Controlling a personal medical device

• US 8,655,450 B2
• Filed: 04/20/2010
• Issued: 02/18/2014
• Est. Priority Date: 01/13/2009
• Status: Active Grant

• Current Assignee: Jeffrey A. Matos
• Original Assignee: Jeffrey A. Matos
• Inventors: Matos, Jeffrey A.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Stice, Paula J
• Application Number:
  US12/763,949
• Publication Number:
  US 20100268304A1
• Time in Patent Office: 1,400 Days
• Field of Search: 607 2- 5, 607/30, 607 59- 60
• US Class Current: 607/60
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/0836 Measuring rate of CO2 production
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2230/201 Glucose concentration
• 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 1/362 Heart stimulators heart defibrillators A61N1/39
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37252 Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
• CPC Class Codes: A61N 1/37258 Alerting the patient
• CPC Class Codes: A61N 1/37264 Changing the program; Upgrading firmware
• CPC Class Codes: A61N 1/37282 characterised by communication with experts in remote locations using a network
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: A61N 1/39622 : Pacing therapy
• CPC Class Codes: G16H 10/60 : for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: G16H 40/67 : for remote operation
• CPC Class Codes: H04B 17/309 : Measuring or estimating channel quality parameters
• CPC Class Codes: H04L 1/0003 : by switching between different modulation schemes
• CPC Class Codes: H04L 1/0013 : Rate matching, e.g. puncturing or repetition of code symbols
• CPC Class Codes: H04L 1/0015 : characterised by the adaptation strategy
• CPC Class Codes: H04L 1/0026 : Transmission of channel quality indication
• CPC Class Codes: H04W 24/02 : Arrangements for optimising operational condition
• CPC Class Codes: H04W 4/023 : using mutual or relative location information between multiple location based services [LBS] targets or of distance thresholds

Abstract

Medical monitoring and treatment apparatus, which is controlled by a plurality of control sources, includes a “personal medical device” (PMD) or an “implantable medical device” (IMD), respectively carried by, or implanted in, a patient. The PMD/IMD is alternatively self-controlled or controlled by one or more local external control stations, at or near the location of the patient, and/or one or more remote external control stations, remote from the patient. Either or both of the local and remote stations may be operated by a person, such as the patient, a patient facilitator and/or a medical professional, or the stations may operate automatically. Since the device is controlled by multiple sources, hierarchies are used to select the source of control.

Claims

1. A medical monitoring and treatment system which is controlled by a plurality of control sources, said system comprising, in combination:

(a) an implantable medical device (IMD), which is alternatively self-controlled and remotely controlled, said device comprising, in combination;

a first transmitting/receiving (T/R) device for transmitting at least one signal representing internal medical data of a patient to, and for receiving external control signals from, at least one external control station, and for receiving at least one hierarchy setting signal from at least one external command station;

a medical treatment device for treating said patient in response to a treatment device signal applied thereto;

a first sensor circuit, having a first sensor circuit output, for producing at least one first sensor circuit output signal at said first sensor circuit output in response to the internal medical data sensed from the patient by said first sensor circuit; and

a first processor, coupled to each of

said first sensor circuit output,

said first T/R device, and

said treatment device,

for

analyzing said at least one first sensor circuit output signal and, based on the analysis, generating (A) at least one first medical information signal representing said internal medical data, and (B) an internal control signal

receiving at least one external control signal;

receiving at least one hierarchy-setting signal; and

based on said hierarchy setting signal, generating said treatment device signal in response to a selected one of said internal and received external control signals; and

(b) at least one external control station, each comprising, in combination;

a (P+1)th transmitting/receiving (T/R) device for electronic communication with said first T/R device of said IMD; and

a (P+1)th processor, coupled to said (P+1)th T/R device, for producing at least one external control signal for controlling said IMD;

wherein P is an integer with a value of at least the number one, and at most the number of said external control stations; and

(c) at least one external command station, each comprising, in combination;

a command station transmitting device for electronic communication with said first T/R device of said IMD;

a command station processor, coupled to said command station transmitting device, for producing at least one hierarchy-setting signal for setting at least one hierarchy among said internal and external control signals, for controlling said IMD; and

a command station input device, coupled to said command station processor, for inputting at least one hierarchy-setting command specifying said at least one hierarchy;

Wherein said first T/R device transmits at least one first medical information signal to at least one of said external control stations;

wherein said first processor is operative to receive said at least one hierarchy-setting signal received from at least one of said external command stations by said first T/R device;

wherein in response to said at least one hierarchy-setting signal said first processor is operative to assign a unique priority level to each of said internal and external control signals, wherein the values of said assigned priority levels indicate a control hierarchy among all such control signals; and

wherein based on said assignment, said first processor is operative to generate said treatment device signal in response to the control signal with the highest assigned priority level from among said internal and received external control signals;

thereby to control the treatment provided by said IMD in accordance with the hierarchy.

