IMPROVEMENTS IN OR RELATING TO PACKAGING

Abstract

The invention provides 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. In one embodiment, the invention provides a pack of surgical instruments for use in a pre-determined surgical intervention which pack comprises one or more sterilised surgical instruments suitable for use in the pre-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.

Claims

1. 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.

2. The pack as defined in claim 1 wherein the container is a tray, bag or pouch.

3. The pack as defined in claim 1 which comprises a support for protecting the container.

4. The pack as defined in claim 1 wherein the lid, container and/or the internal tamper-evident seal are transparent.

5. The pack as defined in claim 1 wherein the lid has a clip to secure the lid to the container.

6. The pack as defined in claim 5 wherein the external tamper-evident seal is provided on the clip.

7. The pack as defined in claim 1 wherein the external tamper-evident seal comprises a film seal.

8. The pack as defined in claim 1 which comprises one or more sterilised surgical instruments suitable for use in a pre-determined surgical intervention wherein the container is a tray for receiving the one or more sterilised surgical instruments.

9. The pack as defined in claim 8 wherein the one or more surgical instruments are disposable surgical instruments.

10. The pack as defined in claim 9 wherein, the one or more surgical instruments are formed from a plastic and/or metal material.

11. The pack as defined in claim 8 wherein the tray has one or more tray compartments for receiving the one or more surgical instruments.

12. The pack as defined in claim 11 wherein, the tray compartments are in the form of grooves or slots.

13. The pack as defined in claim 11 wherein, the one or more tray compartments are colour coded.

14. The pack as defined in claim 1 wherein, the tray is formed from a disposable, resilient and sterilisable material.

15. The pack as defined in claim 8 which includes the majority of surgical instruments required for the pre-determined surgical intervention

16. The pack as defined in claim 15 wherein, the pack contains from 50% to 90% of the required surgical instruments.

17. The pack as defined in claim 8 which includes one or more checklists which lists the names of the one or more surgical instruments in the pack.

18. The pack as defined in claim 1 wherein at least one of the seals is transparent.

19. 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; wherein the internal seal is transparent and wherein the lid is formed from a transparent resilient material such that the lid protects the container.

20. 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; wherein the lid is formed from a resilient material such that it protects the container; wherein the pack comprises one or more sterilised surgical instruments suitable for use in a pre-determined surgical intervention; and wherein the container is a tray for receiving the one or more sterilised surgical instruments.

Description

[0037] The invention will now be illustrated with reference to the following Figures of the accompanying drawings which are not intended to limit the scope of the claimed invention:

[0038] FIG. 1 shows a schematic front view of a sealed pack according to a first embodiment of the invention;

[0039] FIG. 2 shows a schematic view of a first embodiment of a container for use in the sealed pack according to the first embodiment of the invention;

[0040] FIG. 3 shows a schematic front view of a sealed pack according to a second embodiment of the invention;

[0041] FIG. 4 shows a schematic plan view of a second embodiment of a container for use in the sealed pack according to the second embodiment of the invention;

[0042] FIG. 5 shows a schematic cross-sectional view of the second embodiment of a container for use in the sealed pack according to the second embodiment of the invention;

[0043] FIG. 6 shows a schematic plan view of a third embodiment of a container for use in the sealed pack according to the second embodiment of the invention.

[0044] A pack according to a first embodiment of the invention is indicated generally at 10 on FIGS. 1 and 2. Pack 10 includes a container 30, a container support crate 80, a container support lid 20, and seals 50,60,70. As shown in FIG. 2, container 30 is in the form of a pouch or bag which has a container aperture 28 such that the contents 40 of container 30 may be accessed. Container 30 has a container collar 35 around container aperture 28 and a tamper-evident transparent container seal 50 to cover and protect container aperture 28 whilst still allowing the contents 40 of container 30 to be inspected. In an alternative embodiment, container 30 may be formed from a transparent material and container seal 50 may be translucent or opaque.

