US20120323215A1 - System and method for administering medicaments on the basis of urine values - Google Patents

System and method for administering medicaments on the basis of urine values Download PDF

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Publication number
US20120323215A1
US20120323215A1 US13/578,799 US201113578799A US2012323215A1 US 20120323215 A1 US20120323215 A1 US 20120323215A1 US 201113578799 A US201113578799 A US 201113578799A US 2012323215 A1 US2012323215 A1 US 2012323215A1
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Prior art keywords
urine
values
patient
measured
medicaments
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Abandoned
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US13/578,799
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English (en)
Inventor
Hans-Otto Maier
Horst Schmoll
Matthias Paetzold
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B Braun Melsungen AG
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B Braun Melsungen AG
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Assigned to B. BRAUN MELSUNGEN AG reassignment B. BRAUN MELSUNGEN AG ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: MAIER, HANS-OTTO, SCHMOLL, HORST, PAETZOLD, MATTHIAS
Publication of US20120323215A1 publication Critical patent/US20120323215A1/en
Abandoned legal-status Critical Current

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • 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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/157—Devices characterised by integrated means for measuring characteristics of blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/08—Sensors provided with means for identification, e.g. barcodes or memory chips
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    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150229—Pumps for assisting the blood sampling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150236—Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
    • A—HUMAN NECESSITIES
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    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150244—Rods for actuating or driving the piston, i.e. the cylindrical body that sits inside the syringe barrel, typically with an air tight seal, and slides in the barrel to create a vacuum or to expel blood
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    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/150763—Details with identification means
    • A61B5/150786—Optical identification systems, e.g. bar codes, colour codes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/155—Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B5/48—Other medical applications
    • A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
    • A61B5/4839—Diagnosis combined with treatment in closed-loop systems or methods combined with drug delivery
    • 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
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M2005/14208—Pressure infusion, e.g. using pumps with a programmable infusion control system, characterised by the infusion program
    • 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
    • A61M2205/60—General characteristics of the apparatus with identification means
    • 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
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A61M2205/6009—General characteristics of the apparatus with identification means for matching patient with his treatment, e.g. to improve transfusion security
    • 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
    • A61M2230/20—Blood composition characteristics
    • A61M2230/201—Glucose concentration
    • 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
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00722—Communications; Identification
    • G01N35/00871—Communications between instruments or with remote terminals
    • G01N2035/00881—Communications between instruments or with remote terminals network configurations
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/28—Electrolytic cell components
    • G01N27/30—Electrodes, e.g. test electrodes; Half-cells
    • G01N27/327—Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
    • G01N27/3271—Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/52—Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/17—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection

