WO2015117193A1

WO2015117193A1 - Medical draping arrangement

Info

Publication number: WO2015117193A1
Application number: PCT/AU2015/000068
Authority: WO
Inventors: Ian Ross JONES
Original assignee: Pretzel Jack And Wonky Pty Ltd
Priority date: 2014-02-10
Filing date: 2015-02-10
Publication date: 2015-08-13

Abstract

A medical draping arrangement for assisting in the treatment of a patient is disclosed. The medical draping arrangement includes a flexible material configured for draping over at least a portion of the patient that includes a treatment site and an aperture formed in the flexible material, the aperture sized and shaped to allow access to the treatment site when the flexible material is deployed over the patient. The draping arrangement further includes an attachment region to attach a medical instrument involved in the treatment of the treatment site and an aperture stabiliser arrangement to restrict movement of the aperture with respect to the treatment site.

Description

MEDICAL DRAPING ARRANGEMENT

PRIORITY DOCUMENT

10001 ] The present application claims priority from Australian Provisional Patent Application No. 2014900396 titled "MEDICAL DRAPING ARRANGEMENT" and filed on 10 February 2014, the content of which is hereby incorporated by reference in its entirety.

TECHNICAL FIELD

[0002 ] The present invention relates to medical procedures. In a particular form, the present invention relates to a medical draping arrangement to assist in surgical procedures and the like.

BACKGROUND

[0003] During many medical procedures it is necessary for retractor devices to be employed to ensure that the treatment site is presented appropriately. As an example, a surgical procedure may involve the use of a scalpel to form an incision in the patient at the treatment site. As the incision is formed and the surgeon cuts deeper into the patient, it will be necessary to retract the skin and other tissue and organs away to expand and keep open the incision to allow access. In another example, a medical procedure may involve a naturally occurring orifice such as the anus or vagina where it is necessary to retract and restrain movement of the tissue that forms the boundary of the orifice to allow access. Further, retraction of tissue may be required if an incision is then made to operate on the patient within the orifice.

10004] While assisting medical staff may be employed to operate these retractor devices, this quickly becomes impractical where appropriate retraction calls for multiple retractors to be used around the treatment site. One attempt to address this problem is by the use of a frame arrangement which is designed to confonn to the surface of the patient and to surround the treatment site. These frame arrangements or retractor rings are designed to be self-retaining with respect to the patient and include notches or slots to which the ends of various types of retraction hooks or other retraction devices may be attached to. Other types of frame arrangements include a hinge between two sub-frame elements in an attempt to provide greater flexibility and conformity with the area surrounding the treatment site

[0005] Unfortunately, these devices can be cumbersome to use in combination with the medical drapes that are used to isolate the treatment site and in some cases to assist in ensuring sterile conditions. This is because the aperture formed in the drape may become misaligned with the frame arrangement which can move during the medical procedure potentially causing contamination as the aperture may move to an area of the patient that has not been prepped appropriately for surgery and then back to the treatment site. In some surgical procedures such as vaginal surgery, the treatment site may be close to an area such as the anus and any movement of the aperture could result in a serious risk of infection. As the frame arrangement is an extra piece of equipment it can also restrict the flexibility of the surgeon to manipulate surgical instruments and intrude during the medical procedure. Further, the mobile nature of these retraction devices presents an extra degree of hazard to the surgeon and any assisting personnel due to needle stick injuries and the like.

[0006] There is thus a need to provide an improved retraction arrangement for use during medical or surgical procedures capable of being operated by the surgeon without necessarily requiring additional assistance and which does not overly interfere with the procedure itself.

SUMMARY

[0007] In a first aspect, the present invention accordingly provides a medical draping arrangement for assisting in the treatment of a patient, the medical draping arrangement comprising:

a flexible material configured for draping over at least a portion of the patient that includes a treatment site;

an aperture formed in the flexible material, the aperture sized and shaped for allowing access to the treatment site when the flexible material is deployed over the patient;

an attachment region for attaching a medical instrument involved in the treatment of the treatment site, the medical instrument including a complementary attachment region for attaching to the attachment region of the medical draping arrangement; and

an aperture stabiliser arrangement for restricting movement of the aperture with respect to the treatment site.

[0008] In another form, the attachment region is configured to allow the medical instrument to be detachably attached to the attachment region at different positions and/or orientations with respect to the treatment site.

[0009] In another form, the attachment region extends around a periphery of the aperture.

[0010] In another form, the attachment region is configured as one or more concentric strips that extend around the periphery of the aperture.

[001 1 ] In another form, the attachment region is configured as one or more discrete attachment portions.

[0012] In another form, the attachment region includes a fastener material for attaching to a medical instrument whose complementary attachment region includes a complementary fastener material. [0013] In another form, the attachment portion includes a reinforced base portion supporting in part or in full the attachment region of the draping arrangement.

[0014] In another form, the aperture stabiliser arrangement includes a patient attachment means to attach the draping arrangement to the patient to restrict movement of the aperture.

[0015] In another form, the patient attachment means includes an adhesive attachment region that removably attaches the draping arrangement to the patient.

[0016] In another form, the aperture stabiliser arrangement includes drape securement means to attach the draping arrangement to a structure involved in the treatment of the treatment site to restrict movement of the aperture.

10017] In another form, the drape securement means includes one or more drape securement devices that may be deployed on the structure, the one or more drape securement devices including a drape securement portion to removably receive or attach portions of the drape arrangement.

10018] In another form, the structure is an operating table.

[0019] In another form, the aperture stabilisation arrangement includes a moulded portion, the moulded portion shaped to conform to the expected contours of the treatment site to restrict movement of the aperture.

[0020] In another form, the aperture stabilisation arrangement includes a hardenable portion which following activation hardens to assist in stabilising the aperture.

[0021 ] In another form, the aperture stabilisation arrangement includes a malleable portion for configuring to a shape that conforms to the patient to assist in stabilising the aperture.

[0022] In another form, the medical draping arrangement is configured as a dressing drape arrangement where the flexible material extends over a confined portion surrounding the treatment site.

[0023] In another form, the aperture stabiliser arrangement includes an adhesive portion located on the underside of the flexible material to attach the dressing drape arrangement to the patient.

[0024] In another form, the adhesive portion covers the entire underside of the flexible material.

[0025] In another form, the aperture stabilisation arrangement includes adhesive strips applied to a boundary portion of the flexible material. [0026] In another fonn, the aperture stabilisation arrangement includes a portion of the flexible material that is elasticised to resiliently engage with the patient.

[0027] In another form, the aperture stabilisation arrangement includes a drape tensioning system to restrict movement of the aperture with respect to the treatment site.

[0028] In another form, the attachment region is configured to provide a retraction function for the treatment site when used in combination with the medical instrument, the medical instrument in the form of a retraction device attached to the attachment region.

[0029] In a second aspect, the present invention accordingly provides a medical instrument for use in combination with a medical draping arrangement, wherein the medical draping arrangement includes an attachment region surround an aperture for positioning over a treatment site and wherein the medical instrument includes a complementary attachment portion adapted to attach to the attachment region of the medical draping arrangement.

[0030] In another form, the medical instrument provides a retraction function for the treatment site.

[0031 ] In a third aspect, the present invention accordingly provides a method for draping a patient for treatment of a treatment site located on the patient, the method including:

arranging a draping arrangement over the patient, the draping arrangement including an aperture, wherein arranging the draping arrangement includes positioning the aperture of the draping arrangement over the treatment site, the draping arrangement further including an attachment region for detachably attaching a medical instrument involved in the treatment of the treatment site; and

stabilising the aperture to restrict movement of the aperture with respect to the treatment site.

[0032] In another form, stabilising the aperture includes attaching or securing the draping arrangement to the patient.

[0033] In another fonn, stabilising the aperture includes attaching or securing the draping arrangement to a structure involved in the treatment of treatment site.

