Apparatuses and methods for automatically assessing and monitoring a patient's responsiveness

• US 20030145854A1
• Filed: 12/27/2002
• Published: 08/07/2003
• Est. Priority Date: 06/03/1998
• Status: Active Grant

• Current Assignee: Scott Laboratories, Inc.
• Original Assignee: Scott Laboratories, Inc.
• Inventors: Hickle, Randall S.
• Granted Patent: US 7,565,905 B2
• Time in Patent Office: Days
• US Class Current: 128/204.18
• CPC Class Codes: A61B 5/1106 to assess neuromuscular blockade, e.g. to estimate depth of anaesthesia
• CPC Class Codes: A61B 5/162 Testing reaction times
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/417 the bone marrow
• CPC Class Codes: A61B 5/4821 Determining level or depth of anaesthesia A61B5/1106 takes precedence
• CPC Class Codes: A61M 16/0051 with alarm devices
• CPC Class Codes: A61M 16/0078 Breathing bags
• CPC Class Codes: A61M 16/0084 self-reinflatable by elasticity, e.g. resuscitation squeeze bags
• CPC Class Codes: A61M 16/009 Removing used or expired gases or anaesthetic vapours filtering, sterilising or disinfecting the exhaust air in drainage systems A61M1/784; bacterial filters in the expiratory path A61M16/1065
• CPC Class Codes: A61M 16/0093 by adsorption, absorption or filtration
• CPC Class Codes: A61M 16/01 specially adapted for anaesthetising A61M16/104, A61M16/18 take precedence
• 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 16/1015 using a gas flush valve, e.g. oxygen flush valve
• CPC Class Codes: A61M 16/107 in the inspiratory path
• CPC Class Codes: A61M 2005/1405 Patient controlled analgesia [PCA]
• CPC Class Codes: A61M 2016/0036 in the breathing tube and used in both inspiratory and expiratory phase
• CPC Class Codes: A61M 2016/1025 the O2 concentration
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2209/084 Supporting bases, stands for equipment
• CPC Class Codes: A61M 2230/205 : partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/43 : Composition of exhalation
• CPC Class Codes: A61M 2230/432 : partial CO2 pressure (P-CO2)
• CPC Class Codes: A61M 5/142 : Pressure infusion, e.g. using pumps
• 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 20/40 : relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: G16H 50/30 : for calculating health indices; for individual health risk assessment

Abstract

A care system and associated methods are provided for alleviating patient pain, anxiety and discomfort associated with medical or surgical procedures. The care system facilitates a procedural clinician'"'"'s safely and efficaciously providing sedation and analgesia and in some measure, amnesia to a patient by providing a responsiveness monitoring system which monitors the responsiveness of the patient and generates a value representing the level of patient responsiveness. In further aspects of the invention, the responsiveness monitoring system is an automated system which includes patient query and response devices. Additional embodiments of the system and methods are directed to alleviating patient pain or discomfort while enabling safe drug delivery (automated, clinician-controlled or patient-controlled) in correlation with the monitoring of patient health conditions.

Claims

1. A patient monitoring system for monitoring a patient'"'"'s responsiveness comprising:

(a) at least one query initiate device for prompting a response from a patient;

(b) at least one query response device for sensing a patient'"'"'s response to a prompt from the at least one query initiate device; and

(c) an electronic controller in communication with the at least one query initiate device and the at least one query response device, wherein said controller generates an assessment of a patient'"'"'s responsiveness based upon patient'"'"'s response or lack of response to a prompt from the at least one query initiate device.

2. The patient monitoring system according to claim 1, wherein the electronic controller generates an assessment of a patient'"'"'s responsiveness based upon a latency period between a prompt by the at least one query initiate device and a patient'"'"'s response to the prompt.

3. The patient monitoring system according to claim 1, further comprising at least one patient physiological monitor for generating patient health data, wherein the system automatically assesses a patient'"'"'s responsiveness based upon the patient health data.

4. The patient monitoring system according to claim 3, wherein the at least one patient physiological monitor is selected from the group consisting of a capnometer, a pulse oximeter, an electrocardiography monitor, a blood pressure monitor, a respiration monitor, and an electroencephalography monitor.

5. The patient monitoring system according to claim 1, wherein the at least one query initiate device may be part of a handset or a headset.

6. The patient monitoring system according to claim 5, wherein the at least one query initiate device prompts the patient with a stimuli, wherein the stimuli is of variable intensity, urgency, and duration.

7. The patient monitoring system according to claim 1, wherein the system is integrated with a system for the delivery or monitoring of drugs during a medical procedure.

8. The patient monitoring system according to claim 7, wherein the system for the delivery or monitoring of drugs is clinician controlled, patient controlled, or automated.

9. The patient monitoring system according to claim 7, wherein said drugs are for sedation and analgesia.

10. The patient monitoring system according to claim 7, wherein the system for the delivery or monitoring of drugs during a medical procedure delivers drugs to the patient, wherein the rate of drug delivery is altered based upon the assessment of the patient'"'"'s responsiveness generated by the electronic controller.

11. The patient monitoring system according to claim 1, wherein a user of the system can manually initiate an automated measurement of patient responsiveness.

