Precision mammographic needle biopsy system

• US 5,078,142 A
• Filed: 11/21/1989
• Issued: 01/07/1992
• Est. Priority Date: 11/21/1989
• Status: Expired due to Term

• Current Assignee: Siemens AG, Trex Medical Corp. (Thermo Fisher Scientific Incorporated)
• Original Assignee: Fischer Imaging Corporation
• Inventors: DePourbaix, Michael A., Siczek, Bernard W., Assa, Michael
• Primary Examiner(s): Howell, Kyle L.
• Assistant Examiner(s): NASSER, ROBERT L
• Application Number:
  US07/440,775
• Time in Patent Office: 777 Days
• Field of Search: 128/916, 128/660.09, 128/653 R, 128/653 A, 73/618, 73/619, 73/620, 378/37, 378/208, 378/209, 606/130, 364/413.01, 269/323, 269/322, 269/324, 269/325
• US Class Current: 600/407
• CPC Class Codes: A61B 10/0233 Pointed or sharp biopsy instruments
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 6/0414 with compression means
• CPC Class Codes: A61B 6/0435 with means for imaging suspended breasts
• CPC Class Codes: A61B 6/502 for diagnosis of breast, i.e. mammography
• CPC Class Codes: A61B 90/17 for soft tissue, e.g. breast-holding devices
• CPC Class Codes: H04N 13/239 using two 2D image sensors having a relative position equal to or related to the interocular distance H04N13/243 takes precedence
• CPC Class Codes: H04N 13/254 in combination with electromagnetic radiation sources for illuminating objects

Abstract

A precision mammographic needle biopsy system in which a patient having a suspected non-palpable lesion of the breast lies on a table having a breast aperture therein through which the patient'"'"'s breast pendulantly protrudes includes a compression paddle for selectively compressing the breast against an X-ray film holder to firmly hold the breast in a suitable projection; a radially pivoting X-ray arm arranged to direct an X-ray beam in horizontal alignment with the patient'"'"'s breast onto an X-ray film; a radially pivoting X-ray film holder arm supporting both the X-ray film holder and a puncture instrument holding a biopsy needle having adjustable azimuth angle, elevation angle, and insertion depth parameters; and a computer-digitizer console including a cursor and having a light box digitizer view area for viewing and digitizing a point of interest depicted in two stereoscopic X-ray images of the patient'"'"'s breast, a computer for analyzing the relative positions of the point of interest depicted on the two stereoscopic X-ray images with reference to a pair of reference marks projected onto each of the images and for determinig the location in 3-dimensional space of the point of interest specified by the azimuth angle, elevation angle, and insertion depth parameters of the biopsy needle, and a visual display for displaying these parameters to the operator.

Claims

1. A precision mammographic needle biopsy apparatus comprising:

table means for supporting a female patient in a prone position, the table means comprising a head portion having a breast aperture therein through which one of the patient'"'"'s breasts is permitted to pendulantly protrude for examination, the table means further comprising a foot portion hingedly attached to the head portion and arranged for gradual motion between a depending mounting and dismounting position and a position of substantial alignment with the head portion;

pedestal means supporting the table means, the pedestal means including motor control means for controllably raising and lowering the table means and for controllably, gradually moving the foot portion of the table means between the depending mounting and dismounting position and the position of substantial alignment with the head portion of the table means to facilitate mounting from a standing position and dismounting to a standing position by the patient, the motor control means being further operative for selectively tilting the table means, film holder arm, and X-ray arm in concert with respect to a horizontal plane;

a film holder arm pivotally mounted to the pedestal means, the film holder arm supporting an X-ray film holder, a compression paddle for compressing the patient'"'"'s pendulant breast into a mammographic position, and a puncture instrument for controllably retaining a biopsy needle; and

an X-ray arm pivotally mounted to the pedestal means in vertical alignment with the film holder arm, the X-ray arm supporting X-ray means for directing an X-ray beam in alignment with the patient'"'"'s compressed pendulant breast for impingement onto an X-ray film retained in the X-ray film holder to thereby produce an X-ray film image of the patient'"'"'s compressed pendulant breast.

2. A precision mammographic needle biopsy apparatus as in claim 1 wherein a patient receiving surface of the table means is generally concave with respect to a longitudinal axis of the table means.

