Prostate BPH and tumor detector also useable on other tissues

• US 20070293792A1
• Filed: 06/15/2007
• Published: 12/20/2007
• Est. Priority Date: 06/15/2006
• Status: Abandoned Application

• Current Assignee: Bryan Oronsky, John Sliwa
• Original Assignee: Bryan Oronsky, John Sliwa
• Inventors: Sliwa, John, Oronsky, Bryan
• Application Number:
  US11/818,685
• Publication Number:
  US 20070293792A1
• Time in Patent Office: Days
• US Class Current: 600/587
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 5/0051 by applying vibrations
• 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 5/6826 Finger
• CPC Class Codes: A61B 5/6838 Clamps or clips
• CPC Class Codes: A61B 5/6847 mounted on an invasive device

Abstract

Prostate probe systems are disclosed for assessing one or both of BPH or prostate cancer. The prostate probe systems comprise either a force or pressure sensor mounted on or in a rectally insertable probe or a temperature sensor mounted on or in a rectally insertable probe, or both. Also disclosed are probe systems for evaluating a condition of a prostate gland. Finally, force or hardness mapping devices are disclosed for palpation-examination of patient anatomical tissues for abnormalities or assessing states of firmness.

Claims

1. A prostate probe system for assessing one or both of BPH or prostate cancer comprising:

(a) a force or pressure sensor mounted on, in or to a rectally insertable probe and necessary means to power, connect to, switch and read data from the sensor;

(b) the force or pressure being measured during probe insertion from or at the rectal wall at two or more wall locations adjacent or juxtaposed to the prostate;

(c) the sensed force or pressure data from the two or more location'"'"'s forming a force-map, pressure-map or data array relevant to the patient'"'"'s underlying prostate condition or prognosis;

(d) the sensed data or force map being utilized at the time of the exam or later after the exam to compare the patients data to at least some other data from at least one other exam,

(e) a conclusion or recommendation regarding the patient'"'"'s prostate condition thereby being providable by a practitioner to a patient based at least partly on a quantitative data comparison;

the probe optionally including one or more of;

(1) a mechanical exciter integrated in or capable of being mechanically coupled to the probe to excite at least a prostate anatomical portion;

(2) a motion, deflection, angle or inertial sensor of any type integrated in or couple able to the probe to track or monitor at least one probe or sensor position, orientation, angle, velocity or acceleration;

(3) a deflectable or inflatable balloon, membrane or mechanism capable of applying a load or deflection to one or more of the probe, the probe'"'"'s sensor, or the anatomy to improve the probes performance or sensitivity;

or

(4) an inflatable balloon or membrane used, at least in part, to measure a volume or compliance of any of a rectal wall or cavity or to heat or cool anatomy.

2. The probe system of claim 1 wherein any of the force or pressure readings are taken any of:

(a) while the patient and probe are essentially static or in mechanical equilibrium except for unavoidable perfusion and breathing motions;

(b) before, during or after the patient intentionally moves, distorts himself, squats, or bounces his anatomy or simulates a bowel movement;

(c) before, during or after the clinician moves or manipulates the probe or sensor manually, or with the aid of a probe-based sensor scanning means;

(d) before, during or after the clinician moves, manipulates, vibrates or oscillates the probe or anatomy with the optional deflectable or inflatable balloon, membrane or deforming mechanism;

(e) by moving the probe or its sensor in any translational, rotational or angular manner to take any of static, dynamic or transient readings;

(f) substantially simultaneously or in close temporal sequence from two or more different locations by two or more corresponding sensor sub-elements located, at the data-reading time, at those locations within a juxtaposed sensor array, some of those readings being at least one of static, dynamic or transient force or pressure readings;

(g) as triggered by a position or orientation sensor reading;

(h) as triggered by software;

(i) under a state of known prostate loading, excitation, oscillation or vibration;

or

j) with accompanying patient identification data.

3. The probe system of claim 1 wherein the probe is or has at least one of:

(a) is finger(s) mounted or attached;

(b) is a handheld probe at least during insertion or removal;

(c) is a probe held by a patient-external exciter means;

(d) is a probe at least partially covered or wrapped in a condom, sheath or membrane while inserted;

(e) is a probe or has a probe sensor that is at least partially contained in, covered by, or manipulated by an inflatable membrane, balloon or deflecting or deforming mechanism;

(f) is a probe that can be immersed in at least one flowable gaseous or liquid-like inflating medium one or both of with or without a containment balloon or membrane;

(g) has a sensor array wrapped-upon, suctioned to, adhered to, fastened, clamped or clipped to or otherwise mounted to at least one surface portion or surface region of the probe;

(h) has a sensor array that is any of (i) 1×

n sub-elements in length, (ii) m×

n sub-elements in areal size, or (iii) includes a mechanically scannable sub-element or sub-element array;

(h) has a sensor which can operate in timed-coordination or synchrony with any of a) the operation of a mechanical exciter, b) the clinician'"'"'s manipulation of the probe, c) the inflation or deflection of an inflatable balloon, membrane or mechanism, or d) software that scans or reads out the sensor;

or

(i) includes a capacitive or resistive force or pressure sensor.

