METHOD, APPARATUS AND SYSTEM FOR AUTOMATIC TREATMENT OF PAIN

• US 20140276549A1
• Filed: 03/15/2013
• Published: 09/18/2014
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Flint Hills Scientific, LLC
• Original Assignee: Flint Hills Scientific, LLC
• Inventors: Osorio, Ivan
• Granted Patent: US 9,579,457 B2
• Time in Patent Office: Days
• US Class Current: 604/503
• CPC Class Codes: A61B 3/11 for measuring interpupillary distance or diameter of pupils
• 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 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• 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 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/165 Evaluating the state of mind, e.g. depression, anxiety
• CPC Class Codes: A61B 5/42 Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems A61B1/00, A61B5/4857, A61B5/486, A61B5/4866, A61B5/4869 take precedence
• CPC Class Codes: A61B 5/4803 Speech analysis specially adapted for diagnostic purposes
• CPC Class Codes: A61B 5/4827 assessing touch sensitivity, e.g. for evaluation of pain threshold
• CPC Class Codes: A61B 5/483 by thermal stimulation
• CPC Class Codes: A61B 5/486 Bio-feedback A61B5/375 takes precedence
• CPC Class Codes: A61M 2005/1405 Patient controlled analgesia [PCA]
• CPC Class Codes: A61M 2205/332 Force measuring means
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/50 : with microprocessors or computers
• CPC Class Codes: A61M 2205/8206 : battery-operated
• CPC Class Codes: A61M 2230/005 : Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/04 : Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 2230/06 : Heartbeat rate only
• CPC Class Codes: A61M 2230/08 : Other bio-electrical signals
• CPC Class Codes: A61M 2230/30 : Blood pressure A61M2230/04 takes precedence
• CPC Class Codes: A61M 2230/40 : Respiratory characteristics
• CPC Class Codes: A61M 2230/42 : Rate
• CPC Class Codes: A61M 2230/50 : Temperature
• CPC Class Codes: A61M 2230/62 : Posture
• CPC Class Codes: A61M 2230/63 : Motion, e.g. physical activity
• CPC Class Codes: A61M 5/14244 : adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14276 : specially adapted for implantation
• 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: A61N 1/025 : Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors
• CPC Class Codes: A61N 1/36021 : for treatment of pain
• CPC Class Codes: A61N 5/0625 : Warming the body, e.g. hyperthermia treatment
• CPC Class Codes: A61N 5/067 : using laser light
• CPC Class Codes: G16H 10/60 : for patient-specific data, e.g. for electronic patient records
• 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 50/30 : for calculating health indices; for individual health risk assessment

Abstract

We disclose methods and medical device systems for automated delivery of therapies for pain and determination of need for and safety of treatment. In one embodiment, such a medical device system may comprise a sensor configured to sense at least one body signal from a patient; and a medical device configured to receive a first sensed body signal from the sensor; determine a patient pain index based at least in part on said first sensed body signal; determine whether said patient pain index is above at least a first pain index threshold; determine a safety index based at least in part on a second sensed body signal; select a pain treatment regimen based on at least one of said safety index and or a determination that said pain index is above said first pain index threshold; and deliver said pain treatment regimen.

Claims

1. A medical device system, comprising:

at least one sensor configured to sense at least one body signal from a patient; and

a medical device configured to;

receive at least a first sensed body signal from said at least one sensor;

determine a patient pain index, wherein said patient pain index is based at least in part on said first sensed body signal;

determine whether said patient pain index is above at least a first pain index threshold;

determine a safety index wherein said safety index is based at least in part on a second sensed body signal;

select a pain treatment regimen based on at least one of said safety index or a determination that said pain index is above said first pain index threshold; and

deliver said pain treatment regimen.

2. The medical device system of claim 1 further comprising determining whether said patient pain index is above a second pain index threshold, wherein the second pain index threshold is indicative of said patient being in distress.

3. The medical device system of claim 2 further comprising determining whether said patient pain index is above a third pain index threshold, wherein the third pain index threshold is indicative of said patient being in a state of suffering.

4. The medical device system of claim 1, wherein said at least one body signal is at least one of:

an autonomic signal selected from a blood pressure, a pulse rate, a respiratory rate, a blood oxygen saturation, or a body temperature;

a kinetic signal selected from a body stability in the erect posture, a length of stride, a rate of stride, a gait rhythm, a type of body movement, one of a frequency, an amplitude, and a velocity of a body movement within a time window, and a time interval between at least two body movements;

a mimetic signal;

a level of consciousness signal selected from a motor output in response to a command and a verbal output in response to a command;

a cognitive signal selected from a simple reaction time and a complex reaction time;

a chemical signal selected from a body concentration of a drug; and

an endocrine signal selected from a catecholamine concentration, a corticosteroid concentration, or an electrolyte concentration.

