U.S. patent application number 11/345015 was filed with the patent office on 2006-12-21 for endourethral device & method.
This patent application is currently assigned to AbbeyMoor Medical, Inc.. Invention is credited to John M. Reid, Mark J. Whalen, Lloyd K. Willard.
Application Number | 20060287570 11/345015 |
Document ID | / |
Family ID | 27401577 |
Filed Date | 2006-12-21 |
United States Patent
Application |
20060287570 |
Kind Code |
A1 |
Whalen; Mark J. ; et
al. |
December 21, 2006 |
Endourethral device & method
Abstract
Embodiments of adjustable length intraurethral devices intended
for patients with Lower Urinary Tract Symptoms (LUTS) are
disclosed. These devices are to be placed within the human urethra
and in communication with the bladder. Each device is easily
adjustable to accommodate the prostatic length and sphincteric
anatomy of the patient. Devices are stabilized in the urethra by
two anchoring elements. The first anchor is fluid filled and
positioned at the outlet of the bladder, and a second anchor is
mechanical and is located at the bulbous urethra. These are
separated by a structure which selectively supports a portion of
the urethra from closing without restricting the portion of the
urethra in the region of the external sphincter. These embodiments
provide for the regulation of the flow of urine from the bladder by
the natural control of the external sphincter when the user
desires.
Inventors: |
Whalen; Mark J.;
(Alexandria, MN) ; Willard; Lloyd K.; (Miltona,
MN) ; Reid; John M.; (Garfield, MN) |
Correspondence
Address: |
NAWROCKI, ROONEY & SIVERTSON;SUITE 401, BROADWAY PLACE EAST
3433 BROADWAY STREET NORTHEAST
MINNEAPOLIS
MN
554133009
US
|
Assignee: |
AbbeyMoor Medical, Inc.
|
Family ID: |
27401577 |
Appl. No.: |
11/345015 |
Filed: |
February 1, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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|
10059100 |
Jan 23, 2002 |
7108655 |
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|
11345015 |
Feb 1, 2006 |
|
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60263202 |
Jan 23, 2001 |
|
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60295535 |
Jun 4, 2001 |
|
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60329859 |
Oct 18, 2001 |
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Current U.S.
Class: |
600/29 |
Current CPC
Class: |
A61M 2210/1085 20130101;
A61M 2210/1089 20130101; F21W 2121/006 20130101; A61M 25/0017
20130101; Y10S 128/25 20130101 |
Class at
Publication: |
600/029 |
International
Class: |
A61F 2/00 20060101
A61F002/00 |
Claims
1-21. (canceled)
22. An endourethral stent adapted to deliver an effective amount of
therapeutic agent to a lower urinary tract, the endourethral stent
comprising a proximal anchor structure for cooperative engagement
with a bladder neck so as to prevent device migration toward a
bulbous urethra, a distal anchor structure for cooperative
engagement with at least portions of the bulbous urethra so as to
prevent device migration toward the bladder, a selectively
dimensionable body for selectively fixing a dimension corresponding
to a distance between said proximal and distal anchor structures,
said body including a segment adapted to permit physiological
external sphincter function.
23. The endourethral stent of claim 22 further comprising means for
selectively fixing said selectively dimensionable body of said
device.
24. The endourethral stent of claim 22 wherein said distal anchor
structure is non-rigidly linked to a portion of said selectively
dimensional body.
25. The endourethral stent of claim 22 wherein said distal anchor
structure non-rigidly extends from a portion of said selectively
dimensional body.
26. The endourethral stent of claim 22 further comprising a
non-rigid linkage, said non-rigid linkage connecting said distal
anchor structure to a portion of said selectively dimensional
body.
27. The endourethral stent of claim 26 wherein said non-rigid
linkage comprises a single suture.
28. The endourethral stent of claim 26 wherein said non-rigid
linkage comprises a configuration of multiple sutures.
29. The endourethral stent of claim 26 wherein said non-rigid
linkage includes a free end terminating at a retrieval tether of
said stent.
30. An endourethral device adapted to deliver an effective amount
of therapeutic agent to a lower urinary tract, the endourethral
device comprising a proximal anchor structure adapted to abuttingly
engage at least portions of a bladder neck so as to at least
proximally anchor said device, a selectively dimensionable body
extending from said proximal anchor, and a distal anchor structure
tethered to said body for engagement with a bulbous urethra.
31. The endourethral device of claim 30 wherein said body is
longitudinally compactable.
32. The endourethral device of claim 31 wherein said body includes
proximal and distal portions.
33. The endourethral device of claim 32 wherein said portions of
said body are adapted for cooperative engagement.
34. The endourethral device of claim 32 wherein said portions of
said body are selectively securable to each other.
35. A catheter apparatus comprising an endourethral stent assembly
and an insertion tool slidably receivable within a portion of said
endourethral stent assembly, said endourethral stent assembly
comprising a proximal anchor structure adapted to abuttingly engage
at least portions of a bladder neck so as to at least proximally
anchor said stent subsequent to delivery, a selectively
dimensionable body extending from said proximal anchor, and a
distal anchor structure tethered to said body for engagement with a
bulbous urethra subsequent to delivery.
36. The catheter apparatus of claim 35 wherein said insertion tool
includes a tubular element translatable within a sheath, said
tubular element having a proximal extremity adapted to deliver
fluid to a proximal end portion of said endourethral stent
assembly.
37. The catheter apparatus of claim 36 wherein said proximal
extremity of said tubular element includes sealing rings for
cooperative engagement with a proximal end portion of said
endourethral stent assembly.
38. The catheter apparatus of claim 36 wherein said proximal anchor
structure of said endourethral stent assembly includes at least a
single fluid fillable element.
39. The catheter apparatus of claim 38 wherein said sealing rings
of said tubular element traverse a fluid filling port of said at
least a single fluid fillable element.
40. The catheter apparatus of claim 36 wherein said selectively
dimensionable body of said endourethral stent assembly is
translatable upon said proximal extremity of said tubular element,
and said distal anchor structure of said endourethral stent
assembly is reversibly retained in a proximal extremity of said
sheath.
41. The catheter apparatus of claim 40 wherein said proximal
extremity of said sheath includes a push cup, at least a portion of
said distal anchor structure of said endourethral stent assembly
confined thereby.
