System and process for the detection, evaluation and treatment of prostate and urinary problems

• US 5,282,472 A
• Filed: 05/11/1993
• Issued: 02/01/1994
• Est. Priority Date: 05/11/1993
• Status: Expired due to Fees

• Current Assignee: Bobby G. Batten, John A. Companion
• Original Assignee: Bobby G. Batten, John A. Companion
• Inventors: Batten, Bobby G., Companion, John A.
• Primary Examiner(s): JAWORSKI, FRANCIS J
• Application Number:
  US08/062,617
• Time in Patent Office: 266 Days
• Field of Search: 128/660.03, 128/662.06, 128/7, 606/108, 606/198, 600/3, 623/1, 623/12
• US Class Current: 600/463
• CPC Class Codes: A61B 1/042 characterised by a proximal camera, e.g. a CCD camera
• CPC Class Codes: A61B 5/03 Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs A61B5/205 takes precedence
• CPC Class Codes: A61B 5/415 the glands, e.g. tonsils, adenoids or thymus
• CPC Class Codes: A61B 5/418 lymph vessels, ducts or nodes
• 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 8/4209 by using holders, e.g. positioning frames
• CPC Class Codes: A61B 8/445 Details of catheter construction
• CPC Class Codes: A61B 8/4461 Features of the scanning mechanism, e.g. for moving the transducer within the housing of the probe
• CPC Class Codes: A61F 2/94 Stents retaining their form, i.e. not being deformable, after placement in the predetermined place
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section

Abstract

A compound system and process for mapping the urethra of a male patient to detect prostate and urinary problems; evaluation of any problems found; a reinforcement insert for the prostate custom fabricated from the mapped data to alleviate any problems found; means for placing the reinforcement insert into position within the patient; and means for removing the reinforcement insert when needed; are disclosed.

Claims

1. A system for detecting, evaluating and treatment of prostate and urinary problems in a male human comprising:

a computerized base structure including a computer and physician operated controls therefor, a display screen and a data recording means;

said computerized base structure also including a fixed main movement track and a secondary movement carriage linearly movable along said main movement track;

a probe support housing supported by and movable with said secondary movement carriage, as well as, movable independently, and linearly, relative to said secondary movement carriage;

computer controlled first motor means for selectively moving said secondary movement linearly along said main movement track;

computer controlled second motor means for selectively moving said support housing linearly along said secondary carriage;

an elongated tubular probe;

a locking assembly carried by said probe support housing for releasably securing said elongated tubular probe thereto and disposed in parallel relationship with said fixed main track on said computerized base structure;

said elongated tubular probe being dimensioned to be received within the urethra of a male patient and to have the capability of extending from the tip of the penis, through the prostate, and to just within the bladder of the patient; and

said elongated tubular probe being selected from the group of elongated tubular probes consisting of a mapping probe and a placement and retrieval probe.

2. The system of claim 1 wherein said elongated tubular probe is a mapping probe, said mapping probe including:

first and second fluid filled chambers;

a transparent hydraulic fluid filling each of said first and said second fluid filled chambers;

said first and said second fluid filled chambers being in hydraulic fluid connection with respective first and second pressure sensing transducers;

said first and said second pressure sensing transducers sensing axial and radial pressure encountered by said mapping probe and being in connection with said computer, said display screen and said data recording means to display and record a spatial pressure density map of the axial and radial pressures relative to incremental length within the prostatic urethra.

3. The system of claim 2 wherein said transparent hydraulic fluid filling each of said first and said second fluid filled chambers is water.

4. The system of claim 2 wherein said mapping probe has a first unattached tip end and a second end releasably attached to said lock assembly;

said first hydraulic fluid filled chamber being disposed at said tip end of said mapping probe and including a flexible, transparent, plastic cover housing a quantity of said transparent hydraulic fluid;

said flexible, transparent, plastic cover being deflectable by external axial pressure;

a fiber optic lens disposed within said first hydraulic fluid filled chamber;

a fiber optic bundle connected to, and extending from said fiber optic lens, through said mapping probe to connect with a video pickup housed within said computerized base structure;

said fiber optic lens and said fiber optic bundle providing visual indication on said display screen, and a permanent record on said data recording means, of the area encountered by said unattached tip end of said mapping probe as said mapping probe is inserted along the path of the urethra under the control of a physician.

