CA2228658A1 - Urethral apparatus with position indicator and methods of use thereof - Google Patents

Abstract

An apparatus and method for placement of a tubular body in the urethra. The tubular body includes a proximal portion adapted for placement toward a bladder end and bladder neck end of the urethra and a distal portion opposite from the proximal portion. A sensor component located on the tubular body is responsive to a feature of the urethra and outputs a first signal indicating proper placement of the proximal portion of the tubular body relative to the bladder and bladder neck. Preferably an insertion tool is used during positioning of the urethral apparatus. The insertion tool is coupled to the distal end of the urethral apparatus and is used to push the urethral apparatus proximally in the urethra. The first signal can be transmitted from the urethral apparatus through the insertion tool from which it is perceivable by the person positioning the urethral device. Upon proper placement the insertion tool is decoupled from the urethral apparatus and withdrawn leaving the urethral apparatus in place in the urethra with the proximal portion properly positioned relative to the bladder neck and bladder.

Description

CA 022286~8 1998-02-04 URETHRAL APPAR~TUS WITH POSITION INDICATOR

1]
I ~ FlEI,D OF THE INVENTION
1~ Tlle present invention relates generally to apparatuses for placement in the 1~ urethra and methods of using such apparatuses, and more particularly to apparatuses , that can be positioned in the urethra for sholt-tel-lll or long-terln use and that provide 7 functions such as valving for flow control or that provide hltroduction passageways for the placement of diagnostic or therape-ltic eguipment into the urinary tract l() 2(i B,~CKGROUND OF TI IE INVENTION
21 Urine flow problems include urille retention, incontinence, and difficult 22 urination These problems, especially retention and ischuria, can have serious2, consequences Retention can result from any of a number of causes, including without 2~ Ihllitatioll, spinal cord injury or tumors, coma, typhoid, peritonitisl prostatic 2- enlargelllent, urethl-al strictul-e, ul-etllritis, cystitis, bladder tumors, urethral calculus, 2(, Parl~inson's disease, prostatitis, or mLIltiple sclerosis Patients sufferillg from these and 27 other conditiolls often require some interventional means to periodically drain the 2~ bladder Failure to do so can result in damage of the epitlleliulll and detlusor muscles ~() associated witll tl-e bladder, and an h~creased potelltial for bacterial h~vasion and .-() ul-illaly tract h~t'ectioll.
. I ~he urine flow problem of hlcontinellce is the hlability to retah~ urille .2 Incontinence can result from paralysis or rela~;ation of the spllillcters or contractioll ot' . . tl-e lon=,itudillal m~lscular layers of the bladder Incotltillellce can also OCCUI h~ con-a, CA 022286~8 1998-02-04 epileptic seizure, spinal cord injury or turnors associated with the spinal cord, spinal 2 meningitis? or local irritation of the bladder. Incontinence may be categorized as either 3 stress incontinence, in which urine is expelled during stresses such as exercise, 4 coughing" and laughing; urge incontinence, in which the patient in unable to control the urge to urinate in part due to uninhibited bladder contractions; or mixed incontinence, 6 in which the patient experiences both stress and urge incontinence.
7 Difficult urination or dysuria can result from urethral strictures, enlarged 8 prostates, atony and impairment of the bladder's muscular power, and inflammatory g conditions involving the urethra, bladder, or lower ureter.
o Devices have been developed to be positioned in the urethra and/or bladder to I l correct the problems of urine flow. These devices, including urinary drainage 12 catheters" have been used for many years. A device of this type requires proper 13 placement in the urethra in order to operate correctly and with minimal discomfort. It 14 can be difficult to properly position a urine-control device in the urethra. Some of s these urethral devices require that a physician use a cystoscope or rely on ultrasound, 6 fluoroscopy, X-ray, or similar technology for position information to properly place a 7 device in the urethra. These techniques require relatively expensive equipment.
Another way that it can be determined that a urethral device has been positioned into 19 the bladcler is to observe the flow of urine through the device which is an indication that the bladder has been entered. This method requires that a through-lumen or valve 1 can be maintained in an open position during insertion and that the bladder be 22 su fficienfly full so that a flow of fluid is readily observable. Therefore, this method 23 may not be available if the patient's bladder is empty. Accordingly, devices for 24 placemellt in the urethra are relatively hard to properly position and have often required that a skilled physician position the device using expensive equipment.26 ~ccordingly, it is an object to provide a urethral device that can be positioned 27 relatively easily.
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29 S U M M A R Y OF Tl3E IN V EN TIO N
3ù To address the above concerns, the present invention provides an apparatus 3 1 and method for placement of a tubular body in the urethra. The tubular body includes 32 a proximal portion adapted for placement in the urethra toward a bladder and bladder CA 022286~8 1998-02-04 neck and a distal portion opposite from the proximal portion. A sensor component2 located on the tubular body is responsive to a feature of the urethra and outputs a first 3 signal indicating proper placement of the proximal portion of the tubular body relative to the bladder and bladder neck. Preferably, an insertion tool is used during positioning of the urethral apparatus. The insertion tool is coupled to the distal end of 6 the urethral apparatus and is used to push the urethral apparatus proximally in the 7 urethra. The first signal can be transmitted from the urethral apparatus through the insertion tool from which it is perceivable by the person positioning the urethral device.
9 Upon proper placement, the insertion tool is decoupled from the urethral apparatus and withdrawn leaving the urethral apparatus in place in the urethra with the proximal I l portion properly positioned relative to the bladder neck and bladder.

1~ In the drawings, in which like reference numerals indicate corresponding parts through lhe several views;
16 Figure l shows a side view of a first embodiment of a urethral apparatus and an 17 insertion tool showing the insertion tool partially cutaway.
1~ Figure 2 is a side sectional view of a distal portion and sensing component of 19 the urethral apparatus of Figure I and a partially cutaway view of a proximal portion of the insertion tool, uncoupled from the urethral apparatus.
21 Figure 3 is an end view of the insertion tool of Figure 2 taken from line 3--3 '.
22 Figure 4A is a side view of the deformable coupling of Figure 3 in a released 23 position.
24 Figure 4B is an end view of the deformable coupling of Figure 4A.
Figure 4C is a side view of the deformable coupling of Figure 4A in a locked 26 position.
27 Figure 5A is a side sectional view of the urethral apparatus of Figure l and a 2~ pal~ially cutaway view of a proximal portion of the insertion tool, coupled to the 29 urethral apparatus.
Figure 5B is a sectional view of the urethral apparatus taken along line 5B--.1 5B' of Fi,,ure 5A.

CA 022286~8 1998-02-04 Figure 5C is a sectional view of the urethral apparatus taken along line SC--2 5C'of Figure 5A.
3 Figure 6Ais an end view of the apparatus first contact collar of Figure 5A.
4 Figure 6Bis a sectional side view of the apparatus first contact collar of 5 Figure 5A.

6 Figure 7 is a side view of the proximal segment of the coupled urethral 7 apparatus and insertion tool of Figure I in one stage of being positioned in a urethra.

8 Figure 8 is a close-up view of a distal end of the sensing component of the 9 urethral iapparatus during the stage of positioning shown in Figure 7 o Figure 9 is a side view of the coupled urethral apparatus and insertion tool of I l Figure 7 in another stage of being positioned in the urethra.
2 Figure 10 is a close-up view of a distal end of the sensing component of the 13 urethral apparatus during the stage of positioning shown in Figure 9.
14 Figure I 1 is a side view of the urethral apparatus of Figure 1 coupled to an s alternate embodiment of an insertion tool.
6 Figure 12 is a side view partially in section ofthe insertion tool of Figure 11.
7 Figure 13 is an exploded view ofcomponents ofthe insertion tool shown in 8 Figure 12.
1~) Figure 14 is a side view of the removable cover with the stop component ofthe insertion tool shown in Figures 1 1-13.
21 Figure 15is a side sectional view of the urethral apparatus of Figure I and a 22 partially cutawav view of a proximal portion of the insertion tool of Figures I I -14, 23 coupled l o the urethral apparatus.
24 Figure 16Ais a schematic flow diagram illustrating the electrical flow during coupling of the insertion tool and urethral apparatus of Figure 15.
26 Figure 16Bis a schematic flow diagram illustrating the electrical flow during 27 positioning of the insertion tool and urethlal apparatus of Figure 15.
2X Figure 17 is a sectional view of anotller embodiment of a urethral apparatus 29 having a prefonned portion.
3() Figure 18 is a sectional view of still another embodiment of a urethral . I apparatus, utilizing a piezoelectric transducer or membrane switch.

CA 022286~8 1998-02-04 Figure 19A is a schematic flow diagram illustrating the electrical flow during 2 coupling of the insertion tool and urethral apparatus of Figure 18.
3 Figure 19B is a schematic flow diagram illustrating the electrical flow during 4 positioning of the insertion tool and urethral apparatus of Figure 18.
s Figure 20 is a sectional view of an alternate embodiment of a urethral 6 apparatus, utilizing acoustic sensing.
7 Figure 21A is a schematic flow diagram illustrating the electrical flow during 8 coupling of the insertion tool and urethral apparatus of Figure 20.
9 Figure 21B is a schematic flow diagram illustrating the electrical flow during o positioning of the insertion tool and urethral apparatus of Figure 20.
Figure 22A is a side view of the proximal end of an embodiment of the 2 insertion tool illustrating the contact collar assembly and its interface with the contact 13 collar of the urethral apparatus.
14 Figure 22B is an end view of the contact collar housing of Figure 22A.
s Figure 22C is an end view of the contact collar of Figure 22A.
6 Figure 22D is an end view of the contact collar housing of the urethral 17 apparatus of Figure 22A.
IX Figure 23 is a sectional view of another alternate embodiment of a urethral 19 apparatus that utilizes acoustic sensing.
Figure 24 is a sectional view of a first alternate embodiment of a urethral 21 apparatus that utilizes fluid flow sensing.
22 Figure 25A is a partially cutaway side view of an insertion tool to be used with 23 the embodiment of Figure 24.
24 F:igure 26B is a close-up view of the proximal portion of the insertion tool of 2~ Figure 25A.
2(, Fiigure 26A is a schematic flow diagram illustrating the electrical flow durhlg 27 coupling of the insertion tool and urethral apparatus of Figure 24.
2x Figure 26B is a schematic flow diagram illustrating the electrical flow durhlg 29 positioning of the insertion tool and urethral apparatus of Figure 24.
Figure 27 is a sectional view of a second alternate embodhllellt of a urethral .1 apparatus that utilizes fluid flow sensing.

CA 022286~8 1998-02-04 Figure 28 is a sectional view of a third alternate embodiment of a urethral 2 apparatus that utilizes fluid flow sensing.
3 Figure 29A is a cross-sectional view taken along line 29A-29A' of Figure 28 4 showing the volume-deformable member in an expanded configuration.
Figure 29B is the same cross-sectional view as shown in Figure 29A showing 6 the volurne deformable member in a depressed configuration.
7 Figure 30A is a sectional view of a fourth alternate embodiment of a urethral 8 apparatus that utilizes fluid flow sensing shown in a closed mode.
9 Figure 30B is a sectional view of the embodiment of the urethral apparatus lo shown in Figure 30A shown in an open mode.
11 Figure 31 is an expanded cross sectional view of the fluid passages shown in 12 Figure 3(), taken along lines 31--31'.
13 Figure 32 is a close-up sectional view ofthe proximal portion ofthe fluid 14 passageways shown in Figures 30 and 31.
Figure 33 A is a partially cutaway side view of an insertion tool for use with the 6 embodiment ofthe urethral apparatus in Figure 32 7 Figure 33B is a close-up view ofthe proximal portion ofthe insertion tool of 1~ Figure 33 A.
19 Figure 34 is a sectional view of an alternate embodiment of a urethral apparatus that uses electrical resistance measurement for position sensing.
21 Figure 35A is a schematic flow diagram illustrating the electrical flow during 22 coupling of the insertion tool and urethral apparatus of Figure 34.
23 Figure 35B is a schematic flow diagram illustrating the electrical flow during 2~ positionhlg of the insertion tool and urethral apparatus of Figure 34.
Figure 36 is a sectional view of an alternate embodiment of a urethral apparatus2(, that uses thermoelectric cooling to provide for position feedback 27 Figure 37 is an expanded side view ofthe semiconductor used in the sensing 2~ component of Figure 36.
2~) Figure 38A is a schematic flow diagram illustrating the electrical flow during coupling of the insertion tool and urethral apparatus of Figure 36.
31 Figure 38B is a schelmatic flow diagram illustrating the electrical flo~ during 32 positionhlg ofthe insertion tool and urethral apparatus of Figure 36.

CA 022286~8 1998-02-04 Figure 39 is an expanded partial top view of an alternate embodiment of a 2 urethral apparatus that uses fiber optics to provide for position feedback 3 Figure 40 is a side view of the urethral apparatus of Figure 39 at one stage of 4 positioni:ng, showing the fiber optic light being block or absorbed.
s Figure 41 is a cross-sectional view of the urethral apparatus of Figure 40 taken 6 along line 41 ~11 '.
7 Figure 42 is a view similar to Figure 40 showing the urethral apparatus at 8 another stage of positioning and showing the fiber optic light being reflected.
g Figure 43 is a cross-sectional view of the urethral apparatus of Figure 42 taken lo along line 43 43' Figure 44A is a schematic flow diagram illustrating the electrical flow during 2 coupling of the insertion tool and urethral apparatus of Figure 39.
3 Figure 44B is a schematic flow diagram illustrating the electrical flow during 4 positioning of the insertion tool and urethral apparatus of Figure 39.
s Figure 45A is a schematic flow diagram illustrating the electrical flow during 6 coupling of the insertion tool and an alternative embodiment of a urethral apparatus 17 that uses only one fiber optic strand and an optical transducer.
Figure 45B is a schematic flow diagram illustrating the electrical flow during 19 positioning ofthe insertion tool and urethral apparatus of Figure 45A.
Figure 46A is a sectional view of an alternate embodiment of a urethral 21 apparatus that incorporates drug delivery.
22 Figure 46B is sectional view of an alternate embodhnent of the urethral 23 apparatus shown in Figure 46A with a flow-restrictor valve.
24 Figure 47 is a sectional view of another alternate embodiment of a urethral 2s apparatus that incorporates drug delivery.
2() Figure 48 is a sectional view of an alternate embodiment of a urethral apparatus 27 that incorporates internal valving for fluid flow control and shown hl a first, closed 2~ stage of operation.
29 Figure 49 is a sectional view of the embodhnent of Figure 48 showing the ~,o valving components in a second, damping stage of operation.
31 Fiigure 50 is a sectional view of the embodiment of Figure 48 showillg the .2 valving compollents in a third, open stage of operation.

