The present invention relates to a surgical pack and in particular to a pack having a re-attachable closure so that the pack can be re-used to dispose of its original contents.
It is common to provide surgical equipment, such as surgical instruments, tools, implants and the like, in packaging which holds the surgical equipment to maintain its sterility. The surgical equipment is then transferred to the surgeon so as to maintain the sterility of the equipment so that the surgeon can use the surgical equipment. With reusable surgical equipment, the surgical equipment is simply kept after use and is then cleaned, repackaged and sterilised for re-use. However, for disposable surgical equipment, the surgical equipment needs to be disposed of. However, it may not be possible simply to dispose of the surgical equipment using normal garbage handling as the surgical equipment may be dirty or potentially dangerous.
There is limited space and time in an operating theatre and so it would be beneficial to be able to dispose of surgical equipment, whether re-useable or not, in a simple and rapid manner without increasing the complexity of the operating theatre environment or increasing clutter within the operating theatre.
The present invention addresses such problems by providing a surgical pack which can be re-used to facilitate safe disposal of at least some of the surgical equipment originally present in the pack.
According to a first aspect of the invention there is provided a surgical pack, comprising: a container having an opening; at least one item of surgical equipment received by the container; and a closure which shuts the opening and which is sealed about the opening of the container by bonding, wherein the closure and the container provide between them at least one attachment mechanism by which the closure can be re-attached to the container over the opening to shut the opening.
As the closure can be re-attached to the container, the container can be re-used, for example to more safely dispose of some of the original contents of the container after their use. Hence, no ancillary waste disposal facilities need to be provided in the surgical environment as the original packaging, which is present anyway, can be re-used for waste disposal without requiring modification of existing waste management. The container helps to protect the user and parts of the conventional waste disposal process from the contents being disposed of and the re-attachable lid helps to retain the contents within the container.
The closure can be bonded, adhered or stuck to the container so as to seal the container using a number of different non-mechanical attachment mechanisms. For example, the closure can be heat bonded or welded or an adhesive can be used. A part or all of the closure can be sealed to the container by bonding. A non-bonded part of the closure can be permanently attached to the container, for example as a living hinge or similar.
The attachment mechanism can be provided in a number of different ways. For example, the attachment mechanism can be a touch or contact fastener. For example the attachment mechanism can use bonding. Various types of bonding can be used. For example the bonding can be provided by an adhesive material. The attachment mechanism can include one or more areas of adhesive. The one or more areas of adhesive can be provided on the container and/or on the closure. The one or more areas of adhesive can be provided around the opening. The adhesive can be a contact adhesive or on surface of a piece or pieces of double sided adhesive tape. Other types of adhesives can be used such as photo-reactive adhesives, chemically reactive adhesives.
The attachment mechanism can comprise one or more regions of hook and loop fastener material. The one or more regions of hook and loop fastener can be provided on the container and/or on the closure. The one or more regions of areas of hook and loop fastener can be provided around the opening.
Other types of non-mechanical attachment mechanisms can also be used. For example, the attachment mechanism may be magnetic, may use static electricity (similarly to cling film) or may use surface tension.
The attachment mechanism can be one or a plurality of mechanical fastener mechanisms. A part of the or each mechanical fastener mechanism can be provided by a part of the container and/or a part of the closure. The attachment mechanisms can be provided around the opening. Each attachment mechanism can comprise a male component and a female component. The male and female components can be engageable or interlockable so as to fasten together. The or each female component can be an aperture, slit or hole. The or each male component can be a projection. The male and female components can be releasably engageable or interlockable so as to releasably fasten together. The or each male component can be provided by a part of the container and the or each female component can be provided by a part of the closure and vice versa.
The or each fastener mechanism can include or wholly comprise an elastic or resiliently deformable part.
Each fastener mechanism can be a releasable fastener mechanism so that the closure can be removed from and further re-attached to the container.
The closure can include a sealing portion which seals about the opening. The closure can be sealed to the container by a number of mechanisms. The closure may be heat sealed or sealed by an adhesive or other form of bonding. Preferably the closure is sealed to the container by a thermal bond.
The closure can include a peripheral portion toward the edge of the closure from the sealing portion. The peripheral portion of the closure can includes at least a part of the attachment mechanism or mechanisms.
