U.S. patent application number 10/014382 was filed with the patent office on 2002-04-18 for rotate to advance catheterization system.
This patent application is currently assigned to Essex Technology, Inc.. Invention is credited to Frassica, James J..
Application Number | 20020045855 10/014382 |
Document ID | / |
Family ID | 25170810 |
Filed Date | 2002-04-18 |
United States Patent
Application |
20020045855 |
Kind Code |
A1 |
Frassica, James J. |
April 18, 2002 |
Rotate to advance catheterization system
Abstract
A system of rotate-to-advance medical devices including
catheters, dilators, occluders, stents, suprapubic catheters and
camera introducers configured with external screw threads and
depending substantially on rotation for means of advancement and
emplacement in mammalian genitourinary and gastrointestinal
passages and organs.
Inventors: |
Frassica, James J.;
(Chelmsford, MA) |
Correspondence
Address: |
Mark J. Pandiscio
Pandiscio & Pandiscio
470 Totten Pond Road
Waltham
MA
02154
US
|
Assignee: |
Essex Technology, Inc.
|
Family ID: |
25170810 |
Appl. No.: |
10/014382 |
Filed: |
December 11, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10014382 |
Dec 11, 2001 |
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09448054 |
Nov 23, 1999 |
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09448054 |
Nov 23, 1999 |
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08797426 |
Feb 10, 1997 |
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Current U.S.
Class: |
604/109 ;
604/103.08; 604/526 |
Current CPC
Class: |
A61M 2025/006 20130101;
A61B 1/00154 20130101; A61B 1/307 20130101; A61M 27/008 20130101;
A61M 2025/1086 20130101; A61F 2/0009 20130101; A61F 2/94 20130101;
A61B 1/273 20130101; A61B 2017/00685 20130101; A61B 2017/349
20130101; A61M 25/0105 20130101; A61B 90/361 20160201; A61M 25/0043
20130101; A61M 25/10 20130101; A61M 25/0017 20130101; A61M 25/0068
20130101; A61M 2025/0191 20130101; A61M 25/01 20130101; A61M
25/0021 20130101; A61M 25/0075 20130101; A61M 25/0102 20130101;
A61B 1/0016 20130101; A61M 25/007 20130101; A61F 2/88 20130101;
A61M 25/0111 20130101; A61B 1/042 20130101; A61M 2210/1078
20130101; A61B 1/015 20130101; A61B 1/00148 20220201; A61B 1/0008
20130101 |
Class at
Publication: |
604/109 ;
604/526; 604/103.08 |
International
Class: |
A61M 029/00 |
Claims
I claim:
1. A threaded catheter for catheterizing mammalian urinary
passages, said catheter comprising a flexible catheter tube having
a lumen extending from a drainage port at the distal end to the
proximal end, said distal end of said tube configured with an
external screw thread of uniform pitch, said thread having a thread
height of at least one fifth (1/5) of the outside diameter of said
catheter tube and a thread pitch not greater than the circumference
of the helix formed by said thread, said tube having sufficient
torsional strength to transmit rotational force applied at said
proximal end of said tube to said thread.
2. The threaded catheter of claim 1, said drainage port being
axially aligned with said lumen.
3. The threaded catheter of claim 1, said catheter tube configured
to accept insertion of a flexible shaft stylet through said
proximal end of said tube into said lumen, the distal tip of said
stylet engagable in a non-rotational fitment secured in said lumen
of said catheter near said distal end.
4. The threaded catheter of claim 1, said catheter further
comprising a thin-walled inflatable balloon encompassing and
terminating on said tube at one end distally of said thread and
proximally of said drainage port and at the other end proximally of
said thread, an inflation lumen extending from an inflation port in
said tube within the envelope of said balloon to said proximal end
of said tube.
5. A threaded dilator for dilating mammalian genitourinary and
gastrointestinal passages, said dilator comprising a flexible shaft
incorporating a tapered bulb near it's distal end with a helical
thread of uniform pitch disposed thereon, said thread having a
thread height of at least one fifth (1/5) of the outside diameter
of said shaft and a thread pitch not greater than the circumference
of the helix formed by said thread.
6. A threaded occluder for occluding mammalian genitourinary
passages, said occluder comprising a flexible shaft incorporating a
tapered bulb near it's distal end with a first helical thread of
uniform pitch disposed distally of the midsection of said bulb and
a second helical thread of uniform pitch disposed proximally of
said midsection of said bulb.
7. The threaded occluder of claim 6, said second thread being
disposed on said shaft proximally of said bulb.
8. A threaded stent for supporting mammalian genitourinary and
gastrointestinal passages, said stent comprising a flexible tube
with an external helical thread disposed thereon, said tube further
comprising means for axial engagement in a non-rotational
relationship with the distal end of a stylet, said thread having a
thread height of at least one fifth (1/5) of the outside diameter
of said tube and a thread pitch not greater than the circumference
of the helix formed by said thread.
9. The threaded stent of claim 8, said thread being of uniform
pitch.
10. A threaded intraurethral valved catheter comprising a flexible
tube with an external helical thread disposed thereon, said tube
further comprising means for axial engagement in a non-rotational
relationship with the distal end of a stylet, said thread having a
thread height of at least one fifth (1/5) of the outside diameter
of said tube and a thread pitch not greater than the circumference
of the helix formed by said thread.
11. The threaded intraurethral catheter of claim 10, said thread
being of uniform pitch.
12. The threaded intraurethral catheter of claim 10, further
comprising external means for controlling said valve.
13. A threaded suprapubic catheter for drainage of a genitourinary
organ, said catheter comprising a flexible catheter tube having a
first axial port at it's distal end and a second axial port at it's
proximal end and a lumen communicating there between, said distal
end of said tube configured with an external screw thread of
uniform pitch, said thread having a thread height of at least one
half (1/2) of the outside diameter of said catheter tube and a
thread pitch not greater than the circumference of the helix formed
by said thread.
14. The threaded suprapubic catheter of claim 13, said thread being
no longer than six turns in length.
15. The threaded suprapubic catheter of claim 13, said catheter
having externally detectable means for determining orientation of
said distal end.
16. A threaded camera introducer system for accessing the
gastrointestinal tract, comprising a flexible catheter tube with a
lumen extending from the distal end of said tube to the proximal
end of said tube, and further comprising an external thread
disposed over said distal end of said tube, said thread having a
thread height of at least one fifth (1/5) of the outside diameter
of said tube and a thread pitch not greater than the circumference
of the helix formed by said thread.
17. The threaded camera introducer system of claim 16, said thread
disposed over substantially the full length of said tube, said
thread having a thread height at said distal end of said tube of at
least one fifth (1/5) of the outside diameter of said tube and a
thread pitch not greater than the maximum circumference of the
helix formed by said thread.
18. The threaded camera introducer system of claim 16, said distal
end of said tube incorporating a window, said lumen terminating at
said window.
19. The threaded camera introducer system of claim 18, said system
further comprising a camera attached to the distal end of a
flexible hollow spine, a cable harness extending from said camera
through said spine and out the proximal end thereof, said camera
and said spine being insertable and securable within said tube with
said camera configured to view through said window.
20. The threaded camera introducer system of claim 19, further
comprising a drum with an axial opening around which a handle is
rotatably attached, said drum sized to hold said camera introducer
system in a coiled configuration, said drum rotatingly dispensing
said system through said axial opening while said handle is held in
a non-rotational grip.
Description
[0001] This application relates to and claims priorty of prior
pending applications Ser. No. 08/463194 filed Jun. 5, 1995, Ser.
No. 08/585040 filed Jan. 11, 1996, U.S.60/012276 filed Feb. 2,
1996, and PCT/US 96/09274 filed Jun. 6, 1996, all by this
inventor/applicant.
BACKGROUND OF THE INVENTION
[0002] 1. Technical Field of the Invention
[0003] This invention most generally relates to apparatus and
methods of catheterization and related treatments of the
genitourinary and gastrointestinal passages of mammals. More
particularly, the invention relates to catheters, dilators,
occluders, stents, suprapubic catheters, camera introducers and
related medical devices subject to being proximally propelled and
directed for advancement and control in mammalian genitourinary and
gastrointestinal passages.
[0004] 2. Description of the Prior Art
[0005] In most mammals, mucous membranes line all those passages by
which the internal parts communicate with the exterior, and are
continuous with the skin at the various orifices of the surface of
the body. They are soft and velvety, and very vascular, and their
surface is coated over by their secretion, mucus, which is of a
tenacious consistence, and serves to protect them from the foreign
substances introduced into the body with which they are brought in
contact.
[0006] They are described as lining the two tracts--the
genitourinary and the gastrointestinal; and all, or almost all,
mucous membranes may be classed as belonging to and continuous with
the one or the other of these tracts. Catheterization of any of
these similar bodily passages may at times be useful or
necessary.
[0007] Urinary outlet problems most likely have been around for as
long as humans. History has the ancient Chinese using onion stalks
to relieve people of acute urinary retention. Literature refers to
such problems as far back as 206 B.C., more than 2000 years ago.
Romans used catheters, first invented by Erasistratus, a Greek
doctor in the third century B.C. Roman catheters were fine tubes
made of bronze. The Roman gynecologist Soranus describes how
catheters could be used to push stones out of the way and back into
the cavity of the bladder, and thus restore urine flow. Excavations
in Pompeii unearthed several bronze catheters. These instruments
were well constructed but relatively simple and showed that designs
changed little from the period 79 AD until 1700 A.D.
