Title of Invention

"SHEATH DEVICE FOR ENDOSCOPIC INSTRUMENTS"

Abstract A sheath device (1) for endoscopic instruments (2) and comprising an elongated tubular member (4) having a proximal end (6), a distal open end (7), and at least one fluid channel (23). A flushing unit (5) is connected to the proximal end (6) of the tubular member (4) and comprises a proximal open end (8) suitable for receiving a first endoscopic instrument (2), a fluid inlet (16) in contact with said fluid channel (23), and a fluid outlet (17). The tubular member and the flushing unit together define a first interior guiding passage (10) for sheathing at least a part of said first endoscopic instrument (2). The connection between the tubular member (4) and the flushing unit (5) allows for axial rotation of the tubular member (4) in relation to the flushing unit (5).
Full Text FIELD OF THE INVENTION:
The present invention relates to a sheath device for an endoscopic instrument, such as a catheter or cystoscope, which, said sheath when mounted onto any optical device, allows for the surgeon to examine or manipulate within an orifice or through a incision, whilst easily manipulating the endoscopic device. The device allows for delivery by means of an agent to the target organ or tissue at variable positions whilst maintaining a fixed position of the optical device or fluid inlet/outlet device.
BACKGROUND OF THE INVENTION
In medical practise, whether for purposes of examination or surgical procedures, the devices used in the practice must allow for the surgeon to easily interact with the patient's organs and cavities. Devices cumbersome to handle or manipulate may result in unsuccessful surgical procedures, misdiagnoses and, particularly in the case where the patient is not anaesthetised, great discomfort to the patient.
UK 2 284 158 discloses an injection catheter consisting of an outer sheath and a needle means located in and axially movable with relation to the outer sheath. Thus, when performing multiple injections, retraction of the needle means and rotation of the outer sheath is required. Moreover, the device does not allow for visualisation during the medical procedure.
WO 99/47069 discloses an instrument for guiding delivery of an injectable material for treating urinary incontinence. The device does not allow for variable positions of injection nor for visualisation during the medical procedure.
US 5,020,514 discloses an endoscope for nasal surgery. Said endoscope comprises an outer shaft with a handle incorporating a switching valve for connecting/disconnecting a source of negative pressure and a source of a flushing fluid. A working insert, for insertion into the outer shaft, comprising a shaft for receiving an optical system, proximally connected to the working insert, a shaft for receiving an auxiliary instrument, and two guides for wires and rods, which are movable by means of handles.
US 5,287,845 describes an endoscope for transurethral surgery, which has a main body irrotationally supporting an optic and a surgical instrument, an outer tube affixed to the main body and tubular enclosing the optics and the surgical instrument. The outer tube is rotational relative to the remaining endoscope parts.


