|Title of Invention||
A MEDICAL DEVICE ADAPTABLE IN AN ENDOSCOPE IN DILATING A BODY LUMEN
|Abstract||The invention relates to a medical device (18) adaptable in an endoscope (50) in dilating a body lumen (60), the medical device comprising a generally transparent segment (21) comprising at least one outer surface portion (21A) having a first outer diameter (D1) sized for providing dilation of a body lumen, and a first channel (23) extending at least partially into said transparent segment (21), wherein the channel is sized for receiving an endoscope (50). The said generally transparent segment (21) is non inflatable.|
|Full Text||FIELD OF THE INVENTION
The present invention relates to a transparent dilator device for use in a lumen
of a patient's body.
Constriction of natural body lumens, such as those of the human gastrointestinal
tract, can occur in numerous ways. Some strictures are caused by muscular
spasm, others by disease, and others by injury. Regardless of the cause, the
typical method of treatment is to physically dilate the region using a medical
device designed for that purpose.
Several types of devices are used for dilation. One generally established type is a
bougie. Bougie tubes may be in the form of a mercury- or tungsten-filled tube
with a tapered end that gradually opens the strictured esophagus as it is pushed
past the treatment site. These devices come in a series of increasing sizes, each
tube having a single effective dilating diameter, generally between 3.3 and 20
mm (10 and 60 French). (French is a measure of circumference based on the
diameter in millimeters, mm). The bougie is typically introduced blindly after the
physician has judged the proper beginning size with an endoscope. Some
physicians follow a rule of thumb not to dilate a stricture more than three
successive French sizes (3 mm) in a single session. If the lumen has not
satisfactorily been opened after three sizes, the patient returns at a later time for
another treatment session.
Another type of device is a wire-guided dilator. These devices are passed into the
patient over a guidewire that has been pre-fed along a lumen of the
gastrointestinal tract. The guidewire keeps the tip of the device in the lumen
while it is being passed, to avoid perforating through the wall of the lumen.
These devices have a single outer dilating diameter and typically have a
radiopaque component so that they are visible under fluoroscopy. The following
patent documents disclose various devices in the art :US 5,366,471; US
6,334,863; US 5,766,202; and GB 2023009A.
A third type of dilating device is a balloon. Balloon dilators may be comprised of
polyethylene, and may be introduced through the working channel of an
endoscope. The physician views the proximal end of a stricture site with an
endoscope and introduces the deflated balloon into the narrowed area. The
balloon is then inflated with saline or other fluid to effectively open the stricture
site pneumatically. Balloons provide the advantages of multiple dilator diameters
with a single intubation, passage through the working channel of an endoscope,
and visualization of a stricture site from the proximal end.
Other devices such as double tapered bougies, pneumatic bougies, illuminating
bougies, solid dilator devices attached to the distal end of an endoscope, and
variable stiffness dilators have been previously described in the art. The following
patent documents disclose various types of devices in the art: US 6,010,520; US
4,832,691; US 5,624,432; US 5,718,666; WO 98/47422.
US 5,188,596 discloses a medical device of the type set forth in the preamble of
the accompanying claim 1.
Summary of the Invention
Applicants have recognized the need for a relatively low cost dilator (disposable
or non-disposable) which is relatively easy and convenient to use, and which
allows the physician to directly visualize the stricture being dilated. In one
embodiment, the present invention provides a medical device for use in dilating a
body lumen. The medical device comprises at least one generally transparent
segment, and a channel associated with the transparent segment sized for
receiving an endoscope. The generally transparent segment includes at least one
outer surface portion having a diameter sized for providing dilation of a body
lumen. The generally transparent segment is non-inflatable. In one embodiment,
the device can comprise a plurality of transparent sections, each section having
an outer surface portion with a different diameter sized for sequential dilation of
a stricture. The medical device can include at least one marking associated with
the transparent segment for indicating the position and/or value of a dilation
BRIEF DESCRIPTION OF THE DRAWINGS
While the novel features of the invention are set forth with particularity in the
appended claims, the invention in all its embodiments may be more fully
understood with reference to the following description and accompanying
FIG. 1 is a side view of wire-guided dilator 10, described in prior art, including a
guidewire channel 13, a first radiopaque marker 14, and a second radiopaque
FIG. 2 is a side view of a first embodiment of the present invention, a dilator 18
which includes a handle 19, a tube 20, a transparent segment 21, and a tapered
FIG. 3 is a sectional view of dilator 18 from FIG. 2 with an endoscope 50 inside a
body lumen 60, proximal to a stricture 61.
