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WO2011126485A1 - Procédé et appareil pour l'administration d'une infusion intraveineuse continue de métoprolol - Google Patents

Procédé et appareil pour l'administration d'une infusion intraveineuse continue de métoprolol Download PDF

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Publication number
WO2011126485A1
WO2011126485A1 PCT/US2010/030362 US2010030362W WO2011126485A1 WO 2011126485 A1 WO2011126485 A1 WO 2011126485A1 US 2010030362 W US2010030362 W US 2010030362W WO 2011126485 A1 WO2011126485 A1 WO 2011126485A1
Authority
WO
WIPO (PCT)
Prior art keywords
metoprolol
patient
sensor
pump
flow
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2010/030362
Other languages
English (en)
Inventor
Umesh Khot
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
CARDIAC PROTECTION SOLUTIONS LLC
Original Assignee
CARDIAC PROTECTION SOLUTIONS LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by CARDIAC PROTECTION SOLUTIONS LLC filed Critical CARDIAC PROTECTION SOLUTIONS LLC
Priority to PCT/US2010/030362 priority Critical patent/WO2011126485A1/fr
Publication of WO2011126485A1 publication Critical patent/WO2011126485A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
    • A61M5/1723—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/18—General characteristics of the apparatus with alarm
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/30—Blood pressure