[0008] However, during the 17th and 18th centuries catheter
construction became more complex with an intensified search for an
appropriate substance that would be at once flexible,
non-irritating and functional. England, France, and the U.S.A. had
individuals and companies deeply involved with urinary catheters
during this period. Many variations were produced but they all
caused much stress on the patient when these rigid devices were
pushed into the urethra. The first practical breakthrough was by
the French using gum elastic catheters--a catheter that would bend
better in the urethral channel and not scour the mucosa so much in
the process.
[0009] Charles Goodyear improved upon what the French produced when
he successfully vulcanized crude rubber. The problem of
manufacturing an instrument which was both sufficiently rigid to
enable it to be pushed through the urethra into the bladder and yet
flexible enough to negotiate the path, had at last reached the
point of practicality, not withstanding its shortcomings. At that
time, and still to this day, a functional urethral catheter is
defined as one that is flexible enough to negotiate the bends and
stable enough to push through the length of the urethral
passage.
[0010] The French urologist J. J. Cazenave, with the hopes that his
country would regain leadership in the catheter field, dedicated
25-30 years of his life improving the flexible durable catheter.
This was in the late 1800's and his catheter, made of decalcified
ivory, was a dated device but shows the consistency of the state of
the art wherein catheters are pushed into and negotiated along the
urethral passage toward the bladder.
[0011] During the past 300 years or so, intensified development
efforts were stimulated by professional pride, national pride and
financial rewards. These efforts yielded many improvements, such as
changes to size, curve shape, materials of construction,
smoothness, lubricants, coatings, combinations of materials,
physical properties, chemical properties and more, yet all
subscribed to the basic principle of external push-to-advance.
[0012] The catheters of the prior art are large and stiff,
difficult and uncomfortable to administer, and uncomfortable to
wear for extended periods. There is a degree of skill, tolerance
and patience required that takes much time, training and practice
to learn. The difficulty, discomfort, risk of injury and infection,
inhibition and inconvenience of the methods and tools of the known
art results in the deprivation for many patients of the freedom to
work, play and travel as do unaffected people.
[0013] The anatomy of the adult male urinary tract, as illustrated
in FIG. 1, has a bladder 004 where urine is collected prior to
exiting the body via the urethra 006. The bladder 004 converges
into the urethra 006 at a muscular exit called the bladder neck
005. Approximately the first one inch of the urethra lies within
the prostate 007, which is a chestnut-sized gland. The next
approximately half inch passes through the external sphincter 008,
which is the muscular flow valve that controls the release of
urine. The remaining six inches of the urethra lie in a spongy
zone, exiting the body at the meatus 009.
[0014] The normal process of emptying the bladder can be
interrupted by two causes. One is bladder outlet obstruction and
the other is failure of the nerves linking the bladder to the
brain. The most frequent cause of bladder outlet obstruction in
males is enlargement of the prostate gland by hypertrophy or
hyperplasia. In older males, it is not uncommon for a progressive
enlargement of the prostate to constrict the prostate urethra. This
condition, known as benign prostatic hyperplasia (BPH), can cause a
variety of obstructive symptoms, including urinary hesitancy,
straining to void, decreased size and force of the urinary stream
and in extreme cases, complete urinary retention possibly leading
to renal failure.
[0015] The most common surgical intervention for BPH, transurethral
resection of the prostate, or TURP, has a lengthy recovery period
of up to one year, and presents a high operative risk for
complications such as sexual dysfunction. Up to 10% of those
subjected to such surgery are left with mild to moderate stress
incontinence. Approximately 400,000 patients in the United States
and approximately 500,000 patients internationally were diagnosed
in 1994 with BPH or cancer-induced bladder outlet obstructions that
were sufficiently severe to warrant TURP or alternative surgery,
according to industry sources.
[0016] Because of the high costs, medical risks and quality of life
compromises associated with TURP, new technologies have begun to
challenge TURP's position as the standard treatment for severe BPH.
Recently, the U.S. Food and Drug Administration approved two drugs,
tera zosin hydrochloride and rinasteride, to treat BPH. These drugs
generally do not improve symptoms for six to nine months after
treatment begins, and are not without side effects.
[0017] Urethral strictures are another cause of outlet obstruction,
often due to fibrous tissue growth resulting from reaction to
catheters or cystoscopes or from injury, birth defects or disease,
and are commonly treated by urethral dilation, catheterization or
surgery. Men with urethral strictures also experience a limited
ability to urinate, which may cause extreme discomfort and, if left
untreated may cause complications that necessitate catheterization.
Approximately 50,000 patients in the United States were diagnosed
with recurrent urethral strictures in 1994, according to industry
sources. The inventor estimates that approximately 75,000
additional patients were diagnosed internationally.
[0018] Women suffer from urinary incontinence far more often than
men and at an younger age primarily because of the stress
associated with pregnancy and childbirth, the shorter length of the
female urethra, and the absence of a prostate. The U.S. Department
of Health and Human Services (HHS) estimates that the involuntary
loss of urine affects approximately 10 million Americans of which
8.5 million are women. Seven million of these women are
non-institutionalized, or community-dwelling.
[0019] For women between the ages of 15 and 64, the prevalence of
urinary incontinence is estimated to range from 10 to 25 percent of
the population. For non-institutionalized persons over the age of
60, the prevalence of urinary incontinence ranges from 15 to 30
percent, with the prevalence in women twice that of men.
[0020] The involuntary loss of urine can be caused by a variety of
anatomical and physiological factors. The type and cause of urinary
incontinence is important to how the condition is treated and
managed. The two broad categories of urinary incontinence are urge
and stress incontinence. Some people suffer from what is termed
mixed incontinence or a combination of stress and urge
incontinence.
[0021] Urge incontinence is the involuntary loss of urine
associated with an abrupt and strong desire to void. In most cases,
urge incontinence is caused by involuntary detrusor (the smooth
muscle in the wall of the bladder) contractions or over-activity.
For many people, urge incontinence can be satisfactorily managed
with pharmaceuticals.
[0022] The more frequently occurring stress incontinence is the
involuntary loss of urine caused by movement or activity that
increases abdominal pressure. The most common cause of stress
incontinence is hypermobility or significant displacement of the
urethra and bladder neck during exertion. A less frequent cause of
stress incontinence is intrinsic urethral sphincter deficiency
(ISD), a condition in which the sphincter is unable to generate
enough resistance to retain urine in the bladder.
[0023] Females, and males with no benign prostatic hyperplasia
condition, might also have the inability to empty their bladder
because of the nerves linking the bladder to the brain. This
condition is known as neuropathic bladder, may occur in a wide
variety of conditions which include spina bifida, multiple
sclerosis, spinal injury, slipped disc and diabetes. When these and
other problems prevent the bladder from effectively controlling
urine there are a number of treatment options. They are catheters,
dilators, occluders, and stents.
[0024] Indwelling Foley-type Catheters
[0025] During continuous catheterization an indwelling catheter is
retained in the bladder by a water filled balloon. It drains urine
continuously from the bladder via a connecting tube into a bag
which is attached to the leg or bed. The bag has a tap so that the
urine can be emptied at intervals. The catheter is usually inserted
by a doctor or nurse and changed about every four to six weeks. But
difficulty in placement has always been inherent in this design.
This is due to the traditional "push to advance" technology which
necessitates a relatively stiff, thick-walled catheter to traverse
the delicate mucosal lined urethra.
[0026] Often the French (unit of measurement) size of the catheter
is dictated by the need for stiffness to insert rather than the
lumen size to pass urine. A 14 French or smaller Foley is rarely
used because catheters of this size lack the column strength needed
to push the full length of the urethra into the bladder. The larger
French Foley catheters are painful to place, uncomfortable when
indwelling, and require a highly skilled care provider to
insert.
[0027] Intermittent Catheters
[0028] During intermittent catheterization a simple catheter made
of plastic, rubber, or metal is inserted by the patient or a helper
for just long enough to empty the bladder completely, which is
typically about one minute. These tubes are usually smaller in
diameter and stiffer than an indwelling catheter of the same size.
This stiffness can make catheterization difficult in men because
the urethra is long and has an acute bend within the prostate. When
the external sphincter is reached the sphincter muscle will
contract making passage difficult. Most patients learn to
catheterize themselves and thereby gain a large degree of
independence. This process is repeated about every 3-4 hours during
the day and occasionally as needed at night.
[0029] Intermittent catheterization is mainly used by people who
are incontinent due to neuropathic bladder. Intermittent
catheterization may also be utilized by people who cannot empty the
bladder because the bladder muscle is weak and does not contract
properly. In some patients, an alternate apparatus and method used
to maintain long term drainage of the bladder is the use of a
suprapubic tube.
[0030] Suprapubic Catheters
[0031] Suprapubic catheterization of the bladder is performed via
transabdominal puncture which enters the body above the pubic arch
and is directed into the bladder using ultrasound or fluoroscopy to
guide the trocar introducer and suprapubic catheter. The needle
introducer is then removed when proper catheter placement within
the bladder is confirmed, leaving the drainage catheter in
place.
