AU2013204867B2 - Detectable surgical product - Google Patents

Abstract

A swab comprising multiple layers of several materials, including non-woven polymeric materials such as, polypropylene, wood pulp-based material, etc., and blends of various 5 acceptable fibres, that are suitable for skin contact and for surgical or other medical absorbent sponge, use as swab or gauze material. The swab 20 is universally and comprehensively stitched by a quilting method to cover substantially the entire surface area 21 of the gauze sheet of the swab 20, so that there is no significant or substantial portion of the gauze sheet of the swab 20 that remains unstitched. 10 Fig. 4 W/ A ~ v N r~ /J'-A'%\-/N /. Y~'~~'A'/ &v~/NAY~tvx K tYN/NNANAXNN'/KNr A % V%i V'N'%-r N \s/ ANN Ai\-/A N NAN/AI\tN/ K / A/. N/s/~KNWr~~N/NNN~/'VN N-',.N \/A ~ A// -N AN, \Kkx NNAY/NNYi/Nr(I K NtAY/~NN NA /N\vN /NNV/.\/ArSi i ./SAY/V //ts/N /VV/N 9 /tw/'N/ /N .A~K % \$ A/t\N% 2NN ///-~S \/y ./.Ny ////\N/A//.. -A~ / A''// %//"/.\ K/v A X /X/tNA'K/NN/NN~tKKA~NAN/N/'VN'v 'N/N 'V/\s N/tQ~?/A W/~~ ~NI/ I'.K! " \//N AA N/AN ///ty//t~Y &N Y'A~ry\W/~ A/ AN' NA A A'' Y AkKN,/v/~ /'' ' V 'WY -$v. 'Y// A'V ''/C V s'V6V,/ ~ '''Y\\ ,AQA/t A AA/Q /N////t'V/Y'~ /r NNN N'vNt W \\ /IS/WA &' \\,,'\'/\ NN~N 't.i A' A7rl/J//i// "/N-.NA4 - A ' 'YA'. N\ %' %xNA %NN//V.-YNwtKst' %NNN/ , ' N 'A" A\AN ,A A /ftXv/NN'~t N LN$ ~W /W.-N N NN~At i' r,'7N '. Si/''.N j' /~ay~ A~ \$.N\sy-Na%/y.,-. N/' N\N \ X/r-./iNA 't"~\// ,\//NN/'/-.''/%/IAN N~ ~r.,, A.,A~t'~g. N//t~N/VN/~/txA /-./NiN' ~.'~'x' " . r--% / f ~ sY' X~ N/.#Nr N". NFlG/ 4AN 7 / NNN '\k~NN ~AY N \~& NV/\V~t ,/N'Nf' - //\<>/N ~ .N ' % A--:\ NCtv t ~--\ -4- |/N \,1/ ] r.'./S~ /.-/G.t ty$A,'.F/N 5bA,\NNN/ Fla/N N/ 5cNpNN

Description

DETECTABLE SURGICAL PRODUCT

FIELD OF INVENTION

This invention relates to a detectable surgical product. More particularly, this invention relates to a detectable surgical gauze or swab. Still more particularly, this invention relates to an X-ray or radio detectable surgical gauze or swab, including abdominal sponges.

CROSS-REFERENCE

This application is Divisional and a Patent of Addition of Australian patent application No. 2010281347, being a national phase application based on International (PCT) patent application No. PCT/AU2010.000974, published as WO2011/014907, the entire contents of which is incorporated into this specification by reference.

BACKGROUND ART

The following references to and descriptions of prior proposals or products are not intended to be, and are not to be construed as, statements or admissions of common general knowledge in the art. In particular, the following prior art discussion does not relate to what is commonly or well known by the person skilled in the art, but assists in the understanding of the inventive step of the present invention of which the identification of pertinent prior art proposals is but one part.

It has been proposed to make swabs and sponges partly using synthetics such as polyester, and/or blends with wood pulp. Purely synthetic cloths may comprise a range of different types of polymers, copolymers and polymer blends. Suitable materials that may be utilized in medical cloth include alginate, viscose, cellulose, urethanes, hydrogels, hydrocolloids and copolymers of acrylates and acrylamides, amongst many others.