Definitions

  • the invention relates generally to the field of medicine and, specifically, to a method and apparatus for providing the continuous infusion of metoprolol to a patient.
  • Metoprolol is a one of the most commonly prescribed member of a class of drugs called beta-blockers (also known as beta-adrenergic blocking agents or beta-receptor antagonists). Beta-blockers work by blocking the effects of catecholamines such as epinephrine on the beta-receptors located within the heart, kidney, and other organ systems. Beta-blockers also reduce sympathetic nervous system activity by decreasing the release of the hormone renin from the kidney and by reducing the amount of sympathetic nervous system activity originating in the brain. The resulting effect on the heart is a decrease in heart rate (negative chronotropic effect) and a decrease in the strength of contraction of the heart (negative inotropic effect).
  • beta-blockers work by blocking the effects of catecholamines such as epinephrine on the beta-receptors located within the heart, kidney, and other organ systems. Beta-blockers also reduce sympathetic nervous system activity by decreasing the release of the hormone renin from the kidney and by reducing the amount of sympathetic nervous system activity originating in the brain
  • beta-blockers such as metoprolol are currently highly recommended and widely used for the treatment of high blood pressure, stable/unstable angina (heart- related chest pains), acute myocardial infarction (heart attack), coronary artery disease, congestive heart failure, and atrial fibrillation (an irregular rhythm of the heart).
  • Metoprolol is typically administered orally. Unfortunately, despite a documented clinical need for the drug, many patients cannot take oral metoprolol during hospitalization. These include the following groups of patients: 1. Patients who are NPO (nil per os - no oral intake) for any reason.
  • the present invention relates to a system and method for providing metoprolol to patients.
  • One object of the present invention is to provide an improved means for administering metoprolol to patients.
  • Related objects and advantages of the present invention will be apparent from the following description.
  • FIG. 1 is a perspective view of a metoprolol delivery system according to a first embodiment of the present novel technology.
  • FIG. 2 is a perspective view of a metoprolol delivery system according to a second embodiment of the present novel technology.
  • FIG. 3 is a perspective view of a metoprolol delivery system according to a third embodiment of the present novel technology.
  • a first embodiment of the present novel technology relates to a system 10 for the continuous infusion of metoprolol to a patient.
  • the system 10 includes a metoprolol supply
  • Metoprolol source 12 is typically a 50 or 100 mg bag, although bags or containers of other sizes may be selected as desired.
  • the metoprolol source 12 may contain a standard concentration of metoprolol, akin to that found in 5 mg single-dosage vials (typically 1 mg/ml), or, alternately, may contain a metoprolol solution having a lower (or greater) metoprolol concentration.
  • the metoprolol source is in liquid communication with an infusion device 13.
  • the infusion device 13 is typically a pump, but may be a stopcock, electronically controlled valve, or the like.
  • the infusion device 13 is connected in liquid communication with catheter 16 or like device for insertion into communication with a patient's circulatory system.
  • a heart rate sensor 26 is connected in electric communication to a telemetry system 18, typically either via direct wire connection or wirelessly to a remotely located telemetry system 18.
  • the patient's blood pressure is periodically measured, either via manual or automatic blood pressure cuff or the like.
  • the infusion device 13 typically delivers a steady infusion rate of metoprolol to the patient, with the rate selected to match the prior dosage of metoprolol (or other beta-blocker) that the patient was taking orally prior to hospitalization. While the actual patient dosing schedule would be determined by the patient's physician and would be based on clinical data, one such exemplary schedule is provided below for illustrative purposes as Table 1 :
  • the infusion device 13 may be set to deliver an
  • a nurse or technician records and reviews the results of the heart rate and blood pressure values, such as in a paper chart, electronic medical record, or the like. Subsequently, through an order set, written algorithm, computer program, calculator or the like, the nurse makes adjustments to the infusion device 13 to correct the dose of metoprolol infusion based on patient's hemodynamic and clinical status.
  • system 10 is similar to the one discussed above, but with heart rate and blood pressure sensors 26, 28 connected, either directly or wirelessly, to a telemetry or
  • hemodynamic monitoring system 18 The nurse records and reviews the results of the heart rate and blood pressure values, either in a paper chart, electronic medical record or the like. Subsequently, typically through an order set, written algorithm, computer program, calculator or like, the nurse makes adjustments to the infusion device 13 to correct the dose of metoprolol infusion based on patient's hemodynamic and clinical status.
  • a third embodiment system 10' as shown in FIG. 2, the system 10' is similar to the first and second embodiments discussed above, but with the heart rate and blood pressure sensors 26, 28 connected either directly or wirelessly to a telemetry or hemodynamic monitoring system 18, which is connected to send the heart rate and blood pressure values to the patient's electronic medical record 41.
  • a nurse or technician reviews the results in the electronic medical record and subsequently, such as through an order set, written algorithm, computer program, calculator or like, makes adjustments to the infusion device 13 to correct the dose of metoprolol infusion based on patient's hemodynamic and clinical status.
  • system 10' is similar to those discussed above but with the heart rate and blood pressure sensors 26, 28 connected, either directly or wirelessly, to a telemetry or hemodynamic monitoring system 18 which is connected to send the heart rate and blood pressure values directly into the patient's electronic medical record 41.
  • the electronic medical record 41 is operationally connected to a microprocessor 43 which applies the hemodynamic data to an internal computer program, which calculates and provides directions to the nurse on making adjustments to the dose of metoprolol infusion, based on the patient's hemodynamic and clinical status.
  • a fifth embodiment system 10 includes a metoprolol supply 12 in liquid communication with an infusion pump 14.
  • the pump 14 is connected in liquid communication with catheter 16 or like device for insertion into a patient's circulatory system.
  • the pump 14 is operationally connected to an electronic controller 18 for governing the flow rate of the metoprolol through the catheter 16.
  • the metoprolol supply 12 is typically connected to the pump 14 via first tubing 20, and the pump 14 is typically connected to the catheter 16 via second tubing 22.
  • a first sensor 26 is operationally connected to the electronic controller 18.
  • the first sensor 26 may be a blood pressure sensor, for example, and is operationally connectable to the patient for providing substantially real time blood pressure data to the electronic controller 18.
  • a second sensor 28 such as for measuring a patient's heart rate
  • a third sensor 30 such as for directly measuring the concentration of metoprolol in the patient's blood, is operationally connected to the electronic controller 18 and is likewise operationally connectable to the patient for providing substantially real-time metoprolol concentration data to the electronic controller 18.
  • Metoprolol source 12 is typically a 50 or 100 mg bag, although bags or containers of other sizes may be selected as desired.
  • Pump 14 is typically a standard intravenous pump as is known in the art.
  • Catheter 16 may be of any convenient vascular access device design for insertion into a central or peripheral vein.
  • the metoprolol source 12 may contain a standard concentration of metoprolol, akin to that found in 5 mg single-dosage vials (typically
  • the electronic controller 18 may be configured to control the pump 14 to provide a predetermined, steady infusion rate of metoprolol to the patient, with the rate selected to match the prior dosage of metoprolol
  • the electronic controller 18 may be configured to control the pump 14 and deliver an empirically or clinically determined rate of infusion if the patient's prior dose of beta blocker is unknown or if the patient has not been on a beta blocker agent previously.
  • the electronic controller 18 is configured to control the pump 14 to deliver metoprolol at a default flow rate similar to that described above, and is also configured to vary the flow rate based on data provided by one or more of the sensors 26, 28, 30.
  • the electronic controller 18 is programmed to decrease the flow of metoprolol if the data received from the sensors
  • the electronic controller 18 is programmed to compare the data received from the sensors 26, 28, 30 with predetermined parameters, such as tabulated data, mathematical relationships, or the like, and vary the flow of metoprolol according to the results. For example, if the patient's blood pressure and/ or heart rate are too high, the flow of metoprolol may be incrementally increased until either a maximum cap flow rate is achieved or the measured blood pressure and/or heart rate decreases below a predetermined level.
  • the electronic controller 18 is configured to control the pump 14 to deliver metoprolol at a default flow rate similar to that described above, and is also
  • the electronic controller 18 may display a recommendation that the flow of metoprolol be increased by a predetermined amount so that the measured blood pressure and/ or heart rate decreases below a predetermined level.
  • the electronic controller 18 may also display a recommendation that the flow of metoprolol be increased by a predetermined amount so that the measured blood pressure and/ or heart rate decreases below a predetermined level.
  • a patient's heart rate and/or blood pressure and/or other like physical conditions as measured by sensors 26, 28, 30 fall outside of predetermined parameters.
  • Such a signal would alert hospital personnel to manually change the flow rate of the metoprolol and/ or take whatever other steps necessary to bring the patient's physical metrics (i.e., heart rate and/ or blood pressure and the like) back into the predetermined parameters.
  • the electronic controller 18 is configured to both vary the flow rate of metoprolol to keep the patient's blood pressure and/or heart rate and the like, as measured by sensors 26, 28, 30 within a predetermined set of parameters and to also generate an alert signal when the patient's blood pressure and/ or heart rate or the like falls outside the scope of those measured parameters.