4. The probe system of claim 1 wherein the optional motion, deflection or inertial sensor is used for one of more of:

(a) to detect any operational parameter of an optional exciter;

(b) to control any operational parameter of an optional exciter;

(c) to detect or control a clinician'"'"'s manipulation of the probe;

(d) to detect or control a patient'"'"'s willful or unwillful movement of the probe or its adjacent anatomy;

(e) to verify or measure an exciter-induced vibration, oscillation or ring-down of a patient'"'"'s anatomy;

(f) to achieve a desired rotation, angulation or translation rate of the probe or sensor;

or

(g) to trigger the force/pressure sensor or sub-element(s) thereof to sample said forces or pressures.

5. The probe system of claim 1 wherein any of:

(i) the probe system utilizes a spatial or spatial plus time coordinate system in its operation, (ii) the probe system utilizes a sensor or sensors having a sensor axis which is aligned to a probe body axis, or (iii) a sensor is wrapped around or upon any portion of the probe.

6. The probe system of claim 1 wherein any of:

(a) a sensor or sensor array is fabricated utilizing flex circuit or lithographic technologies;

(b) a sensor or sensor array utilizes capacitive or resistive sub-element(s);

(c) a sensor or sensor array is read out, fully or in part, at a controlled sub-element read rate or sensor array frame rate

(d) a sensor or sensor array has electrically or optically addressable sensor sub-elements for reading purposes;

(e) a sensor or sensor array is disposable after a recommended number of uses of one or greater or after a system-enforced number of uses;

(f) a sensor or sensor array is larger or longer in at least one dimension than an anticipated tumor that might be detected;

(g) a sensor or sensor array is larger in at least one dimension than a prostate gland dimension which can be sensed at the rectal wall;

(h) any portion of a sensor or sensor array element or sub-element(s) is read as triggered or gated by a clock or by read data from the optional motion, deflection or inertial sensor;

(i) maximum or minimum static, dynamic or transient force or pressure readings are any of detected, recorded or compared;

or

j) any of the force/pressure absolute values or derivatives or slopes of such data or data-graphs are utilized in determining an extent of prostate enlargement or tumor-presence likelihood.

7. The probe system of claim 1 wherein a force or pressure sensing element, sub-element or array of such sub-elements is situated, held, suctioned, adhered, clipped, clamped or mounted upon a foundation or backing material having stiffness or rigidity larger than that of the typical tissues being examined, the tissue force variation thereby being substantially preserved for detection by avoiding conformational relaxation of the sensor shape itself.

8. The probe system of claim 1 wherein a sensor element, sub-element or sub-element array has at least one curved dimension or plane of curvature which enhances the probes force/pressure measurement or measurement-range performance.

9. The probe system of claim 8 wherein said at least one plane of curvature at least one of:

(a) generally conforms to a typical healthy anatomy;

(b) fits or conforms to a healthy anatomy in a manner presenting a substantially uniform or a substantially normal healthy force/pressure map;

(c) allows for a smooth or comfortable probe insertion or manipulation.

(d) assures that despite the tissues of interest being of irregular shape that all such areas contact the sensor and provide a useful pressure/force reading;

or

(e) causes indentation palpation of the prostate in a manner similar to that of a pressing fingertip.

10. The probe system of claim 1 wherein a force/pressure sensor array has at least one radius or curvature in one plane which is substantially larger or more gentle than that of the first inserted probe body radius or finger radius.

11. The force/pressure probe system of claim 1 wherein:

(a) some static force/pressure readings are taken;

(b) some dynamic or transient readings are taken;

(c) both some static and dynamic or transient readings are taken;

(d) some maximum or minimum readings are taken or are reported;

(e) one or more sensing elements or sub-elements takes readings at two or more times;

(f) two or more sensing elements or sub-elements at different locations are read at the same or different times;

or

(g) which element or sub-element(s) is/are read is determined, at least in part, by a probe orientation, a known load on the probe, a state of mechanical excitation of the probe and/or the anatomy or a software program.

