USOO6447462B1

(12) United States Patent (10) Patent No.: US 6,447.462 B1

Wallace et al. (45) Date of Patent: Sep. 10, 2002

(54) URODYNAMIC CATHETER AND METHODS GB

GB
968376
2318513 A
9/1964
4/1998
OF EABRICATION AND USE
WO WO O11/12003 3/2000
(75) Inventors: Wm. Dean Wallace, Salt Lake City; OTHER PUBLICATIONS
Christopher A. Cutler, Centerville;
Steven R. Smith, Draper; Richard A. Tanagho, Emil A., M.D., et al., “Membrane Catheter.”
Dixon, West Jordan, all of UT (US) Urology, Aug. 1977, vol. X. No. 2, pp. 173-176.
The Fundamentals of Female Urodynamic Study Interpre
(73) Assignee: Clinical Innovation Associates, Inc., tation: Case Studies Using the LuMaxTM Fiber Optic Cys
Murray, UT (US) tometry System, (C) 1997, MedAmicus, Inc.
PCT International Search Report, PCT/US01/04749, dated
(*) Notice: Subject to any disclaimer, the term of this Jul. 27, 2001.
patent is extended or adjusted under 35
U.S.C. 154(b) by 0 days. Primary Examiner Kevin Shaver
ASSistant Examiner-Charles Marmor, II
(21) Appl. No.: 09/504,972 (74) Attorney, Agent, or Firm TraskBritt
(57) ABSTRACT
(22) Filed: Feb. 15, 2000
(51) Int. Cl. .................................................. A61B 5/00 A urodynamic catheter incorporating at least one balloon
(52) U.S. Cl. ........................ 600/561; 600/435; 604/915 adjacent a distal end thereof and associated with a pressure
lumen extending to a proximal end to be placed external to
(58) Field of Search ................................. 600/568-589, the body of a patient and usable with a transducer housing
600/588, 591, 433,434, 435, 585; 606/192, including a pressure transducer and a mechanism for alter
193; 604/915,919,920 natively venting an air column defined by the assembled
(56) References Cited preSSure lumen and transducer housing to the ambient
environment and closing the air column and charging it with
U.S. PATENT DOCUMENTS air while reducing volume of the air column. One embodi
3.884.242 A 5/1975 Bazell et al. .......... 128/207.15
ment includes two, Separately-chargeable balloons and a
4,019,505 A 4/1977 Kornblum et al. ..... 604/101.05 bladder fill tube, another embodiment includes a single
4,077,394 A 3/1978 McCurdy ..................... 600/18 balloon and a fill tube, and yet another embodiment, Suitable
4,301,811 A 11/1981 Layton ...... ... 600/S61 for use as a reference catheter to measure abdominal
4,776,347 A 10/1988 Matthews ..... ... 600/587 preSSure, includes only a Single balloon and omits the fill
4,901,735 A 2/1990 von Berg .................... 600/S61 tube. A novel catheter architecture and assembly technique
FOREIGN PATENT DOCUMENTS
are also disclosed, as are methods of using the inventive
catheter.
EP O846 472 A1 6/1998
EP O 972 535 A2 1/2000 49 Claims, 5 Drawing Sheets

S.

SSE
312 306
U.S. Patent Sep. 10, 2002 Sheet 1 of 5 US 6,447.462 B1
U.S. Patent Sep. 10, 2002 Sheet 2 of 5 US 6,447.462 B1

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02

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U.S. Patent Sep. 10, 2002 Sheet 3 of 5 US 6,447.462 B1
U.S. Patent Sep. 10, 2002 Sheet 4 of 5 US 6,447.462 B1
U.S. Patent Sep. 10, 2002 Sheet 5 of 5 US 6,447.462 B1