Because X-ray detectable sponges and swabs are primarily used inside body cavities during invasive surgical procedures to soak up blood, it is desirable that gauze, swabs and other medical cloths display properties of low and consistent bioburden and consistent weight. The former aids in maintaining the desired sterility assurance level as prescribed in ISO 11137; the latter helps health professionals in calculating blood loss from the patient.

Woven swabs and sponges can also suffer from the problem that loose threads, liable to separate from the main body of a swab, can cause contamination or infection. There is therefore a need to provide a product which does not shed loose threads.

Furthermore, a significant systemic problem, in terms of surgical procedure, is the problem of swabs being left in a patient’s wound or body cavity following completion of a surgical procedure. Gauze swabs, saturated with fluids such as blood or mucus, are notoriously difficult to distinguish from surrounding human tissue and body fluids, due to the similar consistency and the lack of contrast in appearance of the used gauze compared to the surrounding tissue. To prevent medical materials and cloth from being inadvertently left in a patient’s body cavity following suturing, a common surgical protocol involves specifically counting each swab on entry and removal from the body cavity or wound. However, despite the best efforts of medical professionals, the inadvertent failure to remove medical materials from a wound or other body cavity continues to be a problem that may lead to septicaemia and, occasionally, death.

Accordingly, the need persists for effective means of detecting surgical products that are inadvertently left in the body of a patient and preventing this occurrence in the first instance. Therefore, sterile X-ray detectable sponges and swabs are typically supplied in packs of 5 having a determinable weight. Having consistent weight is highly desirable in the manufacturing process because the count of items entering a patient’s body (during an operating procedure) may be validated by weight of the pack.

The stitching that may be used to join multiple layers into a discrete surgical swab or sponge is generally minimal and is typically performed by hand. Hand sewing in mass production is time and effort intensive, and costly in terms of labour costs. Therefore, stitching may be made around the edges, with one or two lines of stitching across the area of a sheet, but large areas of the layers remain unstitched. This leads to unsatisfactory performance in terms of material strength and product integrity, aspects that are critical in surgery. Parts of the product may disassociate from the body of the product when laden with fluid, or may be difficult to manipulate or unpredictable in the way they behave, depending on the portion of the product that is grasped by an operator.

An object of the present invention is to ameliorate the aforementioned disadvantages of the prior art or to at least provide a useful alternative thereto.

STATEMENT OF INVENTION A surgical product being a swab or sponge, the surgical product including a non-woven sheet made up of multiple layers of non-woven material defining a sheet area in plan, a detectable element in the form of an x-ray or radio-detectable element, and stitching that universally quilts substantially the entire sheet area.

The sheet comprises, in plan, a central sheet area and an edge area. The edge areas will typically be within about 10mm, preferably 5mm, and most preferably 2.5 - 3.5mm from the edge of the sheet. The edge areas border, and define, the inner central area of the sheet. The central area may be stitched in a separate stitching step to the edge areas. The edge areas are preferably stitched, entangled or otherwise bonded in a separate step to mitigate against fraying of the edges. The edge areas may be stitched, entangled or otherwise bonded in a separate step to the central area to mitigate against separation or parting of layers of the sheet.

Stitching that quilts substantially the entire sheet area means that substantially all portions of the sheet area universally have stitching. The stitching may be regular or may be random. The stitching preferably extends from an upper surface to an underneath surface of the sheet. Preferably, all portions of the sheet area are substantially uniformly stitched.

The product may be stitched or otherwise bonded in any chosen pattern, but preferably is stitched in a straight or linear pattern, that is the thread of each row of stitching is substantially aligned in plan view. The rows preferably run parallel to each other. The rows of stitching preferably extend generally linearly. Preferably, the stitching includes running stitches. Still more preferably, the stitching includes zig-zag stitches. Most preferably, the stitching includes over locking stitches. Preferably, the stitching comprises quilted over locking stitching in multiple parallel rows. Preferably, the multiple rows are aligned parallel to a sheet edge.

Preferably, the sheet edge includes selvedge which may be applied separate to the quilting process. Preferably, the selvedge is applied as part of a programmed quilting process.