12. The probe system of claim 1 wherein any of:

(a) the probe is capable of being powered by an internal energy storage means;

(b) the probe is capable of being powered by an external energy storage or source means;

(c) the probe is capable of being used with a rechargeable or reenergizable energy storage means;

or

(d) the probe has any of a wired, wireless or lumen fluid/gas connection to any of a support utility, console or to a network.

13. The probe system of claim 1 wherein at least one measured, sensed, detected or saved force or pressure reading at one or more sensor elements or sub-elements is at least one of:

(a) a substantially static force or pressure;

(b) a substantially dynamic force or pressure sensed during a mechanical loading or excitation of the probe or of the adjacent anatomy;

(c) a substantially transient force or pressure sensed after a removal, variation in or change in a static or dynamic mechanical loading or excitation;

(d) a force or pressure on an upwards or increasing amplitude slope;

(e) a force or pressure on a downwards or decreasing amplitude slope;

(f) a force or pressure having a known time-phase relationship with a static, dynamic or transient loading or excitation;

(g) a force or pressure nearing or at a peak or minimum value;

(h) a spatially or time-averaged force or pressure from one or more sensor elements or sub-elements, said elements not necessarily being adjacent ones;

(i) a force or pressure determined to be outside of or inside of a range;

or

(j) a force or pressure which has substantially settled to a constant value after a transient or waiting period.

14. The probe system of claim 1 wherein a patient is examined at two or more points in time, including wherein said two or more points comprise two or more sequential scheduled exams or two or more exams on the same day, said results from at least some of the exams being compared to each other or to a those of a larger population.

15. The probe system of claim 1 wherein the exam is performed by any of a doctor, clinician, technician or patient.

16. The probe system of claim 1 wherein the patient receives a medicament or drug which enhances the sought signal of a prostate tissue abnormality or which calms or soothes the patient.

17. The probe system of claim 1 wherein the patient has his tissues manipulated or excited in a mechanical way to enhance the sought signal of a prostate tissue abnormality, said excitation possibly driven by the clinician'"'"'s manipulation of the probe or tissues, the patient'"'"'s manipulation of the probe or tissues, or the excitation of the probe or tissues using a probe exciter means.

18. The probe system of claim 1 wherein the patient'"'"'s tissues are thermally manipulated by the probe or by an associated heating or cooling means, said thermal manipulation allowing for the improvement in a sought force/pressure signal indicative of a tissue abnormality.

19. The probe system of claim 1 wherein some collected or sensed data is registered to, overlaid upon or otherwise compared or correlated to a medical image of the prostate, that image or images taken at any time in any manner or taken in real time during the probe system exam.

20. The probe system of claim 1 wherein some collected or sensed data is used to recommend the patient for follow-up examination using another diagnostic technique, modality, procedure or instrument, said recommendation being deliverable to the patient either at exam time or some amount of time after the exam.

21. The probe system of claim 1 wherein the probe also measures ringdown of vibrating tissues or tumors in any manner, said ringdown time(s) providing an indication of prostate health.

22. The probe system of claim 1 wherein any one or more of:

(a) a removable sheath, membrane, condom or bladder is utilized;

(b) any inflatable entity is utilized for a probe/sensor loading or probe/sensor fixation purpose;

(c) any inflatable entity or cavity containing a flowed material is utilized to control or manipulate an anatomical temperature;

(d) a deformable or inflatable member is utilized which applies a load on a rectal wall or on a prostate organ;

(e) a force or pressure sensor is disposed or abutted to or on a foundation or backer which is at least twice as hard as tissue and more preferably at least ten times as hard as tissue;

(f) a force or pressure sensor is used which has a dimension larger than a tumor dimension or larger than a prostate dimension;

(g) a force or pressure sensor is used which is mounted on or to a flat, curved or convex surface, said flatness, curvature or convexity being at least in one plane;

(h) a force or pressure sensor is used which has a sub-sensor or pixel pitch of less than or equal to 3 mm and more preferably less than or equal to 2 mm;

or

(i) a force or pressure sensor is used which is mounted on a temperature controlled foundation or probe.

23. A probe system for assessing one or both of BPH or prostate cancer coming:

(a) a temperature sensor mounted on, in or to a rectally insertable probe and necessary means to power, connect to, switch and read data from the sensor;

(b) the temperature sensor being employed to sample two or more rectal wall locations adjacent or juxtaposed to the prostate and from the rectal wall during probe insertion or while the probe is inserted;

(c) the sensed data from the two or more location'"'"'s forming a temperature-map or temperature data-array having relationship to the patient'"'"'s underlying prostate;

(d) the sensed temperature data being utilized at the time of the exam or later after the exam to compare the patients data to at-least some other data from at least one other exam; and

(e) a conclusion or recommendation regarding the patients prostate condition thereby being providable by a practitioner to a patient based at-least partly on a quantitative data comparison;

probe optionally including one or more of;

(1) a motion, deflection, angle or inertial sensor of any type integrated in or coupleable to the probe to track or monitor at least one probe or sensor position, orientation, angle, velocity or acceleration;

(2) a deflectable or inflatable balloon, membrane or mechanism capable of applying a load or deflection to one or more of the probe, the probe sensor, or the anatomy to improve the probes performance or sensitivity;

or

(3) a means of injecting or removing heat from a tissue region of interest.