400

Q W %9, ful 402 10, 100

NCG2
22 N. 200
404
 US 6,447.462 B1
1 2
URODYNAMIC CATHETER AND METHODS with a strong urge to void (detrusor instability, or DI). DI is
OF EABRICATION AND USE of unknown origin, in contrast to involuntary bladder con
BACKGROUND OF THE INVENTION
tractions attributable to a known neurological disorder,
which is called detrusor hyperreflexia. Urge incontinence is
1. Field of the Invention frequently associated with identifiable trigger mechanisms,
The present invention relates generally to balloon-type Such as the Sound or feel of running water, or during
catheters and, more Specifically, to urodynamic catheters and intercourse. Urine loSS can be Substantial, as detrusor con
methods of fabrication and use thereof. tractions continue until the bladder is empty. An urgency to
2. State of the Art Void urine responsive to abnormally low volumes during
A significant percentage of urinary tract disorders, par filling of the bladder during a study without other, objective
ticularly among women, are problems of bladder Storage, or evidence of detrusor overactivity is conventionally thought
incontinence, which may be defined for purposes herein as to be due to a hyperSensitive detrusor, and is thus termed
the inability of the body to control the discharge of urine. “Sensory urgency.
Incontinence may result in at least a Social, if not hygienic, Mixed incontinence usually refers to a combination of
15 GSI and DI.
problem, and is of Significant concern to those afflicted.
Types and prevalence of incontinence among ambulatory Aurodynamic evaluation is often employed to identify the
adult women include Genuine Stress Incontinence (GSI), type and magnitude of incontinence experienced by the
detrusor instability (urge incontinence), mixed incontinence patient, in combination with other information regarding the
(stress and urge), and other incontinence (overflow, patient obtained from a physical examination and disclosed
neurogenic). The prevalence of detrusor muscle instability or documented history. Urodynamic evaluations involve
and of mixed incontinence has been observed to increase measurements of the bladder pressure, generally in com
with age of the patient Sample. Adult men have, to a lesser parison with a reference abdominal pressure obtained by a
degree, Similar incontinence problems, which are often rectal or vaginal probe, as well as measurements of urethral
asSociated with the prostate gland. Males also have urine 25
preSSure in comparison to bladder pressure. GSI may be
retention issues due to the prostate. diagnosed during filling of the bladder, as is DI. The former
The International Continence Society has defined GSI as is notable for a loSS of urine in response to the aforemen
“the involuntary loss of urine occurring when, in the absence tioned laughter, coughing or other “provocative' influence,
of a detrusor contraction, intravesical pressure exceeds while the latter is associated with involuntary, marked,
maximum urethral preSSure.” In other words, StreSS incon periodic detrusor contractions initiating voiding. Hypermo
tinence is the accidental loSS of urine resulting from bility and ISD may be identified by the use of two different
laughing, Sneezing, coughing or even Standing up; any Such conventional diagnostic methods, the urethral pressure pro
exertion causes abdominal pressure, as transmitted to the file (UPP); and the Valsalva leak point pressure study (VLPP
bladder and the urine contained therein, to exceed the study). The former procedure measures urethral pressure
resistance to flow generated by the urethra, and principally 35
Versus bladder pressure as a catheter is withdrawn from the
the urethral Sphincter. GSI may be further categorized as bladder through the urethra. The latter procedure fills the
hypermobility of the bladder neck and intrinsic sphincteric bladder to one or more Selected Volumes, at which juncture
deficiency (ISD). the patient is requested to “bear down” slowly as if voiding
Hypermobility of the bladder neck, resulting from descent to a point where leakage occurs past the catheter, or a
of the pelvic floor, may be attributed to weakened pelvic 40
selected bladder pressure differential over the baseline pres
Sure is reached.
floor muscles and connective tissue. This phenomenon may
be observed in combination with nerve damage to the Urodynamic evaluations are employed to obtain quanti
external genitalia resulting from childbirth, but may occa tative data regarding the bladder. The aforementioned blad
Sionally be noted in younger women who have not borne der filling Study, or So-called “filling cystometry', measures
children. In a normal position, the bladder is Supported by 45 the relationship of bladder pressure to Volume of contained
the pelvic muscles, which prevent increases in abdominal fluid. Bladder capacity and compliancy (the ability of the
preSSure from exceeding urethral pressure. When the pelvic bladder to accommodate increasing volumes) is measured,
muscles are weakened or damaged, the bladder neck is as is the desire to void from a Subjective, urgency Standpoint.
abnormally displaced during abdominal StreSS and the ure Finally, detrusor Stability, or the ability of that muscle group
thral Sphincter closure pressure becomes inadequate to 50 to remain relaxed during filling of the bladder, even under
maintain continence. LOSS of urine due to hypermobility the aforementioned types of provocation, is quantified.
related GSI typically occurs in a periodic manner and the So-called “multi-channel” cystometry is employed to
Volume of urine is Somewhat proportional to the Severity of correct measured bladder preSSure to obtain a true bladder
the condition. preSSure by Subtracting abdominal pressure. Bladder pres
ISD is a severe form of stress incontinence which occurs 55 Sure is measured through a Sensing element or port at the
due to an intrinsic deficiency of the urethral closure mecha distal end of a catheter inserted into the bladder through the
nism or due to a dysfunctional urethra wherein, in either urethra, while abdominal pressure is measured by a Sensing
instance, the bladder neck is open at rest. Severe ISD results element at the distal end of a catheter inserted into the
in continuous leakage of urine, or leakage responsive to only rectum or vagina of the patient. The difference in the two
minimal subject exertion. In ISD, the bladder neck may be 60 readings, the magnitudes of which are quantified as units of
fixed, or hypermobile. ISD occurs in a significant number of cm H2O, is characterized as detrusor preSSure. Monitoring
instances due to urethral Scarring from past incontinence the relationship between observed bladder pressure and
Surgeries, but may result from other causes. Only a Small abdominal pressure during filling of the bladder, including
number of patients exhibit StreSS incontinence attributable to response to provocation, results in a cystometrogram docu
ISD. 65 menting quantitative bladder function.
Urge incontinence is the involuntary loSS of urine due to Various catheter designs have been employed in the art for
an uninhibited detrusor muscular contraction associated urodynamic Studies, which designs generally include a fill
 US 6,447.462 B1
3 4
tube to introduce a volume of liquid into the bladder. There and having an outlet terminating within the confines of a
are three categories of catheters known to the inventors: Small-diameter balloon circumferentially Surrounding the
catheters which convey bladder pressure to a transducer outer tubing at or near the distal end thereof. After insertion
external to the bladder through a liquid-filled column into the patient's body, the proximal end of the preSSure