FIG. 4 is a detailed view of transparent segment 21 and tapered tip 22 shown in
FIG.2, including a first outer diameter Dl, a conical inner contour 32 inside
tapered tip 22, an exterior taper angle theta 1, and a narrow leading edge 34.
FIG. 5 shows a detail view of a preferred embodiment of transparent segment
21,including a second outer diameter D2, a third outer diameter D3, a plurality of
markings 43,and at least one transition 44.
FIG. 6 shows endoscope 50 inside a cross section view of dilator 18 shown in FIG
5, taken at line 6-6, including a field of view 52.
FIGs. 7A-7D illustrate steps which can be performed in using dilator 18 with an
endoscope 50. FIG. 7A) is a sectional view of dilator 18 from FIG. 5 and field of view 52 of
endoscope 50 positioned for advancement into body lumen 60 to a stricture 61. FIG. 7 B) is a
sectional view of dilator 18 from FIG. 5 and field of view 52 of endoscope 50 positioned at
first viewpoint 53 dilating to first outer diameter Dl. FIG. 7 C) is a sectional view of dilator
18 from FIG. 5 and field of view 52 of endoscope 50 positioned at second viewpoint 54
dilating to second outer diameter D2. FIG. 7 D) is a sectional view of dilator 18 from FIG. 5
and field of view 52 of endoscope 50 positioned at third viewpoint 55 dilating to third outer
Detailed Description of the Invention
The present invention relates to the field of medicine, specifically to surgery, urology,
or gastroenterology, in which a physician intends to alter the size of a constricted body lumen
in a patient, or otherwise temporarily or permanently enlarge a portion of a body lumen. By
way of example, the present invention is illustrated and described for application to an
esophageal stricture of a human patient. However, the present invention is applicable for use
in other natural lumens of human patients, including the urinary tract, biliary tract, lower
gastrointestinal tract, or bronchus; and the present invention may also be used in other animals
(e.g. for veterinary medicine), including mammals other than humans.
FIG. 1 shows a wire-guided dilator 10 described in prior art, including a guidewire
channel 13, a first radiopaque marker 14, and a second radiopaque marker 15. Guidewire
channel 13 allows wire-guided dilator 10 to be passed over a previously placed guidewire
along the lumen of a patient. First radiopaque marker 14 and second radiopaque marker 15
are detectable under fluoroscopy to determine the position of wire-guided dilator 10 relative
to a strictured area. This provides confirmation to the physician of dilation to the full
diameter of the device. The fluoroscopy procedure can be costly and can expose the
physician and patient to radiation.
FIG. 2 shows a dilator 18 of the present invention, including a handle 19 at the
device's proximal end, a tube 20, a transparent segment 21, and a tapered tip 22 at its distal
end. Handle 19 of FIG. 2 includes a longitudinal channel for receiving an endoscope 50 (see
FIG 3). Handle 19 provides the physician a location to grip dilator 18 and may be made from
an elastic material, such as silicone. In one embodiment, the proximal portion of handle 19
can have an opening (such as an opening in a flexible, elastic seal or boot made of silicone or
a suitable flexible elastic polymeric material), the hole being slightly smaller than the
diameter of the endoscope. Such an arrangement can provide frictional engagement of the
handle 19 with the endoscope 50 due to the drag force encountered in passing the endoscope
through the opening. This feature allows the physician to hold either endoscope 50 or tube 20
in a one-handed fashion to position both the endoscope and the dilator 18 with direct
visualization of a body lumen 60 (FIG. 3) during introduction or advancement of the device.
Tube 20 shown in FIG. 2 may be made of a flexible polymer, examples of which
include polyvinyl chloride (PVC), thermoplastic elastomer (TPE), polyurethane, or silicone.
In one embodiment, tube 20 is made of a transparent flexible polymer, but it may also be
made from an opaque material. A suitable transparent material from which tube 20 can be
manufactured is available as 2222RX-70 Clear 000X from Alpha-Gary Corporation
(Leominster, MA). Commercially available clear flexible PVC tubing such as Kuri Tec K050
0810 from Kuriyama of America Inc. (Elk Grove Village, IL) may also be used for tube 20.