[0032] Long term drainage may require the fixation of the catheter
at the skin using standard adhesive based interface components to
address mechanical fixation, inflection control, and skin
compatibility. The distal end of the catheter is commonly contained
within the bladder by inflated balloon, winged-shaped tip
configurations which expand within the bladder, or pre-shaped
curved catheter tips which curl to their original J-shape when
stiffening wire is removed from the catheter lumen.
[0033] A problem with this form of distal end emplacement through
the bladder wall is that it is only unidirectional; that is, it
only resists the inadvertent pulling out of the tip of the catheter
from the wall of the bladder, while allowing the catheter to freely
pass further into the bladder, and back out up to the point of the
containment structure. This continuing catheter motion in and out
of the bladder puncture site may irritate tissue and cause
infection or other difficulty at the bladder-catheter interface.
Urine is especially irritating to most parts of the human body that
are outside the urinary tract.
[0034] Dilators
[0035] Dilation is accomplished by pushing successively larger
urethral dilation tubes through the urethra to increase the size of
the lumen, a procedure which is painful and traumatic to the
patient. Surgical treatment of strictures involves surgical risks
as well as complications, including infection, bleeding and
restenosis, which requires further treatment.
[0036] With the exception of balloon catheters, the current art of
dilators has also changed little over the passage of time. A shaft
with an increasing taper, bulbous structure, or enlarged end is
pushed from without the passage to advance the tool through the
restricted passage, thus forcing by longitudinally-applied pressure
the lateral expansion of the passage walls. This push-to-advance
method necessitates a stiff shaft which has all the same
liabilities as traditional catheters. Catheters inherently provide
a degree of this dilatorial function to the extent that the passage
is opened sufficiently to accommodate the catheter.
[0037] Occluders
[0038] Occluders are used in some cases to control incontinence.
Occluders of the prior art are constructed and applied with the
same push-to-advance concept as catheters and dilators described
above, with the same liabilities. The basic occluder is a bulb or
plug on a shaft which is inserted within a passageway to stop or
prevent the normal flow of materials through the passageway, or
driven all the way into the bladder, for example, and allowed to
seat as a plug at the neck of the urethra to prevent the flow of
urine from the bladder.
[0039] Stents
[0040] A stent is a tubular metallic mesh device that is implanted
to open and support a stricture to allow for urine flow. The stent
body is between 3.5 cm and 6.5 cm in length depending on the
anatomy, and is expandable by design to anchor in place. The stent
being a mesh has openings that allow the tissue to grow through the
wall making removal difficult and causing encrustation that reduces
urine flow.
[0041] Intraurethral Valved Catheters
[0042] An intraurethral valved catheter is a device that is
implanted to control the flow of urine with an integral valve that
is remotely actuated. Since the entire catheter length is within
the urethra, the chance for external infection is reduced. The
anchoring mechanism of current designs is accomplished with
balloons, or "petal like" projections from the catheter. Both
designs are complicated to install and difficult to remove, and if
the valve fails, leaves the patient in a painful and dangerous
situation.
[0043] Patents in the Prior Art
[0044] There has been patent activity in the prior art indicating
dissatisfaction with the push-to-advance methodology. Catheters
have been adorned with a wide assortment of spiral and threaded
features described as intended to ease the trauma and pain of what
clearly remained a push-in device. Alvord's U.S. Pat. No. 207,932 ,
Peyret's 564,832 (French), Hayes' 1,644,919 (US), and Jacoby's U.S.
Pat. No. 1,888,349 are representative of these. In all cases, these
disclosures fail to recognize that the basic push technique is
fundamentally flawed and should be abandoned, and fail to resolve
the critical features of structure necessary for rotational
advancement as a substitute for the push method.
[0045] Other art reveals the use of spiral features for different
purposes. For example, Spinosa's U.S. Pat. No. 3,815,608 ,
discloses a catheter with a thread designed to hold the urethral
wall away from the shaft to allow urine to flow around the outside
of the catheter. These disclosures likewise reveal a reliance on
push-in methods or an assumption that such structures can be pulled
out without regard to the spiral features, again failing to
recognize rotation as a viable substitute for push, and failing to
resolve the critical features of structure necessary for effective
rotational advancement.
[0046] As a further indication of the failure of prior art similar
to the above inventions to provide effective improvements to
push-in methods, there is no apparent indication among the products
commercially available, or in the medical practices known to the
applicant, that any of these spirally ornamented devices were ever
found to be viable.
[0047] Gastrointestinal Endoscopes
[0048] The current device used for inspection and treatment of the
GI (gastrointestinal) tract is a flexible Endoscope. This device
takes a high level of skill to use, is difficult to maneuver and
can be very painful for the patient, due to the basic
push-to-advance design that has not changed since the device was
invented in the early 1960s. The distal tip of the endoscope has
the following parts:
[0049] 1. a channel opening for suction and passage of
accessories,
[0050] 2. the light guide lens to distribute light from the
fiberoptic bundle to illuminate the visual field,
[0051] 3. the objective lens to focus an image of the mucosa onto
the face of the image bundle and transmit it back to the eye
piece,
[0052] 4. an air/water jet, which supplies air to inflate the organ
being observed, and water to clean off the image lens.
[0053] The Bending Section is the distal end of the tube, ranging
from approx.8-15 cm long, which can articulate to steer the scope
as it is pushed inward and is controlled by a cable mechanism that
is connected to control knobs on the proximal handle.
[0054] The Insertion Tube, which makes up the rest of the 60-150 cm
length, is not capable of controlled deflection. It has a tailored
bending flexibility and torque transmission which is of major
importance in endoscope design. Most instruments have two-stage
bending stiffness, i.e., the distal portion of the insertion tube
is more flexible than the proximal portion. The Flexibility of each
portion of the insertion tube requires extensive clinical testing
to ensure that the endoscope handles easily and produces a minimum
of patient discomfort.
[0055] The colon is a tubular organ which runs from the cecum in
the right lower quadrant to the rectum. It is widest in the cecum
and ascending colon and gradually narrows as one approaches the
rectum. The colon is divided into the following sections:
[0056] a. the cecum; the ascending colon, which runs cephalad
(towards the head) from the cecum to the hepatic flexure;
[0057] b. the transverse colon, which runs from the hepatic flexure
in the upper quadrant of the splenic flexure in the left upper
quadrant;
[0058] c. the descending colon, which runs caudad(toward the feet)
from the splenic flexure to the left lower quadrant;
[0059] d. the sigmoid colon, which runs from the left lower
quadrant to the rectosigmoid junction; and
[0060] e. the rectum, which extends down to the anal canal.
[0061] The inner layer of circular muscle is present throughout the
colon. The outer longitudinal muscle in the wall of the colon is
fused into three bands, the teniae coli. These bands start at the
base of the appendix and run in the wall of the colon down to the
rectum where they diffuse into the muscular coat. The three teniae
cause the colon to have a triangular appearance endoscopically;
this is especially prominent in the ascending and transverse colon.
The haustra are outpouchings of the colon, separated by folds. In
the descending colon the endoscopic appearance is often
tubular.
[0062] Most experienced colonoscopists use similar endoscopic
techniques. Air is introduced to inflate the colon, but as little
as possible to prevent overdistension. The pressure on the device
is gentle to avoid stretching the colonic wall or mesentery (the
connective tissue that holds the colon like a fan) which can cause
pain, a vagal episode, or a perforation. The lumen is kept in view
at all times; little or none of the examination is performed
blindly, because you are pushing a stiff instrument.
[0063] A variety of in and out maneuvers are used to "accordian"
the colon on the colonoscope, keeping the colonoscope free of loops
as possible. In the difficult colon, special maneuvers such as the
creating of an alpha loop in the sigmoid colon are used to pass the
sharply angulated sigmoid/descending colon junction. This maneuver
may require fluoroscopic guidance and training in the
technique.
[0064] The colonoscope is advanced to the cecum under direct
vision. The detailed examination of the mucosa is usually performed
as the colonoscope is slowly removed from the cecum.
[0065] To inspect the whole length of the large intestine requires
a highly skilled practitioner, which makes the procedure costly.
Even still the procedure can be very painful for the patient,
making sedation necessary. This is due to the inherent deficiencies
in the "push-to-advance" design.
[0066] In summary, there are problems in making present push-in
catheters, dilators, and occluders stiff enough for penetration and
flexible enough to make the turns without undue risk of trauma to
the wall of the passageway when being pushed in; and once
installed, comfortable enough to wear for an extended period. The
problems with stent encrustation and removal are well known.
Self-administration is inhibited by all of the short-comings of the
prior art. Further injury, infection and discomfort can result from
unskilled or improper technique. The problems with colonoscopy have
been previously described.
[0067] The long history of push-in catheters/dilators and occluders
has gradually crystallized into an industry wide,
self-perpetuating, fundamental assumption that catheters are to be
mainly pushed through bodily passageways, albeit with some
rotational easing. This "fact" is so widely perpetuated and
pervasive in the commercially available products and medical
practices as to have stifled original thinking in this art. This,
in spite of it's well-recorded short comings of pain, trauma, risk
of rupture, and failed, aborted or incomplete procedures and need
for skilled practitioners and special equipment for monitoring and
safeguarding against the inherent problems.
