Patent Application
20130319888
The present invention relates to containers for surgical instruments and in particular to supports and trays for surgical instruments which can more readily withstand typical use thereof.
Many surgical procedures use a large number of surgical instruments which are typically carried into the operating theatre using a container generally referred to as a tray. Different types of surgical procedures use different types and numbers of instruments. For example, orthopaedic surgical procedures can often use many tens of different instruments. The collection of instruments, and the parts, fixtures and fittings therefore (such as bone pins, screws, etc.) are generally referred to as a kit. Hence, the kit of instruments for an orthopaedic surgical procedure, such as a total hip replacement procedure, may involve eight trays of instruments, with each tray holding several instruments and associated accessories.
The instruments in a specific tray can have a wide range of sizes both in terms of their length and width, i.e. transverse dimension. However, it is generally preferable to provide trays having a single overall size (in terms of length, width and depth) for ease of manufacture. Usually some form of support structure is provided in a surgical try to support the instruments in certain positions so that they can easily be identified and accessed when needed during a surgical procedure. A tray usually includes instruments needed at a particular stage of a surgical procedure. However, that group of instruments may have widely varying sizes and shapes. As the tray typically has a single fixed depth the support structure needs to be able to accommodate the different sized instruments. Also, all of the instruments need to be retained in the support structure so that they do not move around, fall out or become damaged.
One approach to retaining instruments is to adapt the height of the support structure at different locations within the tray so that a lid of the tray helps to retain the instruments in may be provided in the tray with different height portions and/or pockets the support structure during transportation or handling of the tray. For example, a shelf to accept the different width instruments so that the instruments are all held at a height such that the lid helps to retain all the instruments in their respective supports. However, the inclusion of the shelf increases the weight, cost and complexity of the tray. Further, if instruments or ancillary parts are dropped through the shelf, then it can be difficult and time consuming to retrieve the parts and this interfere with the efficiency of the surgical workflow,
Another approach is to use plastic supports within a metal tray and to use an O-ring like part to provide a push fit so that the instruments are securely held within the supports such that there is no need for the lid to help retain the instruments within the supports, However, such plastic supports tend to be bulky in order to provide the required mechanical strength and so can be difficult to accommodate within a try at the desired positions,
Another form of secure retention of instruments in a tray is described in U.S. Pat. No. 6,436,357 which describes a sterilizable bracket for supporting medical instruments. The bracket includes a silicone material that surrounds and encapsulates a relatively rigid metal skeleton which is attached to a plurality of studs which secure the bracket to a sterilizable tray. Instruments are received in indentations in the resilient body. The relatively rigid spring tempered skeleton backbone includes a plurality of peaks and valleys oriented in such a way that they align with peaks and indentations of the resilient body respectively. This structure provides additional strength to the resilient silicone body so as to hold the instruments securely in the indentations.
Similarly U.S. Pat. No. 6,382,575 describes an instrument bracket for holding medical instrumentation in a sterilization tray. The bracket includes a clip which is mountable to a base plate of the tray and a holder part. The clip has a U-shaped configuration with spaced upwardly projecting legs accommodating the holder part which is flexible and shape retaining. The holder part includes a recess to accommodate the instrumentation and the clip part compresses and retains the holder part and secures the holder part to the base plate.
However, the corollary of the push fit retention of the instruments is that it is less easy to quickly remove and return the instruments to the tray. Further, the user does not receive the tactile feedback of positive engagement of the instrument back in its correct support structure, Therefore, such trays generally require more care in their use and therefore also impede efficiency of the surgical workflow.
There is therefore a need for a surgical tray which can easily and reliably be used during a surgical procedure to remove and replace instruments and which does not impede the efficiency of the surgical procedure.
A first aspect of the invention provides a support for use in a surgical tray to support surgical instruments, the support comprising: a holder having a free end presenting a formation arranged to accept a part of a surgical instrument; and a foot by which the support can be attached to a base of a surgical tray, and wherein the support is resiliently deformable.
Preferably, a resiliently deformable support is sufficiently resilient so that the support substantially returns back to approximately its original position after it has been deformed. Preferably, a resiliently deformable support is sufficiently resilient so that once deformed within its elastic limit, it returns to a position back not more than 5 mm from its original position, and preferably not more than 3 mm from its original position.