3. A precision mammographic needle biopsy apparatus as in claim 1 wherein an area surrounding the breast aperture in the table means is dish-shaped to permit examination of a portion of the patient'"'"'s breast that is immediately adjacent her chest wall.

4. A precision mammographic needle biopsy apparatus as in claim 1, further comprising adjustable diaphragm means, rotatable within the breast aperture, for covering a selected portion of the breast aperture to prevent the one of the patient'"'"'s breasts not under examination from protruding at all through the breast aperture, while at the same time permitting the one of the patient'"'"'s breasts under examination to completely protrude through the breast aperture.

5. A precision mammographic needle biopsy apparatus as in claim 1, further comprising compression plate means supported on the film holder arm in a spaced relationship in front the X-ray film holder, the compression plate means cooperating with the compression paddle to compress the patient'"'"'s breast under examination into the mammographic position in a spaced relationship in front of the film holder to thereby magnify the X-ray film image of the patient'"'"'s compressed pendulant breast under examination.

6. A precision mammographic needle biopsy apparatus as in claim 1 further comprising a spring loaded biopsy gun controllably retained by said puncture instrument and operative for rapid insertion of the biopsy needle to an identified point of interest within the patient'"'"'s compressed pendulant breast.

7. A precision mammographic needle biopsy apparatus as in claim 1 wherein said puncture instrument includes a first means for permitting pivotal motion of the biopsy needle about a vertical pivoting axis, and a second means for permitting pivotal motion of the biopsy needle about a horizontal pivoting axis, said biopsy needle being retained with the puncture instrument in a position such that the biopsy needle lies in a plane common with a plane in which the horizontal pivoting axis lies.

8. A precision mammographic needle biopsy apparatus comprising:

table means for supporting a female patient in a prone position, the table means having a breast aperture therein through which one of the patient'"'"'s breasts is permitted to pendulantly protrude for examination;

pedestal means supporting the table means, the pedestal means including motor control means for controllably raising and lowering the table means;

a film holder arm supporting an X-ray film holder, a compression paddle for compressing the patient'"'"'s pendulant breast into a mammographic position, and a puncture instrument for controllably retaining a biopsy needle;

first tapered roller bearing means cooperatively coupling the film holder arm to the pedestal means for permitting radial motion of the film holder arm in a first horizontal plane;

an X-ray arm supporting X-ray means for directing an X-ray beam in alignment with the patient'"'"'s compressed pendulant breast for impingement onto an X-ray film retained in the X-ray film holder to thereby produce an X-ray film image of the patient'"'"'s compressed pendulant breast under examination; and

second tapered roller bearing means vertically aligned with the first tapered roller bearing means and cooperatively coupling the X-ray arm to the pedestal means for permitting radial motion of the X-ray arm in a second horizontal plane.

9. A precision mammographic needle biopsy apparatus as in claim 8, further comprising:

a circular detent plate rotationally mounted in vertical alignment with the first and second tapered roller bearing means, the circular detent plate having a plurality of wedge-shaped detents spaced along the periphery thereof;

arm lock means mounted to the pedestal means for selectively locking radial motion of the film holder arm and X-ray arm with respect to the pedestal means, the arm lock means including a first spring-loaded locking lever having a wedge-shaped lock tab at one end thereof adapted for mating engagement with a selected one of the plurality of wedge-shaped detents spaced along the periphery of the circular detent plate, the first spring-loaded locking lever having a wedge-shaped opening at a pivot end thereof adapted for engagement with a fixed pivot pin; and

X-ray arm lock means mounted to the pedestal means for selectively locking radial motion of the X-ray arm with respect to the film holder arm, the X-ray arm lock means including a second spring-loaded locking lever having a wedge-shaped lock tab at one end thereof adapted for mating engagement with a different selected one of the plurality of wedge-shaped detents spaced along the periphery of the circular detent planted, the second spring-loaded locking lever having a wedge-shaped opening at a pivot end thereof adapted for engagement with a fixed pivot pin.

