Intermediate density marker and a method using such a marker for radiographic examination

• US 7,263,159 B2
• Filed: 11/21/2005
• Issued: 08/28/2007
• Est. Priority Date: 05/07/1993
• Status: Expired due to Fees

• Current Assignee: Beekley Corporation
• Original Assignee: Beekley Corporation
• Inventors: Russell, Donald G.
• Primary Examiner(s): Glick; Edward J.
• Assistant Examiner(s): MIDKIFF, ANASTASIA
• Application Number:
  US11/285,572
• Publication Number:
  US 20060072706A1
• Time in Patent Office: 645 Days
• Field of Search: 378/20, 378/37, 378/162, 378/163, 378/205, 378/207, 600/426
• US Class Current: 378/37
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 6/583 using calibration phantoms

Abstract

The present invention provides a partially radiolucent, partially radiopaque marker and a method for using such a marker for radiographic examination. The marker and the disclosed method may be employed for the examination of tissue structures of various densities. The radiographic density and thickness of the marker are selected so that when the marker and an underlying tissue structure are exposed to x-ray radiation of a specified energy, the marker casts a legible shadow without obscuring anatomical detail present in the underlying tissue structure. The invention also provides a system of partially radiolucent, partially radiopaque markers for use in the method of radiographic examination taught by the invention.

Claims

1. A non-toxic marker for mammographic examination of breast tissue that may anatomical detail present in the tissue, wherein a source of x-ray radiation is provided for generating radiation at a predetermined energy level suitable for imaging breast tissue, the marker is positioned on the breast tissue, and the marker and breast tissue are exposed to the x-ray radiation at the predetermined energy level to generate a radiographic image of the tissue having the shadow of the marker superimposed thereon, the marker comprising:

a first outer surface for contacting a patient'"'"'s breast tissue;

a second outer surface located on an opposite side of the marker relative to the first outer surface; and

at least one non-toxic partially radiolucent, partially radiopaque material located therebetween, said at least one non-toxic partially radiolucednt, partially radiopaque material defining a density and thickness based on a density of breast tissue and the predetermined energy level of the radiation provided which absorbs from about 20% to about 75% of the incident radiation and, in turn, generates a radiographic image of the tissue having the shadow of the marker superimposed thereon with any anatomical detail present in the tissue clearly visible through the radiographic shadow projected by the maker.

2. A mammographic marker as defined in claim 1, wherein the non-toxic partially radiopaque, partially radiolucent material is selected from the group including:

(i) rubber having a thickness of less than about 0.4 inches;

(ii) plastic having a thickness of less than about 0.2 inches;

(iii) vinyl having a thickness of less than about 1 mm; and

(iv) aluminum having a thickness of less than about 0.022 inches.

3. A mammographic marker as defined in claim 2, wherein the non-toxic partially radiopaque, partially radiolucent material is selected from the group including:

(i) rubber having a thickness within the range of 0.2 to about 0.4 inches;

(ii) plastic having a thickness within the range of about 0.1 to about 0.2 inches;

(iii) vinyl having a thickness within the range of about 0.75 mm about 1 mm; and

(iv) aluminum having a thickness within the range of about 0.011 to about 0.022 inches.

4. A mammographic marker as defined in claim 2, wherein the plastic is impregnated with a metal.

5. A mammographic marker as defined in claim 1, wherein the non-toxic partially radiopaque, partially radiolucent material includes metal and plastic having an overall thickness of about 0.015 to about 0.04 inches.

6. A mammographic marker as defined in claim 5, wherein the non-toxic partially radiopaque, partially radiolucent material includes metal and plastic having an overall thickness of about 0.04 inches.

7. A mammographic marker as defined in claim 5, wherein the plastic is impregnated with the metal.

8. A mammographic marker as defined in claim 7, wherein the plastic is impregnated with barium.

9. A plurality of mammographic markers as defined in claim 1, including:

a first marker defining the shape of a circle;

a second marker defining the shape of a triangle; and

a third marker defining the shape of a straight line.

10. A plurality of mammographie markers as defined in claim 9, further including;

a fourth marker defining the shape of cross; and

a fifth marker defining the shape of an arrow.

14. A mammographic marker as defined in claim 1, wherein the non-toxic partially radiolucent, partially radiopaque material is of a uniform density such that the radiographic image of the marker has a uniform, translucent appearance without visible irregularities, conflicting striations or granulations which might obscure the resolution of underlying anatomical detail.

22. A plurality of mammnographic markers as defined in claim 9, wherein each marker includes an adhesive and is adhesively attachable to the breast tissue.

23. A plurality of mammographic markers as defined in claim 1, wherein each marker defines a shape that conveys a specific message, including a first marker defining a circular shape, a second marker defining a triangular shape, and a third marker defining a linear shape.

11. A method of mammographic examination of breast tissue that may have anatomical detail present in the tissue, comprising the steps of:

providing a source of x-ray radiation having a predetermined energy level capable of generating radiation suitable for imaging breast tissue;

providing a non-toxic partially radiolucent, partially radiopaque marker having a radiographic density and thickness which, based on the density of a breast tissue and the predetermined energy level of the radiation provided, absorbs from about 2% to about 75% of the incident radiation and permits the marker to both project a radiographic shadow and transmit sufficient radiation to image anatomical detail present in breast tissue when the marker and the tissue are exposed to the predetermined level of x-ray radiation during mammographic examination;

positioning the marker on the breast tissue; and

exposing the marker and the tissue to the x-ray radiation at the predetermined energy level, and generating a radiographic image of the tissue having the shadow of the marker superimposed thereon with any anatomical detail present in the tissue clearly visible through the radiographic shadow projected by the marker.

