WO 2018/202753 Al 08 November 2018 (08.11.2018) W!P O PCT
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(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2018/202753 Al 08 November 2018 (08.11.2018) W!P O PCT (51) International Patent Classification: OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, B65D 51/20 (2006.01) A61B 50/33 (2016.01) SC, SD, SE, SG, SK, SL, SM, ST, SV, SY,TH, TJ, TM, TN, B65D 55/06 (2006.01) TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (21) International Application Number: (84) Designated States (unless otherwise indicated, for every PCT/EP20 18/06 1304 kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, (22) International Filing Date: UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, 03 May 2018 (03.05.2018) TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, (25) Filing Language: English EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, (26) Publication Language: English TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, (30) Priority Data: KM, ML, MR, NE, SN, TD, TG). 1707145.7 04 May 2017 (04.05.2017) GB Published: (71) Applicant: HERHEALTH LIMITED [GB/GB]; 63 Wa- — with international search report (Art. 21(3)) vertree Road, London SW2 3SL (GB). (72) Inventor: EL-REFAEY, Hazem; 63 Wavertree Road, London SW2 3SL (GB). (74) Agent: PEEL, James P.; J. P. Peel & Co Ltd., 5 Kew Road, Richmond, Surrey TW9 2PR (GB). (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, (54) Title: IMPROVEMENTS IN OR RELATING TO PACKAGING Figure 3 110 26 20 24 130 60 70 o (57) Abstract: The invention provides a sealed pack (lO)which pack comprises a container (30) and a lid (20) wherein the container has an internal tamper-evident seal (50) and the lid has an external tamper-evident seal (60, 70); wherein the internal seal is arranged between the container and the lid; and wherein the lid is formed from a resilient material such that it protects the container. In one embodiment, the invention provides a pack of surgical instruments for use in a pre-determined surgical intervention which pack comprises one or o more sterilised surgical instruments suitable for use in the p e determined surgical intervention and a tray for receiving the one or more sterilised surgical instruments wherein the pack is sealed by at least two seals. IMPROVEMENTS IN OR RELATING TO PACKAGING [001] The present invention relates to packaging for the secure transport of items. [002] There is a need to transport items securely such that it can be checked at each stage of their journey that there has been no tampering. For example, sterile surgical instruments need t o be transported securely to the point of use such that it is clear that they are still sterile, food needs t o be transported securely to its consumer such that it is clear that the food is still sealed at the point of use and high value items need to be transported securely such that it is clear at the point of receipt by their owner that there has been no tampering. [003] Current packaging does not provide means for checking that the contents of a package are secure at each stage of its journey. [004] A way of ameliorating these problems has been sought. [005] According to the invention there is provided a sealed pack which pack comprises a container and a lid wherein the container has an internal tamper-evident seal and the lid has an external tamper-evident seal; wherein the internal seal is arranged between the container and the lid; and wherein the lid is formed from a resilient material such that it protects the container. [006] Advantages of the invention include that the security of the contents of the pack may be checked in different ways during transportation of the pack. During transit, the security of the pack may be checked by inspecting the lid and its external seal. After removal of the lid and before use or otherwise opening of the container, its internal seal may be checked by a user of the container t o ensure that its contents have not been tampered with. [007] In some embodiments, the container may be a tray, bag or pouch. In some embodiments, the pack may comprise a support for protecting the container, particularly where the container is a bag or a pouch. In some embodiments, the container may have a collar to allow it to be suspended in a support. [008] In some embodiments, the lid, container and/or the internal tamper-evident seal may be transparent such that the contents of the container may be checked before use, for example before a tamper-evident seal is opened. [009] In some embodiments, the lid may have a clip to secure the lid to the container. In some embodiments, the external tamper-evident seal may be provided on the clip. In some embodiments, the external tamper-evident seal may be a film seal. Such a film seal may be formed from a layer of plastics material which is wrapped around the pack such that the lid cannot be opened without its removal. [0010] In some embodiments, the pack may be a pack of sterilised surgical instruments for use in a pre-determined surgical intervention which pack comprises a tray, a lid to protect the tray and one or more surgical instruments suitable for use in the pre-determined surgical intervention wherein the pack is sealed by an external seal and an internal seal. [0011] Surgical theatres carry out a large number of different interventions. Some of these interventions can be scheduled and planned well in advance. However, other interventions need t o be carried out with short notice when even a minor delay can impact severely on the likelihood of a successful outcome. Before an intervention can start, a number of steps need t o be taken such as the assembly of the right personnel in a surgical theatre with the correct equipment and suitable instruments. Typically a further step is the sterilisation of the surgical instruments. [0012] In most hospitals at least in the UK, there is a central sterilisation store (CCST) which provides streamlined sterilisation services for all specialities but they can be overwhelmed. It is not unknown for them t o make mistakes in the preparation of the instruments. The staff working in these stores are not medical and they have no knowledge of surgical procedures. It is therefore also not unknown that some procedures in specialities like orthopaedics have t o be cancelled due t o the absence of a small but crucial instrument in the provided surgical trays. Central sterilisation stores can be overwhelmed with work and over the years several changes occurred in the way these important places provide their services. [0013] The preparation of the instruments prior t o surgery is a well-established routine. The metal trays provided by the CSST are opened in a dedicated area or in a side room attached t o a surgical theatre. Nursing staffs that have specific training in the handling of these surgical instruments undertake the preparation, almost out of sight, prior t o surgery. [0014] The preparation process has two aims. Firstly t o ensure that all required instruments are available and secondly t o document that the number of the instruments that will be counted at the end of the procedure is the same as the number counted at the beginning. This process can be time consuming and introduces potential risks into the procedure. [0015] Advantages of the invention include that one possible cause of delay in emergency interventions is removed because a surgical theatre may be provided with one or more packs according t o the invention. There is no need for the staff t o sterilise or prepare the surgical instruments as the instruments in the pack are already sterilised. The only action which needs t o be taken is t o check that at least one of the seals on the pack is intact. [0016] In some embodiments, the tray may form one or more tray compartments for receiving the one or more surgical instruments. Advantages of having one or more tray compartments include that the instruments may be arranged in the tray compartments in a way that will fit with the logic of the operation. [0017] Herein it should be understood that a tamper-proof seal is a seal which cannot be opened without an element of the seal being destroyed such that it is clear that there is evidence of tampering. In some embodiments, at least one of the seals may be a lid clip seal such that a seal is provided where the lid fastens on t o the container or tray.