A sealing assembly for a sterilised pouch

Abstract

A sealing assembly comprises a frame and a surgical pouch 506, the frame being attached about at least a portion of the periphery of an opening in the surgical pouch and comprising two elongate opposi

Description

This invention relates to a sealing assembly for a sterilised pouch. In particular, this invention relates to a sealing assembly designed to ensure that the contents of a sterilised pouch remain sterile until the point of use. Sterilised items, which have been treated to remove bacteria, funghi, viruses and spores, are used in a range of different environments, but their use is particularly important in the medical and healthcare sectors. The use of sterilised tools and instruments ensures that harmful pathogens are not spread from person to person via the instruments used by the medical practitioner, protecting the patients who are undergoing treatment. Typically, items needing to be sterilised are placed in a bag or pouch before being autoclaved (sterilised using pressurised steam) to kill harmful bacteria, funghi, viruses and spores. The tools and surgical instruments can then be safely used during treatment, without the risk of pathogens being spread from one patient to another. Items are not always sterilised immediately before use and, once sterilised, may be stored and / or transported before use. The methods of sterilisation and storage therefore need to be sufficiently robust and reliable that the items remain sterile up until the point of use. The unintended contamination of items before use wastes time and resources due to the need to resterilise, and risks harm to the patient. Commonly, the items to be sterilised are placed into a vapour-permeable pouch such as that described in GB2540117, which is formed from a tube of plastic-coated vapour permeable membrane. The items to be sterilised are placed into the tube, and the tube is clamped at both ends with hinged clips. Once sterilised, the pouch may be stored and / or transported, with the clips being removed only at the point of use. However, the simple hinged clip which is conventionally used to seal the surgical pouch is susceptible to becoming dislodged during handling, thus exposing the sterilised items and risking contamination. The items would then have to be resterilised, wasting time and resources. In addition, opening the bag at the point of use requires manual handling of the surgical pouch by the practitioner, thus introducing a further risk of contamination. There has now been developed an improved sealing assembly for a surgical pouch which overcomes or substantially mitigates the above mentioned and / or other problems associated with the prior art. According to the invention, there is provided a sealing assembly comprising a frame and a surgical pouch, the frame being attached about at least a portion of the periphery of an opening in the surgical pouch and comprising two elongate opposing members which are connected at at least one end by an extendible member, the extendible member being biased to move from a collapsed configuration to an extended configuration wherein, when the extendible member is in the collapsed configuration the two elongate members are brought into abutment, such that the interior of the surgical pouch is not accessible, and when the extendible member is in the extended configuration the two elongate members are drawn apart, forming an aperture through which the interior of the surgical pouch is accessible. Previously, opening a surgical pouch to remove the sterilised items inside involved handling the opening of the pouch, and risking contamination of the sterilised items. In contrast, the present invention provides aseptic opening of the surgical pouch, in which the biasing of the extendible member creates an aperture in the frame and thus opens the pouch, without the need for the user to manually draw apart the sides of the pouch. This reduces or eliminates the risk of contamination of the sterile items during opening of the pouch. The frame comprises first and second elongate members, each having a proximal end and a distal end. At least the proximal end of the first elongate member is joined to the proximal end of the second elongate member by a first extendible member. The distal end of the first elongate member may be joined directly to the distal end of the second elongate member, or the two distal ends may be connected together by a second extendible member. Each elongate member may be substantially rectangular in shape. Each elongate member may comprise an inner face and an outer face. By ‘inner face’ is meant the face of each elongate members which, in use, is directed towards the opposing elongate member and is thus located on the inside of the frame. Typically, it is the inner faces of the elongate members that are brought partially or wholly into abutment when the extendible member is in the collapsed configuration. A recess may extend longitudinally along an inner face of one or both elongate members. A recess may extend longitudinally along an inner face of each of the elongate members. The recess may extend longitudinally along the whole or along part of the inner face of one or both elongate members. More than one recess may be present, for example, a first recess may extend from the distal end along up to 20%, or up to 30%, or up to 40% of the length of the elongate member, while a second recess extends from the proximal end along up to 20%, or up to 30%, or up to 40% of the length of the elongate member. Preferably, a recess extends longitudinally along the full length of the inner face of both elongate members. Each extendible member comprises