Apparatus and method for mechanical imaging of breast

• US 6,620,115 B2
• Filed: 04/26/2001
• Issued: 09/16/2003
• Est. Priority Date: 04/28/2000
• Status: Expired due to Term

• Current Assignee: ProUroCare Medical, Inc.
• Original Assignee: Armed, LLC
• Inventors: Sarvazyan, Armen P., Egorov, Vladimir
• Primary Examiner(s): Hindenburg, Max F.
• Assistant Examiner(s): WINGOOD, PAMELA LYNN
• Application Number:
  US09/843,056
• Publication Number:
  US 20020004630A1
• Time in Patent Office: 873 Days
• Field of Search: 600/587, 600/595
• US Class Current: 600/587
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 2562/043 in a linear array
• 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 5/4312 Breast evaluation or disorder diagnosis A61B5/0091 takes precedence
• CPC Class Codes: A61B 5/6835 Supports or holders, e.g., articulated arms

Abstract

A method and device in accordance with the present invention enabling detecting mechanical and structural properties of the breast tissue that are indicative of breast cancer. Detection of nodules is achieved by placing the breast into a mechanical scanning unit comprising of a two-dimensional pressure sensor array and a mobile linear pressure sensor array located opposite to the two-dimensional pressure sensor array, and analyzing the signals from the pressure sensors. The device is able to objectively detect presence of lesions suspicious for cancer or other breast pathologies in the breast and provide means for computerized three-dimensional mechanical imaging of the breast.

Claims

1. A breast examination device comprising:

a scanning housing receiving a breast;

a linear pressure sensor array formed of a plurality of first sensors and a two-dimensional pressure sensor array formed of a plurality of second sensors, each of said first sensors and said second sensors producing a signal in response to pressure imposed on said respective sensor as said first sensors and said second sensors are pressed and moved against the breast tissue in a predetermined manner, said linear pressure sensor array and said two dimensional pressure array being coupled to said scanning housing;

a robotic positioning system coupled to said scanning housing for positioning said linear pressure sensor array integrated with a compression mechanism for mechanical compression and a scanning unit for scanning of the breast located inside said scanning housing;

a positioning system for linear and rotary displacement of said scanning housing; and

an electronic unit for providing acquisition, scanning, processing and displaying of mechanical imaging data from said first sensors and said second sensors,

wherein said linear pressure sensor array comprises plurality of flexing diaphragms positioned in a cylinder filled with an elastic compound and strain gages bonded to an inner side of said flexing diaphragms.

2. A breast examination device comprising:

a scanning housing receiving a breast;

a linear pressure sensor array formed of a plurality of first sensors and a two-dimensional pressure sensor array formed of a plurality of second sensors, each of said first sensors and said second sensors producing a signal in response to pressure imposed on said respective sensor as said first sensors and said second sensors are pressed and moved against the breast tissue in a predetermined manner, said linear pressure sensor array and said two dimensional pressure array being coupled to said scanning housing;

a robotic positioning system coupled to said scanning housing for positioning said linear pressure sensor array integrated with a compression mechanism for mechanical compression and a scanning of the breast located inside said scanning housing, said robotic positioning system comprises a plurality of linear actuators and rotary actuators to provide three-dimensional motion of said linear pressure sensor array;

a positioning system for linear and rotary displacement of said scanning housing; and

and an electronic unit for providing acquisition, scanning, processing and displaying of mechanical imaging data from said first sensors and said second sensors, wherein said compression mechanism comprises;

an airbag mounted on a support connected to one of said linear actuators;

a pressure controller to maintain a predetermined pressure in said airbag; and

a holder for holding said two-dimensional pressure sensor array.

3. The breast examination device of claims 2 wherein said scanning unit is located between said airbag and said holder.

4. A breast examination device comprising:

a scanning housing receiving a breast;

a linear pressure sensor array formed of a plurality of first sensors and a two-dimensional pressure sensor array formed of a plurality of second sensors, each of said first sensors and said second sensors producing a signal in response to pressure imposed on said respective sensor as said first sensors and said second sensors are pressed and moved against the breast tissue in a predetermined manner, said linear pressure sensor array and said two dimensional pressure array being coupled to said scanning housing;

a robotic positioning system coupled to said scanning housing for positioning said linear pressure sensor array integrated with a compression mechanism for mechanical compression and a scanning unit for scanning of the breast located inside said scanning housing;

a positioning system for linear and rotary displacement of said scanning housing; and

an electronic unit for providing acquisition, scanning, processing and displaying of mechanical imaging data from said first sensors and said second sensors,

wherein said scanning unit comprises;

a plurality of rollers, at least one of said rollers is pressed against the breast and used for total scanning of the breast by means of linear motion of said scanning unit;

a head coupled to said linear pressure sensor array providing oscillating scanning of the breast by means of back-and-forth motion along a predetermined axis and moving up and down against the breast; and

a rotary actuator with at least two predetermined positions for changing the pressing of said linear pressure sensor array against the breast.

5. A method for mechanical imaging the breast comprising the steps of:

placing the breast into a scanning housing of a breast examination device, said breast examination device comprising a scanning housing receiving the breast;

a linear pressure sensor array formed of a plurality of first sensors and a two-dimensional pressure sensors array formed of a plurality of second sensors, each of said first sensors and said second sensors producing a signal in response to pressure imposed on said respective sensor as said first sensor and said second sensor are pressed and moved against the breast tissue in a predetermined manner, said linear pressure sensor array and said two dimensional pressure array being coupled to said scanning housing;

a robotic positioning system for positioning said linear pressure sensor array integrated with a compression mechanism for mechanical compression and a scanning unit for scanning of the breast located inside said scanning housing coupled to said scanning housing;

said compression mechanism comprising;

an airbag mounted on a support connected to one of said linear actuators;

a pressure controller to maintain a predetermined pressure in said airbag; and

a flat holder for holding said two-dimensional pressure sensor array;

compressing the breast by means of lowering said scanning unit towards the breast and following increase of pressure in said airbag;

scanning of the breast by means of linear movement of in said scanning unit;

scanning of the breast by means of a local oscillatory deformation of the breast tissue portion by said linear pressure sensor array being pressed against that tissue portion; and

acquiring pressure response data of said linear pressure sensor array and said two-dimensional pressure sensor array during the said scanning steps.

6. The method of claim 5 further comprising:

repeating said oscillatory deformation over a plurality of the breast tissue portions;

and detecting oscillatory signal from said first sensors.

7. The method of claim 6 further comprising:

synchronizing and filtrating pressure response data from first sensors and said second sensors.

8. The method of claim 7 further comprising;

correcting displacement and shifting of the breast during examination;

correcting noise of said signals and of said first sensors and said second sensors;

analyzing spectral and phase characteristics of said pressure response data; and

analyzing spatial and temporal derivatives of said pressure response data.

9. The method of claim 8 further comprising the steps of:

evaluating type and degree of mechanical heterogeneity of the examined breast; and

evaluating deviation of the type and degree of mechanical heterogeneity of the breast from the normal range of mechanical heterogeneity of the breast.

10. The method of claim 8 further comprising the steps of:

calculating a pattern of pressure responses and pressure gradient responses of the breast from said pressure response data;

calculating geometrical parameters and hardness in local regions of the breast;

determining mechanical and geometrical features of the inner structures of the breast; and

comparing said mechanical and geometrical features to a normal state of the breast using information from a database.

11. The method of claim 5 further comprising the steps of:

synthesizing and displaying a mechanical image of the breast.