Implantable medical device which may be controlled from central station

• US 9,095,727 B2
• Filed: 08/12/2014
• Issued: 08/04/2015
• Est. Priority Date: 08/10/2006
• Status: Active Grant

• Current Assignee: Jeffrey A. Matos
• Original Assignee: Jeffrey A. Matos
• Inventors: Matos, Jeffrey A.
• Primary Examiner(s): Wieland, Robert N
• Application Number:
  US14/457,944
• Publication Number:
  US 20150039054A1
• Time in Patent Office: 357 Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37276 characterised by means for reducing power consumption during telemetry
• CPC Class Codes: A61N 1/37282 characterised by communication with experts in remote locations using a network
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: A61N 1/3987 characterised by the timing or triggering of the shock

Abstract

An implantable medical device (IMD) comprises a transmitting/receiving (T/R) device for transmitting medical data sensed from a patient to, and for receiving control signals from, a medical expert (a human medical professional and/or a computerized expert system) at a remote location; an electronic medical treatment device for treating the patient in response to control signals applied thereto; and a sensor circuit, having a sensor circuit output, for producing sensor circuit output signal(s) representing medical data sensed from the patient. The IMD also includes a logic device (processor) which analyzes the sensor circuit output signal(s) to detect a medical abnormality and, upon detecting an abnormality, either sends a notification signal representing a medical state of said patient to the medical expert at the remote location or sends a local treatment device control signal to the medical treatment device, or does both. The medical expert can transmit an external treatment control signal to the IMD to effect patient treatment, if treatment is warranted. To ensure that the medical expert is authorized to provide such treatment, data which identify one or more authorized medical experts is stored in an IMD memory and compared with identification data transmitted from the putative authorized medical expert along with the external treatment control signal. Only if the identification data received from the putative authorized medical expert matches the pre-stored identification data of an originally authorized medical expert does the IMD effect treatment.

Claims

1. Electronic medical apparatus adapted to be implanted in a human patient, a so-called implantable medical device (IMD), which may be alternatively automatically self-controlled and externally controlled by a properly identified medical expert, said apparatus comprising, in combination:

(a) a sensor circuit, having a sensor circuit output, for producing at least one sensor circuit output signal at said sensor circuit output in response to medical data sensed from the patient;

(b) a first transmitting/receiving (“

T/R”

) device for transmitting the medical data sensed from said patient to an external location, and for receiving from said external location at least one external signal representing (i) control information for the IMD, and (ii) incoming identification information (“

III”

) which identifies a source of said control information;

(c) an electronic medical treatment device for treating said patient;

(d) a memory device, for storing identification information indicating allowed sources of said control information; and

(e) a first processor coupled to each of

(i) said sensor circuit output,

(ii) said first T/R device,

(iii) said treatment device, and

(iv) said memory device;

for

(i) analysis of said at least one sensor circuit output signal,

(ii) generating an external station notification signal,

(iii) generating at least one local treatment device control signal,

(iv) generating at least one external treatment device control signal representing said control information;

(v) comparing said III with said stored identification information (“

SII”

), and

(vi) indicating an identification (“

ID”

) match upon a determination that said III and said SII are substantially similar; and

wherein;

(1) said first processor analyzes said at least one sensor circuit output signal to detect a medical abnormality which requires notification of the medical expert at the external location, and is operative to generate a notification signal representing at least one medical state of the patient for consideration by said medical expert when said analysis reveals said medical abnormality;

(2) upon receipt of said notification signal, said first T/R device transmits said notification signal to the external location;

(3) said first processor analyzes said at least one sensor circuit output signal to detect a medical abnormality which requires treatment and is operative to generate at least one local treatment device control signal, if required;

(4) upon the determination of said ID match, said first processor is operative to generate at least one external treatment device control signal in response to the control information represented by said at least one external signal received from the external location by said first T/R device; and

(5) said treatment device delivers therapy, if required, in response to one of said at least one local treatment device control signal and said at least one external treatment device control signal; and

whereby;

(1) said processor determines whether to issue said notification signal, to issue said at least one local treatment device control signal, to issue both said notification and said at least one local treatment device control signal, or to issue neither said notification nor said at least one local treatment device control signal, based on said analysis, and

(2) said first processor generates said at least one external treatment device control signal only upon receipt of control information from a properly identified source of control.

2. The apparatus defined in claim 1, wherein upon generation of both a local treatment device control signal and an external treatment device control signal, said treatment device provides the treatment specified by said external treatment device control signal.

3. The apparatus defined in claim 1, wherein upon generation of both a local treatment device control signal and an external treatment device control signal, said treatment device provides the treatment specified by said local treatment device control signal.

