Device for breast haptic examination

• US 5,833,633 A
• Filed: 11/03/1997
• Issued: 11/10/1998
• Est. Priority Date: 12/21/1992
• Status: Expired due to Term

• Current Assignee: ProUroCare Medical, Inc.
• Original Assignee: Artann Laboratories Inc.
• Inventors: Sarvazyan, Armen Paruir
• Primary Examiner(s): Nasser, Robert L.
• Application Number:
  US08/963,385
• Time in Patent Office: 372 Days
• Field of Search: 600/587, 600/561, 600/437, 73/818, 73/788, 73/789, 73/790, 73/794-6, 73/798
• US Class Current: 600/587
• CPC Class Codes: A61B 1/0052 Constructional details of control elements, e.g. handles
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 5/0053 by applying pressure, e.g. compression, indentation, palpation, grasping, gauging
• CPC Class Codes: A61B 5/036 by means introduced into body tracts A61B5/032 and A61B5/035 take precedence
• CPC Class Codes: A61B 5/064 using markers A61B5/062 takes precedence
• CPC Class Codes: A61B 5/4312 Breast evaluation or disorder diagnosis A61B5/0091 takes precedence
• CPC Class Codes: A61B 8/0825 for diagnosis of the breast, e.g. mammography
• CPC Class Codes: A61B 8/0833 involving detecting or locating foreign bodies or organic structures
• CPC Class Codes: A61B 8/406 using means for diagnosing suspended breasts
• CPC Class Codes: A61B 8/485 involving measuring strain or elastic properties
• CPC Class Codes: G01S 7/52042 determining elastic properties of the propagation medium or of the reflective target diagnostic techniques involving the measurement of strain A61B8/485

Abstract

In one embodiment of the invention, a pressure sensor array, data acquisition circuit, and a microprocessor are mounted in a hand held pad. Detection of nodules is achieved by analyzing the dynamic and spatial features of the pressure pattern while the probe pressed to the breast is periodically moved transversely to the ribs. The ribs play a role as an amplifier of the measured effect. The device will be able to objectively detect the presence of lumps in a breast and provide a warning signal. Another embodiment of the invention is a clinical device for imaging the mechanical structure of the examined breast and diagnosing diseases accompanied by changes in the elasticity of breast tissue. This embodiment is made up of an electronically controlled mechanical scanning unit incorporated into a patient support bed. The mechanical scanning unit includes a compression mechanism and positioning system, a local pressure source located opposite a pressure sensor array, and electronic control and interface circuitry. The local pressure source is either a roller moving over the examined breast, or in another embodiment, an indenter which can be moved in all three dimensions and be controlled either automatically by a computer or manually by a mouse. In yet another embodiment, the mechanical scanning system serves as a biopsy guidance means and determines target lesions in the breast to be reached by a biopsy gun or aspiration needle.

Claims

1. A method of identifying a region within a tissue portion of a human breast having a different elasticity than the surrounding tissue, said method comprising the steps of:

causing a deformation of an examined tissue portion of said breast;

detecting temporal and spatial changes in a pressure pattern caused by said deformation measured simultaneously at a plurality of locations on an accessible surface of the tissue portion;

defining a model of the tissue portion with homogenous tissue and with boundary conditions corresponding to the examined tissue portion;

evaluating respective temporal and spatial changes in the pressure pattern for said defined model under the same loading conditions as in the detecting step;

adjusting iteratively said defined model by varying a spatial distribution of modulus of elasticity in the model to minimize the difference between temporal and spatial changes in the pressure pattern obtained in the detecting step and the respective temporal and spatial changes in the pressure pattern evaluated for the adjusted model, thereby obtaining spatial distribution of elasticity modulus in the tissue portion; and

visualizing and displaying spatial distribution of modulus of elasticity in said adjusted model of the examined tissue portion for indicating the presence and location of a differing elasticity region of tissue within the tissue portion.

2. The method of claim 1 wherein the causing a deformation step further comprises creating strain and stress in the tissue portion placed between a pressure sensing array and a support member by moving the pressure sensing array and the support member in respect to each other.

3. The method of claim 2 wherein the causing a deformation step further comprises urging the tissue of the tissue portion toward the support member.

4. The method of claim 2 wherein the causing a deformation step further comprises shifting laterally the surface of the tissue portion along the support member, thereby causing shear deformation in the tissue portion.

5. The method of claim 2, wherein said support member is a rib cage.

6. The method of claim 5 wherein the causing a deformation step further comprises shifting laterally the tissue portion along the rib cage in direction perpendicular to the ribs.