A further aspect of the invention relates to a method of injecting a material into the human
body comprising the use of the device of the invention. The invention further relates to a
kit comprising the device and a material suitable for injection into the human body, such
as a polymeric hydrogel comprising polyacrylamide.
A further aspect of the invention relates to a device for use in the examination or surgical
treatment of a mammalian body, such as a human.
DESCRIPTION OF THE INVENTION
It is an object of the present invention to provide an endoscopic device that allows for the
surgeon to manipulate the working element during operation and/or diagnosis while keep
non-working elements immobile.
Further, it is an object of the present invention to provide for a sheath of an endoscopic
equipment which needs minimal sterilisation and is disposable.
According to the invention, the above objectives is fulfilled by a sheath device suitable for
endoscopic instruments, the device comprising:
a) an elongated tubular member comprising:
a proximal end,
a distal open end, and
at least one fluid channel extending longitudinally from said proximal end to a fluid
exit; and
b) a flushing unit connected to said proximal end of the tubular member and comprising:
a proximal open end suitable for receiving a first endoscopic instrument,
a fluid inlet being in contact with said fluid channel, and
a fluid outlet,
the tubular member and the flushing unit together define a first interior guiding
passage extending longitudinally from the proximal open end of the flushing unit to the
distal open end of the tubular member for sheathing at least a part of said first
endoscopic instrument,
and wherein the connection between the tubular member and the flushing unit allows for
axial rotation of the tubular member in relation to the flushing unit.
The term "internal organ" is intended to mean an organ, tissue or any cellular structure
located inside the body cavity.
The term "endoscopic instrument" is intended to mean any kind of scope for surgery or
diagnosing of internal cavities of a human body.
In a preferred embodiment, the elongated tubular member and the flushing unit each
comprises an interior guiding passage, which together defines said first interior passage,
when the two elements are connected to each other. Thus, the first endoscopic instrument
may be received through the proximal open end of the flushing unit and pushed into the
guiding passage. The first endoscopic instrument may be a lens for viewing internal tissue
or organs during operation or diagnosing, said instrument being coupled to a camera that
may be connected to a television/screen.
The tubular member sheaths at least the part of the endoscopic instrument to be
positioned inside the body, and while sheathing said part, the open distal end of the
tubular member is introduced e.g. through a cavity in the body into the tissue or organ.
The sidewall of tubular member may have a smooth outer surface so as to expose the
patient for as less pain as possible, when introducing it into the cavity, e.g. the urethra,
vagina or rectum. Preferably, the cross-section perpendicular to the longitudinal direction
of the tubular member is substantially circular, but it may be substantially oval shaped.
The entire tubular member or just be the part, which is to be introduced to the body, e.g.
5-15 cm of the tubular member (measured from the distal end), may have a circular or an
oval outer cross-section.
The diameter of the tubular member may differ depending on the sort of endoscopy, such
as from 3 mm and up to 15 mm. For treatment of incontinence, the diameter of the part,
which is to be introduced through the urethra, is preferably 7-8 mm.
Also the length of the tubular member may vary depending of the sort of endoscopy, so
the length can be e.g. 5-30 cm, such as 10-25 cm, such as 15-20 cm.
The flushing unit is arranged for providing a flush of water (or other fluids) through the
fluid exit, which preferably is located near said distal end or in said distal end. The flush
may be used for flushing e.g. removed tissue or bone parts out of the body during an
operation, or for flushing e.g. the bladder when operating for incontinence. The fluid
channel is preferably placed between said interior guiding passage and the sidewall of the
tubular member, but it may be placed separately inside the interior guiding passage of the
tubular member. The diameter of the outlet may be larger than the diameter of the inlet.
In case the sheath device e.g. is used for treatment of anal incontinence, it is not needed
to flush water into the rectum and therefore the flushing unit may be removed. Thus, the
sheath device may in this case be rotationally connected directly to the endoscopic
instrument.
The fluid exit is preferably positioned in the distal open end, but alternatively it may
comprise one or more holes provided in the sidewall near the distal open end of the
tubular member, so that the water exits the tubular member in an angle in relation to the
longitudinal direction of the tubular member.
The tubular member and the flushing unit are preferably fixed (but still rotatable)
connected to each other, but they may be detachable connected so that the two elements
can be separated.
In a preferred embodiment of the invention, the tubular member further comprises a
second guiding passage extending substantially longitudinal from a location near the
proximal end or from the proximal end to the distal end of the tubular member, the second
passage being suitable for receiving and guiding a second endoscopic instrument.
As the second guiding passage is positioned in the tubular member, it allows for rotation of
the second endoscopic instrument in relation to the first endoscopic instrument and
flushing unit. This is a major advantage during operation, as an endoscopic operation
requires movement and rotation of one or more of the instruments positioned inside the
body during the operation, and which can be complicated to control. As the second guiding
passage can be rotated separately, the surgeon only needs to move the tubular member
with the second instrument and not the flushing unit and first endoscopic instrument, when
moving the second instrument e.g. from one tissue area to another. This provides an
easier handling of the equipment and a less painful operation for the patient.
In particular, the second guiding passage is useful when treating a patient for
incontinence. This treatment comprises i.a. the step of injecting a bulking agent in
different tissue areas of the urethra near the bladder neck. In that case, the first
instrument may comprise a lens and second instrument may comprise a needle to be
introduced to the tissue, the needle being guided into the second guiding passage upon
introducing the tubular member into the bladder through the urethra. The needle is
introduced to the tissue area and the bulking agent injected, and if the surgeon wants to
inject agent in another tissue area, he/she, may just retract the needle from the tissue,
rotating the tubular member without moving the lens and flushing unit, and introducing
the needle in another tissue area. Thus, the surgeon can maintain the lens in the same
orientation while moving the needle (by the tubular member) inside the body.
The tubular member may be rotatable within an angle range of 0° to 360° in relation to
