MRI-compatible patches and methods for using the same

• US 8,195,272 B2
• Filed: 09/24/2008
• Issued: 06/05/2012
• Est. Priority Date: 09/24/2007
• Status: Active Grant

• Current Assignee: Clearpoint Neuro, Inc., Mdesign & Product Development, Inc.
• Original Assignee: MRI Interventions, Inc. (Clearpoint Neuro, Inc.)
• Inventors: Piferi, Peter, Mazzei, Raffaele, Diener, Alex, Steele, Brady
• Primary Examiner(s): Le, Long V.
• Assistant Examiner(s): Negarestan, Farshad
• Application Number:
  US12/236,621
• Publication Number:
  US 20090177077A1
• Time in Patent Office: 1,350 Days
• Field of Search: 128/845, 128/846, 128/849, 378/162, 378/163, 378/164
• US Class Current: 600/414
• CPC Class Codes: A61B 2034/101 Computer-aided simulation of surgical operations
• CPC Class Codes: A61B 2034/252 indicating steps of a surgical procedure
• CPC Class Codes: A61B 2034/256 having a database of accessory information, e.g. including context sensitive help or scientific articles
• CPC Class Codes: A61B 2090/103 Cranial plugs for access to brain
• CPC Class Codes: A61B 2090/374 NMR or MRI
• CPC Class Codes: A61B 2090/3933 Liquid markers
• CPC Class Codes: A61B 2090/3937 Visible markers
• CPC Class Codes: A61B 2090/395 with marking agent for marking skin or other tissue
• CPC Class Codes: A61B 2090/3954 magnetic, e.g. NMR or MRI
• CPC Class Codes: A61B 2090/3983 Reference marker arrangements for use with image guided surgery
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61B 34/25 User interfaces for surgical systems
• CPC Class Codes: A61B 5/055 involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
• CPC Class Codes: A61B 90/11 with guides for needles or instruments, e.g. arcuate slides or ball joints
• CPC Class Codes: A61B 90/14 Fixators for body parts, e.g. skull clamps; Constructional details of fixators, e.g. pins
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61N 1/086 Magnetic resonance imaging [MRI] compatible leads
• CPC Class Codes: G01R 33/285 Invasive instruments, e.g. catheters or biopsy needles, specially adapted for tracking, guiding or visualization by NMR
• CPC Class Codes: G01R 33/34007 Manufacture of RF coils, e.g. using printed circuit board technology; additional hardware for providing mechanical support to the RF coil assembly or to part thereof, e.g. a support for moving the coil assembly relative to the remainder of the MR system
• CPC Class Codes: G01R 33/3415 comprising arrays of sub-coils , i.e. phased-array coils with flexible receiver channels

Abstract

An MRI-compatible patch for identifying a location includes a flexible base layer, a flexible substrate and at least one of MRI-visible fiducial element. The flexible base layer is mountable on and substantially conformable to a patient'"'"'s body surface. The base layer has opposed upper and lower primary surfaces. The flexible substrate is releasably attached to the upper primary surface of the base layer and substantially conformable to the patient'"'"'s body surface. The at least one MRI-visible fiducial element is defined by or secured to the flexible substrate. The patch may include a plurality of the MRI-visible fiducial elements arranged in a defined pattern.

Claims

1. An MRI-compatible patch for identifying a location, the patch comprising:

a flexible base layer that is mountable on and substantially conformable to a patient'"'"'s body surface, the base layer having opposed upper and lower primary surfaces;

a flexible substrate that is releasably attached to the upper primary surface of the base layer and substantially conformable to the patient'"'"'s body surface;

a plurality of MRI-visible fiducial elements defined by or secured to the flexible substrate, wherein the MRI-visible fiducial elements are arranged in a defined pattern; and

indicia on the base layer corresponding to the MRI-visible fiducial elements on the flexible substrate, wherein the indicia has a second prescribed pattern having a higher resolution than the defined pattern of the MRI-visible fiducial elements on the flexible substrate.

2. The patch of claim 1 including a layer of adhesive disposed on a lower surface of the flexible substrate and engaging the upper primary surface of the base layer and releasably attaching the flexible substrate to the base layer.

3. The patch of claim 1 including an adhesive disposed on the lower primary surface of the base layer to attach the base layer to the body surface.

4. The patch of claim 3 including a release liner releasably backing the adhesive on the lower primary surface of the base layer.

5. The patch of Claim 1 including second indicia on the flexible substrate corresponding to the indicia on the base layer.