(lumen) extending through the catheter; catheters which lumen is connected by a disposable connector to a housing
employ an electronic microtransducer proximate the distal incorporating a transducer and the air column extending
ends thereof, and fiber optic transducer-tipped catheters. The between the balloon and the transducer is Subsequently
two former catheter types are primarily employed in hospital closed and charged with a minuscule Volume (for example,
urology Studies and urogynecology, while the latter type is ~15 uliters) of air. Charging may be effectuated by an air
generally employed in urology and gynecology evaluations Volume displacement within the closed air column to mini
performed in a physicians office. mize dead Space therein after closure thereof. In one
Existing urodynamic catheter technologies each Suffer embodiment of the invention, two balloons independently
from disadvantages. For example, liquid-filled catheters chargeable may be employed, one proximate the distal end
require elimination of air bubbles from the liquid column of the catheter and the other separated by a distance (for
extending from the entry port in the bladder to the external 15 example, -6 cm) proximally therefrom.
transducer, require hydrodynamic compensation and may be Architecture of the catheter also comprises a significant
Susceptible to hydrostatic influence if the external transducer aspect of the invention. For example, the balloon is of Small
and distal fill port of the catheter are not on the same diameter (-0.160 inch fully inflated) and length (-0.200
horizontal plane. Electronic microtransducer- and fiber optic inch) when inflated for enhanced coupling of urethral pres
transducer-tipped catheters, on the other hand, are relatively Sure and is extremely thin-walled, on the order of
expensive. In addition, fiber optic transducers require Special 0.0002-0.0010 inch, resulting in exceptional pliability so
optical/electronic interface modules. While some that wrinkles therein do not impose artifactual forces
transducer-tipped catheters are designed for re-use, the rela (pressures) for ideal fluid pressure transmission through the
tively fragile transducer and catheter Structures preclude the balloon membrane. Moreover, the balloon volume is heat
most rigorous and effective Sterilization techniques and thus 25 Stabilized by using a heat-shrink material to enable Shrink
make confirmation of absolute Sterility impossible. Due to age of the balloon to a fixed volume and attachment to the
the increasing incidence of Sexually-transmitted diseases, outer tubing by heat-shrink of the balloon end cuffs using a
most notably AIDS and its HIV precursor, such uncertainty hot air Stream, thus avoiding the need for Separate heat
is of obvious concern. Moreover, transducer-tipped catheters Shrink tubing hoops or adhesives at the balloon ends and
typically tap pressure along only a portion of the circum providing an extremely Smooth transition between the outer
ferential Side wall of the catheter, and are thus Susceptible to tubing and balloon on the catheter exterior. A small I.D.
inaccurate and inconsistent readings during UPP procedures, (between about 0.005–0.008 inch) pressure lumen about
as well as to missing anomalies in portions of the urethral eighteen to twenty-four inches long leading to the balloon
Side wall which are not traversed by a rotationally-displaced provides a low internal volume relative to the balloon
transducer during longitudinal withdrawal of the catheter 35 Volume within the closed air column, ensuring acceptable
through the urethra in the course of a UPP. frequency response and providing a relatively wide mea
Thus, it would be beneficial to the art to provide a reliable, surement range (between 0 and 250 cm H2O).
disposable, and robust yet easily manufactured catheter Overall, the catheter is of Small size, Such as 7 French, and
employing a transducer external to the patient's body which construction thereof affords good flexibility for easy inser
would not rely upon a liquid-filled column and which would 40 tion and added patient comfort and Safety. Use of preSSure
provide an automatic “Zero” or reference preSSure and an lumen tubing of a different, higher durometer in comparison
accurate physiological pressure, both of which may easily be to the outer tubing provides a Soft Outer jacket and a rounded
repeated as needed while the catheter remains inserted and catheter distal end in combination with more rigid, leSS
the catheter and transducer remain assembled. It would also kink-prone preSSure lumen tubing inside the Outer tubing to
be desirable to provide a catheter design affording the 45 achieve precision, Small-bore preSSure lines with a lower
capability for assessment of urethral Sphincter function risk of perforation due to stiffness and less tendency to “set”
through measurement of urethral closure pressure circum in position when curled in a packaging pouch during ship
ferentially about the catheter as it is withdrawn from the ment and Storage prior to use. Moreover, the pressure lumen
bladder through the urethra during a UPP, so as to identify tubing is not affixed to the outer tubing except at a balloon
any anomalies in the urethral Side wall regardless of cir 50 location at a distal end of the pressure lumen tubing and
cumferential location and to avoid false readings from Such where the preSSure lumen tubing exits the Outer tubing,
anomalies. promoting a flexible catheter with lower kink risk and
minimizing contribution of the pressure lumen tubing to
BRIEF SUMMARY OF THE INVENTION overall catheter stiffness. Similarly, a fill tube extending
55 from the proximal end of the outer tubing to proximate a port
The present invention comprises a disposable urodynamic at the distal end thereof is only secured distally to the outer
catheter employing at least one thin-walled, tubing in the vicinity of pressure lumen tubing affixation and
circumferentially-extending balloon proximate the distal, or more proximally at an exit point of the preSSure lumen
patient end thereof which communicateS preSSure external to tubing from the outer tubing. The use of a thin-walled,
the balloon proximally to a transducer external to the 60 Somewhat translucent material for the outer tubing permits
patient's body through a Small-volume, closed air column. the desirable use of UV-light curable adhesives (see below)
The catheter is inserted with the at least one balloon in a without leaving the interior lumen tubing visible. The luer
collapsed State, which is then charged after entry of the lock (or similar) type pressure connectors employed at the
catheter into the patient's bladder, or vagina, or rectum proximal end of the pressure lumen tubing provide a low
during a multi-channel cystometry procedure. 65 dead Space connection and do not produce Significant
The present invention includes at least one preSSure lumen counter-torque on the catheter when twisted on to couple to
extending distally from a proximal end of an outer tubing a mating connector of the transducer housing port due to the
 US 6,447.462 B1
S 6
Substantially ends-only affixation of the pressure lumen incorporating two balloons and a fill tube, and an enlarged,
tubing to the outer tubing. Further, the relative isolation of partial Sectional side elevation of a distal end thereof;
the pressure lumen tubing and fill tubing from the outer FIGS. 2A and 2B respectively depict a side elevation of
tubing provides Strain relief to the former when physical a Second embodiment of a catheter according to the inven
StreSS is applied to the catheter, as mechanical loading is tion incorporating a Single balloon and a fill tube, and an
