Systems and methods for patient control of stimulation systems

• US 20070270921A1
• Filed: 02/28/2007
• Published: 11/22/2007
• Est. Priority Date: 05/17/2006
• Status: Active Grant

• Current Assignee: Medtronic Urinary Solutions, Inc. (Medtronic Plc)
• Original Assignee: NDI Medical, Inc. (Medtronic Plc)
• Inventors: Strother, Robert B., Bennett, Maria E., Mrva, Joseph J., Thierfelder, Christopher A., Thrope, Geoffrey B., Pack, Danny R., Rubin, Stuart F., Barber, James E.
• Granted Patent: US 9,480,846 B2
• Time in Patent Office: Days
• US Class Current: 607/60
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37223 Circuits for electromagnetic coupling
• 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 1/37264 Changing the program; Upgrading firmware
• CPC Class Codes: A61N 1/3787 from an external energy source
• CPC Class Codes: G08C 17/02 using a radio link
• CPC Class Codes: G08C 2201/11 Energy harvesting
• CPC Class Codes: G08C 2201/30 User interface
• CPC Class Codes: H02J 50/20 using microwaves or radio frequency waves
• CPC Class Codes: H02J 50/90 involving detection or optimisation of position, e.g. alignment
• CPC Class Codes: H04W 4/06 Selective distribution of broadcast services, e.g. multimedia broadcast multicast service [MBMS]; Services to user groups; One-way selective calling services

Abstract

Provided is a portable controller and associated method that provides a patient or caregiver the ability to recharge and alter the parameters of an implanted medical device, while allowing the patient substantially unobstructed mobility. To enable mobility, the controller may be worn on a belt or clothing. The controller also allows the patient to turn device stimulation on and off, check battery status, and to vary stimulation parameters within ranges that may be predefined and programmed by a clinician. The controller communicates with the medical device to retrieve information and make parameter adjustments using wireless telemetry, and it can send and receive information from several feet away from the implanted medical device. Charging of a battery contained in the implanted medical device is achieved via an inductive radio frequency link using a charge coil placed in close proximity to the medical device.

Claims

1. A portable controller for recharging and communicating with an implanted medical device, the medical device adapted for non-inductive radio frequency (RF) wireless communications in VHF and UHF frequency ranges, the medical device including an adjustable parameter, the adjustable parameter having a first number of settings, the controller comprising:

a. a shell;

b. an electronic circuit at least partially disposed in the shell, the electronic circuit comprising

i. a recharging module adapted to recharge a rechargeable power supply of the medical device, and

ii. a telemetry module adapted for non-inductive radio frequency (RF) wireless communications with the medical device over a distance,

the electronic circuit adapted to adjust the adjustable parameter to one of a second number of settings, the second number being less than the first number; and

c. a user interface operative through the shell and providing interaction with the electronic circuit.

2. A portable controller according to claim 1, wherein the recharging module is contained in the shell.

3. A portable controller according to claim 1, wherein the distance is up to at least six feet.

4. The portable controller of claim 1, further comprising a port extending through the shell, the port in electrical communication with the electronic circuit.

5. The portable controller of claim 4, wherein the port is keyed.

6. The portable controller of claim 4, further comprising an accessory having a plug electrically coupled to the port.

7. The portable controller of claim 6, wherein the accessory plug is keyed.

8. The portable controller of claim 6, wherein the accessory is the recharging module.

9. The portable controller of claim 6, wherein the accessory is an alternating current (AC) power adaptor.

10. The portable controller of claim 1, wherein the user interface comprises a user input interface.

11. The portable controller of claim 10, wherein the user input interface comprises a plurality of buttons.

12. The portable controller of claim 11, wherein the user input interface comprises no more than five buttons.

13. The portable controller of claim 1, wherein the user interface comprises a user output interface.

14. The portable controller of claim 13, wherein the user output interface comprises a liquid crystal display.

15. The portable controller of claim 13, wherein the user output interface comprises at least one light-emitting diode.

16. The portable controller of claim 13, wherein the user output interface comprises an audible tone.

17. The portable controller of claim 10, wherein the user interface further comprises a user output interface.

18. The portable controller of claim 1 wherein the shell comprises:

a. a base having a bottom surface and sidewalls extending therefrom, the sidewalls having an upper edge defining a base perimeter;

b. a bezel secured to the base adjacent the base perimeter; and

c. a protective lens secured to the bezel.

19. The portable controller of claim 1, wherein the shell is about 7 centimeters long, about 4 centimeters wide and about 1 centimeter thick.

20. A method for communicating with an implanted medical device, the method comprising the steps of:

a. providing a portable communicative device having a user input interface and a user output interface, said communicative device capable of non-inductive radio frequency (RF) communication;

b. supplying electric power to the portable communicative device;

c. activating the portable communicative device;

d. broadcasting a wireless communication message from the portable communicative device;

e. receiving a wireless communication response from the implanted medical device; and

f. indicating a status of the implanted medical device on the user output interface.

21. The method of claim 20, wherein the activating step is carried out through the user input interface.

22. The method of claim 20, wherein the broadcasted message contains a predetermined medical device identifier.

23. A method for detecting proper positioning of a transcutaneous recharger for an implanted medical device the method comprising the steps of:

a. providing a handheld controller including a recharging module and a telemetry module;

b. positioning the recharging module proximate the implanted medical device;

c. transmitting a radio frequency magnetic field from the recharging module; and

d. indicating the proximity between the recharging module and the implanted medical device.

24. A method for treating a patient having an implanted medical device, said medical device adapted for non-inductive radio frequency (RF) wireless communications in VHF and UHF frequency ranges, said medical device including an adjustable parameter, said adjustable parameter having a first number of settings, the method comprising the steps of:

a. developing a treatment regimen;

b. programming the adjustable parameter for use in the regimen; and

c. providing to the patient a portable controller adapted to adjust the adjustable parameter to one of a second number of settings, the second number being less than the first number.

25. A controller kit comprising

a. packaging;

b. a portable controller adapted for non-inductive radio frequency (RF) wireless communications with an implantable medical device, the controller disposed in the packaging; and

c. a power adaptor mateable with the controller, the power adaptor disposed in the packaging.

26. The controller kit of claim 25, further comprising a set of user instructions disposed in the packaging.

27. The controller kit of claim 25, further comprising a set of clinician instructions disposed in the packaging.

28. The controller kit of claim 25, further comprising a controller carrying case disposed in the packaging.

29. The controller kit of claim 25, further comprising record media.

30. The controller kit of claim 25, further comprising a charging coil.

31. The controller kit of claim 25, further comprising a second portable controller, the second protable controller adapted for non-inductive radio frequency (RF) wireless communications with the implantable medical device, the second controller disposed in the packaging.

32. The controller kit of claim 25, further comprising a magnet adapted for transcutaneous control of the implantable medical device.

33. The controller kit of claim 25, wherein the packaging is sealed substantially air-tight about the controller and adaptor.