Central Site Photoplethysmography, Medication Administration, And Safety

• US 20130276785A1
• Filed: 08/08/2011
• Published: 10/24/2013
• 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: Xhale Assurance, Inc. (Koninklijke Philips N.V.)
• Inventors: Melker, Richard J., Dennis, Donn M., Melker, Jeremy, Rice, Mark, Hurley, Robert, Gold, Mark, Allen, Richard
• Granted Patent: US 10,137,245 B2
• Time in Patent Office: Days
• US Class Current: 128/204.23
• CPC Class Codes: A61B 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• 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 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 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 5/0826 Detecting or evaluating apnoea events A61B5/4818 takes precedence
• CPC Class Codes: A61B 5/0836 Measuring rate of CO2 production
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61B 5/4821 Determining level or depth of anaesthesia A61B5/1106 takes precedence
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6803 Head-worn items, e.g. helmets, masks, headphones or goggles
• CPC Class Codes: A61B 5/7246 using correlation, e.g. template matching or determination of similarity
• CPC Class Codes: A61M 16/0051 with alarm devices
• CPC Class Codes: A61M 16/026 specially adapted for predicting, e.g. for determining an information representative of a flow limitation during a ventilation cycle by using a root square technique or a regression analysis
• CPC Class Codes: A61M 16/0666 Nasal cannulas or tubing devices for improving normal breathing through the nose A61F5/08; nose filters A62B23/06; outside holding devices A61M25/02
• CPC Class Codes: A61M 16/0677 Gas-saving devices therefor
• CPC Class Codes: A61M 16/10 Preparation of respiratory gases or vapours
• CPC Class Codes: A61M 16/161 with means for measuring the humidity
• CPC Class Codes: A61M 2005/16863 Occlusion detection
• CPC Class Codes: A61M 2016/0027 : pressure meter
• CPC Class Codes: A61M 2205/3368 : Temperature
• CPC Class Codes: A61M 2230/04 : Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 2230/205 : partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/432 : partial CO2 pressure (P-CO2)
• CPC Class Codes: A61M 2230/60 : Muscle strain, i.e. measured on the user
• 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: G16H 20/10 : relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16H 20/40 : relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16Z 99/00 : Subject matter not provided for in other main groups of this subclass

Abstract

A monitoring and control system, apparatus and method for safe administration, reduction or cessation of administration of at least on medication, fluid or both, which includes at least one Central Source Site (CSS) Photoplethysmography (PPG) sensor coupled to means for control of delivery of the at least one medication, fluid or both.

Claims

1. A system comprising acquiring patient physiological data from a central source site of a patient, and utilizing information derivable from that signal in the control of delivery of medication or fluids to a subject in need of such treatment.

2. The system of claim 1 for monitoring and control for safe administration, reduction or cessation of administration of at least on medication, fluid or both, which includes at least one Central Source Site (CSS) Photoplethysmography (PPG) sensor coupled to means for control of delivery of the at least one medication, fluid or both.

3. The system according to claim 2 for enhancing the safety of a medical procedure wherein said medical procedure involves delivering medication(s), fluid(s) or both to a subject in need thereof, said system comprising:

means for monitoring (a) the combined effect of said medical procedure, (b) indicia of the underlying clinical condition for which said medical procedure is initiated, or both (a) and (b), said means, based on said monitoring, either (A) provides at least one output signal to advise medical personnel of the need for modifying said medical procedure, or (B) receives said at least one output signal to automatically initiate at least one intervention to secure the safety of said subject, or both (A) and (B), wherein said intervention is selected from the group consisting of;

i. initiating infusion of a fluid, active pharmacologic agent or both;

ii. limiting or terminating an already initiated infusion of a fluid, active pharmacologic agent or both;

iii. checking that fluid, active pharmacologic agent or both is being delivered to the correct subject in the correct dosage and at the correct time and if not, limiting or terminating delivery of said fluid, active pharmacologic agent or both and initiating an alert;

iv. initiating, increasing, decreasing or terminating ventilation of the subject.

4. The system of claim 2 comprising at least one or a combination of the following additional elements:

(a) a second site PPG sensor, preferably at a peripheral site, selected from the group consisting of a finger, a toe, or both;

(b) an infusion pump and at least one reservoir of at least one fluid, active pharmacologic agent, or both;

(c) an occlusion apparatus which, on receipt of a signal from a PPG sensor or a controller to which said PPG sensor is operatively coupled, partially or completely occludes a conduit from a medication reservoir to said subject;

(d) a controller which receives at least one signal from at least one PPG or other sensors operatively coupled to said subject and which outputs signals based on the signals received by the controller and algorithms programmed into the controller for producing output signals based on signals received from the sensors;

(e) sensors other than PPG sensors, selected from the group consisting of ECG, pulse oximeters, capnometers, or any sensor involved in polysomnography, PSG;

(f) ventilation means for applying positive ventilation pressure to said subject upon receipt by the ventilation means a control signal to initiate, increase or decrease ventilation; and

(g) SMART medication and SMART medication detection means for providing confirmation that a given medication has been taken or been administered, that it has been taken or administered at the correct dosage and at the correct time and in the right person.