The quilting and the selvedge processes are preferably performed separately. Optionally the selvedge operation is performed on each sheet manually by an operator tasked to selvedge each fray able edge.

The quilting process may be performed by any suitable quilting machine. The quilting machine may be an industrial quilting machine comprising a quilting machine mounted to a quilting table comprising tensioned rollers to secure the sheet. A suitable quilting machine is supplied by Gammill (R). The quilting machine is preferably computer-controlled to effect a pre-set stitching pattern on the sheet.

The sheet may comprise multiple layers as described in the Applicant’s Publication No. WO2011/014907.

Although each individual stitch may be a running stitch extending in the same direction as the stitch row that it forms part of, other alternatives include a Z or X pattern. The Z or X pattern preferably includes overlocking of the stiches. Preferably, the stitching is performed in rows. The rows may be wavy lines or may be linear. The rows may be spaced from one another, but preferably not to an extent that the upper surface or layer can materially or effectively separate from the underneath surface or layer. can materially or effectively separate from the underneath surface or layer. For clarification, what is meant by “materially or effectively separate”, is that a majority of first fibres of one layer become undesirably spaced from a majority of second fibres of an adjacent layer. Therefore, it is preferable that the first fibres and second fibres adjacent and normally entangled or abutting each other when the sheet lies flat. Preferably, the layers lie in substantially parallel planes. Preferably, the respective first, second and any further layer fibres are entangled or in physical proximity to each other. In this event, the respective layers are not spaced from each other and there are no substantial cavities defined therebetween.

Preferably, each stitching row in the central area is spaced no more than 1 OX from each adjacent row, where X is the length of a standard stitch in one of the rows. The different rows may have different length and patterned stitching, but are preferably consistently the same. More preferably, between rows the spacing is less than 3X. Even more preferably, the spacing between rows is about 1.0 - 1.5X.

The length of a stitch may be between 2mm and 7mm, preferably about 2 - 4mm between point entries marking the length of a thread forming a stitch. Preferably, the spacing between rows is between 2mm and 10mm, and preferably between about 3mm and 5mm, and most preferably about 3mm. Preferably, the length of a stitch may be between about 2.5 - 3.5mm and the spacing between parallel rows of stitching in the central area about 2.0 - 5mm. This tight stitch pattern substantially restricts disassociation of the upper, any intermediate and underneath surfaces or layers, making the product extremely strong in all dimensions and having a high tear strength or tear resistance.

The stitching may be continuous, may be intermittent and spaced, and/or may be continuous and contiguous between rows. The stitching may comprise a first set of rows of stitching in a first direction and a second set of rows of stitching in a transverse direction. The surgical product may include one set of parallel rows in a first direction and a second set of rows crossing the first set and aligned and parallel in a second direction.

The surgical product may come in a variety of sizes and shapes, such as circular, kidney-shaped, oval or rectangular. Preferably, the surgical product is rectangular in shape and may be optionally folded in use.

The surgical product may be provided in a range of sizes. The surgical product may be square shaped. Sizes may range from 100mm square through to 500mm square whereby different sizes suit different applications. The nonwoven sheet may be left unfolded or may be folded once or more. In one embodiment, a first or primary nonwoven sheet is folded about a secondary separate single sheet, stitched and then folded again, to form a sponge which may be unfolded to act as a swab, this giving versatility to the product.

Preferably, the surgical product is wholly or predominantly made from polypropylene or wood pulp and polyester spun bonded layers of non-woven material. The sheet may include a single sheet folded over one or more times. For example, a 100 x 100 mm sheet may be folded once to form a rectangular swab and twice or more to form a sponge. In UK, Australia and in NZ, if the folded surgical product is also stitched together, it is generally referred to as a “sponge” and if it is simply folded without stitching the folded layers, it is referred to as a swab. Typical swabs are 100mm x 100mm and 100mm x 150mm, 4-ply - 16-ply. For example, a 100mm x 100mm 4-ply swab is made from a 200mm x 200mm sheet. A “sponge” is usually made from a 250mm x 250mm sheet. The range of products that are used for packing include 125mm x lm rolls and may be referred to as “X-ray Detectable Packing Gauze”. Such packaging products may be provided in rolls having widths between 10mm to 125mm, and preferably widths of 12.5mm to 100mm, and in lengths of lm to 2m.

