Surgery – Endoscope – With protective sheath
Reexamination Certificate
1999-07-16
2002-04-23
Leubecker, John P. (Department: 3739)
Surgery
Endoscope
With protective sheath
C600S112000, C600S125000, C359S510000, C359S507000
Reexamination Certificate
active
06375610
ABSTRACT:
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 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.
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 U.S. Pat. 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 “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.
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.
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.
The present invention provides a method and an apparatus that overcomes or at least ameliorates the above-mentioned disadvantage of the prior art.
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.
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 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 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.
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.
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.
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.
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.
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.
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
Fairmont Medical Products Pty. Ltd.
Leubecker John P.
Ram Jocelyn
Wallenstein & Wagner Ltd.
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