Method for periprosthetic bone mineral density measurement

• US 5,480,439 A
• Filed: 02/01/1994
• Issued: 01/02/1996
• Est. Priority Date: 02/13/1991
• Status: Expired due to Term

• Current Assignee: Lunar Corporation
• Original Assignee: Lunar Corporation
• Inventors: Mazess, Richard B., Bisek, Joseph P., Hanson, James A.
• Primary Examiner(s): Willse, David H.
• Application Number:
  US08/189,821
• Time in Patent Office: 700 Days
• Field of Search: 623/16, 606/76-77, 128/661.03, 128/653.1, 378/4, 378/89, 378/90, 250/358.1
• US Class Current: 128/898
• CPC Class Codes: A61B 6/032 Transmission computed tomography [CT]
• CPC Class Codes: A61B 6/4035 the source being combined with a filter or grating
• CPC Class Codes: A61B 6/463 characterised by displaying multiple images or images and diagnostic data on one display
• CPC Class Codes: A61B 6/482 involving multiple energy imaging
• CPC Class Codes: A61B 6/505 for diagnosis of bone
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/32 for the hip
• CPC Class Codes: A61F 2/367 Proximal or metaphyseal parts of shafts trochanteric devices connected to said proximal parts A61F2/30739
• CPC Class Codes: A61F 2/3676 Distal or diaphyseal parts of shafts
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61F 2/4657 Measuring instruments used for implanting artificial joints for surgical instruments A61B90/06
• CPC Class Codes: A61F 2/468 Testing instruments for artificial joints for testing non-implantable prostheses A61F2/76
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2240/008 Means for testing implantable prostheses
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/00011 Metals or alloys
• CPC Class Codes: A61F 2310/00179 Ceramics or ceramic-like structures
• CPC Class Codes: G01T 1/163 Whole body counters hand or feet contamination measurement G01T1/167; lung, brain, thyroid, kidney or the like counting G01T1/16
• CPC Class Codes: G06T 2207/30008 Bone
• CPC Class Codes: G06T 7/62 of area, perimeter, diameter or volume
• CPC Class Codes: Y10S 623/914 : Bone

Abstract

A method of evaluating bone density around a radiolucent composite prosthesis establishes an implant boundary by fitting a stored template to radio-opaque reference markers embedded in the prosthesis. The implant boundary is used to create a measurement boundary displaced from the implant boundary toward the bone producing a conformal region of interest. Matched histograms of bone density in a lateral and medial such region of interest may be displayed to evaluate symmetrical stress effects. Alternatively, bone density may be displayed plotted along an axis cutting across the medial and lateral sides. Fiducial points are identified from the bone and implant morphology to ensure that either display will have a repeatable reference and hence that such displays will be directly comparable to later and earlier displays thereby aiding in the detection of bone change.

Claims

1. A method of evaluating bone quality in a patient having a substantially radiolucent prosthesis implanted in a bone, the prosthesis having at least one edge and having radiographically detectable reference markers, the method comprising the steps of:

collecting bone mineral density data over at least two dimensions, including portions of the prosthesis holding the reference markers, by means of a body penetrating digital imaging instrument, to generate a matrix of data values wherein the value of each data element of the matrix is proportional to the mineral content of the bone at the corresponding location in the dimensions;

employing an electronic computer to;

(a) analyze the matrix of data values to identify the location of the reference markers;

(b) determine the best fit of a stored template, having stored reference marker data and at least one stored edge, to the location of the reference markers;

(c) employ the best fit to identify an implant boundary within the matrix of data values based on the stored template edge;

(d) establish a measurement boundary translated from the implant boundary by a predetermined distance along a translation axis;

(e) calculate bone mineral density within a plurality of segments following the path of the measurement boundary to produce a set of segment values; and

(f) display a plot of segment values versus distance along the implant boundary.

2. The method of claim 1 including the step of analyzing the matrix of values to identify a fiducial point with respect to the bone and referencing an origin of the plot of segment values to the fiducial point.

3. The method of claim 1 wherein the implant has opposed medial and lateral edges and where the stored template provides a medial and lateral edge, wherein:

step (c) establishes a medial and lateral implant boundary based on the medial and lateral template edges;

step (d) establishes a medial and lateral measurement boundary translated by predetermined distances along a translation axis from the medial and lateral implant boundary; and

step (e) calculates bone mineral density within a plurality of segments following the path of the medial and lateral measurement boundaries; and

wherein

step (f) displays plots of segment values versus distance along the medial and lateral measurement boundaries with segment values plotted along first axes and distance along the implant boundary plotted along the second axes, where the second axes are aligned so that the corresponding medial and lateral segment values are aligned for comparison.