5. The medical device system of claim 1, further comprising:

a pain threshold determination unit configured to

provide at least one stimulus to a patient,

receive a response of the patient to the at least one stimulus, and

determine, based on said response to the at least one stimulus, whether at least one pain threshold has changed.

6. The medical device system of claim 5, wherein the at least one stimulus is a noxious stimulus selected from a temperature, a pressure, a force, a smell, a sound, a visual stimulus, an electrical stimulus, a tactile stimulus, a chemical stimulus, and a mechanical stimulus.

7. The medical device system of claim 1 further comprising

an emotional state unit configured to determine an emotional state, wherein said emotional state unit is configured to

provide at least one of an emotional stimulus or a psychological stimulus to the patient,

receive a response from the patient to the at least one of an emotional stimulus or a psychological stimulus;

and

determine, based on the response to the at least one of an emotional stimulus or a psychological stimulus, whether at least one pain threshold has changed.

8. The medical device system of claim 1 wherein selecting a pain treatment regimen comprises one of:

modifying at least one parameter of a previously applied pain treatment regimen, or

modifying a previously applied treatment modality to a different treatment modality;

and wherein delivering said pain treatment regimen comprises applying the modified pain treatment regimen to the patient.

9. The medical device system of claim 1, wherein the medical device is further configured to determine a body tolerance index relating to a first medication for said patient based at least in part on, a subjective response of the patient to a first exogenous painful stimulus, or a response of the patient pain index to a second exogenous painful stimulus.

10. The medical device system of claim 1, wherein said pain treatment regimen comprises at least one of a medication, a dose of said medication, a delivery route of said medication, a cocktail of medications, a dose of said cocktail, a delivery route of said cocktail, an electrical stimulation, at least one parameter of said electrical stimulation, a target tissue of said electrical stimulation, a cognitive therapy, at least one parameter of said cognitive therapy, a biofeedback, at least one parameter of said biofeedback, a thermal manipulation, at least one parameter of said thermal manipulation, or a target tissue of said thermal manipulation.

11. The medical device system of claim 1, wherein said medical device comprises:

a reservoir to store at least one medication;

a medication dispenser operatively coupled to said reservoir, said medication dispenser adapted to release said medication from said reservoir;

a body data collection module adapted for receiving a first body data series of the patient from said at least one sensor;

a patient pain module configured to determine at least one of a patient pain index or a pain level,

a safety module configured to determine a safety index;

a body tolerance module configured to provide a body tolerance index;

a controller adapted to control at least one operation of said medication dispenser based upon at least one output of said patient pain module;

a memory for storing data;

a communication unit to provide communications between said medical device and at least one device external to said medical device; and

a power supply to provide power for the operation of said medical device.

12. The medical device system of claim 11, wherein said patient pain module comprises:

a pain index determination unit for determination of a patient pain index based upon said body data,

a patient input unit for receiving an input relating to at least one of a patient input of a pain level experienced by the patient and a request for a medication; and

a pain index comparison unit for comparing said determined pain index to said first pain index threshold.

13. The medical device system of claim 3, further comprising a communication unit configured to communicate an alert if said determined pain index is below at least one of said first pain level or threshold, said second pain level or threshold, and said third pain level or threshold, and said determined pain level indicates a desire of said patient for medication delivery.

14. The medical device system of claim 11, wherein said body data comprises at least one of heart beat data, blood pressure data, respiration data, blood gas data, neurological data, endocrine data, metabolic data, or tissue stress marker data.

15. The medical device system of claim 11, further comprising an external device adapted to communicate with said communication unit and at least one of:

an autonomic data acquisition unit for receiving autonomic data;

a neurological data acquisition unit for receiving neurological data;

an endocrine data acquisition unit for receiving endocrine data;

a metabolic data acquisition unit for receiving metabolic data; and

a tissue stress marker data acquisition for receiving tissue stress marker data.

16. The medical device system of claim 1, wherein said first pain index threshold is selected such that said pain treatment regimen is delivered before said patient perceives pain.

17. The medical device system of claim 1, wherein said delivery of said pain treatment regimen occurs before said patient perceives pain.

18. The medical device system of claim 1, wherein said medical device is configured to automatically perform at least one of determining said patient pain index, determining whether said patient pain index is above said at least a first pain index threshold, determining said safety index, selecting said pain treatment regimen, or delivering said pain treatment regimen.

