Tissue marker for multimodality radiographic imaging

• US 9,795,455 B2
• Filed: 08/22/2014
• Issued: 10/24/2017
• Est. Priority Date: 08/22/2014
• Status: Active Grant

• Current Assignee: Breast-Med, Inc.
• Original Assignee: Breast-Med, Inc.
• Inventors: Bolan, Patrick, Gross, Mark C., Halpern, Daniel A., Nelson, Michael T.
• Primary Examiner(s): Cattungal, Sanjay
• Application Number:
  US14/466,010
• Publication Number:
  US 20160051337A1
• Time in Patent Office: 1,159 Days
• Field of Search: 600407-431
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2090/3925 ultrasonic
• CPC Class Codes: A61B 2090/3933 Liquid markers
• CPC Class Codes: A61B 2090/3954 magnetic, e.g. NMR or MRI
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 2090/3995 Multi-modality markers
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

A radiographic marker containing a sensing medium that initially includes a gas and liquid mixture for producing increased signal intensity in a first imaging modality. The radiographic marker can have a permeable portion allowing the exchange of the gases or liquids of the sensing medium to be changed or exchanged for at least a second fluid in the surrounding tissue to reduce the bubbles or air pockets created by the gas portion of the sensing medium. The change or exchange of gas for the second liquid in the radiographic marker produces a detectable signal intensity of the radiographic marker in a second imaging modality different from the first imaging modality.

Claims

1. A radiographic marker, comprising:

a container wall enclosing an internal chamber and including a permeable portion; and

a sensing medium received within the internal chamber, the sensing medium initially including at least one of a first liquid, a gas portion and a solid portion, the sensing medium configured to be detectable using a first imaging modality;

wherein the permeable portion is semi-permeable to permit, when injected or surgically implanted into a patient'"'"'s body, transfer of enough of a second liquid through the permeable portion of the chamber wall into the inner chamber while confining the sensing medium within the inner chamber to change a ratio of gas to liquid of the sensing medium within the internal chamber to produce a detectable change in signal intensity using a second imaging modality that is of a different type than the first imaging modality.

2. The radiographic marker of claim 1, wherein the gas portion of the sensing medium creates at least one bubble within the internal chamber to produce a detectable signal intensity in a first imaging modality.

3. The radiographic marker of claim 2, wherein the first imaging modality comprises ultrasound imaging.

4. The radiographic marker of claim 1, wherein transfer of the second liquid across the chamber wall produces a detectable signal intensity in a second imaging modality.

5. The radiographic marker of claim 4, wherein the second imaging modality comprises magnetic resonance imaging.

6. The radiographic marker of claim 1, wherein the sensing medium further includes an osmotic agent to create an osmotic gradient drawing the second fluid into the internal chamber through the permeable portion of the chamber walls.

7. The radiographic marker of claim 1, the sensing medium includes at least one contrast agent.

8. The radiographic marker of claim 7, wherein the permeable portion of the container wall retains the contrast agent within the internal chamber as the second fluid and the gas portion are exchanged through the container wall.

9. The radiographic marker of claim 1, wherein the gas portion is dispersed within the first liquid.

10. The radiographic marker of claim 1, wherein the sensing medium includes at least one of a solid and a gel.

11. The radiographic marker of claim 1, further comprising at least one object positioned within the internal chamber;

wherein the object comprises an artificial shape identifiable under an imaging modality.

12. The radiographic marker of claim 11, wherein the at least one object positioned is configured to transmit an electromagnetic signal.

13. The radiographic marker of claim 1, wherein the permeable portion is a semi-permeable material.

14. The radiographic marker of claim 1, wherein the container wall comprises an impermeable portion.

15. The radiographic marker of claim 1, wherein the impermeable material is selected from at least one of glass, ceramics, polymers, metals and composites.

16. The radiographic marker of claim 1, wherein the container wall includes a seal enclosing the internal chamber.

17. The radiographic marker of claim 1, wherein the radiographic marker includes at least one therapeutic agent received within the internal chamber;

wherein the therapeutic agent elutes through the permeable portion of the container wall.

18. The radiographic marker of claim 1, wherein the radiographic marker is sized and shaped to fit within a lumen of a cannula configured to deliver the radiographic marker to a fully implanted location within the subject.

19. The radiographic marker of claim 1, wherein the contrast agent is sensitive of at least one analyte in tissue surrounding the radiographic marker;

wherein the analyte permeates through the permeable portion of the chamber wall.

20. The radiographic marker of claim 19, wherein the analyte is selected from a group consisting of hydrogen ions, oxygen molecules, nitric oxide, small organic molecules, proteins, hormones or therapeutic agents and combinations thereof.

21. The radiographic marker of claim 1, wherein the contrast agent is sensitive to at least one physical condition of the tissue surrounding the radiographic marker.

22. The radiographic marker of claim 21, wherein the physical condition is selected from a group consisting of pH, temperature, oxygenation, tissue perfusion and combinations thereof.

23. The radiographic marker of claim 1, wherein the first liquid and the second liquid are immiscible.

24. The radiographic marker of claim 1, wherein the permeable portion permits transfer of liquids and gases across the chamber wall.

25. The radiographic marker of claim 1, wherein the permeable portion includes a permeability that is configured to controllably limit transfer of the second liquid across the permeable portion of the chamber wall to inhibit or prevent a sensing artifact using the second imaging modality.

26. The radiographic marker of claim 1, wherein the permeable portion is configured to confine the sensing medium within the internal chamber.

27. The radiographic marker of claim 26, wherein the permeable portion is configured to retain an osmotic agent within the internal chamber.

28. A method of making a radiographic marker, comprising:

providing a chamber wall defining an internal chamber, the chamber wall including a permeable portion;

at least partially filling the internal chamber with a sensing medium initially including at least one of a first liquid, gas portion and a solid portion, the sensing medium configured to be detectable using a first imaging modality; and

sealing the chamber wall to enclose the internal chamber;

wherein the permeable portion is semi-permeable to permit, when injected or surgically implanted into a patient'"'"'s body, transfer of enough of a second liquid through the permeable portion of the chamber wall into the inner chamber while confining the sensing medium within the inner chamber to change a ratio of gas to liquid of the sensing medium within the internal chamber to produce a detectable change in signal intensity using a second imaging modality that is of a different type than the first imaging modality.

29. The method of claim 28, wherein the gas portion of the sensing medium creates at least one bubble within the internal chamber to produce a detectable signal intensity in a first imaging modality.

30. The method of claim 29, wherein the first imaging modality comprises ultrasound imaging.

31. The method of claim 28, wherein the gas portion permeates through the permeable portion to change the gas to liquid ratio of the sensing medium to produce in detectable signal intensity in a second imaging modality.

32. The method of claim 31, wherein the second imaging modality comprises magnetic resonance imaging.

33. The method of claim 28, comprising applying a coating to at least one of an internal surface of the biocompatible container and an external surface of the biocompatible container.

34. The method of claim 28, comprising at least partially filling the internal chamber with the sensing medium within a chamber at a pressure other than ambient pressure.