AU9736001A - Surgical drape and suction head for wound treatment - Google Patents

Surgical drape and suction head for wound treatment Download PDF

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Publication number
AU9736001A
AU9736001A AU97360/01A AU9736001A AU9736001A AU 9736001 A AU9736001 A AU 9736001A AU 97360/01 A AU97360/01 A AU 97360/01A AU 9736001 A AU9736001 A AU 9736001A AU 9736001 A AU9736001 A AU 9736001A
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AU
Australia
Prior art keywords
adhesive
drape
film
coated
suction head
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Granted
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AU97360/01A
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AU755496B2 (en
Inventor
Keith Patrick Heaton
Kenneth William Hunt
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KCI Licensing Inc
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KCI Medical Ltd
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Publication of AU755496B2 publication Critical patent/AU755496B2/en
Assigned to KCI LICENSING, INC. reassignment KCI LICENSING, INC. Alteration of Name(s) in Register under S187 Assignors: KCI MEDICAL LIMITED
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Description

-1-
AUSTRALIA
PATENTS ACT 1990 COMPLETE SPECIFICATION FOR A STANDARD PATENT
ORIGINAL
Name of Applicant/s: Actual Inventor/s: Address for Service:
CCN:
Invention Title: KCI Medical Limited Keith Patrick Heaton and Kenneth William Hunt BALDWIN SHELSTON WATERS 60 MARGARET STREET SYDNEY NSW 2000 3710000352 'SURGICAL DRAPE AND SUCTION HEAD FOR WOUND
TREATMENT'
Details of Original Application No. 89934/98 dated 9 September 1998 The following statement is a full description of this invention, including the best method of performing it known to us:- File: 27471AUP01 la SumEjz2 Drape and Suction Hlead for Wound 7reatment This invention relates to surgical drapes and suction heads for wound treatment.
Surgical drapies are widely used in su]a operations for the purpose of reducing infection and faciitating. the handlizn of skin around incisions- Normally, they am transparent or transhuzceaL Typically, they consist of a flexible, plastics film which is adhesive-coated and which -is, applied to the area of the operati.on, pior to Making the incision. SurIca drapes are also used for attaching treatment devices to paltients after an operation, such as catheters or drainage tubes.
A further, recently developed use is for connecting a suction tube to a wound 0 for the purpose of stimu~lating heakig othe wound Such use is descled incour ealier PCT Applications Nos. WO 96105873 and WO 97/18007.
Various proposals have been. made in the past to design the surgical d :rape so that handling of the sticky, flexible, plastic film is facuiited For example, 'US Patent NO. 5,437,622, describes a surgical drape which is a laminat of three materials.
The. first material comprising a trspareut,. thin plastics fim which is adhesive-coated and this is protected with a layer- of release-coated papar. The other'face of the adhesive-coatd urnm is' st=4nthened'with a. reinforcing layer of a less flexible,- plastics ilm. andin bars or stips are attached to the flexible, plastics film at its lateral edges. to fai~litate handling of the flexibl, Plastics film after stripping away the protectzve releasable laycr.
Where it is desired to use a surgical drape primarily to attach a device such as a cathete -to a wound area after an operation or for long term treatment, it is inconvenient for the surgeou or nurse to have to adapt a stnad surgicaidrape for this pUrpose. It would be more convenient to have a surgical drape which. 'was suitable wlithout adaptation to accommuodate. the treatment device -2- Any discussion of the prior art throughout the specification should in no way be considered as an admission that such prior art is widely known or forms part of common general knowledge in the field.
It is an object of the present invention to overcome or ameliorate at least one of the disadvantages of the prior art, or to provide a useful alternative.
Accordingly, the invention provides a surgical drape which comprises a thin, flexible, adhesive-coated plastics film and a strengthening layer applied to the face opposite to the adhesive coating, the strengthening layer being a plastics film which is thicker or less flexible than said adhesive-coated film, and a protective, releasable layer 10 applied to the adhesive coating, the drape having an aperture through at least the oo..
strengthening film and adhesive-coated film to permit, in use, access to a wound area, at least one first edge of the drape having a non-adhesive coated handling bar for o:ooo S•separating the adhesive-coated film from the protective layer, and wherein the protective 00o.
layer comprises a separate strip extending parallel to the first edge of the drape, and 15 which protects the adhesive coating in the region of the aperture and carries at least one •oooo flap overlapping the adjacent portion of the protective layer, said flap constituting a oooo• S• handle for facilitating removal of said strip prior to use.
Unless the context clearly requires otherwise, throughout the description and the claims, the words 'comprise', 'comprising', and the like are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense; that is to say, in the sense of "including, but not limited to".
Preferably, non-adhesive-coated handling bars are positioned at opposite lateral edges of the drape.
In practice, surgical drapes may be manufactured by laminating an adhesivecoated flexible film, such as a polyurethane film, to a protective releasable layer, such as 2aa siliconised paper. A strengthening layer of thicker plastics material, e.g. a polyolefin such as polyethylene, may be applied to the non-adhesive coated face of the flexible film, so that a three-layer laminate is produced. These laminates are produced in substantial width and may be slit longitudinally to the desired width and then laterally to form drapes of the desired size.
After slitting to a desired width, handling bars are normally applied to the adhesive-coated layers at one or both lateral edges to facilitate separation of the film o e -3from the protective, releasable layer. While an aperture could be cut at the desired position through the layers to accommodate a catheter or a device such as those described in our above-mentioned applications, it is difficult to handle the highly pliable and adhesive film after the releasable layer has been stripped off.
