AU766143B2 - Endoscopic drape - Google Patents

Description

P/00/01i1 Regulation 3.2

AUSTRALIA

Patents Act 1990

ORIGINAL

COMPLETE SPECIFICATION DIVISIONAL PATENT Invention title: Endoscopic drape The following statement is a full description of this invention, including the best method of performing it known to us: 226 18570.doc\hg ENDOSCOPIC

DRAPE

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.

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 endo'scopic surgical procedure, 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.

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.

One such sterile cover is disclosed in United States Patent No. 4,914,521 in the name of Adair. This patent discloses an apparatus for enclosing a non-sterile 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 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 004414808 2 the camera cable to maintain sterility about the camera cable.

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 US 4,914,251. 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.

A potential difficulty with the apparatus described in US 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 difficulty to obtain a leak-proof seal that will be effective in maintaining sterility.

The present invention provides a method and an apparatus that overcomes or at least ameliorates the above-mentions disadvantage of the prior art.

S. 15 In a first aspect, the present invention provides a drape for use in an endoscopic surgical procedure, the drape comprising a housing and a sheath of flexible material i having a portion thereof connected to the housing, the housing comprising a first housing piece joined to a second housing piece, the housing including a first connecting means for S"connecting an endoscopic telescope thereto and a second connecting means for connecting a camera thereto, the housing also including an optical pathway to enable transmission of light between the endoscopic telescope and the camera, said optical pathway including a clear window or lens therein, and wherein the portion of the sheath is trapped between the first and second housing pieces to thereby establish a leak-proof seal between the sheath and the housing.

S 25 Preferably, the portion of the sheath is an end of the sheath. Preferably, the portion :i of the sheath is joined to one of the first or second housing pieces by joining the sheath to S"a thermoplastic material positioned on the one of the first or second housing pieces prior to joining the first and second housing pieces.

004414808 3 The housing comprises a camera coupling for coupling a camera thereto and a telescope coupling for coupling a telescope thereto, the housing being 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 filed. The barrier is suitably provided by the lens or the clear window. The combination of the sterile barrier within the housing and the sterile sheath that may be draped over the camera and its associated cord ensures that the non-sferile camera does not compromise the sterile field.

The telescope coupling may comprise a "C"-coupling that is well known to skilled person. 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.

In a second aspect, the present invention provides a method for manufacturing a drape comprising a housing and a sheath of flexible material having a portion thereof connected to the housing, the housing comprising a first housing piece joined to a second housing piece, the housing including a first connecting means for connecting an endoscopic telescope thereto and a second connecting means for connecting a camera thereto, the housing also including an optical pathway to enable transmission of light between the endoscopic telescope and the camera, said optical pathway including a clear window or lens therein, the method including the step 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 an entrap the portion of the sheath between the first housing piece and the second housing piece.

0* o 004414808 4 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.

Preferably the sheath of flexible material is generally cylindrical in shape. The distal end of the sheath is suitably 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.

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.

The housing includes 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.

The housing also includes 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.

25 o As the housing includes a camera coupling and a telescope coupling, 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 004414808 housing comprises the first and second housing pieces joined together and the camera coupling and/or telescope coupling connected thereto.

The housing 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.

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.

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 least a portion of their faces.

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.

25 *CC 25 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 004414808 6 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.

In another embodiment, the method of the present invention includes the steps of providing a thermoplastic material on one of the first or second housing pieces, positioning the portion of the sheath over the thermoplastic material and adjacent to or in abutment with the joining portion of the first or second housing pieces, joining the sheath to the thermoplastic material, and subsequently joining the first and second housing pieces.

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.

.o 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.

'.6 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 coupling that is widely used in endoscopic procedures and need not be discussed further.

004414808 7 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 pulltab 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.

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.

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 housing pieces, molten plastic from the housing pieces may flow around the edge of the end of the sheath to further hold the sheath.

~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.