The sheet of the surgical cloth may comprise between one and four or more layers. The surgical product may be in the form of an abdominal sponge. The abdominal sponge can be made with three layers of fabric. In such cases, the edges of the respective layers are preferably stitched together. The surgical product may be in the form of a swab. The swab may have the plan dimensions 100mm x 100mm. The swab may be made by folding a 200mm x 200mm fabric twice.

Each layer of non-woven web or fabric may be separately manufactured by an extrusion process in which fibres or filaments are deposited on a forming surface in a so-called Machine Direction (MD) corresponding to the direction of travel of the extrusion machine. Each layer is preferably made from non-woven spun bonded material. Cross fibres are simultaneously laid perpendicular to the MD in a cross-direction (CD). The strength of the resulting fabric or web layer in the MD is considerably stronger than in the CD. The present Applicants have found that by overlaying multiple layers of fabric in alternating perpendicular orientation, relative to one another, then the resulting multilayered sheet is extremely strong in both MD and CD of the first layer. When this is combined with the quilting of the layers together as described above, this results in a strong, homogenously or uniformly bonded or stitched sheet of multiple layers.

Preferably sheets of non-woven material comprise four or more layers of non-woven fabric alternatively layered in MD and CD directions. Preferably, the layers are joined by quilted stitching extending through the sheet’s upper surface to secure the layers in overlaid relationship relative to one another.

Optionally, one or more sheets of the same or a different material may be combined to form the sheet. A single sheet of a first material may sandwiched within a folded sheet. Preferably, the sheet comprises a single sheet comprising a blend of wood pulp and cotton or polyester spun bonded or melt blown non-woven material

The sheet may be wholly or predominantly made from wood pulp/polyester fibres or outer layers of spun bonded polypropylene fibre web and internal layers comprising melt blown polypropylene fibre web. The material constituting such products is generally characterised by reasonable physical strength, a high body fluid absorption capacity and hypo-allergenic properties. The surgical cloth product, to be most effective and least hazardous, should retain its integrity when wet so that loose fibres or particles thereof are not easily separated from the main body of the product when used as a swab or sponge or as packing/spacing material during a surgical procedure. However, comprehensive retention of integrity of non-woven material is difficult to achieve and the present invention addresses this problem.

The surgical cloth product fibres may be impregnated with agents to improve and modify the properties of the material. Advantageously, however, and in a particularly preferred aspect of the invention, the surgical cloth product may be sterilised by ethylene oxide or irradiation after they are counted and packed.

The X-ray or radio detectable element is preferably a barium sulphate coated thread or ribbon. The X-ray opaque material may comprise a range of suitable materials having large atomic particles adapted to display good X-ray-detectable properties. For example, barium salts such as barium sulphate are particularly preferred.

The X-ray- or radio-detectable element is advantageously not susceptible to separation from the surgical cloth product in use. The element is preferably non-removably associated with the sheet. The element may be embedded in the sheet.

The surgical cloth product may be made from one or more folded sheets with X-ray detectable thread or tape embedded or attached by means of heat bonding. The X-ray detectable thread or tape is usually made from a barium sulphate and polymer composite. The thread or tape may be coloured a dark colour, such as blue or black, for visual identification against the typically light-coloured background (such as white) of the surgical cloth product. Preferably, the detectable element is presented close to the upper or underneath surface to enhance visibility.

The X-ray- or radio-detectable element may comprise an X-ray opaque material made from barium sulphate held together by an inert polymer. The X-ray opaque material may be in the form of a wire, thread, ribbon, seam or bead interposed across, through or between the sheet layers. Preferably, the element is in the form of a thread that is hydroentangled with one or more of the spun bonded layers or is stitched into the fabric of the sheet, preferably between adjacent rows of stitching.

The X-ray opaque material may alternatively be particulate. In the latter case, the X-ray opaque material may be sprayed onto the fibres or may be otherwise impregnated by emersion, by brush application, injection or spraying. Therefore, the X-ray detectable elements may be added by planting or spraying them into the fibre web or into the surface of the fibre web or by heating them into the surface of the surgical cloth product.