4. The apparatus defined in claim 1, wherein said first processor is further operative to receive an instruction specified by said control information specifying which of said local and said external treatment device control signal shall determine the treatment provided if both said local and said external treatment device control signals are generated.

5. The apparatus defined in claim 1, wherein said III includes information which identifies a control device which is the source of said received III.

6. The apparatus defined in claim 1, wherein said III includes information which identifies a human medical expert which is the source of said control information.

7. The apparatus defined in claim 6, wherein:

(a) each of said control information and said III are inputted by a camera and transmitted to said first T/R device, said camera being configured to generate at least one composite image which includes both (1) an act of said human medical expert selecting a treatment selection, and

(2) a unique identifying feature of said human;

said treatment selection indicating a treatment choice selected from a plurality of possible treatment choices;

(b) said SII represents at least one unique visual feature of at least one human allowed to input said treatment selection; and

(c) said first processor is further operative to;

(1) determine said III based on a first analysis of said composite image, and to

(2) determine said treatment selection based on a second analysis of said composite image; and

(3) generate said at least one external treatment device control signal representing said determined treatment selection, if said III is substantially similar to said SII;

whereby said control information represented by said composite image generates said at least one external treatment device control signal if said III represented by said composite image is substantially similar to said SII.

8. The apparatus defined in claim 6, wherein:

(a) each of said control information and said III are inputted by a camera and transmitted to said first T/R device, said camera being configured to generate as “

composite III”

at least one composite image which includes an act of said human medical expert selecting a particular treatment selection, said image including both (1) said particular treatment selection and (2) a unique identifying feature of said person, said treatment selection indicating a treatment choice selected from a plurality of possible treatment choices;

(b) said memory device is operative to store as composite SII, information representing composite images, each image showing an act of a treatment selection including (1) said particular treatment selection; and

(2) a unique identifying feature of a particular human allowed to input a particular treatment selection, and

(c) said first processor is further operative to

(1) determine said treatment selection based on an analysis of said composite image;

(2) compare said composite III with said composite SII and to determine said ID match if (i) said composite III and (ii) said composite SII are substantially similar; and

(3) generate said at least one external treatment device control signal representing said determined treatment selection, if said composite III is substantially similar to said composite SII;

whereby said control information represented by said composite image generates said at least one external treatment device control signal if said composite III represented by said composite image is substantially similar to said composite SII.

9. The apparatus defined in claim 6, wherein:

(a) each of said control information and said III are inputted by a camera and transmitted to said first T/R device, said camera being configured to generate as “

composite III”

at least one composite image which includes an act of said human medical expert selecting a particular treatment selection, said image including both (1) said particular treatment selection and (2) a unique identifying feature of said human;

said treatment selection indicating a treatment choice selected from a plurality of possible treatment choices;

(b) said memory device is operative to store as “

composite SII”

information representing composite images, each image showing an act of a treatment selection including (1) said particular treatment selection; and

(2) a unique identifying feature of a particular human allowed to input a particular treatment selection, and

(c) said first processor is further operative to

(1) compare said composite III with composite SII and to determine both (i) said ID match, and (ii) said treatment selection, based on a determination of a substantial similarity between said III and at least one particular composite SII representing both;

(A) a particular allowed person and

(B) a particular treatment selection;

(2) generate said at least one external treatment device control signal representing said treatment selection, if said composite III is substantially similar to said stored III;

whereby said control information represented by said composite image generates said at least one external treatment device control signal if said composite III represented by said composite image is substantially similar to said composite SII.

10. The apparatus defined in claim 6, wherein:

(a) said control information is a treatment selection indicating a treatment choice by said human medical expert, selected from a plurality of possible treatment choices, inputted by a keypad and transmitted to said first T/R device;

(b) said III is inputted by a camera and transmitted to said first T/R device, said camera being configured to generate as “

composite III”

at least one composite image which includes both (1) an act of said human medical expert selecting said treatment selection, and (2) a unique identifying feature of said human;

(c) said memory device is operative to store as “

composite SII”

information representing composite images, each image showing an act of a treatment selection including (1) said particular treatment selection, and (2) a unique identifying feature of a particular human allowed to input a particular treatment selection; and

(d) said first processor is further operative to;

(1) compare said composite III with composite SII and to determine both (i) said ID match, and (ii) an image-based treatment selection, based on a determination of a substantial similarity between said composite III and at least one particular composite SII representing both;

(A) a particular allowed person and

(B) a particular treatment selection;

(2) determine a key pad-based treatment selection based on said received control information;

(3) determine an input match, indicating that said treatment selection was inputted to said keypad by the same human that inputted said III to said camera if said key pad-based treatment selection and said image-based treatment selection are identical; and

(4) generate said at least one external treatment device control signal representing said determined treatment selection, if (A) said III is substantially similar to said SII and (B) said first processor determines said input match;

whereby said control information inputted via said keypad generates said at least one external treatment device control signal if both said ID match and said input match are determined.