5. The system of claim 4 wherein said second fluid filled chamber is disposed in spaced adjacency to said first fluid filled chamber and aft of said tip end of said mapping probe;

said second fluid filled chamber having a diameter equal to the interior diameter of said mapping probe and in fluid communication with said second pressure sensing transducer;

an ultrasonic transducer housing rotatably disposed within said second fluid filled chamber;

an ultrasonic transducer housed within said ultrasonic transducer housing; and

an air backed acoustic mirror also contained within said ultrasonic transducer housing and disposed at a forty-five angle facing, and in spaced relationship with said ultrasonic transducer.

6. The system of claim 5 including,

at least the portion of said mapping probe forming said second fluid filled chamber being formed of an acoustically transparent plastic material;

said acoustically transparent plastic material being provided with a circumferential, depressed, crease in the exterior surface thereof at each end of said second fluid filled chamber, and

at least one longitudinal depressed crease formed in said acoustically transparent plastic material and extending between said circumferential depressed creases;

whereby,

said portion of said mapping probe forming said second fluid filled chamber is deflectable by external radial pressure, with any deflection being transmitted by the hydraulic fluid in said second fluid filled chamber to said second pressure transducer, and displayed and recorded, respectively, by said display screen and said data recording means.

7. The system of claim 5 including focusing means for said acoustic mirror;

said focusing means including a micro-actuator engaging the back of said air backed acoustic mirror;

said micro-actuator serving to change the curvature of said air backed acoustic mirror to provide an adjustable focal length for the ultrasonic beam impinging on said mirror in direct proportion to the movement of said micro-actuator.

8. The system of claim 7 including, a reinforcement insert for a diseased prostate;

said reinforcement insert being custom designed from dimensional, optical, axial pressure, radial pressure data and ultrasonic scan data obtained from physician operation of said mapping probe during the examination of the prostate of a patient.

9. The system of claim 1 including lubrication and/or anesthesia dispensing means for said elongated tubular probe;

said lubrication and/or anesthesia dispensing means including a reservoir supported by said support housing and containing a pressurized source of at least one gel selected from the group of gels consisting of lubricant gels and topical anesthesia gel;

an annular chamber disposed about said elongated tubular probe and in spaced adjacency to said locking assembly for releasably securing said elongated tubular probe thereto;

said annular chamber being in fluid communication with said reservoir;

a plurality of tubular passageways in fluid communication with said annular chamber;

said plurality of tubular passageways being disposed in parallel spaced relationship within said elongated tubular probe;

at least one of said plurality of tubular passageways extending the length of said elongated tubular probe and opening adjacent the end thereof opposite to the end thereof releasably secured to said locking assembly; and

the remaining of said plurality of tubular passageways terminating individually at spaced exterior ports disposed along the length of said elongated tubular probe.

10. The system of claim 1 wherein said elongated tubular probe is a placement and retrieval probe;

said placement and retrieval probe having an open first unattached tubular tip end and a second tubular end releasably attached to said lock assembly;

a fiber optic lens disposed adjacent said open first unattached tip end;

an optic fiber connected to said fiber optic lens and disposed within the wall and extending the length of said placement and retrieval probe to connect with a video pickup housed within said computerized base structure;

said fiber optic lens and said optic fiber providing visual indication on said display screen of the location of said open unattached tip end of said placement and retrieval probe as said placement and retrieval probe is inserted along the urethra of a patient under the control of a physician;

a custom designed reinforcement insert compressed and disposed within the lumen of said open unattached tip end of said placement and retrieval probe;

an elongated ram having a first end slidably extending through said locking assembly and said support housing and attached to said secondary movement carriage;

said elongated ram having a second end disposed within the lumen of said placement and retrieval probe and positioned in engagement with an end of said custom designed reinforcement insert;

whereby

said probe support housing is linearly moved along said fixed main track to insert said placement and retrieval probe into the urethra of the patient and position the open unattached tubular end thereof containing said custom designed reinforcement insert within the prostatic urethra of the patient.