[0034] In another form, the method further includes attaching a retraction device to the attachment region of the draping arrangement, the retraction device providing a retraction function for the treatment site. BRIEF DESCRIPTION OF DRAWINGS

[0035J Illustrative embodiments of the present invention will be discussed with reference to the accompanying drawings wherein:

[0036] Figure 1 is a front view of a medical draping arrangement in accordance with an illustrative embodiment;

[0037] Figure 2 is a rear or underside view of the medical draping arrangement illustrated in Figure 1 ;

[0038] Figure 3 is a side perspective view of the medical draping arrangement illustrated in Figure 1 deployed over a patient;

[0039] Figure 4 is a detailed top view of the attachment region of the medical draping arrangement illustrated in Figure 1 ;

[0040] Figure 5 is side sectional detail of the attachment region of the medical draping arrangement illustrated in Figure 4;

[0041 ] Figure 6 is an end on figurative view of the patient ill ustrated in Figure 3 depicting the attachment region of the medical draping arrangement illustrated in Figures 1 to 4 showing the use of various medical instruments in combination with the medical draping arrangement including a tissue retractor and a retractor and attachment strip combination;

[0042] Figures 7A-D are various detailed views of the tissue retractor illustrated in Figure 6;

[0043 ] Figures 8A-D are various detailed views of the attachment strip illustrated in Figure 6 ;

[0044] Figure 9 is an end on figurative view of the patient illustrated in Figure 3, similar to Figure 6, depicting the attachment region of the medical draping arrangement showing the use of various medical instruments in combination with the medical draping arrangement including a posterior vaginal retractor and a haemostatic clamp and instrument attachment clip combination;

[0045] Figures lOA-C are various detailed views of the posterior vaginal clamp illustrated in Figure 9;

10046] Figures 1 1 A-C are various detailed views of the instrument attachment clip illustrated in Figure 9; [0047] Figures 12A-C are various detailed views of an alternative instrument attachment clip to that illustrated in Figures 1 1 A-C;

[0048] Figure 13 is a view of a patient similar to Figures 6 and 9 showing the use of medical instruments in combination with the medical draping arrangement including an anterior vaginal retractor and a haemostatic clamp and instrument attachment clip combination;

[0049] Figures 14A-C are various detailed views of the anterior vaginal clamp illustrated in Figure 13;

[0050] Figure 15 is a view of a patient similar to Figures 6, 9 and 13 showing the use of medical instmments in combination with the medical draping arrangement including a posterior vaginal retractor as illustrated in Figures l OA-C, an anterior vaginal retractor as illustrated in Figures 14A-C and two lateral vaginal retractors;

[0051 ] Figures 16A-C are various detailed views of the lateral vaginal retractor illustrated in Figure 15;

[0052] Figures 17A-C are various detailed views of a drape attachment clip for securing a medical draping arrangement such as that illustrated in Figures 1 to 3;

[0053 ] Figure 18 is a top perspective view of a medical draping arrangement in accordance with an illustrative embodiment in the form of a compact drape;

[0054] Figure 19 is a figurative view of a retraction hook adapted for use with the compact drape illustrated in Figure 18;

[0055] Figure 20 is a figurative view depicting a range of different aperture configurations in accordance with various illustrative embodiments;

[0056] Figures 21 A-C are figurative views showing different attachment region configurations in accordance with various illustrative embodiments;

[0057] Figures 22A-C are figurative views of an adjustable tissue retractor in accordance with an illustrative embodiment;

[0058] Figures 23A-F are various detailed views of an instrument attachment clip adapted for use with a haemostatic clamp in accordance with an illustrative embodiment;

[0059] Figure 24 is a front view of a draping arrangement incorporating a drape tensioning system according to a further illustrative embodiment; [0060 ] Figure 25A is a detailed perspective view of a drape tensioner component of the drape tensioning system illustrated in Figure 24 prior to deployment;

[0061 ] Figure 25B is a detailed perspective view of an attachment point component of the drape tensioning system illustrated in Figure 24 prior to deployment;

[0062] Figure 26 is a detailed perspective view of the drape tensioning system illustrated in Figure 24 as deployed;

[0063] Figure 27 is a perspective view of a drape attachment mount according to an illustrative embodiment for securing a medical draping arrangement such as that illustrated in Figures 1 to 3; and

[0064] Figure 28 is a perspective view of an alternative drape attachment mount according to another illustrative embodiment.

[0065] In the following description, like reference characters designate like or corresponding parts throughout the figures.

DESCRIPTION OF EMBODIMENTS

[0066] Referring now to Figures 1 and 2, there is shown front and rear views of a draping arrangement 100 for assisting in the treatment of a patient according to an illustrative embodiment. Draping arrangement 100 comprises a flexible material 1 10 that is configured for draping over at least a portion of the patient that includes a treatment site that requires medical attention. In this illustrative embodiment, the flexible material is formed from a multi-layer non-woven drape comprising an outer layer that provides absorption of bloods and liquids, an intermediate layer that provides a fluid/moisture/bacteria barrier and an inner layer that provides low allergenic soft contact with the patient's skin. While in this illustrative embodiment, the draping arrangement 100 assists in maintaining the sterility of a treatment site, in other embodiments the flexible material may consist of less layers and not necessarily provide a sterile barrier. In yet other embodiments, the drape may be formed of a disposable reinforced paper material.

[0067] Draping arrangement 100 includes an aperture 120 in the flexible material 1 10 that is sized and shaped to allow access to the treatment site. In this illustrative embodiment, aperture 120 is elliptical or oval shaped being sized and shaped for treatment of a female patient's vaginal area (as best shown in Figure 3). Draping arrangement 100 further comprises a mounting or attachment region 130 to in this embodiment detachably mount or attach a medical instrument that is involved in the treatment of the treatment site. Attachment region 130 in this illustrative embodiment is fonned as a reinforced portion as wall be discussed below in relation to Figure 4.

[0068] Referring now to Figure 3, there is shown draping arrangement 100 that is draped over a patient 200. In this illustrative embodiment, it can be seen that drape 100 is configured to allow treatment of the vaginal or perineal area of a female patient 200 who in this depiction is lying on the operating table 300 with her legs 210 elevated and spread by suitable leg support arrangement 310 extending from the bottom portion of the operating table 300 to allow access to the vaginal area of patient 200. In this example, draping arrangement 100 extends almost completely over the patient's torso to isolate the treatment site.

[0069] For this example, elliptical aperture 120 extends approximately 10 cm in the horizontal dimension (as depicted) and approximately 15 cm in the vertical dimension with the mounting or attachment region 130 extending substantially radially from the aperture 120 a further distance of approximately 10 cm. In another example, suitable for abdominal surgery, the aperture would typically have a horizontal dimension of approximately 20 cm and may be rectangular or elliptical with a vertical dimension of approximately 25 cm again surrounded by an attachment region extending approximately 10 cm from the aperture.

10070] In other embodiments, the attachment region may extend from the aperture between around 2.5 cm - 5 cm, 5 cm - 7.5 cm, 7.5 cm - 10 cm, 10 cm - 12.5 cm, 12.5 cm - 15 cm, 15 cm - 17.5 cm, 17.5 cm - 20 cm, 20 cm - 22.5 cm, 22.5 cm - 25 cm, 25 cm - 27.5 cm, 27.5 cm - 30 cm or greater than 30 cm depending on the requirements.

[0071 ] As would be appreciated, the aperture 120 may be of any appropriate size and shape depending on the treatment site and/or the medical procedure with some non-limiting examples depicted in Figure 20. Some example uses include the use of a circular aperture for ear, nose and throat surgery or cranial surgery. Elliptical or elongated circular, rectangular or square apertures may be adopted for abdominal surgery. In addition to elliptical or elongated circular apertures, inverted triangle shaped apertures may also be used for gynaecological surgery. For orthopaedic surgery, elongated square or rectangular or small square shaped apertures may be employed.

[0072] Elliptical or elongated circular apertures may be used for eye surgery and small circular apertures may be used for minimal surgery procedures. As would be appreciated, as well as regular shapes, the aperture may have a non-regular shape that is indicated by the treatment site and/or medical procedure. In yet another embodiment, the medical draping arrangement may be deployed with a cut-out region so that an aperture may be cut out and configured precisely for the treatment site by medical personnel as required. In a further embodiment, the medical draping arrangement includes a perforated region which may be pushed out to form the aperture prior to the medical procedure. [0073] Referring now to Figure 4, in this illustrative embodiment, attachment region 130 is configured as an aperture surrounding region that completely surrounds treatment aperture 120 and includes three concentric oval or elliptical attachment rings 132, 133, 134 formed of a fastener material such as a hook and loop type fastener material (eg Velcro^IM) that is attached to a reinforced base portion 135 formed in this illustrative embodiment of a suitable plastic material such as medical grade polyethylene or other suitable synthetic material. In other embodiments, reinforced base portion 135 may be formed of a reinforced cardboard material having suitable resistance to tearing, crumpling and wrinkling. In other embodiments, the fastener material includes, but is not limited to, hook and mushroom or mushroom and mushroom type configurations.

[0074] Referring now to Figures 21 A-C, in other embodiments and as shown in Figure 21 A, the attachment region 130 may include arcuate or part arcuate frame members 1410 that surround or part surround the treatment site and which have a series of radially extending slots to which retractor stays of the type having an elongated elastic hollow tubing may be attached to if required. Frame members 1410 may also assist in providing rigidity to the attachment region if required. Similarly, while the attachment region may completely surround the aperture as depicted in Figures 1 to 4, in other embodiments the attachment region may be comprised of separate discrete mounting or attachment portions 138 extending from the aperture such as in a "+" configuration (see Figure 21 A) or an "X" configuration (see Figure 21 B). In yet other embodiments, the attachment region may consist of attachment portions located substantially remote from the aperture.

10075] While in many of the embodiments described above, the attachment region is comprised of a fastening material it will be understood that any attachment or mounting arrangement involving an attachment region on the draping arrangement that is configured to attach to a complementary attachment region on an associated medical instrument is contemplated here. In other non-limiting examples, attachment regions may include adhesives, press studs, threaded portions, releasable catches or clips or joint arrangements such as a dovetail arrangement. An adhesive region may also be included adjacent to the aperture to substantially prevent operating instruments from falling into the aperture.