SUMMARY OF THE INVENTION
[0068] For the purposes of this disclosure, including the appended
claims, the terms "distal", "distally", and "distal end", as they
relate to the devices and methods described herein, refer to the
end of the device further from or in the direction away from a
practitioner who might be applying the device or method to the
subject. Stated otherwise, the terms refer to the end of the device
closer to or in the direction towards the subject's interior.
[0069] The terms "proximal", "proximally", and "proximal end", as
they relate to the devices and methods described herein, refer to
the end of the device closer to or in the direction towards the
practitioner who might be applying the device or method, rather
than the subject.
[0070] Objects of the invention include providing and employing
screw-based means for rotational advancement and anchoring of
catheters, probes, occluders, stents, and dilators into
genitourinary and gastrointestinal passageways such as the urethra,
ureter, esophagus and fallopian tube, and for the emplacement of
suprapubic catheters for draining genitourinary organs such as the
bladder, whereby the subject device is applied through a natural
body orifice or surgically created opening and is drawn through the
passage by the longitudinal pull of a helix on the walls of the
passage or organ as the device is rotated. This technology is a
radical departure from the 4000 year old traditional "push to
advance" methodology previously discussed.
[0071] Indwelling and Intermittent Catheters
[0072] Flexible, thin wall indwelling and intermittent catheters
and related devices and delivery stylets, made possible by this
form of emplacement, are less traumatic and easier for the medical
practitioner or patient to use. The catheter of the invention
eliminates the problems of conventional devices by using helix or
rotational technology that provides controlled insertion and
flexibility to negotiate the urethra. The helix design accomplishes
a pre-dilatation of the passageway at a steady rate that relaxes
the sphincter and lessens or prevents spasm. Once placed, the
device is anchored by the radial displacement and close pitch of
the helix, preventing longitudinal migration due to body movement
or fluid flow.
[0073] In another embodiment, the helix is located on the shaft
under a Foley-type balloon and disappears when the balloon is
inflated. The flexible reinforced shaft need be only about half the
wall thickness of conventional Foley Catheters, which means a
smaller OD catheter can be used. The helix advances the shaft and
dilates the urethra as the catheter is inserted. Once the bladder
is reached the balloon is inflated with sterile water, the helix is
engulfed by the balloon. The process is then reversed to remove the
catheter. This technology fosters reduced costs for patent care,
improved clinical outcomes and enhanced patient quality of
life.
[0074] Continence Catheter with Valve
[0075] The continence catheter of the invention, indicated for
bladder outlet obstructions, is intended for BPH patients who are
not able to, or choose not to undergo TURP. This embodiment of the
invention allows the urethra in the area of the prostate to remain
open. At the proximal (external end) of this catheter there may be
a flow valve which can be depressed or otherwise opened to empty
the bladder. The catheter may be produced as a sterile, single-use,
disposable item that can be used once and replaced as needed.
[0076] The same embodiment of the catheter of the invention
provides a female Stress UI sufferer with lifestyle benefits that
greatly outperform absorbent products intended to manage this
condition.
[0077] The patient simply inserts the catheter into the urethral
opening and rotates the shaft to advance the catheter into the
bladder. This can be done in the morning in the convenience of
home. When the user needs to urinate, the valve end of the flexible
shaft may be exposed through the clothing and the valve opened to
empty the bladder. Since the device is not removed and reinserted
after each voiding the risk of infection is reduced. At the end of
the day the catheter is easily removed and disposed.
[0078] Intraurethral Valved Catheter
[0079] The male or female intraurethral valved catheter of the
invention is indicated for bladder control. This embodiment of the
invention allows the flow of urine to be controlled by a valve
mechanism that is within the catheter. This valve may be actuated
directly by insertion of a tool such as a stylet, or remotely by
using a magnetic field device.
[0080] The intraurethral device reduces the potential for infection
by eliminating the external tubing which can be an entry path for
bacterial contamination. These catheters are typically 3.5 to 6.5
centimeters in length, depending on the anatomy, and have the
helical element of the invention on the outer diameter of the body.
The thread height of the helix may vary over it's length, as an aid
to the advancement and retention characteristics of the device. The
sidewall of the catheter may be reinforced to resist collapsing due
to contraction pressure. This catheter may be inserted in the
urethra under fluoroscopy, using a detachable flexible stylet which
keys into the proximal end of the catheter in a non-rotational
fitment, and may be inserted in an outpatient procedure using
topical anesthesia.
[0081] Stents
[0082] The stent of the invention, indicated for bladder outlet
obstructions, keeps the urethra open in the area of the stricture.
The stent body may be between 3.5 cm and 6.5 cm in length depending
on the anatomy, and has a helical element on the outer diameter of
the body to advance and retain the stent. The sidewall of the stent
may have a reinforcement means to prevent collapsing due to
prostate pressure. The stent can be inserted in the urethra under
fluoroscopy, using a detachable flexible stylet which keys into the
proximal end of the stent body, and may be inserted in an
outpatient procedure using topical anesthesia.
[0083] The stents of the invention are not susceptible to being
incorporated by the urethral mucosa in a manner preventing
rotation, thereby permitting a lengthy period of emplacement and
subsequent removal by the same rotational technique. The stent may
also have a sufficiently large internal diameter, or lumen, to
permit cystoscopies, thereby allowing examination of the bladder
without removing the stent.
[0084] Dilators and Occluders
[0085] Helically-adapted dilators and occluders of the invention
are likewise rotatingly advanced and retracted; the helical element
performing a dilatory function to some degree. Dilators of
respectively larger diameters may be used to achieve a gradually
more pronounced effect. The rotational advancement means may be
combined with the push-to-advance methodology in any of these
devices. In a dilator, for example, a helically equipped leader
shaft extending distally of the bulbous portion of the device
rotatingly advances the device up to the point that the helix
passes out of the interior end of the passage, the remainder of the
leader shaft then providing a guide wire that leads the bulb
through the remainder of the passageway when the dilator is pushed
from the proximal end.
[0086] Suprapubic Catheters
[0087] The adaptation of the invention to suprapubic catheters used
in a classic transabdominal puncture for the drainage of the
bladder or other genitourinary organs, permits the helix on the
distal end of the catheter to be emplaced in the wall of the organ
far enough so that the helical vane extends from both sides of the
organ wall, so that the longitudinal sliding motion of the catheter
into and out of the organ is inhibited by the helical vane. This
reduces a source of irritation and associated complications at the
organ wall entry point.
[0088] The helically-adapted suprapubic catheter may be placed in
the organ using ultrasound or fluoroscopy to visualize placement,
by rotatingly advancing the catheter over a guidewire leading to
the organ; the guidewire having been installed through a tubular
access created by using a cannula and trocar to reach the organ,
the trocar and the cannula having been successively removed.
[0089] General Construction
[0090] Any embodiment of the invention may be radiopaque, or have
radiopaque features, markers or other components, permitting the
use of fluoroscopy to monitor emplacement or removal of the device,
or even the rotational orientation and rotational movement.
[0091] The thread element may be solid, hollow, or fluid filled. It
may taper in height at various locations to optimize advancement
and anchoring. Embodiments or elements of the invention may be
fabricated, molded, wound, extruded or otherwise constructed of
non-toxic, non-corrosive materials or combinations of materials
that are otherwise tolerant of bodily fluids and durable when
implanted in vivo. Such materials may include but are not limited
to polyurethane, medical grade stainless steel, silicone, bicarbon,
polytetrafluoroethylene, tantalum, titanium, or nickel-titanium
alloy. Conversely, materials may be specifically chosen to be
bioabsorable so as to obviate the need for removal.
[0092] The devices of the invention may be enhanced with one or a
combination of the following coatings: water based hydrophilic,
antibacterial coatings such as nitrofurazone, bateriostatic
coatings such as silver, or other mediations to further enhance
their clinical performance.
[0093] Camera Introducer
[0094] The threaded camera introducer system, briefly stated,
presents a novel means for the introduction of sensors and other
implements into and through the full length of the colon. The
fundamental structure of the introducer, consistent with the
rotate-to-advance structure and methodology of the invention, is a
large, soft, flexible worm-like tubular device with a helix of
soft, pliant threads which translate rotational force at the
proximal end to a pulling action on the colon wall.
[0095] The hollow core or central lumen connects the distal and
proximal ends of the tube. A camera head or other visual sensor can
be introduced into the device and arranged to "see" forward from
the center of the bulbous tip on the distal end. Light bundles or
wires connected to the camera pass through the central lumen and
out the proximal end of the device to an appropriate control and
viewing apparatus.
[0096] The distal end of the device is gently urged into the rectum
sufficiently far to engage the helix. The device is rotated from
just outside the point of entry, to slowly advance into and through
the entire length of the colon to the cecum. The helical threads
pulling the device gently along the interior colon wall; the
flexibility of the device allowing it to easily negotiate the major
turns of the colon. The larger threads at the distal end provide
the greatest grip or pull, the smaller threads closer to the
proximal end contributing a lesser degree of grip or pull. The
device is removed using the same method in reverse.
[0097] As illustrated in the figures, the light bundles or cables
may be encased in a flexible torque tube or assembly which provides
or contributes to the torsional strength necessary to rotatingly
advance and withdrawn the device.
[0098] The interior wall of the main tubular device or introducer,
may be configured to contain the torque tube or vertebra in a
non-rotational manner, such that torque applied at any place on the
exterior wall of the introducer is transmitted to the torque tube
and hence over the full length of the device.