First channel 23 of FIG. 2 is appropriately sized to receive endoscope 50 (see FIG. 3).
Various endoscopes of varying types and sizes may be used inside the present invention,
including, but not limited to, bronchoscopes, colonoscopes, cystoscopes, and gastroscopes.
Endoscope 50 may comprise a fiberscope or a videoscope, and may employ a CMOS
(Complimentary Metallic Oxide Semiconductor) chip, a miniature camera, or other
visualization device. In one embodiment, first channel 23 may be about 2mm greater in
diameter than the diameter of endoscope 50 used in the procedure so that relative motion
between endoscope 50 and dilator 18 can occur smoothly under physician control. By way of
example, a 9.5mm diameter gastroscope could be inserted into an 11.5mm diameter first
channel 23 of dilator 18 to dilate an esophageal stricture. However, dilator 18 can be sized
and configured to accommodate other endoscopes. In various other embodiments, first
channel 23 may have a diameter in the range of, but not limited to, about 3mm to about
Fourth outer diameter D4 of FIG 2 can be made as small as feasible for reason of
patient tolerance during the procedure. Fourth outer diameter D4 may be the same as the
largest diameter of transparent segment 21, or alternatively, D4 may be less than the largest
diameter in transparent segment 21. The dimensions of first channel 23 and fourth outer
diameter D4 determine the wall thickness of tube 20. This wall thickness should provide
adequate axial stiffness to advance transparent segment 21 of dilator 18 past stricture 61
without kinking, when used in conjunction with endoscope 50. The presence of endoscope 50
inside tube 20 during advancement adds to the stiffness of dilator 18, and greatly reduces the
likelihood of kinking or folding tube 20 during use. When tube 20 is made from a flexible
polymer such as a flexible PVC material, wall thickness including a range from about 1mm to
about 4mm may be used. If a portion of transparent segment 21 is made from a relatively
more rigid material, a wall thickness of 1mm or less may be used.
The length of tube 20 in FIG. 2 should be appropriately sized to comfortably reach the
targeted area within the body while handle 19 remains outside the body for physician control.
A low coefficient of friction on tube 20 allows easy sliding along the surface of body lumen
60. And, because the physician can reposition endoscope 50 within tube 20 to get a different
view, easy sliding of endoscope 50 within tube 20 may also be desired. A suitable lubricant
or low friction material (wet or dry) can be employed. For instance, a lubricating gel may be
used to lower the coefficient of friction between tube 20 and body lumen 60, and between
endoscope 50 and tube 20. Likewise, a suitable lubricant or other low friction material (such
as a coating 31 shown in Figure 4) could be applied to the inner or outer surfaces (or both) of
tube 20 or transparent segment 21 (or both) to facilitate sliding of endoscope 50 within tube
20 and also sliding of tube 20 within body lumen 60.
FIG.3 shows the dilator 18 being used in body lumen 60 to dilate a stricture 61.
Dilator 18 dilates stricture 61 in body lumen 60 under direct visualization by endoscope 50
positioned inside the device, allowing the physician to see along the entire length of stricture
61 from the inside out. The invention replaces the current methods of dilating body lumen 60
without direct visualization and improves on current methods of dilating with balloons and
other devices that allow visualization from only the proximal side of stricture 61 during the
procedure. By way of example, this illustration shows the invention used to dilate an
esophageal stricture, but it could be used to dilate constrictions in other body lumens.
Transparent segment 21 shown in FIG. 4 and in FIG. 5 is a transparent portion of the
device through which a physician views the stricture 61 during dilation of stricture 61.
Transparent segment 21 extends from the distal portion of tube 20 and may be made of a
transparent material, including clear PVC, TPE, polyurethane, glass, or polycarbonate.
Attachment means for attaching transparent segment 21 to tube 20 may include a flange with
adhesive, a plurality of mechanical ribs, a plurality of screw-type threads, or other
combinations of geometric projections and adhesives. Tube 20 and transparent segment 21
may also be formed as a single, unitary piece, such as by forming tube 20 and transparent
segment 21 together by molding or casting. Rigid segments may also be incorporated into
transparent segment 21, especially in instances where wall thickness is about 1mm or less.
Such rigid segments could be over-molded in place or fixed by adhesive in a desired location.
In one embodiment, first channel 23 (FIG. 2) extends into transparent segment 21 so that
endoscope 50 may be advanced within transparent segment 21.