[0076 ] Referring now to Figure 5, there is shown a cross-sectional detail through 5-5 of the attachment region 130 which is comprised of an adhesive attachment region in the form of a bottom adhesive layer 131 that adheres to the patient's skin. The adhesive layer 131 is in turn attached to the flexible drape material 1 10 comprised in this embodiment of inner, intermediate and outer separate layers 1 10a, 1 10b and 1 10c as described previously. Attached to the drape material 1 10 is the reinforced base portion 135 which provides the support structure for the concentric oval attachment rings 132, 133, 134. In this illustrative embodiment, the bottom adhesive layer 131 fonns part of an aperture stabiliser arrangement to restrict movement of the aperture with respect to the treatment site by attaching the attachment region 130 to the patient in the region surrounding the treatment site. Prior to deployment, the bottom adhesive layer 131 is covered by a protective layer that is peeled off during deployment of medical draping arrangement 100.

[0077] In another illustrative embodiment, the reinforced base portion 135 may be a moulded portion fonned in one example of a medical grade plastic that is moulded to conform to the expected contours of the treatment site further assisting in stabilising the aperture 120. As would be appreciated, the attachment region 130 may be preferentially braced or reinforced in a given direction to allow for different operative requirements to enable specific retraction or increased retraction in a direction indicated by the medical procedure.

[0078] In yet other embodiments, a hardenable base portion or layer either surrounding or part surrounding the aperture 120 may be impregnated or fomed of a hardenable material which prior to activation is flexible and following activation then hardens to assist in stabilising the aperture 120. In one example, the hardenable material is water activated hardenable material which will harden in response to the addition of water such such as by dampening or the like. Examples of such materials include prepolymerised materials that polymerise on addition of water or those that include carbon fibre or fibreglass components which harden on exposure to moisture.

[ 0079] In this manner, the aperture may be relevantly positioned and the hardenable base portion conformed to the underlying patient anatomy. Following placement, the hardenable base portion is then dampened causing is to harden in place and as a result further stabilising aperture 120. In other examples, the hardenable base portion is fonned from a UV-curable or heat curable material which on exposure to either UV radiation or heat respectively will transition from a flexible state to a hardened state.

[0080] In further embodiments, a malleable or pliable base portion or layer either surrounding or part surrounding aperture 120 may be employed to assist in stabilising aperture 120. In this example, malleable base portion is fonned of a material that may be manipulated or configured into a shape that conforms to the underlying patient anatomy. Malleable base portion may incorporate a malleable sheet formed of a suitable metal such as suitably coated aluminium or tin or plastic that can be pressed and fonned into shape as required.

[0081 ] As would be appreciated, the hardenable or malleable base portion may be sized and configured as required to assist in stabilising the aperture and the expected degree of retraction required.

Additionally, the hardenable or malleable base portion may include multiple distinct regions depending on the underlying patient anatomy indicated for the surgical procedure being carried out.

[0082] To further assist in restricting the movement of the aperture with respect to the treatment site, the aperture stabiliser arrangement further includes drape securement devices in the form of drape attachment clips 1 100 which function to secure the flexible material 1 10 to the operating table 300 (see Figure 3). As aperture 120 is stabilised with respect to the treatment site this provides not only a fixed operating field for medical personnel but also a platform for various medical instruments that may be involved in the treatment of the treatment site.

[0083] Although in this embodiment, the attachment region 130 includes a number of peripheral attachment strips that extend around aperture 120 in the form of concentric rings of Velcro™ that extend around the entire periphery of treatment aperture 120, it would be understood that the number and size of rings or attachment strips could be varied according to requirements. As will be clear from the discussion below, the concentric rings provide reference attachment locations at predetermined distances from the aperture 120 to which a surgeon may selectively attach a medical instrument such as a tissue retractor hook or similar at different positions and/or orientations. As discussed above, attachment region 130 may also be configured as a number of discrete locations that are adapted for a specific surgical procedure where a particular medical instrument used in that procedure is attached to the discrete location.

[0084] Referring now to Figure 6, there is shown a figurative end on view of the patient 200 illustrated in Figure 3 depicting the position of the aperture 120 and the attachment region 130 which in this illustrative embodiment includes three concentric oval rings 132, 133, 134 forming part of draping arrangement 100 where for clarity purposes the flexible material is transparent in this diagram. In this example, the treatment site is the vaginal area or vulva 220 of the patient 200. Three types of medical instruments or devices each having a complementary attachment region that detachably mount or attach to the attachment region 130 are depicted. The first is a tissue retractor 400 and Figure 6 depicts three of these devices that are attached at one end to left hand labia minora 222 and detachably mounted to oval ring 133 at the other end. The tissue retractor device 400 is discussed below with reference to Figures 7A-D.

[0085] The second medical instrument is an adhesive vulval attachment strip 500 which in Figure 6 is attached to the right labia majora 221 of patient 200 and which in combination with a third medical instrument in the form of a retractor 550 detachably mounted to Velcro^IM oval ring 133 functions to retract outwardly the right labia majora 221 of patient 200. The adhesive vulval strip 500 is discussed below with reference to Figures 8A-D.

[ 0086] As can be readily appreciated, the attachment region 130 allows the tissue refractors 400 and retractors 550 to be selectively placed at a predetermined orientation and distance from the treatment site. Depending on the type of medical procedure and/or the physiol ogy of the patient 200, the tissue retractor 400 may be placed as required. The adhesive vulval strip 500 in this example is attached to the labia majora 221 and forms an attachment surface which can then be retracted by the use of retractors 550. In this case, the surgical procedure might require minimal retraction on the right hand side of the vulva 220 indicating the use of the vulval strip 500 and retractor 550, whereas on the left hand side, the vulva 200 requires attention and so tissue retractors 400 are employed that directly hook into the labia minora 222.

[0087] Should the degree of retraction require adjustment, it is a relatively simple procedure for the surgeon to detach a tissue retractor 400 or retractor 550 from the attachment region 130 and attach it at a different position to vary the degree or direction of retraction as required. As would be readily appreciated, the retraction arrangement shown in Figure 6 may be positioned and adjusted by the surgeon without requiring any assistance from other medical personnel.

[0088 ] Referring now to Figures 7A-D, there are shown various views of a tissue retractor 400 that may be detachably mounted to an attachment region 130 of draping arrangement 100. Tissue retractor 400 includes an oval shaped body 410 having attached to its underside a pad 420 formed of fastener material such as Velcro^{1 M} configured to detachably attach to the complementary fastener material of attachment region 130. Extending from body 410 is a stay member 430 which is attached at one end to socket 415 formed in body 410 and which at the other end terminates in a hook member 440. In this example, the hook includes two prongs 441, 442 (as best seen in Figure 7B) separated by gap 443 and is formed of stainless steel for direct attachment to tissue. As can be seen in Figure 6, the tissue retractors 400 attach directly to tissue such as the labia minora 222 of patient 200. The stay member 430 in this embodiment is formed of an elastomeric material which allows flexing of hook member 440 with respect to body 410 in terms of both extensibility and bending. In other embodiments, stay member 430 may be rigid.

[0089 ] Retractor 550 as illustrated in Figure 6, and which is depicted as attached to vulval strip 550, is essentially equivalent to tissue retractor 400 except that due to there being no need to directly attach retractor 550 to tissue instead a blunt hook may be employed instead of the two pronged hook member 440 of tissue retractor 400.

[0090 ] Referring now to Figures 22A-C, there is shown an adjustable tissue retractor 1400 according to another embodiment which may be detachably mounted to attachment region 130 and whose degree of retraction may be adjusted. In this embodiment, adjustable tissue retractor 1400 is formed of a base portion 1410 and a removable retractor portion 1450. Base portion 1410 in this embodiment includes an oval shaped body 141 1 having attached to its underside a pad 1420 formed of fastener material that is configured to detachably attach to the complementary fastener material of attachment region 130.

Extending across the top of body 141 1 is a centrally disposed tubular portion 1412 which presents an orifice 1413 to receive the tubular stem 1455 of retractor portion 1450 which terminates at its end with a hook member 1440 which in this embodiment comprises three prongs and which may be configured for either direct attachment to tissue and/or other medical instruments such as attachment strips or the like (eg, see vulval attachment strip 500 depicted in Figures 8A-D). [0091 ] In this example, the tubular stem 1455 of retractor portion 1450 is comprised of an initial end portion 1456 having a sectional radius smaller than remaining portion 1457 to which hook member 1440 is attached. In this embodiment, the initial sectional radius of end portion 1456 is 2 mm and the sectional radius of remaining portion 1457 is 3 mm for an associated internal diameter of tubular portion 1412 of base portion 1410 of 2.5 mm. Furthermore, tubular stem 1455 is formed of an elastomeric material such as rubber or an equivalent synthetic material that is compressible. As best seen in Figures 22B and 22C, this stem configuration allows the tubular stem 1455 of retractor portion 1450 to be initially inserted or threaded into tubular portion 1412. To ad just the tension or amount of retraction force the tubular stem 1455 may be further pulled through tubular portion 1412 in the direction of the indicated arrow at which point the larger sectional radius of remaining portion 1 156 will frictionally engage with the inner surface of tubular portion 1412 due to the resiliency of the tubular stem 1455. In this manner, a surgeon may further increase the tension for a given placement of the adjustable tissue retractor 1400 on attachment region 130 by pulling the tubular stem 1455 further through the tubular portion 1412 of tissue retractor 1400 providing even further adjustability.