Although the strengthening layer does somewhat improve the handling characteristics, this is not a complete answer to the problem. However, the handling characteristics are substantially improved by providing a protective layer which is in at least two portions, one of which is in the form of a strip, e.g. one extending parallel to the lateral edges of the drape, and covering the peripheral area around the aperture ooo.
through the drape. By providing a flap on this portion of the releasable layer, it can be stripped off initially so that the drape is first positioned around the device which is to pass through the aperture, and then the remaining part of the protective releasable layer is stripped off to adhere the drape to the patient's skin around the area to be treated.
oo o In a preferred form of the invention in which negative pressure therapy is applied 15 to a wound area, the surgical drape described above is combined with a suction head S° having a connector piece which is adapted to be connected to a suction tube. Thus, in this embodiment, the suction head can be adhered to the patient's skin in the area of the wound after removing the strip of protective releasable layer, and then the remaining part of the drape affixed to the patient's skin. In this way, the suction head is held firmly in place and, at the same time, seals the suction head to the wound area and prevents leakage of air from atmosphere into the wound area.
The invention also preferably includes a suction head having a design which facilitates the suction of fluid from a wound area.
According to a further preferred feature of the invention, therefore, there is provided a suction head for applying suction to a wound area which comprises a generally planar -4flange portion and a tubular connector piece on a first face, for connecting a suction tube to an aperture through the flange portion to'the other face, said other face having projections defining flow channels facilitating flow of fluid towards said aperture.
Preferably, the suction head described above is combined with a surgical drape, the drape comprising a thin, flexible, adhesive-coated plastics film, and the tubular connector piece extends through an opening in the plastics film with the adhesive coating adhered to said first face of the flange portion.
Preferably, the suction head is used in conjunction with an open-celled foam pad so that one surface of the foam pad is placed in contact with a wound area and the S 10 suction head applied to the other surface of the foam pad. In the case of deep wounds the foam may be shaped and placed so that it is packed into the wound cavity as described in our above cited PCT applications. According to another technique, which is S* particularly applicable to superficial wounds, the foam pad may be a relatively thin pad which is placed over the wound. The suction head is placed in contact with the open 15 face of the foam pad and the drape applied over the suction head to fix the assembly to the patient's skin.
Various types of open celled foams can be used as described in our above cited PCT applications. The foam may be a polyurethane foam but polyvinyl acetate (pva) foams are preferred, especially when used as a pad which is placed over the wound.
These are to some extent hydrophilic, which seems to exhibit beneficial comfort properties when applied to the skin. Wound healing is stimulated by maintenance of moist conditions in the wound area, and this is facilitated by using a hydrophilic foam.
A preferred embodiment of the invention will now be described, by way of example only, with reference to the accompanying drawings in which: Referring to the accompanying drawings: FPigure 1 represents a conventional design of surgical drape; Figure 2 represents a variation in the design of the handling bars at one end of t e deshowninFigure 1; Figure 3 is a view similar ta Figure 1 of a surgical drape in accordance with the invention; Figure 4 is a plan view of the surgical drape shown ini Figure 3; Figure 5 is a plin view from beneath of a suction head in accordance with. the invention; and Figure 6 is a side elevation of the suction h*a shown in Figure 7 is a view simia to. Figure 6 but shows the suction head secred to a surface with the drape and with a foam pad located between the bead anid the skin .surface.
Figure 8 is a perspective view of the drape. with a central strip portion of the protective sheet in the course of being removed, and.
Figures illustrate -the steps of affxing thc dressing assembly to a wound area on a patient's leg and attachment to a negative pressure aisenbly.
Ref~uingto Figures I and 2 of the accmpaqying drawings, a conventional larninate for use -as a surgical drape comprises a thin, fleibl, transparent plastics film I which is adhesive-coated on one face 2, nominally with a high-tack pressure-sensitive adhesive and is protected'with a releasable layer 3. The thin plastics film is coniveniently of polyurethane because it transmits moistur. Layer 3 is normally considerably thicker than film I and is coated on the sur&=c adjaent to the adhesive with a releasable material suich as a silicone to facilitate stripping away from the adhesive-coated fllum In order to faciitte removal of the adhesive-coated film, prior to use of the device, handling bars 4 ame bonded at each end to the adhesive-coated film 1. Thus, bY holding one of the bars 4, the protcctive layer, 3 cau be stripped off and the adhesive face applied to the si of the patient. To facil[itate, handling of the thin, flexible film a stbitenn plastics film 5 is frequently applied to the firee face of the plastics film 1. This is geunerly also trnsparent or trasucent. Film 5 is preferably not bonded with adhesive to film 1, but may-remain in contact by reason of electrostatic forces or because of close contact between the two confonning surfaces of im I and Usually, the surgeon or nurs wil wish to strip off the protective layer 5 after the film I has been correcly placed on the patient sin, and this can be faciltated by making partial. cuis 6 through the films I and S, so tMat as the handfling bar 4 is drawn 10 upwards from the patient's skin, the adhesive film* 1 remains adhered to the padit,1 ~wbile the partia cuts 6 causes seprto of the flexible fm from the stregthening fim 5. Strengthenig bars 7 may be provided to hold the lateral edges of the stgthening film 5 and film I together with thirm main Pubts An Alternative is show in Figure 2, in which the strengthening film 5is provided with a separate overlapping handling bar 14, to facilitae it removal from the flexile film 1.