said flushing unit, such as 45° or 90°. The connection between the tubular member and the
flushing unit may comprise indicating means for indicating the axially angular rotation
between the tubular member and the flushing unit + the first instrument.
Preferably, the second guiding passage comprises an inlet in its end closest to said
proximal end of the tubular member, the inlet being arranged in an outer surface of said
tubular member. The inlet may be substantially conical shaped so as to provide a better
guidance of said second instrument into the passage. The inlet may comprise a penetrable
sealing to be penetrated by the instrument. Preferably, inlet may comprise the conical
shaped inlet made of rubber.
In order to improve the bending moment of the tubular member and thus prevent a
breakage of the member, it may comprise reinforcement ribs extending on the outer
surface of the tubular member from its proximal end and along at least a part of the
tubular member towards the distal end. The inlet of the second guiding passage may be
incorporated in one of the reinforcement ribs.
The second endoscopic instrument may comprise a needle, such as a needle for injecting
bulking agent or another medical, the needle being flexible over a substantial portion of its
length. The needle may be an ablation needle having cutting edge(s) for ablating and/or
penetrating tissue.
Alternatively, the second instrument may comprise a fibre optic probe for operation of
internal tissue.
Preferably, the sheath device may be disposable (onetime use) in order to provide a
surgical equipment that requires as less sterilisation time as possible. Also the flushing unit
may be disposable, in particular if the tubular member and the unit is fixed connected to
each other.
In order to prevent reuse of the disposable sheath device and the flushing unit, a rubber
sealing may be provided e.g. between the flushing unit and the tubular member, the
rubber sealing being destroyed when exposing the sheath device to a sterilisation process
e.g. in an autoclave.
The flushing unit is provided for the purpose of flushing water into the internal organ of the
body so as to flush out removed tissue or bone parts. The fluid inlet may be connected to a
water reservoir via a flexible tube for flushing clean water through the fluid channel and
out of said fluid exit into the organ. The outlet may also be connected via a flexible tube to
another water reservoir for flushing filthy water away from the internal organ via said
interior passage.
The fluid outlet may be in contact with said open distal end of the tubular member via an
interior passage extending longitudinally in said tubular member. Preferably, the interior
passage is composed by the first guiding interior guiding passage of the tubular member,
the diameter of which being larger than the diameter of the endoscopic instrument
introduced therein. Thus, filthy water may flow into said distal open end, along the outer
surface of the endoscopic instrument and out through the outlet. Alternatively, the outlet
may be in contact with the distal open end via a separate passage/fluid channel provided
in the tubular member.
In a preferred embodiment, the flushing unit comprises an inner tube and an outer tube
surrounding the inner tube with a space therebetween. The inlet is connected to the space
created between the outer and inner tube, and the outlet is connected to the space inside
the inner tube. When assembling the flushing unit with tubular member, the inner tube will
be connected to the first guiding passage, and the outer tube will be connected to the fluid
channel(s). Thus, when e.g. flushing the bladder and/or urethra the fluid that exits the
distal end of the tubular member will be flushed back into the first interior guiding passage
without applying a suction in the first passage. This is a substantially faster process than
for devices described in the prior art where flushing and suction are turned on separately.
However, a suction may be provided in the first guiding passage so that the fluid is sucked
out of the bladder and/or urethra.
The first interior guiding passage of the flushing unit may be arranged coextendingly inside
the inner tube, so that this passage is connected to the interior guiding passage of the
tubular member when connecting the flushing unit thereto. Thus, the first interior guiding
passage, extending longitudinally from the proximal open end of the flushing unit to the
distal open end of the tubular member for sheathing at least a part of said first endoscopic
instrument, is defined, cf. claim 1.
The proximal open end of the flushing unit is suitable for receiving and guiding the first
endoscopic instrument into said interior guiding passage. Sealing means may be provided
in said proximal open end of the flushing unit to obtain a tight connection to the
endoscopic instrument.
The first and second guiding passages and the fluid channel preferably extends
substantially parallel to each other. When seeing the tubular member in the cross-section
perpendicular to its longitudinal direction, it may have a honeycomb-like cross-section,
wherein the first guiding passage is provided in the middle (on the centre line of the
tubular member) and the fluid channel(s), second guiding passage or more guiding
passages are provided between the first guiding passage and the sidewall of the tubular
member.
Due to ease of production of the sheath device, the fluid channel and guiding passages
may provided by a detachable wall member positioned inside the tubular member, and
which is not moulded simultaneously with the tubular member, but inserted therein
afterwards. The detachable wall member may, together with the sidewall of the tubular
member, define said fluid channel(s) and passages.
The tubular member may comprise two or three further longitudinal extending guiding
passages for further endoscopic instruments.
The distal end of the tubular member may comprise a circumferential inwardly extending
bulge for guidance of a distal end of said second endoscopic instrument, in particular the
abovementioned flexible needle. The bulge is useful in connection with the
abovementioned treatment for incontinence, because the distal end of the needle can be
bend, so as to provide an even better control of the needle tip. The bulge may bend the
distal end of the needle such that it may emergence the tubular member at angle of 5-45°
in relation to the centre line of the tubular member.
Depending on the sort of endoscopic operation/diagnosing, the sheath device may be
suitable for different kinds of endoscopic instrument. The instruments to be introduced to
the first interior guiding passage may comprise a cystoscope or a gastroscope or an
ureteroscope or a resectoscope or an arthroscope or a telescope or an obturator.
The first endoscopic instrument may also comprise a camera lens e.g. for viewing internal
tissue or organs. The lens is connected to a camera so that the surgeon can view the
inside of the body on a screen. Due to the second guiding passage, the surgeon only has
to look at the screen and not on the endoscopic equipment, as the passage guides e.g. the
needle.
The lens may be disposable (onetime use). A type of lens used for this purpose could be
the sort of lenses used in the "night vision goggles" in the military. The disposable lens