42. An catheter apparatus comprising an endourethral device, a
retrieval system, and an insertion tool, said endourethral device
comprising a stent body having a proximal fluid fillable anchor
supported thereby, an expandable mechanical anchor non-rigidly
linked to said stent body, said proximal fluid fillable anchor
adapted to receive fluid via said insertion tool in furtherance of
anchoring said device at a bladder neck, said retrieval system
comprising a non-rigid tether having a first and second segments,
said first segment terminating in a plug received by said fluid
fillable anchor, said second segment passing through a portion of
said device.
Description
[0001] This is a continuing application filed under 37 CFR
.sctn.1.53(b) of a regular application Ser. No. 10/059,100, filed
Jan. 23, 2002 under 35 U.S.C. .sctn.111(a) claiming priority under
35 U.S.C. .sctn.119(e)(1), of provisional application Ser. No.
60/263,202, having a filing date of Jan. 23, 2001; provisional
application Ser. No. 60/295,535, having a filing date of Jun. 4,
2001; and, provisional application Ser. No. 60/329,859, having a
filing date of Oct. 18, 2001, all of which were filed pursuant to
35 U.S.C. .sctn.111(b), each of which being incorporated herein by
reference.
TECHNICAL FIELD
[0002] The present invention generally relates to medical devices,
more particularly to endourethral devices, and still more
particularly to endourethral devices having anchor structures which
permit the discharge of urine therethrough and/or there around.
BACKGROUND OF THE INVENTION
[0003] Urinary problems can have serious consequences, particularly
when the problem is one of retention, incomplete emptying, or
dysuria. Urine flow problems include urine retention, incontinence,
and difficult urination. Retention can result from any of a number
of causes, including without limitation, spinal cord injury,
typhoid, peritonitis, prostatic enlargement, urethral stricture,
urethritis, cystitis, bladder tumors, or urethral calculus.
Patients suffering from these and other conditions often require
some interventional means to periodically drain or augment drainage
of the bladder. Failure to do so can result in damage of the
epithelium and detrusor muscles associated with the bladder, and an
increased potential for bacterial invasion which is commonly
thought to contribute to urinary tract infection potentially
leading to life-threatening kidney failure.
[0004] Beyond notions of intervention, in roads are presently being
made in the area of office and office/home based monitoring of
patients for purpose of diagnosing the contribution of the
prostatic urethra to the outflow urodynamics. Differential
diagnosis is understood by accepting that there are three primary
anatomical organs which interact to contribute to the function of
urination. First the bladder, second the urethra, and third the
sphincter(s). The prostatic gland surrounds the urethra in the very
short segment between the bladder, at its outlet, and the external
sphincter. When the patient experiences symptoms of bother which
may be made manifest in several independent or co-existing
difficulties during urination, treatment is often sought.
[0005] For example, bothersome symptoms might include: (i)
incomplete emptying, (i.e., the patient is only able to urinate
small volumes, e.g. <100 milliliters (ml), or has an elevated
volume of urine left in the bladder following urination, e.g.
>100 ml. per attempt); (ii) frequent urges to urinate (i.e.,
experiencing a frequent feeling of needing to urinate by an
individual); (iii) intermittency (e.g. a patient's flow stops and
starts often during urination); (iv) has a very weak and
inconsistent urine flow stream; (v) stress incontinence (e.g.
leaking during lifting or straining as a result of excessive urine
in the bladder or weakened sphincters. With the exception of stress
incontinence, each of these may contribute to nocturia (i.e., poor
sleep due to the repeated need to urinate during the night), yet a
further symptom.
[0006] Up to two million office visits annually in the United
States are attributed to patients being bothered by some form of
lower urinary tract symptoms (LUTS). As previously noted, there are
two primary organs, and the prostate, involved with the event of
urination. The symptoms are virtually always suspected to be caused
by the intrusion of an enlarged prostate gland upon the urethra,
however, symptoms are often caused by irregularities in bladder
function, or sphincter deficiencies. For this reason, bladder
outlet obstructions (BOO) is a major subgroup of LUTS. In men
between the ages of 55 and 75 years, it is estimated that between
50 and 75% have some degree of bladder outlet obstruction, however,
it may not be responsible for their symptoms.
[0007] Bladder outlet obstructions are primarily caused by the
enlargement of the prostate gland (e.g., benign prostate
hyperplasia (BHP)) which results in radial compression of the
urethra surrounded thereby (i.e., the prostatic urethra), thus
obstructing (i.e., constricting) urine flow, resulting in
incomplete emptying of the bladder (i.e., there being what is
clinically referred to as a "post void residual" (PVR) remaining in
the bladder). Heretofore, males presenting with LUTS have few
diagnostic options prior to either long term pharmacological, or
invasive irreversible medical procedures such as trans urethral
resection of the prostate (TURP), or non-surgical procedures such
as thermal treatment of the prostate.
[0008] It is well known within the urological community that
significant numbers of men undergoing treatment for prostate
disease have sub-optimal results. According to Bruskewitz, BPH can
be discussed in terms of prostatic enlargement, outlet obstruction
and LUTS. Jepsen J. V. and Bruskewitz R. C., Comprehensive Patient
Evaluation for Benign Prostatic Hyperplasia, 1998, Urology 51
(A4):13-18. In addition to the usual factors believed to lead to
prostate induced LUTS (e.g., enlarged prostate and increased
prostate muscle tone) other conditions of the lower urinary tract
impact male voiding and need to be considered. Bruskewitz stated
that a large part of the symptomotology of BPH might be explained
by bladder dysfunction.
[0009] Bladder conditions that are prevalent in men with LUTS,
either separately or in combination with outlet obstruction,
include detrusor instability and detrusor hypocontractility. Kaplan
S. A. and, Te A. E., Uroflowmetry and Urodynamics, 1995, Urologic
Clinics of North America 22 (2):309-320. In a population of 787 men
with symptoms of prostatism, Kaplan found that 504 (64%) had
demonstrable prostatic urethral obstruction, of which 318 had
concomitant detrusor instability. In the group, 181 had detrusor
instability as their sole diagnosis. Impaired detrusor
contractility was present in 134 (17%) and 49 of these had impaired
detrusor contractility as their only diagnosis. Bruskewitz and
others have also shown that a significant number of men with LUTS,
including those who receive definitive treatment, are unobstructed.