11. The system of claim 10 including means for moving said probe support housing and said attached tubular portion of said placement and retrieval probe in such a manner relative to said elongated ram to push said reinforcement insert out of the lumen of said placement and retrieval probe, as the probe retreats from the prostate of the patient, thereby laying the reinforcement insert within the prostate of the patient;

said custom designed reinforcement insert expanding from the compressed condition as it emerges from the lumen of said placement and retrieval probe, under the impetus of said elongated ram, to the designed expanded condition to overcome any pressure being exerted on the prostatic urethra by the diseased prostate; and

means for withdrawing said tubular portion of said placement and retrieval probe and said elongated ram from the patient to leave said reinforcement insert in place within the prostate of the patient.

12. The system of claim 11 wherein said custom designed reinforcement insert is a helix having a spindle shaped configuration and is constructed from a ribbon of material selected from the group of biocompatible materials consisting of stainless steel and polycarbonate plastics.

13. The system of claim 12 wherein said ribbon of material is provided with a flattened oval cross sectional area and wherein the ends of said helix are fused to remove any sharp edges.

14. A system for detecting, evaluating and treatment of prostate and urinary problems in a male human comprising:

a power driven instrument element including a physician controlled elongated tubular mapping probe;

said elongated tubular mapping probe having a first end for insertion within the penile urethra, through the voluntary sphincter adjacent the prostate, into the prostate urethra and adjacent to the involuntary sphincter at the bladder opening of a patient;

optical means disposed through, and having a lens disposed at said first end of said mapping probe to permit visual observations along the length of the urethra during movement of said first end of said placement and removal device along the urethra;

axial pressure sensor means disposed on said elongated tubular mapping probe to sense axial pressure resistance to movement of said elongated tubular mapping probe through the urethra of a patient;

radial pressure sensor means also disposed within said mapping probe to detect and measure radial pressure variables along the length of the prostate urethra during movement of said placement and removal device therealong;

said elongated tubular mapping probe having a second end releasably secured to a physician controllable, power driven, gear train housed within a base housing structure;

a computer driven display screen in circuit connection with said optical, axial pressure sensor and said radial pressure sensor means to provide optical data, as well as, axial and radial pressure data displays thereon;

means within said base housing structure and connected to said display screen to indicate pressures within the prostate in tubular form by location, dimension of the prostate and spatial relationship of the voluntary and involuntary sphincters; and

recording means in circuit connection with said optical and said radial and said axial pressure sensor means to permanently record a patient profile of the pressure and dimensional data displayed on said display screen;

whereby

radial pressure data are produced in tabular form as a function of location along the urethra, axial pressure data show the force needed to overcome the resistance of the voluntary and involuntary sphincters and their geometric relationships, and said optical data may be compared with the same information taken by previous scans of the same patient and compared with similar data from any on-line data base available.

15. The system of claim 14 including a custom fabricated prostate reinforcement insert, said reinforcement insert being custom fabricated from the measured, visual and tabulated dimensional observations and by the data obtained from said optical, said radial and said axial pressure sensor and ultrasonic scan data means.

16. The system of claim 15 wherein said prostate reinforcement insert is constructed of a material selected from the group of materials consisting of biocompatible metals and biocompatible plastics;

said material being shaped as a helix of ribbon having a flattened oval cross section and forming an elongated flexible spindle configuration wherein the diameter of a center length portion thereof exceeds the diameter of the ends.