[0099] Various embodiments and enhancements are possible, all
within the scope of the invention:
[0100] 1. The helical thread or spiral extending the length of the
device may be used for auxiliary purposes, including to:
[0101] a) Carry fluids into the colon/passage,
[0102] b) Provide vacuum to the passage way itself or vacuum within
the device to facilitate the advancement of the camera or endoscope
into the device,
[0103] c) Convey light bundles or electrical wires for specific
purposes, and/or
[0104] d) Provide depth markers to assist the practitioner in
determining the general position of the device within the body.
[0105] 2. The spiral may also be inflated with a fluid during entry
to obtain full thread form and rotationally grip or fix the
catheter to the camera element, and deflated to permit
non-rotational removal by pulling the device through the colon.
[0106] 3. The video screen or the image on the screen as seen
through the rotating camera introducer as it advances, may be
electronically processed to hold the image in a non-rotating,
stationary manner for the benefit of the person administering the
procedure.
[0107] 4. The distal portion of the device may be relatively more
flexible to enhance trackability along the path of the
colon/passageway.
[0108] 5. The device may have sufficient torque transmission
capability from the proximal to the distal end so the distal
portion of the device can be thus rotated at full length in the
colon without interior support.
[0109] 6. The distal tip or zone may have a sufficient thread
height to grip the colon wall and provide the primary "pulling
power" to advance the device into the body and negotiate the turns,
while the somewhat lower thread height along the balance of the
device is adequate to support rotational advancement without drag
and avoid bunching or gathering the colon wall.
[0110] 7. There are at least three methods of containing and
controlling this 160 cm long instrument to ensure it remains within
the operating field:
[0111] a) A dispensing device as shown in FIG. 34,
[0112] b) A straight tubular component, or
[0113] c) Held by an assistant.
[0114] 8. Material of construction:
[0115] a) The main body may be produced from polyvinylchloride
plastic and may be reinforced with wire or fabric.
[0116] b) The helix may be made of PVC and may be reinforced with
wire or otherwise.
[0117] c) A distal end window may be a flat, optically clear
plastic lens made from PVC, polycarbonate, or acrylic plastic.
[0118] 9. Alternative Uses:
[0119] a) Variations on the introducer device within the scope of
the invention include full length tubes, or short sections
analogous to urethral stents, being emplaced in the colon by the
rotational structures and techniques of the invention for temporary
purposes such as to aid in the repair of a damaged colon or a
related abdominal injury or condition, by providing a supplemental
lining and/or form to the colon or to a section of the colon.
[0120] 10. Camera with torque control umbilicus:
[0121] a) The camera body which houses both the camera and the
light sources may be made of stainless steel or molded with a
dimensionally stable plastic such as polycarbonate.
[0122] b) The vertebrae which makes up the torque control umbilicus
may be made of a high strength thermoplastic or a metal such as
stainless steel or beryllium copper.
[0123] By means of the invention, the entire colon can be examined
without the need for a conventional colonoscope or endoscope, and
without the attendant expertise, pain, medication, post procedure
recovery time, and cost. The means and method of the invention
require less training and have far greater likelihood of reaching
the cecum, (far end of the colon), than conventional tools and
procedures. Other body cavities and passageways may be similarly
examined.
[0124] The camera introducer catheter can be used in four different
modes:
[0125] 1. As an INTRODUCER, it includes the following
characteristics and benefits:
[0126] a) Conveys a camera assembly along the entire colon to
screen patients for polyps, lesions, cancer sights and other
maladies.
[0127] b) The entire colon can be examined without the need for a
conventional colonoscope/endoscope.
[0128] c) A total examination of the colon can be successfully
performed with significantly less manipulation technique, pain,
medication and post procedure recovery time.
[0129] d) Requires less training and has greater success in
reaching the cecum.
[0130] e) As a single-use disposable device, allowing the expensive
camera with its torque controlled umbilicus to be used repeatedly
without danger of sequential infections.
[0131] f) Procedure is less expensive when compared to the cost of
cleaning and repairing the conventional endoscopes and amortizing
the cost of today's costly video processing unit.
[0132] g) The procedure can be successfully performed by less
specialized, less expensive individuals.
[0133] h) The INTRODUCER is supplied sterilized and ready for
use.
[0134] 2. As a more CONVENTIONAL STYLE ENDOSCOPE:
[0135] By adapting a conventional endoscope to the structure and
method of the invention, the benefits of the invention are coupled
with the following conventional functions:
[0136] a) Tip articulation.
[0137] b) Air & water delivery.
[0138] c) Suction of fluids.
[0139] d) Illumination of passages.
[0140] e) Imaging capability.
[0141] f) Drug delivery.
[0142] g) Accessories.
[0143] 3. As a HYBRID CATHETER having some of the functions and
features of the more CONVENTIONAL ENDOSCOPE and/or the INTRODUCER
style built into the device for procedure-specific applications.
Also, it could be used in conjunction with or independent of
conventional endoscopic devices and accessories.
[0144] 4. As a TRANSPORTER or introducer to deliver a conventional
endoscope to any location of the colon or other passageway. This
may occur by:
[0145] a) Providing a fluid tight envelope for the endoscope.
[0146] b) Providing a means for the endoscope to exit the distal
end of the INTRODUCER to perform diagnostic/therapeutic procedures
normally done with the endoscope.
[0147] Still other objects and advantages of the present invention
will become readily apparent to those skilled in this art from the
following detailed description, wherein I have shown and described
preferred and other embodiments of the invention, simply by way of
illustration of the best mode contemplated by me on carrying out my
invention. As will be realized, the invention is capable of other
and different embodiments, and its several details are capable of
modifications in various obvious respects, all without departing
from the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0148] FIG. 1 is an illustration of the lower abdominal anatomy of
a male subject, with the threaded portion of the catheter of FIG. 2
extending into the bladder.
[0149] FIG. 2 is a perspective view of a threaded catheter for a
male.
[0150] FIG. 3 is a cross sectional view of the threaded portion of
the catheter of FIG. 2.
[0151] FIG. 4 is a illustration of the threaded end of the catheter
of FIG. 1 engaged in the urethra.
[0152] FIG. 5 is a perspective view of a threaded catheter for a
female.
[0153] FIG. 6 is a cross sectional view of the threaded portion of
the catheter of FIG. 5.
[0154] FIG. 7 is a perspective view of a threaded catheter and
flexible shaft stylet with which it is installed.
[0155] FIG. 8 is a cross section of the tip of the catheter of FIG.
7, showing the non-rotational fitment that receives the tip of the
stylet of FIG. 7.
[0156] FIG. 9 is a perspective view of the tip of the stylet of
FIG. 7 that is insertable into the fitment of FIG. 8.
[0157] FIG. 10 is a diagrammatic longitudinal cross section view of
a threaded balloon catheter showing the thread element inside the
inflated balloon, with lumens shown as dashed lines.
[0158] FIG. 11 is a cross section view of the shaft of the catheter
of FIG. 10, showing the central drain lumen and the smaller
inflation lumen.
[0159] FIG. 12 is a longitudinal cross section view of the distal
end of the catheter of FIG. 10, showing the balloon contracted
around the helical element.
[0160] FIG. 13 is a side elevation of a threaded dilator.
[0161] FIG. 14 is a side elevation of a threaded occluder.
[0162] FIG. 15 is a side elevation of another variation of a
threaded occluder.
[0163] FIG. 16 is a perspective view of a threaded stent, dashed
lines showing an internal sidewall reinforcement member and a
bushing with a hexagon drive socket.
[0164] FIG. 17 is a cross section view of the stent of FIG. 16.
[0165] FIG. 18 is a proximal end view of the stent of FIG. 16, with
the hexagon drive socket visible at the center.
[0166] FIG. 19 is a perspective view of a stylet with a grip on
it's proximal end and a hexagon drive tip on it's distal end.
[0167] FIG. 20 is a perspective view of the hexagon drive tip of
the stylet of FIG. 19.
[0168] FIG. 21 is a perspective view of a stent-follower with a
helical element at it's distal end.
[0169] FIG. 22 is a cross section closeup view of the distal end of
the stent-follower of FIG. 21, showing the hidden portion of the
bushing with it's hexagonal drive aperture in dashed lines.
[0170] FIG. 23 is a cross section view of a intraurethral catheter
with flow control, showing the coiled wall reinforcement member
acting as a spring on the ball of the check valve.
[0171] FIG. 24 is a closeup perspective view of a stylet tip for
operating the check valve of the intraurethral catheter of FIG.
23.
[0172] FIG. 25 is a diagrammatic illustration of a suprapubic
catheter emplaced through the abdomen with the distal end anchored
by it's helical thread in the bladder wall.
[0173] FIG. 26 is a partial side perspective view of the helical
thread of the suprapubic catheter of FIG. 25, anchored by it's
helical thread in a hole in the bladder wall.
[0174] FIG. 27 is a partial front perspective of the suprapubic
catheter of FIGS. 25 and 26 anchored in a hole in the bladder wall;
the hole being stretched and deformed to fit tightly about the tube
and thread of the catheter.
[0175] FIG. 28 is a diagrammatic view of a trocar, cannula and
guide wire, used to install the suprapubic catheter of FIG. 25.