CA 022286~8 1998-02-04 Figure S l is a sectional view of the embodiment of Figure 48 showing the fluid 2 flow path.
3 Figure 52 is a side view of the fluid flow director of Figure 48.
4 Figure 53 is an end view of the fluid flow director of Figure 48.
Figure 54A is an end view of an embodiment of the magnet of Figure 48.
6 Figure 54B is an end view of an alternative embodiment of the magnet of7 Figure 54A.
8 Figure 55 is a sectional view of an alternate embodiment of a urethral apparatus 9 that includes anchoring features for securing the apparatus in the urethra.
Figure 56 is a sectional view of an alternate embodiment of a urethral apparatushaving anchoring features.
2 Figure 57 is a sectional view of the embodiment of Figure 55 positioned within 3 the urethra with lines illustrating forces applied to the apparatus.
4 Figures 58A, 58B, and 58C show alternative embodiments for females of urethral apparatuses having anchoring structures.
IG Figures 59A, 59B, 59C, 59D, and 59E show alternative embodiments for males 7 of urethral apparatuses having anchoring structures.
1~

2() PRESENTLY PREFERRED EMBODIMENTS
21 I. GENER~L OVERVIEW
22 Disclosed below are various embodiments of apparatuses for urethral 2., placement. The disclosed embodiments provide functions that require proper 2~ placement of the apparatus in the urethra. For example, in embodiments that are used 25 for control of incontinence, it is required that a proximal part of the apparatus be in or 2-, close to the bladder so that urine can flow into an opening in the proximal end of the 27 apparatus. These embodiments described below include a feature that facilitates 2x proper placemel1t of the apparatus.
2~) .,() Il. EMBODIMENTS WITH MECHANICAL SENSING:
, I A I~ t I n7bo~iltt~ll l of a lll ~Ihl a/ A/~/~al alt/.~
,2 Figures I - 10 show a first embodiment of an apparatus 100. The apparatus 100 " is intended to be positioned in a uretl1ra (shown in Figures 7- 10) and to extend partially CA 022286~8 1998-02-04 into a bladder (shown in Figures 7 and 9) of a patient. The patient may be either a 2 male or female human, or alternatively, embodiments of the apparatus may be used in 3 other mammals or even in non-mammals, with suitable changes in dimensions.
4 R.eferring to Figures 1 and 2, the apparatus 100 includes a body 101 having a wall 102 with an exterior surface 103. The body 101 has a generally tubular shape 6 around axis 111. The body 101 has a distal portion 105 terminating in a distal end 106 7 and a proximal portion 107 terminating in a proximal end 108. (As used herein, the 8 term "proximal" refers to the end which is at or close to the bladder and the term 9 "distal" refers to the end opposite the proximal end and farther away from the bladder o when the apparatus is in place. The proximal end would be inserted first. This 11 terminology convention applies as well to the insertion tool, described below.) 12 The cross sectional shape ofthe body 101 may be generally circular or may be 13 flattened to conform to the anatomical shape ofthe urethra. The body 101 has a 14 generally tubular shape around an axis 111. The proximal portion 107 ofthe body 101 has at lea,st one port 109 which may be located at the proximal portion 107 or proximal IG end 108 to allow for urine flow into and through the apparatus. Alternately, the 7 proximal end 108 may have an open through-lumen to allow the apparatus to be used x as an introducer for fluids, stents, or other apparatuses or to function as a temporary t 9 stent itself for diagnostic and therapeutic procedures in the lower or upper urinary tract. The body 101 defines a passageway or lumen I 10 that extends through the 21 length of'the body 101 from the proximal port 109 to a distal opening 115.
22 In one ernbodiment the apparatus 100 is produced using a composite 23 construclion of a base tube and cast external features. A base tube is constructed as a 24 braid reinforced silicone tube using a stainless steel wire braid and Shore A 60 durometer silicone compound as the tube polymer (tubing produced by New England 2(, Electric ~Nire Corp. Lisbon, NH). The internal diameter of the base tube is 0. 160 27 inches using a braid core diameter of 0.180 inches. The external diameter of the base 2x tube is 0.210 inches.
29 ln one class of embodiments of the urethral apparatus 100, the body 101 has an .~) overall length such that the body 101 resides entirely within the urinary tract of the ~ I patient, preferably primarily witllin the urethra, except to the extent to WhiCIl the ,2 proximal end 108 extends partially or completely into either the bladder or the bladder CA 022286~8 1998-02-04 neck. In these embodiments, the distal end 106 of the body 101 of the apparatus 100 2 does not extend outside the urethra after it is positioned. In these embodiments that 3 are retained entirely within the patients' bodies, additional elements or capabilities may 4 be provicLed, such as a fluid valving or drug delivery, as described more fully below. In s present embodiments, the body 101 is less than 10 cm in length in versions for adult-6 sized male users and 5 cm in length for adult-sized female users, but more preferably 7 less than 5 cm in length for female users.
8 In certain applications, such as certain short-term applications, alternate g embodiments of the apparatus 100 can be employed in which the overall length of the lo body lO L is greater than the above dimensions. In these embodiments, the distal end 106 of the body 101 extends outside the urethra while the proximal end 108 is 2 positioned within the bladder or the bladder neck. In embodiments of the apparatus in 13 which the distal end extends outside the body, the distal end 106 can be connected to a 14 fluid collection or introducer system.
s The body 101 may be sized from about 10 French to 34 French to 16 accommodate the large range of urethral sizes from infants to adults. The exterior 17 surface 103 of the body l O 1 is constructed of molded silicone or alternatively of latex.
1~ Alternative materials include molded polyurethane~ polyethylene, polycarbonate, or 19 other biocompatible materials.
2() 21 B. I~i~st ~n1boc~in1ef1t Of l~7.s~rtio71 Tool.
22 R.eferring to Figures I and 2, the urethral apparatus lO0 is releasably coupled 23 with an insertion tool 150 for placement and removal. The insertion tool 150 provides 24 three functions. First, the insertion tool 150 couples to the urethral apparatus 100 and aids h1sel-tion of the apparatus 100 into the urethra, bladder neck, or bladder. Second 26 the insert:ion tool 150 completes the respective electrical circuits to provide feedback 27 that the urethral apparatus 100 is coupled with the insertion tool 150. Third, the 2~ insertiol1 tool 150 interfaces with the urethral apparatus l O0 and completes the various 29 electrical, optical, fluid, or mechanical circuits, channels, or linkages of the urethral 3l) apparatu, 100 to provide feedback to the caregivel- that the urethral apparatus 100 is 3 l properly positioned hl relation to the bladder neck or bladder. These functiol1s of the 32 insertion tool 150 are described below.

I ~) Referring to Figures I and 2~ the insertion tool 150 has a handle 151 and a 2 linkage 152 that passes through a shaft 154. The linkage 152 is connected to an 3 actuating mechanism, such as a plunger 156, at a distal end 158 ofthe insertion tool 4 and is connected to a deformable coupling 160 at a proximal end 162 ofthe insertion tool 150. (In an alternative embodiment (not shown) the locking mechanism can be a 6 bayonet-type mechanism, which engages the alternate locking mechanism to maintain 7 the plunger in a depressed position.) The deformable coupling 160 fits into an inner 8 recess 113 in an entrance channel 114 in the distal portion 105 of the body 101 of the g urethral apparatus 100, thereby locking the insertion tool 150 with the apparatus 100.
o Figure 2 shows the insertion tool 150 uncoupled from the apparatus 100 with the deformable coupling 160 at the proximal end 162 of the insertion tool 150 in an 12 uncompressed mode, and Figure 5A shows the insertion tool 150 coupled to the13 urethral apparatus 100 with the deformable coupling 160 in a compressed mode.
1~
C . Se~1si~ C 0111pO~ 1t.
16 Referring again to Figure 1, the urethral apparatus 100 includes a sensing 17 component 112. In this embodiment, the sensing component 112 is associated with the 18 body 101, and in particular, the sensing component 112 is located along the axial 19 length of the body 101. The sensing component 112 senses a change in the 2() environment of the urethra or a change in a feature of the urethra as the apparatus is 21 being positioned in the urethra. For example, the sensing component 112 may respond 22 to changes in anatomical features of the urethra as a portion of the apparatus 100 23 moves along the urethra and enters the bladder neck and bladder. The sensing24 component 112 does not necessarily measure any particular condition or feature but instead detects a change in a condition, parameter, or feature. For example, the2(, sensing component 112 may detect a change from a compressed state to an 27 uncompressed state or to a less-compressed state, from an environment where outward 28 force is registered to an environment where the same force is either no longer 2(~ registered or is contained with less resistance, or from having one light or sound reflection quality or parameter to an environment having a different reflection quality 31 (e.g., the urethra versus the bladder neck or the bladder). As such, the sensing 32 component 112 can be a tactile sensor, a pre-loaded spring, a force-sensitive contact, a CA 022286~8 1998-02-04 photo cell interacting with a fiber optic strand by radiating and receiving reflected light, 2 a pair of fiber optic strands, a piezoelectric transducer or a membrane switch, a 3 pneumatic or hydraulic electrical or mechanical indicator, a strain gauge, an acoustical-4 reflection sensor, a thermal couple, a thermistor, or a fluid-introduction port or fluid s circuit in combination with a movable element actuating electrical or mechanical 6 components. Utilizing any of these or other sensing technologies to sense any of the 7 features or conditions in the urethral environment, the sensing component 112 includes 8 appropriate scaling so that it can provide a positive indication when the apparatus is 9 properly positioned relative to the features of the urethral environment. By0 appropriate scaling, the sensitivity of the sensing component is established so that it I outputs a signal (preferably a single signal) indicating proper placement of the tubular 2 body rela.tive to the bladder neck and bladder. In this manner the sensing component 3 distinguishes the change in the sensed feature from the urethral background 14 environment to provide a signal indicating that the bladder neck or bladder have been I S reached.
6 One embodiment ofthe sensing component 112 is described in conjunction 7 with Figures 5A through 5C. This embodiment of the sensing component is a 18 mechanical-type sensor or pressure sensor. This embodiment of the sensing 19 component 112 is responsive to compressive forces applied to a portion ofthe body 101 of the urethral apparatus 100.
21 The sensing component 1 12 comprises a first wall 123 and a second wall 124.
22 The first and second walls are formed of tubular parts of the body 101 of the urethral 23 apparatus 100 close to the proximal end 108. The first wall 123 has shape-memory 24 characteristics and assumes at least first and second positions (compare, for example, 2s Figures 7 and 8 with Figures 9 and 10). ln this embodiment, the first wall 123 is 26 resilient and flexible. The first wall 123 is formed so that it bows outward, as shown in 27 Figure 5A, in its at-rest condition. In this bowed condition, the first wall 123 is spaced 2x away fonn the second wall 124, as shown in Figure 5A. However, when compressive 29 forces are applied to the first wall 123, it deflects to the flattened condition shown in 3() Figure 7. Movement from the bowed-out condition to the flattened condition causes a 3 l correspondil1g movement of axial length of the first wail 123 . Because the proximal 32 end 125 of the first wall is fixed, the distal end 12~ of the first wall 123 is caused to -- l 2 -CA 022286~8 1998-02-04 move proximally or distally as a result of the bowing out or flattening of the first wall 2 123.
3 Referring to Figures 5A, 5B, and 5C, lead wires 117 and 118 interconnect 4 conducting surfaces 116a and 116b of the apparatus first contact collar 116 to conducting surfaces 120a and 120b, respectively, of an apparatus second contact collar 6 120. As shown in Figure 5B, the apparatus conducting surfaces 120a and 120b are 7 separate(l by apparatus non-conducting surfaces 120c and 120d. The distal end 126 of 8 the first wall 123 has an apparatus third contact component 122 which has a 9 continuous metalized conducting surface 122a. Completion of an electrical circuit o between the apparatus second contact collar 120 and the apparatus third contact l l component 122 provides a feedback signal to the person positioning the apparatus, 12 such as the caregiver, that the urethral apparatus is in the urethra. Conversely, opening 13 the electrical circuit between the apparatus second contact collar 120 and the 14 apparatus third contact component 122 provides a feedback signal that the urethral apparatus is properly positioned in the bladder neck or bladder (explained in more 16 detail below). This allows the circuit between the apparatus second contact collar 120 17 and the apparatus third contact component 122 to be alternately opened or closed, IX depending on the position of the urethral apparatus 100 along the urinary tract.
19 Figures 6A and 6B show the apparatus first contact collar 116 in more detail 2() and show conductive surfaces 116a and 116b separated by nonconductive surfaces 21 116c and 116d. In an alternative embodiment, the apparatus first contact collar 116 22 can be replaced with a contact film having conducting areas corresponding to the 23 conductive surfaces 116a and 116b and non-conducting areas corresponding to the 24 surfaces 116c and 116d.

