U.S. patent application number 09/356220 was filed with the patent office on 2001-12-27 for endoscopic drape.
Invention is credited to VERSCHUUR, MARK.
Application Number | 20010056221 09/356220 |
Document ID | / |
Family ID | 3799087 |
Filed Date | 2001-12-27 |
United States Patent
Application |
20010056221 |
Kind Code |
A1 |
VERSCHUUR, MARK |
December 27, 2001 |
ENDOSCOPIC DRAPE
Abstract
A method for producing an endoscopic drape includes positioning
a portion of a sheath of flexible material (22) in abutment with a
joining portion (23) of a first housing piece (14). A joining
portion (24) of a second housing piece (16) is positioned close to
joining portion (23) and the joining portions are then joined
together, for example, by ultrasonic welding. This forms a housing
(12) in which the portion of the sheath (22) is entrapped between
the first housing piece (14) and the second housing piece (16). The
portion of the sheath (22) may be joined to the first housing piece
(14) by a thermoplastic gasket or o-ring (35) prior to joining the
first and second housing pieces (14, 16) to improve the seal
between the sheath (22) and the housing (12). The housing (12)
includes a clear lens or window (27) that provides an optical
pathway through the housing and also provides a sterility
barrier.
Inventors: |
VERSCHUUR, MARK; (LILYDALE,
AU) |
Correspondence
Address: |
MONIQUE A MORNEAULT ESQ
WALLENSTEIN & WAGNER
311 SOUTH WACKER DRIVE 5300
CHICAGO
IL
60606
|
Family ID: |
3799087 |
Appl. No.: |
09/356220 |
Filed: |
July 16, 1999 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
09356220 |
Jul 16, 1999 |
|
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|
PCT/AU98/00036 |
Jan 23, 1998 |
|
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Current U.S.
Class: |
600/122 |
Current CPC
Class: |
A61B 46/10 20160201 |
Class at
Publication: |
600/122 |
International
Class: |
A61B 001/04 |
Foreign Application Data
Date |
Code |
Application Number |
Jan 23, 1997 |
AU |
PO-4783 |
Claims
1. A method for manufacturing a drape for use in endoscopic
surgical procedures, the method including the steps of positioning
a portion of sheath of flexible material adjacent to or in abutment
with a joining portion of a first housing piece, positioning a
joining portion of a second housing piece adjacent to or in
abutment with the portion of the sheath and the joining portion of
the first housing piece and joining the joining portions of the
first housing piece and the second housing piece to thereby form a
housing and entrap the portion of the sheath between the first
housing piece and the second housing piece.
2. A method as claimed in claim 1 wherein the portion of the sheath
is an end of the sheath.
3. A method as claimed in claim 1 wherein an edge of the portion of
the sheath is entrapped between the first housing piece and the
second housing piece.
4. A method as claimed in claim 1 further including the steps of
providing a thermoplastic material on the first housing piece,
positioning the portion of the sheath over the thermoplastic
material and adjacent to or in abutment with the joining portion of
the first housing piece, joining the sheath to the thermoplastic
material, and subsequently joining the first and second housing
pieces.
5. A method as claimed in claim 4 further including the step of
removing any material of the sheath extending across an optical
pathway in the first housing piece prior to joining the first
housing piece and the second housing piece.
6. A method as claimed in claim 1 further including the step of
placing a lens in one of the first or second housing pieces prior
to joining the first housing piece and the second housing
piece.
7. A method as claimed in claim 6 wherein the lens is affixed to
the one of the first or second housing pieces prior to joining the
first housing piece and the second housing piece.
8. A method as claimed in claim 1 wherein the portion of the sheath
does not fully cover or fully extend between the joining portions
of the first and second housing pieces whereby at least a part of
one joining portion is in contact with at least a part of the other
joining portion.
9. A method as claimed in claim 1 wherein the step of joining the
joining portions comprises ultrasonic welding.
10. A method as claimed in claim 4 wherein the step of joining the
sheath to the thermoplastic material comprises impulse welding.
11. A drape for use in an endoscopic surgical procedure, the drape
including a housing comprising a first housing piece joined to a
second housing piece and a sheath of flexible material having a
portion thereof connected to the housing, wherein the sheath is
connected to the housing by positioning a portion of the sheath
between the first housing piece and the second housing piece prior
to joining the first and second housing pieces and wherein the
portion of the sheath is trapped between the joined first and
second housing pieces to thereby establish a leak-proof seal
between the sheath and the housing.
12. A drape as claimed in claim 11 wherein the portion of the
sheath is an end of the sheath.
13. A drape as claimed in claim 11 wherein one of the first or
second housing pieces is provided with a thermoplastic material and
the portion of the sheath is joined to the thermoplastic
material.
14. A drape as claimed in claim 11 wherein the housing includes an
optical pathway therein.
15. A drape as claimed in claim 14 wherein a lens or window is
positioned in the optical pathway.
16. A drape for use in an endoscopic surgical procedure, the drape
including a housing including a first housing piece having a
portion joined to a joining portion of a second housing piece, a
sheath of flexible material having a portion positioned between the
first and second housing pieces, a thermoplastic material
positioned between the portion of the sheath and one of the first
and second housing pieces, the thermoplastic material affixing the
portion of the sheath to the one of the first and second housing
pieces and wherein the joining portions of the first and second
housing pieces surround and entrap an edge of the portion of the
sheath in the completed housing.
17. A drape as claimed in claim 16 wherein a lens or window is
positioned within the housing.
