/112.
The pulse oximeter sensor 110 can be implemented to help determine an oxygen saturation level of a wearer. In one example, the pulse oximeter sensor 110 can implement reflectance pulse oximetry to measure oxygen saturation levels. It is to be appreciated that other means of measuring oxygen saturation can be implemented without exceeding a scope of the present invention. The pulse oximeter sensor 110 can be operatively connected to the control module 106 to send data to the control module 106. The control module 106 can be configured to receive the data and determine an oxygen saturation level based on the data received. The control module 106 can further determine if the analyzed oxygen saturation level is below or above a predetermined threshold. In some instances, the control module 106 can average several calculations of the oxygen saturation level based on data received from the pulse oximeter sensor 110 at different times. For example, the control module 106 may average two or more data sets from data received 30 seconds apart.
The inertial sensor 112 can typically include at least one accelerometer and at least one gyroscope. Embodiments of the inertial sensor 112 can include other sensors adapted to measure acceleration and directional orientation. The inertial sensor 112 can be operatively connected to the control module 106 to send data to the control module 106 of which the control module 106 can determine movement. In some instances, the inertial sensor 112 can send data in set intervals to help conserve battery life of the smart user device 102.
Referring to
As shown, the cartridge 104 can include, but is not limited to, an autoinjector 120 and a release mechanism 122. The release mechanism 122 can be operatively connected to the autoinjector 120. Generally, the control module 106 can send a signal to an actuator to engage the release mechanism 122 and activate the autoinjector 120. In one instance, the autoinjector 120 can be a jet injector. When the release mechanism 122 may be activated by the control module 106, the release mechanism 122 can mechanically activate the autoinjector 120 which can inject contents of the autoinjector 120 into the wearer of the medicament delivery system 100.
In one embodiment, the autoinjector 120 can include, but is not limited to, a medicament container 130, a spring 132, a piston 134, and a nozzle 136. The medicament container 130 can be configured to store a medicament and can include a first opening and a second opening. The spring 132 can typically be a compression spring that can be located proximate the piston 134. The compression spring 132 can be operatively connected to the release mechanism 122 such that the release mechanism 122 can be implemented to release the compression spring 132 under compression. The piston 134 can be located inside the first opening of the medicament container 130. A first side of the piston 134 can engage the compression spring 132 and a second side can engage the medicament in the medicament container 130. Of note, the piston 134 can be sized to frictionally fit within the medicament container 130 such that the medicament does not leak out of the piston side of the medicament container 130. The nozzle 136 can be fluidly connected to the second opening of the medicament container 130. In one instance, the nozzle 136 may include a seal that can be implemented to prevent the medicament from leaking. When the compression spring 132 may be released pushing the piston 134 through the medicament container 130, the seal may be broken allowing the medicament to exit the nozzle 136. As can be appreciated, a size of an opening of the nozzle 136 can be adjusted based on a medicament being administered. For instance, a viscosity of the medicament may be used to determine a nozzle opening size.
Referring to
Of note, a jet injector can generally be shown in
Referring to
Referring to
Referring to
Referring to
Referring to
After the strap 116 has been secured to a wearer, the wearer can turn the smart user device 102 “ON” which can then power on the display, the control module 106, the first sensor 110, and the second sensor 112. The first sensor 110 and the second sensor 112 can then start sending data to the control module 106.
In block 202, a wearer can insert a cartridge into the receptacle 115 of the smart user device 102. It is to be appreciated that a cartridge may already be inserted into the receptacle 115 and operatively connected to the smart user device 102.
In block 204, the control module 106 can determine the type of medicament stored in the cartridge and can load an appropriate application (or program) based on the type of medicament and sensors available to the control module 106. The selected application can contain a protocol having predetermined thresholds for the control module 106 to determine whether or not to administer the medicament based on data from the sensors 110/112. Of note, the control module 106 can be configured to load an appropriate application based on the medicament to be administered to a user. In some instances, the wearer may confirm the medicament in the cartridge after the cartridge has been inserted into the receptacle 115.
In block 206, the control module 106 can receive data from one or more sensors. The control module 106 can be configured to calculate appropriate physiological measurements from data received from the one or more sensors.
In block 208, the control module 106 can compare the data received to predetermined thresholds for physiological data measurable by the one or more sensors. Typically, the control module 106 can include predetermined thresholds for a minimum (or maximum) value for calculated physiological measurements. In one example, a pulse oximeter sensor can be implemented to measure oxygen saturation levels. The control module 106 may then determine if a calculated oxygen saturation level as determined from data from the pulse oximeter sensor is below a predetermined threshold.
