System for examining, mapping, diagnosing, and treating diseases of the prostate

• US 6,824,516 B2
• Filed: 03/11/2003
• Issued: 11/30/2004
• Est. Priority Date: 03/11/2002
• Status: Active Grant

• Current Assignee: Medili Technology (H.K.) Limited
• Original Assignee: Medili Technology (H.K.) Limited
• Inventors: Companion, John A., Batten, Bobby G.
• Primary Examiner(s): IMAM, ALI M
• Application Number:
  US10/385,577
• Publication Number:
  US 20030171678A1
• Time in Patent Office: 630 Days
• Field of Search: 600/407, 600/437-472, 600/587, 606/108, 324/318, 324/322, 601/2, 601/3, 128/898, 736/25--33
• US Class Current: 600/439
• CPC Class Codes: A61B 10/0241 for prostate
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 8/0833 involving detecting or locating foreign bodies or organic structures
• 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 8/4254 using sensors mounted on the probe
• CPC Class Codes: A61B 8/485 involving measuring strain or elastic properties
• CPC Class Codes: A61B 8/5238 for combining image data of patient, e.g. merging several images from different acquisition modes into one image for image registration algorithms G06T7/30
• CPC Class Codes: A61N 2005/1011 Apparatus for permanent insertion of sources
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

A holistically integrated ultrasonic system for examining, mapping, diagnosing, and treating diseases of the prostate gland in a male human includes an ultrasonic transrectal probe and an ultrasonic transurethral probe. Each of these probes is adapted to pulse and to receive, as well as to produce and operate within a liquid-filled volume of the lumen into which they are inserted. Each probe is in operative communication with an integrated patient support platform and an integrated expert system. The integrated expert system collects data transmitted by sensors in the transrectal and transurethral probes and produces level-of-suspicion mapping of the prostate gland with cancer probability assessments for areas contained within the level-of-suspicion mapping. The integrated expert system communicates with, and provides targeting coordinates for operation of an automated slave biopsy subsystem and directs a biopsy needle to a selected point within the prostate gland. The biopsy needle includes a means for extracting a biopsy tissue sample from the prostate gland. The integrated patient support platform includes a multi-degree of freedom positioning chair which optimizes positioning of a patient for scanning and biopsy procedures and affords repeatability thereof.

Claims

1. A holistically integrated ultrasonic system for examining, mapping, diagnosing, and treating diseases of the prostate gland in a male human, the system comprising:

an ultrasonic transrectal probe and an ultrasonic transurethral probe, each of which is outfitted to pulse and to receive, and each of which is in operative communication with an integrated patient support platform;

the ultrasonic transrectal probe adapted to produce and operate within a liquid-filled volume of the rectum of the male human, and the ultrasonic transurethral probe adapted to produce and operate within a liquid-filled volume of the urethra of the male human;

the ultrasonic transrectal probe being adapted to remain in a fixed position after being inserted into the rectum of the male human, and the ultrasonic transrectal probe having ultrasonic sensors therein which are adapted for movement by a motor controlled by a computer, so that ultrasonic scans of the prostate gland are effected;

the ultrasonic transurethral probe being adapted to remain in a fixed position after being inserted into the urethra of the male human, and the ultrasonic transurethral probe having ultrasonic sensors therein which are adapted for movement by a motor controlled by a computer, so that ultrasonic scans of the prostate gland are effected;

the ultrasonic transrectal probe containing an integrated position sensor suite which provides angular and relational data to an integrated expert system;

an integrated expert system which collects data transmitted by sensors in the ultrasonic transrectal and the ultrasonic transurethral probes, utilizing analytical techniques and integrated results to produce level-of-suspicion mapping of the prostate gland with cancer probability assessments for areas contained within the level-of-suspicion mapping.

2. The system of claim 1, wherein the ultrasonic transrectal probe and the ultrasonic transurethral probe are adapted to produce and operate within aqueous liquid-filled volumes of the rectum of the male human and the urethra of the male human respectively.

3. The system of claim 1, wherein the ultrasonic transrectal probe is outfitted with a duct which provides a bleed off of air from the rectum of the male human, thereby allowing liquid to completely fill the volume of the rectum of the male human within which the ultrasonic transrectal probe is adapted to operate.

4. The system of claim 1, wherein the integrated patient support platform is in operative communication with a coacting automated slave biopsy subsystem the operation of which is controlled by position targeting data provided by functions of the ultrasonic transrectal probe and the integrated expert system, the automated slave biopsy subsystem being also adapted for specific area selection by a medical practitioner, as well as for achieving a redundancy-in-safety consideration.

