Systems and methods for positioning implanted devices in a patient

• US 9,345,891 B2
• Filed: 01/15/2015
• Issued: 05/24/2016
• 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): Wu, Eugene
• Application Number:
  US14/598,114
• Publication Number:
  US 20150224327A1
• Time in Patent Office: 495 Days
• US Class Current: 1/1
• 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 signal generator to deliver a neural modulation signal;

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

an array of external signal detector elements and display elements that is movable relative to the signal delivery device, the external signal detector elements being positionable to detect the locator signal wirelessly through the patient'"'"'s skin, the display elements being operatively coupled to the signal detector elements to display data based on information provided by the detector elements, wherein the array defines a plane, and wherein individual detector elements and corresponding individual display elements are co-located to have the same coordinates in the plane.

2. The treatment system of claim 1 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.

3. The treatment system of claim 2 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.

4. The treatment system of claim 1, wherein the display elements are operatively coupled to the external signal detector elements to present an indication of a signal strength detected at the external signal detector elements.

5. The treatment system of claim 1, further comprising an insertion tracker operably coupleable to the signal delivery system to track a length of the signal delivery system inserted into the patient.

6. The treatment system of claim 5 wherein the insertion tracker includes an electromechanical device that is releasably engageable with the signal delivery system.

7. The treatment system of claim 5, further comprising 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 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.

8. The treatment system of claim 1 wherein the array has at least one releasable fixation element positioned to releasably secure the array to the patient'"'"'s skin.

9. The treatment system of claim 1 wherein the array is carried by a flexible, conformable support member.

10. The treatment system of claim 1 wherein the signal transmission system includes an electromagnetic signal emitter.

11. The treatment system of claim 1 wherein the transmission system includes an RF signal emitter.

12. The treatment system of claim 1 wherein the transmission system includes a magnet.

13. The treatment system of claim 1 wherein the transmission system includes an ultrasound signal emitter.

14. The treatment system of claim 1 wherein the transmission system includes an ultrasound signal reflector.

15. The system of claim 1 wherein the signal generator includes a pulse generator.

16. A patient treatment system, comprising:

a signal delivery system that includes;

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

a therapy contact carried by the signal delivery lead and coupleable to a signal generator to deliver a neural modulation signal; and

a stylet removably received in the axial opening;

a signal transmission system carried by the signal delivery system, the signal transmission system including a signal emitter carried by the stylet and coupleable to a power source;

an external signal detector configured to detect a locator signal emitted by the signal emitter, the signal detector being movable relative to the signal delivery device, the signal detector having an array of detection elements; and

a display device operatively coupled to the signal detector to present an indication of individual signal strengths received at the corresponding individual signal detectors, the display device including an array of display elements wherein the array defines a plane, with individual display elements co-located with corresponding individual detection elements to have the same coordinates in the plane.

17. The treatment system of claim 16 wherein the signal detector has a releasable fixation element positioned to releasably secure the signal detector to the patient'"'"'s skin.

18. The treatment system of claim 16 wherein the signal transmission system includes an electromagnetic signal emitter.

19. The treatment system of claim 16 wherein the transmission system includes an RF signal emitter.

20. A method for treating a patient, comprising:

emitting a locator signal from a signal delivery system positioned beneath the patient'"'"'s skin, the signal delivery system including a signal delivery device having at least one electrical contact;

detecting the locator signal from external to the patient at a plurality of locations via an array of signal detector elements;

presenting display data at an array of display elements, based on information provided by the array of signal detector elements, wherein the array of display elements defines a plane, and wherein individual detector elements and corresponding individual display elements are co-located to have the same coordinates in the plane; and

directing a therapy signal from the electrical contact.

21. The method of claim 20 wherein directing the therapy signal includes directing the therapy signal to treat pain in the patient.

22. The method of claim 20 wherein the signal delivery system includes a signal delivery device and an implanting tool carrying the signal delivery device, and wherein emitting the locator signal includes emitting the locator signal from the implanting tool.

23. The method of claim 22 wherein the implanting tool includes a stylet slideably and releasably received in an aperture of the signal delivery device.

24. The method of claim 20 wherein the signal delivery system includes a signal delivery device and an implanting tool carrying the signal delivery device, and wherein emitting the locator signal includes emitting the locator signal from the signal delivery device.

25. The method of claim 20 wherein emitting the locator signal includes emitting the locator signal from the signal delivery device.

26. The method of claim 25 wherein emitting the locator signal includes emitting the locator signal from the electrical contact.

27. The method of claim 20 wherein individual signal detector elements receive corresponding individual indications of the strength of the locator signal.

28. The method of claim 20, further comprising interpolating results obtained from the plurality of signal detector elements to identify an estimated position of the signal delivery device.

29. The method of claim 20 wherein the array of signal detector elements is releasably carried by the patient.

30. The method of claim 20, further comprising releasably attaching the array of signal detector elements to the patient'"'"'s skin.

31. The method of claim 20 wherein emitting a locator signal includes emitting an RF signal.

32. The method of claim 20 wherein emitting a locator signal includes generating and emitting an ultrasound signal.

33. The method of claim 20, further comprising detecting a location of the signal delivery device based at least in part on detecting the locator signal.

34. The method of claim 33 wherein detecting a location includes detecting a lateral location and a rostral/caudal location.

35. The method of claim 33 wherein detecting a location includes detecting a dorsal/ventral location.