The transparency of transparent segment 21 allows direct visualization of tissue
outside the device from endoscope 50 located within the device. Therefore, it can be
desirable to minimize distortion or obstruction of view through transparent segment 21.
Suitable transparency of transparent segment 21 can be accomplished by controlling material
selection and molding finish. The material from which transparent segment 21 is constructed
should be clear, and the mold used should be polished so that the molded part has a smooth
outer surface. Transparent segment 21 may include markings 43 (Figure 5) such as one or
more markings 43 indicating the outside diameter of transparent segment 21 at the
longitudinal position of the particular marking. Anatomical landmarks, color variations,
tissue differences, foreign bodies, and any markings 43 (FIG. 5), and other items of interest
should be recognizable when viewed with endoscope 50 disposed within transparent segment
21. An appropriate material for transparent segment 21 can have a haze value of about 5% or
less, and have a light transmission property of about 80% or greater. Haze value is a material
property, expressed in percent, describing the amount of "cloudiness" in a material caused by
particulate impurities, molecular structure, or degree of crystallinity, resulting in scattering of
light and apparent cloudiness. Light transmission is a material property indicating the
percentage of incident light that passes through an object. In addition to using transparent
material to form segment 21, a mold used to create segment 21 can be highly polished to
create a smooth surface that does not distort the view seen through endoscope 50 when the
viewing device of endoscope is disposed inside segment 21 to view lumen tissue outside of
Having a low coefficient of friction of transparent segment 21 allows the device to
slide freely inside body lumen 60, especially during dilation of stricture 61. Lubricating gel,
such as K-Y brand lubricating jelly available from Johnson and Johnson can be used to lower
the coefficient of friction during use. In one embodiment, a coating 31 (FIG. 2) can be
disposed on one or both of the inner and outer surfaces of the transparent segment 21, in
which coating 31 is transparent and has a lower coefficient of friction when hydrated than
when dry. One example of coating 31 is a hydrogel material made by the interaction of poly-
vinylpyrrolidone with one or more isocyanate prepolymers. A coating such as Hydromer®
Lubricious Medical Coatings by Hydromer Inc. (Somerville, NJ) can be used for coating 31.
Such a coating can reduce the drag force along the axis of a lumen during dilation, creating a
more efficient device when compared to existing dilators.
FIG. 4 shows a section view of dilator 18 including a first outer diameter Dl and a
tapered tip 22. Tapered tip 22 may be made of a flexible polymer that is pliable compared to
body tissue and may be attached to the distal end of transparent segment 21. In one
embodiment, tapered tip 22 can be made with the same material as transparent segment 21, if
transparent segment 21 is made of a flexible polymer. In one embodiment, a biomedical
grade of clear flexible PVC having a hardness value of about 60 to 80 on the Shore A scale
can be used to form tapered tip 22 and transparent segment 21. For example, a clear flexible
PVC material such as XV-3450 from PolyOne Corp. (Avon Lake, OH) could be used to mold
both transparent segment 21 and tapered tip 22 as a single part. Another material from which
tip 22 and segment 21 may be formed is material designated 2222RX-70 Clear 000X from
Alpha-Gary Corp (Leominster, MA), which material can be gamma stable to allow gamma
radiation to be used for sterilization. Other suitable materials such as TPE or polyurethane
can also be used.
Tapered tip 22 facilitates intubation into body lumen 60 by gradually tapering from a
first outer diameter D1 to a narrow leading segment 34 with an exterior taper angle thetal, as
shown in FIG. 4. In one embodiment, tapered tip 22 includes a second channel 27 in
communication with a conical inner contour 32 and first channel 23 so that the device can be
threaded over a guidewire. Second channel 27 can be sized appropriately for a guidewire,
including diameters in the range from about 0.5mm to about 1.5mm. Exterior taper angle
thetal can be selected to provide a desired amount of radial force transmitted against stricture
61 for a given level of axial force (force parallel to length of the dilator 18) applied by the
physician. Generally, a low value of exterior taper angle provides an efficient, comfortable
transmission of radial force against the stricture, with the trade-off that low values of exterior
taper angle generally increase the length of the dilator 18 that must be inserted past the
stricture. For instance and without limitation, the dilator can have an exterior taper angle
thetal in a range including about 3 degrees to about 15 degrees. In one embodiment, the taper
angle can be between about 6.5 and about 7.5 degrees.
