IP Library Granted Patent US 10,285,597
Granted Patent B2
US 10,285,597 · App. 13/005,810 · Granted May 14, 2019

Process and device for monitoring a patient during anesthesia and for determining the combined effect of a plurality of anesthetics

Inventors: Frank Franz (Lübeck, DE); Maral Haar (Hamburg, DE); Jürgen Manigel (Scharbeutz, DE); Kai Kück (Hamburg, DE); Susanne Stahlkopf (Hamburg, DE); Marcel Voigt (Schönberg, DE); Thomas Bouillon (Basel, CH); Martin Luginbühl (Hinterkappeln, CH); Peter Schumacher (Kirchlindach, CH)
Assignees: DRÄGERWERK AG & CO. KGAA; INSELSPITAL BERN, DIREKTION LEHRE UND FORSCHUNG
A61B5/0205A61B5/024A61B5/0836A61B5/4821A61M16/01A61M2016/1035A61M2205/502A61M2230/06A61M2230/205A61M2230/30A61M2230/432
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Quick Facts
Patent No.
US 10,285,597
App. No.
13/005,810
Granted
May 14, 2019
Kind
B2
Abstract

A process is provided for monitoring a patient being anesthetized, as well as a process for determining a combined effect of different anesthetics used. Devices for carrying out the processes are also provided.

Claims (185)

1. An anesthetic process comprising the steps of:

administrating a plurality of active anesthetic ingredients to a patient undergoing a painful procedure;

determining a concentration of each of the active anesthetic ingredients at a site of action;

determining an action of each of the active anesthetic ingredients from the determined concentrations of each active anesthetic ingredient at the site of action;

determining an interaction relationship between each of the active anesthetic ingredients;

combining the actions of the plurality of active anesthetic ingredients according to the interaction relationship to obtain a combined potency of all the plurality of active anesthetic ingredients;

converting said combined potency to a Noxious Stimulus Response Index (NSRI), said NSRI being a one-dimensional parameter and having a full scale range with a first endpoint of said range indicating an alert and nonanesthetized patient, and with a second endpoint of said range indicating a deepest anesthesia;

displaying the NSRI to an operator controlling said administering of the plurality of active anesthetic ingredients.

2. An anesthetic process in accordance with claim 1 , wherein:

the interaction relationship is calculated using a mathematical formula based on the individual potencies of each of the active anesthetic ingredients;

the NSRI is calculated using a mathematical formula based on the combined potency.

3. An anesthetic process in accordance with claim 1 , further comprising:

grouping the active anesthetic ingredients into different classes based on action mechanisms;

combining the actions for each of the active anesthetic ingredients in each class to determine a class potency;

said determining of the interaction relationship is determined between the different classes of active anesthetic ingredients;

said combining of the actions includes combining the class potencies according to the interaction relationship to obtain the combined potency of all the plurality of active anesthetic ingredients.

4. An anesthetic process in accordance with claim 3 , wherein:

said step of determining an interaction relationship is performed using a mathematical formula.

5. An anesthetic process in accordance with claim 1 , wherein:

said combined potency of the active anesthetic ingredients are based on a mean anesthetic efficacy of the active ingredients used.

6. An anesthetic process in accordance with claim 1 , wherein:

said step of determining the interaction includes determining a synergistic interaction between the active anesthetic ingredients used for the anesthesia by means of extrapolation.

7. An anesthetic process in accordance with claim 1 , wherein:

said combined potency of the anesthetic actions of the active ingredients administered is determined based on a mean anesthetic efficacy of the active ingredients used.

8. An anesthetic process in accordance with claim 1 , further comprising the step of:

stating the combined potency as a value in a range from 0 to 100.

9. An anesthetic process in accordance with claim 1 , wherein:

said combining of the actions of all active ingredients, includes combining the actions of all active ingredients within each class of active anesthetic ingredients used.

10. An anesthetic process in accordance with claim 9 , further comprising the step of:

displaying said combined potency of a plurality of classes by means of a display means.

11. An anesthetic process in accordance with claim 10 , further comprising:

displaying at least one comparison value for guiding the anesthesia and/or the wakability of the patient by means of said display means.

12. An anesthetic process in accordance with claim 1 , further comprising the step of:

displaying all parameters that are variable over time over a time curve by means of a display means.

13. An anesthetic process in accordance with claim 1 , further comprising the step of:

displaying a prediction of future values by means of a display means based on current drug dosages.

14. An anesthetic process in accordance with claim 1 , further comprising the step of:

displaying a trend for the development of calculated values by means of a display means.

15. An anesthetic process in accordance with claim 1 , further comprising the steps of:

providing a monitoring device having a display means for displaying information concerning the anesthetics; and

displaying physiological states of the patient, which are variable during the anesthesia including at least one of heart rate, mean arterial pressure, and expiratory CO 2 content, by means of a display means.

16. An anesthetic process in accordance with claim 1 , further comprising the step of:

displaying pharmacokinetic and/or pharmacodynamic information concerning the anesthetic administered by means of a display means.

17. An anesthetic process in accordance with claim 1 , further comprising the step of:

displaying a dispensing history of the one or more anesthetic.