The closure can include one or more tabs adjacent a closure part of the attachment mechanism and manipulable by a user to help re-attach the closure and/or operate the or each attachment mechanism.
The pack can have a plurality of attachment mechanisms. A peripheral part of the closure can include a plurality of apertures spaced around the closure. The container can include a plurality of male parts spaced around the opening of the container. The positions of the female and male parts can coincide or be in registration to allow each male part to engage or interlock with a respective female part.
The closure can comprise or include a lid, a base or a wall. The container can include one or more side walls. When the closure comprises a lid, a component of the attachment mechanism can be provided by one or more of the side walls of the container. Each side wall of the container can include at least one component of a one of the attachment mechanisms.
The closure can be entirely removable from the container. The closure can be permanently attached to the container while moveable to expose the opening sufficient to access the interior of the container. The closure can be attached to the container by one or more hinge portions.
The closure can be a sheet or film of material. The closure can be a single layer or a multi-layer film. The film can have a 2-layer construction. The closure can be made of a flexible material. The closure can be made of a plastic and/or a polymeric material. The closure can be a thermoplastic material. Various types of material can be used, including polycarbonates, polyethylene, polyethylene terephthalate, polyurethane, thermoplastic polyurethane, polyvinyl chloride, polyester or polypropylene. The closure can have a layer of adhesive material as a bottom layer.
A portion of the container can be deformable, preferably resiliently deformable, to allow the attachment mechanism to operate. The closure and/or the container can be resiliently deformable to allow the attachment mechanism to be engaged. The material and/or the structure of the closure and/or the container can make them or it resiliently deformable.
The attachment mechanism can include one or a plurality of container components. The or each container component can be provided as an integral or unitary part of the container. The or each container component can be a molded or otherwise formed part of the container.
The container can be a formed, vacuum formed, thermo-formed or molded article.
The container can be made of a thermoformable thermoplastic material, such as a thermoplastic polymer. The container can be made from a formable, vacuum formable, thermo-formable, or moldable material. Suitable materials for the container include acrylonitrile butadiene styrene (ABS), polypropylene (PP), polystyrene, high impact polystyrene (HIPS), polyethylene terephthalate (PET), Polyethylene terephthalate glycol (PETG), crystallised polyethylene terephthalate (CPET), styrene acrylonitrile (SAN), polyvinyl chloride (PVC) or polymethylmethacrylate (PMMA).
The surgical pack can include at least one item of disposable surgical equipment. The surgical pack can include non-disposable and disposable items of surgical equipment. The surgical pack can include a plurality of items of surgical equipment. The surgical pack can include a plurality of items of disposable surgical equipment. The surgical equipment can include orthopaedic surgical equipment. The surgical equipment can include tools, instruments, cutting blocks, guides, trial implants, implants, fixings and ancillary components, parts, fixtures and fittings thereof.
The container can include one or a plurality of formations toward a floor of the container. The formation or formations can be positioned, sized, shaped and/or otherwise configured to define one or a plurality of locations each for receiving a specific piece of surgical equipment. The or each formation can be formed in the floor of the container. The or each formation can be formed in one or more separate parts which are located on the floor of the container. The separate part can be in the form of a tray. This can assist with checking and counting parts out of the patient to ensure that nothing is left behind during use of the pack.
According to a second aspect of the invention there is provided a method of providing a surgical pack, the surgical pack comprising a container holding at least one item of surgical equipment and a closure sealed about the opening by bonding, the method comprising: locating at least one item of surgical equipment in a container via an opening of the container; shutting the opening by sealing a closure over the opening by bonding the closure to the container, wherein the closure and container provide between them at least one attachment mechanism by which the closure can be re-attached to the container over the opening to shut the opening.
As the closure can be re-attached to the container, the container can be re-used to dispose of surgical waste or disposable items.
The method can further comprise manufacturing the container using a molding or forming process. One or more container components of one or more attachment mechanisms can be formed as part of the container by the molding or forming process.
The closure can be bonded to the container by a heat sealing process. Other non-mechanical bonding processes can be used, such as welding or an adhesive can be used.
The method can further comprise sterilising the surgical pack. The method can further comprise delivering the sterilised surgical pack to a medical facility.