2G 1). I~lse7~ion 70011~ icalo7 rJ~7it.
27 The sensing component 112 in the urethral apparatus 100 works in conjunction 28 with the insertion tool 150 Referring to Figures 2 and 3, the proximal end 162 ofthe 2') insertion tool 150 includes an atraumatic proximal tip 172 and an insertion tool contact ~() collar 170. The tool contact collar 170 is composed of three conductive areas 170a, 31 170b, and 170c. The contact collar 170 has an oval cross-sectional shape.

The insertion tool 150 includes an indicator unit 164 (Figure 1). The indicator 2 unit 164 uses any of various visual, audible, or other signaling indicators (e.g., a first 3 light 165, a second light 166, and an alarm 167) that (1) receive electrical feedback 4 that the urethral apparatus 100 and the insertion tool 150 are coupled and (2) receive feedback from the sensing component 1 12 that the apparatus 100 is properly 6 positioned. This information is relayed along the tool shaft 154 through a lead bundle 7 168, for example, to the indicator unit 164 where it is observable by the caregiver or 8 the patient. The indicator unit in the insertion tool 150 is powered by a battery (not g shown).
0 (In alternative embodiments, all or part of the functions of the indicator unit may be located at the distal end of the urethral apparatus. Such embodiments may be 12 used in conjunction with an insertion tool that is used to facilitate positioning or may 13 be used without insertion tools. In embodiments ofthe urethral apparatus in which the 14 distal portion of the body of the urethral apparatus extends outside of the urethra during use, the indicator unit may be incorporated into the distal portion and may -) include appropriate audible, visual, or other signaling to indicate that the apparatus is 7 properly positioned.) 1~
19 k Opera~io~7 - placeme~ll 2() Referring to Figure 2, in the uncoupled mode, the deformable coupling 160 of 21 the insertion tool 150 has a first diameter ] 74 and a first width 175 (as shown in 22 Figures 4A and 4B) and is able to pass through the tapered distal end 106 of the 23 tubular body 101. The proximal end 162 ofthe insertion tool 150 is inserted into the 24 entrance channel 114 and into the inner recess 113, which has a greater vertical cross-2s sectional area. The deformable coupling 160 is compressed by an actuating linkage 26 152 using the plunger 156. The vertical diameter of the coupling 160 is extended to a 27 second, larger diameter 176 and a second width 177 (Figure 4B and 4C), thereby 2~ pressillg the deformable coupling 160 into the outer extremities of the inner recess 1 13 29 of the urethral apparatus and pressing the conductive areas 1 70a, 1 70b, and 1 70c of 3() the h1sertiion tool contact collar 170 against the conductive surfaces I 1 6a and I 1 6b of 31 the apparatus first contact collar 116 (Figure 5A). This contact activates the first light 32 165 of the indicator unit 164 providing a feedback signal that the insertion tool 150 CA 022286~8 1998-02-04 and the urethral apparatus 100 are coupled. The two units are now securely engaged 2 together and are ready for insertion into the urethra. As shown in Figure 1, a biasing 3 force applied to the plunger 156 (and thereby to the linkage 152) by the spring 178 4 helps to maintain the deformable coupling 160 in a locked or coupled mode, and the s stop 179 aids to limit travel of the plunger 156 thereby controlling the diameter of the 6 deformable coupling 160. Further~ a locking mechanism can be provided, such as a 7 simple screw 180 and nut 181 combination, to secure the plunger shaft 182 in an 8 uncompressed mode.
g Figures 7 and 8 show the coupled insertion tool 150 and urethral apparatus 100 being inserted into the urethra 40. In Figures 7 and 8, the urethral apparatus 100 is I l passing through the urethra 40 and approaching the bladder neck 42. In this positionl 2 the sensing component 112 is responsive to an environment that is relatively consistent 13 within the urethra 40. In this example, the sensing component 112 is in a flattened 14 configuration, and the apparatus second contact collar 120 is in contact with the apparatus third contact component 122, which is part ofthe sensing component 112.
16 This circuit between the apparatus second contact collar 120 and the apparatus third 17 contact component 122 is maintained while the proximal end 108 ofthe urethral 18 apparatus 100 is still within the urethra 40. As the coupled urethral apparatus 100 and 19 hlsertion tool 150 are advanced through the urethra 40, the sensing component 112 is deformed due to the compressive forces exerted by the continuous surface of the 21 urethra 40.
22 As shown in Figures 9 and 10, when the urethral apparatus 100 moves into the 23 larger diameter channel of the bladder neck 42 or bladder 44, the sensing component 24 112 undergoes a change in shape. This change causes the apparatus third contact 2s component 122 to move away from the apparatus second contact collar 120, opening 26 that circuit and thereby sending a feedback signal to the person positioning the urethral 27 apparatus, such as the caregiver, that the urethral apparatus 100 is in proper position in 28 relation to the bladder neck 42. The insertion tool 150 can now be uncoupled from the 29 uretllral a.pparatus 100. Figure 9 shows the insertion tool 150 uncoupled from the urethral apparatus 100, leaving the urethral apparatus 100 in proper position in relation to the bladder neck 42 and bladder 44. The proximal end 162 of the insertion tool 150 1 ~

CA 022286~8 1998-02-04 may have a tapered transition 184 from the shaft 154 to the deformable coupling 160 2 to ease withdrawal ofthe insertion tool 150.

4 F Operation- l?en10lJal of apparatus.
s Removal ofthe urethral apparatus 100 is accomplished using the above steps in reverse c,rder. The linkage 152 ofthe insertion tool 150 is actuated by the plunger 156 7 and locked to maintain the deformable coupling 160 in the first diameter 174 and the 8 first width 175. The insertion tool 150 is inserted into the urethra until it engages the g distal end 106 ofthe urethral apparatus 100. The proximal end 162 ofthe insertion tool 150 is further inserted into the entrance channel 114 ofthe distal end 106 ofthe Il urethral apparatus 100 until the tool contact collar 170 ofthe insertion tool 150 12 engages the apparatus first contact collar 116. This engagement can be confirmed by 13 observing actuation ofthe first light 165. The deformable coupling 160 is then 14 changed to the second, larger diameter 176 and the second width 177 by releasing the plunger 156 thereby locking the insertion tool 150 to the urethral apparatus 100. Once 16 coupled, removal ofthe tool and urethral apparatus can proceed by pulling on the 17 distal end ofthe tool.

se of a77 Inse7 tio71 I~/ee\~e.
In alternative embodiments, the coupled or joined urethral apparatus 100 and 21 insertion tool 150 can be inserted in the urethra with the aid of an insertion sleeve (not 22 shown), which is inserted in the urethra 40 either prior to or simultaneously with the 23 joined urethral apparatus and tool. The insertion sleeve can be a short or a long sleeve, 24 or an everting sleeve that may aid in reducing the introduction of bacteria higher into 2~ the urethra or bladder. The sleeve has a length such that it does not interfere with the 2(, sensing component 112 on the body of the urethral apparatus. The sleeve may also 27 have a longitudinal line of weakness to facilitate removal of the sleeve, for example by 2x tearing. Those skilled in the art will realize that a coating on the sleeve, preferably 29 including lubricating and antibacterial substances, may be used to aid in insertion within tlle urinary tract.
~1 CA 022286~8 1998-02-04 h'. Alt~rnativ~ ~mho~iment of I~ls~rtion Tool 2 Figures 11 through 15 show an alternative embodiment 250 of the insertion 3 tool, which can be used for placement of the urethral apparatus 100. The insertion 4 tool 250 provides for an axial orientation of the caregiver's hand during insertion and removal. In this embodiment of the insertion tool 250, the plunger and locking 6 mechanism are integrated within a handpiece housing 251. A proximal end 262 of the 7 insertion tool 250 has an atraumatic distal tip 272, which is interconnected with a cable 8 or other linkage 252 that passes through a shaft 254 ofthe insertion tool 250. The 9 linkage 252 is connected to a plunger 256 and has a biasing spring 278 (best shown in o Figure 12). A sleeve 257 serves to center the spring 278 over the linkage 252 (Figure 13). As the plunger 256 is moved forward and backward, it engages a stop 279 2 (Figure 14), which secures a deformable coupling 260 either in an engaged or13 disengaged position with the urethral apparatus 100. A battery 259, which supplies 4 power for the insertion tool 250, is inserted through a distal end 258 of the insertion s tool 250 and is held in place with a nut 281 and a battery spring 261. A ground 6 contact strip 263 for the battery 259 is located adjacent to and in contact with the 7 battery spring 261 and with a ground lead 269. A positive contact 283 for the battery ls 259 is connected to a positive lead 284 and is connected to the circuitry in an indicator 1~) unit 264. Figure 12 also shows a lead bundle 268 consisting of individual leads 268a, () 268b, and 268c (best shown in Figure 15) that carry feedback signals indicating proper 1 coupling and positioning. The individual leads terminate within the indicator unit 264 22 which is iurther detailed in the circuit flow diagrams and descriptions discussed below.
23 The indicator unit 264 is joined to the shaft 254 of the insertion tool 250 with a 24 slip connector 255. The slip connector 255 allows the distal end 258 to be rotated to aid h1 coupling the insertion tool 250 with the urethral apparatus 100 and to aid 2(, insertion of the coupled tool and urethral apparatus through the urethra.
27 Referring to Figure 15, the insertion tool 250 has an insertion tool contact 2~ collar 27() close to its proximal end 262. (This contact collar 270 may be similar to the 2~) contact collar 170 ofthe insertion tool 150 in the previously described embodiment.) 3~) The contact collar 270 includes three conducting surfaces 270a, 270b and 270c (Figure 31 16B), which interface with the conducting surfaces 116a and 116b of the first contact 32 collar 116 of the urethral apparatus 100 to complete a circuit that indicates proper CA 022286~8 1998-02-04 coupling ofthe insertion tool 250 with the urethral apparatus 100. The conductive 2 surfaces 270a, 270b, and 270c are connected to the three electrical leads, 268a, 268b, 3 and 268c, respectively. These leads are located within the shaft 254 of the insertion 4 tool 250 and terminate within the indicator unit 264 at electrical contacts that communicate with a first light 265, a second light 266, and an alarm 267.
6 The electrical circuit flows during coupling and insertion are diagrammed in 7 Figures 16A and 16B. The circuit flow during coupling is shown in Figure 16A. The 8 battery 2.59 is connected to a switch 285 at a first contact 286 by the positive lead 284 9 A second contact 287 and the conductive surface 270b are interconnected by the lead o 268b. When the insertion tool is engaged with or coupled to the urethral apparatus 100, an electrical connection between the insertion tool conductive surfaces 270b and 12 270c is made when each comes in electrical contact with the conductive surface 116a 13 ofthe urethral apparatus 100. In this coupled mode, the first light 265 is activated.
4 Also receiving power through the switch 285 is an inverter 294 and a relay s 295, which receive power through a third switch contact 288 and a lead 268d. The 6 switch 285 can be in one of two positions for receiving feedback. The first position is 7 used during coupling, and the second position is used during positioning.
x After the urethral apparatus 100 and the insertion tool 250 are coupled, the 19 switch 285 is moved to a second position~ and the first light 265 remains lit. Figure 1 6B illustrates the circuit flow during insertion and positioning. The sensing 21 component 1 12 is compressed against the outer surface of the body 101 such that the 22 conductive surface 122a ofthe third contact component 122 electrically interconnects 23 the second conducting surfaces 120a and 1 20b of the second contact collar 120. The 24 leads 1 17 and 1 18 electrically interconnect the first contact collar 1 16 with the second 2s contact collar 120. Both the first and second lights 265 and 266 are on unless the 26 switch 285 is in the offposition. The invelter 294 translates the electrical signal 27 returning through the lead 268a to indicate when the sensing component 1 12 becomes 2x uncompressed, i.e. the third contact component 122 located on the sensing component 29 1 12 becomes electrically disconnected from the conducting surfaces 1 20a and 1 20b 3() whell the urethral apparatus 100 enters the bladder, and an electrical signal is 3 1 transferred tl1rougll the lead 268e to the switcl1 285 to activate the second light 266 CA 022286~8 1998-02-04 and/or alarm 267 The second light 266 and the alarm 267 may be selectively activated 2 depending on the user's setting of the switch 285 3 In a present embodiment, the switch 285 has four positions. In a first position, 4 the electrical circuitry is off. In a second position (for coupling), the first light 265 is s activated when the circuits are completed between the insertion tool contact collar 270 6 and the first contact collar 116 of the urethral apparatus 100. When the switch 285 is 7 in a third position (for positioning or insertion), the input contact 289 and the light 8 contact 290 are interconnected and the second light 266 activates indicating entrance 9 to a body passageway with increased area (e.g., diameter). In a fourth position, the o input contact 289 is interconnected to the light/alarm contact 291 and the second light 266 and the alarm 267 are activated, thereby indicating entrance to a body passageway 2 of increased area (i.e. diameter). The input contact 289 is activated either directly via 13 the voltage source, or with an optional relay 295.
14 'rhose skilled in the art will appreciate that the inverter 294 reverses the activation of the second light 266 (or the alarm 267) relative to the operation described IG in connection with the first embodiment of the insertion tool. Instead of being turned 17 offwhen a current path between the apparatus conducting surfaces 120a and 120b and 18 the apparatus component surface 122a is interrupted, the inverter 294 causes the 19 second light 266 (or the alarm 267) to be turned on when the current path isinterrupted. Thus, the inverter 294 is provided to effect this alternative mode of 21 operation. Accordingly, it is understood that the use of the inverter is optional 22 depending upon the mode desired.

