Intelligent drug and/or fluid delivery system to optimizing medical treatment or therapy using pharmacodynamic and/or pharamacokinetic data

• US 9,950,112 B2
• Filed: 08/17/2011
• Issued: 04/24/2018
• Est. Priority Date: 08/17/2010
• Status: Active Grant

• Current Assignee: Xhale Assurance, Inc. (Koninklijke Philips N.V.), University of Florida Research Foundation, Incorporated (State University System of Florida)
• Original Assignee: University of Florida Research Foundation, Incorporated (State University System of Florida), Xhale, Inc.
• Inventors: Melker, Richard J., Dennis, Donn M., Melker, Jeremy, Rice, Mark, Hurley, Robert
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Hall, Deanna K
• Application Number:
  US13/817,165
• Publication Number:
  US 20130296823A1
• Time in Patent Office: 2,442 Days
• Field of Search: 604131, 604246, 604500, 604503, 604504, 604505, 6048901
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/02416 using photoplethysmograph signals, e.g. generated by infrared radiation A61B5/14552 takes precedence
• CPC Class Codes: A61B 5/0261 using optical means, e.g. infrared light
• CPC Class Codes: A61B 5/036 by means introduced into body tracts A61B5/032 and A61B5/035 take precedence
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/25 Bioelectric electrodes therefor
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/168 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 flow control in general G05D7/00
• CPC Class Codes: A61M 5/16854 by monitoring line pressure
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/31511 Piston or piston-rod constructions, e.g. connection of piston with piston-rod A61M5/5066 takes precedence
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A pharmacodynamic (PD), pharmacokinetic (PK), or both and PK guided infusion device, system and method optimizes the safety and efficacy of various forms of treatment or therapy (e.g., drug and/or fluid) in a variety of health-care and other settings.

Claims

1. A medication delivery control system comprising:

(a) an apparatus comprising at least one photoplethysmography (PPG) sensor that obtains a PPG signal from a site at a subject'"'"'s nose;

(b) an infusion device that provides medication to the subject'"'"'s nose;

(c) a controller for receiving PPG signals from the PPG sensor and, based on the signals, increasing, decreasing or maintaining a rate of infusion of the infusion device, and

(d) an accelerometer or other motion sensing device

wherein the system is in a sleep mode wherein power consumption is reduced until the controller determines that the subject is sleeping or in state of respiratory depression based on signals from the accelerometer or other motion sensing device; and

wherein the medication delivery control system is a wearable device adapted to be secured to the nose and/or head of the subject.

2. The medication delivery control system according to claim 1, wherein the PPG signals are obtained from the subject'"'"'s nasal alar.

3. The medication delivery control system according to claim 1, further comprising a nasal pressure or flow sensor, and optionally, an ECG electrode.

4. The medication delivery control system according to claim 1, further comprising an intranasal tube that is adapted to be emplaced inside the subject'"'"'s nostril and delivers pre-metered doses of medications.

5. The medication delivery control system according to claim 4, wherein the system delivers nitric oxide, histamine, or methacholine to nasal mucosa, either as part of the medications or as a separate feed.

6. The medication delivery control system of claim 4, wherein the medications comprise at least one of opioids, opioid antagonists, vasoactive drugs, steroids, dissociative agents and anxiolytics.

7. The medication delivery control system of claim 4, wherein the system delivers medications through the nasal epithelium.

8. The medication delivery control system of claim 1, further comprising at least one PPG sensor adapted to be secured to a peripheral site of the subject.

9. The medication delivery control system of claim 1, wherein the system:

(i) obtains measurements of at least one of the subject'"'"'s vital signs selected from the group consisting of nasal pressure/flow, electrocardiographic signals, blood pressure, heart rate, heart rate variability, arrhythmias, respiratory rate, respiratory effort indicative of work of breathing, inspiratory and expiratory breathing ratios (I;

E ratios), patterns of indicative of normal respiration or respiratory depression, plethysmography signals, blood oxygen saturation, blood volume, including local arterial blood flow amplitude, venous capacitance and comparative flows and capacitance from two or more site indicative of hypovolemia/shock and/or loss of extremity perfusion, pulse transit time, pulse wave velocity and combinations thereof,

(ii) processes the measurements to determine a relative state of health and, based on the determination,

(iii) infuses at least one medication to the subject based on the determination in (ii).

10. The medication delivery control system of claim 1, wherein the system is operated by remote personnel.

11. The medication delivery control system of claim 1, wherein the system is part of a helmet, telemetry or communications gear.

12. The medication delivery control system of claim 9, wherein the system wirelessly communicates vital sign information to remote personnel.