18. A drape as claimed in claim 11 or claim 16 further including a
camera coupling for coupling a camera thereto.
19. A drape as claimed in claim 11 or claim 16 further including a
telescopic coupling for coupling an endoscopic telescope
thereto.
20. A drape as claimed in claim 19 wherein the telescopic coupling
comprises a "C"-coupling.
21. A drape as claimed in claim 13 or claim 16 wherein the
thermoplastic material comprises a thermoplastic gasket or
O-ring.
22. A drape as claimed in claim 21 wherein the thermoplastic gasket
or O-ring is positioned in a groove on the one of the first or
second housing pieces.
23. A drape as claimed in claim 11 or claim 16 wherein the sheath
is substantially cylindrical.
24. A drape for use in an endoscopic surgical procedure comprising
a housing and a sheath of flexible material joined to the housing
to form an essentially leak-proof seal between the sheath and the
housing, the housing having a camera coupling means for coupling a
camera thereto and a telescope coupling means for coupling an
endoscopic telescope thereto, the housing having an optical pathway
therein to enable light and/or an image from the endoscopic
telescope to be transmitted to the camera, wherein a corrective
lens is placed in the optical pathway.
25. A drape as claimed in claim 24 wherein the lens has a
corrective power sufficient to produce an in-focus picture on a
visual display unit during an operative procedure.
26. A drape as claimed in claim 25 wherein the lens has a power of
from 1 to 10 dioptive.
27. A drape as claimed in claim 26 wherein the lens has a power of
about 2.0 dioptive.
28. A drape as claimed in claim 24 wherein the lens comprises an
anti-fog lens or has an anti-fog coating applied thereto.
29. A drape as claimed in claim 24 wherein the housing comprises a
first housing piece joined to a second housing piece and a sheath
of flexible material having a portion thereof connected to the
housing, wherein the sheath is connected to the housing by
positioning a portion of the sheath between the first housing piece
and the second housing piece prior to joining the first and second
housing pieces and wherein the portion of the sheath is trapped
between the joined first and second housing pieces to thereby
establish a leak-proof seal between the sheath and the housing.
30. A drape as claimed in claim 29 wherein the portion of the
sheath is an end of the sheath.
31. A drape as claimed in claim 29 wherein one of the first or
second housing pieces is provided with a thermoplastic material and
the portion of the sheath is joined to the thermoplastic
material.
32. A drape for use in an endoscopic surgical procedure comprising
a housing and a sheath of flexible material joined to the housing
to form an essentially leak-proof seal between the sheath and the
housing, the housing having a camera coupling means for coupling a
camera thereto and a telescope coupling means for coupling an
endoscopic telescope thereto, the housing having an optical pathway
therein to allow light and/or an image from the telescope to be
transmitted to the camera, wherein the telescope coupling means
includes locking means operative between a first position wherein
the telescope is connected to the telescope coupling means and can
rotate within the telescope coupling means and a second position
where the telescope is connected to the telescope coupling means
and locked against rotation within the telescope coupling.
33. A drape as claimed in claim 32 wherein the telescope coupling
means comprises a moveable body having an engaging surface, said
moveable body being fitted into a second housing piece of said
housing, said moveable body being moveable from an open position in
which the telescope can be inserted therein and removed therefrom
and a closed position wherein said telescope is retained by said
telescope coupling means.
34. A drape as claimed in claim 33 wherein the locking means
comprises a rolling cam mounted on a pivot pin, said rolling cam
engaging said moveable body in the locked position to thereby fix
the telescope against rotational movement.
35. A drape as claimed in claim 33 wherein the locking means
comprises a wedging member.
36. A drape as claimed in claim 33 wherein the locking means
comprises a camming plate.
37. A drape as claimed in claim 32 wherein the drape further
comprises a corrective lens positioned in the optical pathway.
38. A drape as claimed in claim 32 wherein the housing comprises a
first housing piece joined to a second housing piece and a sheath
of flexible material having a portion thereof connected to the
housing, wherein the sheath is connected to the housing by
positioning a portion of the sheath between the first housing piece
and the second housing piece prior to joining the first and second
housing pieces and wherein the portion of the sheath is trapped
between the joined first and second housing pieces to thereby
establish a leak-proof seal between the sheath and the housing.
Description
[0001] The present invention relates to a method for manufacturing
a drape for use in endoscopic surgery and to a drape for use in
endoscopic surgery.
[0002] Endoscopic surgery is a low-invasive surgical technique.
Also known as keyhole surgery, endoscopic surgical procedures
require that only small incisions be made in the skin, which
minimises damages to muscle, skin and tissue. In endoscopic
surgical procedures, thin, elongate medical instruments are passed
through one or more incisions in the skin. In order to provide the
surgeon with a view of the site of the operation (the actual site
of the operation is covered by the skin), it is usual to use an
endoscopic telescope to supply pictures to a camera and from there
to a visual display unit, such as a television screen. The
endoscopic telescope is easily sterilised by autoclaving and this
is necessary because the telescope has one end thereof inserted
through an incision in the patient during the operation. The other
end of the telescope is optically linked to the camera and the
camera sends pictures of the operating site to the visual display
unit. Unfortunately, the camera is normally not able to be
sterilised by autoclaving because autoclaving would damage the
optical components of the camera.
[0003] The camera is optically linked to the telescope and this may
represent a potential breach of the sterile field. To avoid
potential difficulties with breach of the sterile field, it has
become common practice to cover the unsterile camera and its
associated cable with a sterile cover.