Preferably, the X-ray opaque material is in the form of filament having sufficient flexibility to bend with the fibres of the sheet during use. The X-ray detectable element is preferably barium sulphate thread. The X-ray detectable element may optionally include barium phosphate. The barium phosphate component may be in the form of a coating applied to a synthetic thread, such as polypropylene extruded thread. The X-ray detectable element may be heated onto the surface of the non-woven cloth, for example by hot heating, hot pressing or ultrasonic wave treatment.

Preferably the X-ray detectable element is in the form of a strip or ribbon oriented in the MD, although the X-ray detectable element may be alternatively or additionally oriented in the CD. By alternatively layering layers in the MD and CD, the X-ray elements cross paths. This arrangement provides an improved visual clue to users of the presence of the X-ray element, because of the distinguishable opaque line extending in two different directions. It also informs the user, notably theatre staff, of the MD of a particular layer and also improves the X-ray detectability of the product in the unfortunate event that it is inadvertently left in a patient post-surgery.

The radio-detectable element may be a passive inductor chip trapped in the tangled fibres of the surgical product. The inductor chip is thus detectable by an RF device that avoids the further use of X-ray and the deleterious affects such use may have on patients and medical staff. The inductor chip may comprise peripheral nodules, hooks, notches, apertures or other surface features with which the fibres of the surgical product material may mesh, for example by hydraulic entanglement.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention may be better understood from the following non-limiting description of preferred embodiments, in which:

Figure la is a plan view of a surgical product according to the prior art;

Figure lb is a schematic side view of the surgical product through section A-A shown in Fig. la;

Figure 2 is a plan upper surface view of a surgical product according to a preferred embodiment of the invention;

Figure 3 is a schematic side sectional view of the surgical product according to the embodiment shown in Fig. 2; and

Figure 4 is a plan lower surface view of the surgical product according to the embodiment shown in Fig. 2;

Figures 5a-c show exemplary stitching patterns that may be used according to the invention.

DETAILED DESCRIPTION OF THE DRAWINGS

Preferred features of the present invention will now be described with particular reference to the accompanying drawings. However, it is to be understood that the features illustrated in and described with reference to the drawings are not to be construed as limiting on the scope of the invention.

Referring to Figures 1 and 2, there is shown an example of the prior art in the form of a swab sheet 10 comprising multiple layer, including outer layers 11 a, b comprised of a single sheet of light crossing mesh 11 folded over at 12, and an internal single sheet of spun bonded melt blown non-woven fibre 14 interposed between the folded sheet of cotton mesh 11.

The three layers 11a, 14, 1 lb are held together by lines of stitching 15 that extend around the periphery of the swab 10 on the non-folded edges 16a, b, c, the stitching 15 extending fully through all three layers 11a, 14, lib to join all three layers in fixed relationship. Internal stitching 15b, c is provided in the form of linear diagonal lines of stitching extending between diagonally opposed comers 17 of the swab 10 act to join the three layers 11a, 14, 1 lb to reduce separation and relative movement therebetween. However, as the skilled person will appreciate, when the swab 10 becomes full of heavy fluid and tissue, separation of the various layers from each other and the ability of the layers 11a, 14, 1 lb to remain adhered to each other and to not lose form (become floppy or sloppy and difficult to manipulate), may be compromised.

However, stitching of swabs of the type shown in Figures la, lb are sewn using an industrial or standard sewing machine and the amount of stitching is necessarily kept to a minimum for the purposes of swab 10 production costs and minimization of labour. Additional stitching is discouraged and would not be contemplated as the labour and production costs would be prohibitive. Other attempts to promote adhesion of the layers, one to another, include entanglement of the non-woven fibres, but such adhesion has limitations, particularly when the highly absorbent material becomes laden with fluid and tissue.