Abrams P., In Support of Pressure Flow Studies for Evaluating Men
with Lower Urinary Tract Symptoms, 1994, Urology 44 (2): 153-55.
Patient satisfaction rates after definitive prostate treatment vary
from 100% to 75% or less. In some cases the lack of success may be
related to unidentified bladder dysfunction. Bruskewitz concluded
that bladder dysfunction should receive more attention (in the
evaluation and treatment of LUTS) and better measures should be
developed to quantify it. Presently, urodynamic methods to assess
bladder outlet obstruction generally include uroflow testing,
pressure flow testing and general patient history/examination.
[0010] Uroflow testing provides information about the combined
contribution of the detrusor and urethra to uroflow. The limitation
of uroflow testing is that it is not possible to determine with
certainty in all cases whether a low flow and a poor voiding
pattern are secondary to outlet obstruction, detrusor
hypocontractility or a combination thereof. Further, the test can
be problematic because it is only a single event that can be
influenced by patient factors such as anxiety and performance of
the test (i.e. direction of the urine steam into the collecting
reservoir). Abrams found that the success rate was only 70% when
uroflow was used to select patients for surgery. Abrams P. H.,
Prostatism and Prostatectomy: The Value of Flow Rate Measurement in
the Preoperative Assessment for Operation. J. Urol 1977,
177:70-71.
[0011] Pressure flow testing can be used to define outlet
obstruction and, in addition, provides information about the
contractility and performance of the bladder. The pressure flow
test, however, is not much more successful in predicting success of
treatment, as defined by the patient, than uroflow (75% v 64%).
Jepsen J. V. and Bruskewitz R. C., Comprehensive Patient Evaluation
for Benign Prostatic Hyperplasia, 1998, Urology 51 (A4):13-18.
Therefore the urological community as well as the Agency for
Healthcare Policy & Research (AHCPR) do not find justification
for its routine use.
[0012] Finally, the standard work-up of patients with LUTS being
evaluated for bladder outlet obstruction generally consists of
history and physical examination, including assessment of prostate
volume, PSA, uroflow testing, quality of life, and symptom and
bother index. Based on the results, treatment decision are made.
Using these evaluations underlying problems with bladder function
cannot be detected.
[0013] In lieu of traditional urodynamic test methodologies such as
the use of video urodynamics simultaneously with the holding and
release of urine, cystometry, urethral pressure profiling,
ultrasonic volume assessments (i.e., PVR), and uroflowmetry, each
of which address the filing/emptying conditions (i.e., dynamics) of
the bladder, endourethral devices and accompanying methodologies
have been developed specifically to ascertain the nature of the
BOO. For instance by permitting the structures of the lower urinary
tract to physiologically act in a sequential and incremental manner
upon portions of a device during a natural micturition event, an
observable change in fluid dynamics in furtherance of lower urinary
tract symptoms diagnosis may be noted.
[0014] Devices have been developed to be positioned in the urethra
and/or bladder to correct the problems of urine flow. Problems and
disadvantages of heretofore known devices include the deleterious
effects (i.e., pitting, depositions, etc.) associated with the
urethral environment upon critical device components (e.g., valve
actuators, flow conduits, etc.) which at a minimum render such
devices less effective, and which at a maximum, cause device
component failure or render the device wholly ineffective, which
necessitates emergent removal and, as the case may be, urinary
tract damage repair. Problems of device leakage, or less than
complete emptying of the bladder are also widely known.
Furthermore, issues surrounding device deployment and fit,
positioning, repositioning, and retention (i.e., sufficient
anchoring) have also been well documented.
[0015] It is especially critical that the endourethral device be
stable with respect to position (i.e., a physiologically properly
deployed and stable position), and comfortable to wear, as the
urinary tract is sensitive to contact. Inter-urethral stents have
been utilized within the male urethra within the prostatic region
with many users foregoing such devices for alternate therapies due
to feelings of discomfort and/or pain. Many endourethral devices
have similarly been evaluated for urinary incontinence for females.
Based upon clinical findings, many have been shown to be
uncomfortable, thus severely retarding their utility as a therapy.
Other devices have migrated into the bladder, or have been expelled
under straining conditions.
[0016] Furthermore, it is imperative that the device be no more
invasive as is necessary. For instance, it is advantageous that the
device minimally engage the structures of the lower urinary tract,
particularly in accomplishing an anchoring function. For example,
it is well known that secretions of the prostatic urethra,
including the Cooper's gland, whether during sexual function or
otherwise, is clinically beneficial, the secretions are comprised,
in part, of antimicrobial agents which assist in the prevention of
urinary tract infections. It is further believed that bathing of
the bladder neck with urine assists infection prevention.
Generally, flow of urine external of an endourethral device permits
the free passage of urinary tract fluids from the urethra as urine
is released, thereby allowing a more physiologically normal urine
discharge. Thus, whether it be a short or long term endourethral
device, for interventional, diagnostic or other purpose, stable
anchoring in combination with physiologically proper, non-traumatic
device deployment and retention is essential.
SUMMARY OF THE INVENTION
[0017] The adjustable urethral device of the subject application,
in all its embodiments, enables a clinician to reduce inventory
requirements, and allows for precise fitting to the patient's
needs. Urologists are increasingly finding great utility in fitting
the patient accurately. This precise fitting will enhance the value
of the use of lower urinary tract flow control apparatus. While
adjustments have been described in several specific manners, it may
be easily appreciated by those skilled in the art that adjusting
either the threads which "span" the proximal element and the tube,
or the length of the proximal tubes, adjustments may be
accomplished which enhance the utility and methodology of the use
of the device. Further, it may be appreciated that a fixed length
proximal tube which passes through at least 40% of the prostatic
urethra coupled with adjustable threads cooperatively will provide
for a suitable device in many patients. It may be further
appreciated that when incorporating the previous applications, that
a variable length flow around device may be easily accomplished
when the proximal support structure which is analogous in
anatomical location during use with the tubes may be enabled by
either allowing it to telescope, or changing the thread
lengths.
[0018] Accordingly, it is an objective of the invention to provide
additional device and procedural options for the care and diagnosis
of patients who present to the urologist with lower urinary tract
symptoms (LUTS).
[0019] For each user, there are two inter-dependent parameters
which may be easily measured in order to gain an increased
understanding of the patients urodynamic status. First, the post
void residual (PVR). Increased PVR will occur when there is either
hyperplasia (i.e., thickening) of the prostatic gland, or a bladder
that is not functioning properly due to decompensation of the
muscular function. Secondly, the flow rate of urine during emptying
of the bladder is a strong indicator of the function of the bladder
when obstruction due to the prostate is not present.