FIG. 4 shows conical inner contour 32 connecting first channel 23 to second channel
27 with an interior taper angle theta2. The connection has a conical shape to reduce the glare
from endoscope 50 during use. Conical inner contour 32 also facilitates molding by allowing
a central core pin to be tapered for ease of removal. In one embodiment, the value of interior
taper angle theta2 is different from value of exterior taper angle thetal to provide a varying
wall thickness along the length of the device, so that radial strength can be tailored as needed
along the length of the device. By way of example, the exterior taper angle thetal can be
about 7 degrees, and the interior taper angle theta2 can be about 6 degrees.
In FIG. 4, conical inner contour is shown initiating at the distal end of a segment with
first outer diameter Dl, but other initiation locations are possible. For example, if conical
inner contour 32 initiates at a more proximal location (e.g. forward of the "14 mm" marking
in Figure 4), a thicker wall is created at the distal portion of a segment with first outer
diameter Dl, providing radial stiffness to that area while still allowing endoscope 50 to slide
far enough to view out tapered tip 22 during insertion. Such an arrangement can help ensure
adequate radial strength of in the portion of the device having inner diameter Dl.
FIG. 5 depicts a preferred embodiment of transparent segment 21 comprised of a first
transparent section 21A having a first outer diameter Dl; a second transparent section 21B
having a second outer diameter D2, and a third transparent section 21C having a third outer
diameter D3, each pair of adjacent sections separated by a transition 44. The first, second and
third sections can each be generally cylindrical. Transitions 44 provide a tapered (linear or
curvilinear) transition in diameter from the outer diameter of one section to the outer
diameter of the adjacent section. The transitions can have can have a hollow conical
configuration, such as a conical shape generally the same as that of a truncated cone having a
centrally located passageway. Alternatively, the dilator 18 can have diameters Dl, D2, D3,
and D4 on a single continuous outer surface portion which is tapered linearly or curvilinearly
Figure 5 also shows plurality of markings 43 for the physician to select and position
the desired dilating diameter in the area of stricture 61 during the procedure. Markings 43
provided to be visible through the optical device (e.g. camera, fiber optic cable, etc.)
associated with the endoscope 50 and may have several uses, including delineating the
boundaries of a single dilating diameter, or indicating the numeric value of a dilating
diameter. Markings 43 may be molded into the part, applied with ink, etched on the device,
or applied by any other suitable method. In one embodiment, numerical indications may be
applied to the outer surface of transparent segment 21 in multiple locations, some of which
are readable by endoscope 50 from inside the device (necessitating them to appear backwards
from the exterior of the device, but appearing forward from inside the device), and some of
which are readable from the exterior of the device (appear backward from endoscope 50
inside the device). In addition to markings comprising numerals or letters, other embodiments
of plurality of markings 43 may include use of various other indicia, including without
limitation one or more different colors, and/or use of different geometric shapes, such as to
designate different sections or segments, or attributes of different portions of the device. For
instance, a row or column of circles could be used to designate a first section, a pattern of
circles and dashes could designate a second section, and a pattern of circles, dashes, and
squares could designate a third section. Markings 43 can also be coated or otherwise treated
with a substance to make them luminous or glow in reduced lighting.
FIG. 6 shows a cross section of transparent segment 21 and tapered tip 22 of FIG 5
taken at line 6-6 with endoscope 50 positioned inside. A field of view 52 is depicted to
indicate the area in view by the physician. Because endoscope 50 is movable with respect to
dilator 18, a change in the position of endoscope 50 allows the physician to see a different
area of body lumen 60 within field of view 52.
FIGs 7A-7D show four possible steps a physician may use to dilate stricture 61 with
dilator 18 and endoscope 50. FIG. 7A shows the relative positions of endoscope 50 and
dilator 18 upon insertion into body lumen 60 to a location of stricture 61. In this position,
field of view 52 is used to view body lumen 60 during insertion, and to view the proximal
location of stricture 61.
FIG 7B shows endoscope 50 at a first viewpoint 53 so field of view 52 includes first
outer diameter Dl. While viewing plurality of markings 43 for reference, dilator 18 is
advanced into stricture 61 causing dilation to first outer diameter Dl. Plurality of markings
43 may delineate the boundaries of diameter Dl and may also indicate its numerical value. In
this manner, the physician has a visual indication through endoscope 50 of where to position
dilator 18 with respect to stricture 61 for precise dilation to a desired diameter.