[0004] One such sterile cover is disclosed in U.S. Pat. No.
4,914,521 in the name of Adair. This patent discloses an apparatus
for enclosing a nonsterile camera and its trailing cable. The
apparatus includes a sterile cylindrical housing for receiving a
camera at one end and a flared annular mounting for receiving an
optical transmitting means, such as an endoscopic and associated
"C" mount at its other end. The housing includes a clear window
that is located between the endoscope and the lens of the camera
and that allows light to pass from the endoscope to the camera. The
clear lens also acts as a bacteria barrier between the camera and
the endoscope. A plastic sleeve is attached to the outer part of
the housing by adhesive tape. In use, the sleeve (which is sterile)
is pulled back over the camera cable to maintain sterility about
the camera cable.
[0005] International Patent Application No. PCT/US95/14735
(publication No. WO 96/17558) also in the name of Adair discloses a
surgical drape that allows greater flexibility in use than that
described in U.S. Pat. No. 4,914,521. Again, the drape includes a
housing having a sterile sleeve positioned over a neck portion of
the housing such that a fluid and air tight seal is formed.
Typically, the seal between the sleeve and the housing is formed by
surgical tape, adhesives, shrink wrapping or use of double-faced
adhesive strips.
[0006] A potential difficulty with the apparatus described in U.S.
Pat. No. 4,914,521 and WO 96/17558 resides in the use of adhesives
or similar means to join the sleeve to the housing. In practice, it
can prove to be difficult to obtain a leak-proof seal that will be
effective in maintaining sterility.
[0007] The present invention provides a method and an apparatus
that overcomes or at least ameliorates the above-mentioned
disadvantage of the prior art.
[0008] In a first aspect, the present invention provides a method
for manufacturing a drape for use in endoscopic surgical
procedures, the method including the steps of positioning a portion
of a sheath of flexible material adjacent to or in abutment with a
joining portion of a first housing piece, positioning a joining
portion of a second housing piece adjacent to or in abutment with
the portion of the sheath and the joining portion of the first
housing piece and joining the joining portions of the first housing
piece and the second housing piece to thereby form a housing and
entrap the portion of the sheath between the first housing piece
and the second housing piece.
[0009] The portion of the sheath is preferably an end of the
sheath. Preferably, an edge of the portion of the sheath is
entrapped between the first housing piece and the second housing
piece.
[0010] Preferably the sheath of flexible material is generally
cylindrical in shape. The distal end of the sheath is fitted
between the two housing pieces with an edge of the distal end
overlapping part of the joining portions of the two housing pieces.
Subsequent joining of the two housing pieces to form the housing
also entraps, or crimps, the end of the sheath between the two
housing pieces and this ensures that a leak-proof seal is formed
between the housing and the sheath. It is not necessary to use tape
or adhesive to join the end of the sheath to the outer wall of the
housing. Rather, the end of the sheath is trapped or crimped within
the housing.
[0011] The housing pieces may suitably be made from plastics
material. A suitable material may be general purpose polystyrene
mixed with a blend of K-resin. This material is gamma-ray stable
and can be transparent. Another suitable material may be an ABS
mixture or blend, which lends itself to ultrasonic welding.
[0012] The housing may include a camera coupling for coupling a
camera thereto. The sheath is then pulled along the cable extending
from the cable to cover the non-sterile cable with the sterile
sheath.
[0013] The housing may also include a telescope coupling for
coupling an endoscopic telescope thereto. Throughout this
specification, the term "telescope" is considered to include any
device used in endoscopic surgery to transmit an optical signal to
the camera.
[0014] Most preferably, the housing includes a camera coupling and
a telescope coupling. In this embodiment, the drape provides a
convenient means for optically linking the telescope to the camera
whilst maintaining sterility in the sterile field. It is preferred
that one of the first or second housing pieces includes the camera
coupling and that the other of the first or second housing pieces
includes the telescope coupling. In this arrangement, the housing
can be assembled by joining two pieces. However, it will be
appreciated that the camera coupling and/or the telescope coupling
could comprise separate pieces that can be connected or joined to
the first and/or second housing pieces. In such cases, the complete
housing comprises the first and second housing pieces joined
together and the camera coupling and/or telescope coupling
connected thereto.
[0015] The housing preferably includes an optically clear pathway
between the telescope coupling and the camera coupling to allow
good quality pictures of the operating site to be transmitted to
the visual display unit. The optically clear pathway may be
provided by producing the housing from transparent material.
Alternatively, a clear window or lens may be included within the
housing.
[0016] If a clear window or lens is used, the window or lens is
preferably located between the position of the camera (in use) and
the telescope so that the window acts as a barrier. Indeed, it will
be appreciated that the housing should include a barrier between
the camera and the telescope to maintain sterility and to exclude
the non-sterile camera from the sterile field.
[0017] The joining portion of the first housing piece preferably
comprises a joining face. Similarly, the joining portion of the
second housing piece preferably comprises a joining face. To join
the housing pieces together, the joining faces are placed closely
adjacent to or in abutment with each other (with the edge of the
end of the sheath therebetween) and the joining faces are joined
together at at least a portion of their faces.
[0018] In embodiments where the first and second housing pieces are
made from plastics material, the first and second housing pieces
are preferably joined by ultrasonic welding. The joining portion of
one of the first or second housing pieces may include an energy
director to enhance the ultrasonic weld. The energy director may
comprise a raised ridge extending around the joining portion and
preferably being located towards the centre of the joining
portion.