24. The probe system of claim 23 wherein any one or more of:

(a) a temperature measurement or sensing event utilizes a thermally contacting sensing means including any of a thermocouple, thermistor, diode or precision resistor;

(b) a temperature measurement or sensing event utilizes any type of optical sensing means including mid or near infrared optical means;

(c) an optical temperature measurement or sensing means utilizes one or more of;

a gaseous standoff gap;

an optically transparent window standoff material of any solid or liquid-like type, whether the window material contacts the tissue itself or not;

(d) a two or three dimensional array of temperature detection sub-elements is provided;

or

(e) one or more temperature detection elements or sub-elements utilizes an optical component to achieve spatial scanning.

25. The probe system of claim 23 wherein any one or more of:

(a) two temperatures taken at two different times are recorded, compared or reported;

(b) two temperatures taken at two different tissue locations are recorded, compared or recorded;

(c) a maximum or minimum temperature at a tissue location is recorded, compared or reported;

(d) an increasing or decreasing temperature at a tissue location is recorded, compared or reported;

(e) the slope of a temperature change at least one tissue-location or region of locations is computed, recorded, compared or reported;

or

(f) a substantially static, dynamic or transient temperature or temperature change-rate is computed, recorded, compared or reported.

26. The probe system of claim 23 wherein any of:

(a) substantially rectal wall surface temperatures are detected or measured;

(b) substantially underlying subsurface temperatures are detected or measured;

or

(c) a tissue temperature can be manipulated favorably using a probe system or probe-related heated or cooling means, favorably meaning allowing for a better signal-to-noise ratio of the temperature measurement signal being sought.

27. The probe system of claim 23 wherein any of the listed optional features allows for any one or more of (a) spatial motion control of the probe, (b) improved temperature accuracy or improved spatial accuracy of temperature patterns sampled from the anatomy, (c) determination or control of temperature sampling sites or locations, or d) triggering of temperature data taking at least one sensor sub-element.

28. The probe system of claim 23 wherein the probe is one of (a) a finger(s)-mounted or attached probe, or (b) a standalone probe which is itself insertable in the anatomy, (c) an at least in part disposable probe, (d) a probe that is protected during use by a sheath, membrane or condom which is arranged not to substantially interfere with temperature mapping, (e) a practitioner manipulatable probe, or (f) a probe that any of records or transmits data in a wired or wireless fashion.

29. The probe system of claim 23 wherein a patient is examined at two or more points in time, including wherein said two points comprise two sequential scheduled exams, said results from the exams being compared to each other or to a those of a larger population, said two or more sequential exams being on the same day or different days.

30. The probe system of claim 23 wherein the exam is performed by any of a doctor, clinician, technician or patient.

31. The probe system of claim 23 wherein the patient receives a medicament or drug which enhances the sought signal of a prostate tissue abnormality or which calms or soothes the patient.

32. The probe system of claim 23 wherein the patient has his tissues manipulated or excited in a mechanical way to enhance the sought signal of a prostate tissue abnormality, said excitation possibly drive by the clinician'"'"'s manipulation of the probe or tissues, the patient'"'"'s manipulation of the probe or tissues, or the excitation of the probe or tissues using the probe exciter means.

33. The probe system of claim 23 wherein the patient'"'"'s tissues are thermally manipulated by the probe or by an associated heating or cooling means, said thermal manipulation allowing for the improvement in a sought temperature signal indicative of a tissue abnormality.

34. The probe system of claim 23 wherein some collected or sensed data is registered to, overlaid upon or correlated-to a medical image of the prostate, that image or images taken at any time in any manner or taken in real time during the temperature probe exam.

35. The probe system of claim 23 wherein some collected or sensed data is used to recommend the patient for follow-up examination using another diagnostic technique, modality, procedure or instrument.