Substantially accommodated by the Outer tubing. enlarged, partial Sectional Side elevation of a distal end
A tapered, interference fit connection between the coop thereof;
erative luer-lock connectors of the preSSure lumens and FIGS. 3A and 3B respectively depict a side elevation of
those of the reusable transducer housings minimizes dead
Space in the air column between the transducer and balloon. a third embodiment of a catheter according to the invention
A unique, plunger-type charging Structure incorporated in incorporating a single balloon, and an enlarged, partial
the transducer housing closes the air column from the Sectional Side elevation of a distal end thereof;
ambient environment as the plunger advances beyond the FIGS. 4A and 4B respectively depict enlarged sectional
extent of a relief or vent channel in the Side wall of a plunger elevations of a portion of the catheter of the first
bore, and reduces dead Space in the air column and charges 15 embodiment, FIG. 4A showing the balloons in an uncharged
enough air into the balloon Such that pressure can be State and FIG. 4B showing the balloons in a charged State;
measured across the balloon membrane. In one embodiment, FIGS. 5A, 5B, 5C, 5D and 5E respectively depict a
a deformable mass Such as, for example, resilient Silicone rear-quarter perspective view, a front-quarter perspective
employed at an end of the plunger is compressed in a bore
end as the plunger is advanced in the plunger bore, con View, a side view, and a rear View of the transducer housing
Suming column volume and providing an airtight Seal at the of the present invention and a side Sectional view taken
plunger end of a passage leading to a transducer access port across line 5-5 in FIG. 5D with pressure lumen connected,
and a connector port. In another embodiment, a Solid-ended the air column defined by the transducer and pressure lumen
plunger using an O-ring is employed to charge a fixed assembly being in the vented, or Zero, position;
Volume of air into the column and Seal the passage. The FIGS. 6A, 6B, 6C, 6D and 6E respectively depict a
configuration of the charging mechanism affords the capa 25 rear-quarter perspective view, a front-quarter perspective
bility for repeated, accurate one-handed closure and charg View, a side view, and a rear View of the transducer housing
ing of the air column without disconnection of the catheter of the present invention and a side Sectional view taken
from the transducer housing. across line 6-6 in FIG. 6D with pressure lumen connected,
During fabrication of the catheter preliminary to attach the air column defined by the transducer and pressure lumen
ment of the balloon or balloons to the exterior of the outer being in the charged, or run, position;
tubing of the catheter, the outer tubing is formed to be round FIGS. 7A and 7B respectively depict an enlarged view of
at its distal tip, then Side holes or apertures are punched at
the location or locations of a balloon. Then, the bladder a first embodiment of a plunger assembly for the transducer
(vesicle) filling lumen tubing and the Smaller pressure lumen housing as shown in FIGS. 5E and 6E in retracted and
tubing are fed into the primary tubing for fast, easy assem extended positions,
35
bly. The filling lumen tubing is fed from the proximal end FIGS. 8A and 8B respectively depict an enlarged view of
until reaching the distal tip of the outer tubing. The pressure a Second embodiment of a plunger assembly Suitable for use
lumen tubing (two, if a two-balloon pressure Sensing in the transducer assembly of FIGS. 5A-E and 6A-E, and
embodiment) is fed proximally from the punched aperture or FIG. 9 is a view in partial anatomical cutaway illustrating
apertures in the outer tubing Side wall at the outer catheter the insertion of an embodiment of the urodynamic catheter
tubing distal end and guided to exit the outer tubing through 40
of the present invention in the bladder of a patient and a
a slit in the primary tubing Side wall along the proximal Second, reference abdominal catheter in the patient's vagina.
portion of the outer tubing. A measured Volume of a
UV-light curable (or alternatively an RTV) adhesive is then DETAILED DESCRIPTION OF THE
injected into the outer tubing bore into the Side wall entry INVENTION
point around each pressure lumen tubing to Secure the 45
pressure lumen tubing and isolate the pressure lumen (and In the following description, the same reference numerals
thus, eventually, the associated balloon) from the outer are employed to identify the same elements or features in
tubing bore. The adhesive is then UV-cured to secure the various drawing figures for clarity.
filling lumen tubing and preSSure lumen tubing, the distal Applicants hereby incorporate the disclosures of each of
ends of the preSSure lumen tubing are trimmed Substantially 50 the following United States Patents in their entireties by this
flush with the exterior of the outer tubing, and the interior reference: Bobo, Sr., U.S. Pat. No. 5,573,007; Wallace et al.,
lumen tubing Secured to the primary tubing in the vicinity of U.S. Pat. No. 5,951,497; and Wallace et al., U.S. Pat. No.
the Slit using a collar or sleeve of heat-shrink material. 5,984.879.
The present invention also encompasses a method of use Referring to FIGS. 1A and 1B in a first catheter embodi
of the catheter according to the invention, including mea 55 ment 10 of the present invention, Outer tubing 12 Surrounds
Surement of bladder as well as, optionally, abdominal pres a fill tubing 14 extending Substantially from rounded, distal
Sure using deformation of an air-filled balloon responsive to
preSSure on the exterior thereof to transmit preSSure to a end 16 of catheter 10 to proximal end 18 thereof. First and
transducer external to the patient. In addition, the method of second pressure lumen tubing 20a and 20b respectively
the present invention may include measurement of urethral extend from distal and proximal balloons 22a and 22b,
preSSure, Such as, for example, during a UPP procedure, 60 which are preferably of Substantially the same size, to male
throughout an entire circumference of the catheter as it is luer lock connectors 24a and 24b. Balloon fill ports 26a and
withdrawn from the urethra. 26b at the distal ends of pressure tubing 20a and 20b open
to the interiors 28a and 28b of balloons 22a and 22b. The
BRIEF DESCRIPTION OF THE SEVERAL distal ends of pressure tubing 20a and 20b are secured
VIEWS OF THE DRAWINGS 65 within, and balloon fill ports 26a and 26b isolated from, the
FIGS. 1A and 1B respectively depict a side elevation of bore 30 of outer tubing 12 using a mass of UV-curable
a first embodiment of a catheter according to the invention adhesive 32 injected into bore 30 through the side wall 34 of
 US 6,447.462 B1
7 8
outer tubing 12 adjacent the fill port locations (see FIGS. 4A 3321 offered by Loctite Corporation of Rocky Hill, Conn.
and 4B for enlarged views). Pressure lumen tubing 20a and Curing (cross-linking) of the UV-curable adhesive can be
20b may exit outer tubing 12 through a slit in the side wall initiated in a very Short time, as little as one to two Seconds
34 thereof, at which location a protective heat shrink collar of exposure to UV-wavelength radiation. Curing of the
or sleeve 35 is employed to Secure pressure lumen tubing adhesive also fixes the distal ends of pressure lumen tubing
20a and 20b and fill tubing 14 and prevent kinking thereof. 20a and 20b in place, as well as fill tubing 14. The excess
Fill tubing 14 extends from its distal end near fill port 40 in distal length of pressure lumen tubing 20a and 20b is