[0092 ] Referring now to Figures 8A-D, there are shown various views of an attachment strip in the form of arcuate shaped vulval strip 500 that includes a top surface 510 and an adhesive bottom surface 520. Protruding from top surface 510 there are three rows of fibre loops 530a, 530b, 530c that function as individual attachment points 530 for the hook portion of refractor 550. As would be appreciated, the arrangement of the three rows makes further fine adjustment of the positioning of the vulval strip 500 possible by allowing for either lateral retraction by using the most lateral loops or in situations where the tissue is particularly loose and mobile, the middle or inner row of loops will enable eversion of the labia majora, further increasing access to the treatment site. In this illustrative embodiment, attachment strip is adapted for attachment to the vulval region of a female patient, however, the attachment strip may be specifically configured for other regions including, but not limited to, orifices such as the mouth, eye or nose or support tissues such as the scrotum, penis, ear or breast. As would be appreciated, attachment strips of this type allow a surgeon to control an extended area at the treatment site and further facilitate the surgical procedure.

[0093] In other embodiments, the attachment strip may include a top surface formed of a fastener material such as Velcro™ or the like providing an attachment surface for a complementary fastener material. In yet other embodiments, the attachment strip may include other types of attachment locations or fixtures such as press studs, tie points, threaded portions or the like. As would be readily appreciated, the use of attachment strips as described above will reduce traumatic injury of tissue during the medical procedure and furthermore there is no need for further tissue damage on repositioning of the retractor. While in this illustrative embodiment the attachment strip is configured as an elongate rectangle shape it will be understood that attachment members operating on the same principles and having other shapes and configurations that allow for control and retraction of an extended area of a treatment site may also be used.

[0094] Referring now to Figure 9, there is shown a figurative end on view of the patient 200 similar to that of Figure 6 depicting the use of further medical instruments in combination with draping arrangement 100 that detachably mount to the attachment region 130. The first is a posterior vaginal retractor 600 which is discussed in detail below with reference to Figures l OA-C. The second is an instrument attachment clip 700 which in this illustrative embodiment is combined with a haemostatic clamp 750 to perform a clamping function. The instrument attachment clip 700 is discussed in detail below with reference to Figures 1 1A-C.

[0095 ] Referring now to Figures lOA-C, there are shown various views of a posterior vaginal retractor 600 that is employed in combination with draping arrangement 100 to retract the rear vaginal wall during a medical procedure as depicted in Figure 9. Posterior vaginal retractor 600 in this example is comprised of a general L-shaped body 610 formed of a medical grade plastic such as a high temperature resistant thermoplastic or polyphenylsulfone (PPSU) based plastic where the base portion 616 of L-shaped body 610 is adapted for insertion into the vagina having a curved front surface 620 which in use is seated against the rear vaginal wall.

[0096] The curved front surface 620 not only conforms with the shape of the vaginal wall but also increases the rigidity of retractor 600. The stem portion 615 of L-shaped body 610 includes a

complementary attachment region in the form of an attachment surface 630 for attaching to the attachment region 130 of draping arrangement 100. In this illustrative embodiment, attachment surface 630 is formed from a fastener material such as Velcro^1M or the like and attaches to the complementary fastener material of the attachment region 130 of draping arrangement 100 as shown in Figure 9.

[0097] As can be seen in Figure 10B, the angle between the stem 615 and base 616 portions of posterior vaginal retractor 600 is less than 90 degrees and in this illustrative embodiment the angle is

approximately 75 degrees in line with the expected angle of the vagina relative to a supine female with legs elevated as shown in Figure 3 when vaginal retractor 600 is attached to attachment region 130. This may be contrasted to a hand-held Sims type retractor which has an angle of 90 degrees between the stem and base portion but, due to being hand-held, the portion that is inserted into the vagina is further rotated an angle of 15 to 20 degrees.

10098] As would be appreciated, retractors having the general form of posterior vaginal retractor 600 may be used in a number of medical procedures including, but not limited to, the refraction of the abdominal contents in bladder, renal, colon, small bowel and upper gastrointestinal surgical procedures. It addition, a retractor of this type may be used in cardiac, thoracic surgery, throat surgery and brain surgeiy and indeed in almost all surgical procedures where it is necessary to retract organs such as lung, liver, spleen, stomach, bowel or bladder as examples.

[0099] Referring now to Figures 1 1 A-C, there are shown various views of an instrument attachment clip 700 for use in combination with draping arrangement 100. In this illustrative embodiment, and as depicted in Figure 1 1A, instrument attachment clip 700 is for use with a haemostatic clamp 750 and includes a receiving region or mounting portion 720 that receives the scissor arms 770 of haemostatic clamp 750. Instrument attachment clip 700 in this illustrative embodiment is formed of a moulded oval shaped body 710 having on its top surface a mounting portion 720 consisting of a base region 726 and two opposed upwardly extending and inwardly curved sprung clamping members 725 all formed of a suitable grade medical plastic. Mounting portion 720 is also tapered so that on insertion of haemostatic clamp 750 the scissor anns 770 become wedged and prevented from moving further forwards. Mounting portion 720 may be moulded as a unitary moulding with body 710 or alternatively be moulded separately and attached as desired.

[00100] Instrument attachment clip 700 in this illustrative embodiment includes an attachment surface 730 in the form of a fastener material such as Velcro™ or the like located on the bottom surface of body 710 that attaches to a complementary fastener material located of attachment region 130 of draping arrangement 100. As can be seen in Figure 9, the haemostatic clamp 750 with instrument attachment clip 700 loosely attached may be clamped to tissue and then wedged into instrument attachment clip 700. The tissue is then retracted and held in place by attaching instrument attachment clip 700 to, in this case, one or more of the concentric attachment rings 132, 133, 134 of attachment region 130 of draping arrangement 100. As can be seen from Figure 9, depending on the medical procedure, a number of instrument attachment clips 700 may be employed as part of a medical procedure.

[00101 ] Specifically, Figure 9 demonstrates a typical procedure for repair of the anterior vaginal wall (bladder prolapsed). In this procedure the cystocele (presenting as a bulge in the anterior vaginal wall that is actually a bladder hernia) has been opened in the midline. Posterior vaginal retractor 600 is then used to retract the posterior wall which may also be prolapsing and as a result increases anterior access. Clamps 750 are applied to the cut midline edges of the anterior vaginal wall as depicted and retracted laterally to expose the bladder support defect to enable repair. Typically, clamps 750 would be held by one or more assistants but as illustrated in Figure 9, clamps 750 are held by associated instrument attachment clips 700. This not only allows the surgical procedure to be carried out without additional assistance but the instrument attachment clips 700 and clamps 750 may be placed precisely and further moved as required during the medical procedure.

[00102] Referring now to Figures 12A-C, there are shown various views of an alternative instrument attachment clip 800 also adapted for use with a haemostatic clamp 750. Similar to instrument attachment clip 700, instrument attachment clip 800 includes an oval shaped body 810 having a complementary attachment region in the form of an attachment surface 830 located on its bottom surface. In this case, the mounting portion 820 is formed as a clip including a clamping prong or clip member 825 attached to the body 810 at one end and extending over the body 810 and having a free end 826. Clip member 825 is resiliently biased towards the top surface of body 810 resulting in free end 826 touching the top surface of body 810. Extension 825 may be moulded as a unitary moulding with body 810 or separately and then attached depending on requirements.

[00103] As shown in Figure 12A, instrument attachment clip 800 may be attached to the finger grip ring region 780 of a haemostatic clamp 750 by simply lifting the free end 826 of clip member 825 and capturing ring region 780 between clip member 825 and body 810 and then attaching instrument attachment clip 800 to attachment region 130 of draping arrangement 100 to give the desired retraction. In other embodiments, the mounting portion 820 of instrument attachment clip 800 may be configured as a hook member that hooks onto a suitable abutment surface on the medical instrument. As an example, a hook member of this type could be hooked onto the ring region 780 of haemostatic clamp 750.

[00104] Referring now to Figures 23A-F, there are shown various views of yet another alternative instrument attachment clip 1500 also adapted for use with a haemostatic clamp 750. Instrument attachment clip 1500 is in the form of a foldable clamp arrangement having an open configuration as best shown in Figures 23B-D and a closed or folded configuration where it receives and retains clamp 750 as best shown in Figures 23E and F. Instrument attachment clip 1500 includes a circular shaped base portion 1510 and similarly shaped top portion 1520. Extending between base portion 1510 and top portion 1520 is a flexible hinge portion 1530 that allows top portion 1520 to be folded over to overlie base portion 1510. When viewed in the open configuration, each of the base portion 1510 and top portion 1520 includes a compressible top layer 1540a, b formed of suitable elastomeric material such as rubber or synthetic equivalent having a thickness selected so that on closing of instrument attachment clip 1500 only a small gap is left between each compressible layer 1540a, b.

