SIMPLE CONTROL OF COMPLEX BIO-IMPLANTS

• US 20170246465A1
• Filed: 06/23/2016
• Published: 08/31/2017
• Est. Priority Date: 06/24/2015
• Status: Active Grant

• Current Assignee: Impulse Dynamics NV
• Original Assignee: Tylerton International Inc.
• Inventors: Ben-Haim, Shlomo, Prutchi, David, Ben-Haim, Yuval
• Granted Patent: US 10,188,866 B2
• Time in Patent Office: Days
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 60/148 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• CPC Class Codes: A61M 60/178 drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
• CPC Class Codes: A61M 60/20 Type thereof
• CPC Class Codes: A61M 60/508 Electronic control means, e.g. for feedback regulation
• CPC Class Codes: A61M 60/515 Regulation using real-time patient data
• CPC Class Codes: A61N 1/025 Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36128 Control systems
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/362 Heart stimulators heart defibrillators A61N1/39
• CPC Class Codes: A61N 1/37254 Pacemaker or defibrillator security, e.g. to prevent or inhibit programming alterations by hackers or unauthorised individuals
• 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 2/00 Magnetotherapy
• CPC Class Codes: A61N 2/008 for pain treatment or analgesia
• CPC Class Codes: A61N 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092
• CPC Class Codes: G05B 15/02 electric
• 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 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16H 40/67 : for remote operation

Abstract

Methods and devices for tying management of an implantable medical device to the activities of a primary care physician are described, including access control, simplified parameter optimization, support for tuning a device in response to the effects of other treatments in parallel, and support for helping a primary physician and a patient work together to tune device configuration to the activity and performance needs of the patient. In some embodiments, a medical device is self-configuring in a device parameter domain, based on inputs provided in a patient performance domain. The self-configuring of the medical device is based, for example, on an automatically applied transformation of inputs derived from patient performance domain observations into changes in the configuration of the medical device which affect technical parameters of its operation.

Claims

1. A method of adjusting the operation of an implantable medical device, comprising:

receiving access to selectively activate from among a plurality of technical parameter sets preconfigured for use with the implantable medical device, wherein the parameter sets are ordered according to their effect on a clinical parameter affected by operation of the device;

monitoring the response of the clinical parameter to activation of a first of the preconfigured parameter sets ordered between at least two others of the preconfigured parameter sets; and

activating one of the other two preconfigured parameter sets, based on the ordering of the parameter sets, the monitoring of the clinical parameter and a clinical target for the clinical parameter.

2. The method of claim 1, wherein receiving access comprises presenting the device with an access token accepted by the device.

3. The method of claim 1, wherein the plurality of technical parameter sets was preconfigured after implantation of the implantable medical device within a patient.

4. The method of claim 1, wherein the clinical parameter comprises a clinical measure of patient performance.

5. The method of claim 1, wherein the clinical parameter comprises self-reported patient performance.

6. The method of claim 1, wherein the parameter sets are ordered according to a therapeutic effect of the device.

7. The method of claim 1, wherein the parameter sets are ordered according to a side-effect of the device.

8. The method of claim 1, wherein the implantable medical device is a stimulator configured for cardiac contractility modulation.

9. The method of claim 1, wherein the implantable medical device is a stimulator configured for gastric contractility modulation.

10. The method of claim 1, wherein the implantable medical device is an implanted pulse generator configured for central nervous system stimulation.

11. The method of claim 1, wherein the implantable medical device is a stimulator configured for cardiac resynchronization therapy.

12. The method of claim 1, wherein the plurality of technical parameter sets are configured by a device implantation specialist, and the receiving access is by a primary medical care provider.

13. The method of claim 1, wherein the preconfigured parameter sets are stored by the implantable medical device.

14. The method of claim 1, comprising continued monitoring of the response of the clinical parameter, and activating of other parameter sets based on the ordering of the parameter sets and as indicated by the state of the monitored clinical parameter relative to the clinical target.

15. The method of claim 14, wherein the continued monitoring ends when the clinical parameter reaches the clinical target.

16. An implantable medical device system supporting configuration by a primary care physician, comprising:

a data store configured to receive and store a plurality of inactive technical parameter sets for use with the implantable medical device; and

a selection interface for selecting from among the inactive technical parameter sets and activating at least one of them;

wherein the implanted medical device provides access allowing parameter set activation based on recognition of an access key.

17. The implantable medical device system of claim 16, wherein the data store indexes the technical parameter sets according to a parameter of their effect on patient performance, and the selection interface presents inactive technical parameter sets for selection according to the index.

18. The implantable medical device system of claim 16, wherein the data store is integrated with the implanted medical device.

19. The implantable medical device system of claim 16, wherein the access key does not give access to modify the inactive technical parameter sets of the data store.

20. The implantable medical device system of claim 16, wherein the access key comprises an alphanumerically represented key.

21. The implantable medical device system of claim 16, wherein the access key comprises a cryptographic key.

22. The implantable medical device system of claim 16, wherein the access key comprises a charger device.

23. The implantable medical device system of claim 16, wherein the access key comprises the data store.

24. The implantable medical device system of claim 16, wherein operation of the selection interface comprises entering data about the operation of another implantable medical device of the patient.

25. The implantable medical device system of claim 16, wherein operation of the selection interface comprises entering data about a medicament prescription of the patient.

26. An implantable medical device configured to convert from an unmanaged post-implantation state to a managed post-implantation state upon activation of a state changing function by a primary care physician, wherein the managed post-implantation state allows activation of a treatment function not available in the unmanaged post-implantation state.

27. The implantable medical device of claim 26, wherein the activation comprises presenting an access key to the implantable medical device.

28. The implantable medical device of claim 26, wherein the activation comprises activating a channel reserved for use by a primary care physician.

29. The implantable medical device of claim 28, wherein the device provides an access key to the physician upon activation of the channel, and thereafter allows activation of the treatment function based on presentation of the access key.