the side wall 34 of outer tubing 12 proximally through outer trimmed Substantially flush with the exterior of the side wall
tubing 12 to a female connector 36, which may comprise a 34 of outer tubing 12. The proximal ends of fill tubing 14
luer lock or other suitable connector and which preferably and pressure lumen tubing 20a and 20b are sheathed with a
has associated there with a plug element or cap (shown) 38 protective sleeve or collar 35 of a heat shrink material
for closure thereof. Fill tubing 14 is thus sealed inside of the (which is Subsequently shrunken) over the area of the Slit in
outer tubing 12, which physically supports the fill tubing 14 outer tubing 12 where pressure lumen tubing 20a and 20b
and prevents it from kinking. exits therefrom to prevent kinking, and then bonded to their
Referring to FIGS. 2A and 2B, a second catheter embodi 15 respective connectors 36, 24a and 24b, as known in the art.
ment 100 of the present invention is depicted. Catheter 100 After the balloons 22a and 22b are formed and cut, they are
is similar to catheter 10, but includes only a single balloon placed and Sealingly bonded at their longitudinal ends to
22 and associated pressure lumen tubing 20. Construction of extend over balloon fill ports 26a and 26b, respectively, by
catheter 100 is otherwise the same as that of catheter 10. heat-shrinking the longitudinal balloon ends, or cuffs, to the
Referring to FIGS. 3A and 3B, a third catheter embodi outer tubing 12 using a highly directional, hot-air Stream.
ment 200 of the present invention is depicted. Catheter 200 The balloons are baked at an elevated temperature, Such as
is similar in construction to both catheters 10 and 100, but about 60° C. for about forty minutes to stabilize their
omits the fill tubing 14 and associated female connector 36 respective volumes. Subsequently, a male plug element or
with plug element or cap 38. Catheter 200 is configured for cap 38 is placed on the fill tubing connector 36, and the
use as a reference, or abdominal, catheter in urodynamic 25 catheter is leak-tested, as known in the art.
procedures, placement thereof during Such procedures hav Referring to FIGS. 5A through E and 6A through E, the
ing been previously noted above. particulars of transducer assembly 300 according to the
In the above-described embodiments, the outer tubing 12 invention will be described. Transducer assembly 300
is of 7 French (0.092 inch) diameter and formed of includes a two-piece, injection-molded plastic housing 302
lubricious, soft, low durometer (-60 Shore A) polyurethane which encompasses a transducer block 304 (FIGS. 7A, 7B)
or polyethylene with EVA (ethyl vinyl acetate), and is about having transducer recess 306 within which transducer 308 is
45 cm in length. Balloons 22 are of -0.3 inch in length, of received. A Suitable transducer for use with the present
~0.0002-0.0010 inch wall thickness, and formed of poly invention is offered by Lucas Novasensor of Fremont, Calif.
ethylene with EVA. Outer tubing 12 is preferably marked in Transducer 308 is powered, and Sends Signals to a monitor,
one centimeter increments for 30 centimeters and numerical 35 through conductors 310 of cable 312, which extends to a
five centimeter gradations to a twenty-five centimeter mark, monitor (not shown) as known in the art and is connected
beginning at the distal end of the most distal balloon 22, thereto with a compatible connector. Suitable monitors are
which is ~1 cm from distal end 16 of outer tubing 12. If a offered by various companies, including without limitation
Second balloon is employed, as in catheter 10, it is located Life Tech, Laborie, Dantec, MMS, Circon/Surgitek, and
~7 cm from distal end 16 of outer tubing 12. Pressure lumen 40 Brown Medical Monitors. There is preferably a Velcro(R)
tubing 20 is preferably formed of polycarbonate or other type hook patch (not shown) secured to the cable 312 or to
Substantially rigid thermoplastic and has an I.D. of between transducer housing 302, by which the cable 312 or housing
about 0.005-0.008 inch, as previously noted, and preferably 302 may be Secured to the patient's leg using a disposable
~0.008 inch. Fill tubing is preferably formed of polyure Velcro (E) type loop adhesive patch Supplied with each cath
thane or other Semi-rigid thermoplastic having a durometer 45 eter.
of Shore A and preferably has an I.D. of ~0.035 inch. Transducer block 304 includes a manifold comprising a
In a manner exemplary of the fabrication of catheters 10, charging and vent passage 314 extending from a plunger
100 and 200, catheter 10 is formed by making a slit about 15 bore 316 to a transducer port 318 opening into transducer
inches from the distal end 16 of outer tubing 12 and recess 306, transducer port 318 being faced by a sensor
providing distal end 16 with a soft, rounded tip by tech 50 element, Such as a diaphragm, of transducer 308, the junc
niques known to those of ordinary skill in the art. The tion of port 318 and the transducer sensor element being
exterior of Outer tubing 12 is marked, as previously noted. A Sealed about the periphery thereof So as to be airtight, by
distal end of fill tubing 14 is notched at about a 45 degree techniques known in the art. Pressure lumen port 320 also
angle (see FIGS. 1B and 2B) and inserted into outer tubing communicates with passage 314 and extends to the bore of
12 from the proximal end thereof. Pressure lumen tubing 55 female luer connector 322, which is configured to receive
20a and 20b are inserted into outer tubing 12 through tapered male connector element 324 associated with a male
apertures 42a and 42b punched in side wall 34 at predeter luer lock connector 24. Plunger 330 is received within
mined locations close to the distal end 16 of outer tubing 12 plunger bore 316 and may comprise a plunger 330a includ
and threaded through Outer tubing 12 proximally to the ing a deformable cylindrical mass 332, Such as Silicone,
aforementioned slit in the side wall 34 thereof, where they 60 molded over a retention head 334 (see FIGS. 7A and 7B). In
exit. Then a mass of UV-curable adhesive 32 is injected into this embodiment, the diameter of mass 332 may be slightly
the bore 30 of outer tubing 12 through each of adhesive fill less than that of plunger bore 316, or vent grooves 335 may
ports 44a and 44b extending through the side wall 34 of be formed in the plunger bore wall, the reason for which will
outer tubing 12 respectively adjacent apertures 42a and 42b be hereinafter explained. Further, if plunger 330a is
So as to encompass the entry points of pressure lumen tubing 65 employed, the inner end 336 of plunger bore 316 may be
20a and 20b and isolate the bore 30 of outer tubing 12 formed as a cone or other Suitable decreasing cross-sectional
therefrom (see FIGS. 4A and 4B). A suitable adhesive is UV shape, mass 332 being deformable thereinto responsive to
 US 6,447.462 B1
9 10
inward plunger movement to charge the air column between and moving plunger slide 350 using the thumb. It is also
transducer 308 and a balloon 22 with a small volume of air. notable that the air column between each transducer assem
Alternatively, a plunger 330b may be employed using an bly 300 and balloon or balloons 22 of a joined catheter 10,
o-ring seal 340 about the inner end thereof (see FIGS. 8A 100 or 200 may be vented, the monitor Zeroed, and the air
and 8B). Again, the outer end of the bore may be enlarged 5 column accurately and repeatably re-charged as desired
to allow venting past o-ring seal 340, or vent grooves 335 without removal of the catheter.
may be formed in the plunger bore wall. In use, a catheter Such as 10 or 100 is inserted into a
Saddle-shaped plunger slide 350 is disposed on the upper patient’s bladder 400 (see FIG. 9) through the urethra 402 by