[0176] FIG. 29 is a distal end view of the suprapubic catheter of
FIG. 21, showing rotational orientation markers.
[0177] FIG. 30 is a front perspective diagram of a threaded camera
introducer catheter advanced into the transverse colon area.
[0178] FIG. 31A is a partial front-side perspective of the distal
end of the catheter of FIG. 30, showing the larger thread height of
the thread in the distal area of the catheter's length.
[0179] FIG. 31B is a partial side view of the mid section of the
catheter of FIG. 30, showing the reduced thread height of the
thread in other than the distal area of the catheter's length.
[0180] FIG. 32 is a perspective view of a camera assembly with a
video camera or visual sensor head attached to a flexible torque
tube or assembly within which run electrical cables and/or light
bundles.
[0181] FIG. 33 is a partial cross section view of the distal end of
the preferred embodiment of FIG. 1, with the camera assembly of
FIG. 2 installed as it would be used, with textual information
relating to the construction and use of the device.
[0182] FIG. 34 is a rotating container and dispensing device by
which the catheter of FIG. 30 may be managed and administered
during it's application to a patient.
DESCRIPTION OF THE PREFERRED EMBODIMENT
[0183] To those skilled in the art, the invention admits of many
variations and appellations in apparatus and methodology. By way of
example, there is provided in accordance with the present
invention, a rotate-to-advance structure and methodology applicable
to a range of medical devices that have here-to-fore relied
entirely or substantially on a push-to-advance technique for
penetration of bodily passages. Such devices include catheters,
dilators, and occluders for mammalian genitourinary or
gastrointestinal passages such as the urethra or ureter for the
usual purposes associated with such devices where no incising or
rupture of passage walls or membranes is intended.
Catheters
[0184] Referring now to FIGS. 1, 2 and 3, threaded catheter 101 for
males is made up of tube 102 with external thread 103, attachable
to flow control device 104. Tube 102 is extruded from polyurethane
material, has an inside diameter of 0.06 inches, an outside
diameter 103d of 0.125 inches, and is approximately 13 inches long.
The durometer as measured on the smooth, outside wall of the tube
is 85 Shore A. Distal end 105 is closed off, with it's tip rounded
to a uniform radius of about 0.06 inches. Proximal end 106 of tube
102 is simply cut off square and attached to flow control device
104. Tube 102 is sufficiently strong such that when the majority of
its length is contained within the urethra, it will withstand and
transmit torque as applied by finger force at the lower end
external of the urethra, to the thread.
[0185] A useful alternative embodiment of catheter 101 incorporates
the recited external thread 103 for rotational advancement, but
provides for the central lumen to connect to or terminate in a
straight-through or axially aligned drainage port at the distal tip
of the catheter, similar to the most basic conventional catheters.
This is likewise useful for drainage and also enables the insertion
or passage of guide wires or other devices where specific
procedures require it.
[0186] Referring to FIGS. 2 and 3, external thread 103 is formed
from a strip of polyurethane material with a rectangular cross
section of width 103a, 0.05 inches, and height 103b, 0.032 inches,
and continuously attached over it's length to tube 102 starting 0.2
inches from distal end 105 and extending four complete turns around
tube 102 in a clockwise direction towards proximal end 106 at a
uniform pitch 103c of 0.25 inches, resulting in a four-turn thread
or helix about one inch long.
[0187] It is readily apparent from the dimensions of FIGS. 2 and 3
that the thread height 103b of catheter 101 is greater than twenty
percent (20%) of the 103d thread diameter. This relative height is
necessary to expand and penetrate the longitudinal folds of the
urethra to a sufficient depth to achieve a useful grip by the
thread.
[0188] The diameter of the helix formed by thread 103 of catheter
101 is referred to as thread diameter 103d, and is equal to two
thread heights 103b plus the outside diameter 102d of catheter tube
102, or in this case 2 times 0.032 inches plus 0.125 inches or
approximately 0.19 inches. The circumference C of the helix formed
by thread 30 is calculated as .pi. (pi) times thread diameter 103d,
or in this case 3.14 times 0.19 or approximately 0.6 inches.
C=.pi..multidot.103d
[0189] The ratio R of thread pitch 103c, 0.25 inches, to the
circumference of thread diameter 103d, at 0.6 inches, is much less
than 1 to 1, thereby improving the leverage of the screw thread for
converting rotation into longitudinal pulling power as compared to
ratios larger than 1/1.
R=103c/C
[0190] The shoulders of thread 103 have a radius of 0.015 inches.
In small quantities, thread 103 may be attached to tube 102 by
wicking tetrahydrofuran (THF) solvent under the thread using a fine
hollow tube. Catheter 101 may be molded in large quantities with
thread 103 being an integral part of the molded structure.
[0191] Referring to FIG. 4, two drainage ports 107, connecting to
lumen 108, are oval in shape, the major axis of the oval being
parallel with the axis of tube 102 and about 1.5 times the minor
axis, which is about equal to the diameter of the lumen. The two
ports are configured 180 degrees apart radially, and spaced
longitudinally to fit between the turns of thread 103.
[0192] Both ends of thread 103 are tapered from zero to full height
in one-half turn of the helix, to facilitate gentle, gradual
displacement of urethra wall 002 by thread 103 when catheter 101 is
rotated clockwise for advancement into the urethra and
counterclockwise for retraction. The difference between thread
width 103b and pitch 103c shown in FIG. 3 is sufficient that the
urethra wall 002 does not bridge between adjacent turns of thread
103, but rather is only displaced in a manner closely conforming to
the cross section of thread 103, thereby providing the longitudinal
grip on urethra wall 002 for advancing and retracting the
catheter.
[0193] Referring to FIG. 1, catheter 101 is shown in proper
position for draining bladder 004, after it has been advanced
through the urethra 006 until the helix passes out of the urethra
into the bladder.
[0194] It is apparent from the anatomy shown in FIG. 1, that thread
103 must be limited in length to be advanced to any point above the
sphincter 008, so that the sphincter may contract directly onto the
smooth, round, exterior of tube 102, thereby preventing leakage
around the tube, and further constraining catheter 101 from
migrating or being forced out of the urethra by pressure from urine
in the bladder. It is further apparent from the figure that there
is a limit to the length of thread 103 on a catheter that can be
advanced to a position above the sphincter 008, not more than about
six turns within the optimal range of thread pitch, and still fit
within the bladder 004 without interference. A limited length of
thread 103 also localizes the area of pulling force to the upper
end of catheter 101, assuring that the trailing length of the
catheter is drawn, not pushed, through the passage.
[0195] Referring to FIGS. 5 and 6, threaded catheter 111 for
females, similar to catheter 101 for males, is made up of tube 112
with thread 113, attachable to flow control device 114. Tube 112 is
extruded from polyurethane material, has an inside diameter of
0.063 inches, an outside diameter 112d of 0.125 inches, and is
approximately seven inches long. The durometer as measured on the
smooth, outside wall of the tube is 85 shore a. Distal end 115 is
closed off, it's tip rounded to a uniform radius of about 0.06
inches. Proximal end 116 of tube 112 is simply cut off square and
attached to flow control device 114. Tube 112 is sufficiently
strong such that when the majority of its length is contained
within the urethra, it will withstand and transmit torque as
applied by finger force at the lower end external of the urethra,
to the thread or helix.
[0196] Referring to FIGS. 5 and 6, thread 113 of catheter 111 is
formed from a strip of polyurethane material with a rectangular
cross section of width 113a of 0.05 inches and height 31b of 0.10
inches, attached to tube 112 starting 0.2 inches from distal end
115 and extending four turns around tube 112 in a clockwise
direction towards proximal end 116 at a uniform pitch 113c of 0.25
inches, resulting in a four-turn thread or helix about one inch
long.
[0197] It is readily apparent from FIGS. 5 and 6 that the thread
height 113b of catheter 111 at 0.10 inches, is much greater than
twenty percent (20%) of tube diameter 112d, at 0.125 inches. This
relative thread height is necessary in order to expand and
penetrate the longitudinal folds of the female urethra sufficiently
far to achieve a useful grip by the thread.
[0198] Similar to the description of threaded catheter 101, the
diameter 113d of the helix formed by thread 113 is equal to two
thread heights 113b plus the diameter 112d, or in this case 2 times
0.10 plus 0.125 or approximately 0.33 inches. The circumference C
of the helix formed by thread 113 is calculated as .pi. (pi) times
the thread diameter 113d, or in this case 3.14 times 0.33 or
approximately 1.0 inches. The ratio R of thread pitch 113c, at 0.25
inches, to the circumference C, at 1.0 inches, is again much less
than 1 to 1, thereby improving the leverage of the thread for
converting rotation into longitudinal pulling power as compared to
larger ratios.
[0199] The shoulders of thread 113 have a radius of 0.015 inches.
Catheter 111 may be constructed or fabricated by the same means as
catheter 101.
[0200] Referring to FIG. 5, two side drainage ports 117, connecting
to lumen 118, are oval in shape, the major axis of the oval being
parallel with the axis of tube 112 and about 1.5 times the minor
axis, which is about equal to the diameter of the lumen. The two
sideports 117 are configured 180 degrees apart radially, and spaced
longitudinally to fit between the turns of the thread.