5. The system of claim 2 for use:

a. by individuals who are or may become isolated and in need of medical attention to provide an interim, substantially automated solution for evaluation of a plethora of pharmacodynamic (PD), pharmacokinetic (PK) or both PD and PK parameters of the individual and, based on processing of signals acquired, at least in part by at least one CSS PPG, and, optionally, additional monitors and sensors, initiates emergency delivery of appropriate medications, fluids or both;

b. in not only acquiring PD, PK or both PD and PK parameters of a subject, but in also confirming delivery of the correct medication at the correct dosage within appropriate time frames, the use of medications which include Self Monitoring and Reporting Technology (SMART), which permits, at a minimum, not only acquisition of PD, PK, or both PD and PK parameters of said subject, but also provides an independent means for confirming that fluctuations in these parameters correlate with the administration of the SMART medication;

c. where a medication is being delivered to a subject via an infusion pump, whether in an open-loop or closed-loop context, and an adverse parameter is detected from monitoring the total PK, PD, or both PK and PD parameters, of said subject undergoing infusion, to activate an infusion pump agnostic component to reduce or terminate the infusion;

d. to provide close monitoring of the effect of anesthetic agents, opioids or like compounds and combinations of compounds, delivered by patient controlled analgesia (PCA) or in any context in which minimal sedation is sought to be achieved (whether trained anesthesia providers (e.g., anesthesiologists) are present or not), on respiration, so that if respiratory depression, elevation in respiratory effort, elevation in blood CO₂, decrease in blood O₂ saturation, or any other indicator of hypoventilation is detected, means for delivery of positive pressure ventilation to said subject is initiated.

6. The system according to claim 2 for use in the improvement of safety of conscious sedation or delivery of drugs which produce or could produce respiratory depression, comprising providing at least one subject sensor to non-exclusively acquire breathing rate data or breathing effort data or both, while said subject undergoes conscious sedation or infusion of at least one drug which produces respiratory depression, in combination with means for delivery of ventilation to said subject upon detection of reduced breathing rate, increased breathing effort or both.

7. The system according to claim 2 comprising:

(a) at least one apparatus comprising at least one sensor for measuring pharmacodynamic (PD), pharmacokinetic (PK), or both PD and PK parameters in a subject;

(b) an infusion device with a rate of infusion which is increased, decreased, or maintained at a given level of infusion based on said PD, PK, or both parameters; and

(c) a controller for receiving said PD, PK or both PD and PK parameters and, based on said parameters, increasing, decreasing or maintaining the rate of infusion of said infusion device.

8. The system according to claim 2 for concurrent pharmacokinetic (PK) and/or pharmacodynamic (PD) and adherence monitoring, comprising providing an apparatus and method including a photoplethysmograph integrated with Self Monitoring and Reporting Therapeutics (SMART) medication technology.

9. The system according to claim 2 to improve infusion pump safety comprising providing at least one subject sensor to acquire subject physiologic condition data while said subject undergoes infusion pump controlled delivery of at least one active agent, in combination with an infusion pump tubing occlusion device, wherein control of said infusion pump occlusion device is independent of control of said infusion pump.

10. The system according to claim 2 to improve the safety of conscious sedation or delivery of drugs which produce respiratory depression comprising providing at least one subject sensor to acquire breathing rate data or breathing effort data or both, while said subject undergoes conscious sedation or infusion of at least one drug which produces respiratory depression, in combination with means for delivery of ventilation to said subject upon detection of reduced breathing rate, increased breathing effort or both.

11. A method which comprises acquiring a signal reflecting patient physiological status from a central source site and utilizing information derivable from that signal in the control of delivery of medication or fluids to a subject in need of such treatment.

12. The method according to claim 11 for safely initiating, increasing, reducing or terminating administration to a subject of at least one medication, fluid or both, which comprises:

operatively adhering at least one Central Source Site (CSS) Photoplethysmography (PPG) sensor to a subject to acquire data indicative of the physiologic status of said subject;

converting said data indicative of said subject physiologic status into at least one output control signal;

interfacing means for control of delivery of the at least one medication, fluid or both to receive said at least one output control signal so that said means for control either initiates, increases, decreases or terminates administration of said medication, fluid or both to said subject, dependent on said at least one output control signal.

13. An apparatus for safely initiating, increasing, reducing or terminating administration to a subject of at least one medication, fluid or both, which comprises:

at least one Central Source Site (CSS) Photoplethysmography (PPG) sensor for operative adherence to a subject to acquire data indicative of the physiologic status of said subject;

a processor for converting said data indicative of said subject physiologic status into at least one output control signal;

means for control of delivery of the at least one medication, fluid or both to receive said at least one output control signal so that said means for control either initiates, increases, decreases or terminates administration of said medication, fluid or both to said subject, dependent on said at least one output control signal.