24 1. ~econd ~mbodln7~nt of th~ ~Jr~th~al Appa~atus:
Figure 17 shows another embodiment I OOA of the urethral apparatus. The 2G urethral apparatus I OOA includes a tubular body 101 A having a proximal portion 107A
27 terminating in a proximal end 108A. In this embodiment, a sensing component 112A is 28 comprised of a preformed, shape-memory portion incorporating internal electrical 2~) switchingr. The proximal portion 107A includes a preformed portion 131 A. The ~() preformed portion 131 A is flexible and resilient and has an other-than-straight shape 31 when at rest. A slidable contact 132A is fixed distally at a position 134A and displaced 32 relative to a proximal contact pair 135A as deformation ofthe preformed portion 13 IA

CA 022286~8 1998-02-04 occurs upon entry into the bladder neck or bladder. This displacement causes the2 proximal contact pair 135A to open, thus opening an electrical circuit through the 3 apparatus conductive leads 117A and 118A, which interconnect the proximal contact 4 pair 135A and the apparatus first contact collar 116A, which is in contact with the s insertion tool 150 (or 250), thereby activating a signal on the indicator unit 164 (or 6 264) thereof. Optionally, the apparatus proximal contact pair 135A can be located in a 7 more distal position near the apparatus first contact collar 116A. In an alternative 8 embodiment, the preformed portion 131 A is incorporated within or utilized with an 9 anchoring mechanism, which provides for an electrical feedback to give an indication 0 of entry into the bladder neck or bladder and to confirm proper positioning in relation I to the bL1dder neck or bladder.
3 J. Third ~mboG~In1enl of IJrefhral A~paratus:
14 Figures 18, 19A, and 19B show another alternate embodiment of a urethral apparatus 100B. In this embodiment, a sensing component 112B comprises 6 conductive contact terminals that form a switch that can sense entry into a bladder 7 neck or bladder. A proximal portion 107B of a body 101 B of the urethral apparatus s 100B includes a switch 127B that displaces an internal contact pair 128B (shown in the 19 circuit flow diagram of Figures 19A and 19B) as the proximal portion 107B of the urethral apparatus 100B containing the switch 127B enters the bladder neck or 21 bladder. This displacement causes the contact pair 128B to open, thus opening the 22 electrical circuit through the conductive leads 117B and 118B, which interconnect the 23 switch 127B and a first contact collar 116B, which is in contact with the insertion tool 24 150 (or 250), thereby activating a signal on the indicator unit 164 (or 264) thereof 2s 2G 111. E.MBODIME~NTS WITH ACOUSTIC SENSING:
27 A. ]~ir.sl rn1boc~rn1e~1 of a IJrelhral Ap/~arcrt1/.5 wilh Acolr~s~ic l~e~7si~.
2s As mentioned above, the sensing component can be designed to sense changes 2~) in light, pressure, force, vibration, compression, heat, or other sensed conditions.
These alternative embodiments are described below.
31 Referring to Figures 20, 21 A, and 21 B, there is shown an embodiment of a 32 urethral apparatus 200 that utilizes a acoustic sensing component 212 to generate an - 2() --CA 022286~8 1998-02-04 indication of proper placement. The embodiment of Figures 20, 21 A, and 21 B
2 functions similarly to the embodiment in Figure 18 except that the switch 127B of 3 Figure 18 is replaced with an acoustical transducer 227. The acoustical transducer 227 4 is preferably a piezoelectric acoustical transducer, but alternatively, may be a s magnestrictive acoustical transducer The acoustic transducer 227 is preferably 6 located within the body 201 of the urethral apparatus 200. The acoustic transducer 7 227 is activated to generate a pulsed mode signal and receive an acoustical signal .
8 l~igure 21B shows the electrical current flow path during positioning ofthe 9 embodiment of the urethral apparatus 200 shown in Figure 20 operating in a pulsed lo echo mode. Current flows from a third contact 288 of a switch 285 through a lead I l 268d to a voltage conditioner 280. The voltage conditioner 280 (which may optionally 12 be a component of the pulse generator/time delay 282) provides for the necessary 3 preamplification. Following voltage preamplification, the pulse generator/time delay 14 282 provides for the formation of the excitation impulse wave form used to resonate ls the acoustical transducer 227. The impulse wave form is transmitted through a lead 6 268f to a conducting surface 270b of the insertion tool contact collar 270 and then to 7 the conductive surface 216a of the first contact collar 216 of the urethral apparatus ls 200. The wave form is then transmitted through the lead 217 to the acoustical 19 transducer 227.
The acoustical transducer 227 is resonated at the characteristic frequency of 21 the transducer which may range from as low as approximately I Kilohertz to as much 22 as approximateb~ 100 Megahertz. In one embodiment, a range of resonate frequencies 23 within two orders of magnitude of 1 Megahertz is appropriate. The resonate 24 frequency of the transducer is dependent on its material properties and thickness. The pulse generator wave form is a triangular or square wave with amplitudes ranging up 26 to approximately 100 volts. The pulse generator/time delay 282 provides for an 27 excitation voltage followed by a wait state prior to re-initiation of the next resonance.
28 The resonance of the transducer 227 provides for an energy transmission into the 29 adjacent materials; this transmission is in the fonn of an acoustical beam as the energy is transmitted througll the adjacent material at the speed of sound of the material itself 31 T he surrounding materials either reflect, absorb, or transmit the energy. The 32 energy that is reflected provides an indication of the surrounding environment. The CA 022286~8 1998-02-04 initial reflections which impact the acoustical transducer surface 204 following the 2 completion of the resonance from the initial excitation re-resonate the transducer 227.
3 This resonance produces an electrical potential (voltage) at the surfaces which is 4 conducted back through leads 217 and 218 to the conductive surfaces 216a and 216b of the first contact collar 216, through the conductive surfaces 270a and 270b of the 6 insertion tool contact collar 270, and to the pulse generator/time delay 282 through 7 leads 268a and 268f.
8 l'he voltage differential between the leads 268a and 268f ~liminishes 9 substantially during the pulsed echo cycle when the acoustical transducer 227 enters lo the regions of increased area in the bladder neck and bladder. Because the distance from the acoustical transducer surface 204 to the body tissue surface increases at the 2 bladder neck and bladder, there is a substantial reduction in the reflected energies 13 compared to the more intimate contact within the tighter areas ofthe body such as the 14 urethra.
The voltage threshold comparator and a relay 299 register the peak reflected 16 voltage. When the average peak voltage produced by the reflected energy is less than 17 the predetermined threshold (or alternatively a differential between high and low 8 reflected peak voltages), an input contact 289 is activated either directly via the l9 voltage source, or with an optional secondary relay (not shown). When the switch 285 20 iS in a position in which the input contact 289 and the light contact 290 are21 interconnected, the second light 266 lights indicating entrance to a body cavity with 22 increased area. Alternatively, when the switch 285 is in the position where the input 23 contract 289 and the light/alarm contact 291 are interconnected, both the second light 24 266 and the alann 267 are activated.
Upon receipt of the pressure wave on the acoustical transducer 227, a voltage 26 iS generated and transmitted to the insertion tool 250 external to the patient's body 27 where the wave form is processed using the analog or digital circuitry contained within 2S h1sertion tool 250. The distance away from the transducer to the surface of the 29 urethra, bladder neck, or bladder is determined by the elapsed time from the 30 completion of a generated signal until the first wave return. Alternatively, the distance 31 from the transducer to the surface of the urethra, bladder neck, or bladder is 32 determined by the change in intensity of the reflected acoustical waves. In either case, CA 022286~8 1998-02-04 a change in state becomes apparent by the acoustical reflections as the apparatus 200 2 enters the or bladder. The insertion tool 250 then generates an appropriate audible, 3 visual, analog, or other signal of this change.

B. A lternate En?bodimetlts of Inse7 ~ion Tool.
6 Several other embodiments of the sensing component are described below that 7 use other methods of initiating feedback to the caregiver that the urethral apparatus is 8 properly positioned. Among these other embodiments are the use of one- and two-g way fluid flows, fiber optics, electrical resistance, thermoelectric semiconductors, and lo two-transducer acoustic mechanisms. These embodiments use an alternate 11 embodiment of the insertion tool electrical contact collar.
12 R.eferring now to Figures 22A through Figure 22D, an alternate embodiment of 13 an insertion tool contact collar 270A for use with the urethral apparatus first contact 14 collar (e.g., 116 or 216) allows for additional convenience when coupling. Both s contact collars include conducting surfaces and non-conducting surfaces that form 6 circuits to indicate either coupling of the insertion tool with the urethral apparatus or 17 proper positioning within the bladder neck or bladder. In further embodiments, both 18 contact collars are oval-shaped and have additional mating contact points to19 accommodate various fluid-flow pathways and fiber optics connections. For convenience, there are twice as many of these additional mating contact points on the 21 insertion tool contact collar 270A as there are mating contact points on the urethral 22 apparatus first contact collar (116 or 216) so that either ofthe two 180-degree 23 orientations are functional.
24 Figure 22A shows the proximal portion of the insertion tool 250 and further illustrates the assembly ofthe contact collar 270A to the contact collar housing 270.5.
2G Also shown in the figure is the contact collar 116 (or 216) ofthe urethral apparatus 27 100 (or 200) to illustrate how the contact collars of the insertion tool 250A and the 28 urethral apparatus 100 (or 200 and following embodiments) interface with one another.
29 The table below shows the number and type of the contact points or mating contact points provided on the insertion tool contact collar 270A, the urethral 31 apparatus first contact collar 116 (or 216), and the number of leads for the various 32 embodiments in this disclosure. As mentioned above, the number of contact points or CA 022286~8 1998-02-04 ports on the insertion tool contact collar 270 may be doubled for convenience when 2 coupling.

Insertion Tool Urethral Apparatus Urethral Embodiment Contact collar Tool Contact collar Apparatus Contacts * Insertable Contacts Leads Electrical Switch 3 electrical 2 electrical 2 electrical Acoustic ( 3 electrical 2 electrical 2 electrical 1 transducer Fluid - 1 way flow 2 electrical I fluid 1 electrical I fluid 1 fluid port port port Fluid - 2 way flow 2 electrical 2 fluid 1 electrical 2 fluid 2 fluid ports ports ports Electrical 3 Electrical 2 electrical 2 electrical Resistance Thermoelectric 3 electrical 2 electrical 2 electrical Semiconductor Fiber Optic- 2 Electrical 1 electrical 2 fiber 2 f. optical Fiber Optic 2 Fiber Optic optic Fiber Optic- 4 Electrical 3 electrical 2 electrical Photocell 1 fiber optic 1 fiberoptic 1 fiber optic Acoustic 5 electrical 4 electrical 4 electrical (2 transducer) 4 (*number of contact points can be doubled.) 6 (~ econd En1boc~iment of a lJrethral Apparatl/s with Acoustic ~5'ensin~:
7 Figure 23 illustrates a second acoustic embodiment (apparatus 200A). In this x embodiment, a sensing component that uses acoustic sensing in shown generally at 9 212A. This embodiment utilizes two magnestrictive, or preferably, piezoelectric o acoustical transducers 227A(1) and 227A(2) on an exterior surface 203A ofthe urethral apparatus 200A. These transducers 227A(1) and 227A(2) are activated to 12 respectively generate and receive a continuous mode acoustical signal. This13 embodiment is similar to the first acoustic embodiment except that in this embodiment, 1~1 a first transducer 227A(I) generates a continuous mode acoustic signal rather than a pulsed signal, while a second transducer 227A(2) receives the signal. Electrical leads IG 217Aa, 217Ab, 218Aa, and 218Ab carry an electrical potential (voltage) to and from 7 the transducers 227A(I) and 227A(2), respectively, and are interfaced with electrical x leads 268 in the insertion tool 2~0 through the contact collars 270 and 216A to CA 022286~8 1998-02-04 provide ~or a feedback signal. Circuitry in the insertion tool is similar to that shown 2 for the first acoustic embodiment (see Figure 21 A) except that the pulse generator is 3 replaced by a continuous mode generator.
4 As the urethral apparatus 200A is inserted into the urethra, the surrounding materials either reflect, absorb, or transmit the energy. Acoustic energy is emitted by 6 the first acoustical transducer 227A(l), reflected by the urethral wall, and received by 7 the second transducer 227A(2), which resonates and produces an electrical potential 8 (voltage) that provide an indication of the surrounding environment. This voltage g diminishes substantially when the transducers enter the bladder neck and bladder where the distance from the transducer surfaces to the body tissue surface increases and I l causes a substantial reduction in the reflected energies compared to the more intimate 12 contact within tighter areas of the body such as the urethra.
13 In an alternate embodiment, the two transducers are placed facing each other 14 separated by a non-reflective, shape-memory member similar to that used in the fiber optic embodimentsl described below. A change is acoustic signal is noted when the 16 proximal end of the urethral apparatus carrying the transducers enters the bladder neck 17 and bladder, thereby allowing the shape memory member to be displaced outward x which, in turn, permits an unobstructed face-to-face orientation of the two transducers.
1~
I11. EMBODIMENTS WITH FLUID FLOW SENSING:
21 Pressurized fluid flow may be used to provide for position feedback to 22 ascertain that the urethral apparatus is properly positioned. Four approaches using 23 pressurized fluids in combination with an insertion tool and urethral apparatus are 24 described below. The first three approaches provide a one-way flow of fluid from an insertion tooll through the urethral apparat:usl and into the urethra, bladderl or a fluid 26 reservoir located in urethral apparatus. This flow can be restricted to varying degrees.
27 In these embodiments, as the coupled inseltion tool and urethral apparatus pass 2X through the urethral fluid flow is restricted because of the urethra. However, as the 2') proximal portion of the urethral apparatus enters the bladder neck or bladderl the flow becomes less restricted. This change in fluid restriction is detected by circuitry in the 31 insertion tool. The fourth approach, described below, does not permit fluid to escape into the urethra and bladder, but incorporates a two-way flow of fluid from the 2 insertion tool, through the urethral apparatus, and back to the insertion tool.