[0045] As shown in FIG. 1, container support 80 is in the form of a crate formed from a cuboid lattice having sides which form openings 86 to allow inspection of the container 30, an open base and a container support top which is closed by container support lid 20. The sides 86 have edges which are defined by horizontal slats 82 and vertical slats 84. Container support top forms a container support aperture (not shown) which is defined by container support aperture slats (not shown) which are shaped such that container 30 may be inserted into container support 80 through the container support aperture. The container support aperture slats support container collar 35 such that container 30 is suspended in container support 80. The container support 80 is shaped such that container 30 is spaced from the sides 86 of support 80 such that support 80 protects container 30 and its contents. In an alternative embodiment, container support 80 may be in the form of a box having solid sides. In an alternative embodiment, the container support 80 may support a plurality of containers 30. In an alternative embodiment, the container support 80 may not have the container support aperture slats such that container support 80 can be used with one or more containers 30, each in the form of a tray or a box.

[0046] As shown in FIG. 1, container support lid 20 is formed from a resilient plastics material and has a corresponding shape to the container support top such that the lid 20 may be used to seal container 30. Lid 20 has a clip 26 for securing the closure 24 of lid 20 and container support 80. Lid 20 is connected to container support 80 by a hinge (not shown) such that the lid 20 may be moved in relation to the container support 80. The container support lid 20 has a lid clip seal to close and secure the lid on support 80. Lid 20 forms a recess shaped to receive the container seal 50 and the container collar 35 such that the closure 24 of lid 20 and container support 80 support container 30.

[0047] Seals 50,60,70 comprise an internal tamper-evident container seal 50, an external tamper-evident lid clip seal 60 and an external tamper-evident film seal 70. Furthermore, lid 20 provides an external tamper-proof seal. Container seal 50 is an internal seal as it is arranged internally in pack 10 between the container 30 and lid 20. Container seal 50 is in the form of a removable film seal and is for use by a consumer or recipient of the container 30 such that the consumer or recipient has proof that the contents of container 30 are secure. Outer film seal 70 is an external tamper-evident seal which is formed from a layer of plastics material which is wrapped around the pack 10 such that the lid 20 cannot be opened without removal of film seal 70 and is shown arranged on an external surface of the pack 10, in particular across closure 24 where lid 20 joins support 80. Lid clip seal 60 is a further external tamper-evident seal on the clip 26 which fastens lid 20 to container 30 and enables lid 20 to act as a further seal for container 30. The integrity of lid 20 and seals 60 and 70 provide reassurance during transit to transportation personnel that the support 80 is secure and that its contents have not been tampered with.

[0048] A pack according to a second embodiment of the invention is indicated generally at 110 on FIGS. 3, 4, and 5. Like features of the second embodiment of the pack 110 to the features of the first embodiment of the pack 10 are identified by like reference numerals. Pack 110 includes a container 130, a correspondingly shaped lid 20, a set of disposable sterilised surgical instruments 40 and seals 50,60,70.

[0049] As shown in FIGS. 4 and 5, container 130 is in the form of a tray and is formed from a resilient plastics material such that it protects and supports surgical instruments 40. Container 130 has an aperture 28 through which the surgical instruments 40 may be accessed. Aperture 28 of container 130 is sealed by internal transparent film seal 50. In an alternative embodiment, container 130 may be formed from a transparent resilient plastics material and internal film seal 50 may be opaque or translucent. In an alternative embodiment, container 130 may be used to protect and support food.

[0050] As shown in FIG. 1, lid 20 has a hinge 22 and a clip 26. Lid 20 is formed from a resilient transparent material such as a transparent plastics material and has a corresponding shape to the container 130 such that the lid 20 may be used to seal the contents of container 130. Lid 20 is connected to container 130 by hinge 22 such that the lid 20 may be moved in relation to the container 130 as shown in FIG. 2. Lid 20 may be secured to container 130 in its closed position by clip 26. In an alternative embodiment, for example where internal film seal 50 is opaque or translucent, lid 20 may be formed from an opaque or translucent material.