17. A system for detecting, evaluating and treatment of prostate and urinary problems in a male human comprising:

a tubular probe means for detection of the presence of diseases and abnormalities of the prostate and urethra of a human male;

p1 drive means releasably connected to said tubular probe means and controllable by a physician operator to insert said tubular probe means through the penile urethra, through the voluntary sphincter disposed between the penile urethra and the prostate urethra, into the prostate urethra to a position therein adjacent to the involuntary sphincter connecting the bladder to the prostatic urethra;

data collecting means carried by said tubular probe means;

computer means in operative connection with said data collection means for converting informational data received from said data collection means into visual images;

a display screen in operative connection with said computer means to receive and display the visual images of data from said computer means; and

recording means in operative connection with said display screen to make a permanent record of the computer converted informational data displayed on said display screen.

18. The system of claim 17 wherein said data collecting means includes:

a radial pressure sensor, an axial pressure sensor, an ultrasonic scanner, and fiber optic means;

said radial pressure sensor serving to measure radial pressure variations along the insertion path of said tubular probe means through the prostate urethra;

said axial pressure sensor serving to measure axial pressures encountered as said tubular probe means encounters said voluntary sphincter and the path of movement through said prostatic urethra;

said ultrasonic scanner serving to provide tissue and density characterization throughout the volume of the prostate; and

said fiber optic means permitting visual observation of the penile and prostatic urethras as said tubular probe is moved therealong.

19. The system of claim 17 wherein said data collecting means includes mapping and measurement instrumentation to accurately provide measurements of distance from the tip of the penis to the voluntary sphincter at the entrance to the prostate and an accurate distance measurement between said voluntary and said involuntary sphincters to thereby provide an accurate measurement of the prostate urethra length;

the distance between said voluntary and said involuntary sphincters; and

a visual and tabulated pressure map of the penile urethra, the prostate urethra, and said sphincters; and

a tomographical type, volume map showing structures, both normal and abnormal, present within the prostate, their location, density and texture.

20. A method of detecting, evaluating and treatment of prostate and urinary problems in a male human comprising the steps of:

providing a computerized base structure including a computer and controls therefor, a display screen and a data recording means;

providing a fixed main movement track and a secondary movement carriage linearly movable along the main movement track;

providing a probe support housing supported by an movable with the secondary movement carriage and independently and linearly movable relative to the secondary movement carriage;

releasably securing an elongated tubular probe, adapted for insertion through the urethra of a male patient, to the probe support housing;

providing an optic fiber connection from the computerized base structure to the tip end of the elongated tubular probe;

inserting the tip end of the tubular elongated probe into the penile urethra of a male human patient;

computer controlling movement of the probe support housing to gradually move the elongated tubular probe through the penile urethra, the voluntary sphincter, the prostatic urethra and, at least, to a point adjacent the involuntary sphincter leading from the bladder opening into the prostate urethra of a male patient;

providing a lighted optical lens on the optic fiber connection at the tip end of the tubular elongated probe and in optical connection through the optic fiber with the display screen; and

observing movement of the tubular elongated probe on the display screen through the lighted optical lens.

21. The method of claim 20 wherein the elongated tubular probe is a mapping probe and including the steps of providing axial and radial pressure data collecting apparatus within the body of the elongated tubular probe;

converting the axial and radial pressure data collected into tabular form;

displaying the visual images obtained from the optic fiber connection and the tabulated pressure data received from the axial and radial pressure data collecting apparatus onto the display screen to thereby provide a dimensional map of the penile and prostate urethras as well as the spatial relationship of the voluntary and involuntary sphincters; and

recording the visual and tabulated data as a permanent profile record of the urethra and prostate of the patient.

22. The method of claim 20 wherein the elongated tubular probe is a tubular placement and retrieval probe;

and including the steps of;

providing a custom designed reinforcement insert for the prostate observed;

providing the custom designed reinforcement insert of a spindle configuration to provide an enlarged diameter central insert area and reduced diameter ends;

wherein,

the enlarged diameter central insert area is designed to press against the prostate urethra wall with sufficient force to overcome any pressures exerted thereon by the diseased prostate and maintain the prostatic urethra open for flow of urine therethrough and the reduced diameter ends are disposed adjacent the voluntary and involuntary sphincters.