[0019] As mentioned above, the end of the sheath is trapped between
the first and second housing pieces when they are joined together
to form a leak-proof seal. The seal between the sheath and the
housing may be improved by positioning a thermoplastic material
between the end of the sheath and one of the joining portions. The
thermoplastic material is a material that can melt and adhere to
the material of the sheath. Once the end of the sheath has been
placed over the joining portion, the sheath material may be impulse
sealed to the joining portion via the thermoplastic material. The
thermoplastic material is preferably a thermoplastic rubber (TPR).
The thermoplastic material may be in the shape of a gasket or an
"O"-ring. To assist in positioning the gasket or O-ring, a groove
may be formed on the associated joining portion and the gasket or
O-ring placed in the groove. It is believed that use of a
thermoplastic material, such as a TPR gasket or O-ring, will assist
in improving the seal formed between the sheath and the housing.
Indeed, it is believed that use of the thermoplastic material
should result in the formation of a water-tight, leak proof seal
which will thus form a sterility barrier. However, it will be
appreciated that a leak proof seal between the sheath and the
housing may be obtained without use of the thermoplastic
material.
[0020] In another embodiment, the method of the present invention
includes the steps of providing a thermoplastic material on the
first housing piece, positioning the portion of the sheath over the
thermoplastic material and adjacent to or in abutment with the
joining portion of the first housing piece, joining the sheath to
the thermoplastic material, and subsequently joining the first and
second housing pieces.
[0021] In a preferred form of this embodiment, the invention
further includes the steps of placing a lens in the first housing
piece prior to joining the first and second housing pieces.
Alternatively, the lens may be placed in the second housing piece
prior to joining the first and second housing pieces. The lens may
be placed in the first housing piece either before or after the
thermoplastic material and sheath are joined. The step of joining
the first and second housing pieces may act to affix the lens in
the housing, for example, by ultrasonic welding. Alternatively, the
lens may be affixed to either of the first housing piece or second
housing piece prior to joining the first and second housing
pieces.
[0022] The thermoplastic material may be joined to the sheath by
welding, such as impulse welding. The thermoplastic material
preferably comprises a gasket. The gasket may be placed in a groove
formed in the first housing piece.
[0023] In some instances, the sheath may extend across the optical
pathway in the housing. If the sheath is made from a material that
will affect optical clarity or quality, the sheath material is
preferably removed from the optical pathway prior to joining the
first and second housing pieces together or after joining the first
and second housing pieces together.
[0024] The camera coupling and telescope coupling of a preferred
embodiment of the present invention may be any suitable couplings
known to the skilled person. The camera coupling is preferably a
"C" coupling that is widely used in endoscopic procedures and need
not be discussed further.
[0025] The sheath is preferably made from thin film plastics
material. Polyethylene is a suitable material for the sheath. The
sheath is preferably transparent. The sheath may be rolled up or
folded in a telescopic or accordion-like manner to facilitate
positioning of the sheath over the camera cable. The proximal end
of the sheath may be fitted with a pull-tab to simplify positioning
of the sheath. One or more resealable adhesive tabs may be placed
on the sheath to enable the sheath to be closely conformed to the
cable.
[0026] In some embodiments of the present invention the material of
the sheath may not readily join to the material of the housing
pieces. In such cases, it is preferred that the sheath is
positioned between the housing pieces such that the sheath does not
fully cover or extend fully between the joining portions of the
housing pieces. This allows at least a part of one joining portion
to be in contact with at least a part of the other joining portion.
The joining procedure then joins the parts of the joining portions
in contact with each other.
[0027] To improve the seal between the end of the sheath and the
housing, the joining portions of the first and second housing
pieces may have a degree of surface roughness, surface serrations,
or the like, to improve mechanical contact between the sheath and
the housing. When the housing pieces are joined to form the
housing, the first and second housing pieces are located very close
to each other and thus sandwich the end of the sheath between them.
The surface roughness, surface serrations or the like assist in
holding the sheath in the housing. Moreover, if ultrasonic welding
is used to join the two housing pieces, molten plastic from the
housing pieces may flow around the edge of the end of the sheath to
further hold the sheath.
[0028] The present invention also encompasses a drape. In
accordance with a second aspect, the present invention provides a
drape for use in an endoscopic surgical procedure, the drape
including a housing comprising a first housing piece joined to a
second housing piece and a sheath of flexible material having a
portion thereof connected to the housing, wherein the sheath is
connected to the housing by positioning a portion of the sheath
between the first housing piece and the second housing piece prior
to joining the first and second housing pieces and wherein the
portion of the sheath is trapped between the joined first and
second housing pieces to thereby establish a leak-proof seal
between the sheath and the housing.
[0029] Preferably, the portion of the sheath is an end of the
sheath. Preferably, the portion of the sheath is joined to one of
the first or second housing pieces by joining the sheath to a
thermoplastic material positioned on the one of the first or second
housing pieces prior to joining the first and second housing
pieces.
[0030] The housing preferably further comprises a camera coupling
for a coupling a camera thereto and a telescope coupling for
coupling a telescope thereto, the housing effective to establish an
optical link between the telescope and the camera. The housing
should provide an optically clear pathway between the telescope and
the lens of the camera. The housing should also include a barrier
between the camera and the telescope to preserve sterility in the
sterile field. The combination of the sterile barrier within the
housing and the sterile sheath that may be draped over the camera
and it associated cord ensures that the non-sterile camera does not
compromise the sterile field.