may be incorporated in the tubular member, so that the surgeon only has to connect the
sheath device to the endoscopic instruments needed for the operation and connect the lens
to a camera. After the operation, the sheath device with the lens incorporated is thrown
away, and the sterilisation process is dispensed with.
Preferably, the distal end of the tubular member exceeds a distal end of the lens, so that
the surgeon, when introducing an instrument through the second guiding passage, may
view the tip of the instrument on the screen, before the instrument is introduced into the
tissue or organ.
When treating for incontinence known methods and equipment require a visual survey
meaning that the surgeon need to view an outflow of urine before knowing the right
location to be treated in the bladder neck. As the sheath device according to the invention
allows for use of both a camera lens and an injection needle at the same time, a visual
survey is dispensed with, as the surgeon can find the right location to be treated on the
television/screen.
The sheath device may be made of an appropriate plastic material or a metal.
A generally interesting aspect of the invention relates to a method of injecting a material
into the human body comprising the use of the device of the invention.
A very interesting aspect of the invention relates to a kit comprising i) the device of the
invention; ii) a material suitable for injection into the human body. The material is selected
from the group consisting of silicone, hyaluronic acid, polyacrylamide hydrogel, soya,
alginates such as modified alginates, bacterial polysaccharides such as gellan gum, plant
polysaccharides such as carrageenans, hyaluronic acids, polyethylene oxide-polypropylene
glycol block copolymers, proteins such as fibrin, collagen, and gelatin, mixtures of
polyethylene oxide and polyacrylic acid, cross-linked chitosan, photochemically crosslinked
ethylenically unsaturated groups, macromers such as PEG-oligolactyl-acrylates,
polyethylenimine, poly-lysine, poly(vinylamine), and poly(allylamine). In a preferred
embodiment, the material is polyacrylamide and derivatives thereof.
Suitable material, may be selected from Metacril, Dermagen, Evolution®, OutLine®.
Formacryl(R)f Arqiform®, Bioformacryl. DermaLive, DermaDeep(R), Amazing Gelf
Bioplastique®. Artecoll®. Arteplast®, Silicone Injections, Prof ill or Prof i I, AouamidCR)r Bio-
Alcamid™, Radiance (by Bioform) or derivatives thereof or materials of essentially the
same chemical composition.
As stated, in a preferred embodiment, the material is polyacrylamide and derivatives
thereof, most preferably wherein the cross-linked polyacrylamide was prepared from
methylene-bis-acrylamide.
A further aspect of the invention relates to a device for use in the examination or surgical
treatment of a mammalian body, such as a human.
A further aspect of the invention relates to the use of a device of the present invention for
the examination or surgical or diagnostic treatment of a mammalian body, such as a
human. The invention relates to a method of treating or examining an internal organ of a
mammalian body comprising the use of the device of the invention.
In a typical embodiment, the method of the invention relates to a method of treating,
examining or diagnosing a urogenitial organ comprising the use of the device of the
present invention. In a typical aspect of the invention, the invention relates to a method of
performing a gynealogical examination, typically on a woman, comprising the use of the
device of the invention.
In a particularly interesting aspect, the invention is directed to a method of treating
incontinence comprising the use of the device of the invention, typically urinary
incontinence or anal incontinence.
In a further aspect, the invention is directed to a method of treating an articular joint in a
mammal comprising the use of the device of the invention.
In a further aspect, the invention is directed to a method of treating vesicouretal reflux
comprising the use of the device of the invention
In a further aspect, the invention is directed to a method of treating reflux esophagitis
comprising the use of the device of the invention.
In a further aspect, the invention is directed to a method of treating arthritis comprising
the use of the invention. Similarly, in a further aspect, the invention is directed to a
method of treating tendonitis comprising the use of the device of the invention.
In a preferred embodiment, the hydrogel of the invention is for use in the treatment of
urinary and anal incontinence, more preferably urinary incontinence.
Urinary incontinence may be stress or reflex urinary incontinence or urge urinary
incontinence. Typically, the hydrogel of the invention is suitable for the treatment of stress
or reflex urinary incontinence.
In a further aspect of the invention, the present hydrogel is used in the preparation of an
endoprosthesis. Thus, a further object of the invention is the use of a hydrogel, as
described supra, comprising about 0.5 to 25% by weight polyacrylamide, based on the
total weight of the hydrogel, for the preparation of an endoprosthesis for the treatment
and prevention of incontinence and vesicouretal reflux.
The endoprosthesis is suitably formulated as an injectable suspension. The suspension
^comprLses^JiQrnogenised formulation of the hydrogel. Typically, a syringe is filled with the
ENDOSCOPIC ATTACHMENT DEVICE
FIELD OF THE INVENTION
The present invention relates to a sheath device suitable for an endoscopic device, such as
a catheter or cystoscope, which, said sheath when mounted onto any optical device, allows
for the surgeon to examine or manipulate within an orifice or through a incision, whilst
easily manipulating the endoscopic device. The device allows for delivery by means of an
agent to the target organ or tissue at variable positions whilst maintaining a fixed position
of the optical device or fluid inlet/outlet device.
BACKGROUND OF THE INVENTION
In medical practise, whether for purposes of examination or surgical procedures, the
devices used in the practice must allow for the surgeon to easily interact with the patient's
organs and cavities. Devices cumbersome to handle or manipulate may result in
unsuccessful surgical procedures, misdiagnoses and, particularly in the case where the
patient is not anaesthetised, great discomfort to the patient.
UK 2 284 158 discloses an injection catheter consisting of an outer sheath and a needle
means located in and axially movable with relation to the outer sheath. Thus, when
colon (or canalis analis); and the ureter for the treatment of urinary incontinence, anal
incontinence, and vesicouretal reflux, respectively; wherein said device is injectable and
comprising the hydrogel as described herein.
The method of the invention preferably includes the administering of the hydrogel by
means of injecting the hydrogel into the appropriate conduit. In the treatment of urinary
incontinence, the hydrogel is typically injected into the urethra, specifically under the
submucosal membrane of the urethra. Injection is via the external surface of the urethra
and toward the submucosal membrane.
The present investigators have found that typically 2 to 5 mL of the hydrogel are suitable
to provide adequate resistance in the urethra by bulking the urethra. Typically, 3 ml of