2. The system defined in claim 1, wherein said first processor is operative to permanently assign at least one of said priority levels indicating said control hierarchy.

3. The system defined in claim 1,

wherein at least one of said input devices is operative to input a password prior to inputting of said at least one hierarchy-setting command, for transmission by said respective T/R device to said first processor,

wherein said first processor is operative to store at least one password;

and

wherein said first processor is operative to assign said priority levels indicating said control hierarchy only if said received password matches the stored password;

whereby access to setting the control hierarchy is restricted to at least one designated person.

4. The system defined in claim 1,

wherein at least one of said input devices is operative to input information representing a biologic identifier prior to the inputting of said at least one hierarchy-setting command, for transmission by said respective T/R device to said first processor,

where said first processor is operative to store information representing at least one biologic identifier;

wherein said first processor is operative to assign said priority levels indicating said control hierarchy only if said received biologic identifier information matches the stored biologic identifier information.

5. The system defined in claim 4, wherein said biologic identifier is at least one of:

a fingerprint image,

an image of a face,

an image of a retina,

an image of an iris,

a voiceprint, and

a sample of DNA.

6. The system defined in claim 1, wherein said internal control signal is assigned the highest priority;

thereby to give said internal control signal the highest priority for controlling said IMD.

7. The system defined in claim 1, wherein internal control signal is assigned a priority selected from the group consisting of:

second highest priority,

third highest priority,

fourth highest priority, and

fifth highest priority.

8. The stem defined in claim 1, wherein said P external control stations further comprises at least one first patient input device, coupled to its respective processor, for inputting therapy commands from said patient;

and wherein the inputted patient therapy command causes said processor to produce a patient external control signal which indicates the therapy choice of said patient.

9. The system defined in claim 8, wherein said one external control station further comprises a display device, coupled to said processor of said one external control station, for displaying medical information to said patient.

10. The system defined in claim 9, wherein the T/R d vice of said one external control station is operative to receive at least one medical information signal for consideration by said patient, in selecting said therapy choice.

11. The system defined in claim 8, wherein said patient external control signal is assigned the highest priority;

thereby to give the highest priority to said patient, for controlling said IMD.

12. The system defined in claim 8, wherein said patient external control signal is assigned a priority selected from the group consisting of:

second highest priority,

third highest priority,

fourth highest priority, and

fifth highest priority.

13. The system defined in claim 1,

wherein one of said P external control stations further comprises a second sensor circuit, coupled to its respective processor, said second sensor circuit having a second sensor circuit output, for producing at least one second sensor circuit output signal at said second sensor circuit output in response to external medical data sensed from the patient by said second sensor circuit;

and

wherein said processor of said one external control station is operative to analyze said at least one second sensor output signal to produce a patient device external control signal which indicates the therapy choice of such processor of said one external control station, for controlling said IMD.

14. The system defined in claim 13, wherein:

wherein the processor of said one external control station is operative to generate at least one second medical information signal representing said external medical data; and

wherein the T/R device said one external control station is operative to transmit said second medical information signal to at least one of;

said first T/R device, for analysis by said first processor, and

the T/R device of at least one other external control station;

whereby said external medical data is available for use by at least one of said IMD, and at least one other external control unit.

15. The system defined in claim 13,

wherein the T/R device of said one external control station is operative to receive at least one additional medical information signal;

and

wherein the respective processor of said one external control station is further operative to analyze said at least one additional medical information signal received by said T/R device of said one external control station to produce a patient device external control signal which indicates the therapy choice of such processor;

wherein said processor of said one external control station analyzes at least one of;

said at least one second sensor output signal, and

by said at least one additional received medical information signal,

to produce said patient device external control signal for controlling said IMD.

16. The system defined in claim 13, wherein said patient device external control signal is assigned the highest priority;

thereby to give the highest priority to the therapy choice of the processor of said external medical data sensed from the patient, for controlling said IMD.

17. The system defined in claim 13, wherein said patient device external control signal is assigned a priority selected from the group consisting of:

second highest priority,

third highest priority,

fourth highest priority, and

fifth highest priority.

18. The system defined in claim 13, wherein said one external control station further comprises at least one sensor, placed external to and in proximity to said patient, and coupled to said sensor circuit, for providing physiologic data about said patient.