[0051] As shown in FIG. 1, seals 50,60,70 comprise an internal tamper-proof film seal 50, an external tamper-proof lid clip seal 60 and an external tamper-proof film seal 70. Outer film seal 70 is a tamper-evident seal which is arranged across closure 24 where lid 20 joins container 130. Lid clip seal 60 is a further tamper-evident seal on the clip 26 which fastens lid 20 to container 130 and enables lid 20 to act as a further seal for container 130. Inner film seal 50 is a tamper-evident seal provided across aperture 28 of container 130 such that a surgical instrument 40 may not be removed from the container 130 without removal of inner film seal 50.

[0052] As shown in FIGS. 4 and 5, the set of surgical instruments 40 includes surgical clamps 42, swab 43, scalpel 44, a first pair of surgical forceps 46 and a second pair of surgical forceps 48. Container 130 forms a plurality of tray compartments 32,34,36,38 which are shown in FIG. 4 or tray compartments 32,33,34,35,36,38 which are shown in FIG. 5. Each tray compartment 32,33,34,35,36,38 receives a respective surgical instrument 42,43,44,46,48 of the set of surgical instruments 40. In an alternative embodiment, each tray compartment 32,33,34,35,36,38 may be shaped to receive its respective surgical instrument 42,43,44,46,48. In an alternative embodiment where the respective surgical instrument 42,43,44,46,48 is formed from a suitable metal, its corresponding tray compartment 32,33,34,35,36,38 may have a magnet to help retain the respective surgical instrument 42,43,44,46,48 in its tray compartment 32,33,34,35,36,38. In an alternative embodiment, the plurality of tray compartments 32,34,36,38 of container 130 may be used to receive different types of food such as a different element of a meal such as food for a first, second or third course of a meal.

[0053] In an alternative embodiment, lid 20 may not have a hinge 22 and lid 20 may be mounted on container 130 such that it may be moved by sliding in relation to container 130 into an open position. In an alternative embodiment, the set of surgical instruments 40 may comprise the disposable sterilised surgical instruments 40 listed in Table 2A, 4, 6, 8, 10, 12A or 12B.

[0054] A container 230 according to a third embodiment of the invention for use with the pack according to the second embodiment of the invention is shown on FIG. 6. Container 230 forms a plurality of zones 82,83,84,85,86,88 of tray compartments 32 where the zones 82,83,84,85,86,88 are colour coded such that there are six colour coded groups of tray compartments 32 wherein each of which colour coded groups contains a group of surgical instruments having a pre-determined functionality as set out in Table 2B. For example for surgical instruments for use in a caesarean section, a first zone 82 may comprise tray compartments 32 and surgical instruments 40 in group 1 which are colour coded pink and may include surgical instruments 40 used to clean and prepare the skin for the intervention; a second zone 84 may comprise the tray compartments 32 and surgical instruments 40 in group 2 which are colour coded blue and may include surgical instruments 40 used to cut the skin (e.g. the abdomen); a third zone 83 may comprise the tray compartments 32 and surgical instruments 40 in group 3 which are colour coded yellow and may include the surgical instruments 40 that are used for handling tissue; a fourth zone 85 may comprise the tray compartments 32 and surgical instruments 40 in group 4 which are colour coded green and may include the surgical instrument that is used to deliver the baby; a fifth zone 86 may comprise tray compartments 32 and surgical instruments 40 in group 5 which are colour coded brown and may include the instruments that are used to close the uterus; and a sixth zone 88 may comprise the tray compartments 32 and surgical instruments 40 in group 6 which are colour coded red and may be used to close the abdomen and the skin.