6. The patch of Claim 1 wherein the defined pattern includes a grid pattern defining a coordinate system.

7. The patch of claim 6 including codified indicia representing the coordinate system.

8. The patch of claim 6 wherein the MRI-visible fiducial elements are discrete elements arranged in a defined grid of columns and rows of the MRI-visible fiducial elements.

9. The patch of claim 1 wherein the flexible substrate includes a pull tab to facilitate removal of the flexible substrate from the base layer.

10. The patch of claim 1 wherein the base layer is frangible to permit selective access to the body surface when the base layer is mounted thereon and the flexible substrate has been at least partially removed.

11. The patch of claim 1 including at least one MRI-visible reference indicator to indicate an orientation of the patch.

12. The patch of Claim 1 wherein at least one of the MRI-visible fiducial elements has a first MRI-visible geometric shape, and at least one of the MRI-visible fiducial elements has a second MRI-visible geometric shape different from the first MRI-visible geometric shape.

13. The patch of Claim 1 wherein at least some of the MRI-visible fiducial elements include a pocket containing MRI-visible material.

14. The patch of claim 13 wherein the MRI-visible material includes an MRI-visible liquid.

15. The patch of Claim 1 wherein at least some of the MRI-visible fiducial elements are selectively discretely removable from the flexible substrate.

16. The patch of claim 1 including perforations defined in the flexible substrate to thereby enhance conformity of the flexible substrate to the body surface.

17. The patch of claim 1 wherein the flexible substrate is formed of a stretchable material to allow the flexible substrate to conform to a head body surface.

18. The patch of claim 1 wherein the flexible substrate is a mesh.

19. The patch of claim 1 including a supply of ink that is transferable to the patient'"'"'s body surface when the patch is mounted on the patient'"'"'s body surface.

20. The patch of claim 1 wherein at least one of the MRI-visible fiducial elements has a width and a height greater than its width to define a heightwise axis.

21. The patch of claim 1 wherein the flexible substrate has a thickness in the range of from about 0.001 to 0.100 inches.

22. The patch of claim 1 wherein the flexible substrate is a substrate material selected from the group consisting of polyvinyl, PET, silicone, polyethylene, polyurethane, and polyamide.

23. The patch of claim 1 further including:

an adhesive disposed on the lower primary surface of the base layer adapted to attach the base layer to the body surface;

a release liner releasably secured to the adhesive on the lower primary surface of the base layer; and

at least one MRI-visible reference indicator to indicate an orientation of the patch;

wherein at least some of the MRI-visible fiducial elements include a pocket containing MRI-visible liquid; and

wherein the defined pattern includes a grid pattern defining a coordinate system.

24. The patch of claim 23 wherein:

the patch includes a layer of adhesive disposed on a lower surface of the flexible substrate and engaging the upper primary surface of the base layer and releasably attaching the flexible substrate to the base layer;

the indicia represents the coordinate system;

the base layer and the flexible substrate are adapted to be substantially conformable to a head body surface of the patient;

the flexible substrate has a thickness in the range of from about 0.001 to 0.100 inches; and

the flexible substrate is a substrate material selected from the group consisting of polyvinyl, PET, silicone, polyethylene, polyurethane, and polyamide.

25. The patch of claim 1 wherein the flexible substrate includes a flexible sheet and the MRI-visible fiducial elements are releasably secured to the flexible sheet.

26. The patch of claim 25 including a layer of adhesive disposed on a lower surface of the flexible sheet and engaging the upper primary surface of the base layer and releasably attaching the flexible sheet to the base layer.

27. The patch of claim 25 wherein the flexible sheet is peelably releasably attached to the base layer such that the flexible sheet can be peeled off of the base layer with the MRI-visible fiducial elements disposed on the flexible sheet.

28. A medical kit for designating a physical location on a head of a patient, the medical kit comprising:

a patch including;

a flexible base layer that is mountable on and substantially conformable to a patient'"'"'s body surface, the base layer having opposed upper and lower primary surfaces;

a flexible substrate that is releasably attached to the upper primary surface of the base layer and substantially conformable to the patient'"'"'s body surface;

a plurality of MRI-visible fiducial elements defined by or secured to the flexible substrate, wherein the MRI-visible fiducial elements are arranged in a defined pattern; and

indicia on the base layer corresponding to the MRI-visible fiducial elements on the flexible substrate, wherein the indicia has a second prescribed pattern having a higher resolution than the defined pattern of the MRI-visible fiducial elements on the flexible substrate; and

a head marking tool being configured to mark the head of the patient.

29. The medical kit of claim 28 wherein the head marking tool is configured to mark a skull of the patient.