hydrogel is injected and preferably the 2-5 mL are distributed by depositing the gel at
more than one cross-sectional position along a single longitudinal position of the urethra.
In a particularly suitable embodiment, 3 or more depots are made along a single
longitudinal position of the urethra. The present investigators have found that depots 0.5
cm distally from the neck of the bladder are particularly suitable.
The present investigators have found that submucosal injections at positions 10, 2, and 6
o'clock of the cross-sectional axis of the urethra to be particularly suitable for the
treatment of urinary incontinence.
The depots are typically made by means of a syringe or by use of a cytoscope or catheter.
Suitably a 21 to 27G needle is employed for the injection.
For the treatment of anal incontinence, the hydrogel is typically injected into the colon or
rectum (canalis analis) specifically under the submucosal membrane of the colon or
rectum. Injections of 2 to 6 ml are suitable. The hydrogel is preferably distributed at more
than one cross-sectional position along a single longitudinal position of the colon or
rectum. In a particularly suitable embodiment, 3 or more depots are made along a single
longitudinal position of the colon or rectum, preferably at positions 10, 2, and 6 o'clock of
the cross-sectional axis of the colon or rectum.
For the treatment of vesicouretal reflux, submucosal injections into the ureter of the
patient is required. Injections of 2 to 5 ml are suitable. The hydrogel is preferably
distributed at more than one cross-sectional position along a single longitudinal position of
the ureter In a particularly suitable embodiment, 3 or more depots are made along a single
longitudinal position of the ureter, preferably at positions 10, 2, and 6 o'clock of the crosssectional
axis of the ureter.
In an alternative embodiment of the invention, the method comprises the use of a
prosthetic device comprising cells, such as stem cells. Polyacrylamide provides an excellent
template and matrix for cell growth. The use of cells in combination with the hydrogel of
the invention for the preparation of the device would allow for cellular engraftment to the
surrounding tissue in the ureter, urethra or analis canalis. A method comprising the
hydrogel of the invention and the appropriate cells allows for greater resistance and
greater efficiency in providing resistance.
In a further embodiment of the invention, the device prosthetic device comprises cells,
such as stem cells or fat cells. Polyacrylamide provides an excellent template and matrix
for cell growth. The use of cells with the hydrogel of the invention for the preparation of
the device would allow for cellular engraftment to the surrounding tissue in the ureter,
urethra or analis canalis. A device comprising the hydrogel of the invention and the
appropriate cells allows for greater resistance and greater efficiency in providing
resistance.
Description of the figures
A preferred embodiment of the invention will now be described with reference to the
accompanying figures, wherein
Fig. 1 shows the sheath device connected to a scope,
Fig. 2 shows a cross-sectional view of the sheath device connected to a scope,
Fig. 3 shows cross-sectional view of the proximal end of the sheath device,
Figs. 4-6 shows a cross-sectional view of the sheath device,
Fig. 7 shows a flushing unit according to the invention,
Figs. 8-9 show cross-sectional view of the flushing unit,
Fig. 10 shows an elongated tubular member according to the invention, and
Fig. 11 shows a detachable wall member for providing a fluid channel and guiding
passages.
Fig. 1 shows a sheath device 1 connected to a scope 2, and an injection needle 3 is also
introduced. The sheath device comprises a tubular member 4 and a flushing unit 5, which
are detachably connected to each other in a way that allows rotation of the tubular
member in relation to the flushing unit and scope.
Fig. 2 shows a cross-sectional view of the sheath device 1 connected to a scope 2. The
tubular member has a proximal end 6 and a distal open end 7, the flushing unit 5 being
connected to the proximal end 6. The flushing unit comprises a proximal open end 8 and a
distal end 9 (see e.g. figs. 7-8), the proximal end 8 being adapted to receive said scope.
The tubular member 4 and the flushing unit 5 together define a first interior guiding
passage 10 extending longitudinally from the proximal open end 8 of the flushing unit to
the distal open end 7 of the tubular member for sheathing a part of the endoscopic
instrument 2.
The tubular member further comprises a second guiding passage 11 extending
substantially longitudinal from a location 12 near the proximal end or from the proximal
end 6 to the distal end 7 of the tubular member, the second passage being suitable for
receiving and guiding a second endoscopic instrument 3 (needle).
Fig. 3 shows detail X of fig. 2, wherein the needle 3 is positioned in the second guiding
passage 11, and the endoscope is positioned in the first guiding passage. The second
guiding passage 11 comprises an inlet 14 in its end closest to said proximal end 6 of the
tubular member 4, the inlet being arranged in an outer surface of said tubular member.
The inlet 14 is substantially conical shaped so as to guide said treatment instrument 3 into
the passage. The inlet comprises a penetrable sealing 15 to be penetrated by the
instrument 3. Preferably, inlet may comprise the conical shaped inlet made of rubber.
The flushing unit 5 comprises a fluid inlet 16 and a fluid outlet 17, the fluid inlet being in
contact with the first guiding passage 10 which also may be used as fluid channel, and
which comprises a fluid exit 13 in the distal open end of the tubular member, cf. fig. 2.
Fig. 4 shows cross-section C-C of fig. 2, which is a cross-section of the tubular member 4.
The tubular member comprises reinforcement ribs 18 extending on its outer surface. The
first guiding passage 10 is positioned such that its centre line is coincident with a centre
line of the tubular member. The inlet 14 of second guiding passage 11 is positioned in a
detachable rubber element 19 being slided over the rib 20.
A detachable wall member 21 is positioned inside the tubular member 4, and which is not
moulded simultaneously with the tubular member, but inserted therein afterwards. The
detachable wall member 21, together with the sidewall 22 of the tubular member, defines
channels/passages 23.
Fig. 5 shows cross-section B-B of fig. 2, wherein the detachable wall member 21 defines
channels 23 for fluid and/or instruments. The second guiding passage 11 is shown.
Fig. 6 shows cross-section A of fig. 2, comprising the scope 2, the needle 3 and the tubular
member 4.
Fig. 7 shows the flushing unit 5 with the fluid inlet 16 and the fluid outlet 17, the inlet
being in contact with the fluid channel 24 and the outlet being in contact with the fluid
channel 25.
Fig. 8 shows a cross-section of the flushing unit comprising the inlet 16, the outlet 17 and
the guiding passage 10.
Fig. 9 is a cross-section of the flushing unit taken perpendicular in relation to the crosssection
of fig. 8.
Fig. 10 shows the tubular member 4 of the sheath device.
Fig. 11 shows the detachable wall member 21 for providing fluid channels and/or guiding
passages within the tubular member 4, see description of fig. 4 above.