a proximal end and a distal end, and is biased to extend from a collapsed configuration to an extended configuration. In the collapsed configuration is the proximal and distal ends of the extendible member are brought close together, and in the extended configuration the proximal and distal ends of the extendible member are drawn further apart. That is, when in the collapsed configuration distance between the proximal and distal ends is shorter than when in the extended configuration. The extendible member(s) may comprise a foldable, bendable or compressible member. Preferably, the extendible member(s) comprise a foldable member. The extendible member(s) may comprise two, or three, or more individual rods which are connected together by flexible joint(s). The flexible joint(s) may be hinged joints, and may comprise any suitable type of hinge, including a living hinge, a butt hinge, a spring-loaded hinge, a concealed hinge or a pivot hinge. Thus, the extendible member may comprise an articulated member which can move between a collapsed (folded) configuration and an extended (unfolded) configuration. The extendible member may comprise two, three or more individual rods in series each connected to the next another by a pivot hinge. The extendible member(s) may comprise two individual rods connected together by a pivot hinge. The pivot hinge(s) may be integrally formed with the individual rods which comprise the extendible member. Thus, an end of a first rod may comprise two opposing indents, the indents lying along a single axis, which are brought into registration with corresponding protrusions on a second rod, thus forming a joint which pivots along the single axis. The two opposing indents may lie in opposing walls, preferably in opposing parallel walls, along a single axis extending in a direction perpendicular to the walls. The two protrusions may lie along a single axis extending in a direction perpendicular to the walls from which the protrusions extend. When in the collapsed configuration, the angle between the two individual rods may be between 0° and 10°, or between 0° and 5°. When in the extended configuration, the angle between the two individual rods may be between 150° and 180°, or between 160° and 180°, or between 170° and 180°. The extendible member is biased towards the extended configuration. That is, when no force is applied, the extendible member will return to and / or rest in the extended configuration, enabling the sterilised instruments to be removed from the pouch without the need to touch the pouch. The extendible member may be biased towards the extended configuration using any suitable means, for example using a spring or resilient member. The extendible member may be biased towards the extended configuration by a resilient member, eg a spring. Where the extendible member is formed of two rods joined together by a hinge, the resilient member may connect the two rods together across the hinge. The resilient member may be a tension spring, a compression spring or a plastic spring, but may particularly be a compression spring. A compression spring may connect the two individual rods which form each extendible member, extending between the rods on the inside of the hinge, such that when no force is applied the spring extends and the rods are biased towards the extended configuration. A tension spring may connect the two individual rods which form each extendible member, extending between the rods on the outside of the hinge, such that when no force is applied the spring contracts and the rods are biased towards the extended configuration. The extendible member(s) may be attached to the elongate members by hinged joints. An end of an extendible member may be attached to an end of an elongate member by a hinged joint. The hinged joint may comprise any suitable type of hinge, for example, the hinged joint may comprise a living hinge, a butt hinge, a spring-loaded hinge, concealed hinge or a pivot hinge. The hinged joint may comprise a pivot hinge. The pivot hinge may be integrally formed with the elongate member and / or extendible member. The elongate member may comprise two opposing indents or protrusions lying along a single axis which are brought into registration with corresponding indents or protrusions on the extendible member, such that the extendible member pivots about the single axis. Where present, the opposing indents or protrusions on the elongate member may be integrally formed within opposing walls of the recess, along a single axis. The single axis may extend in a direction perpendicular to the wall of the elongate member in which the indent or protrusion is formed. An end of the extendible member may be housed within the recess, indents or protrusions on the end of the extendible member being brought into registration with opposing indents or protrusions integrally formed within 7 opposing walls of the recess, and forming a pivot hinge which pivots about a single axis. Thus, the extendible member may pivot from a position in which it extends outwardly from the recess, to a position in which it lies along the recess and is partially or wholly housed within the recess. When the frame is in the closed configuration, that is, when the extendible member(s) are in the collapsed configuration and the elongate members are brought into abutment, the recess may receive at least a part of an extendible member. The extendible member may be retained within the recess of one elongate member, or be partially retained within the recess of each elongate member. This allows the two elongate members to be brought into closer contact with each other, providing a better seal. A flange may extend from each