The supports extend from the base of the tray and so no shelf is needed thereby reducing weight and complexity. The supports can be of differing lengths so that the lid can be used to help retain the instruments in the supports thereby avoiding the need for any further securing mechanism and allowing easy removal and replacement of instruments. The supports can be made long and thin as they can resiliently deform or flex and so if knocked by an instrument during use of the tray, e.g. a heavy instrument being returned to the tray, then the supports can temporarily deform to help absorb that impact and will also not be permanently deformed or bent out of shape. Otherwise, long thin supports would be prone either to breaking or being permanently bent out of position, thereby preventing the instrument being returned to the tray and requiring the tray to be repaired. Hence, the surgical tray of the invention can be reliably used in a surgical procedure while allowing the rapid removal and return of instruments and so not interfering with the efficiency of the surgical procedure.
Further, by avoiding the need for some other supporting structure, such as a shelf, the weight and complexity of the tray are reduced making them easier to handle and manufacture. Further, there is improved access to the body of the tray for retrieval of parts.
The support can comprise a holder and a foot and either or both may be resiliently deformable. The resilient deformability can be provided by a resilient hinge. The hinge can be a live hinge. The hinge can be provided by a materials property or a mechanical property or a combination thereof. The resilience can be provided by a materials property or a mechanical property or a combination thereof.
The support can include an attachment formation for attaching the support to the base of the tray. The attachment formation can be a push fit or snap-fit formation extending from an underside of the foot. The attachment formation can be arranged to engage with an aperture or opening in the base of the surgical tray.
The support can have a unitary construction. The support can be made from a single part or piece of material. A property of a part of the material adjacent the foot can differ from a property of a part of the material forming holder part in order to allow the support to resiliently deform. The property can be the stiffness and/or hardness of the material.
The support can have a composite construction. The support can be made from at least two separate parts. The support can include a rigid material. The rigid material can provide a first component including the holder. The support can also include a resiliently deformable material. The resiliently deformable material can provide a second component including the foot.
Hence, the holder provides the tactile feedback of positive engagement to the user that the instrument has been correctly received by the tray supports.
The rigid material can be a metal. Suitable metals include steel and stainless steel. The resiliently deformable material can be an elastic material, such as a rubber, a rubber-like or an elastomer material. Suitable materials include synthetic rubbers, such as a silicone rubber.
The metal can have a plastic coating. The plastics coating can be nylon. The plastics coating can help to prevent or reduce scratches to the surface of surgical instruments.
The support can include a connector by which the first component and the second component can be attached. A part of the first component and a part of the second component can provide between them the connector. The connector can be a push fit or a snap fit connector.
A further aspect of the invention provides a surgical tray for holding a plurality of surgical instruments. The tray can comprise a body having walls defining a main opening and a base. A lid is engagable with the main opening to close the tray. A plurality of supports according to the preceding aspect of the invention can extend from the base.
Each support can have any of the preferred features of the first aspect of the invention.
The base can have a plurality of apertures or openings. Each support can engage a respective one of the plurality of apertures or openings to attach each of the plurality of supports to the base. The apertures or openings can also assist with the ingress of steam for cleaning and/or sterilisation.
The surgical tray can further comprise a plurality of surgical instruments located within the body of the tray and supported by the plurality of supports.
A further aspect of the invention provides a method of manufacturing a surgical tray. The method can comprise manufacturing a body having walls defining an opening and a base. A lid engagable with the opening to close the tray is also manufactured. A plurality of supports are manufactured. Each of the supports comprises a holder having a free end presenting a formation arranged to accept a part of a surgical instrument and a foot, wherein the support can resiliently deform to substantially return the support to an initial state if the support is knocked in use. The foot of each of the plurality of supports is attached to the base so that the plurality of supports extend from the base.
The method can include manufacturing supports or the surgical tray including any of the preferred features of the supports or surgical tray.
An embodiment of the invention will now be described in detail, by way of example only, and with reference to the accompanying drawings, in which:
Similar items in different Figures share common reference signs unless indicated otherwise.
