Systems and methods for implantable leadless gastrointestinal tissue stimulation

• US 8,494,637 B2
• Filed: 01/18/2011
• Issued: 07/23/2013
• Est. Priority Date: 06/20/2006
• Status: Active Grant

• Current Assignee: EBR Systems, Inc.
• Original Assignee: EBR Systems, Inc.
• Inventors: Cowan, Mark W., Riley, Richard E., Brisken, Axel F., Echt, Debra S.
• Primary Examiner(s): Bertram, Eric D.
• Application Number:
  US13/008,521
• Publication Number:
  US 20110112600A1
• Time in Patent Office: 917 Days
• Field of Search: 607/40, 607/60
• US Class Current: 607/40
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile

Abstract

Systems and methods are disclosed to stimulate gastrointestinal tissue to treat medical conditions such as eating disorders, gastroparesis, and gastric reflux. The invention uses electrical stimulation of the nerve, where vibrational energy from a source is received by an implanted device and converted to electrical energy and the converted electrical energy is used by implanted electrodes to stimulate the pre-determined gastrointestinal tissue site. The vibrational energy is generated by a controller-transmitter, which could be implanted or located externally. The vibrational energy is received by a receiver-stimulator, which could be located in the various regions on or around the gastrointestinal tissue that needs to be stimulated. The implantable receiver-stimulator stimulates different gastrointestinal tissue to provide the desired therapeutic benefit.

Claims

1. A system for gastrointestinal tissue stimulation therapy, said system comprising:

an acoustic controller-transmitter configured to transmit acoustic energy wherein the controller-transmitter comprises acoustic transducers disposed in a housing and one or more sensors disposed on an external surface of the housing, and wherein the one or more sensors are configured to detect an electrical stimulation output and wherein the acoustic energy contains both energy and signal information; and

an implantable acoustic receiver-stimulator having a stimulation electrode assembly adapted to be in direct contact with gastrointestinal tissue, wherein the receiver-stimulator is configured to receive and convert the acoustic energy into the electrical stimulation output delivered to the gastrointestinal tissue by the stimulation electrode assembly;

wherein the controller-transmitter is configured to sense the electrical stimulation output of the receiver-stimulator using one or more of the sensors; and

adjust energy transmission accordingly in order to compensate for changes in electrical stimulation output of the receiver-stimulator.

2. The system as in claim 1, wherein the receiver-stimulator comprises an acoustic receiver which receives acoustic energy and generates alternating current, means for converting the alternating current to a pre-determined waveform, and the stimulation electrode assembly adapted to deliver the pre-determined waveform to stimulate the gastrointestinal tissue.

3. The system as in claim 2, wherein the implantable receiver-stimulator is adapted to be located in close proximity to the gastrointestinal tissue stimulation site.

4. The system as in claim 2, wherein the implantable receiver-stimulator is adapted to be located at a predetermined gastrointestinal tissue stimulation site, and stimulate the gastrointestinal tissue site for achieving a therapeutic effect, wherein said predetermined gastrointestinal tissue stimulation site is selected for treating one or more medical conditions chosen from the list comprising eating disorders, gastroparesis, and gastric reflux.

5. The system as in claim 1, wherein the controller-transmitter comprises a power source, control and timing circuitry to provide a stimulation signal, means for converting the stimulation signal to an acoustic energy signal, and means for transmitting the acoustic energy signal to the receiver-stimulator.

6. The system as in claim 5, wherein the controller-transmitter is adapted to be implantable.

7. The system as in claim 5, wherein control circuitry includes one or more means for sensing physiologic variables in order to adjust stimulation with one or more parameters chosen from pulse amplitude, pulse duration, duty cycle, or timing.

8. The system as in anyone of claims 3-5, further comprising at least one additional receiver-stimulator device.

9. The system as in claim 8, wherein, the system is programmed to activate the receiver-stimulator devices sequentially.

10. The system as in claim 8, wherein the system is programmed to activate the receiver-stimulator devices simultaneously.

11. The system as in claim 1, adapted to transmit and receive acoustic energy wherein the frequency of the acoustic energy is between 20 kHz and 10 MHz, the burst length is between 3 cycles and a continuous burst, the duty cycle is between 0.01% and 100.00%, and the mechanical index is less than 1.9.