[00105 ] Located on the periphery of base portion 1510 and opposed to the location of hinge potion is an upwardly extending locking tab 151 1 having an centrally disposed aperture 1512 to receive a similarly located tongue portion 1521 extending upwardly from top portion 1520 which is configured to engage with locking tab 151 1 to form a releasable locking arrangement to lock instrument attachment clip 1500 in the closed or folded configuration. To release the locking arrangement, locking tab 151 1 may be flexed outwardly to free tongue portion 1521 from aperture 1512. Instrument attachment clip 1500 also includes an attachment surface 1530 in the form of a fastener material such as Velcro ^rM or the like located on the bottom surface of bottom portion 1510 that attaches to a complementary fastener material located on attachment region 130 of draping arrangement 100. [00106] In use, the scissor arms 770 of haemostatic clamp 750 are positioned within instrument attachment clip 1500 in the open configuration and the instrument attachment clip 1500 then folded over and locked, resulting in clamp 750 being retained and held between compressible layers 1540a, b. Once the procedure has been completed, the clamp 750 may be removed from instrument attachment clip 1500 by releasing locking tab 151 1 to open instrument attachment clip 1500 as required. As would be appreciated, while foldable instrument attachment clip 1500 in this embodiment is configured to retain and hold a haemostatic clamp, in other embodiment the clip may be configured to foldably hold and retain other medical instruments.

[00107] As would be appreciated, instrument attachment clips may be configured in any suitable manner to provide a complementary mounting or attachment region to which a medical instrument may be attached to with the instrument attachment clip then being removably attached to the draping arrangement 100 as required. In this manner, draping arrangement 100 may be used with standard medical instruments used during medical procedures. Some relevant medical instruments that could be used in this way include, but are not limited to, Babcock, Maingot or Kocher clamps or other forceps type instruments as required.

[00108] Referring now to Figure 13, there is shown a figurative end on view of the patient 200 similar to that of Figures 6 and 9 depicting the use of an anterior vaginal retractor 900 with haemostatic clamps 750 and complementary instrument attachment clips 700 (as previously described) in combination with draping arrangement 100. Figure 13 is similar to Figure 9 except that in this case the adjustable anterior vaginal retractor 900 is holding the anterior wall and cervix out of the way instead of the posterior wall as depicted in Figure 9. This is so the posterior wall can be opened and repaired.

[00109] Referring now to Figures 14A-C, there are shown various views of the anterior vaginal retractor 900 depicted in Figure 13. Anterior vaginal retractor 900 includes a main body 910 having a generally L-shaped configuration. The base portion 916 of body 910 includes a curved front surface 920 similar to the corresponding front surface 620 of posterior vaginal retractor 600 and in use is inserted into the patient's vagina to retract the front wall. The stem portion 915 of L-shaped body 910 is generally curved to conform with the abdominal profile above the vagina and further includes an extendible region 950 having located at its bottom an attachment surface 930 in the form of a fastener material such as Velcro^1M that is attachable to a complementary fastener material of attachment region 130 of draping arrangement 100 as previously described.

[001 10] Stem portion 915 includes an elongate slot 917 which forms a guide track for the stem of a bolt (not shown) attached to extendible region 950 which allows extendible region 950 to be extended or withdrawn with respect to stem portion 910 and then tightened off by a captured wing nut 960. This allows the anterior vaginal retractor 900 to be adjusted to both conform to the anatomy of the patient and to also adjust the degree of retraction and tension if required during the medical procedure. In another embodiment, a ratchet mechanism may be employed between the extendible region 950 and stem portion 910 to allow adjustment and tensioning of anterior vaginal retractor 900.

[001 1 1 ] Referring now to Figure 15, there is shown a figurative end on view of the patient 200 similar to that of Figures 6, 9and 13 depicting in this case the use of additional lateral vaginal retractors 1000 in combination with an anterior vaginal retractor 900 and posterior vaginal retractor 600 as previously described. As shown in Figures 16A-C, corresponding to perspective, side and top views respectively, lateral vaginal retractor 1000 is similar in configuration to posterior vaginal retractor 600 having an L-shaped body 1010 and a base portion 1016 for insertion into the vagina and a stem portion 1015 having an attachment surface 1030 which in this illustrative embodiment is a fastener material such as Velcro^{I M} or the like and which is attachable to the attachment region 130 of draping arrangement 100 as previously described. As can be readily appreciated, the use of one or more of the various retractors as described above allows procedures such as an hysterectomy or vaginal wall repair to be carried out without assistance.

[001 12] As has been described previously, draping an-angement 100 includes an aperture stabiliser arrangement to restrict movement of the aperture with respect to the treatment site. In this illustrative embodiment, aperture stabiliser arrangement includes the bottom adhesive layer 131 of attachment region 130 and further includes drape securement devices in the form of drape attachment clips 1 100 which function to secure the flexible material 1 10 to the operating table 300.

[001 13 ] Referring now to Figures 17A-C, there are shown various views of drape attachment clip

1 100. As can be seen in Figure 17 A, drape attachment clip 1 100 is configured to be inserted between the mattress 360 and the base portions 370 of the operating table 300 and is formed as a body 1 1 10 including a plate portion 1 130 and a drape attachment or clip portion 1 120 extending along one edge of plate portion 1 130. Plate portion 1 130 is insertable into the gap between mattress 360 and base portions 370 of an operating table 300 with clip portion 1 120 designed to sit just above the mattress but inside the lateral margins of the operating table so as not to restrict the surgeons access to the patient.

[001 14] Clip portion 130 includes a resilient part cylindrical portion 1 125 having an outwardly protruding lip 1 127 that forms a receiving region 1 126 to receive the flexible material 1 10 of draping an-angement 100. In this manner, edge and other portions of the draping arrangement 100 may be secured to the operating table 300 as depicted in Figure 3 to assist in restricting movement of the aperture with respect to the treatment site. In other embodiments, the drape attachment portion maybe implemented having a serrated edge on the inside surface of the clip portion or be spring loaded similar to a bulldog clip or the like. [001 15] Referring now to Figure 27 there is shown a perspective view of a drape securement device in the form of a drape attachment mount 1800 according to an illustrative embodiment. Drape attachment mount 1800 is formed as a right angled or L-shaped body 1810 of a suitable rigid medical grade material and includes an insert or plate portion 1830 that is configured to be inserted between the mattress and base portions of an operating table (eg, see Figure 17 A) and a rectangular shaped drape attachment portion 1820 configured at right angles to insert portion 1830. In this illustrative embodiment, drape attachment portion 1820 includes an adhesive portion configured as two horizontally extending elongate adhesive strips 1 821 a, 1 821b of double sided adhesive tape to which the draping arrangement may be secured to. As would be appreciated, the size and shape of the insert portion and the drape attachment portion and adhesive portion may be varied according to the operating table and the procedure. In one application where the treatment site is the vaginal area of a patient, the drape attachment portion 1820 of drape attachment mount 1800 is configured to extend down to the floor in line with the treatment site to assist in directly stabilising the aperture of the medical draping arrangement.

[001 16] The adhesive tape may be replaced as necessary when sufficient adhesion is lost. While drape attachment mount 1800 may be used with draping arrangements formed of various types of flexible materials, they are particularly effective for securing draping arrangements formed of paper like material. Once the drape attachment mounts are secured by virtue of the pressure exerted by a patient on the mattress, the underside of the draping arrangement may then be secured to each drape attachment mount as required.

[001 17] Referring now to Figure 28, there is shown a drape attachment mount 1900 according to another illustrative embodiment. Similar to drape attachment mount 1 800 illustrated in Figure 27, drape attachment mount 1900 may be employed in the treatment of the vaginal area of a patient. As with drape attachment mount 1800, drape attachment mount 1900 is configured as a right angled or L-shaped body 1910 of a suitable rigid medical grade material and includes an insert or plate portion 1930 that is configured to be inserted between the mattress and base portions of an operating table and a rectangular shaped lower drape attachment portion 1920 configured at right angles to insert portion 1830 and having two horizontally extending elongate adhesive strips 1921 a, 1921 b of double sided adhesive tape. In addition, drape attachment mount 1900 includes two opposed spaced apart upwardly extending attachment portions 1925 each incorporating a vertically extending elongate strip 1926a, 1926b of double sided adhesive tape.