19. The system defined in claim 18, wherein said sensor is selected from the group consisting of:

an electrocardiogram electrode,

a blood pressure cuff,

an oxygen saturation sensor,

a carbon dioxide detector,

an accelerometer,

a detector of body attitude,

a ketone detector,

a respiration detector,

an electroencephalogram electrode,

an electrode for measuring skin resistance,

a video camera, and

a microphone.

20. The system defined in claim 13, further comprising:

an output device, coupled to said processor of said one external control station, for providing at least one question to said patient, and

a patient response input device, coupled to said processor of said one external control station, for inputting at least one response from said patient;

wherein said response, if any, to said at least one question indicates a degree of necessity of therapy for said patient;

wherein said processor of said one external control station is operative to determine said degree of necessity from the inputted response, if any;

wherein said processor of said one external control station utilizes the determination of said degree of necessity to select a therapy choice; and

wherein said processor of said one external control station produces a patient device external control signal which indicates said therapy choice of said external device based on said determination, for transmission to said first processor.

21. The system defined in claim 20,

wherein the processor of said one external control station is further operative to generate at east one third medical information signal representing said degree of necessity;

and

wherein the T/R device of said one external, control station further operative to transmit said third medical information signal to at least one of;

said first T/R device, for analysis by said first processor, and

the T/R device of another external control station;

whereby said information indicating said degree of necessity is available for use by at least one of said IMD, and at least one other external control unit.

22. The apparatus defined in claim 13, wherein said processor of said one external control station is further operative to determine a control hierarchy, and to cause the T/R device of said one external control station to transmit information representing said hierarchy to said IMD.

23. The system defined in claim 1, wherein one of said P external control stations further comprises a display device for displaying medical information to a medical professional, and a medical professional input device, each coupled to the processor of said one external control station, for inputting therapy choices from the medical professional;

and wherein an inputted medical professional therapy choice causes said processor of said one external control station to produce a medical professional external control signal representing said therapy choice.

24. The system defined in claim 23, wherein the T/R device of said one external control station is further operative to receive at least one medical information signal for consideration by said medical professional.

25. The system defined in claim 23, wherein said medical professional external control signal is assigned the highest priority;

thereby to give the highest priority to said medical professional, for controlling said IMD.

26. The system defined in claim 23, wherein said medical professional external control signal is assigned a priority selected from the group consisting of:

second highest priority,

third highest priority,

fourth highest priority, and

fifth highest priority.

27. The system defined in claim 1, wherein one external control station further comprises a database, coupled to the processor of said one external control station, for storing information about at least one of:

the patient,

the IMD,

the prior use of the IMD by the patient,

the prior use of other implanted medical devices (IMDs) by the patient,

the prior use of a substantially similar IMD by other patients, and

the prior use of different IMDs by other patients;

wherein said processor of said one external control station is operative to select a therapy based on its analysis of;

at least a portion of said information stored in said database, and

said at least one first medical information signal; and

wherein said processor o said one external control station produces a medical expert external control signal which indicates the therapy selection based on said analysis, for transmission to said first processor.

28. The system defined in claim 27,

wherein the processor of said one external control station is operative to generate at least one fourth medical information signal representing information stored in said database;

and

wherein the T/R device of said one external control station is operative to transmit said fourth medical inform on signal to at least one of;

said first T/R device, for analysis by said first processor, and

the T/R device of another one of said external control stations;

whereby said database information is available for use by at least one of said IMD, and at least one other external control station.

29. The system defined in claim 27,

wherein the device of said one external control station is operative to receive at least one additional medical information signal;

and

wherein the processor of said one external control station is further operative to analyze said at least one additional medical information signal received by the T/R device of said one external control station to produce a medical expert external control signal which indicates the therapy choice of said processor;

whereby said processor of said one external control station analyzes at least;

said database information, and

said at least one additional received medical information signal,

to produce said medical expert external control signal for controlling said IMD.

30. The system defined in claim 27, wherein said medical expert external control signal is assigned the highest priority;

thereby to give the highest priority to the therapy choice selected by the processor performing the analysis of the database information, for controlling said IMD.

31. The system defined in claim 27, wherein said medical external control signal is assigned a priority selected from the group consisting of:

second highest priority,

third highest priority,

fourth highest priority, and

fifth highest priority.

