LOCATING GUIDE

• US 20080039866A1
• 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: Chun, Thomas, Bonde, Eric, Stetz, Eric, Tropsha, Yelena
• Granted Patent: US 8,204,575 B2
• Time in Patent Office: Days
• US Class Current: 606/129
• CPC Class Codes: A61B 2090/376 using X-rays, e.g. fluoroscopy
• CPC Class Codes: A61B 2090/3916 Bone tissue
• CPC Class Codes: A61B 2090/3983 Reference marker arrangements for use with image guided surgery
• CPC Class Codes: A61B 90/11 with guides for needles or instruments, e.g. arcuate slides or ball joints
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes

Abstract

A locating guide for locating a target tissue site within a patient includes a body, a first substantially radiopaque reference marker on the body, and a second substantially radiopaque reference marker extending from a major surface of the body. The reference markers provide reference points that extend in at least two dimensions, and may be useful for registering a medical image of tissue with an actual location on or within the patient in order to more accurately and precisely locate a target tissue site within the patient. In some embodiments, the second reference marker is oriented at a predetermined angle relative to the major surface of the body, and provides a guide that a clinician may reference in order to orient a medical element introducer when introducing the introducer into the patient to access a particular target tissue site.

Claims

1. A target tissue site locating guide comprising:

a body defining a major surface;

a first substantially radiopaque reference marker on the body; and

a second substantially radiopaque reference marker extending from the major surface of the body.

2. The locating guide of claim 1, wherein at least one of the first or second reference markers are integrally formed with the body.

3. The locating guide of claim 1, wherein at least one of the first or second reference markers are fixed to the body.

4. The locating guide of claim 1, wherein the body comprises a substantially radiopaque material.

5. The locating guide of claim 1, wherein the body comprises a substantially radio-transparent material.

6. The locating guide of claim 1, wherein the first reference marker extends substantially along the major surface of the body.

7. The locating guide of claim 1, wherein the first reference marker comprises at least one reference line printed on the body with a radiopaque material.

8. The locating guide of claim 1, wherein the first reference marker comprises a plurality of lines defining a grid.

9. The locating guide of claim 1, wherein the first reference marker comprises a plurality of distance markers.

10. The locating guide of claim 1, wherein the first reference marker is configured to overlay at least a portion of a boney landmark of a patient.

11. The locating apparatus of claim 10, wherein the boney landmark comprises at least one of an Ilium bone or a spinal canal of the patient.

12. The locating guide of claim 1, wherein the second reference marker is oriented at an angle relative to the major surface of the body.

13. The locating guide of claim 12, wherein the angle is in a range of about 45 degrees to about 100 degrees.

14. The locating guide of claim 13, wherein the angle is about 60 degrees.

15. The locating guide of claim 13, wherein the angle is about 90 degrees.

16. The locating guide of claim 1, wherein the second reference marker extends from the major surface of the body about 0.25 cm to about 2 cm.

17. The locating guide of claim 1, further comprising a centerline marker positioned along a center axis of the body.

18. The locating guide of claim 1, wherein the body defines a first portion and a second portion substantially perpendicular to the first portion.

19. The locating guide of claim 18, wherein at least one of the first portion or the second portion of the body is configured to substantially conform to a size and shape of at least a portion of a boney landmark of a patient.

20. The locating guide of claim 19, wherein the first portion of the body is configured to substantially overlay at least a portion of an Ilium bone of a patient and the second portion of the body is configured to substantially overlay at least a portion of a spinal canal of the patient.

21. The locating guide of claim 1, wherein the body defines a first shape substantially corresponding to a second shape defined by a human sacrum.

22. The locating guide of claim 21, wherein the body defines at least one aperture configured to receive an introducer for a medical element.

23. The locating guide of claim 1, further comprising a third reference marker extending substantially perpendicular to the first reference marker along the major surface of the body.

24. The locating guide of claim 1, wherein the body defines at least one aperture configured to receive an introducer for a medical element.

25. The locating guide of claim 1, further comprising an adhesive along a skin contact surface of the body.

26. A locating guide comprising:

a body configured to overlay a skin surface of a patient proximate to a sacrum of the patient; and

a radiopaque reference marker on the body and configured to extend away from the skin surface of the patient at an angle when the body is positioned on the skin surface, wherein the angle indicates an orientation for introducing an introducer into the patient to access a sacral foramen of the sacrum.

27. The locating guide of claim 26, wherein the reference marker comprises a first reference marker, the locating guide further comprising a second first reference marker on the body and configured to align with a boney landmark of the patient in order to align at least a portion of the body of the locating guide with the sacrum.

28. The locating guide of claim 26, wherein the body defines at least one aperture configured to receive an introducer needle for a medical device.

29. A method comprising:

positioning a locating guide on a skin surface of a patient, wherein the locating guide comprises;

a body;

a first radiopaque reference marker on the body; and

a second radiopaque reference marker on the body and configured to extend away from the skin surface of the patient when the locating guide is positioned on the skin surface;

generating an image of at least a portion of the locating guide and at least a portion of tissue of the patient proximate to the locating guide with a medical imaging device;

registering the image with an actual location on or within the patient based on at least one of the first or second reference markers.

30. The method of claim 29, wherein the image comprises a radiographic image.

31. The method of claim 29, wherein registering the image comprises:

identifying at least the first reference marker of the locating guide in the first image; and

identifying at least the second reference marker of the locating guide in the second image.

32. The method of claim 29, further comprising identifying a first location of a target tissue site within the tissue based on the image, wherein registering the image comprises registering the first location of the target tissue site with a second location on the skin surface of the patient based on at least one of the first or second reference markers.

33. The method of claim 32, wherein the first reference marker of the locating guide comprises a plurality of lines defining a grid, and registering the first location of the target tissue site with the second location on the skin surface of the patient based on at least one of the first or second reference markers comprises identifying, within the image, an intersection of the grid proximate to the target tissue site.

34. The method of claim 32, wherein the first reference marker of the locating guide comprises a plurality of substantially radiopaque distance markers that indicate a distance along the body, and registering the first location of the target tissue site with the second location on the skin surface of the patient based on at least one of the first or second reference markers comprises:

identifying, within the image, at least one of the plurality of distance markers proximate to the nerve site; and

identifying the at least one of the plurality of distance markers proximate to the nerve site on the locating guide.

35. The method of claim 32, further comprising introducing a medical device into the patient proximate to the target tissue site within the patient.

36. The method of claim 35, wherein the body of the locating guide defines an aperture, and wherein introducing the medical device into the patient comprises introducing the medical device into the patient through the aperture.

37. The method of claim 35, wherein introducing the medical device into the patient comprises introducing an introducer needle into the patient, the method further comprising orienting the introducer needle to substantially match an orientation of the second reference marker relative to the skin surface.

38. The method of claim 29, wherein positioning the locating guide on the skin surface of the patient comprises:

locating a boney landmark of the patient; and

positioning the first reference marker of the locating guide on the skin surface of the patient proximate to the boney landmark.

39. The method of claim 29, wherein the image comprises a first image of a first perspective of the locating guide, the method further comprising generating a second image of a second perspective of at least a portion of the locating guide and at least a portion of tissue of the patient proximate to the locating guide with the medical imaging device.