Systems and methods for implantable leadless bone stimulation

• US 8,078,283 B2
• Filed: 06/18/2007
• Issued: 12/13/2011
• 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:
  US11/764,561
• Publication Number:
  US 20070293912A1
• Time in Patent Office: 1,639 Days
• Field of Search: 607/51
• US Class Current: 607/51
• CPC Class Codes: A61N 1/326 for promoting growth of cells, e.g. bone cells
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36038 Cochlear stimulation
• CPC Class Codes: A61N 1/3604 for correcting spinal deformities, e.g. scoliosis
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

Systems and methods are disclosed to enhance bone growth by stimulating bone sites for bone regrowth, fusion, or grafts. The invention uses electrical stimulation of the bone site, 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 bone site. The vibrational energy is generated by a controller-transmitter, which could be located either externally or implanted. The vibrational energy is received by a receiver-transmitter, which could be incorporated into an orthopedic device, such as pin, cage, plate or prosthetic joint used for bone healing.

Claims

1. A method for bone stimulation therapy comprising:

implanting a bone attachment device at a bone healing site, wherein a receiver-stimulator is housed within the bone attachment device;

generating acoustic energy using a controller-transmitter, wherein the controller-transmitter comprises one or more sensors;

receiving the acoustic energy by means of the receiver stimulator;

converting the received acoustic energy into electrical bone stimulation energy using the receiver stimulator based on energy and signal information included in the generated acoustic energy;

wherein the bone attachment device comprises one or more stimulation electrodes connected to the receiver stimulator, such that the stimulation electrodes lie in electrical communication with the bone healing site, and the bone healing site is chosen to treat for bone regrowth, bone repair, fusion of bones, or fusion of bone grafts;

delivering the electrical bone stimulation energy to the bone healing site using the one or more stimulation electrodes;

sensing the electrical bone stimulation energy, wherein the sensors are adapted to sense the electrical bone stimulation energy; and

adjusting the acoustic energy generated by the controller-transmitter to compensate for changes in the electrical bone stimulation energy.

2. A method of claim 1 wherein the controller transmitter is externally located.

3. A method of claim 1, wherein the sensors are configured to detect one or more physiological parameters.

4. A method of claim 1, wherein the controller-transmitter comprises a hermetically sealed housing and wherein the one or more sensors are disposed at least partly within the housing.

5. A method of claim 4, wherein the one or more sensors have a portion within the housing and a portion external to the housing.

6. A method of claim 4 or 5, wherein the one or more sensors are directly connected to a signal processing circuitry of the controller-transmitter.

7. A method of claim 1, further comprising:

using an external programmer to program one or more settings of the controller-transmitter.

8. A method of claim 7, wherein the external programmer transmits a radiofrequency signal and the controller-transmitter comprises circuitry for receiving the radiofrequency signal.

9. A method of claim 1, wherein the receiver-stimulator consists essentially of an ultrasound transducer which generates a stimulation signal in response to the acoustic energy transmitted by the controller-transmitter, circuitry which rectifies the stimulation signal, and wherein the one or more stimulation electrodes deliver the rectified signal to bone tissue.

10. A method of claim 1, wherein the bone attachment device is a screw, rod, pin, cage, plate, prosthetic joint, or bone graft.