Figure 1 shows a side view of the apparatus in accordance with the present invention; Figure 2 shows an expanded view of the housing piece that comprises a camera coupling with the sheath positioned ready for manufacture; 004414808 8 Figure 3 shows an expanded view of the joining portions of the housing pieces and the sheath after the housing has been completed byjoining the joining portions; Figure 4 shows an end view of a drape in accordance with another embodiment of the present invention; Figure 5 shows a cross-section side view of the first housing piece of the drape of Figure 4; Figure 6 shows the first housing piece of Figure 5 with the sheath positioned and ready for joining to the first housing piece; Figure 7 shows the arrangement of Figure 6 with the sheath joined to the first housing piece; Figure 8 shows the arrangement of Figure 7 with excess sheath material removed for optical clarity; Figure 9 shows the arrangement of Figure 8 with a lens positioned in the first housing piece; Figure 10 shows a side view of the second housing piece of the drape of Figure 4; Figure 11 is an end view of the second housing piece of Figure 10; and Figure 12 is a side, cross-sectional view showing how the first and second housing pieces fit together.

The apparatus 10 in accordance with the present invention shown in Figure 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 oooo o oo.o 18 to be coupled thereto. The second housing piece 16 provides a coupling for coupling camera 20 thereto. The apparatus furthler 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 and camera lead 21 to be contained within a sterile sheath.

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.

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 Figure 1, the distal end of sheath 22 is positioned such that the edge 26 lies over joining portion 2-5 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.

S"20 Housing piece 16 further includes a clear lens 27 that aligns with the lens of *g* 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 25 The piece 12 further includes a conventional coupling 28 that is used to o* o 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.

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.

Figure 2 shows an expanded view of second housing piece 16 and sheath 22.

As can be seen from Figure 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 tiece 14 is achieved even if the material of sheath 22 is not compatible with ultrasonic welding to the housing pieces 16, 14.

Figure 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 0-ring.

Figure 3 shows an expanded view of the joining faces 23, 24 after they have been joined. As carl be shown in Figure 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 00960 20 molten plastic 34 also-extends around the edges 26 of sheath 22.: 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.

In Figures 1 and 3, the spacing between joining portions 23 and 24 has been *goo 25 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 5cbe in abutment or closely adjacent and they will be so closely spaced that the sheath 22 will be trapped therebetween.

The apparatus shown in Figures 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 11 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.

In Figures 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.

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 to the housing. The unsterile camera 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 S: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 15 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 S* may be provided on the sheath.

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.

20 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.

Figures 4 to 13 relate to another embodiment of the present invention. As shown in Figure 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.

Figure 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 12 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.

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 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 Figure 5, the inner most annular portion 52 defines a shoulder.

As shown in Figure 6, a gasket or O-ring 53 is positioned in groove Gasket or O-ring 53 is made from a thermoplastic material, such as tpr.

In order to manufacture the drape shown in Figure 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 see from Figure 6, portion 44a comes ooooo 15 into contact with gasket or o-ring 53.

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 Figure 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 20 gasket or O-ring 53 to at least partially melt and to thereby join-to portion 54 of the sheath 44.

As can be seen from Figure 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 Figure 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 Figure 9.

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 13 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.

Figures 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

I

extending part 59 having a downwardly extending rear surface 60 and a stop member 61. Rearwardly extending portion 59, downwardly extending portion 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.

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 o inside the opening in 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 0.0: short distance away from cylindrical projection 62. The energy director 63 substantially encircles cylindrical projection 62.

ooo..: •o 2. The fitment together of the first housing piece 41 and second housing piece 42 is best shown in Figure 13, where it can be seen that cylindrical projection 62 20 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 0' pieces together. As a result of the ultrasonic welding process, ajoint similar to that shown in Figure 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.

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.

r: 14 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.