Definitions

  • the invention concerns a system and a method for administering medicaments to a patient.
  • Supply devices can be infusion pumps which keep the vital blood values of the patient at a predeterminable level in reaction to a blood picture/blood gas analysis previously performed in the blood circulation of the patient.
  • All supply devices of this type also when integrated into a system for administering medicaments and/or nutrients, have previously required the input of values by a doctor or further clinical personnel to form the basis for the supply by means of the supply device. For example here quantity values, time intervals at which the supply should be made, intermittent supply etc. are entered as the basis for subsequent supply of medicaments.
  • This supply is preceded by a usually manual taking of a blood specimen from the patient, which requires the intervention of clinical personnel. Also further clinical personnel is required with the necessary professional knowledge of the input functions of the supply device, such as the infusion pump, in order to subsequently perform this supply.
  • infusion therapies in particular when involving urine values, are not determined to targeted values today. Rather the usual procedure is to set an infusion rate on the basis of a urine value status and/or a blood value status based on the experience of the clinical personnel and/or prespecified standards, protocols, instructions, specifications or similar.
  • the object of the invention is to provide a system and method for administration of medicaments to a patient which, also taking into account urine values, allows a supply of medicaments with the correct medicament parameters in an automated manner.
  • the core concept of the invention is that a system for administering medicaments to a patient contains the following devices:
  • Such a system advantageously allows measured urine values to be taken into account in calculating the medicament parameters of the medicaments to be administered by the supply device.
  • the active substance furosemide can be administered to the patient automatically by means of the supply device as a function of the previously measured urine and blood values. This allows an additional control of the values measured for optimised administration of the active substance and for optimised setting of the infusion rate, wherein instead of the active substance furosemide, other medicaments can also be supplied.
  • the calculation device can also take into account differences occurring in the relation between individual measured values and between these values, in calculating the optimised infusion value and hence does not rely on measurement of absolute values. Also the calculation device in calculating the infusion values, for example an infusion rate, can take into account the chronology and sequence of the previously measured values of this patient and their relative importance.
  • the urine values measured by the first measurement device can, as well as the said values, be further urine values for example the pH value, the protein content, the glucose content of the urine, the nitrite content of the urine, the bilirubin content of the urine, the ketone content of the urine, the bacteria content of the urine and/or the urine sediment results.
  • a second measurement device measures the quantity of urine eliminated by the patient and a connected second analysis device can be used to analyse the urine quantity measured. Also the second measurement device can also measure the quantity of secretion from the patient's wounds and the second analysis device can analyse this accordingly.
  • a fluid balance of the patient's body can be calculated from the quantity of fluids eliminated and fluids supplied.
  • the fluids eliminated can for example be the measured urine quantity previously analysed and the measured secretion quantity analysed, and the fluids supplied can be liquid medicaments supplied. Second medicament parameters are calculated from this.
  • a third measurement device serves to measure vital values of the patient such as ECG, EEG and similar data and a connected analysis device serves to analyse the vital values measured.
  • a third calculation device By means of a third calculation device, third medicament parameters are calculated on the basis of the measured vital values analysed.
  • the common medicament parameters can be calculated from the first, second and third medicament parameters. This has the consequence that all medicament parameters resulting from the calculated urine values, calculated blood values, fluid balance values and vital values can be taken into account to calculate optimised common medicament parameters in order to initiate the infusion with the optimised infusion rate.
  • the patient's blood values can also be measured which can be analysed by the first analysis device and used by the first calculation device to calculate the first medicament parameters.
  • an automated function of the complete system and an associated method for administering medicaments should be provided, wherein the transfer of the respective values, medicament parameters and other data can take place automatically.
  • the medicament parameters and nutrient parameters determined for the proposed infusion for treatment of the patient can be displayed as proposed parameters or respectively data to support the clinical personnel on a corresponding display on the bed of the patient to be treated, so that the clinical personnel can set up the infusion pump by means of these displayed and entered data to the patient.
  • these data are transferred by means of a data protocol which contains the patient ID, the time the measurement was taken, the time the specimens were taken, the identification of the measurement device concerned, the quality class of the measurement device as well as further quality features.
  • the fluid balance takes place automatically and the determination of eliminated fluids is not carried out by means of complicated weighing techniques. Rather more, the quantity of all eliminated measurable fluids is determined preferably automatically and the remaining fluids lost by the human body are simulated by calculation. These eliminated fluids are compared with the fluids supplied in the form of liquid medicaments or nutrients which can easily be determined.
  • a fluid balance of the patient's body is calculated and/or determined and carried out by measurement and calculation of the eliminated fluids and measurement and calculation of the supplied fluids.
  • FIGURE is a diagrammatic depiction of the system for administration of medicaments according to one embodiment of the invention.
  • the system shown in this FIGURE for the automated administration of medicaments is an automatic infusion system 1 with a multiplicity of infusion pumps for the treatment of individual incorrectly set values within the body of the patient 2 .
  • a patient 2 in intensive care thus according to reference numeral 3 receives from the automated infusion system 1 medicaments with the associated infusion rates, where applicable taking into account a change in medicament quantity, administration period and further parameters.
  • the patient 2 in intensive care can be analysed in various aspects, as priority in his urine values, by means of one or more measurement devices 4 , 7 , 8 , or 9 .
  • the urine values and/or blood values can be measured automatically at the intensive care unit by the taking of urine and blood specimens from the patient 2 .
  • the urine values are the pH value of the urine, the protein content of the urine, the glucose content of the urine, the nitrite content of the urine, the bilirubin content of the urine, the ketone content of the urine, the bacteria content of the urine and the urine sediment results.
  • the blood values are individually the glucose value, the lactate value, the electrolyte value (Na + , CL + , K + ).
  • the pO 2 value, the pCO 2 value the medicament level values, the calcium antagonist values (blood pressure) and the propofol values (sedation).
  • the blood values are shown according to reference numeral 6 b.
  • the urine and secretion quantity values can be measured, preferably automatically, by means of a second measurement device 9 . From these, the urine quantity and secretion quantity values are determined by means of analysis device 10 .
  • a third measurement device 4 By means of a third measurement device 4 , preferably by means of sensors, automatically vital parameters such as ECG and EEG values and similar values are determined which are analysed in a third analysis device 5 .
  • the analysed values from all analysis devices 5 , 6 and 10 are transmitted preferably automatically to a respective associated first, second and third calculation device 11 , 12 and 13 .
  • the transfer takes place according to reference numerals 14 , 21 and 22 by means of a data protocol which additionally comprises data such as the patient identification numbers, the time the measurement was performed, the time the specimen was taken, the identification of the respective measurement device, the quality class of the measurement device and an allocated quality feature.
  • a calculation is performed of the relevant medicament parameters and nutrient parameters for the administration of medicaments and/or nutrition with the infusion system 1 .
  • a balance is produced of all eliminated fluids i.e. for example the measured secretion quantity and urine quantity, and the fluids supplied such as for example the liquid medicaments and liquid nutrition according to the supply device 1 .
  • Fluids Human beings are known to eliminate fluids in various ways. Firstly, urine quantities and wound secretion quantities are eliminated which can be measured automatically and directly for patients in intensive care. In addition to the directly measurable fluids, there are further fluids which can be established indirectly such as water vapour eliminated by respiration, transpiration through the skin of the body and fluid elimination by faeces and similar. These fluid quantities are determined by means of physiological models taking into account the body surface area, body temperature and similar.
  • the second medicament parameters can be calculated for the medicament to be administered by means of the infusion system 1 and where applicable associated nutrients.
  • the medicament parameters and nutrient parameters can be calculated for the medicaments and nutrients to be administered by means of the infusion system 1 .
  • the calculated medicament parameters and nutrient parameters are transmitted according to reference numerals 15 , 16 and 17 to the infusion system 1 , hard-wired or wirelessly, preferably encrypted.
  • All calculation devices 11 , 12 and 13 are combined within a common calculation device.
  • the urine values and blood values can be determined by means of a measurement device 7 within a laboratory.
  • the calculation devices 11 , 12 and 13 can take these into account and apply a corresponding correction, taking into account the weighting of the individual measurement devices and the values measured therewith.
  • the calculation devices take into account the chronology of measurements, the sequence of measurements and the quality of measurements in determining the medicament parameters and/or nutrient parameters. Also relations and differences of individually determined values in relation to each other and to other values from other measurement devices are taken into account in determining the medicament parameters and/or the nutrient parameters.