18. An anesthetic process in accordance with claim 1 , further comprising the step of:

adapting said administrating of the active anesthetic ingredients based on changes observed from said step displaying the NSRI in at least one parameter that is variable over time.

19. An anesthetic process in accordance with claim 1 , further comprising the step of:

displaying information, which marks events of the anesthesia.

20. An anesthetic process in accordance with claim 1 , further comprising the step of:

the operator adjusting said administrating of the plurality of active anesthetic ingredients to the patient depending upon said displaying of the combined potency.

21. An anesthetic process in accordance with claim 1 , further comprising the step of:

providing one of said plurality of active anesthetic ingredients as an opioid;

providing another one of said plurality of active anesthetic ingredients as an non-opioid;

determining C50 values for each of said plurality of active anesthetic ingredients;

determining and standardizing the combined potency N of all the plurality of active anesthetic ingredients by means of C50 values corresponding to them.

22. An anesthetic process in accordance with claim 21 , wherein:

said determining and standardizing of the combined potency N is performed using the formulas

N

=

C

hyp

C

50

hyp

*

A

out

A

out

=

A

i

n

*

(

1

-

C

opi

C

50

opi

+

C

opi

)

where: A in indicates the stimulus intensity in the absence of opioids;

C hyp indicates the concentrations of the non-opioid active anesthetic ingredient;

C opi indicates the concentrations of the opioid active anesthetic ingredient; and

C50 xxx the corresponding C50 or EC50 values corresponding to the mean efficacy or potency.

23. An anesthetic process in accordance with claim 1 , wherein:

said NSRI is calculated by

NSRI

=

(

1

-

(

N

/

N

)

sl

1

+

(

N

/

N

)

sl

)

where:

N is the combined potency;

N′ is a specific value at which an NSRI of 50% is reached; and

sl is a slope factor for the transformation of N into NSRI.

24. An anesthetic process comprising the steps of:

administrating a plurality of active anesthetic ingredients to a patient undergoing a painful procedure at a site of action, one of said plurality of active anesthetic ingredients being an opoid, another one of said plurality of active anesthetic ingredients being an non-opoid;

determining C50 values for each of said plurality of active anesthetic ingredients;

determining a concentration of each of the active anesthetic ingredients at the site of action using pharmacokinetic/pharmacodynamic models;

determining and standardizing a combined potency N of all the plurality of active anesthetic ingredients by means of C50 values corresponding to them;

converting said combined potency to a Noxious Stimulus Response Index (NSRI), said NSRI being a one-dimensional parameter and having a full scale range with a first endpoint of said range indicating an alert and non-anesthetized patient, and with a second endpoint of said range indicating a deepest anesthesia;

displaying the NSRI to an operator controlling said administering of the plurality of active anesthetic ingredients.

25. An anesthetic process in accordance with claim 24 , wherein:

said determining and standardizing of the combined potency uses the formulas

N

=

C

hyp

C

50

hyp

*

A

out

A

out

=

A

i

n

*

(

1

-

C

opi

C

50

opi

+

C

opi

)

where: A in indicates the stimulus intensity in the absence of opioids;

C hyp indicates the concentrations of the non-opioid active anesthetic ingredient;

C opi indicates the concentrations of the opioid active anesthetic ingredient; and

C50 xxx the corresponding C50 or EC50 values corresponding to the mean efficacy or potency.

26. An anesthetic process comprising the steps of:

providing a plurality of pumps for administration of a plurality active anesthetic ingredients;

administrating a plurality of active anesthetic ingredients to a patient through the plurality of pumps;

providing an information management system for receiving data from the plurality of pumps about the administration of a plurality of anesthetics;

providing a plurality of pharmacokinetic models connected to the information management system;

determining a concentration of each of the active anesthetic ingredients at a site of action;

determining an action of each of the active anesthetic ingredients from the determined concentrations of each active anesthetic ingredient at the site of action;

determining an interaction relationship between each of the active anesthetic ingredients;

combining the actions of the plurality of active anesthetic ingredients according to the interaction relationship to obtain a combined potency of all the plurality of active anesthetic ingredients;

converting said combined potency to a Noxious Stimulus Response Index (NSRI), said NSRI being a one-dimensional parameter and having a full scale range with a first endpoint of said range indicating an alert and non-anesthetized patient, and with a second endpoint of said range indicating a deepest anesthesia;

providing a display means for displaying information concerning the anesthetic;

displaying the NSRI on the display means to an operator controlling said administering of the plurality of active anesthetic ingredients.

Assignments (1)
MERGER Recorded Jun 1, 2016
From: DRÄGER MEDICAL GMBH; DRÄGERWERK AG & CO. KGAA
To: DRÄGERWERK AG & CO. KGAA
Reel/Frame 038853/0688 →
Priority Claims (2)
DE 10 2007 030 505 · Jun 30, 2007 · national
DE 10 2007 038 975 · Aug 17, 2007 · national
Continuity (2)
Continuation 12136315 · Jun 10, 2008
Related Publication 20110105914A1 · May 5, 2011
Cited By (1)
US 12,665,061