elongate member. The flange may extend outwardly from an edge of the elongate member. The flange may extend longitudinally along the elongate member. The flange may extend outwardly from an upper edge of the elongate member. The flange may extend outwardly from a lower edge of the elongate member. First and second flanges may extend outwardly from upper and lower edges of the elongate member. The recess may be located between the first and second flanges. The flange(s) may form part or all of the inner face of the elongate member(s). When the frame is in the collapsed configuration, the flanges of the opposing elongate members may be brought into abutment, creating a closer seal between the elongate members. The surgical pouch comprises at least one opening. The frame is attached about at least a portion of the periphery of the opening in the surgical pouch. The frame may be attached about the entire periphery of the opening in the surgical pouch. While the frame may extend about the entire periphery of the opening in the surgical pouch, it may only be fixedly attached (or bonded) about a portion of the periphery of the opening, eg only the elongate members may be fixedly attached to the surgical pouch. Where a surgical pouch comprises more than one opening, a frame and associated features as described herein may be attached about the periphery of both or each opening. The frame may be connected to the surgical pouch by any suitable means, including bonding, gluing, welding or sewing, or any combination of these. For example, joins in the pouch and between the pouch and the seam may be achieved by a line of sewing which has been sealed with a silicone sealant. In particular, an end of the surgical pouch may comprise a conduit extending around the periphery of the opening, or comprise two conduits extending along two sides of the opening, the frame being retained at least partially within the conduit. This is advantageous as the frame cannot become dislodged from the surgical pouch. The frame may be retained entirely within the conduit, or only the elongate members may be retained within the conduit. The extendible member(s) may extend between the elongate members, along an outside face of the surgical pouch such that, when the extendible member(s) are moved to the collapsed configuration, the pouch fabric is retained between the extendible member(s) and the elongate members, sealing the pouch closed. The pouch used in conjunction with the sealing assembly of the invention may be any suitable pouch known in the art. In particular, it may be formed from a PTFE membrane laminated between layers of woven or knitted polyester. The pouch preferably has a pore size not larger than 0.5pm, or 0.3 pm, or 0.2 pm, to act as a barrier against contamination from the outside environment. The laminate may be sewn to form the pouch, and is preferably sewn using french seams which have been sealed with a silicone sealant or sealing tape, to provide a further barrier to contamination. The sealing assembly may further comprise retaining means. The retaining means may lock the frame in its closed configuration, in which the interior of the surgical pouch is not accessible. Thus, the retaining means prevents inadvertent opening of the frame and contamination of the sterilised articles held therein. The retaining means may be any suitable means which prevents the extendible member from extending, and may form part of the frame, or may be a separate component. For example, the retaining means may comprise a clip, a hook, a clamp or other locking means, and may be integrally formed with the frame. The retaining means may alternatively comprise a separate component, and may be in the form of a clamp or clip. The retaining means may comprise a clamp. The clamp may fit over at least a part of the frame, applying a force to act against the bias of the extendible member(s), preventing the frame from opening. The clamp may comprise a first portion which is applied to or over a first side of the frame (eg the first elongate member) and a second portion which is applied to or over a second side of the frame (eg the second elongate member). The first and second portions of the clamp may be separate components which are connected together by a clip, hook or other locking means once they have been placed about the frame. Alternatively, the first portion and second portion may be connected together by a hinged or flexible joint. The first portion and second portion may be integrally formed with a living hinge therebetween, or may be connected together by any other suitable hinge, such as a butt hinge, a spring-loaded hinge, concealed hinge or a pivot hinge. In use, the hinge may be placed along a top edge of the frame, and the first and second portions folded down on either side of the frame such that they lie along the first and second elongate members, compressing the frame together. The clamp may further comprise locking means, which retain the clamp in place about the frame. Suitable locking means are known in the art, and may comprise, for example, a hook, a clip, or corresponding indents and / or protrusions on the first and second portions which are brought into locking registration with each other when the clamp is closed. The shape of the first and second portions may correspond to the shape of the frame, such that there is a close fit between each of the first and second portions and the part of the frame against which it is brought into contact. Each of the first and second portions may comprise indents which correspond to the shape of the frame. Thus, the cross-sectional profile of an inner face of the first portion of the retaining means may comprise