portion of housing 302 and retained thereon by engagement techniques known in the art. Optionally, another, reference
of grooves 352 with tracks 354 of housing 302. The outer catheter 200 is inserted into the patient's rectum or vagina
end 356 of a plunger 330 extends through an aperture 358 in 404 (see FIG. 9), again as known in the art. After insertion,
housing 302 between tracks 354 in a transverse orientation the pressure lumens of each catheter are respectively con
thereto. With plunger slide 350 in a left-most “Zero” position nected to a transducer assembly 300 in the Zero, or venting
(as depicted in FIGS. 5A through 5E), plunger 330 is in its mode or position, the monitor associated with each trans
outward-most position resting against leading inner flat 360a 15 ducer assembly 300 zeroed, and then the balloons 22
of plunger slide 350, and the air column defined between charged by the aforementioned manipulation of plunger
transducer assembly 300 and a catheter 10, 100 or 200 is slides 350. The transducers are automatically zeroed with
vented to the ambient environment through the enlarged the transducer assembly 300 in the Zero, or venting mode, as
plunger bore portion or vent grooves 335. When plunger ambient atmospheric pressure acts on both Sides of Sensor
slide 350 is advanced to the right, as depicted in FIGS. 6A elements, Such as diaphragms, of the transducers, before the
through 6E, inclined leading inner face 360b of plunger slide air column is closed and charged. Thus, the air column
350 biases plunger 330 inwardly to close the air column and charge is thus referenced against ambient pressure. Bladder
charge it with a very Small Volume, for example 15 liters, filling may then be commenced through a fill tubing 14, with
of air, at which point plunger 330 resides under trailing inner attendant preSSure data being accumulated by a monitor or
flat 360c of plunger slide 350. With plunger 330a, mass 332 25
monitors to which transducer assemblies are 300 connected
is deformed into inner end 336 of plunger bore 316 so as to by cables 312, as known in the art. Other, conventional
reduce volume of the air column while effecting the charge maneuverS may be performed, Such as a VLPP study, again
by displacing air in inner end 336 of plunger bore 316 and as known in the art. AS bladder (or abdominal) pressure
closing off passage 314. With plunger 330b, o-ring seal 340 increases, deformation of a balloon 22 modifies pressure in
closes off the air column as it advances into the inner end of its associated air column, which is transmitted to the trans
plunger bore 316 inwardly of vent grooves 335 (or a ducer Sensor element, Such as a diaphragm, through the
narrower bore portion, as the case may be) and charges the preSSure lumen extending therebetween. Response of the
air column by displacing air trapped in inner end of plunger Sensor element to the pressure variation generates an elec
bore into passage 314. FIGS. 7A and 7B are enlarged views trical or other Signal which is relayed to a monitor through
of the plunger area of transducer block 304 with a plunger 35
the transducer cable 312.
330a respectively in Zero and charged positions, while If a UPP procedure is to be initiated, a catheter 10 carrying
FIGS. 8A and 8B are enlarged views of the plunger area of two balloons 22 will be used. As known in the art, urethral
transducer block 304 with a plunger 330b respectively in pressure will be measured during withdrawal of catheter 10
Zero and charged positions. from the bladder through the urethra using the most proxi
When the air column is charged, the balloon 22 becomes 40 mal balloon 22b, while bladder pressure is monitored using
at least partially filled with air, for example, 40% to 70% balloon 22a at the distal end 16 of outer tubing 12. As noted
filled, but not completely filled, to prevent the balloon previously, the circumferential envelopment of outer tubing
material from introducing artifact into a pressure reading. 12 of balloon 22b provides a pressure responsive element for
Thus, the flaccid, partially filled balloon 22 will prevent or effecting an accurate measurement of urethral pressure and
at least Significantly reduce the occurrence of aberrant 45 urethral Sphincter Strength and integrity regardless of Small
effects in pressure detection due to temperature changes as anatomical anomalies of the urethra. Further, the presence of
dictated by Charles Law, or other aberrant effects attribut any Such anomalies is more easily identified due to the
able to the balloon wall, or inadvertent, external balloon circumferential contact of the balloon 22b with the urethral
compression. The volume of air which respectively fills a wall than by prior art, Single reference, pin-point localized
balloon 22 and its associated pressure lumen 20 and trans 50 transducer elements Such as micro-transducers and fiber
ducer assembly 300 will vary, depending on balloon and optic transducers.
lumen length and internal diameter. However, it is preferred While the present invention has been described with
that the Volume of air in the air column is Such that at least reference to certain illustrated embodiments, those of ordi
fifty percent of the volume of air in the air column will nary skill in the art will recognize and appreciate that it is not
remain in balloon 22. The balloon will thus be sensitive to, 55 So limited. Accordingly, additions, deletions and modifica
and accurately transmit pressure from outside the balloon 22 tions to the embodiments of the invention as disclosed may
to the balloon interior 28 and, through the coupling provided be effectuated without exceeding the Scope of the invention
by the closed air column, to the transducer 308, without the as encompassed by the claims following hereinafter.
introduction of artifact from the balloon wall. In the dis What is claimed is:
closed embodiment wherein a 7 French diameter catheter 60 1. A catheter System for use in detecting pressure changes
outer tubing 12 is employed, charging the air column with within a body, comprising:
the aforementioned ~15 liters of air inflates a balloon 22 to an elongated tube having at least one lumen extending
about 0.105 inch diameter (8 French), which is believed to therethrough to a port located proximate a distal end
exhibit an accurate pressure response when employed in the thereof;
urethral anatomy. 65 a preSSure-compliant balloon element Secured to the elon
It is notable that plunger slide 350 may be manipulated by gated tube over the port and having an interior in
the clinician using a single hand by grasping housing 302 communication there with;
 US 6,447.462 B1
11 12
a pressure transducer removably operably coupled to a 12. The catheter system of claim 10, wherein the housing
proximal end of the at least one lumen and including a is sized and configured and the plunger Slide is placed on the
Sensor element in communication with an interior of housing in a position to permit manipulation of the plunger
the preSSure-compliant balloon element through the at Slide with a thumb of a hand grasping the housing.
least one lumen; and 13. A catheter for use in detecting pressure changes within
a charging Structure for displacing a Substantially prede a body, comprising:
termined Volume of air into an air column extending an elongated outer tubing element comprising a bore
between the pressure-compliant balloon element and defined within a circumferential side wall thereof;
the pressure transducer Sensor element through the at at least one elongated pressure lumen tubing element
least one lumen, the charging Structure being extending at least partially within the bore of the