Further details of the mke-up and manufacture of surgcal drapes aegiven in ~~US Patent No. 5,437,622 and EurpeanPaten Application No. 0161865 and thepir art refered to therein, the disclosure of which is. incorporated herelin Refciing to Figure 3 and 4, the surgical drape of this invention conmrse a Protective outer film 20, laminated to a thin, flexible film 21. .'The fleible film 21 includes an adhesive-coated layer which is protected with a release-coated sheet mcarterial 24. Lateral edges of the flexible film 21 are provided with handling bars 23.
Thus far.. the design is essentially the same as tha shown in Figures I and 2.
The drape of the present ivcntion differs from the drape shown in Figures I and 2 int that an aperture 25 is cut through the strengthening layer 20 and through the flexible. layer 21.- The other difference compared with the prior art drapes is that the protective rcleasable layer is formed in at least two sections.
In the embodimertts shown in Figures 3 and the central portion of the releasable layer comprises a strip 26, having flaps 27 which overlap the remnaining outboard portions of the releasable layer. Thw purpose of this is to enable the central strip 26 -to be removed first, without disturbing the remaining portions of the releasable layer. The drape can thcn be fitted around the wound area and, if desired a suction *device or other treatment device passed throagh the aperture 25 and secured to the 10 patient's skin with the peripheral areas -of exposed adhetsive-coated filmL An example of a device far applying suction to the wound area is illustrated in Figures 5, 6 and 7.
Referring to these- Figures, the suction bead comprises a flinge portion 0 0 merilyr~nde at ts dges Onthe face of the flange 30 intended fbr contact with patient's sIn or a foam pad are formed a seuies of projections 32 which are distriue vrteszaeo the flange apart from the peripheral edge portion 3 1.
***The Purpose of these projections is to provide fluid channels 33 facilitating the flow of fluids from any point of the flange to a central point 34, from. which it is intended to apply suctioa. The suction head includcs: a connector 35, located above the aperture 2034, having a tubular end 36 adapted for receiving and connecting a catheter. The tubular end may have an outwardly caperied portion to facilitate feeding a catheter into the r-onnctor. The upper surface 37 of the suction head hasa substantially smooth surface.
In use, the connecor portioi..35 is sized so that it extend, throvgh the aperture.
i the surgical drape shown in Figume 3 and 4, with the adhesive surface around the aperture bonded to the smnooth surface 37 of the flange 30. The suction head may be packaged in this condition with the surgical drape so that in use, the strip 26 is removed by pulling on the handles 27 thus exposing the adhesive surface in the viciity of and surrounding the suction head. The suction head can then fixed in the desired position on the patient's wound and then the Iremig portion of the protective film removed to fix the drape to the p atient. The flange 30 of the suction head may be somewhat oval as shown in vigure 5, and have dimensions as indicated in this Figur, Le. a longer dimenioan of about 95mm and a short dimnusion of about Atraiey h lne a e.rdradb m in. plan..~. For. ex~ample, the diameter of a circular suction head may be from -about. 30 to 50mm in diameter, Figure 7 shows the -suction head attached to. a wound. area 71 of a patient I Te suction head is pressed into firm contact with a flexile open-celled foam 73, which is itself pressed into contact with the wound area 71. The suction head and :foam pad are pressed into contact with the wound area by a surgical drape 20 having an adhesive surfce 74. The adhesive surface is bonded to the patient's sin outside the periphery of the foam pad and suction head. It is also bonded to upper surface 37 of the suction head. An. aplrtre is formed in the drape to permit the connector portion 35 to extend upwardly through the drape In order to avert the danger of incorrec catheter tubes being- fited -to the connector 35, the latter may have a custuiied ros-secionor ntenalprojection such as a rib o" key which co-operates with ~a corresponding slot or key way in the catheter Alternat ively, the cathc=e xnay be moulded with a projection or longitudinal rib which co-operates with a corresponding slot or key way in the aperture of the connector The foam, pad may be packaged in a plastic pouch, sterilised by gamma iradiation and supplied in the same box or in other packing units as the suction head and drape.
Figures 8 and ilustrate the way in which the drape/suction head combination is fitted to a wound on a patient's skin. In Figure 8, a backing sheet 10 1 having a release coated surface is removed in the first step from the adhesive face 102 of the drape to expose the face of the connector 30. A pad 103 of foam is positioned over the wound area and the drape placed over the foam pad, the drape being adhered to the 10 skin above and below the pad (Figure 9a). The lateral protective strips 104 and 105 are -removed in turn from the drape and the assembly adhered to the skin (Figures 9(b) and 00 0 Finally, the spout 36 is connected to a tube 106 which is then connected to a source of suction, e.g. a pump as described in our above PCT application, in order to apply negative pressure to the wound. The suction head and drape assembly is shown in Figure 8, with the smooth surface 37 adhered to the-drape, is conveniently packaged in an easily openable plastic bag or pouch, and sterilised for immediate use..
00 0 Although the invention has been described with reference to specific examples it will be appreciated to those skilled in the art that the invention may be embodied in many other forms.