at least a portion which is the inverse of the cross-sectional profile of an outer side of the frame (eg an outer face of an elongate member), such that the retaining means fits closely about the frame. The clamp or other retaining means as described above provides an additional layer of security to the sealing assembly, preventing the frame from inadvertent opening and ensuring it does not become dislodged. Where the clamp is shaped to fit snugly around the frame, the close fit has the additional advantage of securing the clamp in place over the frame and preventing undue movement, which may risk contamination. The clamp further provides a simple means of carrying the surgical pouch without the need to touch the sterilised fabric. The invention may further comprise a secondary retaining means. The secondary retaining means may further secure the retaining means, preventing the surgical pouch from inadvertent opening. The secondary retaining means may typically be applied over the retaining means, and may prevent the retaining means from opening (either instead of, or in addition to, any locking mechanism present on the retaining means). The secondary retaining means may comprise a slider, which is applied over at least a portion of the retaining, eg along an edge of a clamp, preventing the clamp from opening. The slider may comprise an elongate member having a longitudinal recess along a lower edge. The longitudinal recess may have a width corresponding to a width of the retaining means, eg to a width of a longitudinal edge of the clamp, and may, in use, house at least a portion of the retaining means. Where the retaining means is a clamp as previously described, the slider may be slid along an edge of the clamp such that it houses at least a part of each of the first and second portions, compressing the first and second portions together and thus preventing the clamp from opening. The slider may be slid along the hinged edge of the clamp. The longitudinal recess along a lower edge of the slider may be closed at one end, such that when the secondary retaining means has been slid into the correct position the closed end of the recess is brought into contact with an end of the retaining means, ensuring that the secondary retaining means is correctly located. The sealing assembly may be used in conjunction with a security tag. A security tag may be applied to the sealing assembly once it has been closed, so that opening the sealing assembly will cause damage to the security tag. The security tag may also indicate if the pouch has been sterilised, eg by a colour change. This enables practitioners to see immediately if the sealing assembly has been opened, and hence whether the contents remain sterile, prior to use. The invention will now be described, by way of example only, by reference to the attached drawings: Figure 1 shows a perspective view of an elongate member which forms part of the sealing assembly described herein; Figures 2a and 2b show perspective views of first and second rods which connect together to form an extendible member, which forms part of the sealing assembly of the invention; Figure 3 shows perspective views of first and second portions of a retaining means; Figure 4a shows a perspective view of a slider, which may be used as part of the sealing assembly of the invention; Figure 4b shows a cross-sectional view of the slider of Figure 4a; and Figure 5 shows a sealing assembly according to the invention. Components which may be combined together to form the sealing assembly of the invention are shown in Figures 1-4. An elongate member 10 is shown in Figure 1. The elongate member comprises a longitudinal recess 101 extending along the length of an inner face, and first and second flanges 102, 103 extending outwardly from the top and bottom edges of the elongate member, along the length of the recess. Pairs of opposing protrusions 104, 105 are located on opposing walls at each end of the recess. Each pair of protrusions 104, 105 lies along a single axis, the axis extending in a direction perpendicular to the wall from which the protrusion 104, 105 extends. The frame according to the invention may comprise first and second elongate members arranged to face each other such that the recess lies on the inner edge, that is, that the recess lies on the faces of the elongate members which are orientated towards each other so that, when the frame is closed, the flanges 102, 103 of the first and second elongate members are brought into abutment. The extendible member(s) may be formed from two or more rods. First and second rods 20, 25 are shown in Figures 2a and 2b. The rods 20, 25 comprise an elongate body 201,251. A pair of parallel arms 202 extend from a distal end of the first rod 20, each arm bearing a recess or aperture 203. The apertures 203 lie along a single axis, the axis extending in a direction perpendicular to the surface of the walls in which the apertures 203 lie. When the frame is assembled, the apertures 203 are brought into registration with the protrusions 104 of the elongate member 10, creating a hinged joint in which the parallel arms 202 of the first rod 20 are housed at least partially within the recess 101 of the elongate member 10. A third arm 204 extends from a proximal end of the body 201. The third arm 204 carries a pair of protrusions 205 extending outwardly from two outwardly facing parallel faces of the third arm 204. A pair of parallel arms 252 also extend outwardly from a distal end of the body 251 of the second rod 25. Each arm 252 bears a recess or aperture 253. The apertures 253 lie along a single axis, the axis extending in a direction perpendicular to the surface of the walls