In decision block 210, the control module 106 can determine if a first physiological measurement is below (or above) the predetermined threshold. If not, the process can move back to block 206. If the first physiological measurement is below (or above) the predetermined threshold, the process can move to decision block 212.
In decision block 212, the control module 106 can determine if a second physiological measurement is below (or above) the predetermined threshold. If not, the process can move back to block 206 to check the first physiological measurement again. If the second physiological measurement is below (or above) the predetermined threshold, the process can move to block 214.
In block 214, the control module 106 can activate the release mechanism 122 to activate the autoinjector 120. The autoinjector 120 can then administer the medicament to the wearer.
Embodiments are contemplated where the medicament delivery system 100 can alert authorities (e.g., 911 or a physician) that the medicament has been administered to the wearer.
Referring to
After the strap 116 has been secured to a wearer, the wearer can turn the smart user device 102 “ON” which can then power on the display, the control module 106, the first sensor 110, and the second sensor 112. The first sensor 110 can be a pulse oximeter sensor and the second sensor 112 can be an inertial sensor.
In block 222, a wearer can insert a cartridge having naloxone into the receptacle 115 of the smart user device 102. It is to be appreciated that a cartridge may already be inserted into the receptacle 115 and operatively connected to the smart user device 102.
In block 224, the control module 106 can determine the type of medicament stored in the cartridge and can load an appropriate application (or program) based on the type of medicament and sensors available to the control module 106. The selected application can contain a protocol having predetermined thresholds for the control module 106 to determine whether or not to administer the medicament based on data from the sensors 110/112. Based on the cartridge containing naloxone, the control module 106 can be configured to load an application allowing the control module 106 to determine when to administer the naloxone based on data from the sensors 110/112.
In block 226, the control module 106 can receive data from the pulse oximeter sensor 110 and the inertial sensor 112. The control module 106 can calculate an oxygen saturation level based on data from the pulse oximeter sensor 110 and can determine if the wearer is moving based on data received from the inertial sensor 112.
In block 228, the control module 106 can compare the data received to predetermined thresholds for oxygen saturation level and movement. Typically, the protocol, implemented based on naloxone being in the cartridge, implemented by the control module 106 can include predetermined thresholds for a minimum oxygen saturation level and a minimum threshold for movement within a certain timeframe.
In decision block 230, the control module 106 can determine if the calculated oxygen saturation level is below the predetermined threshold. If not, the process can move back to block 226. If the calculated oxygen saturation level is below the predetermined threshold, the process can move to decision block 232. In one example, the predetermined threshold can be based on a breathing rate of a wearer. Of note, a breathing rate can be approximated from data received from the pulse oximeter sensor. In such an embodiment, a breathing rate less than 12 breaths per minute can be the threshold. In embodiments where oxygen saturation levels are calculated, 90% oxygen saturation level can be the threshold.
In decision block 232, the control module 106 can determine if the calculated oxygen saturation level is below a critical level. For example, an oxygen saturation level below 85% can be the critical level. If the calculated oxygen saturation level is below the critical level, the process 220 can move to block 236. If the calculated oxygen saturation level is above the critical level, the process 220 can move to block 236. It is to be appreciated that the provided levels are approximate and not exact.
In decision block 234, the control module 106 can determine if the inertial sensor 112 has detected any movement from the wearer within a predetermined timeframe. If movement has been detected within the timeframe, the process 200 can move back to block 206 to check the oxygen saturation levels again. If no movement has been detected, the process can move to block 236.
In block 236, the control module 106 can activate the release mechanism 122 to activate the autoinjector 120. The autoinjector 120 can then administer the wearer with naloxone.
Embodiments are contemplated where the medicament delivery system can alert authorities (e.g., 911 or a physician) that the medicament has been administered to the wearer.
Referring to
As shown, the medicament delivery system 300 can include, but is not limited to, a smart user device 302 and one or more smart medicament delivery assemblies 304. The smart user device 302 can include a control module 306, a power source 308, and one or more sensors 310. The smart medicament delivery assembly 304 can be assembled as a cartridge that may be removably coupled to the smart user device 302. Typically, the smart user device 302 can include a receptacle for receiving the smart cartridge 304 therein. The receptacle can be configured to operatively connect the smart cartridge 304 to the smart user device 302 allowing for communication between the two components.