[0031] The telescope coupling may comprise a "C"-coupling that is
well known to skilled persons. Any other suitable coupling may also
be used as the telescope coupling. Similarly, the camera coupling
may comprise any suitable coupling known to the skilled person. The
telescope coupling and/or camera coupling may be formed integrally
with the first and second housing pieces, or they may comprise
additional pieces to be connected to the housing.
[0032] In a third aspect, the present invention provides a drape
for use in an endoscopic surgical procedure, the drape including a
housing including a first housing piece having a joining portion
joined to a joining portion of a second housing piece, a sheath of
flexible material having a portion positioned between the first and
second housing pieces, a thermoplastic material positioned between
the portion of the sheath and one of the first and second housing
pieces, the thermoplastic material affixing the portion of the
sheath to the one of the first and second housing pieces and
wherein the joining portions of the first and second housing pieces
surround and entrap an edge of the portion of the sheath in the
completed housing.
[0033] The housing of the drape of the second and third aspects of
the invention preferably includes a lens positioned between the
first and second housing pieces.
[0034] In another aspect the present invention provides a drape for
use in an endoscopic surgical procedure comprising a housing and a
sheath of flexible material joined to the housing to form an
essentially leak-proof seal between the sheath and the housing, the
housing having a camera coupling means for coupling a camera
thereto and a telescope coupling means for coupling an endoscopic
telescope thereto, the housing having an optical pathway therein to
enable light and/or an image from the endoscopic telescope to be
transmitted to the camera, wherein a corrective lens is placed in
the optical pathway.
[0035] The housing of the drape acts as an adaptor for connecting
the camera and the telescope. Instead of the camera and telescope
being directly connected to each other, the housing is positioned
between the camera and the telescope with the camera and the
telescope each connected to the housing. This acts to interpose a
member between the camera and the telescope which results in the
respective ends of the camera and telescope being separated
somewhat during the operation. This may result in the image from
the telescope not being properly focussed on the camera, which can
result in the image from the camera that is displayed on the visual
display unit during the operation being out of focus. The
corrective lens incorporated into the housing overcomes this
problem. As a further advantage, the corrective lens also acts to
enhance or maintain the size of the picture on the visual display
unit.
[0036] The corrective lens preferably has a corrective power
sufficient to produce an in-focus picture on the visual display
unit during the operative procedure. A lens with a power of from 1
to 10 dioptive is preferred, more preferably about 2.0
dioptive.
[0037] The drape of the present invention is preferably made in
accordance with the first aspect of the present invention, as
described hereinabove. In this method, the housing is made from
first and second housing pieces joined together, with the sheath
entrapped between the first and second housing pieces.
[0038] The lens preferably is an anti-fog lens or has an anti-fog
coating applied thereto in order to minimise fogging during use.
For example, the lens may be made from an anti-fog material or it
may be sprayed or coated with an anti-fog material.
[0039] The telescope coupling means may be any conventional
coupling means known by the person of skill in the art to be
suitable. A conventional "C" coupling is one example. Similarly,
the camera coupling means may be any convention coupling means
known to be suitable to a person of skill in the art.
[0040] The sheath is preferably made from thin film plastics
material. Polyethylene is a suitable material for the sheath. The
sheath is preferably transparent. The sheath may be rolled up or
folded in a telescopic or accordion-like manner to facilitate
positioning of the sheath over the camera cable. The proximal end
of the sheath may be fitted with a pull-tab to simplify positioning
of the sheath. One or more resealable adhesive tabs may be placed
on the sheath to enable the sheath to be closely conformed to the
cable.
[0041] In yet another aspect, the present invention provides a
drape having a housing in which the telescope coupling means can
allow at least a degree of rotation of the telescope or
substantially prevent rotation of the telescope.
[0042] In this aspect the present invention provides a drape for
use in an endoscopic surgical procedure comprising a housing and a
sheath of flexible material joined to the housing to form an
essentially leak-proof seal between the sheath and the housing, the
housing having a camera coupling means for coupling a camera
thereto and a telescope coupling means for coupling an endoscopic
telescope thereto, the housing having an optical pathway therein to
allow light and/or an image from the telescope to be transmitted to
the camera, wherein the telescope coupling means includes locking
means operative between a first position wherein the telescope is
connected to the telescope coupling means and can rotate within the
telescope coupling means and a second position where the telescope
is connected to the telescope coupling means and locked against
rotation within the telescope coupling means.
[0043] The drape of the present invention preferably includes the
corrective lens of the one aspect of the invention and the locking
means of another aspect of the invention.
[0044] Preferred embodiments of the present invention will now be
described with reference to the drawings. It is to be understood
that the drawings are intended to illustrate the present invention
and should not be considered to limit the invention.
[0045] FIG. 1 shows a side view of the apparatus in accordance with
the present invention;
[0046] FIG. 2 shows an expanded view of the housing piece that
comprises a camera coupling with the sheath positioned ready for
manufacture;
[0047] FIG. 3 shows an expanded view of the joining portions of the
housing pieces and the sheath after the housing has been completed
by joining the joining portions;
[0048] FIG. 4 shows an end view of a drape in accordance with
another embodiment of the present invention;
[0049] FIG. 5 shows a cross-sectional side view of the first
housing piece of the drape of FIG. 4;
[0050] FIG. 6 shows the first housing piece of FIG. 5 with the
sheath positioned and ready for joining to the first housing
piece;
[0051] FIG. 7 shows the arrangement of FIG. 6 with the sheath
joined to the first housing piece;
[0052] FIG. 8 shows the arrangement of FIG. 7 with excess sheath
material removed for optical clarity;
[0053] FIG. 9 shows the arrangement of FIG. 8 with a lens
positioned in the first housing piece;
[0054] FIG. 10 shows a side view of the second housing piece of the
drape of FIG. 4;
[0055] FIG. 11 is an end view of the second housing piece of FIG.