36. The probe system of claim 23 wherein the probe also measures ringdown of tissues or tumors therein in any manner.

37. The probe system of claim 23 wherein any one or more of:

(a) a removable sheath, membrane, condom or bladder is utilized;

(b) any inflatable entity is utilized for a loading or fixation purpose;

(c) any inflatable entity of cavity containing a flowed material is utilized to control a temperature;

(d) a deformable or inflatable member is utilized which applies a load on a rectal wall or on a prostate organ;

(e) a force or pressure sensor is disposed or abutted to a foundation which is at least twice as hard as tissue and more preferably at least ten times as hard as tissue;

(f) a force or pressure sensor is used which has a dimension larger than a tumor dimension or larger than a prostate dimension;

(g) a force or pressure sensor is used which is mounted on or to a flat, curved or convex surface, said flatness, curvature or convexity being at least in one direction;

(h) a force or pressure sensor is used which has a sub-sensor or pixel pitch of less than or equal to 3 mm and more preferably less than or equal to 2 mm;

(i) a force or pressure sensor is used which a contacting temperature sensor is mounted on a temperature controlled foundation or probe;

or

(j) a temperature sensor utilizes infrared optical light.

38. A combined prostate probe system having both force/pressure detection capability and temperature detection capability for assessing one or both of BPH or prostate cancer comprising:

(a) a force or pressure sensor mounted on, in or to a rectally insertable probe and necessary means to power, connect to, switch and read the sensor;

(b) the force or pressure being employed to sample two or more rectal first wall locations adjacent or juxtaposed to the prostate during probe insertion or while the probe is inserted;

(c) a temperature sensor mounted on, in or to a rectally insertable probe and necessary means to power, connect to, switch and read the sensor;

(d) the temperature sensor being employed to sample two or more second rectal wall locations adjacent or juxtaposed to the prostate during probe insertion or while the probe inserted;

(e) the sensed data from the first locations and the second locations being utilized to form a force-map, pressure-map or force/pressure data array as well as a temperature-map or temperature data-array each having relationship to the patient'"'"'s underlying prostate, the first and second locations being the same or different locations;

(f) the quantitative force/pressure and temperature data being compared or correlated with similar data from at-least one other exam or exam database; and

(g) the comparison or correlation being utilized to judge a state of prostate health or condition;

the probe optionally including one or more of;

(1) a mechanical exciter integrated in or capable of being coupled to the probe;

(2) a motion, deflection, angle or inertial sensor integrated in or couple able to the probe;

(3) a deflectable or inflatable balloon, membrane or mechanism capable of applying a load or deflection to one or both of the probe or the anatomy;

or

(4) a means of injecting or removing heat from a tissue region of interest.

39. The combined prostate probe system of claim 38 wherein said probe also allows for at least one of:

(a) physical registration of the force/pressure data and the temperature data if both data types are taken;

(b) sampling or detection of force/pressure data and temperature data from a combined or interdigitated sensor or sensor(s);

(c) taking of either or both data types in any desired sequential, parallel or time-interleaved sequence;

(d) the ability to detect an undesirable tissue condition evidenced both by a pressure/force anomaly and a temperature anomaly;

(e) immediate or follow-up reporting to a patient as to how he compares to a database of prior exams done on one or more persons;

or

(f) data network connectivity for any reason.

40. The combined prostate probe system of claim 38 wherein said probe is one or more of:

(a) finger(s) mounted or attached;

(b) a standalone probe itself capable of being inserted;

(c) has one or more exchangeable sensors including at least one force/pressure sensor and/or one temperature sensor;

(d) has one or more disposable sensors or sensor types;

(e) utilizes a reusable sensor or handle;

(f) during measurement is covered by a sheath, condom or membrane which is arranged not to substantially interfere with said measurement(s);

(g) has a force/pressure sensor in one probe region and a temperature sensor in a second probe region, the two regions preferably being opposed regions presentable to target tissues via rotation or angulation of the probe;

(h) is wipeable or immersable in a liquid, gaseous or plasma sterilant or antiseptic without a covering condom, membrane or sheath installed;

(i) contains or is connectable to a power source;

or

(j) contains or is connected to a wired or wireless data network or a data recording means.

41. The combined prostate probe system of claim 38 wherein a patient is examined at two or more points in time, including wherein said two points comprise two sequential scheduled exams, said results from the exams being compared to each other or to a those of a larger population, said sequential exams being on different days or on the same day.

42. The combined prostate probe system of claim 38 wherein the exam is performed by any of a doctor, clinician, technician or patient.

43. The combined prostate probe system of claim 38 wherein the patient receives a medicament or drug which enhances the sought signal of a prostate tissue abnormality or which soothes or calms the patient.

44. The combined prostate probe system of claim 38 wherein the patient has his tissues manipulated or excited in a mechanical way to enhance the sought signal of a prostate tissue abnormality, said excitation possibly drive by the clinician'"'"'s manipulation of the probe or tissues, the patient'"'"'s manipulation of the probe or tissues, or the excitation of the probe or tissues using any probe mechanical exciter means.