12. The patient monitoring system according to claim 1, further comprising a manual responsiveness test function for allowing a user to manually assess patient responsiveness and manually enter the results of the manual assessment into a user interface.

13. The patient monitoring system according to claim 1, further comprising an interface for a user of the system to interact with and monitor the functions of the system.

14. A method for monitoring a patient'"'"'s responsiveness comprising the steps of:

(a) querying a patient with at least one stimulus;

(b) sensing a patient'"'"'s response to the at least one stimulus or noting the lack of a patient'"'"'s response within a pre-determined amount of time after the initiation of the at least one stimulus; and

(c) assessing the patient'"'"'s level of responsiveness based upon the step of sensing a patient'"'"'s response or noting the lack of a patient'"'"'s response.

15. The method for monitoring a patient'"'"'s responsiveness according to claim 14, wherein the at least one stimulus comprises one or more of tactile, aural, and visual stimuli.

16. The method for monitoring a patient'"'"'s responsiveness according to claim 14, further comprising the step of displaying the assessed responsiveness of the patient via an interface device to a clinician attending to the patient.

17. The method for monitoring a patient'"'"'s responsiveness according to claim 14, further comprising the step of querying the patient with a subsequent at least one stimulus a pre-determined amount of time after a first at least one stimulus.

18. The method for monitoring a patient'"'"'s responsiveness according to claim 17, further comprising the step of modifying the pre-determined amount of time based on the assessed responsiveness of the patient.

19. The method for monitoring a patient'"'"'s responsiveness according to claim 17, further comprising the steps of determining a physiological parameter of a patient and modifying the pre-determined amount of time based on the physiological parameter.

20. The method for monitoring a patient'"'"'s responsiveness according to claim 19, wherein the physiological parameter of the patient is selected from the group consisting of pulse oximetry, blood pressure, heart rate, and respiratory rate.

21. The method for monitoring a patient'"'"'s responsiveness according to claim 17, wherein the method for monitoring a patient'"'"'s responsiveness is performed in conjunction with a medical procedure.

22. The method for monitoring a patient'"'"'s responsiveness according to claim 21, wherein the medical procedure includes the delivery of drugs to the patient.

23. The method for monitoring a patient'"'"'s responsiveness according to claim 22, wherein the delivery of drugs is altered based on the assessed responsiveness of the patient.

24. The method for monitoring a patient'"'"'s responsiveness according to claim 22, wherein the drugs are for sedation and analgesia.

25. The method for monitoring a patient'"'"'s responsiveness according to claim 14, wherein the at least one stimulus is part of a series of stimuli, the series comprising a pre-determined number of stimuli.

26. The method for monitoring a patient'"'"'s responsiveness according to claim 25, wherein a subsequent stimulus of the series of stimuli is of a heightened intensity to the previous stimulus of the series.

27. The method for monitoring a patient'"'"'s responsiveness according to claim 25, wherein a subsequent stimulus of the series of stimuli is separated by a pre-determined interval of no stimuli from the previous stimulus of the series.

28. A care system for alleviating patient pain, anxiety and discomfort associated with medical or surgical procedures said system comprising:

(a) one or more patient health monitor devices adapted so as to receive a signal reflecting at least one physiological condition;

(b) a patient responsiveness monitor adapted so as to receive at least one signal reflecting patient responsiveness;

(c) a drug delivery controller supplying one or more drugs;

(d) a memory device storing a safety data set reflecting safe and undesirable parameters of at least one monitored patient physiological condition and of patient responsiveness; and

(e) an electronic controller interconnected between the one or more patient health monitor devices, the patient responsiveness monitor;

the drug delivery controller and the memory device storing the safety data set;

wherein said electronic controller receives said signal reflecting at least one physiological condition and said signal reflecting patient responsiveness, and in response manages the application of the drugs in accord with the safety data set.

29. A method of using the care system of claim 28, the method comprising the steps of:

(a) assessing a level of responsiveness; and

(b) managing application of drugs in a manner to promote amnesia and to promote loss of responsiveness.

30. A method of using the care system of claim 28, to safely administer a medical procedure comprising the steps of

(a) managing the application of the drugs so as to increase the drugs delivered at a pre-determined rate of increase;

(b) continually assessing a level of responsiveness during the step of managing the application of the drugs;

(c) determining there is a loss of responsiveness; and

(d) determining an effect site concentration during the step of determining there is a loss of responsiveness; and

(e) managing the application of the drugs so as to maintain said effect site concentration.

31. The method according to claim 30, the method further comprising the step of administering a medical procedure during the step of managing the application of the drugs so as to maintain said effect site concentration.

32. A method of using the care system of claim 28, to safely administer a medical procedure comprising the steps of:

(a) managing the application of the drugs so as to increase the drugs delivered at a pre-determined rate of increase;

(b) continually assessing a level of responsiveness during the step of managing the application of the drugs;

(c) determining at least one effect site concentration during the step of managing the application of the drugs so as to increase the drugs delivered; and

(d) determining a predicted effect site concentration that is predicted to exist at a point at which there will be a loss of responsiveness.

33. The method according to claim 32, further comprising the step of managing the application of the drugs so as to maintain an effect site concentration at which there is no loss of responsiveness.