10; and
[0056] FIG. 12 is a side, cross-sectional view showing how the
first and second housing pieces fit together.
[0057] FIG. 13 is a view generally similar to that shown in FIG. 9
but with a corrective lens substituted for the flat lens of FIG.
9;
[0058] FIG. 14 is a side view of the second housing portion with a
locking means incorporated therein in accordance with the present
invention;
[0059] FIG. 15 shows the side view of FIG. 14 with the complete "C"
coupling in place;
[0060] FIG. 16 is an end view of FIGS. 14 and 15; and
[0061] FIG. 17 is a side view of a telescope coupled to the housing
with the sheath extended over the camera and accompanying
cable.
[0062] The apparatus 10 in accordance with the present invention
shown in FIG. 1 includes a housing 12 comprising a first housing
piece 14 and a second housing piece 16. The first housing piece 14
provides a coupling for endoscopic telescope 18 to be coupled
thereto. The second housing piece 16 provides a coupling for
coupling camera 20 thereto. The apparatus further includes a sheath
of flexible material 22 that, in use, is adapted to be placed over
and surround camera 20 and the associated camera cable 21. Sheath
22 thereby enables the unsterile camera 20 and camera lead 21 to be
contained within a sterile sheath.
[0063] Housing 14 includes a joining portion 23 that is able to be
abutted onto a complementary joining portion 24 on housing piece
16. Joining portion 24 of housing piece 16 includes an energy
director 25 in the form of a circular raised ridge.
[0064] The distal end of sheath 22 is provided with a hole that is
defined by edge 26. In order to form the apparatus 10 shown in FIG.
1, the distal end of sheath 22 is positioned such that the end 26
lies over joining portion 25 of housing piece 16. Housing piece 14
is then positioned such that housing portion 23 either abuts or is
closely adjacent to the edge 26 of sheath 22 and joining portion 24
of housing piece 16. The joining portions 23, 24 are then joined
together by ultrasonic welding to thereby form housing 12. This
step also acts to entrap the end of sheath 22 between the now
connected housing pieces and this ensures that the end of sheath 22
is connected to the housing in a manner that ensures a leak proof
seal is obtained.
[0065] Housing piece 16 further includes a clear lens 27 that
aligns with the lens of the camera when the camera is connected to
the housing. This ensures that an optically clear pathway is
obtained from the telescope to the camera lens. Moreover, it also
ensures that a bacteria barrier exists between the housing piece 16
and the camera 20.
[0066] The piece 12 further includes a conventional "C" coupling 28
that is used to couple the telescope to the housing. The camera
includes a conventional coupling 29 that enables the camera to be
coupled to the housing piece 16. Both "C" coupling 28 and camera
coupling 29 are conventional items used in endoscopic apparatus and
need not be discussed further.
[0067] It is also noted that the telescope 18 includes a
fibre-optic port 30 to enable connection of a fibre-optic light
source to the telescope.
[0068] FIG. 2 shows an expanded view of second housing piece 16 and
sheath 22. As can be seen from FIG. 2, the edge 26 defining the
hole in the end of the sheath 22 is positioned such that the end of
the sheath 22 does not cover all of joining portion 24 of housing
piece 16. This ensures that the joining portion 23 of housing piece
14 can come into contact with and be joined to at least the inner
portion of housing portion 24, which assists in ensuring that a
good join between housing piece 16 and housing piece 14 is achieved
even if the material of sheath 22 is not compatible with ultrasonic
welding to the housing pieces 16, 14.
[0069] FIG. 2 also shows a thermo-plastic rubber gasket or O-ring
32 that is positioned in a groove or channel formed in the surface
of joining portion 24. The gasket or O-ring 32 is positioned such
that it comes into contact with the end of the sheath 22. The
gasket or O-ring 32 is made from a material that is compatible for
joining with the material of sheath 22 and thus the gasket or
O-ring 32 can further assist in obtaining a leak proof seal.
Thermoplastic rubber (TPR) is a suitable material for the gasket or
O-ring.
[0070] FIG. 3 shows an expanded view of the joining faces 23, 24
after they have been joined. As can be shown in FIG. 3, ultrasonic
welding causes melting of joining portions 23, 24 in places where
they abut and the molten plastic, shown by reference numeral 34
connects joining portions 23, 24 together. Preferably, the molten
plastic 34 also extends around the edges 26 of sheath 22.
[0071] To further improve the quality of the join, the TPR gasket
32 is also impulse joined to the sheath 22. This results in a mass
of molten plastic 35 being formed which can adhere to the material
of the sheath 22.
[0072] In FIGS. 1 and 3, the spacing between joining portions 23
and 24 has been exaggerated to clearly show the construction of the
apparatus. However, it will be appreciated that in the completed
article joining portions 23 and 24 will essentially be in abutment
or closely adjacent and they will be so closely spaced that the
sheath 22 will be trapped therebetween.