Turning now to Figures 2 to 5c, there is shown a swab 20 made according to the invention that is made using one or more layers of several materials, including polymeric materials such as, polypropylene, wood pulp-based material, etc., and blends of various acceptable fibres, that are suitable for skin contact and for surgical or other medical-absorbent sponge, use as swab or gauze material. As the material is non-woven, fibre particles might tend to disassociate from the body of the swab 20, potentially causing contamination or irritation in the body of the patient and would be a hygiene, infection and general health risk. However, substantial stitching of the gauze has not been considered an option prior to this invention. It may be that the perception has been that over-stitching the material may have been considered to have adverse effects on desirable properties of the swab 20, such as absorbance, softness, pliability and flexibility.

However, the swab 20 of the preferred embodiment is universally and comprehensively stitched by a quilting method to cover substantially the entire surface area 21 of the gauze sheet of the swab 20, so that there is no significant or substantial portion of the gauze sheet of the swab 20 that remains unstitched. Combining the quilted stitching with highly absorbent and flexible materials surprisingly results in a reliable swab product that is resistant to fraying, maintains fibre integrity when laden with blood and tissue and manipulated roughly in the rigours of surgery whilst performing as a highly absorbent swab. Moreover, the universal or quilted, tight knit stitching gives the swab 20 structural form to allow the surgeon to manipulate and position the swab 20 as packing, etc. Moreover, the tight stitching pattern gives the swab 20 form whereby it is better distinguishable from the surrounding patient body tissue, thereby reducing the risk of confusion of the swab 20 relative to the patient’s tissue.

In practical terms, tight stitching or quilting of the swab 20 sheet may mean that no area of the swab 20 greater than 2.25mm2, preferably 100mm2, still more preferably 25mm2, even more preferably 12 mm2, and alternatively 9mm2, may be left without stitching or thread. Furthermore, the insertion points between needle point thread entries through the sheet of the swab 20 of one row of stitching are preferably spaced no more than 15mm apart, preferably no more than 10mm apart, still more preferably no more than 5mm apart, yet more preferably no more than 35mm apart, and alternatively no more than 3mm apart, from the closest insertion point of the adjacent row of stitching. To achieve such concentrated stitching patterns, a gauze stitching machine capable of longitudinal travel ‘L’ coupled with reciprocal lateral oscillation ‘R’ back and forth with each stitching stroke across the width ‘ W’ of the sheet is provided to longitudinally traverse the sheet of the swab 20 to achieve automation of the swab 20 stitching process.

The sewing assembly may be positioned over the sheet 20 and may be adapted to form multiple rows of stitching 22 in longitudinal alignment parallel to each other, whereby to substantially cover the total surface area 21 of the gauze sheet of the swab 20. To achieve multiple, closely adjacent rows of stitching, the sewing assembly being a standard industrial quilting machine capable of forming preferably overlocked straight rows of stitching. Manual reinforcing of the stitching on the peripheral edges 26 are preferably performed using the a standard industrial or other selvedge sewing machine to ensure strong and accurate sewing of the selvedges 26, however, selvedging may be automated. The selvedge machine may be adapted to perform a more complicated, reinforced stitching pattern 27 along the side edges 26 to tightly bind the fibres of the swab 20 at the edges 26. As shown in Figure 3, the swab 20 is tightly bound by the universal quilting, so that there is a reduced risk of loose fibres disassociating from the swab 20.

The swab 20 may be fed through a pair of counter -rotating rollers on a quilting table of the sewing assembly. The sewing assembly table on which the swab 20 is supported, may move for relative, opposed direction movement therebetween, it being preferred that the sewing machine long arm be computer manipulated to control the operation of the machine needle as the sheet 20 is fed through the rollers.

The sewing assembly may be an industrial quilting machine of the type supplied by Gammill, Inc. of 1452 Gibson Street, West Plains, MO 65775. The sewing assembly 30 is preferably a long arm quilting assembly computer program controlled to determine the stitching pattern, whilst the sheet 20 is stretched under tension on a quilting table or like operational bed. The sheet 20 may be a cut piece of a large sheet that is quilted first and then cut into rectangular pieces to form multiple swab sheets 20. The sheets 20 may be then separately selvedged, that ius sewn around its edges 26 to secure the sheet 20 edges 26 from fraying.