11. The apparatus defined in claim 6, wherein:

(a) said control information is a treatment selection indicating a treatment choice by said human medical expert, selected from a plurality of possible treatment choices, inputted by a keypad and transmitted to said first T/R device;

(b) said III is inputted by a camera and transmitted to said first T/R device, said camera being configured to generate at least one composite image which includes both (1) an act of said human medical expert selecting said treatment selection, and (2) a unique identifying feature of said human;

(c) said SII represents at least one unique visual feature of at least one human allowed to input said treatment selection; and

(d) said first processor is further operative to;

(1) determine said III based on an analysis of said composite image;

(2) determine said treatment selection based on said received control information;

(3) determine an input match, indicating that said treatment selection was inputted by the same human that inputted said III to said camera; and

(4) generate said at least one external treatment device control signal representing said determined treatment selection, if (A) said III is substantially similar to said SII and (B) said first processor determines said input match;

whereby said control information inputted via said keypad generates said at least one external treatment device control signal if both said ID match and said input match are determined.

12. The apparatus defined in claim 11, wherein said first processor is further operative to:

(a) determine an image-based treatment selection based on analysis of said composite image; and

(b) determine said input match if said treatment selection inputted to said keypad is identical to said image-based treatment selection.

13. The apparatus defined in claim 6, wherein:

(a) each of said control information and said III are inputted by a camera and transmitted to said first T/R device, said camera being configured to generate at least one composite image which includes an act of said human medical expert inputting said control information, said image including each of;

(1) a body part of said human in the act of selecting a treatment choice from among a plurality of treatment choices,

(2) a unique identifying feature of said human, and

(3) each visible contiguous body part lying between said selecting body part (1) and said identifying body part (2);

(b) said first processor is further operative to determine an absence of at least one of said contiguous body parts in said composite image; and

(c) upon determination of said absence, said first processor is further operative to prevent the determination of said ID match.

14. The apparatus defined in claim 1, further comprising a control device, said control device comprising:

(a) a control transmitting device for transmitting signals to said first T/R device;

(b) at least one input device for inputting

(i) said control information, and

(ii) said incoming identification information; and

(c) a second processor, coupled to said control transmitting device and to said at least one input device for causing said control transmitting device to transmit said control information and said incoming identification information to said first T/R device;

wherein said input device is configured to input identification information of a human medical expert who inputs said control information.

15. The apparatus defined in claim 14, wherein one input device is operative to input both said control information and said incoming identification information.

16. The apparatus defined in claim 14, comprising at least one input device for inputting said control information and at least one other input device for inputting said identification information.

17. The apparatus defined in claim 16, wherein said device for inputting control information is a keypad, and said device for inputting identification information is a camera.

18. The apparatus defined in claim 14, wherein said control device further comprises:

(d) a control receiving device, coupled to said second processor, for receiving a notification signal from said first T/R device, and

(e) a presentation device, coupled to said second processor, for presenting the information represented by said notification signal to said medical expert;

wherein said processor is further operative to cause said presentation device to display said information to said medical expert.

19. The apparatus define in claim 18, wherein said presentation device presents visual information.

20. The apparatus defined in claim 18, wherein said presentation device presents audio information.

21. The apparatus defined in claim 14, wherein at least one input device is a camera configured to generate at least one image representing identification information of a human medical expert providing said control information.

22. The apparatus defined in claim 21, wherein said camera is configured to image a fingerprint of a finger of said human medical expert.

23. The apparatus defined in claim 22, wherein said camera is further configured to image said finger inputting said control information which is the source of said fingerprint.

24. The apparatus defined in claim 23, further comprising a keypad, imaged by said camera, for indicating said inputted control information by said finger.

25. The apparatus defined in claim 24, wherein:

(a) said keypad is at least partially transparent;

(b) said camera is situated on a side of said keypad opposite said finger, for imaging the act of said keypad selection including both (i) said fingerprint and (ii) said finger indicating said keypad selection; and

(c) said control information represents said keypad selection.

26. The apparatus defined in claim 24, wherein said keypad is further operative to generate a signal indicating said control information.

