Device for palpation and mechanical imaging of the prostate

• US 6,142,959 A
• Filed: 07/22/1999
• Issued: 11/07/2000
• Est. Priority Date: 12/21/1992
• Status: Expired due to Fees

• Current Assignee: ProUroCare Medical, Inc.
• Original Assignee: Armed, LLC
• Inventors: Sarvazyan, Armen P., Egorov, Vladimir
• Primary Examiner(s): O'Connor, Cary
• Assistant Examiner(s): MARMOR II, CHARLES ALAN
• Application Number:
  US09/359,200
• Time in Patent Office: 474 Days
• Field of Search: 600/437, 600/438, 600/439, 600/440, 600/442, 600/443, 600/444, 600/445, 600/446, 600/561, 600/587
• 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 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/4381 Prostate evaluation or disorder diagnosis
• CPC Class Codes: A61B 5/6847 mounted on an invasive device
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• 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

The present invention relates to a method for mechanically imaging the prostate with a prostate examination device. In the method, position data and pressure response data are acquired along predetermined trajectories overlaying the prostate by periodic pressing or sliding of a pressure sensor assembly attached to a probe against the prostate. In a preferred embodiment, the prostate examination device comprises a probe sized to fit within the rectum and having a head connected by a shaft to a handle. A support is connected to the probe for providing a point of rest for the shaft during the prostate examination. As the pressure sensor assembly is pressed against and moved over the prostate, it generates signals in response to forces imposed on the pressure sensor assembly. A positioning system is coupled to the support and probe for determining position data of the pressure sensor assembly during prostate examination. An electronic unit receives the data from the pressure sensor assembly and the position data from the positioning system and determines a structure of the prostate.

Claims

1. A method for mechanically imaging a prostate comprising the steps of:

acquiring position data and pressure response data of a pressure sensor assembly during movement of said pressure sensor assembly along predetermined trajectories overlaying said prostate;

determining a plurality of positions and measured pressures of said pressure sensor assembly from said position data and said pressure response data;

calculating a pattern of pressure responses and pressure gradient responses from the determined plurality of positions and measured pressures; and

generating a mechanical image of the prostate from the calculated pressure responses and pressure gradient responses.

2. The method of claim 1 wherein said predetermined trajectories pass radially from the sphincter and said movement of said pressure sensor assembly along each of said trajectories away from the sphincter is performed without pressing of said pressure sensor assembly and said movement of said pressure sensor assembly toward the sphincter is performed with periodic pressing of said pressure sensor assembly against the prostate, thereby minimizing prostate displacement during prostate examination.

3. The method of claim 1 wherein said predetermined trajectories pass radially from the sphincter and said movement of said pressure sensor assembly along each of said trajectories away from the sphincter is performed without pressing of said pressure sensor assembly and said movement of said pressure sensor assembly toward the sphincter is performed under constant pressure with sliding of said pressure sensor assembly over the prostate in the rectum.

4. The method of claim 1 wherein said predetermined trajectories are formed of at least one radial trajectory passing radially from the sphincter and at least one lateral trajectory passing laterally from one side of the prostate to the other.

5. The method of claim 1 wherein said movement of said pressure sensor assembly along said predetermined trajectories is indicated in real-time during prostate examination on a display in a plane projection over said trajectories shown on the prostate image.

6. The method of claim 5 wherein an average level of pressure applied to said pressure sensor assembly is indicated on said display.

7. The method of claim 5 wherein said movement of said pressure sensor assembly along said predetermined trajectories is displayed beginning from the sphincter.

8. The method of claim 1 wherein said pressure sensor assembly comprises a plurality of pressure sensors and said step of determining a plurality of positions comprises:

determining an origin of a coordinate system connected to the human body; and

calculating the position of each of said pressure sensors in said coordinate system.

9. The method of claim 8 wherein said step of determining an origin of a coordinate system connected to the human body comprises the step of:

calculating coordinates of the sphincter in a coordinate system connected to a positioning system.

10. The method of claim 1 wherein said pressure sensor assembly comprises a plurality of pressure sensors and said step of calculating a pattern of pressure responses comprises the step of:

forming a data file containing pressure, position coordinates and time for all of said plurality of pressure sensors during prostate examination.

11. The method of claim 10 further comprising the step of eliminating data from tissue surrounding the prostate from said pattern of pressure responses to create a corrected pattern of pressure responses of the prostate.

12. The method of claim 1 wherein said step of calculating the pattern of pressure gradient responses comprises the step of:

calculating partial derivatives of pressure for said pattern of pressure responses to determine size and position of stiffer tissue inside the examined prostate.