We claim:
1. A sheath device (1) for endoscopic instruments (2), the device comprising:
a) an elongated tubular member (4) having:
- a proximal end (6),
- a distal open end (7),
- at least one fluid channel (23) extending longitudinally from said proximal end to a fluid exit; and
b) a flushing unit (5) connected to said proximal end (6) of the tubular
member (4), and said flushing unit having:
- a proximal open end (8) suitable for receiving a first endoscopic instrument (2),
- a fluid inlet (16) being in contact with said fluid channel (23), and
-a fluid outlet (17),
wherein the tubular member and the flushing unit together define a first interior guiding passage (10) extending longitudinally from the proximal open end (8) of the flushing unit (5) to the distal open end (7) of the tubular member (4) for sheathing at least a part of said first endoscopic instrument (2),
wherein the connection between the tubular member (4) and the flushing unit (5) allows for axial rotation of the tubular member (4) in relation to the flushing unit (5),
characterized in that the tubular member (4) is provided with a second guiding passage (11) extending longitudinal or almost longitudinal from a location (12) near the proximal end (6) or from the proximal end (6) to the distal end (7) of the tubular member (4), the second passage (11) receiving and guiding an injection needle (3), and

wherein the second guiding passage (11) is an inlet (14) in its end closest to said proximal end (6) of the tubular member (4), the inlet (14) being located in an outer surface of said tubular member, such that an injection needle may be introduced through said second guiding passage (11).
2. A device as claimed in claim 1, wherein the inlet (14) is conical or almost conical shaped so as to guide said injection needle (3) into the passage.
3. A device as claimed in claim 1 or 2- wherein the tubular member (4) is disposable (i.e. onetime use).
4. A device as claimed in any of claims 1-3, wherein the flushing unit (5) is disposable.
5. A device as claimed in any of claims 1-4, wherein the tubular member (4) and the flushing unit (5) are fixedly connected to each other.
6. A device as claimed in any of claims 1-4, wherein the tubular member (4) and the flushing unit (5) are detachably connected to each other.
7. A device as claimed in any of claims 1-6, wherein the fluid exit (13) is located near said distal end (7).
8. A device as claimed in any of claims 1-7, wherein the fluid exit (13) is located in said distal end (7).
9. A device as claimed in any of claims 1-8, wherein the fluid outlet (17) is in contact with said open distal end (7) of the tubular member (4) via an interior passage extending longitudinally in said tubular member (4).