The smart user device 302 can typically include a hardware platform and software components. In general, the hardware platform can include a processor, a user interface, storage, and a display. The processor can be a single microprocessor, multi-core processor, or a group of processors. The user interface can include one or more buttons and the display when implemented as a touch display. The storage can include random access memory and nonvolatile storage. The random access memory can store executable code as well as data that can be immediately accessible to the processor. The nonvolatile storage can store executable code and data in a persistent state. Typically, the display can be a touch display configured to receive input from a user.
The one or more smart medicament delivery assemblies 304 and the one or more sensors 310 can each be operatively connected to the control module 306. The power source 308 can be implemented to provide power to the components of the medicament delivery system 300.
Typically, the power source 308 can be a rechargeable power source. In some embodiments, the smart user device 302 can include a solar powered battery. In other embodiments, the smart user device 302 can implement a kinetically charged battery. Embodiments are contemplated where the power source 308 is removable and replaceable with a second power source. For instance, a small rechargeable battery bank can be implemented such that a strap of the smart user device 302 can be worn while replacing the power source 308.
The one or more sensors 310 can be implemented to measure one or more physiological conditions and provide data to the control module 306. Typically, the sensors 310 can be adapted for a specific purpose and send appropriate signals to the control module 306 to analyze. In one instance, a first sensor can be a pulse oximeter sensor configured to measure an oxygen saturation level in a wearer and a second sensor can be an inertial sensor configured to determine if a wearer is moving. The pulse oximeter sensor can be implemented to help determine an oxygen saturation level of a wearer. In one example, the pulse oximeter sensor can implement reflectance pulse oximetry to measure oxygen saturation levels. The pulse oximeter sensor can be operatively connected to the control module 306 to send data to the control module 306. The control module 306 can be configured to receive the data and determine an oxygen saturation level based on the data received. The control module 306 can further determine if the analyzed oxygen saturation level is below or above a predetermined threshold. In some instances, the control module 306 can average several calculations of the oxygen saturation level based on data received from the pulse oximeter sensor at different times. For example, the control module 306 may average two or more data sets from data received 30 seconds apart. The inertial sensor can typically include at least one accelerometer and at least one gyroscope. Embodiments of the inertial sensor can include other sensors adapted to measure acceleration and directional orientation. The inertial sensor can be operatively connected to the control module 306 to send data to the control module 306 of which the control module 306 can determine movement. In some instances, the inertial sensor can send data in set intervals to help conserve battery life of the smart user device 302.
In some instances, the control module 306 may continuously analyze the data from the sensors 310. In other instances, the control module 306 may analyze data in predetermined intervals. The control module 306 can be configured to determine when to administer the medicament in the smart cartridge 304 based on data received from the smart cartridge 304 and data from the sensors 310. For instance, the smart cartridge 304 can include instructions for when a medicament should be administered. The smart user device 302 can be configured to implement the instructions from the smart cartridge 304.
Referring to
The delivery mechanism 320 can be configured to inject contents of a medicament container into a wearer of the medicament delivery system 300. Typically, the delivery mechanism 304 can include an autoinjector and a release mechanism operatively connected to the control module 302. In one example, the delivery mechanism 320 can be substantially similar to the autoinjector 120 and the release mechanism 122 of the first embodiment cartridge 104. In such an example, the delivery mechanism 320 can further include a medicament container, a spring, a piston, and a nozzle. In one instance, the delivery mechanism 320 can implement a jet injector. In another instance, the delivery mechanism 320 can implement a spring loaded sharp. In yet another instance, the delivery mechanism 320 can be a mechanism to dispense a gel (or lotion) onto a skin of the wearer. It is to be appreciated that the delivery mechanism 320 can be configured to administer a variety of different medicaments via various means.
The smart cartridges 304 can be removably coupled to the smart user device 302. When a smart cartridge 304 is inserted into a receptacle of the smart user device 302, the smart cartridge 304 can be operatively connected to the control module 306. The smart cartridge 304 may then update the smart user device 302 with instructions (e.g., a protocol) and information about the medicament stored in the inserted smart cartridge. A user may be prompted to confirm the medicament and related parameters for administering the medicament. The smart user device 302 can be configured to determine when to administer the medicament based on the protocol provided to the smart user device 302 by the smart cartridge 304. In some embodiments, the smart cartridge 304 may include a power source.