[0020] The device of all embodiments provides and allows patients
to empty their bladders in a natural way and will assist in the
reduction of PVR in patients with obstructed urethras due to an
enlarged prostate if the prostate is the sole factor, as it often
is. All embodiments provide relatively unrestricted passage of
urine from the bladder to that location. Simple placement of these
devices allows for a urologist to easily determine whether
prostatic hyperplasia is the cause of the LUTS.
[0021] Each of the devices and methods of use are for individuals
with sufficient bladder contractility, and offer a high probability
of reducing PVR. Reducing the PVR will in many instances further
result in relief from sleep deprivation and reduce the risk of full
retention. This diagnostic utility is provided when the user has
experience with an unobstructed prostatic urethra. The change in
his symptoms will assist greatly in confirming whether an enlarged
prostate is the cause of his symptoms. If the symptoms persist
after the prostatic urethra is supported open, it is unlikely that
he will benefit from a trans-urethral resection procedure (TURP),
or alternative therapies. In this situation the source of his
problems may be bladder or sphincter related.
[0022] The devices of these embodiments are easily placed into the
patient without the necessity for external visualization such as
rectal or abdominal ultrasound. Though these visualization methods
are available to the urologist or physician, it is undesirable to
use them because of cost and/or discomfort to the patient. The
devices of all the embodiments may be installed in similar fashion
to a Foley catheter by simply inserting the device, inflating the
proximal anchor, withdrawing the device into the bladder outlet,
and removing the insertion device. This provides further utility
for a patient who is has excessive symptoms of being obstructed, or
is in danger of going into a state of urinary retention due to use
of drugs such as antihistamines, or having had a recent
surgery.
[0023] Finally, the following U.S. patents, printed publications or
provisional applications are noted, and incorporated herein by
reference: 60/168,306 (see U.S. Pat. No. 6,551,304); 60/179,038
(see U.S. Pat. Nos. 6,527,702, 7,001,327); 60/223,345 (see US
2003/0208183 A1); 60/229,143 (see U.S. Pat. No. 6,719,709);
60/259,809; 60/263,202 (see US 2002/0107540); 60/264,700 (see U.S.
Pat. No. 6,719,709); 60/265,535 (see US 2002/0107540); and,
60/299,973 (see US 2002/0198506 A1).
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] FIG. 1 schematically depicts the human male urinary bladder
and urinary passage;
[0025] FIG. 2 illustrates an endourethral device of the subject
invention, particularly showing "flow by" proximal and distal
anchor systems;
[0026] FIG. 2A is a section view of the device of FIG. 2 taken
about line 2A-2A, more particularly, a sectional view of the
proximal anchor of same;
[0027] FIG. 3 is a longitudinal cross section of an alternate
embodiment of the device of the subject invention, the anchor
elements in extension;
[0028] FIG. 3A is a section view of the device of FIG. 3 taken
about line 3A-3A, more particularly, a sectional view of the distal
anchor of same;
[0029] FIG. 4 is a view of the device of FIG. 3, the anchor
elements in retraction;
[0030] FIG. 5 illustrates an alternate embodiment of the
endourethral device of the subject invention, particularly
illustrating a distal mechanical anchor, a proximal anchor element
in extension;
[0031] FIG. 6 is a view of the device of FIG. 5, the proximal
anchor element in retraction;
[0032] FIG. 7 illustrates an alternate embodiment of the
endourethral device of the subject invention, particularly
illustrating a distal mechanical anchor along with a proximal
anchor element in extension, lateral flow permitted;
[0033] FIG. 7A is a section view of the device of FIG. 7 taken
about line 7A-7A;
[0034] FIG. 8 illustrates a side view of the device of a further
embodiment;
[0035] FIG. 8A illustrates the device of FIG. 8 with the length
adjusted and secured;
[0036] FIG. 9 illustrates a side view of the device of yet a
further embodiment with the length adjusted and secured;
[0037] FIG. 10 illustrates a side view of an insertion/inflation
tool employed in the introduction of the devices of the previous
figures;
[0038] FIG. 11 illustrates the preparation of the proximal portion
of the insertion/inflation tool;
[0039] FIG. 11A illustrates the preparation of the distal extremity
of the proximal tubular body;
[0040] FIG. 12 illustrates the preparation and loading of the
distal anchor into the insertion/inflation tool;
[0041] FIG. 13 illustrates the prepared assembly prior to insertion
into the urethra;
[0042] FIG. 14 illustrates the distal portion of the
insertion/inflation tool; and,
[0043] FIG. 15 illustrates a representative urethral device of the
subject invention in situ.
DETAILED DESCRIPTION OF THE INVENTION
[0044] A schematic of the human male urinary bladder and urinary
passage (i.e., the lower urinary tract) is presented in FIG. 1. The
bladder 30 temporarily stores urine 32 and periodically expels it
when the bladder neck 34 opens, as the bladder 30 contracts. Urine
32 passes through the prostatic urethra 36, which is completely
surrounded by the prostate 38. The distal limit of prostate 38 is
marked by a small projection called the verumontanum 40. This is a
important landmark because distal thereto, is the external urethral
sphincter 42, which relaxes soon after the urination process
begins. Beyond this is the urethra 44, affording a free passage of
urine 32 external to body, beyond the external urethral meatus
46.
[0045] Generally referencing FIG. 2 (see also FIGS. 3, 5, and 7-9
having reference numerals +600, +700, +800, +900, and +1000
respectively, for like structures), there is shown an endourethral
device 50 which generally comprises an elongate member 52 having
proximal 54 and distal 56 segments, the elongate member 52 being
positionable within the lower urinary tract so as to at least
partially traverse the prostatic urethra. A proximal anchor 58,
adapted to preferably abuttingly engage portions of the bladder
neck so as to at least proximally anchor the device, is supported
at least indirectly by the proximal segment 54 of the elongate
member 52. The proximal anchor 58 includes bladder engaging
elements 60 radially extending from a portion of the proximal
segment 54 of the elongate member 52, urine being freely
dischargable about at least the proximal segment 54 so as to
substantially bathe the bladder neck therewith. Preferably, but not
necessarily, the bladder engaging elements 60 radially extending
from a body 64 of the proximal anchor 58 such that urine is freely
dischargable about or around an exterior surface of the anchor body
64. A distal anchor 62, adapted to engage portions of the bulbous
urethra so as to at least distally anchor the device, is supported
by at least a portion of the distal segment 56 of the elongate
element 52. The elongate member 52, may alternately be interposed
(FIG. 3), or at least indirectly extend (FIGS. 5 & 7) between
proximal and distal anchor elements or structures, as will be
subsequently described.