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.

o.o o *o o

Claims (24)

1. A drape for use in an endoscopic surgical procedure, the drape comprising a housing and a sheath of flexible material having a portion thereof connected to the housing, the housing comprising a first housing piece joined to a second housing piece, the housing including a first connecting means for connecting an endoscopic telescope thereto and a second connecting means for connecting a camera thereto, the housing also including an optical pathway to enable transmission of light between the endoscopic telescope and the camera, said optical pathway including a clear window or lens therein, and wherein the portion of the sheath is trapped between the first and second housing pieces to thereby establish a leak-proof seal between the sheath and the housing.

2. of the sheath. A drape as claimed in claim 1 wherein the portion of the sheath is an end a a

3. A drape as claimed in claim 1 or claim 2 wherein the first housing piece is provided with a joining portion that is joined to a joining portion of the second housing piece.

4. A drape as claimed in any one of claims 1-3 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.

A drape as claimed in claim 3 wherein the thermoplastic material comprises a thermoplastic gasket or an O-ring. oooo oooo 25 o e• o

6. A drape as claimed in claim 5 wherein the thermoplastic gasket or O-ring is positioned in a groove on the one of the first or second pieces.

7. A drape as claimed in any one of the preceding claims wherein the first housing piece and the second housing piece are made of a plastics material and the first housing piece and the second housing piece are joined by ultrasonic welding such that a part of the first joining piece or the second joining piece or both melts and the first housing piece and the second housing piece are joined upon hardening of molten plastic. 004414808 16

8. A drape as claimed in claim 7, when appended to claim 3, wherein the joining portions of the first housing piece and the second housing piece melt during ultrasonic welding and molten plastic joins the first housing piece and the second housing piece.

9. A drape as claimed in claim 8 wherein the molten plastic extends around an edge of the sheath.

A drape as claimed in any one of the preceding claims wherein the sheath is substantially cylindrical.

11. A drape as claimed in any one of claims 1 to 10 wherein the first connecting means comprises a coupling.

12. is transparent. A drape as claimed in any one of the preceding claims wherein the housing

13. A method for manufacturing a drape as claimed in any one of claims 3 to 12, the method including the steps of positioning a portion of the sheath of flexible 15 material adjacent to or in abutment with the joining portion of the first housing piece positioning the joining portion of the 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 the housing and entrap the portion of the sheath between the first housing piece and the second housing piece. o° oooo ooo 25 oeoo oe

14. A method as claimed in claim 13 wherein the portion of the sheath is an end of the sheath.

15. A method as claimed in claim 13 or claim 14 wherein an edge of the portion of the sheath is entrapped between the first housing piece and the second housing piece.

16. A method as claimed in any one of claims 13 to 15 wherein the portion of the sheath does not fully cover or fully extend between the joining portions of the first 004414808 17 and second housing pieces whereby at least a part of one joining portion is in contact with at least a part of the otherjoining portion.

17. A method as claimed in any one of claims 13 to 16 wherein the step of joining the joining portions comprises ultrasonic welding.

18. A method as claimed in claim 17 wherein said ultrasonic welding causes melting of the joining portions and molten plastic extends around an edge of the sheath.

19. A method as claimed in any one of claims 13 to 18 further including the steps of providing a thermoplastic material on one of the first housing piece or the second 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 or the second housing piece, joining the sheath to the thermoplastic material, and subsequently joining the first and second housing pieces.

A method as claimed in claim 19 further including the step of removing any material of the sheath extending across the optical pathway in the first housing piece, 15 prior to joining the first housing piece and the second housing piece. o

21. A method as claimed in any one of claims 13 to 20 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.

22. A method as claimed in claim 21 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.

23. A method as claimed in claim 22 wherein the step of joining the sheath to oo the thermoplastic material comprises impulse welding. *••ooo

24. A drape for use in endoscopic surgery substantially as hereinbefore described with reference to the accompanying drawings. A method for manufacturing a drape for use in endoscopic surgery substantially as hereinbefore described with reference to the accompanying drawings.