4 ~. F irst Emboc~i~netlt of a I Jrethral ~pparatu~ with ~12lid ~low Sensi~7~:
A first fluid flow embodiment is shown in Figures 24, 25a, 25b, 26a and 26b.
6 A urethral apparatus 300A provides for a limited passage of fluid into the urethra or 7 bladder. In this embodiment, the sensing component is shown generally at 312A. In 8 this embodiment, fluid is allowed to pass from an insertion tool 3 50 and into a urethral g apparatus 300A. The fluid is under pressure in a fluid reservoir 353 that is contained o within the insertion tool 350. Pressure can be applied by a thumb screw and piston in combination with a biasing spring 353 .5 located on the distal end of a handpiece 12 housing 351. Fluid flows through a fluid passageway 373a, through a passageway port 13 374, against the a flexible conduit wall 375 which contacts a normally closed, pressure-4 responsive membrane switch 376, and through a fluid passageway 373b that extends through a shaft 354.
IG When fluid is in stasis due to resistance or complete retention of fluid, the 7 normally closed membrane switch 376 is electrically open: When the fluid pressure diminishes due to a dynamic fluid state, the flexible conduit wall collapses under the 19 pressure ofthe normally closed membrane switch 376. The fluid then flows through a mating contact point 37l of an insertion tool contact collar 370 through a contact port 21 334A of the urethral apparatus 300A, through a passageway 3 l l A, and out through a 22 apparatus port 313A, which could be a porous or microporous membrane. The fluid is 23 expelled into the urethra, the bladder neck, or the bladder, depending upon the location 24 ofthe coupled insertion tool 350 and apparatus 300A.
The change in restriction of flow is detected by the normally closed membrane 2G switch 376. As the apparatus 300A enters the bladder neck or bladder, the fluid 27 encounters less pressure due to the lack of surface contact with the urethra. Since the 2~ source ofthis fluid pressure is within the h1sertion tool 350, the membrane switch 376 29 detects the lower system pressure. The pressure-responsive, normally closed~o membrane SWitCIl 376 then returns to the unel1gaged position and closes the internal 3 l contacts, thus completing a circuit between the contacts 377a and 377b, the energizing 32 input contact 389, and the second light 366. Depending on the position of the switch - 2() -CA 022286~8 1998-02-04 385, either the light only, or the light and alarm, gives an indication that the proximal 2 portion 307A of the urethral apparatus 300A has entered the bladder neck or bladder 3 as previously described in the other embodiments. The input contact 389 is activated 4 either dh-ectly via the voltage source or with an optional secondary relay (not shown).

6 ~ econd Embo~lime7~t of a llrethral Apparat1/s with Fl1lid Flow Se~7sin~:
7 Referring to Figure 27, there is shown a second embodiment 300B of a urethral 8 apparatus that uses fluid-flow for sensing. In this embodiment, the sensing component 9 is shown generally at 312B. This embodiment provides for a limited passage of fluid lo into the bladder neck or the bladder when a proximal portion of the apparatus 300B
I l containing a restricted apparatus port 313B enters the bladder neck or bladder. This 12 configuration is similar to the first fluid-flow embodiment 300A except that no fluid is 13 allowed to pass into the urethra during insertion due to the physical contact of the 14 urethra on the flow restrictor valve 315B that thereby closes the apparatus port 313B.
The system mechanics and electronics function similarly to the first fluid-flow 16 configuration.

8 (~'. Third Fn1bodlme77~ of a IJrethral Apparaltl.s with Fltlid Flow ~e7t.si77~:
19 A third embodiment of a urethral apparatus 300C using a fluid-flow configuration is shown in Figure 2~ through Figure 29B. In this embodiment, the 21 sensing component is shown generally at 312C. This embodiment provides for fluid 22 feedback without the introduction of fluid into either the urethra, bladder neck, or 23 bladder by providing for a one-way fluid flow from the insertion tool 350 into a fluid 24 reservoir 319C located in the urethral apparatus 300C. Adjacent to the fluid reservoir 319C is a volume-deformable member 321 C . As in the first two fluid-flow 26 configurations, the fluid is under pressure in the reservoir 353 contained within the 27 hlsertioll tool 350. This fluid flows through the fluid passageway 373a and 373b, 2X througll the shaft 354, then through the mating contact point 371 ofthe insertion tool 2') contact collar 370, through a contact port 334C of the urethral apparatus 300C, througtl the apparatus passageway 311 C and the port 313C, and into a fluid reservoir i 1 319C. As the insertion tool 350 and the urethral apparatus 300C are introduced 32 thl-ough the urethra, the volume-deformable member 321C is hl a flattened profile, as CA 022286~8 1998-02-04 shown in Figure 29a. When the portion ofthe urethral 300C containing the volume-2 deformable member 321C enters the bladder neck or bladder, fluid pressure within the 3 system causes the volume-deformable member 321C to deform to a second, larger 4 profile as shown in Figure 29b, thus lowering fluid pressure within the circuit. This change in fluid pressure causes the pressure-responsive, normally closed membrane 6 switch 376 to return to the undeflected position, thus completing a circuit between the 7 contacts 377a and 377b and the energizing input contact 389 and the second light 366.
8 The system electronics function similarly to the first two fluid-flow configurations.

o D. Fourth Embodin1ent of a ~Irethral ~pparalus with Fluid Flow Sens~7~:A fourth embodiment of a urethral apparatus 300D that uses fluid-flow sensing 12 iS shown in Figure 30A through Figure 33B. This embodiment also provides for fluid-13 initiated feedback without the introduction of fluid into either the urethra, bladder 4 neck, or bladder by providing for a two-way fluid flow from the insertion tool 350 through lhe urethral apparatus 300D and back to the insertion tool 350. In this 16 embodiment, the sensing component is shown generally at 312D. Like the other17 embodiments ofthe fluid-flow configurations, the fluid, which is under pressure in the first fluid reservoir 353a that is contained within the insertion tool 350, flows tl1rough 19 the shaft 354 and into the urethral apparatus 300D. In this embodiment, however, fluid is allowed to flow through an input passageway 311Da of the urethral apparatus 21 300D and return through a return passageway 311 Db. The input passageway 311 Da 22 and the return passageway 311 Db are interconnected (as illustrated in Figure 32) distal 23 to a depressible contactor 329D, allowing for fluid flow in the fluid circuit when a 24 depressible contactor 329D is open, but preventing fluid flow in the circuit when the 2~ depressible contactor 329D is depressed. The depressible contactor 329D is located 26 on the surface of the urethral apparatus 300D and is responsive to the physical contact 27 of the urethra. The depressible contactor 329D serves to restrict the flow of fluid 2~ withil1 the fluid circuit by preventing the return flow while the insertion tool 350 and 29 apparatus 300D are being inserted througl1 the urethra.
When the portion of apparatus 300D containing the depressible contactor 31 329D enters either the bladder neck or the bladder, the depressible contactor 329D is 32 fi-ee to move outward, (Figure 30B) thus allowing the fluid within the fluid circuit to CA 022286~8 1998-02-04 .

return through the return passageway 31 lDb and collect in a second fluid reservoir 2 353b in the insertion tool 350. This change in fluid pressure causes the pressure-3 responsive, normally closed membrane switch 376 to return to the unengaged position, 4 thus completing a circuit between contact:s 377a and 377b and energizing the input contact 389 and the light 366. The system electronics function similarly to the first 6 three fluid-flow configurations.

8 IV. E MBODIMENTS WITH ELECTRICAL RESISTANCE SENSING:
9 Referring to Figure 34, there is shown an embodiment of a urethral apparatus 0 400 that uses electrical resistance measurement for position sensing. In this embodiment, the sensing component is shown generally at 412. The electrical 2 resistance between two spaced-apart locations along the urethra will differ from the 3 resistance across the same distance within an aqueous fluid such as urine. For this 4 reason, the embodiment ofthe urethral apparatus 400 includes two, spaced electrical s contacts (a first contact 428a and a second contact 428b positioned along the body 16 401 thereof. These electrical contacts allow for the passage of a minute current 17 between them as apparatus 400 is installed. The urethra itself allows an electrical 1~ conduction as the apparatus 400 is fed through the urethra. When the electrical 19 contacts 428a and 428b reach the or bladder, the electrical resistance between the contacts changes as the apparatus 400 enters a pool of urine in the bladder neck or 21 bladder. This change may be detected electronically with relatively simple analog or 22 digital circuitry and thus activate a feedback signal.
23 Figures 35A is a circuit flow diagram showing the current flows during2~ coupling for this embodiment and aid to further explain the embodiment. Figure 34B
is circuit flow diagram showing the current flows during positioning. The current 2() flows from a battery 459, through a positive lead 484, to a switch 485 in the insertion 27 tool 450, then through a lead 468b to a voltage conditioner 480, which provides the 2~ correct voltage. The current flows through an electrical lead 468f, through the contact 2() collars 4'70 and 416, and through an electrical lead 417 in the urethral apparatus 400 to a first contact 428a on or near the surface 403 of the body 401 of the urethral 31 apparatus. The current is then conducted across the conductive media of the urethl-a .,2 or urine ~:o a second contact 428b, through an electrical lead 418, througll the contact - 2') -CA 022286~8 1998-02-04 collars 416 and 470, and back through the electrical lead 468a in the insertion tool 450 2 to a voltage threshold comparator and relay 499. When the portion of apparatus 400 3 that contains the first contact 428a and second contact 428b enters the bladder neck or 4 bladder and is situated in a pool of urine as described above, the change in electrical resistance is detected by the voltage threshold comparator and relay 499 due to the 6 resultant change in voltage. The voltage threshold comparator and relay 499 then 7 compares this voltage with the predetermined, preset voltage. When the voltage value 8 correlates with the preset range, the voltage threshold comparator and relay 499 9 energizes the input contact 489 through the lead 468e with the line voltage from the lo battery 459. Depending on the position of the switch 485, either the light only, or the light and alarm gives an indication that the urethral apparatus 400 has entered the 2 bladder neck or bladder as previously described in other embodiments.

14 V. EMBODIMENTS WITH THERMOELECTRIC SENSING:
Referring to Figures 36 through 38B, there is shown an alternative embodiment IG of a uret:hral apparatus 500 that uses thermoelectric cooling to provide for position 17 feedback. The position ofthe urethral apparatus in the urinary tract is ascertained in x response to feedback from the conduction of current through a thermoelectric module.
l~) In this embodiment, the sensing component is shown generally at 512. The thermoelectric module typically is composed of one or more pairs (couples) of 21 semiconductors of Bismuth Telluride that has been negatively or positively doped. The 22 pairs of semiconductor are in a thermally parallel circuit and in an electrical serial 23 circuit. When a low-voltage, direct current is applied to the semiconductor pairs, heat 24 energy is absorbed to one surface, which causes it to become cool, and heat energy is conducted through the semiconductor electrically to the opposite surface, which 2G becomes thermally elevated in temperature causing a liberation of heat to that 27 environment. For this reason the thermoelectric heat transfer effectively performs the 2x functioll of transferring heat from a donor surface to a receptacle surface. The rate of 2() heat transfel- is determined by the sen1iconductor characteristics as well as the electrical 3() power being transferred through the semiconductor pairs. Given a constant direct 31 voltage, the current increases when more heat is being transferred, and the current 32 decreases whell less heat is being transferred between the surfaces.

- 3() CA 022286~8 1998-02-04 The Peltier-effect cooling method uses the two junctions of a semiconductor 2 530 (Figure 37) which are heat-transfer activity cells in a manner such that a first 3 junction 531 is in contact with the fluid or tissue adjacent to it which transmits heat 4 energy from the urethra to a second heat junction 532 within the body 501. This transmitted heat is quickly reabsorbed by the body 501 and surrounding tissue or fluid 6 surrounding the body 501. Similar to the electrical resistance embodiment above, a 7 voltage threshold comparator and relay 599 then compares this current with the 8 predetermined, preset current. When a change in the rate of heat transfer occurs 9 (dQ/dt = change in heat flow/change in time), it provides an electrical indication that lo the emergence into the bladder neck or bladder from the urethra (or withdrawal I l therefrom) has occurred because the thermal conductivity differs when the apparatus 12 500 is in the urethra or is in the bladder neck or bladder. Electrical circuitry 13 controlling the current flow through the apparatus 500 then generates an appropriate 4 feedback signal as explained below. The emergence into the bladder neck or bladder, which normally contains some residual of fluid, provides for a difference in heat 6 transfer to or from the urethra.
7 The semiconductor 530 has a thin construction of an overall dimension of x approxhnately .008 inch in thickness with width dimensions of.020 inch and .040 inch.
19 On each of the heat transfer surfaces, a gold or platinum conductive layer is applied using vapor deposition. Alternatively a .0008 conductive film may be adhered to the 21 surface 503 of the body 501 using conductive epoxy adhesive. The foil assists in the 22 transfer of heat and provides a noble and biocompatible surface for interface with the 23 surrounding environment. The dimensions of semiconductor 530 determine the ability 24 to transfer heat from the lower temperature junction to the higher temperature 2s junction. In this application the useful determinate indicator of position is derived from 26 the change in power which is used to transfer the heat rather than a measurement of 27 the heat transfer The power changes as the surrounding environment changes when 2s the first junction 531 of the semiconductor 530 enters the bladder neck or bladder from 2() the urethra.
Figures 38A is a circuit flow diagram showing the current flows during 31 coupling for this embodiment and aids to fùrther explain the embodiment. Figure 38B
,2 is a circuit flow diagram shows the current flows during positioning. Low-voltage, CA 022286~8 1998-02-04 .

direct current flows from a battery 559 through a positive lead 584 to the switch 585 2 and then through a lead 568b and is conditioned by a voltage conditioner 580, which 3 provides the desired voltage and current limits. The current flows then through a lead 4 568Ab, through a contact collar 570 of the insertion tool 550 and a contact collar 516 s of the apparatus 500, and through the electrical lead 517 to the semiconductor 530.
6 The current passes through the semiconductor junctions 531 and 532 and is conducted 7 back through the electrical lead 518, through the contact collars 516 and 570, and 8 through the second electrical lead 568a in the insertion tool 550 to the voltage g threshold comparator and relay 599. When the insertion tool 550 and apparatus 500 lo enter the bladder neck or bladder, the change in environment causes the first junction I l 531 to absorb a different amount of heat, thereby causing a resultant change in current.
12 The voltage threshold comparator and relay 599 then compares this current with the 13 predetermined, preset current. When the current value exceeds the preset level, the 14 voltage threshold comparator and the relay 599 energizes the input contact 589 s through the lead 568e with line voltage from the battery 559. Depending on the 16 position of the switch 585, either the light only, or the light and alarm give an 17 indication that the apparatus 500 has entered the bladder neck or bladder as previously IX described in other embodiments.