The non-volatile storage 322 of the smart cartridge 304 can be configured to include one or more databases which can store information related to a medicament associated with the cartridge 304. The one or more databases can also store methodologies (or protocols) for determining when to administer a particular medicament. For instance, the protocol may include one or more predetermined thresholds for physiological measurements measurable by the sensors 310. Of note, in instances where the medicament is a routinely administered medicament, the smart cartridge 304 can include a protocol for when the medicament should be administered based on a predetermined schedule. The non-volatile storage 322 may further include an application that can run on the smart user device 302. The application can implement the protocol for determining when to administer a medicament stored in the medicament container 320. In other instances, the smart user device 302 can include a program (or application) for extracting data from the smart cartridge 304 and generate a protocol based on the data provided by the smart cartridge 304.
In some instances, the smart user device 302 can include a power source external to the smart user device 302. For instance, a rechargeable power bank may be coupled to the strap of the smart user device 302. In such an instance, the rechargeable power bank can be implemented as a backup power source to the smart user device 302. The rechargeable power bank may be powered by solar energy.
Referring to
Referring to
In block 402, a wearer can insert a smart cartridge into the receptacle of the smart user device 302. As previously mentioned, the smart cartridge can include non-volatile storage having instructions and information about a medicament stored in the smart cartridge. The instructions can include one or more parameters measurable by the smart user device 402 for activating an injection (or application) of the medicament stored in the smart cartridge.
In block 404, the control module 306 can receive data from the smart cartridge. The data can include a type of medicament stored in the smart cartridge, one or more parameters for determining when to administer the medicament, and one or more sensor requirements for the medicament. The smart cartridge can provide a protocol having predetermined thresholds for the control module 306 to determine whether or not to administer the medicament based on data from the sensor(s) 110. In some instances, the control module 306 can be configured to receive and run an application provided by the smart cartridge. The application can include a protocol for determining when to administer a medicament to a user. In some instances, the wearer may confirm the medicament in the smart cartridge after the smart cartridge has been inserted into the receptacle.
In block 406, the control module 306 can receive data from one or more sensors 310. The control module 306 can be configured to calculate appropriate physiological measurements from data received from the one or more sensors 310. Of note, the control module 306 can be preconfigured to calculate physiological measurements from sensors associated with the smart user device 302. Instances are contemplated where a sensor is provided with a smart cartridge that can be operatively connected to the smart user device 302. The smart cartridge can be configured to update the smart user device 302 to allow for the smart user device 302 to analyze and interpret data from the additional sensor. In one example, a glucose sensor can be included with a smart cartridge having insulin. The glucose sensor can be remotely located from the smart user device 302 and can wirelessly transmit data to the smart user device 302.
In block 408, the control module 306 can compare the data and calculated physiological measurements to predetermined thresholds for physiological measurables by the one or more sensors 310. Typically, the smart cartridge can provide predetermined thresholds for a minimum (or maximum) value for calculated physiological measurements to the control module 306. In one example, a pulse oximeter sensor can be implemented to measure oxygen saturation levels. The control module 306 may then determine if a calculated oxygen saturation level as determined from data from the pulse oximeter sensor is below a predetermined threshold.
In decision block 410, the control module 306 can determine if a physiological measurement is greater than or less than the predetermined threshold. Of note, depending on the physiological measurable being monitored, whether a medicament is administered may happen either based on the physiological measurement being greater or less than the predetermined threshold. Hereinafter, a protocol indicating that the medicament should be administered when the physiological measurement is above the predetermined threshold will be assumed. If the physiological measurement is less than (or below) the predetermined threshold, the process 400 can move back to block 206. If the physiological measurement is greater than (or above) the predetermined threshold, the process can move to block 412.
In block 412, the control module 306 can activate the release mechanism 324 of the smart cartridge 304 to activate the autoinjector 322. The autoinjector 322 can then administer the medicament to the wearer.
The various embodiments and variations thereof, illustrated in the accompanying Figures and/or described above, are merely exemplary and are not meant to limit the scope of the invention. It is to be appreciated that numerous other variations of the invention have been contemplated, as would be obvious to one of ordinary skill in the art, given the benefit of this disclosure. All variations of the invention that read upon appended claims are intended and contemplated to be within the scope of the invention.
This application is a continuation-in-part of U.S. application Ser. No. 18/089,656, filed Dec. 28, 2022. This application claims the benefit of U.S. Provisional Application No. 63/294,184, filed Dec. 28, 2021.
| Number | Date | Country | |
|---|---|---|---|
| 63294184 | Dec 2021 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 18089656 | Dec 2022 | US |
| Child | 18657481 | US |