In Figure 4, there is shown the reverse side of the swab 20, demonstrating the “W” pattern achieved by the longitudinal travelling laterally reciprocating sewing assembly 30. However, as illustrated in Figures 5a-5c, other stitching patterns, such as block stitching shown in Figure 5 a, linear stitching shown in 5b, or “Z” pattern stitching shown in Figure 5c, maybe utilized with adequate effect to achieve universal quilting of the entire area 21 of the gauze sheet 20.

Throughout the specification and claims the word “comprise” and its derivatives are intended to have an inclusive rather than exclusive meaning unless the contrary is expressly stated or the context requires otherwise. That is, the word “comprise” and its derivatives will be taken to indicate the inclusion of not only the listed components, steps or features that it directly references, but also other components, steps or features not specifically listed, unless the contrary is expressly stated or the context requires otherwise.

In the present specification, terms such as “component”, “apparatus”, “means”, “device” and “member” may refer to singular or plural items and are terms intended to refer to a set of properties, functions or characteristics performed by one or more items having one or more parts. It is envisaged that where a “component”, “apparatus”, “means”, “device” or “member” or similar term is described as being a unitary object, then a functionally equivalent object having multiple components is considered to fall within the scope of the term, and similarly, where a “component”, “apparatus”, “assembly”, “means”, “device” or “member” is described as having multiple items, a functionally equivalent but unitary object is also considered to fall within the scope of the term, unless the contrary is expressly stated or the context requires otherwise.

Orientational terms used in the specification and claims such as vertical, horizontal, top, bottom, upper and lower are to be interpreted as relational and are based on the premise that the component, item, article, apparatus, device or instrument will usually be considered in a particular orientation, typically with the upper surface uppermost.

It will be appreciated by those skilled in the art that many modifications and variations may be made to the methods of the invention described herein without departing from the spirit and scope of the invention.

Claims (13)

1. The Claims:

   1. A surgical product being a swab or sponge, the surgical product including a non-woven sheet made up of multiple layers of non-woven material defining a sheet area in plan, a detectable element in the form of an x-ray or radio-detectable element, and stitching that universally quilts substantially the entire sheet area.
2. 2. The surgical product according to Claim 1, wherein the sheet is stitched in rows each row having a straight or linear pattern.
3. 3. The surgical product according to Claim 1 wherein the sheet comprises rows of stitching each row having a Z or X pattern.
4. 4. The surgical product according to Claim 2, wherein the rows include rows that are parallel and spaced from one another, but not to an extent that an upper surface of the sheet can materially separate from an underneath surface of the sheet in any portion of the central area.
5. 5. The surgical product according to Claim 4, wherein the rows are spaced no more than 1.5 X from each adjacent row, where X is the length of a standard stitch in one of the rows.
6. 6. The surgical product according to Claim 4, wherein the length of a stitch ranges between 2.5 - 3.5mm and the spacing between parallel rows of stitching in the central area about 2.0 - 5mm.
7. 7. The surgical product according to Claim 1, including a first row of stitching in a first direction and a second row of stitching in a transverse direction.
8. 8. The surgical product according to any one of Claims 1 to 7, wherein the surgical product is wholly or predominantly made from polypropylene or wood pulp and polyester spun bonded layers of non-woven material.
9. 9. The surgical product according to any one of Claims 1 to 8, wherein the surgical product is an abdominal sponge in which the sheet is made with three layers of fabric, the edges of the respective layers stitched together.
10. 10. The surgical product according to any one of Claims 1 to 9, wherein the X-ray-or radio-detectable element is non-removably associated with the sheet between adjacent rows of stitching and/or layers of the sheet.
11. 11. A method of forming the surgical product according to any one of Claims 1 to 10, including the steps of: (a) providing a primary nonwoven sheet; (b) folding the primary nonwoven sheet about a secondary separate non-woven sheet; and (c) stitching the primary and secondary sheets together to quilt the entire sheet area.
12. 12. The method of claim 11 further including the step of: (d) folding the primary nonwoven sheet again, to form a sponge which may be unfolded to act as a swab.
13. 13. The method of claim 12, wherein the step of stitching the sheets together includes stitching the central area and stitching the edges separately.