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  • General Physics & Mathematics (AREA)
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  • Electrochemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
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US13/578,799 2010-03-05 2011-03-03 System and method for administering medicaments on the basis of urine values Abandoned US20120323215A1 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
DE102010010567 2010-03-05
DE102010010567.8 2010-03-05
DE102010012733.7 2010-03-24
DE102010012733 2010-03-24
PCT/EP2011/053245 WO2011107568A1 (de) 2010-03-05 2011-03-03 System und verfahren zur verabreichung von medikamenten unter berücksichtigung von urinwerten

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US20120323215A1 true US20120323215A1 (en) 2012-12-20

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Family Applications (6)

Application Number Title Priority Date Filing Date
US13/577,017 Abandoned US20130023851A1 (en) 2010-03-05 2011-03-03 System and method for administering medicaments to a patient
US13/575,857 Abandoned US20120316465A1 (en) 2010-03-05 2011-03-03 System and method for monitoring the time period for blood parameter monitoring processes
US13/521,713 Abandoned US20130023819A1 (en) 2010-03-05 2011-03-03 System and method for monitoring at least one blood parameter
US13/579,858 Active 2033-11-09 US9861745B2 (en) 2010-03-05 2011-03-03 System and method for monitoring time intervals during blood parameter monitoring
US13/578,799 Abandoned US20120323215A1 (en) 2010-03-05 2011-03-03 System and method for administering medicaments on the basis of urine values
US13/581,225 Abandoned US20120323141A1 (en) 2010-03-05 2011-03-03 System for determining treatment-related data for the administration of drugs to patients to be treated taking into account important individual factors

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US13/577,017 Abandoned US20130023851A1 (en) 2010-03-05 2011-03-03 System and method for administering medicaments to a patient
US13/575,857 Abandoned US20120316465A1 (en) 2010-03-05 2011-03-03 System and method for monitoring the time period for blood parameter monitoring processes
US13/521,713 Abandoned US20130023819A1 (en) 2010-03-05 2011-03-03 System and method for monitoring at least one blood parameter
US13/579,858 Active 2033-11-09 US9861745B2 (en) 2010-03-05 2011-03-03 System and method for monitoring time intervals during blood parameter monitoring

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US13/581,225 Abandoned US20120323141A1 (en) 2010-03-05 2011-03-03 System for determining treatment-related data for the administration of drugs to patients to be treated taking into account important individual factors

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US (6) US20130023851A1 (de)
EP (6) EP2542992B1 (de)
JP (6) JP2013517030A (de)
CN (5) CN102762144B (de)
AU (6) AU2011222944B2 (de)
BR (6) BR112012021524B1 (de)
CA (6) CA2787324C (de)
ES (2) ES2655370T3 (de)
IL (6) IL220765B (de)
MX (6) MX2012008144A (de)
PL (1) PL2542142T3 (de)
RU (6) RU2517562C2 (de)
SG (6) SG183352A1 (de)
WO (6) WO2011107570A1 (de)

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