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  • Health & Medical Sciences (AREA)
  • Diabetes (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention porte sur un système pour la fourniture automatique d'un écoulement continu de métoprolol par voie intraveineuse à un patient, lequel système comprend une source de solution de métoprolol, une pompe reliée en communication fluidique à la source de solution de métoprolol, un contrôleur électronique relié de manière fonctionnelle à la pompe, un dispositif d'accès vasculaire relié en communication liquide à la pompe, et au moins un capteur relié de manière fonctionnelle à la pompe. La pompe fournit un écoulement continu de métoprolol par l'intermédiaire du dispositif d'accès vasculaire et l'au moins un capteur fournit des données concernant l'état physique d'un patient au contrôleur électronique. Le contrôleur électronique peut commander la pompe pour faire varier le débit de métoprolol en réponse à des données issues de l'au moins un capteur et peut générer un signal d'alarme en réponse aux données issues du capteur tombant en dehors de paramètres prédéterminés.
PCT/US2010/030362 2010-04-08 2010-04-08 Procédé et appareil pour l'administration d'une infusion intraveineuse continue de métoprolol Ceased WO2011126485A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/US2010/030362 WO2011126485A1 (fr) 2010-04-08 2010-04-08 Procédé et appareil pour l'administration d'une infusion intraveineuse continue de métoprolol