2() Vl. EMBODIMENTS WITH FIBER OPTIC SENS~NG:
21 Figures 39 through 45B show alternative embodiments of urethral apparatus 22 600A and 600B that use fiber optics for position sensing. In these embodiments, the 23 fiber optics are incorporated into the urethral apparatus to initiate a feedback signal 24 that the apparatus is properly positioned. In this embodiment, the sensing component are shown generally at 612A and 612B, respectively. The embodiment 600A shown in26 Figures 39 through 44B includes two fiber optic strands that provide for signal 27 transmission and return. The fiber optic strands are composed of a central core of 2X diameter of approximately 8 to 10 micron with a total clad or unclad diameter of 2') approximately 125 micron (or approximately .005 inch).
3() Referring to Figures 44A and 44B, current flows from a battery 659A to a 31 switch 685A, then through a lead 668Ab to a voltage conditioner 680A, which32 provides the correct voltage and current to an LED 696A. A low-energy light wave CA 022286~8 1998-02-04 preferably in the visible light spectrum wavelengths of 400 - 750 nanometers is 2 transmitted by a bulb or light-emitting diode (LED) 696A or bulb into the first 3 insertion tool fiber optic strand 697Aa to the insertion tool contact collar 670A and 4 terminates there within the strand casing at a mating contact point 671Aa, which may be a similar glass fused contact mounted within the contact collar 670A or a dissimilar 6 material that has been bonded around the perimeter, which in turn is bonded into the 7 insertion tool contact collar 670A.
8 A first apparatus fiber optic strand 633Aa (Figure 40) terminates in like manner g at a mating contact point 634Aa of an apparatus first contact collar 616A and extends lo within the body 601A to a location at a proximal portion 607A. A second apparatus I l fiber optic strand 633Ab lies alongside the first apparatus fiber optic strand 633Aa and 12 iS coupled in like manner at a mating contact point 634Ab ofthe apparatus first contact 13 collar 616A. Facing the terminal ends of the first and second apparatus fiber optic 14 strands 633Aa and 633Ab is a mirror 635A, which reflects light emitting from the first apparatus fiber optic strand 633Aa into the second apparatus fiber optic strand 633Ab.
6 Similarly, a second insertion tool fiber optic strand 697Ab lies alongside the first 17 insertion tool fiber optic strand 697Aa and terminates in a handpiece housing 651 A and 18 contact collar 670A at a mating contact point 671Ab.
19 An additional feature of this embodiment is the use of a shape-memory, nonreflective member 636A (Figures 40 and 41) that is interposed between the 21 terminal ends ofthe first and second apparatus fiber optic strands 633Aa and 633Ab 22 and the mirror 635A during insertion ofthe coupled insertion tool 650A and urethral 23 apparatus 600A, thus, effectively preventing light from being returned through the 24 second apparatus fiber optic strand 633Ab. When the portion ofthe apparatus 600A
containirlg the nonreflective member 636A enters the bladder neck or bladder, the 2G shape-mem ory characteristics of the nonreflective member 636A cause it to move 27 outward and therefore allow the light circuit to be completed (Figures 42 and 43). The 28 nonreflective member 636A optionally has an additional leaf 637A to ensure complete 2') blockage of the light circuit between the terminal ends of the apparatus fiber optic .() strands 633Aa and 633Ab and the mirror 635A. Alternately, deformation can take , I place in response to internal pressure from self-contained fluid in a reservoir adjacent ~2 the nonreflective member 636A. Altemately, the reflective and absorptive propelties CA 022286~8 1998-02-04 of the leaf 637A and the mirror 635A could be reversed in such a manner that the light 2 from the fiber optic strands is reflected by the leaf 637A and the mirror 635 is replaced 3 by a nonreflective surface.
4 As the urethral apparatus 600A enters the bladder neck or bladder, the shape-memory characteristics (or, alternately, fluid pressure) cause the nonreflective member 6 636A to move outward and thereby allow the light circuit to be completed (see Figure 7 44b). As the light is returned to the second insertion tool optic fiber strand 697Ab and 8 is incident upon the optical transducer 698A, the light energy is converted into an 9 electrical signal, which is carried by the lead 668Aa to a voltage threshold comparator o and relay 699A. The voltage threshold comparator and relay 699A then compares this I l voltage with the predetermined, preset voltage. When the voltage value exceeds the 12 preset level, the voltage threshold comparator and relay 699A energizes an input 13 contact 689A through the lead 668Ae with line voltage from the battery 659A.4 Depending on the position of the switch 685A, either the light only, or the light and alarm give an indication that the apparatus 600A has entered the bladder neck or16 bladder as previously described in other embodiments.
In an alternative embodiment shown in Figures 45A and 45B, the urethral ls apparatus 600B has only one fiber optic strand 633Ba and has an optical transducer 19 638B located in the distal portion 605B ofthe body 601B with an electrical lead 618B
leading t'rom the optical transducer 638B to a conducting surface 616Bc. Current then 21 flows to a contact 670Bd of the insertion tool 650B and to a voltage threshold 22 co mparator and relay 699B through the lead 668Bd. When the current value exceeds 23 the preset level, the voltage threshold comparator and relay 699B energizes the input 24 contact 689B through the lead 668Be with line voltage from the battery 659B.Depending on the position of switch 685B, either the light only, or the light and alann 26 give an indication that the urethral apparatus 600B has entered the bladder neck or 27 bladder as previously described in other embodiments.
2~ Optionally, the mirror 635A (or 635B) may be eliminated in either ofthe29 configurations shown in Figures 44A and 44B (or 45A and 45B) by orienting the two ends of l:he fiber optic strands 633Aa and 633Ab (or optionally, first fiber optic strand 31 633Ba and optical transducer 638B) at a spaced distance across from each other with CA 022286~8 1998-02-04 the non-reflective shape-memory member 636A (or 636B) interposed between the two2 elements. Similar circuitry to that described above would be employed.
3 In an alternate embodhnent using fiber optics, position sensing can be derived 4 from the reflection of light from the urethral surface. Such reflection is dependent upon the incidence of the surface and the distance to the surface on which the light is 6 impartecl. It is not necessary to visualize details of the internal surface of the urethra in 7 order to detect the position of the apparatus within the urethra. Instead, it is important 8 to be able to macroscopically characterize the environment and identify when the g environment changes from that of the urethral surface to the urine occupying the bladder neck or bladder.
I l IJse of fiber optics to derive position sensing from intraurethral reflection is 12 provided by incorporating one or more fiber optic strands in two locations along the 13 body of the urethral apparatus or the insertion tool. A first strand illuminates the area 14 to be evaluated. The second strand conducts a surface illumination from the illuminated surface to the insertion tool. Alternately, a first strand illuminates the area 16 to be evaluated, and a photovoltaic cell is used to receive the incidence light and 17 generate an electric voltage that produces a current that is conducted to the indicator 1~ unit. There is much information available from this returned illumination; howeverl 1~) little or nothing more is needed than the intensity ofthe returned signal. This output voltage may then be used to indicate the change in reflection that occurs as the21 apparatus enters the bladder neck or bladder. This change may be electronically 22 detected, and the caregiver who is inserting the urethral apparatus is thereby alerted.

24 Vll. ADVANTAGES OF THE DISCLOSED EMBODIMENTS
Advantages of the embodiments disclosed herein include ease of use and low 2~) cost while providing one critical piece of information--proper positioning. These 27 advantages obviate the need for more expensive equipment or expensive professional 2~ medical skills, which would otherwise be necessary to obtain information about the 29 relative position of the urethral apparatus. The disclosed embodiments provide an .o indication of a change sensed when the sensillg component of the urethral apparatus makes the transition from the urethra into the bladder~ or more preferably, the bladder 2 neck. The senshlg component preferably is not used to obtain any specific CA 022286~8 1998-02-04 measurements, such as urethral pressure profiles and so on. The sensing component 2 responds to a one-time change that results in a signal being emitted to the person, such 3 as the caregiver or even the patient. That signal can be audible, visual, tactile, or any 4 other type of signal that informs the caregiver or patient of the change in the conditions s or features surrounding the urethral apparatus as it enters the bladder neck or bladder.

7 V111. FURTHER ALTERNATIVE EME~ODIMENTS
8 T here are additional alternate embodiments that can be made without departing 9 from the scope and the spirit of the inventive subject matter.
0 In some of the embodiments described above that use electrical sensing, the Il sensing component includes a structure (e.g., 123 in Figure 5) having shape-memory 12 characteristics. Such structure can assume any number of alternate shapes, 13 configurations, or characteristics. For example, the sensing component can be a 4 movable or mechanical structure in the shape of flexible fingers or wings~ or can be an electromechanical structure, a pneumatic or hydraulic member, a light-emitting-and-6 receiving member, an electronic member, a heat-transfer member, or any other type of 7 component or structure that detects a change of the component from a first status to a 8 second status.
19 It will be appreciated that other mechanisms for sensing a change in the environmental conditions, features, or parameters proximate the urethral apparatus 21 when it passes out of the urethra and into the bladder or the bladder neck fall within 22 the scope and spirit of the disclosed inventive subject matter. The embodiment 23 disclosed herein should not be construed to include all permutations, but instead 24 provide an indication of some of the permutations that are possible. Some of these alternate embodiments are detailed below.
26 Still other embodiments may incorporate the sensing component as part of the 27 inseltion tool. Such embodiments may be adapted to any of the insertion tool28 embodiments (l50, 250, 350, 450, 550, and 650, described above). A purpose ofthe 2() sensing component 112 is to initiate a feedback chain to indicate the position ofthe body of the urethral apparatus based upon a change in an environmental condition, 31 feature, or parameter as the proximal portion (e.g., 107 in Figure 1) or proximal end 32 (e.g., 10~ in Figure 1) of the body of the urethral apparatus passes at least partially out - 3(, -CA 022286~8 1998-02-04 of the urethra and into the bladder or bladder neck. Since the length of the body 101 2 of the urethral apparatus may be varied, the sensor component can be part of the 3 insertion tool in some alternative embodiments. For example, in an embodiment that 4 uses an optical transducer for position sensing (e.g., Figures 39 through 44B), the optical transducer may be included in the proximal end of the insertion tool (e.g., 6 650A) vvith fiber optics either on the insertion tool itself or on the body of the urethra 7 apparatus.
8 Although many of these embodiments teach the placement of the sensing 9 component 112 at or near the proximal end of the body of the urethral apparatus, the lo sensing component 112 may be located at the distal end or distal portion and still I l provide an indication of the proper placement of the urethral apparatus in relation to 12 the bladder neck or bladder.

14 A . DRI JG DFI I VFRY EMBODIMENT5 Referring to Figures 46A and 46B, an embodiment of a urethral apparatus 16 700A is disclosed. The embodiment 700A provides for drug delivery. For the sake of 17 clarity in the drawings, the sensing component 712A is not illustrated in Figure 46A or 8 46B but is considered to be a part of the embodiment described. The body 701 A
19 incorporates one or more fluid ports 713A with an optional one-way flow-restrictor valve 715A (Figure 46b) in communication with one or more fluid passageways 71 IA
21 that pass through the body 701A and that are in communication with corresponding 22 fluid lumens (not shown) in an insertion tool. The insertion tool may be similar to any 23 of the insertion tool embodiments disclosed above.
24 111 an alternative embodiment of the urethral apparatus 700B shown in Figure 47, the body 701B incorporates a porous or microporous membrane 739B in 26 communication with a fluid lumen 71 IB (or alternately, a reservoir 719B) hI the body 27 701B. The membrane 739B can extend around part or all ofthe circumference of2x body 701 B. These ports or membranes are used to introduce drugs, agents, genes, 29 monoclol1al antibodies, or other materials either passively or actively, for example, 3l) ush1g diffusion, osmosisl iontophoresis, electrophoresis, photodynamic methods, 31 pressure, ultrasound, or other driving or activating forces. Those skilled in the art will CA 022286~8 1998-02-04 recognize that some of these drug-delivery embodiments require the addition of drug 2 reservoirs, electrodes, transducers, or other components necessary to the technology.
3 In other embodiments the alternate fluid ports or membranes are located in a 4 position along the periphery of the body so that drugs or agents are introduced to the s prostate, for example. Similarly, a portion of the alternate body may itself contain 6 drugs or other agents impregnated in a polymer, for example, for a controlled- or time-7 released therapy. Such drugs could, for example, be an antibiotic agent or 8 oligodynamic metal to counter or modify bacterial growth in the urethra, bladder neck, 9 or bladder.