10. A precision mammographic needle biopsy apparatus as in claim 8 further comprising a spring loaded biopsy gun controllably retained by said puncture instrument and operative for rapid insertion of the biopsy needle to an identified point of interest within the patient'"'"'s compressed pendulant breast,

11. A precision mammographic needle biopsy apparatus as in claim 8 wherein said puncture instrument includes a first means for permitting pivotal motion of the biopsy needle about a vertical pivoting axis, and a second means for permitting pivotal motion of the biopsy needle about a horizontal pivoting axis, said biopsy needle being retained within the puncture instrument in a position such that the biopsy needle lies in a plane common with a plane in which the horizontal pivoting axis lies.

12. A precision mammographic needle biopsy apparatus comprising:

table means for supporting a female patient in a prone position, the table means having a breast aperture therein through which one of the patient'"'"'s breasts is permitted to pendulantly protrude for examination;

pedestal means supporting the table means, the pedestal means including motor control means for controllably raising and lowering the table means;

a film holder arm pivotally mounted to the pedestal means for horizontal radial motion, the film holder arm supporting an X-ray film holder, a compression paddle for compressing the patient'"'"'s pendulant breast into a mammographic position, and a puncture instrument for controllably retaining a biopsy needle;

an X-ray arm pivotally mounted to the pedestal means in vertical alignment with the film holder arm, the X-ray arm adapted for horizontal radial motion and for supporting X-ray means for directing a first X-ray beam in alignment with the patient'"'"'s compressed pendulant breast for impingement onto an X-ray film retained in the X-ray film holder when the X-ray arm is in a first position relative to a plane of the X-ray film and for directing a second X-ray beam in alignment with the patient'"'"'s compressed pendulant breast for impingement onto the X-ray film when the X-ray arm is in a second position relative to the plane of the X-ray film to thereby produce first and second stereoscopic X-ray film images of the patient'"'"'s compressed pendulant breast under examination;

means for projecting aligned left and right reference marks onto the first and second stereoscopic X-ray film images; and

computer-digitizer means, including a digitizer platen/light box viewing surface and digitizer cursor means, the digitizer platen/light box viewing surface being operative for receiving the first and second stereoscopic X-ray film images of the patient'"'"'s compressed pendulant breast and for permitting the operator to view those first and second stereoscopic X-ray film images to identify a point of interest within the patient'"'"'s compressed pendulant breast depicted in each of the first and second stereoscopic X-ray film images, the computer-digitizer means being thereafter operative for digitizing, in response to actuation of the digitizer cursor means when sequentially positioned over the left and right reference marks and the identified point of interest depicted on the first and second stereoscopic X-ray film images, the identified point of interest with respect to the aligned left and right reference marks, the computer-digitzer means being further operative for automatically computing the spatial coordinates of the identified point of interest in terms of vertical angle, horizontal angle, and insertion depth parameters relative to insertion of the biopsy needle to the identified point of interest, and for visually displaying those computed spatial coordinates of the identified point of interest to the operator.

13. A precision mammographic needle biopsy apparatus as in claim 12 further comprising a spring-loaded biopsy gun controllably retained by the puncture instrument and operative for rapid insertion of the biopsy needle to the identified point of interest within the patient'"'"'s compressed pendulant breast.

14. A precision mammographic needle biopsy apparatus as in claim 12 wherein the puncture instrument further comprises horizontal angle control means, vertical angle control means, needle insertion depth control means, and motorized position encoder means coupled to the computer-digitizer means and responsive to computation thereby of the horizontal angle, vertical angle, and insertion depth parameters, for positioning the biopsy needle in correspondence with the computed verticle angle and horizontal angle parameters and for thereafter automatically inserting the biopsy needle into the patient'"'"'s compressed pendulant breast a distance corresponding to the computed insertion depth parameter to thereby position a tip of the biopsy needle at the identified point of interest within the patient'"'"'s compressed pendulant breast.

15. A precision mammographic needle biopsy apparatus as in claim 14 further comprising a spring-loaded biopsy gun controllably retained by the puncture instrument and operative for rapid insertion of the biopsy needle to the identified point of interest within the patient'"'"'s compressed pendulant breast.

16. A precision mammographic needle biopsy apparatus as in claim 12 wherein said puncture instrument includes a first means for permitting pivotal motion of the biopsy needle about a vertical pivoting axis, and a second means for permitting pivotal motion of the biopsy needle about a horizontal pivoting axis, said biopsy needle being retained within the puncture instrument in a position such that the biopsy needle lies in a plane common with a plane in which the horizontal pivoting axis lies.