23. The method of claim 22 wherein the tubular placement and retrieval probe includes an elongated ram slidably positioned within the tubular portion thereof;

and including the steps of;

positioning the custom designed reinforcement insert within the open tip end of the tubular placement and retrieval probe;

positioning a slidable ram within the opposite end of the tubular placement and retrieval probe wherein one end of the elongated slidable ram is spaced from the open tip end of the tubular placement and retrieval probe and the other end of the ram extends through the other end of the tubular placement and retrieval probe and is secured to the motor drive assembly;

compressing and positioning the custom designed reinforcement insert into the open tip end of the placement and retrieval probe and against an end of the elongated slidable ram;

employing the motor drive assembly to insert the placement and retrieval probe through the penile urethra into the prostate urethra while observing movement thereof to position the area housing the reinforcement insert completely within the prostate urethra and disposed between the voluntary sphincter and the involuntary sphincter;

maintaining the reinforcement insert within the prostate by pressure from the elongated slidable ram while withdrawing the tubular placement and retrieval probe to lay the reinforcement insert in place within the prostate urethra; and

thereafter,

completely removing the tubular elongated placement and removal probe and elongated ram from the patient.

24. The method of claim 23 including providing a capture mechanism on a modified elongated slidable ram with the capture mechanism being in the form of a half turn, coarse threaded shaft removal tip disposed on the ram end spaced from the open tip end of the tubular placement and retrieval probe;

providing a threaded receptacle within the open end of the reinforcement insert adjacent the voluntary sphincter;

inserting the capture mechanism into the open end of the reinforcement insert;

rotating the modified ram to threadingly capture the insert onto the modified ram;

continuing rotation of the modified ram to rotate the helix of the reinforcement insert, while advancing the tubular probe tube at the same rate that the reinforcement insert is being moved to provide minimum friction both to the urethra walls and to the recompression of reinforcement insert back into the lumen of the placement and retrieval probe tube.

25. The method of claim 20 wherein the elongated tubular probe houses within the radial pressure sensing chamber, a radial ultrasonic transducer assembly to map the volume of the prostatic tissue;

characterizing the configuration, location size, density, and texture of any and all normal and abnormal structures found therein;

displaying said data in tomographical format onto the display screen to thereby provide the capability of detecting and diagnosing any malignant tissue contained therein; and

recording the tomographical data as a permanent record of the malignancy or non-malignancy of the patient at that point in time.

26. A system for detecting, evaluating and treatment of prostate and urinary problems in a male human comprising:

mapping probe means for measuring radial and axial pressure and for ultrasonically scanning the volume of the prostatic capsule, and for optically viewing the interior of the urethra and bladder of a male human patient;

display means permitting visual inspection of the urethra as said mapping probe means measures the radial and axial pressure therealong;

recording means for making a permanent record of the radial and axial pressure measurements, as well as the ultrasonic and optical images made by said mapping probe means;

a reinforcement insert positionable within the prostatic urethra of the patient;

placement probe means for placing said reinforcement insert within the prostate urethra of the patient;

computer control means for inserting and withdrawal of said mapping probe means from within the prostatic urethra of the patient;

said computer control means including a probe support housing releasably connected to said mapping probe means during insertion and withdrawal thereof;

said placement probe means being releasably connected to said probe support housing after withdrawal of said mapping probe means from said patient and removal of said mapping probe from said probe support housing;

said placement probe means including a hollow outer tube and said reinforcement insert being compressed and retained within said hollow outer tube for placement thereof within the prostatic urethra;

ram means carried within said hollow outer tube of said placement probe means for forcing said compressed reinforcement insert out of said placement probe when said placement probe is inserted within the prostatic urethra of the patient.