19. A method for providing pain medication, comprising:

receiving, at a device, a request for delivery of a pain medication to a patient;

receiving, automatically by the device, at least one body data series of said patient in response to said request for delivery of a pain medication;

determining a patient pain index based upon said body data series;

determining whether the patient pain index is above a reference pain index;

determining a safety index

allowing, automatically, delivery of a pain medication based on at least one of said safety index or a determination that said patient pain index is above said reference pain index.

20. The method of claim 19, wherein allowing delivery of a medication comprises:

determining a first dosage of medication received by the patient during a first previous time period;

determining whether a second time period has elapsed since the patient received said first dosage, wherein said second time period is based upon said first dosage;

determining a second dosage of medication to deliver to the patient based upon whether or not said second time period has elapsed since the patient received said first dosage; and

delivering said second dosage of medication to said patient in response to said second time period having elapsed.

21. The method of claim 20, further comprising automatically changing at least one of a dosage or a time of delivery of a pain medication if at least one of a pain threshold is above a reference value, a body tolerance is below a reference value, an emotional state is negative, or the pain threshold is below a reference value.

22. The method of claim 19, wherein at least one of determining a patient pain index and determining a safety index comprises administering at least one of a patient responsiveness test and a patient awareness test.

23. The method of claim 22, wherein determining a safety index comprises administering a patient responsiveness test, and wherein allowing delivery of a pain medication comprises allowing delivery of a pain medication in response to a determination that said patient pain index is above said reference pain index and a determination that the patient'"'"'s responsiveness is not below a responsiveness reference value.

24. A method for providing pain medication to a patient, comprising:

receiving automatically, at least a first body data series of a patient;

determining a first discomfort index of the patient based upon said first body data series;

determining whether the first discomfort index exceeds a first discomfort index threshold;

providing a first therapy in response to determining that said first discomfort index exceeds said first discomfort index threshold.

25. The method of claim 24, further comprising:

receiving a second body data series of the patient;

determining a second discomfort index of the patient based upon said second body data series;

determining whether said second discomfort index exceeds a second discomfort index threshold;

determining a second therapy in response to determining that said second discomfort index does not exceed said second comfort index threshold; and

providing said second therapy to said patient.

26. A non-transitory computer readable program storage unit encoded with instructions that, when executed by a computer, perform a method, comprising:

receiving at a device, a request for delivery of a pain therapy to a patient;

receiving, automatically by the device, at least one body data series in response to said request for delivery of a pain therapy;

determining a patient pain index based upon said body data series;

determining whether the patient pain index is above a patient pain index threshold;

automatically delivering a pain therapy to the patient in response to determining that said patient pain index is above said patient pain index threshold.

27. The computer readable program storage unit of claim 26, further comprising administering a responsiveness test to the patient, wherein automatically delivering a pain therapy comprises delivering a pain therapy in response to determining that said patient pain index is above the patient pain index threshold and determining that the patient'"'"'s responsiveness is not below a responsiveness threshold.

28. A method for providing pain medication, comprising:

receiving at least one of

a request for delivery of a pain medication from a patient,

an indication of an elapsed time period, or

a request for administration of a responsiveness test to a patient;

administering a responsiveness test to the patient in response to said receiving;

allowing delivery of a pain medication based on a determination that the patient'"'"'s responsiveness is above a responsiveness threshold.

29. The method of claim 28, wherein said determination that the patient'"'"'s responsiveness is above said responsiveness threshold corresponds to the patient having normal responsiveness.

30. The method of claim 28, further comprising

receiving at least one body data series of said patient in response to a determination that the patient'"'"'s responsiveness is not above said responsiveness threshold;

determining at least one of heart rate, respiration rate, blood pressure, and oxygen saturation based on the at least one body data series;

determining whether said at least one heart rate, respiration rate, blood pressure or oxygen saturation is below a reference heart rate threshold, respiration rate threshold, blood pressure threshold, or oxygen saturation threshold;

allowing delivery of a pain medication based on a determination that the at least one of a heart rate, respiration rate, blood pressure or oxygen saturation is above said reference heart rate threshold, respiration rate threshold, blood pressure threshold, or oxygen saturation threshold.

31. The method of claim 30, further comprising:

performing an action selected from

issuing a warning and;

suspending a treatment plan and modifying a treatment plan based on a determination that the at least one of a heart rate, respiration rate, blood pressure or oxygen saturation is below said reference heart rate threshold, respiration rate threshold, blood pressure threshold, or oxygen saturation threshold.