[0046] As may be apparent from the aforementioned description, it
is to be understood that the configuration or overall structure of
the elongate member is highly variable, being dependent upon the
sought after functionality of the endourethral device (i.e., the
physiological condition being diagnosed and or treated). In an
interventional setting, the elongate member generally provides a
degree of support to assure patency of an intact but contracted
lumen, see for example published PCT Application No. PCT/US01/24817
entitled ENDOURETHRAL DEVICE & METHOD, incorporated herein by
reference (see WO 02/087412). Alternately, in a diagnostic setting
for instance, the elongate member may comprise a selectively radial
responsive segment for engagement with a portion of the urethra,
namely the prostatic urethra. The radial responsive segment or
diaphragm possesses a dual functionality, namely selective inward
and outward radial responsiveness, in furtherance of qualitatively
and/or quantitatively assessing fluid pressure and/or fluid flow
through portions of the lower urinary tract, and memorializing the
nature of the urethral structures (i.e., the architecture of the
prostatic urethra and the relationship between the structures
thereof) as by obtaining a casting, respectively, see for example,
U.S. Pat. No. 6,719,709 entitled DIAGNOSTIC URETHRAL ASSEMBLY &
METHOD, incorporated herein by reference, now U.S. Pat. No.
6,719,709.
[0047] Referring now to FIGS. 2 & 2A, the endourethral device
(i.e., stent) shown includes a distal anchor 62 adapted to engage
portions of the bulbous urethra, and a proximal anchor 58 adapted
to abuttingly engage the bladder neck, the anchors being linked by
a support element or structure 52. As aforementioned, form fits
function relative to the elongate member or central segment of the
endourethral device, in this instance a support element which
includes a structurally supportive body 66 which is preferably coil
wound of 0.012 inch round stainless steel which has been silicone
encapsulated. A fluid conduit 68, to facilitate expansion of the
reversibly expansive bladder engaging elements 60, distally extends
along a longitudinal device axis from a filling manifold 70 to
distal anchor 62. Emptying of the fluid system is accomplished by
removing a plug 72 from a drain port 74 integral to at least the
distal segment 56 of the elongate member 52, consistent with the
methodology and structures described in published application
serial no. PCT US01/24817, previously cited.
[0048] A tensile member 76 preferably extends adjacent the support
body 66, shown parallel with fluid conduit 68, but is not limited
to such arrangement. The tensile member 76 may extend directly
adjacent fluid conduit 68, or alternatively, be wrapped around the
perimeter thereof. As may be appreciated, the tensile member 76 may
be surplusage (i.e., redundant), being eliminated when fluid
conduit 68 is sufficiently rigid or adequately reinforced. In the
preferred architecture of this device, the tensile member is
compressible along the longitudinal axis under a relatively light
force, however, the tensile member may also be constructed of a
material which is relatively stiff axially such as stainless steel
wire.
[0049] The proximal anchor 58 generally includes body 64 and
bladder engaging elements 60 radially extending therefrom. In
contradistinction to heretofore known bladder discharge aides,
urine may be released from the lowest part of the bladder, often
referred to as the bladder neck, urine being freely dischargable
about/around an exterior surface of the body (i.e., a lateral flow
condition) so as to substantially bathe the bladder neck.
[0050] The lateral urine flow path permitted by the proximal
anchor, and the distal anchor as will later be presented, is
beneficial for several reasons. First, the urine may more freely
contact the bladder neck and bathe it. Second, the retained volume
within the bladder is reduced following a urination event. Third,
an internal passageway does not limit flow of urine to its
boundaries. Urine may act in cooperation with the urethra. This is
important. As an individual ages, the bladder function may weaken
as a result of prostatic obstruction, or independently. The bladder
micturition cycle is a work limited event. The muscle only
contracts until it has spent the energy that is available to it.
When the energy is spent, the muscles have tired, and will stop
contraction regardless of the volume of urine remaining in bladder.
This remaining urine is referred to as the post void residual
(PVR), giving rise to at least two further implications. A high PVR
requires a sooner return to the bathroom. If this is during
sleeping hours, it will result in incomplete sleep and the
deleterious effects associated therewith. Furthermore, a high PVR
is widely viewed as contributing to at least the susceptibility to
urinary tract infections.
[0051] The bladder engaging elements 60 of the proximal anchor 58
are advantageously circumferentially spaced apart about the surface
of the anchor body 64. Preferably, but not necessarily, the
engaging elements 60 are opposingly paired (FIG. 2A), but need not
be so limited. It is further advantageous that the bladder engaging
elements 60 be resilient, and preferably, be reversibly expandable
(e.g., the bladder engagement elements 60 may be opposingly paired
balloons as depicted in FIG. 2/2A). Preferably, the bladder
engaging elements 60 are torpedo shaped when un-deflected by
contact or otherwise unencumbered, this shape contributing only a
minimum of flow resistance when properly filled. As is readily
appreciated, low resistance is a critical consideration with
respect to proper stable device placement within the lower urinary
tract.
[0052] The interface of the resilient bladder engaging elements 60
relative to the anchor body 64, or proximal segment 54 of elongate
member 52, along with the methodology and structure (i.e.,
insertion/filling tool) for reversibly deploying such endourethral
device, or devices of this style, is generally disclosed in
published PCT Application No. PCT US01/24817. Any modification or
adaptation to accommodate the nature (i.e., structural) of the
contemplated endourethral device is considered within the skill of
a person of ordinary skill in the art.
[0053] The proximal anchor 58 further includes at least a pair of
urine flow channels 78, each of the channels being defined or
otherwise delimited by adjacent bladder engaging elements 60, see
especially FIG. 2A. The urine flow channels 78 provide for high
volumetric flow rates, and relatively complete bathing of the
urethra with urine (i.e., the notion of device flow about or around
a/k/a lateral flow). Urine flow is initiated when the external
sphincter is dilated by the natural function of the body at the
users initiation. As will be later generally detailed with respect
to FIGS. 3-4, the distal anchor 62 may, as in the device of FIG. 2,
have elements, and interrelationships therebetween, which
substantially corresponding to those of the proximal anchor 58.