27. The system of claim 26 including lubrication means for said elongated tubular mapping probe;

said lubrication means including a plurality of ports disposed in spaced relationship along the exterior surface of said elongated tubular mapping probe;

a plurality of tubular lubricant passageways disposed in spaced parallel relationship within said elongated tubular mapping probe;

an annular lubricant chamber disposed about said elongated tubular mapping probe adjacent said second end thereof;

each of said plurality of tubular lubricant passageways being in fluid communication with said annular lubricant chamber and with at least one of said ports; and

a lubricant reservoir supported by said base housing structure and in fluid communication with and supplying lubricant to said annular lubricant chamber.

28. The system of claim 26 wherein said elongated tubular mapping probe includes an outer shell structure and an elongated hollow drive shaft contained within said outer shell structure;

said drive shaft having a first end rotatably extending through a first fixed bearing and connected to a drive gear disposed within said base housing;

said drive shaft having a second end rotatably extending through a second fixed bearing;

an elongated transducer housing having a first end secured to said second end of said drive shaft and a second end secured to a third bearing;

said third bearing being rotatably received within the nose portion of said elongated mapping probe;

a fluid filled chamber disposed within said tubular mapping probe; and

said elongated transducer housing being contained within said fluid filled chamber.

29. The system of claim 28 including an ultrasonic scanning transducer disposed within said transducer housing;

an air backed acoustic mirror also contained within said transducer housing and in linear spaced alignment with said ultrasonic scanning transducer;

a curvature control for said acoustic mirror provided within said transducer housing; and

means within said outer shell structure of said elongated mapping probe permitting acoustic vibration over the radius thereof housing said fluid filled chamber.

30. The system of claim 29 wherein said means within said outer shell structure of said elongated mapping probe permitting acoustic vibration over the radius thereof housing said fluid filled chamber includes, a pair of circumferential exterior creases provided within the outer shell;

said circumferential exterior creases being spaced to define the length of the fluid filled chamber therebetween; and

, at least one longitudinal crease provided along the length of said mapping probe between said pair of circumferential exterior creases.

31. The system of claim 29 including means for providing a controlled oscillating, rotative movement, through said drive shaft, to said transducer housing contained within said fluid filled chamber.

32. The system of claim 29 including:

a first pressure tube extending along a length of said mapping probe;

a first pressure transducer disposed on and supported by said base housing;

said first pressure tube providing fluid communication between said fluid filled chamber and said first pressure transducer;

a second pressure tube extending along the length of said mapping probe;

a transparent fluid filled diaphragm disposed at the tip end of said mapping probe;

a second pressure transducer disposed on and supported by said base housing;

second pressure tube providing fluid communication between said transparent fluid filled lens and said second pressure transducer;

whereby radial pressure variations are hydraulically transferred to said first pressure transducer as said mapping probe moves along the urethra and, simultaneously therewith, axial pressure is indicated from said transparent pressure diaphragm to said second pressure transducer, with the output of said first and said second pressure transducers being converted into numerical readings that are displayed on said display screen.

33. The system of claim 29 wherein the fluid contained within said fluid filled chamber and within said transparent fluid filled diaphragm is distilled water.

34. The system of claim 33 including a one way valve disposed within said reinforcement insert;

said one way valve including an annular ring secured within said reinforcement insert downstream from and adjacent the involuntary sphincter of the patient;

a plurality of conical shaped, resilient, depending petals extending downstream from said annular ring;

said petals flexing to permit flow from the bladder of the patient into the reinforcement insert and through the prostatic urethra but resiliently closing to prevent retrograde flow from the prostatic urethra into the bladder.