[0073] The apparatus shown in FIGS. 1, 2 and 3 includes a
passageway 36 formed in housing portion 22 and a passageway 37
formed in housing portion 14. These passageways are in alignment in
the completed article and provide an optically clear pathway
between the telescope and the camera. It will be appreciated that
if the housing 12 is manufactured from a transparent plastic
material, passageways 36, 37 need not be provided as the material
of the housing itself can provide an optically clear pathway.
[0074] In FIGS. 1, 2 and 3, the sheath is shown in its extended
position. However, it will be appreciated that the sheath will
normally be provided in a rolled up or accordion folded manner to
enable compact packaging to be achieved.
[0075] Once the housing has been manufactured, the apparatus 10 is
packaged in sterile packaging. In order to use the apparatus, the
scrub nurse opens the sterile packaging and connects the endoscope
18 tho the housing. The unsterile camera 20 is inserted into the
sheath 22 and connected to the housing. The sheath 22 is then
unrolled or unfolded out along the camera and its trailing cable 21
so that the camera and the trailing cable are surrounded by the
sterile sheath 22. To assist in positioning the sheath over the
camera and cable, the end of the sheath may be provided with a pull
tab. In order to enable the sheath to be closely conformed to the
shape of the camera and the trailing cable, one or more resealable
adhesive tabs may be provided on the sheath.
[0076] If it is desired to change the telescope during use, the
telescope can be easily uncoupled and a new telescope engaged
without compromising the sterile field.
[0077] After use, the telescope is uncoupled and the camera encased
in the sheath is removed from the sterile field. The camera is then
uncoupled and removed from the sheath and the apparatus 10
discarded for disposal.
[0078] FIGS. 4 to 13 relate to another embodiment of the present
invention. As shown in FIG. 4, the drape 40 includes a housing 41
having a first housing piece 42 and a second housing piece 43.
Housing pieces 42 and 43 are joined together to form housing 41. A
sheath 44, which is of a generally cylindrical shape and made from
a flexible plastic material is connected to housing 41.
[0079] FIG. 5 shows a cross-sectional view of first piece 42. First
piece 42 has a joining end 45 and a distal end 46. A passage 47 is
formed in a first piece 42 and passage 47 provides an optical
pathway between an endoscopic telescope and an endoscopic camera.
First piece 42 includes a cylindrical region of reduced diameter
48, which provides a means for coupling an endoscopic camera (not
shown) to the first piece 42.
[0080] Joining end 45 of first piece 42 has an outer annular
surface 49 that surrounds a groove 50. Groove 50 extends
substantially around the joining face 45 of first piece 42. The
inner end of groove 50 is defined by an inner annular portion 51. A
recessed, inner most annular portion 52 extends around the central
passage 47. As can be seen from FIG. 5, the inner most annular
portion 52 defines a shoulder.
[0081] As shown in FIG. 6, a gasket or O-ring 53 is positioned in
groove 50. Gasket or O-ring 53 is made from a thermoplastic
material, such as TPR.
[0082] In order to manufacture the drape shown in FIG. 4, sheath 44
is positioned over the joining face 45 of first housing piece 42
such that a portion 44a of sheath 44 extends over the joining face.
As can be seen from FIG. 6, portion 44a comes into contact with
gasket or O-ring 53.
[0083] Once the portion 44a of sheath 44 has been properly
positioned, impulse welding is used to join the portion 44a to the
gasket or O-ring 53. This is best shown in FIG. 7 where portion 54
of the sheath 44 has been joined to the gasket or O-ring 53. It
will be appreciated that the process of impulse welding causes the
gasket or O-ring 53 to at least partially melt and to thereby join
to portion 54 of the sheath 44.
[0084] As can be seen from FIG. 7, a portion 44a of sheath 44
extends across the optical pathway provided by passage 47 in the
first housing piece. In order to improve the optical clarity, it
may be necessary to remove this portion of the sheath and this may
be achieved by simply cutting that portion of the sheath away, as
is shown in FIG. 9. Removing that portion of the sheath will result
in a substantially circular hole being cut in the sheath, with the
edges of the hole defined by the edge 55 of the sheath material, as
shown in FIG. 9.
[0085] Once the part of the sheath 44 covering the central passage
47 has been removed, lens 56 is positioned in the first housing
piece 42 such that the lens 56 rests on shoulders 52. The lens 56
may be affixed to the first housing piece 42 at this stage.
Alternatively, the lens 56 may be affixed into the housing once the
second housing piece 41 has been joined to the first housing piece
42.
[0086] FIGS. 11 and 12 show side and end views, respectively of
second housing piece 43. Second housing piece 43 includes face 57
that includes a joining portion generally designated by reference
numeral 58. Joining portion 58 will be described in greater detail
hereunder. Second housing portion 41 also includes a rearwardly
extending part 59 having a downwardly extending rear surface 60 and
a stop member 61. Rearwardly extending portion 59, downwardly
extending portion 60 and stop member 61 form a housing for a spring
biased C coupling member (not shown) which is used to enable easy
coupling of an endoscopic telescope to the second housing
piece.
[0087] Turning now to consider the joining portion 58 in more
detail, joining portion 58 includes a cylindrical projection 62
that is sized to fit relatively snugly inside the opening of the
first housing piece 42 defined by the inner most annular portion
52. An energy director in the form of a circular ridge 63 is
positioned a short distance away from the cylindrical projection
62. The energy director 63 substantially encircles cylindrical
projection 62.