I B. VALVED lJRETHRAL APPARA Tll~Sl EMBODIMENT
12 Referring to Figures 48 through 54, there is disclosed another embodiment of a 13 urethral apparatus 800. This embodiment includes a body 801 that incorporates a 14 valving mechanism, such as a magnetic valve 839. (For the sake of clarity in the drawings, the sensing component is not included in the drawings but is considered to 16 be a part of the embodiment described. It will be appreciated that any of the 17 embodiments ofthe urethral apparatus having position sensing can further incorporate 18 a valve in any manner or iteration possible.) This first valving embodiment uses 19 magnetics and stored energy to control the flow of urine and to dampen pressure 2() impulses arising from momentary, and often sharpl increases in bladder pressure as a 21 result of exercise, coughs, laughing, or other sudden or strenuous responses or 22 reflexes.
23 Figure 48 shows the magnetic valve 839 in a closed position. The body 801 24 has an open proximal end 808 that extends into the bladder neck or bladder and comprises a fluid-flow director 837 with a lumen 810. Within the lumen 810, a seal 26 840 is slidable such that it provides for a fluid-tight seal to prevent leakage of urine 27 through the body 801 of the urethral apparatus when the valve is in a closed position 28 (see for example Figure 48) or dampened position (see for example Figure 49) but 29 allows fluid to flow through the body 801 in the open position (see for example .,n Figures 50 and 51). Connected distally to the seal 840 is a plunger 841 and a magnet 31 842. The seal 840, the plungel~ 841, and the magnet 842 function as a unit to control 32 the flow of urine througl1 the body 801.

CA 022286~8 1998-02-04 The magnet 842 travels axially in a longitudinal direction within a magnetic 2 profiler 843 which has an enlarged proximal end 844, an enlarged distal end 845, and a 3 stop 846, which serves to limit travel of the magnet proximally within the magnetic 4 profiler. As shown in Figures 48, 52, and 53, the fluid-flow director 837 has one or more openings 847 that communicate with passageways 832 to allow urine flow.
6 Openings 847 are located distal of the seal 840 when the magnet 842 is positioned in a 7 closed position or is in a damping pOSitiOIl. The magnet 842 is shaped to allow urine 8 to flow around its periphery (Figures 54A and 54B ) and out through the distal end 9 806 of body 801.
0 The proximal end 844 and optionally the distal end 845 of the magnetic profiler 843 are made of a material that interacts with the magnet 842 to controllably influence 12 the travel of the magnet 842 in a longitudinal direction. When the magnet 842 is in a 13 closed position (Figure 48), a magnetic circuit is formed between the magnet 842 and 4 proximal end 844. When bladder pressure is increased above a critical pressure, the s force of urine against the seal 840 causes the magnet 842 to move away from the stop 6 846 in a distal direction. As the magnet 842 moves distally through the magnetic 7 profiler 843, magnetic forces may optionally be exerted by the distal end 845 to interact with the magnet 842 and assist in moving the magnet 842 distally. As bladder l9 pressure is increased to a greater degree, the magnet 842 is physically pushed toward the distal end 845. The seal 840 then moves distally beyond the openings 847 and21 allows urine to flow distally through the body 801 (Figure 50). As the urine flow is 22 diminished and pressure is decreased on the seal 840, the magnet 842 is drawn 23 proximally toward the stop 846 by the magnetic forces existing between the magnet 24 842 and the proximal end 844. The magnetic circuit is again completed between the s magnet 842 and the proximal end 844 to hold the valve in a closed position. If the 26 distal end 845 is also constructed of a material that interacts magnetically with the 27 magnet 842, the force of the magnetic flux or circuit between the magnet 842 and the 2x proximal end 844 is greater than the force of the magnetic flux or circuit between the 29 magnet 842 and the distal end 845, thus allowing the magnet 842 to always return to a closed position. Alternately, a member that interacts with the magnet 842 could be 3 1 located in a pOSitiOIl distal to the distal end 845.

CA 022286~8 1998-02-04 If the user experiences a momentary impulse in bladder pressure due to 2 exercise, coughing, or laughing, for example, the seal 840 experiences very high, but 3 very temporal, pressures. The magnetic field formed between the magnet 842 and the 4 proximal end 844 absorbs the energy exerted upon them by the controlled s displacement of the plunger 84 l and the magnet 842 as the plunger is displaced along 6 the axis of the fluid flow director 837. This displacement provides for energy being 7 stored in the magnetic circuit, which is subsequently returned in the form of work over 8 time as the plunger is repositioned during the pressure impulse and returns to a seated, g closed position after the impulse. During this displacement, the seal is moved distally o but not far enough distally to permit urine flow through the openings 847. Thus, the length of the plunger 841 and the magnetic profiler 843 are such that the maximum 12 impulse in bladder pressure does not cause the seal 840 to move distally beyond the 13 openings 847. It is this relationship of work over time that allows the apparatus to 14 absorb pressure impulses that may be many times greater than the pressure needed to actuate the valve using the Credé method described below.
16 To actuate the valve, the user or caregiver simply uses the Credé method by 17 employing his or her hands to exert pressure over the symphysis pubis. This increases 1~ the pressures within the bladder and initiates the sequence of events that opens the 19 valve.
As a fail-safe feature, the magnetic circuit between the magnet 842 and the 21 proximal end 844 is over-ridden at a bladder pressure that is less than the point at 22 which urine refluxes into the kidneys. Alternately, the apparatus 800 can be actuated 23 by inserting a magnet into the urethra with enough force to overcome the force of the 24 magnetic circuit formed between the magnet 842 and the proximal end 844.
2() ('. ,4N('HORlN(~
27 After positioning, any of the embodiments of the urethral apparatus can be 2~ anchored or secured in the urethral bladder neck, or bladder. This may be facilitated 2~) by purposefully selecting the diameter, size, shape, and other characteristics of the 3() body of the urethral apparatus based on physical characteristics of the urethra, bladder , I neck, or bladder.

CA 022286~8 1998-02-04 First, anchoring of any of these embodiments may be aecomplished by the 2 physical compression of the urethral wall against the body of the urethral apparatus.
3 This is the result of the circumferential pressure instilled upon the body by the urethra.
4 These distributed forces should be sufficient to provide for a longitudinal restriction of movement that exceeds the maximum force instilled upon the projected area of the6 body by the hydraulic pressure of the urine 7 Second, anchoring may also be facilitated by selecting a urethral apparatus 8 body with a cross-sectional area that is appropriate for the individual user. In some 9 embodiments, the projection of the surface area combined with the longitudinal surface o area, shape, and texture may be sufficient for mechanical anchoring to offset incident hydraulic or physiologic forces that would otherwise shift or expel the urethral2 apparatus. Designing the longitudinal axis surface to be cylindrical, ellipsoidal~
3 hyperbolic, sinusoidal, helical, or wedge-shaped, or to have various cross-sectional 4 areas or circumferences along the longitudinal axis (including barb-like projections) is 15 effective in acquiring sufficient anchoring.
1~ Third, anchoring can also be accomplished by the addition of various external 17 features to the exterior of the body or modifications in the material eharacteristics that IX comprise the body or exterior. These include, but are not limited to, features such as 19 flexible fingers or wings that unfold in the bladder, variation of surface texture and 20 asperity heights, surface compressibility, length, contour, protrusions, grooves, axial 21 stiffness, geometric patterns, tissue entrapment surfaces such as recesses or pressure 22 points, material frictional characteristics, material uniformity (or alternately non-23 uniformity), regional rigidity, projected area, and other characteristics. The 24 combination of the urethral system dynamics and of the surface characteristics of the 25 apparatus while in contact with the urethral wall ultimately determine the adequacy of 26 the anchoring of the body of the urethra apparatus. In order for the various 27 embodiments to be effective, controllable anchoring is desirable, if not mandatory, and 2x dependably predictable once the user's urethral environment has been clinically 29 characterized. Any of these anchoring techniques can be enhaneed by the use of 30 adhesives. In addition, the proximal and distal ends of the body may have radiused, 31 atraumatic edges.

CA 022286~8 1998-02-04 An embodiment having an anchoring structure is disclosed in Figures 55 and 2 56. A urethral apparatus 900 includes a sinusoidal surface 910a along an external 3 surface 903 ofthe body 901. External surface 903 has lower surface portions 930a and higher surface portions 932a. These higher surface portions 932a may have varying degrees of compression, ranging from slightly compressible to very 6 compressible. The offset sinusoidal surface 910b (Figure 56) may also aid in insertion 7 of the urethral apparatus, since during insertion, the insertion tool and the urethral 8 apparatus are coupled together in a locked position and are capable of being rotated as g a unit. The offset sinusoidal surface 910b also has lower surface portions 930b and lo higher surface portions 932b.
Il Figure 57 shows the incident forces and hydraulic urine pressures exerted on 2 the body 901. Pressure is incident upon the projected area 941, which is exposed to 3 urine at the bladder neck 42. The urethra 40 contacts the external surface 903 of body 4 901 along its length. This pressure is a function of length P(L), and circumference is a s function of length C(L); either may be variable along the length. (The nomenclature IG dL indicates an infinitesimal change in length as used in integration.) Figure 57 7 illustrates that each variable contributes to anchoring the urethral apparatus 900 within 18 the urethra.
19 Anchoring is accomplished by the summation of all the forces between the body 901 and the urethra 40 exceeds the maximum peak forces exerted over time by21 fluid pressures that contact the projected area 941 ofthe surface. The forces imparted 22 on body 901 are hydraulic and physiological (e.g., spasm). Hydraulic forces may be 23 high pressure, short-duration impulses caused by laughing or coughing or other sudden 2~ stresses on the bladder. The body 901 remains stable when the smaller, hydraulic 2s forces resulting from the urine are imparted on the urethral apparatus over long 26 periods of time. These prolonged hydraulic forces may occur in the use of urethral 27 apparatus 900 with a urine-control feature as in the embodiment of the magnetic valve 2x (Figure 48) at the time just prior to urine release.
29 Embodiments of the urethrAI apparatus body with internal flow-restriction compollellts may be retained in the urethra at the bladder neck or bladder when 31 impulses of pressure peaks upon it range from 4 to 268 inches of water for a time 32 duration of up to 3 seconds, or when the urethral apparatus is subjected to prolonged CA 022286~8 1998-02-04 pressurization ranging from I to 60 inches of water for up to 8 hours without 2 displacement The embodiment of the urethral apparatus body 901 with the higher 3 surface 932a as shown in Figure 55 can be used with changes in amplitudes ranging 4 from approximately 1 percent to approximately 400 percent of the area as measured to s the lower surface 930a. The higher amplitudes and variation of surfaces are useful for 6 greater anchoring requirements.
7 Another alternative structure for anchoring or retaining the urethral apparatus 8 is illustrated in Figures 58A-58C and Figures 59A-59E. Figures 58A-58C illustrate a g female version of a urethral apparatus I OOOA, and Figure 59A-59E illustrate a longer, o male version lOOOB. These embodiments of urethral apparatuses includes external protrusions or anchors 1045A or 1045B. As illustrated, these protrusions 1045A or 2 1045B may be complete helical ribs or partial helical ribs. These embodiments also 13 include one or more complete circumferential sealer rings 1029A, 1029B located 14 adjacent to or intermixed with these anchors 1045A or 1045B, respectively. The s addition of sealer rings 1029A, 1029B aid in preventing urine leakage between the 6 urethral apparatus body 1001 and the urethra. These anchors 1045A, 1045B or sealer 7 rings 1029A, 1029B can vary in height, length, number, compressiveness, axial placement, material characteristics, and helix angle varying from 0 to 300 degrees, and 19 more preferably from 15 to 300 degrees. The maximum amplitude of each anchor may extend along the entire length of a middle portion of the anchor, or may extend along 21 only part ofthe middle portion ofthe anchor. These anchors 1045A, 1045B or sealer 22 rings 1029A, 1029B do not interfere with any ofthe various sensing components 23 described in the alternate embodiments above. Most of the sensing components are 24 preferably located in a proximal portion 1007A (see Figure 58A), although in2s alternative embodiments the sensing components may be located in a middle 1040A or 2(, distal portion 1005A as well.
27 Anchor features are cast onto the outer circumference of the tubular body 2~ IOOIAl lOOlB using a Shore A 30 Durometer silicone rubber compound. The 29 specific compounds used for casting the anchoring and sealing features are RTV 430 silicone rubber resin and Beta I l-Dl silicone catalyst solution, both manufactured by 31 GE Silicones of Waterford, NY.

CA 022286~8 1998-02-04 C'ertain advantages can be gained by using partial helical anchors 1045A, 2 1045B (as shown in Figure 58B and 58C) arranged in such a manner so that as the 3 urethral apparatus is rotated through the urethra, each helical anchor does not come 4 into contact with the urethral surface contacted by the proximally adjacent anchor, thereby eliminating trauma to the urethra while still providing for anchoring and easy 6 insertion.
7 Any of the above described embodiments are compatible with the 8 implementation of valves or other therapeutic, diagnostic, or urine-control elements.
g Embodiments without internal urine-flow restrictions, such as for the implementation lo of a stent or fluid conduit, allow urine flow freely with only a minimal pressure due to ll the small projected area as explained previously and illustrated in Figure 57 In 12 embodiments with relatively unrestricted fluid flow, the extent of surface contact (or 13 total force) required for anchoring is substantially less than in embodiments with more 14 restricted fluid flow. Thus, the surface and size modifications of urethral apparatus body can be purposefully made to make it easily insertable and retainable.
6 Further disclosure regarding anchoring is included in U.S. application Ser. No.
7 08/914,48 7 filed August 19, 1 997 .