[001 18] Upwardly extending attachment portions 1925 may be employed to reinforce the attachment portion 130 of draping arrangement 100 as will be described below. As an example, a draping arrangement 100 deployed as in Figure 3, in combination with drape attachment mount 1900 located immediately below the vaginal area, will provide securement of the draping arrangement below aperture 120 from lower drape attachment portion 1920 and further to each side of aperture 120 where aperture 120 is positioned in the gap between upwardly extending attachment portions 1925 and draping arrangement is secured to vertically extending elongate adhesive strips 1926a, 1926b. In this manner, upwardly extending attachment portions 1925 will further assist in stabilising the aperture 120 where increased lateral vaginal retraction is required. As would be appreciated, drape attachment mounts may be configured with other customised attachment portions to assist in providing suitable retraction for the indicated medical procedure.

[001 19] The aperture stabilising arrangement may take other forms. In another embodiment, the operating table or more generally any structure involved in the medical procedure may include attachment locations to which complementary attachment locations on the draping arrangement may be attached to. In one example, the attachment locations on the operating table will include fastener material such as Velcro^1M or similar material. In another example, press studs may be employed to assist in securing the drape to the operating table or structure in a number of locations. In yet another example, the aperture stabilising arrangement may include flexible ties that allow the draping arrangement to be tied to the operating table or to the person undergoing the medical procedure as required. In yet another

embodiment, the aperture stabilising arrangement may involve the draping arrangement incorporating weighted portions to either secure the weighted portion to the operating table or to otherwise hang from the operating table to restrict movement of the aperture. In a further example, the aperture stabiliser arrangement may include a frame arrangement that directly secures the attachment region 130 of the draping arrangement 100 to parts of the operating table or other relevant structure such as the leg mounts depicted in Figure 3. In yet other examples, the drape may include additional reinforced or rigid segments to further assist in aperture stabilisation.

[00120] In a further illustrative embodiment, the aperture stabilising arrangement may include one or more drape tensioners comprising of, in one example, overlapping tabs or strips extending from different locations on the drape that each include a fastener material such as Velcro^rM or an adhesive portion that can be attached to each other to tension the drape. In another embodiment, the drape tensioner may consist of flexible ties extending from the drape which may be tied to each other to again tension the drape. In yet another embodiment, the drape tensioner may consist of a zip tie arrangement with the ratchet portion at one location on the drape and the cable incorporating the integrated gear rack extending from another location. As would be appreciated, by tensioning the drape, and as a result stabilising the aperture, a drape tensioner may assist in providing a retractive force and in the case of a zip tie arrangement or similar, the drape tensioner may be adopted to provide increased retraction in a specific direction. By locating the drape tensioners close to the aperture this will also avoid the necessity of having to significantly interrupt the medical procedure to manoeuvre drape clips should tensioning be required. [00121 ] Referring now to Figure 24, there is shown a front view of a draping arrangement 1600 for assisting in the treatment of a patient according to an illustrative embodiment. Draping arrangement 1600 is similar to draping arrangement 100 depicted in Figures 1 and 2 above and is formed of a flexible material 1610 and includes an aperture 1620 surrounded by an attachment region 1630 as has been previously described. Compared to draping arrangement 100, draping arrangement 1600 further includes an additional aperture or fenestration 1690 being configured for a laparoscopic assisted vaginal hysterectomy (LAVH) procedure. In this example, fenestration 1690 is rectangular shaped having dimensions of 250 mm x 350 mm. Draping arrangement 1600 includes a further drape tensioning system 1700 forming part of the aperture stabiliser arrangement which functions to stabilise and restrict movement of aperture 1620 with respect to the treatment site.

[00122] In this embodiment, drape tensioning system 1700 includes a pair of resilient drape tensioners 1710 attached to a top portion of attachment region 1630 and configured to extend to respective attachment points 1720 spaced from aperture 1620 and in this illustrative embodiment located above additional aperture 1690.

[00123] Referring now to Figure 25A, there is shown a detailed perspective view of drape tensioner 1710 prior to deployment. In this embodiment, drape tensioner 1710 is formed from a self- fastening tape material 1713 such as Omni-Tape^{I M} which is attached or sutured at a first end 171 1 to the periphery of attachment region 1630 and includes a self- fastening free end 1712. In this embodiment, the self-fastening tape material 1713 includes on one side a hook and loop fastening surface that self-attaches. In the pre-deployed configuration shown in Figure 25A, drape tensioner 1710 is shown coiled, ready to be extended and attached to attachment point 1720 which is shown in Figure 25 B. Attachment point 1720 includes a buckle member 1721 that is attached to the material 1610 of draping arrangement 1600 by a fabric strip 1722 that is looped around one end of buckle member 1721 and sutured to the draping arrangement 1600.

[ 00124] Referring now to Figure 26, there is shown the drape tensioning system 1700 illustrated in Figure 24 as deployed with the free end 1712 of drape tensioner inserted through buckle member, tensioned and then folder over and attached to itself to restrict movement of aperture 1620. As would be appreciated, other type of drape tensioners that are attached at one end to the periphery of the aperture and adjustably attached at a location spaced apart from the aperture to provide a tensional force acting to restrict movement of the aperture may be employed. In one embodiment, the drape tensioner 1720 may be formed of an elasticised material that provides further extendibility of the drape tensioner.

[00125] While the various examples described above have been described with respect to obstetric or gynaecological procedures, the medical draping arrangement may be employed at any treatment site where retraction may be required. [00126] As would be appreciated, many of the hand held retractors employed in medical procedures may be adapted for use with medical draping arrangements in accordance with the embodiments described throughout the specification. In this manner, the hand held retractor need no longer be manually restrained by assisting medical personnel but can be attached to the attachment portion of the medical draping arrangement as required. An example list of hand held retractors that may be adapted by incorporating a complementary attachment region for use with medical draping arrangements in this way includes, but is not limited to, a Hohmann retractor, Lahey retractor, Senn retractor, Blair (Rollet) retractor, rigid rake retractor, flexible rake retractor, Ragnell retractor, Linde- Ragnell retractor, Davis retractor, Volkman retractor, Kocher retractor, Farabeuf retractor, Mathieu retractor, Jackson tracheal hook retractor, Crile retractor, Meyerding finger retractor, Little retractor, Love nerve retractor, Green retractor, Goelet retractor, Gushing vein retractor, Langenbeck retractor,

Richardson retractor, Richardson-Eastmann retractor, Kelly retractor, Deaver retractor, Doyen retractor, Parker retractor, Parker-Mott retractor, Roux retractor, Mayo-Collins retractor, U.S. Army retractor or a ribbon retractor.

[00127] In one example, each of the above retractors may be produced in a disposable version using a suitable medical grade material and having a complementary attachment region that attaches to the attachment region of the medical draping arrangement. In another example, existing non-disposable instruments could be secured to the drape with the use of fastening material such as Velcro ^IM that is attached to the instrument handle by an adhesive or the like. As discussed above, this would in effect convert hand held retractors to self-retaining devices and increase utility of operative assistants. The use of multiple retractors such as Jackson or Deaver retractors attached to the wound periphery could also replace the need for self-retaining retractors and radically improve access during intra-cavity surgery.

[00128] In the case of self-retaining retractors, their utility may be further improved by attaching them to the attachment portion of the medical draping arrangement as this will further stabilise the retractor. An example list of self-retaining retractors that may be adapted for use with medical draping arrangements by incorporating a complementary attachment region includes, but is not limited to, an Aim retractor, Lone Star retractor, Gelpi retractor, Gutow Retractor, Weitlaner retractor, Beckman-Weitlaner retractor, Beckman-Eaton retractor, Beckman retractor, Adson retractor, Balfour retractor, Finochietto retractor or a rib spreader.

[00129] As has been described previously, medical draping arrangements according to the illustrative embodiments described throughout the specification have been described for use with medical instruments including retractors and instrument attachment clips and strips. As would be appreciated, these medical draping arrangements may be used in combination with any medical instrument employed during a medical or treatment procedure such as quivers or pouches that are themselves employed to retain or store other medical instruments during a medical procedure. In other embodiments, suction devices such as suckers may also be attached to the attachment region.

[00130] Some example medical procedures where the medical draping arrangement may be used advantageously are discussed below. It will be understood that this list is not exhaustive and other applications are also contemplated.

[00131 ] Craniotomy

[00132] In this example, the aperture is generally circular and has a diameter of approximately 20 cm and is associated with an incise film, this being a transparent adhesive film that sticks to skin and is incised when making the skin incision and remains attached to the skin edge and as such will assist aperture stabilisation and may form part of the aperture stabilisation arrangement. The attachment region generally completely surrounds the aperture and may incorporate fastener material as previously described and may further include a moulded reinforced portion that is conformed to the shape of the head to assist in aperture stabilisation. Further, aperture stabilisation may be provided by adhesive attachment of the drape arrangement to the patient and drape attachment clips (eg, Figures 17A-C) and/or drape attachment mounts (eg, Figures 27 and 28) may be used if required. Some of the types of medical instruments used in combination with the drape arrangement include hook retractors and adhesive attachment strips for the scalp as well as disposable nerve and brain retractors that each has a

complementary attachment region to allow attachment of the medical instrument to the attachment region of the draping arrangement.