10. A device as claimed in claim 9, wherein the interior passage is a part of said first interior guiding passage (10).
11. A device as claimed in any of the preceding claims, wherein the guiding passages (10,11) and the fluid channel (10) extends parallel or almost parallel to each other.
12. A device as claimed in any of the preceding claims, wherein a centre line of the first interior guiding passage (10) is coincident with a centre line of the tubular member (4).
13. A device as claimed in any of claims 1-12, wherein the first endoscopic instrument comprises a fibre optic probe.
14. A device as claimed in any of the preceding claims, wherein said tubular member (4) is rotatable within an angle range of 0° to 360° in relation to said flushing unit (5).
15. A device as claimed in any of the preceding claims, wherein the fluid inlet (16) is connected to a water reservoir for flushing clean water through the fluid channel (23) and out of said fluid exit (13).
16. A device as claimed in any of the preceding claims, wherein the fluid outlet (17) is connected to a water tank for flushing wastewater away from the internal organ via said interior passage (10).
17. A device as claimed in any of the preceding claims, wherein the tubular member (4) defines a plurality of longitudinal extending guiding passages each accommodating a endoscopic instrument.

18. A device as claimed in any of the preceding claims, wherein an outer diameter near said distal end (7) of said tubular member (4) is between 5-20 mm, such as 10-15 mm, such as 7-8 mm.
19. A device as claimed in any of the preceding claims, wherein the cross-section perpendicular to the longitudinal direction of the tubular member (4) is oval or almost oval shaped or circular or almost circular.
20. A device as claimed in any of the preceding claims, wherein the length of the tubular member (4) is from 5-40 cm.
21. A device as claimed in any of claims 1-20, wherein one or more of the fluid channel (23) and guiding passages (10,11) is provided by a detachable wall member positioned inside the tubular member.
22. A device as claimed in any of claims 1-21, wherein the distal end (7) of the tubular member (4) comprises a circumferential inwardly extending bulge for guidance of a distal end of said second endoscopic instrument.
23. A device as claimed in any of the preceding claims, wherein the first endoscopic instrument (2) comprises a cystoscope or a gastroscope or an ureteroscope or a resectoscope or an arthroscope or a telescope or an obturator.
24. A device as claimed in any of claims 1-22, wherein the first endoscopic instrument (2) comprises a camera lens e.g. for viewing internal tissue or organs.
25. A device as claimed in claim 24, wherein said lens is disposable (onetime use).