45. The combined prostate probe system of claim 38 wherein the patient'"'"'s tissues are thermally manipulated by the probe or by an associated heating or cooling means, said thermal manipulation allowing for the improvement in a sought signal indicative of a tissue abnormality.

46. The combined prostate probe system of claim 38 wherein some collected or sensed data is registered to, overlaid upon or correlated to a medical image of the prostate, that image or images taken at any time in any manner or taken in real time during the probe exam.

47. The combined prostate probe system of claim 38 wherein some collected or sensed data is used to recommend the patient for follow-up examination using another diagnostic technique, modality, procedure or instrument.

48. The combined prostate probe system of claim 38 wherein the probe also measures ringdown of mechanically excited prostate-relevant tissues or tumors in any manner.

49. The combined prostate probe system of claim 38 wherein any one or more of:

(a) a removable sheath, membrane, condom or bladder is utilized;

(b) any inflatable entity is utilized for a loading or fixation purpose;

(c) any inflatable entity or cavity containing a flowed material is utilized to control a temperature;

(d) a deformable or inflatable member is utilized which applies a load on a rectal wall or on a prostate organ;

(e) a force or pressure sensor is disposed or abutted to a foundation which is at least twice as hard as tissue and more preferably at least ten times as hard as tissue;

(f) a force or pressure sensor is used which has a dimension larger than a tumor dimension or larger than a prostate dimension;

(g) a force or pressure sensor is used which is mounted on or to a flat, curved or convex surface, said flatness, curvature or convexity being at least in one plane;

(h) a force or pressure sensor is used which has a sub-sensor or pixel pitch of less than or equal to 3 mm and more preferably less than or equal to 2 mm;

(i) a force or pressure sensor is used which a contacting temperature sensor is mounted on a temperature controlled foundation or probe;

or

(j) a temperature sensor utilizes infrared optical light.

50. A probe system for evaluating a condition of a prostate gland including:

(a) a rectally insertable probe;

(b) a means to excite the tissue of interest into an excited motion state; and

(c) a means to stop said excitation and monitor the decaying ringdown or attenuation of the vibrating tissue portions, the ringdown behavior giving information related to the health of the prostate such as a state of enlargement or presence of tumors.

51. The probe system of claim 50 wherein any of:

(a) the excitation is provided by the patient'"'"'s motion or simulated bowel movement;

(b) the excitation is provided by a clinician'"'"'s manipulation of tissues or of the probe;

(c) the exciter is integrated into, attached to or physically coupled to the probe;

(d) the exciter can excite the tissues using at least one of an impulse or at least one multiwave cyclic frequency;

(e) the ringdown is monitored by at least one of a force/pressure sensor or by an integrated or coupled acceleration, displacement, angle or vibration sensor;

(f) the ringdown is monitored by a MEMs sensor;

(g) the ringdown is evaluated at two or more excitation frequencies;

or

(h) the ringdown is evaluated using a broadband excitation impulse.

52. The probe system of claim 50 wherein the probe also measures ringdown of tissues or tumors therein in any manner.

53. The probe system of claim 50 wherein any one or more of:

(a) a removable sheath, membrane, condom or bladder is utilized;

(b) any inflatable entity is utilized for a loading or fixation purpose;

(c) any inflatable entity of cavity containing a flowed material is utilized to control a temperature;

(d) a deformable or inflatable member is utilized which applies a load on a rectal wall or on a prostate organ;

(e) a force or pressure sensor is disposed on or abutted to a foundation or mechanical backer that is at least twice as hard as a measured tissue;

(f) a force or pressure sensor is used which has a dimension larger than a tumor dimension or larger than a prostate dimension;

(g) a force or pressure sensor is used which is mounted on or to a flat, curved or convex surface, said flatness, curvature or convexity being at least in one plane;

(h) a force or pressure sensor is used which has a sub-sensor or pixel pitch of less than or equal to 3 mm and more preferably less than or equal to 2 mm;

(i) a force or pressure sensor is used which a contacting temperature sensor is mounted on a temperature controlled foundation or probe;

or

(j) a temperature sensor utilizes infrared optical light.

54. A force or hardness mapping device for palpation-examination of patient anatomical tissues for abnormalities or assessing states of firmness comprising:

(a) a force or pressure sensor having at least one sensing element;

(b) the sensor capable of palpating a patient'"'"'s anatomy while at an examiner'"'"'s fingertip palpation position and situated under an examiner'"'"'s glove;

(c) the sensor capable of being parked or removed to a position away from the examiner'"'"'s palpating fingertip such that the examiner'"'"'s bare fingertip is also operable to palpate the patient'"'"'s anatomy also through the glove; and

(d) the sensor being movable between a fingertip position and a removed position at least once in one direction.