[0201] Referring to FIGS. 5 and 6, the ends of thread 113 are
tapered from zero to full height in three-quarters turn of the
helix, to facilitate gentle, gradual displacement of urethra wall
by the thread when catheter is rotated clockwise for advancement
and counterclockwise for retraction. The difference between width
113a and pitch 113c is sufficient that the urethra wall does not
bridge between adjacent tuns, but rather is displaced in a manner
closely conforming to the profile of the thread, thereby providing
the longitudinal grip on the urethra wall for advancing and
retracting the catheter, the same as catheter 101 of FIGS. 2 and
3.
[0202] The optimal position for threaded catheter 111 for draining
the bladder of a female subject is where it is advanced through the
urethra until the thread passes out of the urethra into the
bladder, similar to how catheter 101 is illustrated in FIG. 1, but
for females.
[0203] A detailed method of self-administration of the urethra with
the appropriate respective threaded catheter 101 or 111, or other
similar threaded devices, is explained: The user assembles
materials including a sterile threaded catheter 101 or 111, a
container for urine, soap and water, if the catheter is not
pre-lubricated then a water soluble lubricant, a mirror (for
females), and tissues. The user will then wash the hands and
urethral opening with soap and water, squeeze out a small amount of
lubricant into clean tissue, dip the distal end tip of the catheter
into the lubricant, and manually engage the tip of the catheter
into the urethral opening, (the mirror may be helpful for females
to assist in locating the opening).
[0204] The user will then gently push and turn the catheter in far
enough to engage the thread about one full turn with the urethra,
and gently rotate the tube of the catheter in the direction of the
thread, preferably clockwise, to advance the catheter into the
urethra until urine appears in the tube. The user then pauses to
drain the bladder, directing the urine into the container, then
resumes rotation of the catheter until it is no longer advanced by
the rotation, indicating that the thread of the catheter has passed
into the bladder and the catheter is in proper position.
[0205] The user then places a flow control device on the proximal
end of the catheter and empties the bladder periodically as
required. The catheter is removed when appropriate using similar
precautions for cleanliness and containment, by rotating the
catheter in a direction opposite the direction of insertion,
presumably counterclockwise.
[0206] Referring to FIGS. 7, 8 and 9, another embodiment
contemplated by the claims is illustrated by catheter 121, which is
made up of tube 122 with thread 123 applied in the form of a helix,
and utilizing flexible shaft stylet 131 as an insertion and
retraction tool. Stylet 131 has grip 133 at the proximal end, for
turning. Tube 122 is configured with non-rotational fitment 124
near distal end 125 so that stylet 131 can be inserted through
proximal end 126, up through lumen 128 of tube 122, and tip 134 of
stylet 131 be then engaged with fitment 124 in a manner that allows
rotation of grip 133 in one direction to rotate catheter 121 for
advancement into the urethra, and in the other direction for
retraction.
[0207] The flexible shaft 132 of stylet 131 is sufficiently strong
such that when it is fully inserted into catheter 121, it will
withstand and transmit torque as applied by finger force at the
proximal end knurled knob grip 133 external of the urethra, to the
thread 123. Stylet 131 is removed after catheter 121 is installed,
and reinserted for retracting the catheter when required.
[0208] Fitment 124 is an elongated collar with a multi-faceted
interior wall, securely anchored within tube 122, and configured to
receive in a non-rotational relationship tip 134. Tip 134 is
configured with a corresponding elongated, multi-faceted exterior
shape and rounded end, to readily enter fitment 124. Stylet tip 134
and fitment 124 can be alternatively configured and connected by
various means to provide a non-sliding as well as non-rotational
connection.
[0209] Referring to FIGS. 10, 11 and 12, a threaded foley-type
catheter 141 of the invention is made from polyurethane material.
It has a flexible tube 142 with an axial drainage lumen 148 running
from a drainage port 149 to it's proximal end 146a, and a thread
143 applied to it's external surface near it's distal end 145 in
the manner of threaded catheters previously described. Catheter 141
has a thin-walled inflatable elastic balloon 150 encasing the
helical thread 143 and sealed to tube 142 above and below the
thread 143. Drainage port 149 is located above or distally from
balloon 150. A smaller inflation lumen 151 within tube 142
communicates between inflation port 152 within the envelope of
balloon 150 to the distal end 146b of the catheter. Lumens 148 and
151 are isolated from each other, as indicated by FIGS. 11 and
l2.
[0210] Balloon 150, when uninflated, is normally contracted tightly
about helical element 143 as illustrated in FIG. 12, and may be
inflated as in FIG. 10 by injecting fluid through lumen 151 into
the balloon cavity 153. The flexible tube 142 is of sufficient
torsional strength to withstand and transmit rotational finger
force at the proximal end to thread 143.
Dilators and Occluders
[0211] Referring now to FIGS. 13, 14 and 15, dilator 201 and
occluders 211 and 221 are similarly constructed by configuring the
upper end 205 of a flexible shaft 202 with tapered bulb 204 near
it's distal end, and disposing thereon one or two sections of
thread 203. These threads are similar to thread 103 on catheter 101
of FIGS. 2 and 3, wherein the height of the thread is at least
twenty percent (20%) of the diameter of the shaft 202, and the
ratio of thread pitch to the circumference of the thread diameter
at any given point on the bulb or shaft is less than one to one
(1/1). The ends of threads 203 are tapered for ease of advancing
and retracting, again similar to the threaded catheter of FIGS. 2
and 3.
[0212] Dilator 201, of FIG. 13, is configured with multiple turns
of thread 203 extending over both ends of tapered bulb 204, and is
used to dilate a constricted passage by being rotatingly advanced
and retracted through the obstructed area of the passage in the
same fashion as the threaded catheters of the invention.
[0213] Occluder 211, of FIG. 14, is configured with two sections of
thread 203, leaving the midsection or bulbous portion of tapered
bulb 204 smooth and round in order to provide a uniform occluding
surface. This occluder is used to plug or constrict a passageway at
an interior point; being rotatingly advanced to and retracted from
that point in the same fashion as the threaded catheters of the
invention.
[0214] Occluder 221, of FIG. 15, is configured with two sections of
thread 203, the lower or proximal end thread 203 being disposed on
the shaft 202 below the tapered bulb 204, leaving the lower tapered
end of bulb 204 smooth and round in order to provide a uniform
occluding surface. This occluder is used to plug a passageway at
the interior end neck or entrance; being rotatingly advanced until
the tapered bulb passes entirely through the passage while the
lower thread remains engaged in the passage, and being then
rotatingly retracted to seat the tapered bulb against the neck of
the passage. The occluder is then rotatingly retracted when
appropriate.
Stents and Intraurethral Valve Catheters
[0215] Referring now to FIGS. 16-18, a threaded urethral stent 301
made from polyurethane material has a tube 302 with an external
thread 303 of uniform pitch. Thread 303 is similar to thread 103 on
catheter 101 of FIGS. 2 and 3, wherein the height of the thread is
at least twenty percent (20%) of the diameter of the shaft 202, and
the ratio of thread pitch to the circumference of the thread
diameter is less than one to one (1/1). The ends of thread 303 are
tapered for ease of advancing and retracting through a passage.
There is an interior shoulder 304 at the distal end 305 of the
stent, and a bushing 307 of relatively harder material with a
tapered interior wall 308 extending from the bushing's full
diameter at one end to a uniform hexagonal aperture 309, bushing
307 being affixed within the proximal end 306 of the stent and
oriented with tapered wall 308 extending proximally from aperture
309. Coiled sidewall reinforcement member 310 is secured within the
remaining length of stent 301 by bushing 307 and interior shoulder
304. Alternative embodiments may have a section of the thread being
tapered to a lesser height or no height, to provide a "waist" for
gripping by a muscular zone such as the prostate or sphincter.
Also, reinforcement member 310 could be configured or molded into
the sidewall tube 302.
[0216] Referring now to FIGS. 19 and 20, stylet 331, similar to
stylet 131 of FIG. 7, has flexible shaft 332 with grip 333 at the
proximal end for turning, and hardened hexagon tip 334 at the
distal end which closely fits into aperture 309 of stent 301 in a
non-rotational manner for emplacement of the stent by the method of
the invention. The flexible shaft 332 of the stylet is sufficiently
strong such that when tip 334 is inserted into aperture 309, the
shaft will withstand and transmit torque as applied by rotational
finger force at grip 333 to thread 303.
[0217] Referring now to FIGS. 21 and 22, threaded stent-follower
341 has a flexible tube 342, lumen 347 of which is sized to accept
the ready insertion of tip 334 and shaft 332 of stylet 331 of FIG.
19. Tube 342 is of sufficient torsional strength to accept and
transmit rotational finger force at it's proximal end 346 to it's
distal end 345. A thread 343 of uniform pitch and not more than six
turns is applied to the external surface of tube 342 near distal
end 345. Thread 343 conforms to the same twenty percent (20%) rule
of thread height to tube diameter, and ratio of thread pitch to
thread circumference of less than one to one (1/1), as thread 103
in FIGS. 2 and 3 as described above. The ends of thread 343 are
tapered for ease of advancing and retracting.
