Locating guide

• US 8,204,575 B2
• Filed: 08/07/2007
• Issued: 06/19/2012
• Est. Priority Date: 08/11/2006
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Stetz, Eric M., Bonde, Eric H., Tropsha, Yelena G., Chun, Thomas
• Primary Examiner(s): Chen, Tse
• Assistant Examiner(s): Luong, Peter
• Application Number:
  US11/835,296
• Publication Number:
  US 20080039866A1
• Time in Patent Office: 1,778 Days
• Field of Search: 600/424, 600/426, 600/431
• US Class Current: 600/424
• 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 set of substantially radiopaque reference markers on the major surface of the body, wherein at least one reference marker of the first set extends in a first plane; and

a second set of substantially radiopaque reference markers extending laterally from the major surface of the body, wherein at least one reference marker of the second set extends in a second plane, the first plane being different than the second plane, and wherein at least two reference markers of the second set are arranged to be separated from each other along the major surface.

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

3. The locating guide of claim 1, wherein markers of at least one of the first or second sets of 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 set of reference markers extends substantially along the major surface of the body.

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

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

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

10. The locating guide of claim 1, wherein the first set of reference markers 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 set of reference markers 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 markers of the second set of reference markers 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 set of reference markers 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 method comprising:

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

a body defining a major surface;

a first set of radiopaque reference markers on the major surface of the body,

wherein at least one reference marker of the first set extends in a first plane; and

a second set of radiopaque reference markers configured to extend laterally from the major surface of the body, wherein at least one reference marker of the second set extends in a second plane, the first plane being different than the second plane, wherein markers of one of the first set or the second set of radiopaque references markers are configured to extend away from the skin surface of the patient when the locating guide is positioned on the skin surface, and wherein at least two reference markers of the second set are arranged to be separated from each other along the major 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; and

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

27. The method of claim 26, wherein the image comprises a radiographic image.

28. The method of claim 26, wherein registering the image comprises:

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

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

29. The method of claim 26, 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 markers of at least one of the first or second sets of reference markers.

30. The method of claim 29, wherein the first set of reference markers 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 markers of at least one of the first or second sets of reference markers comprises identifying, within the image, an intersection of the grid proximate to the target tissue site.

31. The method of claim 29, wherein the first set of reference markers 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 sets of reference markers comprises:

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

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

32. The method of claim 29, further comprising introducing a medical device into the patient proximate to the target tissue site within the patient.

33. The method of claim 32, 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.

34. The method of claim 32, 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.

35. The method of claim 26, 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.

36. The method of claim 26, 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.