[0054] With continued reference to FIG. 2A, which illustrates the
endourethral device in situ as viewed axially from proximal
extremity 80, proximal anchor 58 secures the urethral device 50
from moving into the urethra (not shown in this view). The elongate
member 52 may be advantageously provided with a passageway or lumen
82 to allow for introductions of fluids such as drugs, or
antiseptics, or for filling the bladder by an insertion/inflation
tool. This optional passageway may be closed or open following
device insertion, however, it is preferable that the device of FIG.
2 have a closed passageway following removal of insertion device,
the closure limiting the area available for static urine to form
encrustation.
[0055] Referring now to FIGS. 3/3A & 4, an endourethral device
650, similar in general arrangement to that shown in FIG. 2 (i.e.,
having a common proximal anchor feature and elongate member
comprising a helical support element), is shown incorporating a
distal flow around anchor mechanism 662. The distal anchor 662
preferably, but not necessarily, includes a body 665 and urethral
engaging elements 661 extending therefrom. More particularly, the
urethral engaging elements 661 are circumferentially disposed, in a
spaced apart condition, about an exterior surface of the distal
anchor body 665, the elements 661 being radially extendible
therefrom. The distal anchor 662 further includes at least a pair
of urine flow channels 678, each of the channels 678 being
delimited by adjacent urethral engaging elements 661. It should be
readily appreciated that anchoring of an endourethral device may be
satisfactorily accomplished by a proximal segment 654, distal
segment 656, or a sharing of anchor function between each.
[0056] Endourethral device 650 has a proximal extremity 655 and a
distal extremity 657. FIG. 3 illustrates device 650 having proximal
anchor member 664 and distal anchor member 662 in a "filled"
condition (i.e., the anchor elements 660, 661 of the device are in
extension) whereas FIG. 4 illustrates device 650 without fluid in
proximal anchor member 664 or distal anchor member 662 (i.e., the
anchor elements 660, 661 of the device are in retraction). FIG. 3A
is a centerline cross section of distal anchor member 662 of FIG. 3
illustrating filling conduit 668 in fluid communication with the
interior of distal anchor 662. As may be appreciated, urine may
easily flow adjacent distal anchor body 665 within the bulbous
urethra. This particular device 650 may be best described in four
sequentially aligned zones, namely, moving distally from the
proximal end of the elongate member, zones I, II, III, and IV.
[0057] A passageway 682 extends through a first zone I from orifice
684 of the proximal end 654 of the elongate member 652. A second
zone II, which dwells in the prostatic urethra consists of an open
structure, namely an open pitched coil, which continues within a
wall of the proximal portion 654 of the elongate member 652, and
terminates by or in unified construction or attachment to a tensile
member 676 (zone II) which further terminates in the distal zone IV
containing anchor member 662. The tensile member 676 also converges
or attaches to the extremity of proximal segment 654 for safety.
The internal fluid communication between the first zone I and the
distal anchor 662 is accomplished through conduit 668 which is
shown axially separate from tensile member 676 though they are
preferably in close proximity, or the same element.
[0058] The open structure of this endourethral device allows for
the urine to contact the wall of the urethra and flow along the
urethra as it drains. This has the beneficial effect, as likewise
achieved via the structure of FIG. 2, of allowing for the natural
secretions from the prostatic gland into the urethra to participate
in their natural environment. These secretions are known to be
beneficial as natural infection inhibitors as well as participating
in sexual functions. Tensile member 676 is preferably constructed
of a silicone coated silk suture material, or alternatively of a
more rigid material such as a coated stainless steel wire.
[0059] Referring now generally to FIGS. 5-9, a mechanical distal
anchor 762 is illustrated for an endourethral device, more
particularly a wing type structure is shown tethered to an elongate
member of an endourethral device. As emphasized throughout, a
variety of devices may advantageously integrate the new anchor
structures of the subject invention, singularly or in combination.
For instance, the device of FIG. 5 illustrates heretofore known
proximal anchoring in combination with mechanical anchor 762. In
this style device, a circumferentially disposed bladder (shown
uninflated in FIG. 6) is carried about the outer surface of a
proximal portion of the elongate member for fully engaging a
portion of the bladder neck. Proximally of the proximal anchor, the
proximal portion of the elongate member is adapted, as via the
inclusion of an aperture or plurality of same, to receive urine for
passage interiorly of the elongate member (e.g., a tubular
element). The device of FIG. 7 depicts an endourethral device
having the flow around or lateral flow proximal anchor as shown and
previously described with respect to FIG. 2.
[0060] Referring again generally to FIGS. 5-9, the distal anchor
762 (FIGS. 5 & 6, or 862 (FIG. 7/7A), 962 (FIG. 8/8A), 1062
(FIG. 9),) generally includes a body 765 having urethral engaging
elements or portions 761 extending or depending therefrom, or
otherwise integral thereto. As is readily appreciated by a review
of the figures, the distal anchor element 762 is of particularly
low profile (i.e., an insubstantial hindrance to urine discharge),
being reversibly expanded following deployment (e.g., by discharge
from an insertion tool or the like). The mechanical anchor
preferably tapers toward a distal end thereof, such configuration
aiding the retrieval of the mechanical anchor as will be
discussed.
[0061] The distal anchor member 762 preferably, but not
necessarily, includes a silicone encapsulated spring strut 786, or
particular arrangement of struts or strut segments, either directly
or indirectly extending from a central hub 788. When resiliently
expanded, as for instance post deployment, the struts 786 expand to
discretely engage portions of the urethral wall. In the
configuration of FIG. 7A, it is noted that a portion of the
elongate member 852 possesses a cruciform cross-section resulting
from radially extending circumferentially spaced apart ribs
863.
[0062] Referring to FIG. 8, urethral device 950 is illustrated as
an assembly. Urethral device 950 has a proximal extremity 955 and a
distal extremity 957. Near the proximal extremity 955 is a port
984. Balloon 960 is located distal of port 984 on the extremity of
tubular body 966. A second slidable tubular body 966a is oriented
around the outer periphery of tubular body 966. In the subject
embodiment, tubular body 966a is configured with at least one set
of openings 969a for registration with a series of spaced apart
openings 969 of tubular body 966. The openings are provided for
easy fixation of the tubular body 966a with the slidable tubular
body 966 using suture 971 or the like to secure the body
elements.