35. The system of claim 33 including a one way rotary valve;

said rotary valve having a valve housing secured within, and having an external diameter substantially equal to, the internal diameter of said reinforcement insert;

a drive gear rotatably disposed within said valve housing;

a drive shaft having a fixed gear thereon and meshing with said drive gear;

a rotary valve disc secured to said drive shaft and rotatably driven in one direction by said drive gear acting on said fixed gear;

a pawl actuated by muscular control of the patient to effect incremental rotation of said drive gear;

a fixed web disposed within said rotary valve housing;

said fixed web and said rotary valve disc each being provided with a plurality of equal size and number of spaced openings therethrough;

whereby,

when the spaced openings in said fixed web are aligned with the spaced openings in said rotary valve disc, fluid flow is permitted through said rotary valve and said reinforcement insert and, when the spaced openings in said fixed web and the spaced openings in said rotary valve disc are not in alignment, no flow is permitted through said rotary valve and the reinforcement insert.

36. The system of claim 35 wherein said pawl is in the form of a compression ring and disposed externally, relative to said reinforcement insert and, against the prostatic urethra of the patient;

said compression ring having an extending tip end protruding through the body of said reinforcement insert and engaging a space between two teeth on said drive gear;

whereby,

inwardly directed radial pressure on said compression ring, applied by patient voluntary contraction of the bladder, as normally exerted during voluntary urination;

collapses said compression ring and pushes said extending tip inward to effect rotation of said drive gear and resulting rotation of said rotary disc and to cause alignment, or to remove from alignment, the spaced openings in said fixed web and said rotary valve disc.

37. A system for detecting, evaluating and treatment of prostate and urinary problems in a human male patient comprising:

a first elongated probe for insertion through the urethra of a patient from the tip of the penis into the bladder;

computer control means operable by a physician to control the rate and distance of movement of said first probe into and out of the patient;

said first elongated probe including lighted optical viewing means, axial pressure measuring means, radial pressure measuring means, and ultrasonic scanning means;

display and recording means in operative connection with said first elongated probe to provide a visual and tabular display of the visual and pressure data acquired by said optical viewing means, said axial, said radial pressure measuring means, and said ultrasonic scanning means;

a reinforcement insert custom designed from the data observed and recorded by said display and recording means;

said reinforcement insert having a spindle configuration with an enlarged diameter central area and reduced diameter ends and designed to overcome any excess radial pressure being exerted on the prostatic urethra by a diseased prostate to retain the prostatic urethra at a normal diameter; and

a second elongated probe means for inserting said reinforcement insert into the urethra of the patient and for laying said reinforcement insert in place within the prostatic urethra.

38. The system of claim 37 including removal means for removal of said reinforcement insert from the prostate of the patient;

said removal means including said second elongated probe being provided with an outer tubular shell;

an elongated ram slidably received within said outer shell;

an insert capture mechanism disposed on a tip end of said elongated ram;

said insert capture mechanism comprising a half turn, coarse threaded, shaft removal tip portion, and a threaded receptacle formed in an end of said reinforcement insert disposed adjacent the voluntary sphincter of the patient;

means providing for rotation and linear movement of said elongated ram to engage and insert the half turn, coarse threaded, shaft removal tip within the threaded receptacle formed in said reinforcement insert to capture said reinforcement insert; and

means for advancing said tubular shell of said second elongated probe while continuing rotation of said elongated ram and said captured reinforcement insert to recompress said reinforcement insert back into the lumen of said second probe.

39. The system of claim 37 wherein said reinforcement insert is constructed of a material selected from the group of materials consisting of biocompatible metals and biocompatible plastics;

said material being a helix of a flattened oval cross section ribbon, provided with fused ends, and shaped in the form of a spindle;

said reinforcement insert including removable radiation pellets embedded therein to treat a tumor of the prostate; and

means on said reinforcement insert to facilitate removal of said reinforcement insert from the patient.

40. Reinforcement means for placement within a fluid conduit in a human patient to provide support, and to relieve pressure on, the walls of the conduit, comprising:

a spindle shaped reinforcement insert;

said reinforcement being formed of a helix of ribbon and provided with an enlarged diameter central area and reduced diameter ends;

said spindle shaped helix of ribbon having a flattened oval cross sectional area and formed of a biocompatible material; and

said biocompatible material being selected from the group of biocompatible materials consisting of metals and plastics.