26. A device as claimed in claim 24 or 25, wherein the distal end (7) of the tubular member (4) exceeds a distal end of the lens.
27. A device as claimed in any of the preceding claims, wherein the flushing unit comprises tap(s) positioned near the inlet and/or outlet for switching/turning the flushing off/on.

Documents:

171-DELNP-2006-Abstract-(23-01-2009).pdf

171-delnp-2006-abstract.pdf

171-DELNP-2006-Assignment-(28-11-2008).pdf

171-DELNP-2006-Claims-(23-01-2009).pdf

171-DELNP-2006-Claims-(28-11-2008).pdf

171-delnp-2006-claims.pdf

171-delnp-2006-complete specification (granted).pdf

171-DELNP-2006-Correspondence Others-(23-03-2011).pdf

171-DELNP-2006-Correspondence-Others-(13-01-2009).pdf

171-DELNP-2006-Correspondence-Others-(28-11-2008).pdf

171-delnp-2006-correspondence-others-1.pdf

171-DELNP-2006-Correspondence-Others-22-01-2009.pdf

171-delnp-2006-correspondence-others.pdf

171-delnp-2006-description (complete).pdf

171-delnp-2006-description (complete)23-01-2009.pdf

171-delnp-2006-drawings.pdf

171-DELNP-2006-Form-1-(23-01-2009).pdf

171-DELNP-2006-Form-1-(28-11-2008).pdf

171-delnp-2006-form-1.pdf

171-delnp-2006-form-13.pdf

171-delnp-2006-form-18-1.pdf

171-delnp-2006-form-18.pdf

171-DELNP-2006-Form-2-(23-01-2009).pdf

171-DELNP-2006-Form-2-(28-11-2008).pdf

171-delnp-2006-form-2.pdf

171-DELNP-2006-Form-27-(23-03-2011).pdf

171-DELNP-2006-Form-3-(13-01-2009).pdf

171-DELNP-2006-Form-3-22-01-2009.pdf

171-delnp-2006-form-3.pdf

171-delnp-2006-form-5.pdf

171-delnp-2006-form-6-(28-11-2008).pdf

171-DELNP-2006-GPA-(28-11-2008).pdf

171-DELNP-2006-GPA-22-01-2009.pdf

171-delnp-2006-gpa.pdf

171-DELNP-2006-Others-Others-(13-01-2009).pdf

171-delnp-2006-pct-210.pdf

171-delnp-2006-pct-304.pdf

171-delnp-2006-pct-306.pdf

171-delnp-2006-pct-409.pdf

171-delnp-2006-pct-416.pdf

abstract.jpg


Patent Number 228316
Indian Patent Application Number 171/DELNP/2006
PG Journal Number 07/2009
Publication Date 13-Feb-2009
Grant Date 30-Jan-2009
Date of Filing 10-Jan-2006
Name of Patentee CONTURA A/S
Applicant Address SYDMARKEN 23, 2860 SØBORG, DENMARK.
Inventors:
# Inventor's Name Inventor's Address
1 HERN, SOREN KARL MARKS STREET 8, SUITE 18, 2000 MINSK, BELARUS.
PCT International Classification Number A61B 1/12
PCT International Application Number PCT/DK2004/000425
PCT International Filing date 2004-06-18
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 60/479,725 2003-06-20 Denmark
2 PA 2003 00921 2003-06-20 Denmark