FIG. 7C shows a next potential step to further dilate stricture 61 if desired by the
physician. Endoscope 50 is placed at a second viewpoint 54 relative to dilator 18 so that field
of view 52 includes second outer diameter D2. The medical device is further advanced into
stricture 61 to further dilate to second outer diameter D2 while viewing another portion of
plurality of markings 43 for reference.
FIG. 7D shows endoscope 50 at a third viewpoint 55 so that field of view 52 includes
third outer diameter D3. Again, the medical device may be further advanced to dilate stricture
61 to third outer diameter D3 while again viewing yet another portion of plurality of markings
43 as a reference. In this manner, the physician can visually examine the entire length of a
stricture with endoscope 50 as the dilation occurs.
An alternative method of use is to first place a guidewire in body lumen 60 of the
patient, then thread dilator 18 over that guidewire using second channel 27, conical inner
contour 32, and first channel 23. Dilator 18 may then slide into the guidewire, after which
endoscope 50 may be placed into first channel 23. The guidewire does not need to be
threaded through the working channel of endoscope 50, but a physician may do so if desired.
The combination of endoscope 50, dilator 18, and guidewire could then be used according to
the steps illustrated in FIGs. 7A-7D.
A physician advancing a dilator through a stricture 61 will normally feel resistance. In
prior art devices where the physician attempts to "blindly" introduce a dilator, perforation or
other damage to the body lumen may occur. Further, if such damage occurs, the physician
may not immediately recognize that damage has occurred. The present invention can permit
the physician to visualize a medical procedure (e.g. dilation of a stricture) as the procedure is
performed, thereby providing the physician with immediate feedback on the state of the tissue
being treated. Such visualization can help in avoiding unintended damage of tissue which
might otherwise occur if the physician is not able to directly visualize the procedure. In the
unlikely even that damage does occur, the physician can immediately notice it and can choose
to cease treatment and begin a new course of action to repair the damage. Direct visualization
provided by endoscope 50 inside dilator 18 allows the physician to know that he/she has not
perforated, bruised, or otherwise damaged body lumen 60.
Another useful feature of the dilator 18 is that it provides one with the ability to dilate
to more than one diameter with a single introduction of the device, and with precision. This is
made possible by the ability to see plurality of markings 43 from inside transparent segment
21 to identify a particular dilating diameter. Previously disclosed devices with multiple
diameters rely on tactile feedback, remote markings, or costly pressure meters (e.g. in the
case of balloons) to control the diameter. The intuitive nature of plurality of markings 43
allows the physician to easily select the desired diameter by looking clearly through the
device, along the whole length of stricture 61, adding precision to the device when compared
to current methods, which may involve elaborate measuring schemes.
Dilator 18 can also be less costly to manufacture than some balloon style dilators.
Accordingly, devices of the present invention may be cost effectively packaged and sold as a
single-use, disposable product which does not require cleaning or re-sterilization. Dilator 18
can be pre-sterilized and packaged in a sterile pouch or other suitable package.
Dilator 18 can also provide reliability in terms of dilating diameter compared to
certain balloon type dilators. Some balloons may not hold a constant diameter when inflated,
so the dilation is not as reproducible as a tube of known size being passed through a
constricted area. Dilator 18 provides two-vector shearing of stricture 61. This results from
sliding a tapered-tip device through a narrowed area, thereby applying forces in both the axial
and radial directions. Balloons typically only apply a generally radial directed force to a
Dilator 18 can also provide affordable and convenient dilation with the ability to
directly visualize the treatment along the entire length (not just a proximal or distal portion) of
a stricture 61 without the use of expensive or potentially harmful radiographic equipment to
confirm placement. When using radiographic equipment, a dilation procedure is typically
performed in a radiographic suite, which often requires additional logistics of scheduling an
additional appointment and different staffing needs, which in turn can require additional time
and cost. Dilator 18 can provide complete direct visualization with endoscope 50 without the
additional costs or time associated with radiographic equipment.
The present invention has been illustrated as having a transparent segment
having generally circular cross-sections, but non-circular cross-sections (e.g.oval,
elliptical, polygonal) can also be used, in which case the term "diameter" will be
understood to refer to the maximum dimension of the non-circular cross-section
used for providing dilation. The present invention may be provided in kit form
with other medical devices, and the kit elements can be pre-sterilized and
packaged in a sealed container or envelope to prevent contamination. The
present invention may be provided as single use disposable device or
alternatively, may be constructed for multiple uses.
