Systems and methods for positioning implanted devices in a patient

• US 8,965,482 B2
• Filed: 09/30/2010
• Issued: 02/24/2015
• Est. Priority Date: 09/30/2010
• Status: Active Grant

• Current Assignee: Nevro Corporation
• Original Assignee: Nevro Corporation
• Inventors: Thacker, James R., Parker, Jon, Chitre, Yougandh
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Wu, Eugene
• Application Number:
  US12/895,403
• Publication Number:
  US 20120083856A1
• Time in Patent Office: 1,608 Days
• Field of Search: 600/424, 607/60, 607/116, 607/117
• US Class Current: 600/424
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/2072 Reference field transducer attached to an instrument or patient
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 2560/045 with a separable interface unit, e.g. for communication
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 5/063 using impedance measurements
• CPC Class Codes: A61B 5/065 Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
• CPC Class Codes: A61B 5/066 Superposing sensor position on an image of the patient, e.g. obtained by ultrasound or x-ray imaging
• CPC Class Codes: A61B 5/407 Evaluating the spinal cord A61B5/4896 takes precedence
• CPC Class Codes: A61B 90/06 Measuring instruments not otherwise provided for
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36128 Control systems
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• CPC Class Codes: A61N 1/37241 providing test stimulations

Abstract

Systems and methods for positioning implanted devices in a patient are disclosed. A method in accordance with a particular embodiment includes, for each of a plurality of patients, receiving a target location from which to deliver a modulation signal to the patient'"'"'s spinal cord. The method further includes implanting a signal delivery device within a vertebral foramen of each patient, and positioning an electrical contact carried by the signal delivery device to be within ±5 mm. of the target location, without the use of fluoroscopy. The method can still further include, for each of the plurality of patients, activating the electrical contact to modulate neural activity at the spinal cord. In further particular embodiments, RF signals, ultrasound, magnetic fields, and/or other techniques are used to locate the signal delivery device.

Claims

1. A patient treatment system, comprising:

a signal delivery system that includes a patient-implantable signal delivery device coupleable to a power source to deliver a neural modulation signal;

a signal transmission system carried by the signal delivery system to transmit a locator signal;

an external signal detector system that is movable relative to the signal delivery device and positionable to detect the locator signal wirelessly through the patient'"'"'s skin, the signal detector system having at least one releasable fixation element positioned to releasably secure at least a portion of the signal detector system to the patient'"'"'s skin;

an insertion tracker positionable to track a length of the signal delivery system inserted into the patient; and

a computer-readable medium containing instructions that when executed;

compare a first inserted length of the signal delivery device based on information received from the external signal detector system and corresponding to a projected length of the signed deliver device in a plane of the external signal detector system, with a second inserted length of the signal delivery device based on information received from the insertion tracker; and

provide an indication when the first and second inserted lengths differ by at least a threshold amount.

2. A patient treatment system, comprising:

a signal delivery system that includes a patient-implantable signal delivery device coupleable to a power source to deliver a neural modulation signal;

a signal transmission system carried by the signal delivery system to transmit a locator signal;

an external signal detector system that is movable relative to the signal delivery device and positionable to detect the locator signal wirelessly through the patient'"'"'s skin, the signal detector system having at least one flexible, conformable, releasable fixation element positioned to releasably secure at least a portion of the signal detector system to the patient'"'"'s skin, wherein the fixation element is conformable to the patient'"'"'s skin;

an insertion tracker positionable to track a length of the signal delivery system inserted into the patient; and

a computer-readable medium containing instructions that when executed;

compare a first inserted length of the signal delivery device based on information received from the external signal detector system and corresponding to a projected length of the signal delivery device in a plane of the external signal detector system, with a second inserted length of the signal delivery device based on information received from the insertion tracker; and

provide an indication when the first and second inserted lengths differ by at least a threshold amount.

3. The treatment system of claim 2 wherein:

the signal delivery device includes;

a patient-implantable, elongated signal delivery lead having an axial opening;

a therapy contact carried by the signal delivery lead; and

a stylet removably received in the axial opening;

the signal transmission system includes a signal emitter carried by the stylet;

the signal detector system has an array of detection elements; and

wherein the system further comprises

a display device operatively coupled to the signal detection elements to present an indication of individual signal strengths received at the corresponding individual signal detection elements.

4. The system of claim 3 wherein the display device is releasably attachable to the patient'"'"'s skin.

5. The treatment system of claim 3 wherein the display device includes a display screen positionable apart from the patient.

6. The treatment system of claim 2, further comprising a display device operable to present an indication of a signal strength detected at the signal detector system.

7. The treatment system of claim 6 wherein the display device is releasably attachable to the patient'"'"'s skin.

8. The treatment system of claim 6 wherein the display device includes a display screen positionable apart from the patient.

9. The treatment system of claim 2 wherein the signal delivery system includes an implanting tool releasably carried by the signal delivery device, and wherein the implanting tool includes a locator signal transmitter.

10. The treatment system of claim 9 wherein the signal delivery device has an aperture, and wherein the implanting tool includes a stylet slideably and releasably received in the aperture of the signal delivery device.

11. The treatment system of claim 2 wherein the external signal detector system includes a plurality of external signal detector elements arranged in an array.

12. The treatment system of claim 2 wherein the signal detector system includes an array of detection elements and wherein the array defines the plane of the external signal detector system.

13. The treatment system of claim 2 wherein the signal transmission system includes an electromagnetic signal emitter.

14. The treatment system of claim 2 wherein the transmission system includes an RF signal emitter.

15. The treatment system of claim 2 wherein the transmission system includes a magnet.

16. The treatment system of claim 2 wherein the transmission system includes an ultrasound signal emitter.

17. The treatment system of claim 2 wherein the transmission system includes an ultrasound signal reflector.

18. The treatment system of claim 2 wherein the signal delivery device includes an electrical contact positioned to deliver the neural modulation signal, and wherein the signal transmission system includes the electrical contact.

19. The treatment system of claim 2 wherein the insertion tracker includes an electromechanical device that is releasably engageable with the signal delivery system.