41. The reinforcement means of claim 40 wherein said biocompatible material is stainless steel.

42. The reinforcement means of claim 40 wherein said biocompatible material is a polycarbonate.

43. The reinforcement means of claim 40 wherein said reinforcement insert is positioned within the prostatic urethra of a male human patient and designed to relieve pressure being exerted on the prostatic urethra by a diseased prostate;

and, wherein said reduced diameter ends of said reinforcement insert are both contained within the prostatic urethra.

44. The reinforcement means of claim 43 including a one-way valve disposed within said reinforcement insert;

said one way valve including an annular ring secured within said reinforcement insert downstream from and adjacent the involuntary sphincter of the patient; and

a plurality of conical shaped, resilient, depending petals extending downstream from said annular ring;

wherein

said depending petals flex to open and permit normal flow from the bladder of the patient into the prostatic urethra but resiliently close to prevent retrograde flow of fluid from the prostatic urethra into the bladder.

45. The reinforcement means of claim 40 wherein said reinforcement insert is positioned within the prostate of a male human patient;

said reinforcement insert having one end thereof extending through the prostatic urethra into the bladder of the patient to relieve pressure and maintain open the involuntary sphincter at the opening of the bladder that previously was obstructed from an occludent flap resulting from an extremely enlarged Benign Prostatic Hyperplasia; and

, valve means disposed within said reinforcement insert to permit patient control of urine flow from the bladder.

46. The reinforcement means of claim 45 wherein said valve means includes:

a valve housing secured within the inside diameter of said reinforcement insert;

a drive gear rotatably disposed within said valve housing;

a drive shaft having a fixed gear thereon and meshing with said drive gear;

a rotary valve disc secured to said drive shaft and rotatably driven in one direction by said drive gear acting on said fixed gear thereon;

a pawl actuated by muscular control of the patient to effect incremental rotation of said drive gear;

a fixed web disposed within said rotary valve housing;

said fixed web and said rotary valve disc each being provided with a plurality of equal size and number of spaced openings therethrough;

whereby,

when the spaced openings in said fixed web are aligned with the spaced openings in said rotary valve disc, fluid flow is permitted through said rotary valve and said reinforcement insert and, when the spaced openings in said fixed web and the spaced openings in said rotary valve disc are not in alignment, no flow is permitted through said rotary valve and said reinforcement insert.

47. The reinforcement means of claim 46 wherein said pawl is in the form of a compression ring and disposed externally, relative to said reinforcement insert and, against the prostatic urethra of the patient;

said compression ring having an extending tip end protruding through the body of said reinforcement insert;

said extending tip end engaging a space between two teeth on said drive gear;

whereby,

inwardly directed radial pressure on said compression ring, applied by patient voluntary contraction of the bladder, as normally exerted during voluntary urination;

collapses said compression ring and pushes said extending tip end inward to effect rotation of said drive gear, and resulting rotation of said rotary disc, to cause alignment, or removal from alignment, of the spaced openings in said fixed web and said rotary valve disc.

48. The reinforcement means of claim 40 including a piezo-electric valve;

said piezo-electric valve having a valve housing secured within said reinforcement insert;

a fixed web secured within said valve housing;

said fixed web having a semi-circular opening therethrough;

a rotary disc valve disposed within said valve housing adjacent said fixed web;

said rotary disc valve being also provided with a semi-circular opening;

a piezo-electric element secured to and adapted to impart rotation to said rotary disc valve when subjected to an electric pulse;

said rotary disc valve being movable by said piezo-electric element from a closed first position, wherein the semi-circular opening therein is disposed 180 degrees from the semi-circular opening in said web, to an open second position, wherein the semi-circular openings in said rotary disc and said web are in alignment to permit fluid flow therethrough, and

control means for actuating said piezo-electric element to effect controlled rotation of said rotary disc valve.

49. The reinforcement means of claim 48 wherein said control means for actuating said piezo-electric element includes a pair of small insulated wires extending from said piezo-electric element to a control unit operable by the patient.