[0218] Referring to FIG. 17 and FIG. 22, bushing 351 has a uniform
hexagonal aperture 352 the same size as aperture 309 in bushing 307
of stent 301, and a tapered interior wall 353 extended from it's
full diameter at it's proximal end to aperture 352. Bushing 351
also has an external tapered tip 354 at it's distal end. Bushing
351 is affixed within the distal end 345 of tube 342 with tip 354
protruding, such that the distal end 345 of stent-follower 341
mates with a self-centering action with the proximal end of stent
301 when the two devices are brought into contact with approximate
axial alignment. When stent-follower 341 and stent 301 are thus
mated, tip 334 of stylet 331 may be extended through aperture 352
and into aperture 309, thereby locking stent 301 and stent-follower
341 into a fixed rotational relationship. In this condition, the
rotation of the proximal end of stylet 331 and stent-follower 341,
causes the concurrent rotation of stent 301, whether to rotatingly
advance or retract the stent. Stylet 331 may be withdrawn and
stent-follower 341 rotatingly retracted, leaving stent 301
positioned at any useful point within a passageway.
[0219] Referring now to FIG. 23, threaded intraurethral catheter
361, shown in cross section, incorporates means for flow control.
The catheter has a tube 362 made from a section of extruded
polyurethane tubing material. with thread 363 of uniform pitch and
not more than six turns applied to it's external surface. Thread
363 conforms to the same twenty percent (20%) rule of thread height
to tube diameter, and ratio of thread pitch circumference of less
than one to one (1/1), as thread 103 in FIGS. 2 and 3 as described
above.
[0220] Alternative embodiments may have a section of the thread
being tapered to a lesser height or no height, to provide a "waist"
for gripping by a muscular zone such as the prostate or sphincter.
Also, reinforcement member 370 could be configured or molded into
the sidewall tube 362.
[0221] There is an interior shoulder 364 at the distal end 365 of
catheter 361, a bushing 367 of relatively harder material with a
tapered interior wall 368 extending from the bushing's full
diameter at one end to a uniform hexagonal aperture 369, bushing
367 being affixed within the distal end 366 of catheter 361 and
oriented with tapered wall 368 extending proximally.
[0222] A coiled sidewall reinforcement member 370 and a check ball
371 are secured within the remaining length of catheter 361 by
bushing 367 and interior shoulder 364 so that coiled member 370
holds ball 371 in compression against the upper end of bushing 367
in the manner of a check valve, which prevents outward flow through
the lumen 372 of the stent. Coiled member 370 may be compressed by
upward movement of ball 371, thereby opening the check valve to
flow.
[0223] Referring to FIGS. 19, 21, 23 and 24, alternate hexagonal
tip 384 for stylet 331 has a slightly concave proximal end 385 and
flutes 386. When used in conjunction with stent-follower 341 to
actuate the check valve of catheter 361, tip 3 84 is be inserted
through aperture 369 of catheter 361 to push ball 371 upward
against coil member 370, thereby opening the check valve function
and permitting outward flow of fluid through flutes 386 and
aperture 369 into and through stent-follower 341.
Suprapubic
[0224] Referring now to FIGS. and 25-29, the threaded suprapubic
catheter 401 of FIGS. 25 and 26 is constructed with a flexible tube
402 with a lumen 408 connecting axial ports at the proximal end and
the distal end, and an external thread 403 of uniform pitch applied
at it's distal end. As described for catheter 101 of FIG. 2 and 3,
the ratio of thread pitch 403c to the circumference of thread
diameter 403d is much less than one to one (1/1). Tube 402 is of
sufficient torsional strength to accept and transmit rotational
finger force applied at the proximal end to the distal end. The
ends of 403 are tapered for ease of advancing and retracting the
catheter through the abdomen and into the bladder wall.
[0225] Referring to FIGS. 26 and 27, relative thread height 403b,
as a percentage of tube diameter 402d, is necessarily much greater
than in the case of catheter 101 of FIGS. 2 and 3; greater than
fifty percent (50%). The suprapubic catheter is being advanced by
the rotation of thread 403 along an unlined path through the
abdomen, and being anchored against longitudinal displacement by
the low pitch 403c of thread 403 as to it's circumference in a hole
pierced into organ wall 031 that must encompass tube 402 plus
thread 403 passing through the plane of the organ wall 031. This is
distinguished from the longer gripping surface available in a lined
passage way as is the case for catheter 101 of FIG. 4.
[0226] Referring to FIG. 28, a method by which suprapubic catheter
401 is applied is conventional to the extent that trocar 421 and
cannula 422 are used with ultrasound or fluoroscopy to create the
path through abdomen wall 021 into the bladder organ 031; trocar
421 is removed and temporary guide wire 423 is then inserted
through cannula 422. extending from outside the abdomen wall 021 to
inside the bladder organ 031. Cannula 422 is then withdrawn,
leaving guidewire 423 as a connecting path extending from outside
the body, passing through the abdominal wall 021, and into the
bladder organ 031.
[0227] Suprapubic catheter 401 is then threaded through it's axial
ports onto the proximal end of guide wire 423, and gently started
into the abdomen wall 021 with a rotating motion about one turn
until thread 403 is firmly engaged. The catheter is then rotatingly
advanced along the guide wire through the unlined pathway in the
same manner as other threaded devices of the invention, until
thread 403 penetrates the wall of organ 031 about one full turn, as
determined by ultrasound, fluoroscopy or equivalent means. The
distal end of catheter 401 is secured in a non-rotatable fashion to
abdomen wall 021 using conventional adhesive means or equivalent
means, thereby locking thread 403 at the distal end of the catheter
in position in the wall of organ 031. Guide wire 423 is withdrawn.
Threaded suprapubic catheter 401 is then available for use.
[0228] Referring to FIG. 29, radiopaque markers 411 embedded at
select points displaced along the perimeter of thread 403 provide
the capability for external detection and monitoring through
fluoroscopy or other means of orientation and movement of the
distal end of the catheter.
Camera Introducer
[0229] Referring to FIGS. 30 and 31A, threaded camera introducer
catheter 500, suitable for an average size adult's colon, consists
of a bulbous tip 501 connecting to a soft, flexible tube 502 which
is about 5 feet long with a tube diameter 502d of one (1) inch.
Lumen 508 extends from the interior face of a window 511 on the
distal end of tip 501, through tip 501 and tube 502 to the proximal
end of tube 502.
[0230] Referring to FIG. 31A, external thread 503 with uniform
pitch 503c of 1 inch begins at the edge of window 511, tapering
from nothing to a height of about 0.16 inches, extending around tip
501 and tapering there to about 0.32 inches and continuing
proximally for about 6 inches along tube 502. Referring to FIG.
31B, thread height then tapers from a thread height of 0.32 inches
down to 0.16 inches and continues at this height to the proximal
end of tube 502.
[0231] An alternative embodiment of the introducer 500 may have a
relatively diminutive tip, but maintain an external thread of equal
or greater height and total circumference. Another variation of
introducer 500 may have thread 503 applied only to it's distal end,
the thread terminating after a few turns, analogous to catheter 101
of FIG. 2.
[0232] It is readily apparent from the dimensions of FIGS. 31A and
B that the 0.32 inch thread height of thread 503 spanning about 6
inches at the distal end of camera introducer 500 is greater than
twenty percent (20%) of tube diameter 502d. A relative thread
height in the range of 20 percent or more of the camera introducer
diameter size appropriate to the subject's size, is necessary to
expand and penetrate the walls of the colon to a sufficient depth
to achieve a useful grip by the thread in accordance with the
rotate to advance technology of the invention. The relatively lower
thread height of the continuing thread is adequate to assist in the
rotational advancement of the full length of the device without
exerting undue forward pressure on the distal end. It also aids in
the easing of advancement over the full length of the introducer
around and through the bends in the colon.
[0233] It will be further apparent, consistent with the techniques,
structure and methodology of the invention, that the thread pitch
503c, at one inch, is much less than the overall circumference of
thread 503, thereby providing the necessary leverage to translate
rotational effort at the proximal end to a forward force
significantly greater than the perpendicular scrapping force
against the wall of the colon. Simple vector analysis confirms this
result.
[0234] Referring to FIG. 32, a camera assembly 520 consists of
camera 521 with light lens 522 and image lens 523, attached to a
flexible, hollow, jointed spine 531. A cable harness 541 connected
to camera 521, passes through spine 531, extending out the proximal
end and connecting to the necessary power, control and display
equipment. Spine 531 is constructed of a chain of vertebrae 532,
connected by universal joints which combine flexibility with
torsional strength.
[0235] Referring to FIG. 33, camera assembly 520 is shown installed
in camera introducer catheter 501, with camera 521 secured within
tip 501 by set screw 512, so that the camera views forward through
the window. The camera assembly and catheter are combined here as a
camera introducer system.
[0236] Referring to FIG. 34, rotating container and dispensing
system 550 consists of drum 551 with axial opening 552 around which
handle 553 is rotatably attached. Catheter 501 is rotatingly
dispensed during application by holding handle 553 and rotating
drum 551 while catheter 401 is being rotatingly advanced in the
subject colon.
[0237] As will be realized, the invention is capable of other and
different embodiments, and its several details are capable of
modifications in various obvious respects, all without departing
from the invention. The objects and advantages of the invention may
be further realized and attained by means of the instrumentalities
and combinations particularly pointed out in the appended claims.
Accordingly, the drawings and description are to be regarded as
illustrative in nature, and not as restrictive.
* * * * *