configured, while the preSSure transducer is operably elongated outer tubing element, extending through the
coupled to the proximal end of the at least one lumen, side wall thereof proximate a distal end thereof and
to vent the air column to an ambient environment in a
defining a port opening onto the Side wall exterior;
first mode, and to close the air column and effect
displacement of the Substantially predetermined Vol 15 a cured adhesive mass disposed within the bore where the
ume of air in a Second mode. at least one elongated preSSure lumen tubing element
2. The catheter System of claim 1, wherein the charging extends through the Side wall, Securing the at least one
Structure includes a plunger longitudinally movable in a bore elongated pressure lumen tubing element in place and
in communication with the air column, the plunger and bore Sealing the bore from the Side wall exterior; and
being cooperatively configured to provide venting clearance a pressure-compliant balloon element circumferentially
between a Side of the plunger and an interior wall of the bore Surrounding the elongated outer tubing element,
in a first longitudinal plunger position, and to mutually Seal extending over the port of the at least one elongated
in airtight relationship in a Second longitudinal plunger preSSure lumen tubing element and Sealingly bonded to
position. the side wall proximally and distally of the port.
3. The catheter system of claim 2, wherein the venting 25 14. The catheter of claim 13, wherein the cured adhesive
clearance is provided by a portion of the interior wall of the mass is Selected from the group comprising a UV-curable
bore including a longitudinally extending groove therein. adhesive and an RTV adhesive.
4. The catheter system of claim 2, wherein the first 15. The catheter of claim 13, wherein the pressure
longitudinal plunger position comprises a relatively compliant balloon element is formed of a heat-shrink mate
retracted position, and the Second longitudinal plunger posi rial.
tion includes a relatively extended position. 16. The catheter of claim 15, wherein the pressure
5. The catheter system of claim 4, wherein an end of the compliant balloon element is Sealingly bonded to the Side
plunger received within the bore includes a deformable wall of the elongated outer tubing element by heat-induced
SS. contraction of ends of the pressure compliant balloon ele
6. The catheter system of claim 5, wherein at least a 35 ment about the elongated outer tubing element.
portion of an inner end of the bore contracts to a relatively 17. The catheter of claim 16, wherein a volume of the
Smaller croSS-Section, and the deformable mass is deformed preSSure-compliant balloon element has been Stabilized by
into the at least a portion of the inner end of the bore in the temperature elevation of the heat-shrink material.
Second longitudinal plunger position. 18. The catheter of claim 13, wherein the elongated outer
7. The catheter system of claim 4, wherein the plunger 40 tubing exhibits a durometer lower than a durometer of the at
includes a circumferential Seal thereabout. least one elongated preSSure lumen tubing element.
8. The catheter System of claim 4, wherein the charging 19. The catheter of claim 13, wherein the at least one
Structure further includes a movable plunger Slide engage elongated pressure lumen tubing element remains Substan
able with an outer end of the plunger to effect movement tially unsecured to the elongated outer tubing element
thereof between the first longitudinal plunger position and 45 between a location of the cured adhesive mass and an exit
the Second longitudinal plunger position. location of the at least one elongated pressure lumen tubing
9. The catheter system of claim 2, wherein the proximal element from the outer tubing element bore.
end of the at least one lumen, the charging structure and the 20. The catheter of claim 13, further including at least one
preSSure transducer Sensor element are in mutual commu fill tubing element extending at least in part through the bore
nication through passages in a manifold block housing the 50 of the elongated outer tubing element to a location proxi
bore, to which the preSSure transducer is Secured, and which mate the distal end thereof and in communication with an
includes a connector element configured for engagement exterior of the elongated outer tubing element through at
with a connector element at the proximal end of the at least least one aperture in the Side wall, the at least one fill tubing
one lumen. element passing through the cured adhesive mass and being
10. The catheter system of claim 9, wherein the charging 55 fixed in the bore thereby.
Structure and the preSSure transducer are Substantially con 21. The catheter of claim 20, wherein the at least one
tained within a housing on which is slidably mounted a elongated pressure lumen tubing element comprises two
plunger Slide positioned and configured to move the plunger elongated pressure lumen tubing elements extending
between the first longitudinal plunger position and the through the Side wall of the elongated outer tubing element
Second longitudinal plunger position. 60 at longitudinally Separated locations.
11. The catheter system of claim 10, wherein the plunger 22. The catheter of claim 13, further including:
Slide is oriented for movement Substantially transverse to an a pressure transducer removably operably coupled to a
orientation of the plunger and to traverse a path extending proximal end of the at least one elongated preSSure
over the plunger to effect movement of the plunger between lumen tubing element and including a Sensor element in
the first longitudinal plunger position and the Second lon 65 communication with an interior of the pressure
gitudinal plunger position by mutual contact of the plunger compliant balloon element through the at least one
Slide and the plunger. elongated pressure lumen tubing element, and
 US 6,447.462 B1
13 14
a charging Structure for displacing a Substantially prede housing in a position to permit manipulation of the plunger
termined Volume of air into an air column extending Slide with a thumb of a hand grasping the housing.
between the pressure-compliant balloon element and 34. The catheter of claim 23, wherein the plunger and bore
the pressure transducer Sensor element through the at are sized and cooperatively configured to provide a charge
least one elongated pressure lumen tubing element, the of ~15 uliters of air to the air column when the plunger is in
charging structure being configured, while the trans the Second longitudinal plunger position.
ducer is operably coupled to the proximal end of the at 35. The catheter of claim 34, wherein the elongated outer
least one elongated pressure lumen tubing element, to tubing element is of about 7 French diameter and the balloon
vent the air column to an ambient environment in a first element exhibits a diameter of about 8 French when the air
mode, and to close the air column and effect displace column is charged.
ment of the substantially predetermined volume of air 36. The catheter of claim 13, wherein the at least one
in a Second mode. elongated pressure lumen tubing element has an inner diam
23. The catheter of claim 22, wherein the charging Struc eter of about 0.005 to 0.010 inch.
ture includes a plunger longitudinally movable in a bore in 37. The catheter of claim 13, wherein the elongated outer
communication with the air column, the plunger and bore 15 tubing element has an outer diameter of about 7 French.
being cooperatively configured to provide venting clearance 38. A method for conducting a urodynamic procedure,