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2010/030362 WO2011126485A1 (fr) 2010-04-08 2010-04-08 Procédé et appareil pour l'administration d'une infusion intraveineuse continue de métoprolol

Publications (1)

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WO2011126485A1 true WO2011126485A1 (fr) 2011-10-13

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014085395A1 (fr) * 2012-11-29 2014-06-05 Becton, Dickinson And Company Commande sélective de l'écoulement de fluide par l'intermédiaire d'une voie de fluide
US9744298B2 (en) 2011-06-22 2017-08-29 Crisi Medical Systems, Inc. Selectively controlling fluid flow through a fluid pathway
US10293107B2 (en) 2011-06-22 2019-05-21 Crisi Medical Systems, Inc. Selectively Controlling fluid flow through a fluid pathway
US10641632B2 (en) 2017-06-19 2020-05-05 Becton, Dickinson And Company Priming valve to induce appropriate pressure and flow profile and improve sensor readiness

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050059924A1 (en) * 2003-03-04 2005-03-17 Katz Hal H. Patient monitoring and drug delivery system and method of use
US6970742B2 (en) * 2000-01-11 2005-11-29 Savacor, Inc. Method for detecting, diagnosing, and treating cardiovascular disease
US7247154B2 (en) * 1998-06-03 2007-07-24 Scott Laboratories, Inc Method for drug delivery in association with medical or surgical procedures
US20090062730A1 (en) * 2007-09-01 2009-03-05 San Hoon Woo Control of body fluid condition using diuretics, based on biological parameters
US7668731B2 (en) * 2002-01-11 2010-02-23 Baxter International Inc. Medication delivery system

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7247154B2 (en) * 1998-06-03 2007-07-24 Scott Laboratories, Inc Method for drug delivery in association with medical or surgical procedures
US6970742B2 (en) * 2000-01-11 2005-11-29 Savacor, Inc. Method for detecting, diagnosing, and treating cardiovascular disease
US7668731B2 (en) * 2002-01-11 2010-02-23 Baxter International Inc. Medication delivery system
US20050059924A1 (en) * 2003-03-04 2005-03-17 Katz Hal H. Patient monitoring and drug delivery system and method of use
US20090062730A1 (en) * 2007-09-01 2009-03-05 San Hoon Woo Control of body fluid condition using diuretics, based on biological parameters

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9744298B2 (en) 2011-06-22 2017-08-29 Crisi Medical Systems, Inc. Selectively controlling fluid flow through a fluid pathway
US10293107B2 (en) 2011-06-22 2019-05-21 Crisi Medical Systems, Inc. Selectively Controlling fluid flow through a fluid pathway
US10532154B2 (en) 2011-06-22 2020-01-14 Crisi Medical Systems, Inc. Selectively controlling fluid flow through a fluid pathway
US11464904B2 (en) 2011-06-22 2022-10-11 Crisi Medical Systems, Inc. Selectively controlling fluid flow through a fluid pathway
US12458752B2 (en) 2011-06-22 2025-11-04 Crisi Medical Systems, Inc. Selectively controlling fluid flow through a fluid pathway
WO2014085395A1 (fr) * 2012-11-29 2014-06-05 Becton, Dickinson And Company Commande sélective de l'écoulement de fluide par l'intermédiaire d'une voie de fluide
US10641632B2 (en) 2017-06-19 2020-05-05 Becton, Dickinson And Company Priming valve to induce appropriate pressure and flow profile and improve sensor readiness
US11644356B2 (en) 2017-06-19 2023-05-09 Becton, Dickinson And Company Priming valve to induce appropriate pressure and flow profile and improve sensor readiness
US12276534B2 (en) 2017-06-19 2025-04-15 Becton, Dickinson And Company Priming valve to induce appropriate pressure and flow profile and improve sensor readiness

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