in which the apertures 253 lie. When assembled, the apertures 253 are brought into registration with the protrusions 105 of the elongate member 10, creating a hinged joint in which the parallel arms 252 of the first rod 20 are housed at least partially within the recess 101 of the elongate member 10. A second pair of parallel arms 254 also extends outwardly from a proximal end of the body 251 of the second rod 25. Each arm 254 bears a recess or aperture 255, the recesses or apertures 255 lying along a single axis extending in a direction perpendicular to the surface of the walls in which the apertures 255 lie. To assemble the frame, two elongate members 10 bearing first and second rods 20, 25 as described above are connected together, such that the protrusions on the third arm 204 of the first rod 20 on one elongate member are brought into registration with the recesses 255 on the second pair of parallel arms 254 of the second rod 25 on the second elongate member. [This assembly is shown in Figure 5]. Thus, an articulated joint is created between the first and second rods 20, 25. When extended, this draws the two elongate rods apart, creating an aperture through which the interior of a surgical pouch (not shown) may be accessed. When the articulated joint between the first and second rods 20, 25 is folded the two elongate rods are drawn into abutment, closing the surgical pouch. Retaining means in the form of a clamp 30 are shown in Figure 3. The clamp comprises a first side 301 and a second side 302. As shown, the first side 301 comprises a series of hooks 303 along an edge, while the second side 302 comprises a series of bars 307 along an edge, the hooks 303 and bars 307 being brought together, in use, to form a hinged joint. Each end of the first side 301 carries a protrusion 304 which may be brought into registration with a recess 305 at each end of the second side 302, to lock the clamp 30 into a closed position. Both sides 301,302 comprise an indent 306 having a size and shape corresponding to the size and shape of the elongate member. In use, the hinged edge of the clamp 30 is placed along the top edge of the frame, and the two sides closed about the frame to retain it in place. When closed, the indent 305 fits closely about the frame, preventing inadvertent dislodgement of the clamp 30. Secondary retaining means are shown in Figures 4a and 4b. The secondary retaining means comprise a slider 40 having a handle 401 and a recess 402, the recess 402 extending longitudinally along a lower edge of the slider 40. The recess has a flared opening 403 to facilitate attachment of the slider to the retaining means. The slider 40 may be attached to the clamp 30 as hereinbefore described. The slider 40 may be slid along the hinged edge of the clamp 30, such that the hinged edge of the clamp 30 is received within the recess 402 on the slider 40, holding the clamp with a friction fit and locking the clamp 30 in its closed position. Figures 5a and 5b show a sealing assembly according to the invention. The sealing assembly comprises two opposing elongate members 501 which are connected at each end by an extendible member 502. Each elongate member 501 comprises a recess 503 extending along its inner edge, and a flange 504 extending outwardly above and below the recess 503, forming the inner face of each elongate member 501. Each extendible member 502 comprises two rods which are connected to each other by a hinge 505, creating an articulated extendible member which can move between a collapsed configuration and an extended configuration. A spring biases the extendible member 502 towards the extended configuration. Each end of the extendible member 502 is attached via a hinge joint to an end of an elongate member 501, such that a rectangle is formed in which the long edges are formed by the opposing elongate members 501, and the short edges are formed by the extendible members 502. The elongate members 501 are contained within a conduit around the top edge of a surgical pouch 506, while the extendible members 502 are positioned along an exterior face of the surgical pouch 506. The frame has an open configuration and a closed configuration. In the closed configuration, the hinge in the extendible member 502 pivots, folding the extendible member. The folded extendible members 502 are housed within the recesses 503 along the inner faces of the opposing elongate members 501. The outwardly extending flanges 504 of the two elongate members 501 are brought together, sealing the surgical pouch. In the open configuration (towards which the frame is biased), the extendible members 502 are extended, creating a space between the opposing elongate members 501 through which the interior of the pouch can be accessed (as shown in Figures 5a and 5b). The frame is retained in the closed position by a clamp 507. The clamp comprises two sides joined together by a living hinge 508. The two sides of the clamp comprise recesses 509 that, when folded along the living hinge, form an aperture of a size to receive the frame in its closed configuration. The two sides of the clamp 507 comprise corresponding male and female protrusions and indents which, when the clamp is closed about the frame, connect together to lock the clamp in place. A further security measure is applied by a slider 509. The slider 509 is an elongate member having a recess along its lower edge of a width corresponding to the width of the clamp. The slider 509 is slid along the top of the clamp 507, providing further compression to the clamp and ensures the clamp cannot open accidentally. The 5 recess on the slider may be closed at one end to aid in correctly locating the slider on the clamp.