[0063] Securing threads 977 are tied and encapsulated near the
distal extremity 957, and extend to the distal anchor 962. These
threads may be provided either pre-tied to provide a fixed initial
length, or adjustable to provide the physician the ability to
adjust per his measured requirements. Distal anchor 962 is
mechanical in nature, lacking inflatable components, compare with
the embodiment of FIGS. 3/4. It should be easily and readily
appreciated that this adjustment mechanism and technique may be
imported to other endourethral devices, and more generally, other
known indwelling medical devices.
[0064] The anchor 962 is expanded, as illustrated, following
deployment via encapsulated spring strut 963. When expanded, distal
anchor 962 is approximately semi-circular at its expanded
perimeter, and triangular longitudinally. Retrieval tether 993 is
fixed to the distal extremity 957. Retrieval suture 990 is further
joined to drain tether 992, which terminates in a drain plug 995,
and removal tether 993. The mechanism and functions of the tethers
are fully explained in the co-pending applications previously
cited, and will not be further explained in this document.
[0065] Urethral device 950 of FIG. 8A is shown fixed in length.
When the slidable tubular body 996a has been moved longitudinally
along the extremity of tubular body 996 such that a select, proper
length is achieved, securing is accomplished by looping suture 971
through the passageway 969a in the outer slidable tubular body
966a, through passageways 969 in tubular body 966 and securing the
suture ends. This results in a fixation of the body length.
Alternatively, the length may be mechanically fixed using fasteners
or mechanical retainers, as shown in U.S. Pat. No. 6,991,596,
incorporated herein by reference. It may be appreciated that
practicing urologists are also surgeons who are well accustomed to
tying secure knots. For this reason, passageways 969 may be
optionally removed for certain models when the urologist chooses to
make his own passageways with a needle. This will not change the
intent and or scope of this invention. Alternatively, the length
may be mechanically fixed using fasteners or mechanical retainers
such as clips, staples, or locking devices.
[0066] The tubular body 966 and the slidable tubular body 966a are
constructed from medical grade silicone material. These tubular
bodies may be comprised of two separate tubular entities, or
conversely single prolapsing construction. The interior of both
tubes may be optionally reinforced to provide increased resistance
to collapse. Suitable reinforcements include stainless steel coils
or other means. The tubular bodies are preferably medical grade
silicone or other suitable materials such as for example
polyurethanes commonly used in urology applications.
[0067] Referring to FIG. 9, a further, non-limiting adjustable
architecture is illustrated. Urethral device 1050 is illustrated
with tubular body 1066, and second outer tubular body 1066a.
Urethral device 1050 is similar in function to urethral device 950
(FIG. 8), with the variation in that tubular body 1066a is
configured with an internal helical pattern, which cooperates with
tubular body 1066. The body length is thereby adjusted by rotating
one of the tubular bodies relative to the other.
[0068] Like the previous embodiment, when the "slidable" tubular
body 1066a has been moved longitudinally along the extremity of
tubular body 1066 such that a select, proper length is achieved,
securing is accomplished by looping suture 1071 through the
passageways 1069a in the outer slidable tubular body 1066a, through
passageways 1069 in tubular body 1066 and securing the suture ends.
This results in a fixation of the body length.
[0069] The tubular body 1066 and the "slidable" tubular body 1066a
are constructed from medical grade silicone material. The interior
of both tubes may be optionally reinforced to provide increased
resistance to collapse. Suitable reinforcements include stainless
steel coils or other means.
[0070] Referring to FIG. 10, an insertion tool 200 is illustrated
for deploying the contemplated devices of the subject invention,
with the combination illustrated in FIG. 13. Insertion tool 200 has
a proximal extremity 202 and a distal extremity 204. Sealing rings
206 are intended to engage an interior surface of the proximal
portion of the device as will later be explained. Anchor sleeve
208, which encapsulates a portion of elongate tube 210, restrains
the distal anchor of the device within the interior of the tubular
housing 212, and adjacent push cup 213, during device insertion or
deployment. The elongate tube 210 is movable relative to tube 214
which is advantageously lined with coil 216. This movement is
controlled from the proximal extremity, more particularly, via
needle tip 218 of fluid filling port 219 as it is moved relative to
barrel handpiece 220.
[0071] The following instructions for use describe an advantageous
clinical use sequence. Preliminarily, remove the packaged urethral
device and insertion/inflation tool; inspect the device and tool
for damage; verify that balloon plug of the device is in place;
and, flush tool with sterile water or saline to remove any air
therein.
[0072] With reference to FIG. 11/11A, lubricate the sealing ring
area of the tool with lubricant, e.g., K-Y Jelly. Similarly
lubricate the lumen of urethral device, e.g., by injecting
lubricant into distal end of the proximal tube. After lubrication,
the tool, more particularly the proximal extremity thereof, may be
inserted into the device's proximal tube portion until the proximal
tip of the tool is fully seated into the proximal end of the
device. For adjustable models, first determine device length and
secure the tubes (i.e., tubular bodies) together to achieve a
suitable length device. For non-adjustable models, select a
suitably sized device.
[0073] Referring now to FIG. 12, following sterile preparation,
retract the anchor sleeve or sheath of the tool so as to expose the
push cup thereof. Hold the push cup, just distal of the anchor
sheath, while inserting the distal end of the distal anchor of the
device into the push cup. Note that the push cup is marked with a
black indicator. Distal anchor end should be inserted so as to be
positioned under the black indicator.
[0074] Thereafter, the distal anchor of the device is collapsed and
wrapped around the shaft of the inflation tool. The wrapped distal
anchor is then pushed or more generally inserted into the anchor
sheath of the tool until the anchor is completely housed in the
sheath. The spacer sleeve of the tool should abut the proximal end
of the anchor sheath. The retrieval suture is then routed along the
length of the tool.