13. The method of claim 12, wherein said pattern of pressure responses of the prostate is corrected subject to distortion from tissue hardness variations inside prostate to determine prostate geometrical features.

14. A prostate examination device comprising:

a probe sized to fit within the rectum and having a head connected by a shaft to a handle;

support means connected to said probe for providing a point of rest for said shaft during a prostate examination;

a pressure sensor assembly coupled to said head for generating signals in response to forces imposed on said pressure sensor assembly as said pressure sensor assembly is pressed against and moved over the prostate;

a positioning system coupled to said support means and probe for determining position data of said pressure sensor assembly during prostate examination; and

an electronic unit for receiving said signals from said pressure sensor assembly and said position data from said positioning system, determining and displaying a structure of said prostate from said pressure sensor signals and said position data.

15. The prostate examination device of claim 14 wherein said positioning system comprises:

a plurality of mechanical transducer elements for generating signals in response to movements of said handle relative to said support means.

16. The prostate examination device of claim 15 wherein each of said mechanical transducer elements comprises:

a load cell coupled to said support means and mechanically connected to said probe handle.

17. The prostate examination device of claim 16 wherein each of said mechanical transducer element comprises a load cell coupled to said support means and mechanically connected to said probe handle and said electronic unit further comprises:

a force sensing circuit responsive to the signals generated by said load cell for measuring the force imposed on each of said load cells of said positioning system.

18. The prostate examination device of claim 14 wherein said positioning system comprises:

a plurality of optical devices for generating signals in response to movements of said handle relative to said support means.

19. The prostate examination device of claim 18 wherein said each of optical devices comprises:

an opto-electronic pair having a receiving optical element coupled to said support means and a transmitting optical element connected to said handle.

20. The prostate examination device of claim 19 wherein said electronic unit comprises:

a distance sensing circuit responsive to the signals generated by said optical elements for determining the distance between said elements from the intensity of light received at said receiving elements and detecting the position of said probe relative to said support.

21. The prostate examination device of claim 14, wherein said positioning system comprises:

a plurality of capacitance transducers for generating signals in response to movements of said handle relative to said support means.

22. The prostate examination device of claim 21 wherein each of said capacitance transducers comprises:

a first electrode connected to said support means and a second electrode connected to said shaft for determining the distance between said first electrode and said second electrode.

23. The prostate examination device of claim 22 wherein said electronic unit further comprises:

a distance sensing circuit responsive to the signals generated by said capacitance transducers for detecting the position of said probe relative to said support.

24. The prostate examination device of claim 14 wherein said support means comprises:

a slot with a revolving locker for locking said probe in a working position.

25. The prostate examination device of claim 14 wherein said support means is connected to said probe with a ball and socket joint, said ball and socket joint providing rotational motion of said shaft.

26. The prostate examination device of claim 14 wherein said pressure sensor assembly comprises:

a plurality of flexing diaphragms containing strain gages bonded to an inner side of said flexing diaphragms.

27. The prostate examination device of claim 14 wherein said pressure sensor assembly comprises:

a plurality of flexing diaphragms positioned in a cylinder filled with an elastic compound, whereby strain gages are bonded to an inner side of said flexing diaphragms.

28. The prostate examination device of claim 14 wherein said pressure sensor assembly comprises:

a plurality of microfabricated pressure sensors integrated into a monolithic sensor-circuit chip and a sensing surface of said pressure sensors is covered with an elastic protective film.

29. The prostate examination device of claim 14 wherein said head comprises:

a biconvex sensing surface and a plurality of pressure sensors are arranged in a few lines along said biconvex sensing surface.

30. The prostate examination device of claim 14 wherein said head comprises:

a flat sensing surface and a plurality of pressure sensors arranged in a few lines along said flat sensing surface, and said sensing surface is inclined to an axis of said shaft.

31. A prostate examination device comprising:

a probe sized to fit within the rectum and having a head connected by a shaft to a handle;

a pressure sensor assembly coupled to said head for generating signals in response to forces imposed on said pressure sensor assembly as said pressure sensor assembly is pressed against and moved over the prostate;

a positioning system comprising a triaxial accelerometer; and

an electronic unit for receiving said signals from said pressure sensor assembly and said position data from said positioning system and determining and displaying a structural image of said prostate from said pressure response signals and said position data.

32. The prostate examination device of claim 31 wherein said electronic unit comprises:

an acceleration sensing circuit responsive to the signals generated by said accelerometer for detecting accelerations;

a plurality of analog integrating circuits connected to said acceleration sensing circuit for detecting relative 3D motion of said probe during a prostate examination; and

a storage device for storing results of the prostate examination.