32. The system defined in claim 27, wherein said processor of said one external control station is operative to carry out an analysis which comprises at least one of:

analyzing the results of the prior use of the IMD by the patient, at a time when internal medical data sensed from the patient was substantially similar to the current patient internal medical data;

analyzing the results of the prior use of the IMD by the patient, at a time when internal medical data sensed from the patient was substantially different from the current patient internal medical data;

analyzing the results of the prior use of another IMD by the patient, at a time when internal medical data sensed from the patient was substantially similar to the current patient internal medical data;

analyzing the results of the prior use of another IMD by the patient, at a time when internal medical data sensed from the patient was substantially different from the current patient internal medical data;

analyzing the results of the prior use of substantially similar IMDs by other patients, at a time when internal medical data sensed from said other patients was substantially similar to the current patient internal medical data;

analyzing the results of the prior use of substantially similar IMDs by other patients, at times when internal medical data sensed from said other patients was substantially different from the current patient internal medical data;

analyzing the results of the prior use of different IMDs by other patients, at times when internal medical data sensed from said other patients was substantially similar to the current patient internal medical data; and

analyzing the results of the prior use of different IMDs by other patients, at a time when internal medical data sensed from said other patients was substantially different from the current patient internal medical data;

thereby to determine an optimal medical treatment based on information in said database.

33. The apparatus defined in claim 27, wherein said processor of said one external control station is further operative to determine a control hierarchy, and to cause the T/R device of said one external control station to transmit information representing said hierarchy to said IMD.

34. The system defined in claim 1,

wherein said first T/R device is operative to receive at least one medical information signal transmitted by the T/R device of an external control station, and

wherein said first processor is further operative to generate said internal control signal based on the analysis of both:

said received medical information signal, and

said first medical information signal.

35. The apparatus defined claim 1, wherein at least one external control station processor is operative to produce an external control signal representing an instruction to said treatment device not to provide a treatment.

36. The apparatus defined in claim 1, wherein said first processor is operative to produce an internal control signal representing an instruction to said treatment device not to provide a treatment.

37. The apparatus defined in claim 1, wherein said first processor is operative to produce a treatment device signal instructing said treatment device not to provide a treatment in response to a selected control signal instructing said treatment device not to provide treatment.

38. The apparatus defined in claim 1, wherein said first processor is operative not to produce a treatment device signal in response to a selected control signal instructing said treatment device not to provide treatment.

39. The apparatus defined in claim 1, wherein, in the absence of one received external control signal, said first processor is operative to interpret such absence as an instruction to refer to the control signal with the assigned priority level immediately below the priority level assigned to said non-received control signal.

40. The apparatus defined in claim 1, wherein, in the absence of a generated internal control signal, said first processor is operative to interpret such absence as an instruction to refer the control signal with the assigned priority level immediately below the priority level assigned to said internal control signal.

41. The apparatus defined in claim 1, wherein in the absence of one received external control signal, said first processor is operative to interpret such absence as an external control signal from the respective control station instructing said treatment device not to provide a treatment.

42. The apparatus defined in claim 1, wherein in the absence of a generated internal control signal, said first processor is operative to interpret such absence as an internal control signal instructing said treatment device not to provide a treatment.

43. The apparatus defined in claim 1, wherein, in the absence of any internal and external control signal, said first processor does not produce a treatment device signal.

44. The apparatus defined in claim 1, wherein, in the absence of any internal and external control signal, said first processor produces a treatment device signal instructing said treatment device not to provide treatment.

45. The apparatus defined in claim 1, wherein said first processor is further operative to

distinguish among each one of plurality of medical conditions based on said analysis of said at least one first sensor circuit output signal, and for each of said conditions, generate an internal control signal;

receive a plurality of hierarchy-setting signals, each such signal representing a hierarchy among the internal and external control signals for one of said conditions;

in response to each of said hierarchy-setting signals, said first processor is operative to assign a unique priority level to each of said internal and external control signals for each of said conditions, wherein the values of said assigned priority levels indicate a control hierarchy among all such control signals for each of said conditions; and

based on said assignments, said first processor is operative to generate said treatment device signals in response to the respective control signal with the highest assigned priority level from among said respective internal and received external control signals, for each of said conditions;

whereby non-identical hierarchies apply to the treatment of different medical conditions;

thereby to control different treatments provided by said treatment device in said IMD, each in accordance with a different hierarchy.

46. The apparatus defined in claim 1, wherein at least one command station further comprises:

a command station receiving device, coupled to said command station processor, for receiving said at least one first medical information signal representing said patient medical data; and

a display device, coupled to said command station processor, for displaying a representation of said data;

wherein said first T/R device is operative to transmit said at least one first medial information signal to said least one command station;

thereby to provide medical information to guide a human person inputting hierarchy setting commands.

47. The apparatus defined in claim 46, wherein said command station processor is further operative to determine a control hierarchy based on said received information signals, and to cause said command station transmitting device to transmit information representing said hierarchy to said IMD.