27. The apparatus defined in claim 24, wherein said keypad comprises a touch-sensitive screen.

28. The apparatus defined in claim 24, wherein said keypad is a virtual keypad.

29. The apparatus defined in claim 24, wherein said keypad is a mechanical keypad.

30. The apparatus defined in claim 21, wherein said camera is configured to image an iris of an eye of said human medical expert.

31. The apparatus defined in claim 21, wherein said camera is configured to image a retina of an eye of said human medical expert.

32. The apparatus defined in claim 21, wherein said camera is configured to image a face of said human medical expert.

33. The apparatus defined in claim 21, wherein said camera is oriented such that each image includes each of:

(a) a body part causing the input of said control information;

(b) a body part displaying said identification information; and

(c) each of the contiguous body parts lying between said inputting body part (a) and said identifying body part (b).

34. The apparatus defined in claim 14, wherein at least one input device is a microphone for inputting audio information.

35. The apparatus defined in claim 14, wherein at least one input device is a keypad, for inputting alphanumeric information.

36. The apparatus defined in claim 1, further comprising an automatic control device, said automatic control device comprising:

(a) an automatic control T/R device for communication with said first T/R device;

(b) a third processor, coupled to said automatic control T/R device for

(A) generating said at least one external signal representing (i) said control information for the IMD, and (ii) said incoming identification information which identifies said automatic control device, in response to said medical data received by said automatic control T/R device from said first T/R; and

(B) causing said automatic control T/R device to transmit said at least one external signal to said first T/R.

37. The apparatus defined in claim 1, wherein upon said determination that said III and said SII are substantially similar, said first processor is further operative (i) to generate a confirmation signal and (ii) to cause said first T/R device to transmit said confirmation signal.

38. The apparatus defined in claim 1, wherein upon a determination by said first processor that said III and said SIT are not substantially similar:

(a) said first processor does not generate said at least one external treatment device control signal in response to said at least one external signal received from the external location by said first T/R device; and

(b) said first processor is operative (i) to generate a non-confirmation signal and (ii) to cause said first T/R device to transmit said non-confirmation signal.

39. The apparatus defined in claim 21, further comprising:

(d) a prompt receiving device, coupled to said second processor, for receiving a prompt signal from said first T/R device, and

(e) a prompt producing device, coupled to said second processor, for producing at least one prompt in response to said prompt signal, said prompt inducing at least one change in the appearance of a visible identifying feature of a human medical expert who wishes to control said IMD;

wherein;

(i) said SII includes a plurality of images of at least one visible identifying feature of at least one registered human medical expert (“

RHME”

) who is allowed to control said IMD;

(ii) said first processor is further operative to produce at least one prompt signal for transmission to said prompt producing device;

(iii) said camera is operative to repeatedly generate images of said visible identifying feature of said human medical expert;

(iv) said first processor is further operative to;

(A) compare each of said repeated images of said identifying feature of said human medical expert with said SII to verify the identity of the human medical expert; and

(B) indicate said ID match only if both;

(1) the III is substantially similar to said SII prior to the transmission of said prompt signal, and

(2) the III is substantially similar to said SII after the transmission of said prompt signal;

thereby to verify that the human medical expert is the same individual as one of said at least one RHME, or to determine that the human medical expert is not the same individual as any one of said at least one RHME.

40. The apparatus defined in claim 39, wherein

(i) said prompt producing device is a light source, located in proximity to said human medical expert and arranged to provide light which impinges on a visible feature of said human medical expert;

and

(ii) said prompt is an instruction which causes said prompt producing device to alter the light output of said device.

41. The apparatus defined in claim 40, wherein

(i) said SII comprises a plurality of images of an iris of a RHME, obtained during each of a plurality of lighting conditions;

(ii) said prompt producing device is arranged to provide light which impinges on an eye of said human medical expert, for altering the anatomic configuration of a respective iris of said eye;

(iii) said control transmitting device is operative to transmit at least one of said images of said iris to said IMD before and after the transmission of said prompt;

(iv) said first processor is operative to compare the received iris images before the transmission of said prompt with said SII;

(v) said first processor is further operative to compare the received iris images after the transmission of said prompt with said SII; and

(vi) said first processor is operative to indicate said ID match if both said comparisons indicate an ID match.