19 It is to be understood, however, the even though numerous characteristics and 2() advantages of the present invention have been set forth in the foregoing description, 21 together with details of the structure and function of present invention, the sequence or 22 order of the specific steps, or the actual compositions, environmental conditions, and 23 the like experienced or sensed may vary somewhat. Furthermore, it will be appreciated 24 that this disclosure is illustrative only and that changes may be made in detail, especially in matters of shape, size, arrangement of parts, or sequence of elements of 2G the various aspects of the invention within the principles of the invention to the full 27 extent indicated by the broad general meaning of the terms in which the appended 28 claims are expressed.

Claims (50)

1. An apparatus for placement in a urethra comprising:
a tubular body sized for placement in the urethra, said tubular body having a proximal portion adapted for placement toward a bladder end and bladder neck end of the urethra and a distal portion opposite from said proximal portion, and a sensor component coupled to said tubular body and responsive to a urethral feature to provide a first indication of proper placement of said proximal portion at the bladder end and bladder neck end of the urethra whereby proper placement of saidtubular body can be ascertained.

2. The invention of Claim 1 wherein said sensor component comprises:
a pressure sensor responsive to compressive forces applied thereto and operative to provide said first indication upon a transition to an area of lowercompressive forces from an area of higher compressive forces.

3. The invention of Claim 1 wherein said sensor component comprises:
a preformed portion located at said proximal portion, said preformed portion operative being flexible and resilient and having an other-than-straight shape when at rest, said preformed portion providing said first indication upon a transition to an area of greater cross-sectional area from an area of lesser-cross sectional area

4. The invention of Claim 1 wherein said sensor component comprises:
a pressure membrane switch responsive to compressive forces applied thereto and operative to provide said first indication upon a transition to an area of lower compressive forces from an area of higher compressive forces.

5. The invention of Claim 1 wherein said sensor component comprises:
at least one acoustic transducer located on the tubular body and oriented in a radially outward direction, said at least one acoustic transducer operative to transmit and receive acoustic signals and operative to provide said first indication upon a transition to the bladder neck from an area within the urethra.

6. The invention of Claim 1 wherein said sensor component comprises:
a first acoustic transducer located on the tubular body and oriented in a radially outward direction, said first acoustic transducer operative to transmit acoustic signals;
and a second acoustic transducer located on the tubular body and oriented to receive said acoustic signals after being reflected, said second acoustic transducer operative to provide said first indication upon a transition to a bladder neck from an area within a urethra.

7. The invention of Claim 1 wherein said sensor component comprises:
a fluid passageway extending through said tubular body and communicating with a proximal passageway opening in the proximal portion, said fluid passageway containing a fluid under a higher pressure when flow of the fluid from said proximal opening is restricted and containing fluid under a lower pressure when flow of the fluid from said proximal opening is unrestricted.

8. The invention of Claim 1 wherein said sensor component comprises:
a fluid passageway extending through said tubular body and communicating with a proximal passageway opening in the proximal portion, said fluid passageway containing a fluid under a higher pressure when flow of the fluid from said proximal passageway opening is restricted and containing fluid under a lower pressure when flow of the fluid from said proximal passageway opening is unrestricted; and a flow restrictor valve at said proximal passageway opening and adapted to prevent flow from said proximal passageway opening while said proximal passageway opening is within the urethra.

9. The invention of Claim 1 wherein said sensor component comprises:
a first fluid passageway extending through said tubular body to said proximal portion; and a second fluid passageway extending through said tubular body adjacent to said first fluid passageway and communicating with said first fluid passageway at said proximal portion, and a contactor adjacent one of said fluid passageways and operative to restrict fluid flow therethrough in response to application of compressive forces to said contractor.

10. The invention of Claim 1 wherein said sensor component comprises:
a first electrical contact located at a first position on an exterior of said proximal portion, said first electrical contract coupled to a first electric lead extending from said first electrical contact to a first electrical coupling located at said distal portion of said tubular body; and a second electrical contact located at a second position on said exterior of said proximal portion, said second electrical contact spaced away from said first electrical contact, said second electrical contract coupled to a second electric lead extending from said second electrical contact to a second electrical coupling located at said distal portion of said tubular body.

11. The invention of Claim 1 wherein said sensor component comprises:
a thermoelectric module located at said proximal portion, said thermoelectric module comprising said first semiconductor portion coupled to a first electric lead extending from said first semiconductor portion to a first electrical coupling located at said distal portion of said tubular body; and a second semiconductor portion coupled to a second electric lead extending from said second semiconductor portion to a second electrical couplinglocated at said distal portion of said tubular body.

12. The invention of Claim 1 wherein said sensor component comprises:
a first fiber optic lead extending from a first fiber optic coupling located at said distal portion of said tubular body to a first position at said proximal portion of said tubular body at which light energy can be transmitted from said first fiber optic lead to an area adjacent said proximal portion;
a second fiber optic lead extending from a second position located at said proximal portion at which light energy from the area adjacent said proximal portion can be received into said second fiber optic lead to a second fiber optic coupling located at said distal portion of said tubular body.

13. The invention of Claim 1 wherein said sensor component comprises:
a first fiber optic lead extending from a first fiber optic coupling located at said distal portion of said tubular body to a first position at said proximal portion of said tubular body at which light energy can be transmitted from said first fiber optic lead;
a second fiber optic lead extending from a second position located at said proximal portion at which light energy can be received into said second fiber optic lead to a second fiber optic coupling located at said distal portion of said tubular body;
a non-reflective member located adjacent a light path between said first position and said second position, said non-reflective member being deformable upon application of a force thereupon to interrupt said light path.

14. The invention of Claim 1 wherein said sensor component comprises:
a fiber optic lead extending from a first fiber optic coupling located at said distal portion of said tubular body to a first position at said proximal portion of said tubular body at which light energy can be transmitted from said fiber optic lead;
an optical transducer located relative to said first position to receive light via a light path from said first position; and and at least one electrical lead coupled to said optical transducer and to a distal electrical coupling located at said distal end of said tubular body.

15. The invention of Claim 1 further comprising:
a plurality of anchors extending outward from an exterior surface of said tubular body.

16. The invention of Claim 1 further comprising:
a plurality of anchors extending outward from an exterior surface of said tubular body wherein each of said plurality of anchors extends less than 360° around said exterior surface.

17. The invention of Claim 1 wherein said tubular body comprises a wall that defines a passageway extending from said proximal portion to said distal portion and further wherein said tubular body has a proximal opening located in said proximal portion and communicating with said passageway and a distal opening located in said distal portion and communicating with said passageway.

18. The invention of Claim 17 further comprising a valve located in said passageway.

19. The invention of Claim 17 wherein a distal portion of said passageway includes a recess for receiving an insertion tool.

20. The invention of Claim 1 wherein said tubular body has a length such that a distal end is retained inside the urethra during use.

21. The invention of Claim 1 wherein said device has a size between 6 and 34 French.

22. The invention of Claim 1 wherein said tubular body comprises a wall that defines a passageway extending from said proximal portion to said distal portion and further wherein said tubular body has a proximal opening located in said proximal portion and communicating with said passageway and a distal opening located in said distal portion and communicating with said passageway, and further wherein a magnetically-actuatable valve is located in said passageway.

23. The invention of Claim 1 further comprising:
an apparatus first contact member operative to provide a signal upon connection to an insertion tool.

24. The invention of Claim 1 further comprising:
an apparatus contact component operative to convey a signal from said sensor component.

25. The invention of Claim 24 wherein said apparatus contact component comprises a first electrical contact terminal and a second electrical contact terminal spaced apart from each other at a fixed distance and a third electrical contact terminal coupled to said sensor component and movable between two positions in relation to said first electrical contract terminal and said second electrical contact terminal to electrically couple said first electrical contract terminal to said second electrical contact terminal in a first of said two positions and to maintain said first electrical contract terminal and said second electrical contact terminal electrically isolated from each other in a second of said two positions.

26. The invention of Claim 1 further comprising:
an apparatus first contact member coupled to said tubular body and operative to provide a first signal upon connection of said tubular body to an insertion tool; and an apparatus contact component operative to convey a second signal from said sensor component upon positioning of the tubular body at the bladder neck.

27. The invention of Claim 1 further comprising:
a urethral apparatus connection component coupled to said tubular body and responsive to said sensor component to transmit a second indication in response to said first indication;
an insertion tool having an insertion tool body including a proximal end and a distal end;
an insertion tool connection component located at said proximal end of said insertion tool body and disconnectably matable with said urethral apparatus connection component, and adapted to receive said second indication therefrom; and an indicator coupled to said insertion tool connection component and adapted to provide a signal indicative proper placement of said urethral apparatus.

28. The invention of Claim 1 wherein said tubular body defines a passageway extending from said proximal portion to said distal portion and further wherein distal portion of said passageway includes a recess for receiving an insertion tool.

29. The invention of Claim 1 wherein an exterior surface of said tubular body is constructed of a material selected from a group consisting of: molded silicone, latex, polyurethane, polyethylene, and polycarbonate.

30. The invention of Claim 1 wherein said tubular body is formed of silicone rubber.

31. The invention of Claim 1 wherein said tubular body is formed of a material having a Durometer hardness in a range between approximately 20 and 80 Shore.

32. The invention of Claim 1 further comprising:
an insertion tool having an insertion tool body including a proximal end and a distal end;
an insertion tool connection component located at said proximal end of said insertion tool body and disconnectably matable with said distal portion of said tubular body and adapted to receive said second indication therefrom.

33. The invention of Claim 32 further comprising:
an indicator coupled to said insertion tool connection component and adapted to provide a signal indicative of proper placement of said urethral apparatus.

34. An insertion tool for use in the positioning of a tubular apparatus in a urethra comprising:
an elongate shaft:
a handpiece coupled to a distal end of said shaft;
a coupling member coupled to a proximal end of said shaft; and a manually operable actuator located on said handpiece and adapted to operate said coupling member by means of said shaft to cause said coupling member to engage and disengage a distal end of a urethral apparatus.

35. A tool for use in the positioning of a tubular apparatus in a urethra comprising:
an elongate shaft:
a handpiece coupled to a distal end of said shaft;
a coupling member coupled to a proximal end of said shaft and releasibly connectable to a distal end of a urethral apparatus; and an indicator coupled to said coupling member and adapted to indicate placement of a proximal portion of a urethral apparatus coupled to said couplingmember at a bladder end of the urethra.

36. The invention of Claim 35 further comprising:
a manually operable actuator located on said handpiece and adapted to operate said coupling member by means of said shaft to cause said coupling member to engage and disengage a urethral apparatus.

37. A method of positioning a tubular body of a urethral apparatus in a urethra comprising the steps of:
inserting a proximal end of the tubular body in the urethra;
manually moving the urethral apparatus proximally toward the bladder, and ceasing movement upon receiving an indication from the urethral apparatus that the proximal end is at the bladder.

38. The method of Claim 37 wherein said indication causes an audible signal to sound.

39. The method of Claim 37 wherein said indication causes a visually observable signal.

40. The method of Claim further 37 comprising the step of:
coupling a distal end of the tubular body of the urethral apparatus to a proximal end of an insertion tool prior to the step of manually moving the urethral apparatus toward the bladder.

41. The method of Claim 40 further comprising the step of:
decoupling the insertion tool from the urethral apparatus after the step of ceasing movement thereby leaving the urethral apparatus in place in the urethra.

42. The method of Claim 40 wherein said indication is transmitted through the insertion tool.

43, The method of Claim 41 comprising the step of:
after the step of decoupling, removing the insertion tool from the urethra;
after a period of time, removing the urethral apparatus by advancing the proximal end of the insertion tool into the urethra, engaging the distal end of the urethral apparatus with the proximal end of the insertion tool, and withdrawing the coupled insertion tool and urethral apparatus from the urethra.

44. The method of Claim 40 further comprising the step of:
after the step of coupling the insertion tool to the tubular body, receiving a signal from the insertion tool that the insertion tool and urethral apparatus are coupled together.

45. A method of positioning a urethral apparatus comprising:
coupling a distal end of the urethral apparatus to a proximal end of an insertion tool;
advancing the coupled urethral apparatus and insertion tool proximally through the urethra toward the bladder;
sensing a change in a feature of the urethra with a sensing component located on the urethral apparatus;
transmitting a signal in response to said sensed change from the urethral apparatus to said insertion tool, and providing a signal from the insertion tool that the proximal end of the urethralapparatus is properly positioned relative to the bladder neck and bladder.

46. An apparatus for placement in a urethra comprising:
a tubular body sized for placement in the urethra, said tubular body having a proximal portion adapted for placement toward a bladder end and bladder neck end of the urethra and a distal portion opposite from said proximal portion; and means for sensing a urethral feature to provide a first indication of proper placement of said tubular body at the bladder end and bladder neck end of the urethra, said sensing means coupled to said tubular body.

47. An apparatus for controlling incontinence comprising:
a tubular body sized for placement in the urethra, said tubular body having a proximal portion adapted for placement toward a bladder end and bladder neck end of the urethra and a distal portion opposite from said proximal portion; and a component on tubular body that responds to a feature in the urethra and provides a first signal in response thereto upon location of the proximal portion of the tubular body at the bladder neck, said first signal transmitted from the tubular body outside the urethra where a person positioning the tubular body can cease proximal advancement of the tubular body upon receipt of the first signal.

48. The invention of Claim 47 further comprising:
an insertion tool having a proximal coupling member that releasibly connects to the urethral apparatus, wherein said coupling member includes a connector terminal that receives said first signal transmitted from the urethral apparatus.

49. The invention of Claim 48 wherein said insertion tool further comprises:
an indicator unit that receives the first signal from the urethral apparatus andprovides a perceivable indication to the person positioning the urethral apparatus that the proximal portion of the urethral apparatus is at the bladder neck.

50 The invention of Claim 48 wherein said coupling member includes a second contact terminal that transmits a second signal indicating that the insertion tool and urethral apparatus are coupled together.