According to a third aspect of the invention there is provided a method of using a surgical pack comprising a container holding at least one item of surgical equipment and a closure sealed about an opening of the container by bonding, the method comprising: at least partially removing the sealed closure to provide access to the at least one item of surgical equipment via an opening of the container; removing the at least one item of surgical equipment; replacing the at least one item of surgical equipment in the container; an re-attaching the closure to the container over the opening to hold the replaced surgical equipment within the container using at least one attachment mechanism provided by the closure and the container.
Hence, the container can be re-used to facilitate disposal of at least one item of surgical equipment originally supplied in the pack.
The method can further comprise disposing of the container holding the replaced item of surgical equipment and the re-attached closure.
Either of the method aspects of the invention can be applied to any of the surgical pack aspects of the invention.
Embodiments of the invention will now be described in detail, by way of example only, and with reference to the accompanying drawings, in which:
Similar features in the different Figures share common reference numerals unless indicated otherwise.
With reference to
As best illustrated in
The side and end walls each bear container components of an attachment mechanism for re-attaching closure 104 as will be described in greater detail below. More specifically, each side wall bears three formations 122, 124, 126 each having a downward projecting tongue 128, 130, 132. Similarly, each end wall bears two similar formations 134, 136 similarly each having a generally downward projecting tongue 138, 140.
The container 102 is made from a sheet of thermo-formed material and the container attachment mechanism components are integrally formed with the main structure of the container when the container is formed. Suitable materials for the container include polystyrene, polypropylene and high density polyethylene (HDPE). The container can also be made from ABS, PET, SAN, PVC, HIPS, PETG, CPET or PMMA, amongst others. The container can be made by other manufacturing processes such as vacuum forming, injection molding, blow molding and draping.
The container 100 also includes closure 104 which, in the illustrated embodiment, takes the form generally of a lid. Lid 104 shuts opening 116 of the container and is sealed to the lip 120 of the container all the way around opening 116. The lid is heat sealed to the lip 120 of the container. In other embodiments, depending on the material of the lid, the lid may be sealed to the container about the container's opening using an adhesive or other sealing technology. The lid is in the form of a flexible sheet of material. A suitable material for the lid includes a non-woven high-density polyethylene material such as Tyvek as provided by DuPont (Tyvek is a registered trade mark in some countries). Other suitable materials for the lid include other plastics and polymers, including, for example, PC, PE, PET, PU, TPU, PVC, Polyester and PP. The lid can be made of a 2-layer film including a layer of PET and an adhesive or sealant layer on the bottom. A suitable material for the lid is the RPP#21-1260 film as provided by Rollprint Packaging Products, Inc. of Illinois, USA. Other sealant materials would include a polybutene blend (e.g. polybutene-LDPE-EVA), polypropylene blends and polyethylene blends.
As best illustrated in
As also shown in
One or more items of surgical equipment is located within the container. The surgical equipment may include surgical instruments, tools, implants or similar. At least one of the items of surgical equipment may be disposable in that it may be intended for a single use such that it is disposed of after use during surgery. Commonly, a tray holding the one or more items or surgical equipment may be located within the cavity defined by the container.
Before describing use of the surgical pack, the method of manufacture of the surgical pack will be described with reference to
Once the lid has been sealed to the container, any other layers or wrapping material and further packaging can be added to the surgical pack. The surgical pack may then be sterilised, for example by gamma irradiation, either at the manufacturing facility or at a separate sterilisation facility. The sterilised pack may then be stored or delivered to a medical facility for storage and subsequent use.
The items of surgical equipment are then used during the surgical procedure by the surgeon. After use, or at the end of the surgical procedure, at least one of the items of surgical equipment is placed back in the container 102 at step 226. Other items of surgical equipment not originally present in the surgical container may also be placed in the surgical container after use. Because of the nature of the material of which the surgical container is manufactured, it is not suitable for disposing of genuine sharps, such as blades or syringes, but is suitable for disposing of other items of surgical equipment which may still give rise to the danger of puncture wounds or which are simply contaminated with bodily materials. However, the container could be used to hold sharps before the sharps are placed in a reinforced sharps container for disposal. It is ensured that the surgical equipment placed in the container lies below the plane of the lip 120 of the container.
Then the lid 104 can be reattached over the opening 116 using an attachment mechanism provided by the slits in the lid and the tongues of the container at step 228. As illustrated in
Once the lid has been reattached to the container, the container and its contents may be disposed of using the medical facilities conventional waste disposal. For example, the pack and contents may be disposed of in a sharps bin or similar.
