System and method for assuring validity of monitoring parameter in combination with a therapeutic device

• US 8,728,059 B2
• Filed: 09/29/2006
• Issued: 05/20/2014
• Est. Priority Date: 09/29/2006
• Status: Expired due to Fees

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Karst, Edward, Baker, Clark R. Jr.
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): MEDWAY, SCOTT J
• Application Number:
  US11/541,302
• Publication Number:
  US 20080114211A1
• Time in Patent Office: 2,790 Days
• Field of Search: 604/65, 604/67, 604/890.1, 128/204.18, 600/306, 600/309, 600/340, 600/365, 600/449, 600453-456, 600/468, 600/465, 600481-482, 600/485, 600/504, 600/533, 600/538, 600/547, 600/561, 600/202, 600/363, 600/364
• US Class Current: 604/890.1
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/4821 Determining level or depth of anaesthesia A61B5/1106 takes precedence
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

The disclosed embodiments relate to a system and method for assuring validity of monitoring parameters in combination with a therapeutic device. An exemplary embodiment of the present technique comprises perturbing a treatment administered to a patient, measuring at least one parameter of the patient reflecting the underlying physiological state and associated with the treatment, and comparing the perturbations of the treatment to measurements of the at least one parameter to determine if the perturbations to the treatment are reflected by the parameter.

Claims

1. A method comprising:

administering a treatment non-invasively at a specified level to a patient;

after administration of the treatment has begun and while continuing to provide some level of treatment, temporarily increasing or decreasing the treatment relative to the specified level and returning to the specified level after the temporary increase or decrease, wherein the temporary increase or decrease in the treatment is initiated independently of a change in a parameter indicative of the underlying physiological state of the patient associated with the treatment;

non-invasively measuring the parameter associated with the treatment;

evaluating the measured parameter value to determine whether the temporary increase or decrease in the treatment is correlated with the measured parameter value; and

providing a notification when the temporary increase or decrease in the treatment is not correlated with the measured parameter value within a predetermined period of time after initiation of the temporary increase or decrease; and

providing a notification that the treatment is being delivered when the temporary increase or decrease in the treatment is correlated with the measured parameter value.

2. The method, as set forth by claim 1, comprising temporarily increasing or decreasing the treatment periodically over time.

3. The method, as set forth by claim 1, comprising increasing or decreasing the treatment aperiodically over time.

4. The method, as set forth by claim 1, wherein the temporary increase or decrease of the treatment is distinguished from a naturally occurring physiological process.

5. The method, set forth by claim 1, wherein the administered treatment comprises oxygen, airway pressure, insulin, heat, a cardioactive drug, a vasoactive drug, an anesthetic drug, and/or an antipyretic drug.

6. The method, set forth by claim 1, wherein the parameter comprises oxygen saturation, heart rate, blood pressure, blood flow, cardiac output, and/or blood perfusion.

7. The method, set forth by claim 1, wherein evaluating the measured parameter value comprises comparing waveforms correlating with the temporary increase or decrease in the administered treatment with waveforms correlating with changes in the parameter or with another measurement or calculation made by a non-invasive monitoring device.

8. The method, set forth by claim 1, comprising alerting a clinician if the temporary increase or decrease in the treatment is not correlated with the parameter.

9. The method, set forth by claim 1, comprising automatically adjusting the treatment if the temporary increase or decrease in the treatment is not correlated with the parameter.

10. The method, set forth by claim 1, comprising automatically adjusting the treatment if the temporary increase or decrease in the treatment is correlated with the parameter.

11. The method, set forth by claim 1, comprising reverting to a prior or predetermined treatment level if the temporary increase or decrease in the treatment is not correlated with the parameter.

12. The method, set forth by claim 1, wherein the notification comprises a message on a display.

13. The method, set forth by claim 1, wherein the notification comprises an audible alarm.