While various embodiments of the present invention have been disclosed, it will
be obvious to those skilled in the art that such embodiments are provided by
way of example only. Further, each element or component of the present
invention may be alternatively described as a means for performing the function
or functions performed by the element or component. Numerous variations,
changes, and substitutions will now occur to those skilled in the art without
departing from the invention. Accordingly, it is intended that the invention be
limited only by the scope of the appended claims.
1. A medical device (18) adaptable in an endoscope (50) in dilating a body
lumen (60), the medical device comprising a generally transparent
segment (21) comprising at least one outer surface portion (21A) having a
first outer diameter (Dl) sized for providing dilation of a body lumen, and
a first channel (23) extending at least partially into said transparent
segment (21), wherein the channel is sized for receiving an endoscope
characterized in that said generally transparent segment (21) is non
2. The medical device as claimed in Claim 1 wherein said transparent
segment (21) comprises a plurality of outer surface portions (21A, 21B,
21C), each outer surface portion having a different diameter (D1,D2,D3),
and said diameters sized for providing sequential dilation of a stricture
3. The medical device as claimed in Claim 2 wherein said transparent
segment (21) comprises at least three outer surface portions
(21A/21B,21C), each outer surface portion having a different diameter
4. The medical device as claimed in claim 1,2 or 3 wherein said transparent
segment (21) comprises at least one marking (43) for indicating the
position of a diameter sized for providing dilation.
5. The medical device as claimed in claim 1,2,3 or 4 wherein said
transparent segment (21) comprises at least one marking (43) for
indicating the size of a diameter for providing dilation.
6. The medical device as claimed in claim 4 or 5 further comprising a
plurality of markings (43) on said transparent segment (21) wherein said
plurality of markings are viewable with an endoscope (50) positioned in
said channel (23).
7. The medical device as claimed in claim 6 wherein said plurality of
markings (43) delineates the plurality of outer surface portions
(21A,21B,21C) of said transparent segment (21) .
8. The medical device as claimed in claim 6 or 7 wherein said plurality of
markings (43) indicates the numeric value of the outer diameter
(D1,D2,D3) of each outer surface portion (21A,21B,21C).
9. The medical device as claimed in any preceding claim comprising a
tapered tip (22) and a second channel (27) in said tapered tip in
communication with said first channel (23), said second channel for
receiving a guidewire.
10. The medical device as claimed in any preceding claim comprising a
coating (31) for reducing friction, wherein said coating is generally
11.The medical device as claimed in claim 10, wherein said coating (31) is
located on the inner surface of said transparent segment (21).
12. The medical device as claimed in claim 10 wherein said coating (31) is
located on the outer surface of said transparent segment (21).
13.The medical device as claimed in any preceding claim comprising a handle
(19) positioned proximally of said transparent segment (21), wherein said
handle includes a longitudinal channel in communication with said first
channel (23) for receiving the endoscope (50).
14. The medical device as claimed in claim 3, wherein said transparent
segment (21) comprises:
- a second outer diameter (D2) proximal to said first outer diameter (Dl),
wherein said second outer diameter is larger than said first outer diameter;
- a third outer diameter (D3) proximal to said second outer diameter (D2),
wherein said third outer diameter is larger than said second outer
The invention relates to a medical device (18) adaptable in an endoscope (50) in
dilating a body lumen (60), the medical device comprising a generally
transparent segment (21) comprising at least one outer surface portion (21A)
having a first outer diameter (D1) sized for providing dilation of a body lumen,
and a first channel (23) extending at least partially into said transparent segment
(21), wherein the channel is sized for receiving an endoscope (50). The said
generally transparent segment (21) is non inflatable.
636-kol-2003-granted-reply to examination report.pdf
636-kol-2003-granted-translated copy of priority document.pdf
|Indian Patent Application Number||636/KOL/2003|
|PG Journal Number||07/2009|
|Date of Filing||16-Dec-2003|
|Name of Patentee||ETHICON ENDO-SURGERY, INC|
|Applicant Address||4545 CREEK ROAD, CINCINNATI, OHIO|
|PCT International Classification Number||A61M 29/02|
|PCT International Application Number||N/A|
|PCT International Filing date|