IP Library Granted Patent US 8,195,272
Granted Patent B2
US 8,195,272 · App. 12/236,621 · Granted Jun 5, 2012

MRI-compatible patches and methods for using the same

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Quick Facts
Patent No.
US 8,195,272
App. No.
12/236,621
Granted
Jun 5, 2012
Kind
B2
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 (49)

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.

Assignments (15)
SECURITY INTEREST Recorded May 13, 2025
From: CLEARPOINT NEURO, INC.
To: CALW SA LLC, AS PURCHASER AGENT
Reel/Frame 071276/0191 →
RELEASE OF SECURITY INTEREST Recorded Mar 4, 2022
From: LANDMARK COMMUNITY BANK
To: CLEARPOINT NEURO, INC. (FORMERLY KNOWN AS MRI INTERVENTIONS, INC. AND SURGIVISION, INC.
Reel/Frame 059177/0392 →
CHANGE OF NAME Recorded Jan 12, 2022
From: MRI INTERVENTIONS, INC.
To: CLEARPOINT NEURO, INC.
Reel/Frame 058702/0976 →
CORRECTIVE ASSIGNMENT TO CORRECT THE INCORRECTLY LISTED PROPERTY U.S. PATENT NO. 8374667 PREVIOUSLY RECORDED ON REEL 032528 FRAME 0536. ASSIGNOR(S) HEREBY CONFIRMS THE SECURITY AGREEMENT. Recorded Nov 17, 2015
From: MRI INTERVENTIONS, INC.
To: LANDMARK COMMUNITY BANK
Reel/Frame 037120/0574 →
RELEASE OF SECURITY INTEREST Recorded Sep 12, 2014
From: BOSTON SCIENTIFIC CORPORATION
To: MRI INTERVENTIONS, INC., FORMERLY KNOWN AS SURGIVISION, INC.
Reel/Frame 033727/0668 →
SECURITY INTEREST Recorded Mar 26, 2014
From: MRI INTERVENTIONS, INC.
To: LANDMARK COMMUNITY BANK
Reel/Frame 032528/0536 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 30, 2012
From: PETERSON, DAVID; KEIDL, CHRISTOPHER
To: MIDWEST R.F., LLC
Reel/Frame 028130/0723 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 30, 2012
From: MIDWEST R.F., LLC
To: SURGI-VISION, INC.
Reel/Frame 028130/0750 →
CHANGE OF NAME Recorded Apr 30, 2012
From: SURGI-VISION, INC.
To: SURGIVISION, INC.
Reel/Frame 028130/0842 →
CHANGE OF NAME Recorded Apr 30, 2012
From: SURGIVISION, INC.
To: MRI INTERVENTIONS, INC.
Reel/Frame 028132/0121 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 30, 2012
From: JENKINS, KIMBLE L.; PIFERI, PETER
To: SURGI-VISION, INC.
Reel/Frame 028130/0390 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 30, 2012
From: SAYLER, DAVID JOHN
To: ZIBA DESIGN, INC.
Reel/Frame 028130/0515 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 30, 2012
From: ZIBA DESIGN, INC.
To: MDESIGN & PRODUCT DEVELOPMENT, INC. DBA ZIBA CALIFORNIA
Reel/Frame 028130/0578 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 30, 2012
From: MAZZEI, RAFFAELE; DIENER, ALEX; STEELE, BRADY
To: MDESIGN & PRODUCT DEVELOPMENT, INC. DBA ZIBA CALIFORNIA
Reel/Frame 028130/0645 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 30, 2012
From: MDESIGN & PRODUCT DEVELOPMENT, INC. DBA ZIBA CALIFORNIA
To: SURGI-VISION, INC.
Reel/Frame 028130/0697 →