With reference to
Hence, depending on the instrument to be supported, the depth of the trough and the height of the trough will vary for different supports and depending on what part of the instrument is being supported. For example, as illustrated in
The holder 204 has a circular aperture 212 toward a lower end as illustrated in
The holder 204 is a rigid part made from a suitable rigid material, preferably a metal, such as steel, and is in the form of a generally rectangular plate approximately 1 mm thick. The holder has a plastic coating, e.g. of nylon, approximately 0.1 or 0.2 mm thick in order to help prevent scratching of instruments.
Foot 206 is resilient deformable such that the support can deform or flex and regain its initial position if knocked by an instrument during use of the tray in surgery.
Preferably, a resiliently deformable foot is sufficiently resilient so that the support substantially returns back to approximately its original position after the foot has been deformed. Preferably, a resiliently deformable foot is sufficiently resilient so that once deformed within its elastic limit, it returns to a position back not more than 5 mm from its original position, and preferably not more than 3 mm from its original position.
An inner surface of the wall 214 of the foot 206 has a circular protrusion 220 extending therefrom and an opposed part of the wall 214 has a circular aperture 222 therein in registration with the protrusion. The protrusion 220 and aperture 222 provide a foot part of a connector mechanism by which the holder part 204 and foot part 206 can be attached together in a generally push fit manner. The protrusion extends into the aperture 212 in the holder to securely retain the holder in the foot and connect the holder and foot together.
The foot 206 is made from an elastomer, such as a rubber or rubber-like material, for example a silicone rubber, and can be manufactured by injection molding. For example, the foot can be made of an elastomer such as that provided under the name Silplus (RIM) as available from GE. Silicones and can have a Shore A hardness in the range of approximately 40 to 80. Hence, the foot 206 provides a semi-rigid seat which is sufficiently rigid to present the free end of the support in an initial position to receive the instrument, but which also has sufficient resilient deformability such that, if impacted, the support will deform but then substantially return back to its initial position without being bent out of shape. As the foot provides the support with the ability to resiliently deform, the holder can be made of a thin plate of stainless steel without the likelihood of the metal becoming permanently bent or otherwise damaged during use of the tray. This is particularly an issue for long supports, such as support 102, compared to shorter supports, such as 103, in which the bending moment for a similar impact will be greater. However, by including in the support a mechanism by which the support can resiliently deform, supports of all different heights that might be required in a single tray can be provided. A range of thicknesses of stainless steel plate can be used depending on the specific details of the application. The thickness can be in the range of approximately 0.6 mm to approximately 3.4 mm.
Further as no ancillary support structure is needed, such as a shelf, the weight of the tray can be reduced.
Furthermore, as the foot also acts to connect the support to the base, no secondary fixing, such as a rivet, is needed which again reduces weight and also improves ease of manufacture and assembly.
In contrast foot 306 has a generally parallel sides and its wall 314 has a generally constant thickness. Foot 306 has a pair of extensions 310, 312 extending from opposed sides of the foot and generally in the direction in which the support has the greatest degree of flex. The combination of the extensions, and the materials properties of the silicone rubber, determine the degree of resilience and flex that the foot 306 provides to support 300.
Foot 306 is in the form of a seat or sleeve with a parallel, annular wall 314 of generally constant thickness defining a central aperture 315 extending along its longitudinal axis and having a generally rectangular transverse shape dimensioned to snugly receive the plate-like holder 304 therein. An attachment part 316 extends from a lower end of the foot and includes a groove 318 extending around it and having a similar width to the thickness of the base 114 of the tray, A lower or bottom most end 319 of the attachment part is generally tapered to ease insertion into an aperture 128 in the tray. The groove 318 depth is dimensioned to allow the attachment part 316 to be push fitted into a one of the apertures 128 of the base so as to attach the support to the base 114.
An inner surface of the wall 314 of the foot 306 has a circular protrusion or boss 320 extending therefrom and having a chamfered free end 321. An opposed part of the wall 314 has a circular aperture 322 therein in registration with the protrusion. The protrusion 320 and aperture 322 provide a foot part of a connector mechanism by which the holder and foot part 306 can be attached together in a generally push fit manner. The protrusion extends into a corresponding circular aperture in the holder 304 to securely retain the holder in the foot 306 and connect them together.