12. A method of mammographic examination as defined in claim 11, further compromising the steps of adhesively securing the marker to a patient'"'"'s breast tissue, and transmitting radiation within the range of about 20 kV to about 40 kV through the marker and the tissue.

13. A method of mammographic examination as defined in claim 11, wherein the marker is selected from the group including:

(i) a marker comprising rubber having a thickness of less than about 0.4 inches;

(ii) a marker comprising plastic having a thickness of less than about 0.2 inches;

(iii) a marker comprising vinyl having a thickness of less than about 1 mm; and

(iv) a marker comprising aluminum having a thickness of less than about 0.022 inches.

15. A method of mammographic examination as defined in claim 11, further comprising providing a marker having a non-toxic partially radiolucent, partially radiopaque material that is of uniform density, and generating a mammographic image of the marker having a uniform, translucent appearance without visible irregularities, conflicting striations or granulation obscuring the resolution of any underlying anatomical detail present in the tissue.

24. A method of mammographic examination as defined in claim 11, further comprising the steps of providing a plurality of said markers in predetermined shapes enhancing the information communicated by the markers, including:

(a) a first marker defining the shape of a circle;

(b) a second marker defining the shape of a triangle; and

(c) a third marker defining the shape of a line.

25. A method of mammnographic examination as defined in claim 24, wherein said step of providing a plurality of said markers in predetermined shapes further includes providing:

a fourth marker defining the shape of an arrow.

26. A method of mammographic examination as defined in claim 11, further comprising the steps of adhesively securing the marker to a patient'"'"'s breast tissue.

16. A non-toxic marker for radiographic examination of tissue that may have anatomical detail present in the tissue, wherein a source of x-ray radiation is provided for generating radiation at a predetermined energy level suitable for imaging tissue having a predetermined tissue density, the marker is positioned on the tissue, and the marker and tissue are exposed to the x-ray radiation at the predetermined energy level to generate a radiographic image of the tissue having the shadow of the marker superimposed thereon, the marker comprising:

a first outer surface for contacting a patient'"'"'s skin;

a second outer surface located on an opposite side of the marker relative to the first outer surface; and

at least one non-toxic partially radiolucent, partially radiopaque material located between the first and second outer surfaces, said at least one non-toxic partially radiolucent, partially radiopaque material defining a density and thickness based on the predetermined tissue density and the predetermined energy level of the radiation provided which absorbs from about 2% to about 75% of the incident radiation and, in turn, generates a radiographic image of the tissue having the shadow of the marker superimposed thereon with anatomical detail present in the tissue clearly visible through the radiographic shadow projected by the marker, and said at least one non-toxic partially radiolucent, partially radiopaque material is of a uniform density such that the radiographic image of the marker has a uniform, translucent appearance without visible irregularities, conflicting striations or granulations which might obscure the resolution of underlying anatomical detail.

17. A radiographic marker as defined in claim 16, wherein the non-toxic partially radiopaque, partially radiolucent material is selected from the group including:

(i) rubber having a thickness of less tan about 0.4 inches;

(ii) plastic having a thickness of less than about 0.2 inches;

(iii) vinyl having a thickness of less than about 1 mm; and

(iv) aluminum having a thickness of less than about 0.022 inches.

18. A radiographic marker as defined in claim 17, wherein the plastic is impregnated with a metal.

19. A plurality of radiographic markers as defined in claim 16, wherein each of the plurality of markers defines a respective radiographic density different than the other markers and corresponds to a respective tissue density for imaging tissue having that density, and including (i) a first marker defining a radiographic density approximately equal to the density of water for imaging relatively soft tissue;

(ii) a second marker defining a radiographic density approximately equal to the density of the bones of a patient'"'"'s extremities for imaging relatively intermediate density tissue; and

(iii) a third marker defining a radiographic density approximately equal to the density of at least one of a skull, spine and chest of a patient for imaging relatively dense tissue.

20. A radiographic marker as defined in claim 16, wherein the marker is a mammographic marker for mammographic examination of breast tissue, the marker is adhesively attachable to a patient'"'"'s breast tissue for positioning the marker on the breast tissue, and the predetermined level of the x-radiation is within the range of about 20 kV to about 40 kV.

21. A method of radiographic examination of tissue that may have anatomical detail present in the tissue, comprising the steps of:

providing a source of x-ray radiation having a predetermined energy level capable of generating radiation suitable for imaging a predetermined tissue density;

providing a non-toxic partially radiolucent, partially radiopaque marker having a radiographic density and thickness which permit the marker to both project a radiographic shadow and transmit sufficient radiation to image anatomical detail present in tissue having the predetermined tissue density, when the marker and the tissue are exposed to the predetermined level of x-ray radiation during radiographic examination, said providing step including providing a marker having a density and thickness based on the predetermined tissue density and the predetermined energy level of the radiation provided that absorbs from about 2% to about 75% of the incident radiation, and that includes a non-toxic partially radiolucent, partially radiopaque material of a uniform density such that the radiographic image of the marker has a uniform, translucent appearance without visible irregularities, conflicting striations or granulations which might obscure the resolution of underlying anatomical detail;

positioning the marker on the tissue having the predetermined tissue density; and

exposing the marker and the tissue to the x-ray radiation at the predetermined energy level, and generating a radiographic image of the tissue having the shadow of the marker superimposed thereon with any anatomical detail present in the tissue clearly visible through the radiographic shadow projected by the marker.