A number of advantages arise from re-using the original packaging in which surgical equipment is provided in order to subsequently dispose of the surgical equipment. Firstly, there is no need to provide a different waste disposal facility and the already existing waste disposal facilities of a hospital or medical facility can be used. If no packaging to dispose of the surgical equipment were available, then a nurse may need to find other packaging material to wrap up contaminated equipment or to try and make safe surgical equipment which may give rise to the risk of puncture wounds or other wounds if disposed of without being wrapped. For example, there may be some risk of a blunt instrument still tearing a conventional garbage bag or sack in the absence of some form of wrapping. As the same pack which is used to deliver the sterile surgical equipment is subsequently reused to dispose of the surgical equipment, no further materials not already present in the operating theatre need to be introduced. Further, by reattaching the original lid, the contents of the container are held securely within the container and may not fall out so as to damage a garbage bag or sack. Hence, safe and prompt disposal of surgical equipment can be carried out using the surgical pack of the invention with its reattachable lid.
It will be appreciated that there are a large number of variations and modifications to the surgical pack of the invention. Some further embodiments of the surgical pack will be described below. Unless indicated otherwise, the general construction and use of the other embodiments of the surgical pack are similar to that of the first embodiment.
With reference to
Use of the surgical pack is similar to that of the first surgical pack. Initially, the lid 104 is sealed to the container and is peeled away from the container but not totally removed from the container as it is attached by hinge portion 242. After use, one or more items of surgical equipment are retained to the container and then tabs 156, 158, 160 are used to pull the slots 148, 149, 150 over the respective tongues of the container so as to reattach lid 104 over the opening 116 of the container.
In another version of the third embodiment, the regions of adhesive material are provided on the underside of the lip 120 and not on the underside of the lid 104. In use, the peripheral portions of the lid are folded over the lip and pressed against the regions of adhesive material on the underside of the lip so as to re-attach the lid to the container.
In a yet further version, instead of using an adhesive material, regions of hook and eye fastener, or similar, material are used to provide the attachment mechanism. Suitable material is provided under the name Velcro (Velcro is a trade mark registered in some countries). Regions or hook or eye material are provided on the underside of the lip 120 of the container and the other of the hook or eye material is provided on the underside of the peripheral part of the lid 104. Hence, in use, the peripheral portions of the lid are folded over the lip 120 so as to engage the hook and eye materials to re-attach the lid to the container.
In use, in order to re-attach lid 104 to the container, the flaps of the lid are folded over the lip and the heads of the projections 306 are pushed through the corresponding apertures in the flaps of the lid so as to interlock the projections and apertures. Hence, the lid can be securely re-attached to the container to prevent surgical items falling out of the container and therefore allowing safe disposal.
The lid 104 includes two generally slot shaped apertures 330, 332, 334, 336 positioned in the peripheral skirt portion of the lid 104 generally adjacent the head of the container attachment mechanism component. Slots 330, 332, 334, 336 provide a closure attachment mechanism component which in use interacts with the container attachment mechanism component to re-attach the lid.
It will be appreciated that in other embodiments, a fewer or greater number of closure slots and container components can be provided. Also, slots and container components can be provided on the ends of the surgical pack.
The placing or replacing of instruments back in the pack offers the opportunity to “count out” the instruments from the surgical site so as to help ensure that all instruments are accounted for toward the end of the surgical procedure. An embodiment of the invention includes providing a plurality of formations in the bottom of the container positioned and configured to provide specific locations for each instrument. The formations can be provided as an integral part of the container by being molded or otherwise formed in the floor of the container during manufacture of the package. Alternatively, the formations can be provided as a separate part, like a tray, which sits in the floor of the package. This will assist with checking and counting parts out of the patient to ensure that nothing is left behind.
It will be appreciated that a wide number of variations and modifications are possible to the specific embodiments described above. Further, features of some of the embodiments can be used in combinations with the features of the other embodiments. Further, the number of specific features of each component can be varied depending on the size, geometry and other usability requirements of any particular surgical pack. Therefore, various modifications and alternatives will be apparent to a person of ordinary skill in the art from the discussion of the invention presented above.
Number | Date | Country | Kind |
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1105910.2 | Apr 2011 | GB | national |
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/GB12/50412 | 2/23/2012 | WO | 00 | 11/4/2013 |