7. A device of identifying a region with a tissue portion of human breast having a different elasticity than the surrounding tissue, said method comprising the steps of:

means for causing a deformation of an examined tissue portion of said breast, thereby causing stress and strain in the examined tissue portion;

means for detecting temporal and spatial changes in a pressure patter measured on the surface of the examined tissue portion;

means for defining a model of the tissue portion with homogenous tissue and with boundary conditions corresponding to the examined tissue portion;

means for evaluating respective temporal and spatial changes in the pressure pattern for said defined model under the same loading conditions as in the detecting step;

means for comparing the temporal and spatial changes in the pressure pattern obtained in the detecting step and the temporal and spatial changes in the pressure pattern evaluated in the evaluating step, the difference indicating the presence and location of a differing elasticity region of tissue within the tissue portion;

means for adjusting iteratively said defined model by varying a spatial distribution of modulus of elasticity in the model to minimize the difference between temporal and spatial changes in the pressure pattern obtained in the detecting step and the respective temporal and spatial changes in the pressure pattern evaluated for the adjusted model, thereby obtaining spatial distribution of elasticity modulus in the tissue portion;

means for visualizing and displaying spatial distribution of modulus of elasticity in said adjusted model of the examined tissue portion for indicating the presence and location of a differing elasticity region of tissue within the tissue portion; and

wherein said device is a hand-held unit comprising a pressure sensing array connected to a microprocessor capable of detecting regions of the tissue within a tissue portion having a different elasticity than the surrounding tissue and producing a warning signal.

8. A device of identifying a region within a tissue portion of a human breast having a different elasticity than the surrounding tissue, said method comprising the steps of:

means for causing a deformation of an examined tissue portion of said breast, thereby causing stress and strain in the examined tissue portion;

means for detecting temporal and spatial changes in a pressure pattern measured on the surface of the examined tissue portion;

means for defining a model of the tissue portion with homogenous tissue and with boundary conditions corresponding to the examined tissue portion;

means for evaluating respective temporal and spatial changes in the pressure pattern for said defined model under the same loading conditions as in the detecting step;

means for comparing the temporal and spatial changes in the pressure pattern obtained in the detecting step and the temporal and spatial changes in the pressure pattern evaluated in the evaluating step, the difference indicating the presence and location of a differing elasticity region of tissue within the tissue portion;

means for adjusting iteratively said defined model by varying a spatial distribution of modulus of elasticity in the model to minimize the difference between temporal and spatial changes in the pressure pattern obtained in the detecting step and the respective temporal and spatial changes in the pressure pattern evaluated for the adjusted model, thereby obtaining spatial distribution of elasticity modulus in the tissue portion;

means for visualizing and displaying spatial distribution of modulus of elasticity in said adjusted model of the examined tissue portion for indicating the presence and location of a differing elasticity region of tissue within the tissue portion; and

wherein the means for causing a deformation of the tissue portion comprises an additional means producing local deformation of the surface of the tissue portion, the second deformation occurring over a substantially smaller area than the region of the first deformation, the local deformation producing means is a roller moveable along the surface of the breast.

9. A device of identifying a region within a tissue portion of a human breast having a different elasticity than the surrounding tissue, said method comprising the steps of:

means for causing a deformation of an examined tissue portion of said breast, thereby causing stress and strain in the examined tissue portion;

means for detecting temporal and spatial changes in a pressure pattern measured on the surface of the examined tissue portion;

means for defining a model of the tissue portion with homogenous tissue and with boundary conditions corresponding to the examined tissue portion;

means for evaluating respective temporal and spatial changes in the pressure pattern for said defined model under the same loading conditions as in the detecting step;

means for comparing the temporal and spatial changes in the pressure pattern obtained in the detecting step and the temporal and spatial changes in the pressure pattern evaluated in the evaluating step, the difference indicating the presence and location of a differing elasticity region of tissue within the tissue portion;

means for adjusting iteratively said defined model by varying a spatial distribution of modulus of elasticity in the model to minimize the difference between temporal and spatial changes in the pressure pattern obtained in the detecting step and the respective temporal and spatial changes in the pressure pattern evaluated for the adjusted model, thereby obtaining spatial distribution of elasticity modulus in the tissue portion;

means for visualizing and displaying spatial distribution of modulus of elasticity in said adjusted model of the examined tissue portion for indicating the presence and location of a differing elasticity region of tissue within the tissue portion; and

wherein the means for causing a deformation of the tissue portion comprises an additional means producing local deformation of the surface of the tissue portion, the second deformation occurring over a substantially smaller area than the region of the first deformation, the local deformation producing means is an extendible indenter, capable of moving in all three dimensions.

10. The device of claim 9 further comprising:

a pressure sensor measuring the pressure exerted by the indenter to the tissue;

a mouse controlling the position of the indenter by moving the mouse over a pad and controlling the pressure exerted by the indenter on the tissue using a button controlled by an operator'"'"'s finger, so that the operator has a feeling of changes in the local stress caused by the indenter;

computer means for analyzing temporal and spatial changes in pressure exerted by the indenter on the tissue portion and for evaluating the presence, location and dimentions of regions of the tissue within the investigated tissue portion having a different elasticity than the surrounding tissue;

a means for displaying an image of the tissue portion with the region of a different elasticity to provide a feedback information to an operator about the relative position of the probing indenter and the applied pressure.