Claims (2)

1. A surgical drape which comprises a thin, flexible, adhesive-coated plastics film and a strengthening layer applied to the face opposite to the adhesive coating, the strengthening layer being a plastics film which is thicker or less flexible than said adhesive-coated film, and a protective, releasable layer applied to the adhesive coating, the drape having an aperture through at least the strengthening film and adhesive-coated film to permit, in use, access to a wound area, at least one first edge of the drape having too*a non-adhesive coated handling bar for separating the adhesive-coated film from the 10 protective layer, and wherein the protective layer comprises a separate strip extending 55 0 parallel to the first edge of the drape, and which protects the adhesive coating in the region of the aperture and carries at least one flap overlapping the adjacent portion of the protective layer, said flap constituting a handle for facilitating removal of said strip prior to use. 15
2. A surgical drape substantially as herein described with reference to any one of o o• S. •the embodiments of the invention illustrated in the accompanying drawings. DATED this 21st Day of December, 2001 00 KCI MEDICAL LIMITED Attorney: STUART M. SMITH Fellow Institute of Patent Attorneys of Australia of BALDWIN SHELSTON WATERS
AU97360/01A 1997-09-12 2001-12-21 Surgical drape and suction head for wound treatment Expired AU755496B2 (en)

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GB9719520 1997-09-12
AU97360/01A AU755496B2 (en) 1997-09-12 2001-12-21 Surgical drape and suction head for wound treatment

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AU89934/98A Division AU745271B2 (en) 1997-09-12 1998-09-09 Surgical drape and suction head for wound treatment

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NZ206837A (en) * 1983-01-27 1986-08-08 Johnson & Johnson Prod Inc Thin film adhesive dressing:backing material in three sections
GB9523253D0 (en) * 1995-11-14 1996-01-17 Mediscus Prod Ltd Portable wound treatment apparatus

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