42. The apparatus defined in claim 40, wherein

(i) said SII comprises a plurality of images of a visible anatomic feature of a RHME, obtained during each of a plurality of lighting conditions;

(ii) said prompt producing device is arranged to provide light which impinges on said anatomic feature of said human medical expert, for altering a lighting condition which determines the appearance of said anatomic feature;

(iii) said control transmitting device is operative to transmit at least one of said images of said anatomic feature to said IMD before and after the transmission of said prompt;

(iv) said first processor is operative to compare the received images before the transmission of said prompt with said SII;

(v) said first processor is further operative to compare the received images after the transmission of said prompt with said SII; and

(vi) said first processor is operative to indicate said ID match if both said comparisons indicate an ID match.

43. The apparatus defined in claim 39, wherein

(i) said SII comprises a plurality of images of a visible anatomic feature, whose appearance is subject to voluntary alteration by said human medical expert;

(ii) said prompt producing device is arranged to provide an instruction to said human medical expert to execute said alteration;

(iii) said control transmitting device is operative to transmit at least one of said images of said anatomic feature to said IMD before and after the transmission of said prompt;

(iv) said first processor is operative to compare the received images before the transmission of said prompt with said SII;

(v) said first processor is further operative to compare the received images after the transmission of said prompt with said SIT; and

(vi) said first processor is operative to indicate said ID match if both said comparisons indicate an ID match.

44. The apparatus defined in claim 39, wherein said prompt producing device is configured to provide an instruction requiring said human medical expert to speak.

45. The apparatus defined in claim 39, wherein said prompt producing device is configured to provide a painful stimulus to said human medical expert.

46. A method of controlling an electronic medical apparatus adapted to be implanted in a human patient, a so-called implantable medical device (IMD), which may treat a medical condition in a patient following the detection by said device of an abnormality, which may be alternatively (A) automatically self-controlled by said IMD and (B) externally controlled by a properly identified medical expert, said method comprising the steps of:

(1) at said IMD, storing identification information pertaining to a medical expert permitted to control an IMD implanted in a patient;

(2) at said IMD, monitoring signals which contain information about at least one medical state in said patient and producing medical condition signals representative of said state;

(3) at said IMD, detecting a medical abnormality which may require treatment, based on said signals;

(4) upon detection of said medical abnormality, determining at said IMD whether said treatment is to be selected (A) automatically by said IMD or (B) by said medical expert;

(5) if said determination is for said IMD-selected automatic treatment, automatically selecting and administering said treatment at said IMD, if treatment is warranted;

(6) if said determination is for selection of treatment by said medical expert;

(a) transmitting information from said IMD concerning said medical abnormality to said medical expert;

(b) receiving said information for review by said medical expert;

(c) said medical expert selecting the treatment of said medical abnormality, if treatment is warranted;

(d) said medical expert transmitting to said IMD (i) at least one treatment control signal, and (ii) information identifying said medical expert, if treatment is warranted; and

(e) at said IMD, receiving said at least one treatment control signal and said incoming identification information (“

III”

);

(f) at said IMD, comparing said III with said stored identification information (“

SII”

);

(g) at said IMD, administering said medical expert-selected treatment, in response to said at least one treatment control signal, if said comparison indicates that said III is substantially similar to said SII.

47. A method of controlling an electronic medical apparatus adapted to be implanted in a human patient, a so-called implantable medical device (IMD), which may treat a medical condition in a patient following the detection by said device of an abnormality, which may be alternatively (A) automatically self-controlled by said IMD and (B) controlled by a medical expert, said method comprising the steps of:

(1) at said IMD, storing identification information pertaining to a medical expert permitted to control said IMD;

(2) at said IMD, monitoring information about at least one medical state in a patient and producing at least one medical condition signal representative of said medical state;

(3) at said IMD, detecting a first apparent medical abnormality which may require treatment, based on said at least one medical condition signal;

(4) at said IMD, upon detection of said first apparent medical abnormality, transmitting said at least one medical condition signal to a medical expert;

(5) at said IMD, detecting a second apparent medical abnormality which may require treatment, based on said at least one medical condition signal, and, upon detection of said second apparent medical abnormality generating a local treatment control signal;

(6) at said IMD, in the absence of a received external treatment control signal, administering a first treatment to said patient specified by said local treatment control signal, if any;

(7) said medical expert receiving said at least one medical condition signal and making a determination of whether treatment is warranted based on said at least one received medical condition signal and, if said treatment is warranted, transmitting at least one external treatment control signal to said IMD, said at least one external treatment control signal representing (A) a second treatment to be administered by said IMD and (B) identification information of said medical expert;

(8) at said IMD, receiving said at least one external treatment control signal and comparing said incoming identification information with said stored identification information; and

(9) at said IMD, if said second treatment is different from said first treatment, and if said comparison indicates that said incoming identification information is substantially similar to said stored identification information, administering said second treatment to said patient.