55. The device of claim 54 wherein any one or more of:

(a) the fingertip sensor position is first used to perform the sensor-supported exam-with or without an overlying glove or sheath;

(b) the removed or parked position is used second in order to allow for the sensor-free fingertip to perform a bare-finger palpation-with or without an overlying glove or sheath;

(c) the sensor is slid along a length dimension of the finger between two such positions;

(d) the sensor is pulled along a length dimension of the finger between two such positions;

(e) the sensor is pushed along a length dimension of the finger between two such positions;

(f) the sensor is twisted or rotated in any direction to enable a sensor-free fingertip palpation;

(g) the sensor has two or more force or pressure sensor sub-elements arranged in a pattern;

(h) the sensor has two or more force or pressure sensor sub-elements arranged in an array;

(i) the sensor has a sensor element(s) region and a connecting trace-routing region;

(j) a sled is provided which grips, clamps, is-fastened to or is adhered to at least one of the sensor or then examiners finger;

(k) a sled is provided which any of grips, clamps, is-fastened to or is adhered to both the sensor and the examiners finger-the attachment means possibly being different for each;

(l) the sled slides or rotates along or across at least one examiners finger portion;

(m) the sled slides or rotates along or across a glove surface-preferably an interior glove surface;

(n) the sled and the sensor are a prejoined subassembly;

(o) the sled and the sensor are joined at exam time;

(p) one or more sleds and one or more sensors forms a kit-optionally also containing one or more gloves;

(q) a sliding or rotating interface between finger/sensor or sensor/glove or finger/glove is lubricated in any manner;

(r) at least one of the sled, sensor or glove is disposable;

(s) the sled and sensor are disposable-regardless of their state of temporary or permanent attachment;

(t) the examiner pulls the sensor back away from the examining fingertip using any of i) the thumb of his examining hand, ii) any portion of his other hand;

(u) the sensor utilizes flexible circuit, MEMS or lithographic technologies in its fabrication;

or

(v) a breast, prostate or testicle is being examined.

56. The device of claim 54 wherein any one or more of:

(a) multiple sleds or size/shapes/choices of sleds are provided in a kit;

(b) a reusable sled is employed;

(c) a sled elastically or spring-wise grips a finger portion;

(d) a sled has a controlled hardness or flexural rigidity;

(e) a sled has a hardness or flexural rigidity which;

i) substantially rigidizes the sensor for at least a period or ii) it partially rigidizes the sensor for at least a period;

(f) a sled is molded, shaped, formed or fitted at any stage of manufacture, preparation or use;

(g) a sled is fabricated, at least in part, of a polymeric, metallic or ceramic material;

(h) a sled has variable rigidity and said rigidity is controllably variable by the examiner;

(i) the sled is permanently fastened to the sensor during manufacture;

or

(j) the sensor is mechanically mounted into the sled before use with the possible help of sled mechanical features including slots, channels, clips, clamps, fasteners, springs and elastomeric members.

57. The device of claim 54 wherein any one or more of:

(a) during the instrumented sensor-based palpation the sensor output is any of annunciated, displayed, recorded or passes over a wired or wireless (including optical) network;

(b) during the uninstrumented sensor-free palpation the examiner compares or has compared for him/her his manual palpation results with at least some instrumented sensor results;

(c) the examiner utilizes a 3D positioning system such that the sensor location is known such that positional information can be employed for making anatomical hardness maps or for comparing said maps;

(d) the results of a prior exam are compared to the results of a current exam;

(e) the results from a patient are compared to the results of a population of patients;

or

(f) a single gloved exam allows for instrumented and uninstrumented palpation.

58. The device of claim 54 wherein the sled is any one or more of:

(a) wrappable around an examiners finger segment in any manner such that it is retained substantially in place while that is desired;

(b) receptive of an inserted sensor such that said sensor can be substantially retained in place relative to the sled;

(c) capable of gripping the examiners finger in a manner such that it can both retain the fingertip sensor-mapping position yet still be moved to a removed position without becoming decoupled from said finger during said moving;

or

(d) one or both of the sensor and sled wherein they have a conformal shape to the finger and don'"'"'t easily hang-up on the glove or on the patients tissues.

59. The device of claim 54 wherein the sensor works on variable capacitance, variable resistance, variable-conductance or optical-parameter variation mechanisms.