[00133] Spinal Surgery

[00134] For spinal surgery the aperture or fenestration is generally elongated with the exact configuration being procedure dependant. The attachment region generally completely surrounds the aperture and has an oblong or rectangular configuration and incorporates a fastener material such as Velcro™ or the like as has been previously described. The aperture is either stabilised by the use of adhesive attachment to the patient and/or the use of a number of opposed drape attachment clips and/or mounts which are positioned typically symmetrically either side of the aperture to maximise the lateral retraction. Medical instruments used in these procedures in combination with the draping arrangement include hook retractors for tissue retraction and also nerv e retractors having a complementary attachment region to allow attachment of the medical instrument to the attachment region of the draping arrangement.

[00135] Laparotomy [00136] Depending on the exact procedure, the size and configuration of the aperture will vary. In one example, a transverse rectangular aperture is employed for a procedure involving a Pfannenstiel incision or alternatively a vertical rectangular aperture for vertical incisions. The attachment region generally completely surrounds the aperture and in some configurations is enlarged to provide for more attachment strength. Aperture stabilisation is achieved by a combination of adhesive attachment and the use of drape attachment clips and/or mounts varying in size and number depending on the retraction force required. Medical instruments used in combination with the draping arrangement include hook retractors for tissue retraction, organ retractors, bowel retractor, Jackson retractors or suckers where each of these instruments includes a complementary attachment region to allow attachment of the medical instrument to the attachment region of the draping arrangement.

[00137] Ear Nose & Throat (ENT)

[00138] In one example, the aperture of the medical draping arrangement is sized and shaped to suit neck surgery and the associated attachment region is U-shaped and aperture stabilisation is achieved by an adhesive attachment region in combination with drape attachment clips and/or mounts modified to attach the draping arrangement adjacent to the neck superiorly and the body inferiorly. Medical instruments used in combination with the draping arrangement include retractors for tissue, nerves and vessels where each of the medical instruments include a complementary attachment region to allow attachment of the medical instrument to the attachment region of the draping arrangement.

[00139] Dentistry

[00140] One example of a medical draping arrangement appropriate for dentistry includes a teardrop shaped aperture having a surrounding attachment region. Aperture stabilisation is achieved by adhesive attachment and drape attachment clips and/or mounts spaced equilaterally around the head attaching the draping arrangement to the headrest or the like. Medical instruments used in combination with this draping arrangement include clips and hooks that attach to the lip and tongue for retraction as well as suckers and instrument pouches all having complementary attachment regions to allow attachment of the medical instruments to the attachment region of the draping arrangement.

[00141 ] Breast Endocrine

[00142] A medical draping arrangement for these types of procedures has apertures to suit single or both breasts and/or the neck region as described for ENT procedures. A supplementary axillary drape with appropriate sized and shaped aperture such as circular or ovoid may be employed and is laid over the existing breast draping arrangement for the axillary portion of the surgery. In each case, the attachment region either part surrounds or completely surrounds the corresponding aperture. Aperture stabilisation is provided by adhesive attachment supplemented by drape attachment clips and/or mounts attaching the draping arrangement to the operating table.

[00143] The axillary drape is attached to the primary drape by suitable attachment means and/or attached to the patient by adhesive attachment with further aperture stabilisation achieved through the use of drape attachment cl ips and/or mounts. Medical instruments used in combination with the draping arrangement include attachment strips and hook retractors for breast tissue and blood vessels as well as skin and nerve retractors for the axillary component of the surgery. In each case, the medical instruments used in combination with the draping arrangement include complementary attachment regions to allow attachment of the medical instrument to the attachment region of the draping arrangement.

[00144] Orthopaedic

[00145 ] For orthopaedic procedures, the aperture is sized and shaped to suit the joint region being operated on with the attachment region generally surrounding the aperture but also may include specific attachment regions spaced from the aperture for specific retraction associated with the procedure.

Aperture stabilisation is achieved by adhesive attachment and potentially with the incise film (as discussed previously) and drape attachment clips and/or mounts that attach the draping arrangement to the operating table and/or to the limb being operated on. Medical instruments used in combination with the draping arrangement include skin and tissue hooks and tendon, nerve and vessel retractors. In each case, the medical instruments include complementary attachment regions to allow attachment of the medical instruments to the attachment region of the draping arrangement.

[00146] Ophthalmologic

[00147] For these procedures the aperture is eye shaped, adhesive and may include an incise film.

The attachment region generally completely surrounds the aperture and aperture stabilisation is achieved primarily by adhesive attachment. Medical instruments used in combination with the draping arrangement include eyelash or eyelid clips or hooks each including complementary attachment regions to allow attachment of the medical instruments to the attachment region of the draping arrangement.

[00148] Cardiothoracic

[00149] For these types of procedures a relatively large aperture sized and shaped to suit thoracic surgery is employed. For related procedures such as vascular harvesting on the leg, the draping arrangement has an elongated aperture. The attachment region generally completely surrounds the aperture and aperture stabilisation is achieved through the use of adhesive attachment and/or drape attachment clips and/or mounts spaced equilaterally around the chest for cardiac and thoracic surgery. Generally, no drape attachment clips or mounts are necessary for leg vascular surgery. Medical instruments used in combination with the draping arrangement include tissue hooks and attachment strips for soft tissue and the leg incision. Lung retractors are also used for thoracic surgery. In each case, the medical instruments include complementary attachment regions to allow attachment of the medical instrument to the attachment region of the draping arrangement.

[00150] Urology

[00151 ] For these types of procedures the apertures will vary from those suitable for a laparotomy to those suitable for perineal and retro-pubic prostatectomy. The attachment region generally completely surrounds the aperture and adhesive attachment in combination with drape attachment clips and/or mounts are employed for aperture stabilisation. Medical instruments used in combination with the draping arrangement include tissue retractors as well as Harris and renal transplant blade kits. In each case, the medical instruments include complementary attachment regions to allow attachment of the medical instrument to the attachment region of the draping arrangement.

[00152] Plastic Surgery

[00153] Plastic surgery procedures are applicable for all body regions and as such draping arrangement used for these procedures will have different sized and shaped apertures appropriate for the body region being operated on. Depending on the exact procedure, the attachment region may surround or part surround the aperture as appropriate. Aperture stabilisation may be achieved by incorporating moulded sections into the draping arrangement that conform to the body shape being operated on, adhesive attachment and/or drape attachment clips and/or mounts. Medical instruments used in combination with these draping arrangements include various vessel, tendon and nerve retractor devices each having a complementary attachment region to allow attachment of the medical instrument to the attachment region of the draping arrangement.

[00154] In terms of deployment, the medical draping arrangement would be deployed in a similar manner to standing surgical drapes but with the additional step of stabilising the aperture by in one example attaching the adhesive attachment region of the draping arrangement to the patient and/or by securing the drape to the operating table as necessary.

[00155 ] Referring now to Figure 18, in yet other embodiments, the drape arrangement may be configured to extend over only a limited or confined portion of the patient surrounding the treatment site and includes a dressing drape arrangement 1200 comprising a compact drape formed of flexible dressing type material 1210 having an aperture 1220 for the treatment site and extending over the immediate surrounds of the treatment site with the aperture 1220 surrounded by attachment region 1230 as previously described.

[00156] In this illustrative embodiment, the aperture 1220 of the dressing drape arrangement 1200 would be stabilised by an adhesive layer 1231 on the underside surrounding the aperture 1220 that attaches to the patient's skin. Prior to deployment, the adhesive layer 1231 would be covered by a protective layer that is peeled off during deployment of the dressing drape arrangement 1200.

[00157] In other embodiments, the adhesive layer 1231 could extend over the entire underside of the drape. In yet another embodiment, the underside adhesive layer 1231 would be supplemented by adhesive tape portions 1235 applied to one or more of the boundaries of the dressing drape arrangement 1200. In further embodiments, the dressing drape arrangement 1200 may include a further hardenable or malleable base portion or layer such as has been previously described that surrounds or part surrounds the aperture 1220. In one example embodiment, the further hardenable or malleable layer extends throughout the entire drape.

[00158] Referring now to Figure 19, in one example the compact or dressing drape arrangement

1200 may be used with medical instruments consisting of disposable retractor hooks 1300 similar to those illustrated in Figures 7A-D but having an elastic band or elongate resilient member 1330 extending between the skin hook 1340 and the body portion 1310 which attaches to the attachment region 1230 of the compact drape arrangement 1200. In this example, retraction hooks would be approximately 3.5cm long and the body portion 1310 would be approximately a 1 cm square.