5. The system of claim 4, wherein the integrated expert system comprises a software package containing predetermined distance and angle data for scan positions within the ultrasonic transrectal probe, together with mathematical equations, coupled with means employed in conjunction with ultrasonic data collection for deriving targeting coordinates for operation of the automated slave biopsy subsystem and direction of a biopsy needle to a selected point within the prostate gland.

6. The system of claim 5, wherein the biopsy needle is coupled with means for extracting a biopsy tissue sample from the prostate gland.

7. The system of claim 1, wherein the integrated patient support platform comprises a multi-degree of freedom positioning chair subsystem which is equipped with means for optimizing positioning of a patient for ultrasonic scanning procedures and recording an optimum position of the patient, thereby affording repeatability of ultrasonic scanning procedures for that patient.

8. The system of claim 1, wherein the integrated expert system includes a means for electronically storing complete data collection, mapping, and cancer probability assessments for each examination of a patient, coupled with means for automatically identifying changes in conditions between successive examinations of that patient.

9. The system of claim 1, which additionally comprises a catheter/catheter feeder operatively associated with the ultrasonic transurethral probe to facilitate effective utilization thereof, and a coacting articulated fiber optic scope to serve as a guide for optimal placement of the catheter within the urethra.

10. The system of claim 1, which additionally comprises dual ultrasonic sensors located within the ultrasonic transrectal probe to facilitate data collection and analysis, with application to shadow analysis, the dual ultrasonic sensors being selected from the group consisting of conventional transducers and phased arrays.

11. The system of claim 1, which additionally comprises pulse/echo means for evaluating tissue of the prostate gland, coacting with dynamic elastography means for evaluating induced vibration of tissue of the prostate gland, coacting with doppler means for measuring both induced dynamic vibration and blood flow for imaging and assessing vascular environment within the prostate gland, coupled with 4D doppler means for analyzing dynamic excitation of tissue of the prostate gland.

12. The system of claim 1, wherein the ultrasonic transrectal probe additionally comprises optical means for facilitating hand insertion, as well as mechanically supported introduction, of the ultrasonic transrectal probe into the rectum of the male human.

13. The system of claim 5, wherein the automated slave biopsy subsystem includes a modified biopsy needle, which is interchangeable with the biopsy needle, the modified biopsy needle being outfitted to include means for delivering thermal energy or a medication into the center of a small cancer of the prostate gland for eradication of the cancer.

14. The system of claim 5, wherein the automated slave biopsy subsystem includes a modified biopsy needle, which is interchangeable with the biopsy needle, the modified biopsy needle being outfitted to include means for introducing an eddy current into the center of a determined anomalous area of the prostate gland, in order to measure bioimpedance differential characteristics and thereby distinguish between a benign and a malignant anomalous area of the prostate gland.

15. The system of claim 6, wherein the biopsy needle has a symmetrical, wedge-shaped tip which is open on the forward aspect thereof and comprises integral side plates having conformal guides on inner faces thereof, which conformal guides force coacting dual square-ended cutting blades to follow curvature of the side plates and curve in behind a captive biopsy tissue sample to retain the captive biopsy tissue sample for subsequent extraction from the prostate gland.

16. The system of claim 5, wherein the automated slave biopsy subsystem is adapted to include means for automatically implanting radioactive seeds in the prostate gland in a brachytherapy procedure.

17. The system of claim 16, wherein the means for automatically implanting radioactive seeds in the prostate gland includes means for implanting radioactive seeds having a non-uniform radiation pattern to provide focusing and control over radiation deposition patterns, thereby preventing unwanted damage to viable tissue, coupled with means for providing rotational capability of the biopsy needle, thereby controlling the orientation of the radioactive seeds having a non-uniform radiation pattern.

18. The system of claim 5, wherein the automated slave biopsy subsystem includes means for removal of a cancer of the prostate gland in an endosurgical procedure.

19. The system of claim 5, additionally comprising means for providing verification of the targeting coordinates prior to direction of the biopsy needle to a selected point within the prostate gland.

20. The system of claim 1, wherein the ultrasonic transrectal probe and has a cover comprising:

a first integral passageway containing means for providing liquid filling of a lumen into which the ultrasonic probe is to be inserted, in order to afford a continuous path for ultrasonic examination; and

a second integral passageway containing means for inserting a fiber optic probe therein.

21. The system of claim 1, wherein high frequency ultrasound is employed as a modality for examining, mapping, diagnosing, and treating diseases of the prostate gland in a male human.

22. The system of claim 1, which employs a modality other than ultrasonics for examining, mapping, diagnosing, and treating diseases of the prostate gland in a male human.