The foot 306 is made from an elastomer, such as a rubber or rubber-like material, for example a silicone rubber, and can be manufactured by injection molding. In order to tailor the degree of resilience in different directions, the further foot 306 includes a pair of projections 310, 312 which extend from opposed sides of the foot wall 314 in a direction generally perpendicular to the front 324 and rear 326 faces of the foot wall. The projections extend in a direction generally parallel to the direction in which the foot 306 is likely or intended to deflect if the holder 304 is impacted by an instrument in use. As will be appreciated, the foot 306 will be more resistant to bending or flexing in the perpendicular direction owing to the depth of material of the foot extending in that direction (generally parallel to the front and rear walls of the foot).
As illustrated in
Hence, the foot 306 provides a semi-rigid seat which is sufficiently rigid to present the free end of the support in an initial position to receive the instrument, but which also has sufficient resilient flex that if impacted, the support will deform but then substantially return back to its initial position without being bent out of shape.
Hence it will be appreciated that there are a wide number of ways in which the support can be engineered in order to provide desired degrees of resilience and of deformability and in what directions those qualities exist. Properties that may be varied include generally materials properties and/or mechanical properties and/or shape properties. For example, in some embodiments, the foot may not be made of a resilient material, but instead may be made from a rigid material but which includes a resilient part, such as a spring (for example a torsion spring), that provides the resilience and ability to flex or deform. In some embodiments, the support may be made from a single part (rather than two separate parts) and the material or mechanical properties of a unitary support may be varied in order to provide the rigidity of the holder and the resilient &formability. For example, the support may be made from a single piece or part, but the free end providing the holder may be treated (for example by implantation or doping with another material) in order to be more rigid and the foot part may not be so treated, or treated differently in order to be resilient and deformable. Therefore, various types of support are envisaged including both the compound type illustrated in
It will be appreciated that the support of the invention provides a more reliable tray as it is more able to withstand typical use in an operating theatre in which instruments are rapidly taken from and replaced in a tray. As the retaining formation 210 in the free end of the support freely retains the instrument (i.e. there is no push fit, clamping or other mechanism holding the instrument in the supports) the instruments can be quickly removed from the tray and replaced on the supports. Further, as the free ends of the supports are rigid, tactile feedback of “hard-on-hard” placement makes it easier for users to be confident that the instrument has been correctly replaced in the tray. Furthermore, the user can be less careful in returning instruments to the tray as the supports can deform or flex, and then automatically and substantially return to their initial position if knocked by an instrument thereby reducing the chance of damage to the instrument or supports. Yet further, the resilience of the foot provides a certain amount of damping to prevent inertial damage to the supports and/or instruments during rough handling or mishandling of the tray (e.g. a tray being dropped). Many of these benefits arise from a simpler tray construction which is also light weight and improves the ease of manufacture of the tray.
A method of manufacture 400 of the tray 100 also according to the invention will now be described with reference to
At 404 a plurality of supports are made. If the supports have a unitary construction then they will generally have a one part form. Other vise, if they have a compound construction, then they will have a multi-part form. For example, the supports 200, 300, can be manufactured by cutting a plurality of holders from thin sheets of steel and then plastic coating them and the foot parts can be formed by injection molding. The rigid holder parts 204, 304 are inserted into the foot parts and the connector parts of the holder part and foot part co-operate to securely connect them together. It will be appreciated that the order of steps 402 and 404 is irrelevant and the steps can be carried out in parallel as well.
Once the supports and tray body have been manufactured, then at step 406, the supports are attached to the base of the tray. As described above, the foot parts 206, 306, include an attachment formation on their lower end which is push fit to engage with respective apertures in the base of the tray. The specific height, depth and shape of the retaining formations in the free ends of the rigid parts will vary depending on the instrument, and part of the instrument, that each support is intended to support. It may be that a suite of four or five generic plates 204 may be sufficient to support all or most instruments, with more specific plate shapes being manufactured on an ad hoc basis. The position of attachment within the base of the tray will also vary depending on the specific collection of instruments to be provided in an individual tray. Once the supports have been attached, the tray is ready to receive the instruments and the lid of the tray can then be attached so as to help retain the instruments within the tray.
Although specific embodiments of the invention have been described above, it will be appreciated that a large number of variations, modifications and changes are possible and will be apparent to a person of ordinary skill in the art from the teaching herein.