[0075] In connection to device deployment, the device of the
subject invention, in all its embodiments, is delivered in a
similar fashion as a Foley catheter of equivalent profile. Slowly
advance the device, i.e., the combination or assembly of FIG. 13,
into the urethra, paying close attention to the resistance felt in
the vicinity of the external sphincter. Do not use excessive force
if unexpected resistance is encountered; do not continue without
first determining the cause of resistance. Once the entire length
of the assembly has been advanced, the proximal end of the device
of the assembly will be in the bladder. Using a luer syringe,
"inflate" the balloon of the proximal device portion via the needle
tip of the inflation port with about 5 cc of sterile water or
saline, at a rate of approximately 1 cc per second. Filling rates
in excess of 1 cc/sec may result in incomplete balloon filling.
[0076] Positioning of the urethral device is accomplished by
applying gentle traction to the tool using the inflation port (FIG.
14). Do not pull on the sheath hand piece. Pulling on the sheath
hand piece may cause premature deployment of the distal device
anchor. After resistance is felt, assuring that the now expanded
proximal device balloon is positioned in/at the bladder neck,
retract the anchor sheath by pulling on the sheath hand piece while
holding the inflation port stationary. Pull the sheath hand piece
until it stops sliding (i.e., sheath travel is approximately 1 inch
or 2.5 cm), thereby indicating full sheath retraction.
[0077] Thereafter, apply gentle traction to the tool to "undock"
(i.e., release) it from device, and then completely withdraw it
from the urethra. The retrieval suture, color coded, may then be
trimmed to an appropriate length such that the distal end is just
inside the meatus (reference the deployed device of FIG. 15).
Finally, the patient is to be instructed not to pull or otherwise
manipulate the exposed/accessible portion of the tether as such
action could "deflate" the distal device anchor, and dislodge the
urethral device or cause expulsion of same.
[0078] As should be appreciated in connection with FIG. 15, and
with reference to the device embodiments of FIGS. 8 & 9, in
order to achieve the optimal treatment or therapy, an appropriate
length device must be selected to accommodate the patients
anatomical requirements. To size the device, measure the length of
the prostate gland adjacent to the urethra. Careful measurement
will help assure a properly fitting device. Other methods, such as
direct measurement of the prostatic urethra length with inserted
catheter-devices, can be used, if available, and transrectal
ultrasound (TRUS) may likewise be utilized for such purpose.
Finally, device of U.S. Pat. No. 6,719,709 are likewise suitable,
and advantageous.
[0079] Using the prostatic urethra length, measured in centimeters
(cm), match the measurement to the range defined in Column A of
Table 1 herewith. Follow the row across to select the appropriate
urethral device size in Column D. TABLE-US-00001 TABLE 1 Urethral
Device Size Selection Table Column A TRUS Column C Measurement
Prostatic (Prostatic Stent Length Column D Urethra Column B
(Reference Urethral Length) UMD Measurement only) Device Size
<2.4 <4 2.4 4 2.5 to 3.0 4.1-5.0 3.0 5 3.1 to 3.6 5.1-6.0 3.6
6 3.7 to 4.2 6.1-7.0 4.2 7 4.2 to 4.8 7.1-8.0 4.8 8 4.8 to 5.4
8.1-9.0 5.4 9
[0080] Generally, if the prostate length measurement exceeds 5.4
cm, the patient may not be a candidate for a urethral device, with
device selection and insertion at the discretion of the physician,
depending on the length of the obstructed region, adequate overall
device size, and placement in the prostate anatomy.
[0081] As to preferred materials of construction, the endourethral
device generally, but not necessarily utilizes a core construction
of a 304 stainless steel wire coil encapsulated using implant grade
silicone rubber (shore 30A, Rhoda Silicones, Inc., Ventura, Calif.
PN V40029A & V40029B) to form a prostatic urethral stent. The
proximal anchor of the device is bonded to the prostatic stent
portion of the device. Bonding an anchoring balloon to a cast
proximal tip forms the proximal anchor. The proximal tip is cast
from silicone rubber (Rhoda Silicones). The anchoring balloon is
extruded using an implant grade silicone rubber (NuSil Technology,
Carpenteria, Calif., PN MED-4720), with the balloon being bonded
using silicone adhesive (NuSil Tech. PN MEDl-4213).
[0082] The distal anchor is formed in the same fashion as the
proximal anchor; a balloon is bonded to a distal anchor manifold.
The proximal anchor and distal anchor are connected via an
inflation lumen which is a medical grade silicone rubber tube (SF
Medical, Hudson, Mass.; PN SFM3-1350) possessing a 0.020'' internal
diameter and a 0.009'' wall thickness. The tube is attached to each
anchor using silicone adhesive. The distal anchor manifold provides
the location for receiving the drain plug of the anchoring
balloons. The drain plug is formed from 304 stainless steel
hypodermic tubing bonded/sealed to a size 1/0 silk suture using
medical grade epoxy (TRA-CON, INC., Bedford, Mass.; PN TRA-BOND
FDA2). When the plug is pulled from the distal anchor manifold port
both the proximal and distal anchoring balloons deflate.
[0083] The device preferably uses a retrieval suture formed by size
1/0 silk suture, which is attached both to the distal end of the
distal anchor and the distal end of the prostatic stent section.
The retrieval suture traverses the length of the prostatic stent
and attaches to the proximal end of the stent thereby limiting the
amount of stent extension under tension. The use of silk provides
flexibility due to its multiple strand construction while
maintaining an acceptable break load limit.
[0084] The endourethral device may been fabricated in various
lengths ranging from about 4 to 9 cm, the length measured from the
distal end of the proximal balloon to the proximal end of the
distal balloon. The ratio of the length of the prostatic stent to
the remaining length (i.e., the length spanning the external
sphincter) may be varied, presently the length ratio is 3:2 (i.e.,
for a 5 cm length device, the prostatic stent length is 3 cm). The
external profile of the device may be fabricated from 10 French to
32 French.
[0085] This invention disclosure provides device configurations
which achieve a sought after anchoring function and methodology.
There are other variations of this invention which will become
obvious to those skilled in the art. It will be understood that
this disclosure, in many respects, is only illustrative. Changes
may be made in details, particularly in matters of shape, size,
material, and arrangement of parts without exceeding the scope of
the invention. Accordingly, the scope of the invention is as
defined in the language of the appended claim. As will further be
appreciated, it is contemplated that the anchoring configurations
of the subject invention be readily incorporated into known
endourethral devices for diagnosis, managing or treating urological
disorders, the benefits thereby accruing thusly being available
generally to patient's presenting with such disorders.
* * * * *