GUIDED MEDICAL ELEMENT IMPLANTATION

• US 20080039738A1
• Filed: 08/07/2007
• Published: 02/14/2008
• Est. Priority Date: 08/11/2006
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Bonde, Eric, Dinsmoor, David
• Granted Patent: US 9,439,581 B2
• Time in Patent Office: Days
• US Class Current: 600/547
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/3407 including a base for support on the body
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 5/0536 Impedance imaging, e.g. by tomography
• CPC Class Codes: A61B 5/4504 Bones A61B5/4547 takes precedence
• CPC Class Codes: A61B 90/11 with guides for needles or instruments, e.g. arcuate slides or ball joints
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

A system for locating a target tissue site is described. The system includes a locating guide that frames an area of interest upon placement over skin of a patient, an electrode patch defining an aperture and including two or more electrodes for placement within the area of interest, and a medical imaging device that indicates a location of a target tissue site within the patient based on electrical signals generated by one or more of the electrodes. A clinician may guide an introducer needle into the aperture for implanting a medical lead proximate to the target tissue site.

Claims

1. A system comprising:

a locating guide that defines an area of interest upon placement over skin of a patient;

an electrode patch defining an aperture and including two or more electrodes for placement within the area of interest; and

a medical imaging device that indicates a location of a target tissue site within the patient based on electrical signals generated by one or more of the electrodes.

2. The system of claim 1, wherein the medical imaging device generates an image representing a tissue composition underlying the electrode patch, wherein the image indicates the location of the target tissue site.

3. The system of claim 2, wherein the medical imaging device includes an electrical impedance tomography instrument.

4. The system of claim 1, wherein the electrode patch has a substantially rectangular shape.

5. The system of claim 1, wherein the aperture has a width of at least approximately five millimeters wide and a length of at least approximately five millimeters.

6. The system of claim 1, wherein the locating guide is sized and shaped to substantially conform to a size and shape of at least a portion of a boney landmark of the patient.

7. The system of claim 6, wherein the boney landmark comprises an Ilium bone and spinal canal of a human patient.

8. The system of claim 1, wherein the locating guide comprises a plurality of distance marks.

9. The system of claim 1, wherein the target tissue site includes at least one of a S2 sacral foramen, a S3 sacral foramen or a S4 sacral foramen.

10. The system of claim 1, wherein the electrode patch is a first electrode patch defining a first aperture, the system further comprising a second electrode patch defining a second aperture and including two or more electrodes for placement within the area of interest.

11. The system of claim 10, wherein the medical imaging device indicates a first location of a first target tissue site within the patient based on electrical signals generated by one or more of the electrodes of the first electrode patch and a second location of a second target tissue site within the patient based on electrical signals generated by one or more of the electrodes of the second electrode patch.

12. The system of claim 1, wherein at least one of the electrodes of the electrode patch comprises a small gauge needle.

13. The system of claim 1, wherein the electrode patch defines a plurality of apertures.

14. The system of claim 1, wherein the nonconductive backing and locating guide are each composed at least in part of a flexible material.

15. The system of claim 1, further comprising an electrically conductive material disposed between each electrode and the skin of the patient.

16. The system of claim 15, wherein the electrically conductive material comprises at least one of a NaCl gel, tragacanth gum including a conductive additive, karaya gum including a conductive additive or acrylates including a conductive additive.

17. The system of claim 1, wherein the locating guide and electrode patch are connected.

18. The system of claim 1, wherein a position of the electrode patch is adjustable relative to the locating guide after the locating guide is placed over skin of the patient.

19. The system of claim 1, further comprising:

an electrical stimulator; and

an implantable medical lead, coupled to the electrical stimulator, configured to deliver stimulation to the target tissue site.

20. The system of claim 1, further comprising:

a fluid delivery device; and

a catheter configured to delivers a fluid from the fluid delivery device to the target tissue site.

21. A method comprising:

positioning a locating guide over skin of a patient to frame an area of interest;

positioning an electrode patch within the area of interest, wherein the electrode patch is movable relative to the locating guide, and wherein the electrode patch includes at least two electrodes; and

locating a target tissue site within the patient based on electrical signals generated by one or more of the electrodes.

22. The method of claim 21, wherein locating the target tissue site comprises generating an image indicating the location of the target tissue site based on the electrical signals.

23. The method of claim 21, further comprising:

generating an image of tissue of the patient underlying the electrode patch with a medical imaging device;

repositioning the electrode patch within the area of interest based on the image.

24. The method of claim 21, wherein locating the target tissue site comprises applying electrical impedance tomography to the electrical signals to indicate the location of the target tissue site.

25. The method of claim 21, wherein positioning a locating guide over a skin of a patient to frame an area of interest comprises positioning the locating guide over a boney landmark of the patient.

26. The method of claim 21, wherein the area of interest is a sacrum of a human patient, and wherein the target tissue site is one of a S2 foramen, a S3 foramen, and a S4 sacral foramen.

27. The method of claim 21, wherein the electrode patch defines an aperture, the method further comprising:

introducing an introducer needle into the aperture;

introducing a medical member into the introducer needle; and

positioning the medical member proximate to the target tissue site.

28. The method of claim 27, further comprising adjusting a path of the introducer needle within the aperture.

29. A system for locating a sacral foramen of a patient, the system comprising:

a locating guide for placing on skin of the patient, wherein the locating guide frames a region of skin proximate to a sacrum of the patient;

an electrode patch defining an aperture and including two or more electrodes for placement within the region of skin proximate to the sacrum; and

a medical imaging device that indicates a location of the sacral foramen based on electrical signals generated by one or more of the electrodes.

30. The system of claim 29, wherein the locating guide is configured to be placed over at least a part of at least one of an Ilium bone or a spinal canal of the patient.

31. The system of claim 29, wherein the medical imaging device includes an electrical impedance tomography instrument.

32. A method for locating a sacral foramen of a patient, the method comprising:

positioning a locating guide over at least a part of at least one of an Ilium bone or a spinal canal of the patient to frame a region of skin overlaying at least a part of a sacrum of the patient;

positioning an electrode patch defining an aperture and including two or more electrodes for placement within the region of skin overlaying the sacrum; and

locating the sacral foramen based on electrical signals generated by one or more of the electrodes.

33. The method of claim 32, further comprising introducing a medical element into the patient through the aperture of the electrode patch.