[0088] The fitment together of the first housing piece 41 and
second housing piece 42 is best shown in FIG. 13, where it can be
seen that cylindrical projection 62 on the face 57 of second
housing piece 41 fits into the recess formed by innermost annular
portion 52. Energy director 63 comes into contact with the inner
annular portion 51. Ultrasonic welding then takes place to join the
first and second housing pieces together. As a result of the
ultrasonic welding process, a joint similar to that shown in FIG. 3
is produced between the first and second housing pieces, which
joint firmly joins the first and second housing pieces and also
entraps the edges of the sheath.
[0089] Although not shown in any of the Figures, it is also
possible that the housing could include a water tight gasket or
seal that fits between the end of the endoscopic telescope and the
housing. This water tight gasket or seal would act to prevent the
ingress of water into the lens area of the housing, which would
then minimise or avoid fogging on the lens of the housing.
[0090] FIG. 13 shows a view generally similar to that of FIG. 9,
with the difference being that the flat lens 56 of FIG. 9 has been
replaced by the corrective lens 56A in FIG. 13. Accordingly, FIG.
13 is in accordance with the further aspect of the present
invention. The corrective lens 56A preferably has a corrective
power of 2 dioptive. The corrective lens 56A is incorporated into
the housing when the first housing piece 42 is joined to the second
housing piece 43. It is also possible to ultrasonically weld lens
56A to first housing piece 42 prior to joining the two housing
pieces.
[0091] Referring now to FIGS. 14, 15 and 16, FIGS. 14 and 15 show a
side view of the second housing piece 43 with the full details of
the "C" coupling added to FIG. 15. Dealing initially with FIG. 14,
the locking mechanism of the second aspect of the invention
comprises a rolling cam 80 mounted on pivot pin 81 and operable
between an open position and a locked position by actuating switch
82. As best shown in FIGS. 15 and 16, in order to complete the "C"
coupling, a movable body 83 having a lower engaging surface 84 is
fitted and spring loaded into second housing piece 43. In
particular, rearwardly extending portion 59, downwardly extending
portion 60 and stop member 61 may be formed as a separate entity
that snap fits onto second housing portion 43, for example, by
having the leading edges of rearwardly extending portion 59
snap-fit onto face 57 of second housing piece 43. In order to
complete the "C" coupling, the movable body 83 and associated
spring (for spring loading--not shown) is positioned adjacent the
face opposed to face 57 of second housing piece 43 and the snap-fit
entity comprising rearwardly extending portion 59, downwardly
extending portion 69 and stop member 61 is fitted into place. In
order to actuate the "C" coupling, movable body 83 is pushed
downwardly to increase the distance between the lower part of
rearwardly extending portion 59 and lower engaging surface 84. A
telescope is mounted into this opening and lower engaging surface
84 allowed to move upwardly under the action of a spring (not
shown) to capture and hold the end of the telescope between the
rearwardly extending portion 59 and the lower engaging surface
84.
[0092] When the locking mechanism is in the open position, the
rolling cam member 80 does not engage the movable body 80 and the
telescope can be rotated. However, when moved to the locked
position, rolling cam member 80 engaged movable body 83 and fixes
it in position, thereby preventing rotational movement of the
telescope (for the sake of clarity, the locking mechanism has been
deleted from FIG. 15). In the unlocked position, when a telescope
coupled to the second housing piece 43, the telescope, although
connected to the second piece 43, can rotate within the telescope
couplings. Generally, the telescope rotates around its own
longitudinal axis. However, when the locking mechanism is moved to
the locked position, the telescope coupled to the second housing
piece 43 is locked such that it cannot rotate within the telescope
coupling. This may be achieved in a number of ways in addition to
that shown in FIGS. 14-16. For example, actuation of the actuating
switch or a lever or tab may actuate a camming plate or wedging
member that firmly locks the telescope in place against rotation.
Alternatively, actuation of the tab or lever may move an
interlocking protrusion into interlocking engagement with a
complementary shaped depression or hole formed in the edge of the
telescope. Obviously, a number of other suitable arrangements may
also be used in the locking means.
[0093] Turning now to FIG. 15, this figure shows a telescope 100
connected to housing 101 with drape 102 extending over the camera
and its associated cables. Telescope 100 includes a fibre optic
port 103 having a fibre optic cable 104 connected there too. Fibre
optic cable 104 provides a source of light to the telescope 100. In
the embodiment shown in FIG. 14, when the locking means is in the
open position, the telescope 100 can rotate about its own
longitudinal axis 105. However, it will be appreciated that if the
telescope 100 rotates too far about its longitudinal axis, the
fibre optic cable 104 will become wrapped around the telescope 100.
Accordingly, it is preferred that, when in the open position, it is
preferred that the telescope can only rotate through a restricted
amount, with an amount of between 30 and 70 degrees either side of
the original position being suitable. When the locking means is
placed in the locked position, the telescope cannot rotate at all.
In some operative procedures it is of assistance to the surgeon if
the telescope can be rotated. However, in other operative
procedures, it is preferred that the telescope not be able to be
rotated. According, provision of the locking means in FIG. 14, and
in accordance with the second aspect of the present invention,
allows the surgeon to select the preferred mode.
[0094] The apparatus of the present invention may provide an
inexpensive means for optically coupling the camera and telescope
together. The apparatus includes a superior connection between the
sheath and the housing of the apparatus to ensure that a leak proof
seal between the housing and the sheath is obtained.
[0095] It will be appreciated that the invention described herein
is susceptible to variations and modifications other than those
specifically described. It is to be understood that the invention
encompasses all such variations and modifications that fall within
its spirit and scope.
* * * * *