[00159] In one embodiment, such as illustrated in Figure 18, the compact drape arrangement could be rectangular having approximate dimensions of 15 cm x 25 cm but other approximate dimension may include, but not be limited to, 10 cm x 10 era, 10 era x 15 cm, 10 cm ^χ 20 cm, 10 cm x 25 cm, 10 cm 30 cm, 10 cm x 35 cm, 10 cm ^χ 40 cm, 15 cm ^χ 15 cm, 15 cm ^χ 20 cm, 15 cm ^χ 25 cm, 15 cm x 30 cm, 15 cm x 35 cm, 15 cm ^χ 40 cm, 20 cm ^χ 20 cm, 20 cm ^χ 25 cm, 20 cm ^χ 30 cm, 20 cm ^χ 35 cm, 20 cm x 40 cm, 25 cm ^χ 25 cm, 25 cm ^χ 30 cm, 25 cm x 35 cm, 25 cm x 40 cm, 30 cm ^χ 30 cm, 30 cm x 35 cm, 30 cm ^χ 40 cm, 35 cm ^χ 35 cm, 35 cm ^χ 40 cm and 40 cm ^χ 40 cm. In other embodiments, the compact drape arrangement may be oval or elliptical, triangular or non-regularly shaped depending on requirements.

[00160] The aperture size and configuration will also depend on the medical procedure and/or the treatment site and in the example of the 15 cm ^χ 25 cm compact drape illustrated in Figure 18, the aperture is square and is suitable for a treatment site extending over approximately 6 cm. In other embodiments, the aperture of the compact drape would be suitable for extending over treatment sites of approximate size range including, but not limited to, 1 cm - 2 era, 2 cm - 4 cm, 4 cm - 6 cm, 6 cm - 8 cm, 8 cm - 10 cm, 10 cm - 12 cm or greater than 12 cm and may be of any shape or configuration as indicated by the treatment requirements. As previously described, the size, shape and configuration of the attachment portion 1230 may vary depending on the treatment requirements. In the example depicted in Figure 18, the attachment portion 1230 has a circular configuration extending 2-3 cm from a central square aperture 1220.

[001611 As would be appreciated, the dressing drape arrangements in accordance with the embodiment described above could be combined with other medical instruments such as one or more trays, forceps, tweezers, bandages, cotton wool, needles and retraction or attachment devices that may be attached to the mounting portion 1230 of the dressing drape arrangement 1200. In one example, the dressing drape arrangement 1200 could be supplied with 4 to 6 retraction hooks 1300. In another embodiment, the retraction hooks may be adapted to retract hair for minor surgeiy by replacing hook portion 1340 with a hair clip and shortening or removing elastic band 1330. As would be appreciated, dressing drape arrangement 1200 would be suitable to assist in the removal of small lesions below the skin and foreign bodies where skin retraction is necessary and in particular would greatly assist in removing lesions for the aged population who have particularly loose skin. In another embodiment, retractor hook 1300 may be implemented using Elastoplast^{1 M} or sticking plaster equivalents to retract loose skin to assist in treatment or surgery.

[00162] In another embodiment suitable for the treatment of scalp lacerations and the like, the dressing drape arrangement is implemented having an elasticised shower cap configuration incorporating an aperture that may be positioned over the treatment site. In this embodiment, aperture stabilisation is achieved by the retaining force provide by the resilient cap acting on the skull. As with previous embodiments, the dressing drape arrangement includes an attachment region for the attachment of medical instruments associated with the treatment of the treatment site such as tissue hooks, attachment strips and hair clips. As would be appreciated, not only does this provide an improved dressing drape arrangements but it provides the additional benefit of not covering the face which can be problematical when treating children having scalp lacerations. In another example, suitable for the treatment of a limb such as a leg or arm, the dressing drape arrangement is implemented as an elasticised sleeve whose aperture may be positioned over the treatment site.

[00163] While the various embodiments described throughout the specification have been described with respect to "human" patients it would be understood that use of the term "medical procedure" or "surgical procedure" or any reference to treatment of a patient would also include equivalent veterinary treatments or procedures applicable to animals where the medical draping arrangement may be similarly used. [00164] Throughout the specification and the claims that follow, unless the context requires otherwise, the words "comprise" and "include" and variations such as "comprising" and "including" will be understood to imply the inclusion of a stated integer or group of integers, but not the exclusion of any other integer or group of integers.

[00165] The reference to any prior art in this specification is not, and should not be taken as, an acknowledgement of any form of suggestion that such prior art forms part of the common general knowledge.

[00166] It will be appreciated by those skilled in the art that the invention is not restricted in its use to the particular application described. Neither is the present invention restricted in its preferred embodiment with regard to the particular elements and/or features described or depicted herein. It will be appreciated that the invention is not limited to the embodiment or embodiments disclosed, but is capable of numerous rearrangements, modifications and substitutions without departing from the scope of the invention as set forth and defined by the following claims.

Claims

1. A medical draping arrangement for assisting in the treatment of a patient, the medical draping arrangement comprising:

2. The medical draping arrangement of claim 1, wherein the attachment region is configured to allow the medical instrument to be detachably attached to the attachment region at different positions and/or orientations with respect to the treatment site.

3. The medical draping arrangement of claim 1 or 2, wherein the attachment region extends around a periphery of the aperture.

4. The medical draping arrangement of claim 3, wherein the attachment region is configured as one or more concentric strips that extend around the periphery of the aperture.

5. The medical draping arrangement of claim 1 or 2, wherein the attachment region is configured as one or more discrete attachment portions.

6. The medical draping arrangement of any one of claims 1 to 5, wherein the attachment region includes a fastener material for attaching to a medical instrument whose complementary attachment region includes a complementary fastener material.

7. The medical draping arrangement of any one of the preceding claims, wherein the attachment portion includes a reinforced base portion supporting in part or in full the attachment region of the draping arrangement.

8. The medical draping arrangement of any one of claims 1 to 7, wherein the aperture stabiliser arrangement includes a patient attachment means to attach the draping arrangement to the patient to restrict movement of the aperture.

9. The medical draping arrangement of claim 8, wherein the patient attachment means includes an adhesive attachment region that removably attaches the draping arrangement to the patient.

10. The medical draping arrangement of any one of claims 1 to 9, wherein the aperture stabiliser an-angement includes drape securement means to attach the draping arrangement to a structure involved in the treatment of the treatment site to restrict movement of the aperture.

1 1. The medical draping arrangement of claim 10, wherein the drape securement means includes one or more drape securement devices that may be deployed on the structure, the one or more drape securement devices including a drape securement portion to removably receive or attach portions of the drape arrangement.

12. The medical draping arrangement of claim 1 1, wherein the structure is an operating table.

13. The medical draping arrangement of any one of claims 1 to 12, wherein the aperture stabilisation an-angement includes a moulded portion, the moulded portion shaped to conform to the expected contours of the treatment site to restrict movement of the aperture.

14. The medical draping arrangement of any one of claims 1 to 13, wherein the aperture stabilisation an-angement includes a hardenable portion which following activation hardens to assist in stabilising the aperture.

15. The medical draping arrangement of any one of claims 1 to 14, wherein the aperture stabilisation an-angement includes a malleable portion for configuring to a shape that conforms to the patient to assist in stabilising the aperture.

16. The medical draping arrangement of any one of claims 1 to 7, wherein the medical draping an-angement is configured as a dressing drape arrangement where the flexible material extends over a confined portion surrounding the treatment site.

17. The medical draping arrangement of claim 16, wherein the aperture stabiliser arrangement includes an adhesive portion located on the underside of the flexible material to attach the dressing drape arrangement to the patient.

18. The medical draping arrangement of claim 17, wherein the adhesive portion covers the entire underside of the flexible material.

19. The medical draping arrangement of any one of claims 16 to 18, wherein the aperture stabilisation arrangement includes adhesive strips applied to a boundary portion of the flexible material.

20. The medical draping arrangement of any one of claims 16 to 19, wherein the aperture stabilisation arrangement includes a portion of the flexible material that is elasticised to resiliently engage with the patient.

21. The medical draping arrangement of any one of claims 1 to 20, wherein the aperture stabilisation arrangement includes a drape tensioning system to restrict movement of the aperture with respect to the treatment site.

22. The medical draping arrangement of any one of claims 1 to 20, wherein the attachment region is configured to provide a retraction function for the treatment site when used in combination with the medical instrument, the medical instrument in the form of a retraction device attached to the attachment region.

23. A medical instrument for use in combination with a medical draping arrangement, wherein the medical draping arrangement includes an attachment region surround an aperture for positioning over a treatment site and wherein the medical instrument includes a complementary attachment portion adapted to attach to the attachment region of the medical draping arrangement.

24. The medical instrument of claim 23 , wherein the medical instrument provides a retraction function for the treatment site.

25. A method for draping a patient for treatment of a treatment site located on the patient, the method including:

arranging a draping arrangement over the patient, the draping arrangement including an aperture, wherein arranging the draping arrangement includes positioning the aperture of the draping arrangement over the treatment site, the draping arrangement further including an attachment region for attaching a medical instrument involved in the treatment of the treatment site; and

26. The method of claim 25, wherein stabilising the aperture includes attaching or securing the draping arrangement to the patient.

27. The method of claim 26, wherein stabilising the aperture includes attaching or securing the draping arrangement to a structure involved in the treatment of treatment site.

28. The method of any one of claims 25 to 27, further including attaching a retraction device to the attachment region of the draping arrangement, the retraction device providing a retraction function for the treatment site.