between a Side of the plunger and an interior wall of the bore comprising:
in a first longitudinal plunger position, and to mutually Seal inserting an end of a catheter carrying a pressure respon
in airtight relationship in a Second longitudinal plunger Sive element into a patient's bladder through the
position. patient's urethra;
24. The catheter of claim 23, wherein the venting clear at least partially inflating the pressure responsive element
ance is provided by a portion of the interior wall of the bore with air Such that the pressure responsive element is in
including a longitudinally extending groove therein. Substantially complete circumferential contact with an
25. The catheter of claim 23, wherein the first longitudinal interior of the urethra;
plunger position comprises a relatively retracted position, 25
and the Second longitudinal plunger position includes a adding fluid to the patient's bladder through the catheter
relatively extended position. to elevate bladder preSSure; and
26. The catheter of claim 25, wherein an end of the withdrawing the catheter from the patient’s bladder
plunger received within the bore includes a deformable through the urethra while measuring the bladder pres
SS. Sure and measuring urethral pressure using the pressure
27. The catheter of claim 26, wherein at least a portion of responsive element in Substantially complete circum
an inner end of the bore contracts to a relatively Smaller ferential contact with the interior of the urethra during
croSS-Section, and the deformable mass is deformed into the the withdrawal of the catheter.
at least a portion of the inner end of the bore in the Second 39. The method of claim 38, wherein using a pressure
longitudinal plunger position. 35 responsive element in Substantially complete circumferen
28. The catheter of claim 25, wherein the plunger includes tial contact with the interior of the urethra comprises using
a circumferential Seal thereabout. a balloon element extending circumferentially about the
29. The catheter of claim 25, wherein the charging struc catheter.
ture further includes a movable plunger Slide engageable 40. The method of claim 39, wherein measuring the
with an Outer end of the plunger to effect movement thereof 40 urethral pressure further comprises Substantially continu
between the first longitudinal plunger position and the ously transmitting air pressure in the balloon element
Second longitudinal plunger position. through a closed air column to a transducer located external
30. The catheter of claim 23, wherein the proximal end of to the patient while withdrawing the catheter.
the at least one elongated pressure lumen tubing element, the 41. A method of fabricating a catheter including at least
charging Structure and the pressure transducer Sensor ele 45 one preSSure
ment are in mutual communication through passages in a lumen and an associated balloon element, the method
manifold block housing the bore, to which the pressure comprising:
transducer is Secured, and which includes a connector ele forming an aperture in a Side wall of an elongated tubing
ment configured for engagement with a connector element at element proximate a distal end thereof;
the proximal end of the at least one elongated pressure 50
inserting an elongated pressure lumen tubing element of
lumen tubing element. Smaller diameter than the elongated tubing element
31. The catheter of claim 30, wherein the charging struc through the Side wall aperture into a bore of the
ture and the pressure transducer are Substantially contained elongated tubing element and threading the elongated
within a housing on which is slidably mounted a plunger preSSure lumen tubing element proximally through the
Slide positioned and configured to move the plunger, respon 55
bore to a desired location;
Sive to movement of the plunger Slide, between the first introducing an adhesive mass into the bore of the elon
longitudinal plunger position and the Second longitudinal gated tubing element to Surround the aperture and the
plunger position. elongated pressure lumen tubing element, and
32. The catheter of claim 31, wherein the plunger slide is
oriented for movement Substantially transverse to an orien 60 curing the adhesive mass.
tation of the plunger and to traverse a path extending over 42. The method of claim 41, further comprising:
the plunger to effect movement of the plunger between the removing a portion of the elongated pressure lumen
first longitudinal plunger position and the Second longitu tubing element extending through the aperture and
dinal plunger position by mutual contact of the plunger slide Outside the elongated tubing element;
and the plunger. 65 placing a sheath of heat-shrinkable material Over the
33. The catheter of claim 31, wherein the housing is sized aperture to extend distally and proximally therefrom;
and configured, and the plunger slide is placed on the and
 US 6,447.462 B1
15 16
heat-shrinking distal and proximal ends of the sheath to placing a Second sheath of heat-shrinkable material Over
Sealingly bond the ends to the distal and proximal the another aperture to extend distally and proximally
elongated tubing element to define a balloon extending therefrom; and
circumferentially thereabout. heat-shrinking distal and proximal ends of the Second
43. The method of claim 42, further comprising threading sheath to Sealingly bond the distal and proximal ends of
an elongated fill tubing element distally from a proximal end the Second sheath to the elongated tubing element to
of the elongated tubing element to a location proximate the define a Second balloon extending circumferentially
distal end thereof before introducing the adhesive mass. thereabout.
44. The method of claim 43, further including forming 46. The method of claim 45, further comprising subject
another aperture through the Side wall of the elongated 1O
tubing element at a location longitudinally Spaced ing the sheath and the Second sheath to an elevated tem
therefrom, inserting a Second elongated pressure lumen perature for a Selected period of time to Stabilize an internal
tubing element into the bore through the another aperture volume of the balloon and the second balloon.
and threading the Second elongated pressure lumen tubing 47. The method of claim 46, wherein curing the adhesive
element proximally to the desired location, introducing 15 mass and the another adhesive mass is effected by exposure
another adhesive mass into the bore of the elongated tubing to UV wavelength radiation.
element to Surround the another aperture and the Second 48. The method of claim 42, further comprising subject
elongated pressure lumen tubing element and curing the ing the Sheath to an elevated temperature for a Selected
another adhesive mass. period of time to stabilize an internal volume of the balloon.
45. The method of claim 44, further comprising: 49. The method of claim 41, wherein curing the adhesive
removing a portion of the Second elongated pressure mass is effected by exposure to UV radiation.
lumen tubing element extending through the another
aperture and outside the elongated tubing element; k k k k k
 UNITED STATES PATENT AND TRADEMARK OFFICE
CERTIFICATE OF CORRECTION

PATENT NO. : 6,447.462 B1 Page 1 of 1

DATED : September 10, 2002
INVENTOR(S) : Wm. Dean Wallace et al.

It is certified that error appears in the above-identified patent and that said Letters Patent is
hereby corrected as shown below:

Title page,
Item 56, References Cited, U.S. PATENT DOCUMENTS, change “4,019,505”
to -- 4,019,515 --.
Column 10
Line 25, change “are 300' to -- 300 are --

Signed and Sealed this

Twenty-third Day of December, 2003

JAMES E ROGAN
Director of the United States Patent and Trademark Office