Claims

1. A sealing assembly comprising a frame and a surgical pouch, the frame being attached about at least a portion of the periphery of an opening in the surgical pouch and comprising two elongate opposing members which are connected at at least one end by an extendible member, the extendible member being biased to move from a collapsed configuration to an extended configuration wherein, when the extendible member is in the collapsed configuration the two elongate members are brought into abutment, such that the interior of the surgical pouch is not accessible, and when the extendible member is in the extended configuration the two elongate members are drawn apart, forming an aperture through which the interior of the surgical pouch is accessible.

2. The sealing assembly of Claim 1, which comprises first and second extendible members, a proximal end of a first elongate member being connected to a proximal end of the second elongate member by a first extendible member, and a distal end of the first elongate member being connected to the distal end of the second elongate member by a second extendible member.

3. The sealing assembly of any preceding claim, wherein each elongate member comprises a longitudinal recess along an inner face.

4. The sealing assembly of Claim 3 wherein, when the or each extendible member is in the collapsed configuration, the or each extendible member is at least partially housed within the longitudinal recess.

5. The sealing assembly of any preceding claim, wherein the extendible member(s) comprise a foldable member.

6. The sealing assembly of Claim 5, wherein the or each extendible member comprises first and second rods connected together by a hinged joint.

7. The sealing assembly of any preceding claim, wherein the extendible member is biased towards the extended configuration by a spring.

8. The sealing assembly of any preceding claim, wherein an extendible member is attached to an elongate member by a hinged joint.

9. The sealing assembly of Claim 8, wherein the hinged joint is integrally formed with the extendible member and elongate member.

10. The sealing assembly of any preceding claim, wherein each elongate member comprises at least one flange extending outwardly from an edge of the elongate member.

11. The sealing assembly of Claim 10, wherein the flange forms at least part of the inner face of the elongate member.

12. The sealing assembly of any preceding claim which further comprises retaining means, wherein the retaining means prevents extension of the extendible member(s).

13. The sealing assembly of Claim 12, wherein the retaining mean comprises a clamp, said clamp comprising opposing first and second portions which enclose atleast a portion of the elongate members, preventing opening of the sealing assembly.

14. The sealing assembly of Claim 13, wherein the first and second portions are joined together by a hinged joint.5 15. The sealing assembly of Claim 13 or 14, wherein the cross-sectional profileof an inner face of the first portion of the retaining means comprises at least a portion which is the inverse of the cross-sectional profile of an elongate member, such that the retaining means fits closely about the frame.

16. The sealing assembly of any of Claims 12 to 15, which further comprises a10 secondary retaining means.

17. The sealing assembly of Claim 16 wherein the secondary retaining meanscomprises a recess which, in use, houses at least a portion of the retaining means.

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