60. The device of claim 54 wherein the examiner also utilizes an ultrasound imaging device mounted on his fingertip.

61. The device of claim 54 wherein a patient'"'"'s prostate, breast, or organ is examined.

62. The device of claim 54 wherein a glove or finger sheath is provided separately from the device or is provided with the device.

63. The device of claim 54 wherein a glove or finger sheath is provided to the examiner already mated to one or both of the sensor or to any sled which may be used.

64. The device of claim 54 wherein the sled and the glove are a prefabricated subassembly.

65. The device of claim 54 wherein any part of a glove, sensor or any sled used has a lubricant, adhesive or gripping surface to either cause sliding or to prevent sliding of a first surface relative to a second surface.

66. The device of claim 54 wherein a glove or sheath is fitted over the instrumented finger while said glove or sheath is stretched and is then allowed to collapse in tension upon the finger/sensor.

67. The device of claim 54 wherein said sensor movability includes at least one translation or rotation of the sensor relative to the fingertip.

68. The device of claim 54 wherein said sensor is moved by application of a pulling or tensile force, a pushing force or a twisting or torque applied, directly or indirectly, by the examiner.

69. The device of claim 54 wherein said force or torque is applied to at least one of a sensor or a sled.

70. The device of claim 54 wherein said force or torque is mechanically communicated through at least one of:

(a) a sensor flex circuit portion;

(b) a sensor flex circuit trace region;

(c) an activation wire, string, chain or cable;

(d) a hydraulic or pneumatic means including a vacuum means;

or

(e) an elongated mechanical element fitted along or passing along a finger length dimension-such a flexible or semirigid rod or bar.

71. The device of claim 54 wherein said motion is in one direction only.

72. The device of claim 54 wherein said motion is in either direction.

73. The device of claim 54 wherein said motion is in both directions.

74. The device of claim 54 wherein the sensor presents an array of sensing sub-elements to the anatomy being studied.

75. The device of claim 54 wherein the examiner one or both of presses the sensor against the anatomy being studied or slides the sensor across anatomy being studied.

76. The device of claim 54 wherein a force, pressure or hardness map is displayed or recorded-said map being at least a map of tissue in contact with the sensor at a moment in time-said sensor possibly being smaller in lateral dimension than the overall lateral dimension or extent of the anatomy to be examined.

77. The device of claim 76 wherein the sensor is smaller than the anatomy to be examined thereby requiring movement of the sensor across the anatomy to capture mapping data of the whole anatomical target.

78. The device of claim 76 wherein the sensor is about the same size or is bigger than the anatomical target such that large lateral sliding or movement of the sensor is not required to capture the force map from the entire anatomical region of interest.

79. The device of claim 78 wherein a console or system paints an extended map of the entire anatomy based on data gathered from two or more sensor locations or orientations.

80. The device of claim 79 wherein the console or system deduces sensor position from the pattern of force data passing across its sensing surface.

81. The device of claim 79 wherein the console or system deduces sensor position utilizing a spatial positioning system such as a magnetic, electromagnetic or acoustic positioning system.

82. The device of claim 54 supplied in kit form and including a disposal bag or container for the used device.

83. The device of claim 54 including or coupled to a use-limiter which prevents multiple and unsafe reuse of the device.

84. The device of claim 54 wherein a wireless connection is provided between the device and a remote receiver or console, the wireless capability eliminating the need for a long connecting cable or umbilical connected to the device.

85. The device of claim 54 provided for home use.

86. The device of claim 54 where at least one temperature sensor is also provided, with at least one temperature reading from said at least one temperature sensor providing additional data as to the health condition of the prostate.

87. The device of claim 85 wherein the device is capable of, directly or indirectly, making its mapped data available for transmission over a network such as the internet.

88. The device of claim 85 wherein a patient follows remotely provided or software-delivered instructions for use, said instructions optionally being adaptive to results being measured or not measured.

89. A force or hardness mapping device for palpation-examination of patient anatomical tissues for abnormalities or for assessing states of firmness comprising:

(a) a force or pressure sensor having at least one sensing element;

(b) the sensor capable of palpating a patient'"'"'s anatomy while mounted to or on an examiner'"'"'s palpating fingertip, while situated under an examiner'"'"'s glove;

(c) the sensor having connecting traces routed down the examiner'"'"'s finger away from the palpating fingertip; and

(d) the sensor capable of being clipped, clamped or fastened to the examiner'"'"'s palpating fingertip, optionally with a backer material or component at least temporarily.

90. The device of claim 89 wherein the sensor is moved under the examiner'"'"'s glove between at least two positions, one position allowing for instrumented palpation, and the other position allowing for uninstrumented palpation.