4. The method of claim 1 including the additional step of:

(g) calculating average bone mineral density of a predetermined number of segments along the implant boundary.

5. A method of evaluating bone quality in a patient having a substantially radiolucent prosthesis implanted in a bone, the prosthesis having at least one edge and having radiographically detectable reference markers, the method comprising the steps of:

collecting bone mineral density data over at least two dimensions, including portions of the prosthesis including the reference markers, by means of a body penetrating digital imaging instrument, to generate a matrix of data values wherein the value of each data element of the matrix is proportional to the mineral content of the patient at the corresponding location in the dimensions;

employing an electronic computer to;

(a) analyze the matrix of data values to identify the location of the reference markers;

(b) determine the best fit of a stored template, having stored reference marker data and at least one stored edge, to the location of the reference markers;

(c) employ the best fit to identify an implant boundary within the matrix of data values based on the stored template edge;

(d) establish a measurement boundary translated from the implant boundary by a predetermined distance along a translation axis;

(e) identifying a position of a fiducial point in the bone within the matrix of data elements;

(f) calculate bone mineral density within a plurality of segments following the path of a measurement axis having a predetermined distance and orientation with respect to said fiducial point and removed from the implant as defined by the measurement boundary; and

(g) display a plot of segment values versus distance along the measurement axis.

6. An apparatus to evaluate bone quality in a patient having a substantially radiolucent prosthesis implanted in a bone, the prosthesis having at least one edge and having radiographically detectable reference markers, the apparatus comprising:

a radiation source and detector for collecting bone mineral density data over at least two dimensions, including portions of the prosthesis holding the reference markers to generate a matrix of data values wherein the value of each data element of the matrix is proportional to the mineral content of the bone at the corresponding location in the dimensions;

an electronic computer operating according to a stored program so as to;

(a) analyze the matrix of data values to identify the location of the reference markers;

(b) determine the best fit of a stored template, having stored reference marker data and at least one stored edge, to the location of the reference markers;

(c) employ the best fit to identify an implant boundary within the matrix of data values based on the stored template edge;

(d) establish a measurement boundary translated from the implant boundary by a predetermined distance along a translation axis;

(e) calculate bone mineral density within a plurality of segments following the path of the measurement boundary to produce a set of segment values; and

(f) display a plot of segment values versus distance along the implant boundary.

7. The apparatus of claim 6 wherein the stored program includes the step of analyzing the matrix of values to identify a fiducial point with respect to the bone and referencing an origin of the plot of segment values to the fiducial point.

8. The apparatus of claim 6 wherein the implant has opposed medial and lateral edges and where the stored template provides a medial and lateral edge, wherein the stored computer program is such that:

step (c) establishes a medial and lateral implant boundary based on the medial and lateral template edges;

step (d) establishes a medial and lateral measurement boundary translated by predetermined distances along a translation axis from the medial and lateral implant boundary; and

step (e) calculates bone mineral density within a plurality of segments following the path of the medial and lateral measurement boundaries; and

wherein

step (f) displays plots of segment values versus distance along the medial and lateral measurement boundaries with segment values plotted along first axes and distance along the implant boundary plotted along the second axes, where the second axes are the aligned so that the corresponding medial and lateral segment values are aligned for comparison.

9. The apparatus of claim 6 wherein the stored computer program also:

(g) calculates average bone mineral density of a predetermined number of segments along the implant boundary.

10. An apparatus to evaluate bone quality in a patient having a substantially radiolucent prosthesis implanted in a bone, the prosthesis having at least one edge and having radiographically detectable reference markers, the apparatus comprising:

a radiation source and detector for collecting bone mineral density data over at least two dimensions, including portions of the prosthesis including the reference markers, to generate a matrix of data values wherein the value of each data element of the matrix is proportional to the mineral content of the patient at the corresponding location in the dimensions;

an electronic computer operating according to a stored program so as to;

(a) analyze the matrix of data values to identify the location of the reference markers;

(b) determine the best fit of a stored template, having stored reference marker data and at least one stored edge, to the location of the reference markers;

(c) employ the best fit to identify an implant boundary within the matrix of data values based on the stored template edge;

(d) establish a measurement boundary translated from the implant boundary by a predetermined distance along a translation axis;

(e) identifying a position of a fiducial point in the bone within the matrix of data elements;

(f) calculate bone mineral density within a plurality of segments following the path of a measurement axis having a predetermined distance and orientation with respect to said fiducial point and removed from the implant as defined by the measurement boundary; and

(g) display a plot of segment values versus distance along the measurement axis.