TABLE-US-00002 TABLE 2A Reduced surgical instrument set 40 for Caesarean section Number of Contents instruments Allis Tissue Forceps Green Armitage Forceps Curved 0 Green Armitage Forceps Straight 2 Criles Artery Forceps Curved 0 Spencer Wells Artery Forceps 7 Straight 2 Kocher Artery Forceps 8 Straight 2 Mayo Needleholder 7 2 Cord Scissors Dressing Scissors 0 Mayo Scissors Straight 1 Mayo Scissors Curved 0 McIndoe Scissors, Curved 0 Rampley Sponge Holding Forceps 3 Bonney Toothed Dissecting Forceps 1 Dissecting Forceps 7 Non-Toothed 1 Waugh Dissecting Forceps Non-Toothed 0 Waugh Dissecting Forceps Toothed 0 Bard Parker Handle No. 4 2 Wrigley Obstetric Forceps (Pair L & R) 1 Doyen Hand Retractor 1 Langenbeck Retractors Medium 1 Morris Retractors 0 Mono Polar Diathermy Cable 1 Towel Clip 1 Diathermy Dissecting Forceps 8 1 Chlorohexidine sprayer+++ 1 Shaver 1 Total 25

TABLE-US-00003 TABLE 2B Colour coded reduced surgical instrument set 40 for Caesarean section Number of instruments included in this tray Pink tray for instruments used to clean the skin Shaver 1 Chlorohexidine sprayer+++ 2 Rampley Sponge Holding Forceps 2 Total 5 Blue tray for instruments used to open the abdomen Knife 1 Toothed 1 Scissors 1 Kochers 2 Total 5 Yellow tray for instruments used to handle the tissues Spencer wells 1 Non Toothed Forcep 1 Doyen 1 Forceps Total 3 Green tray for instruments used to deliver the baby Wrigleys 1 Brown tray for instruments used to close the uterus Needle holders 2 Toothed Forceps 1 Green Armitage 2 Total 5 Red tray for instruments used to close the abdomen Allis Tissue Forceps 2 Langenbeck Retractors Medium 1 Stapler 1 Total 4

[0055] In an alternative embodiment, the set of surgical instruments 40 may comprise the reduced set of disposable sterilised surgical instruments listed in Table 4 for use in vaginal hysterectomy and repair. The full sets of surgical instruments for use in these interventions are listed in Tables 3A and 3B.

TABLE-US-00004 TABLE 3A Full set of surgical instruments for Vaginal Hysterectomy Number of instruments Contents included on the storage array Forceps Rampley Sponge Holding 5 Bachaus Towel Clips 5 B.P. Handle No. 3 1 B.P. Handle No. 4 2 Scissors Dressing 1 Scissors Mayo Straight 5 1 Scissors Mayo Curved 5 1 Scissors McIndoes 7 1 Needleholder Mayo 7 2 Forceps Dissecting Bonney Toothed 1 Forceps Dissecting Non-Toothed 5 1 Forceps Dissecting Gillies Toothed 1 Forceps Artery Cairns Curved 5 Forceps Artery Kocher 6 10 Forceps Artery Spencer Wells straight 9 5 Forceps Artery Kocher straight 8 2 Clamps Hysterectomy Gwilliams Curved 4 Forceps Tissue Allis 4 Forceps Vulsellum Teale 2 Dressing Forceps Bozeman Uterine 1 Bladder Sound 1 Female Catheter 1 Speculum Vaginal Medium 1 Retractor Vaginal Landon 2 Diathermy Lead 1 Diathermy Forceps 9 1

TABLE-US-00005 TABLE 3B Full set of surgical instruments for Vaginal/peritoneal Repair Number of instruments CONTENTS included on the storage array Mayo Scissors Straight 1 Mclndoe Scissors Curved 1 Rampley Sponge Holders 2 Crile Murray Needle Holder 1 Crile Artery Forceps Straight 3 Allis Tissue Forceps 4 Officer Rectal D/F, 4 5 toothed 1 Non-Tooted Dissecting Forceps 1 B.P. Handle No. 4 1 London Vaginal Retractor 1 Sims Speculum Large D/E 1

TABLE-US-00006 TABLE 4 Reduced instrument set for Vaginal hysterectomy and repair Number of instruments Contents included on the storage array Sims speculum 2 Vulsulum 2 Knife 1 Mayos scissors 1 Stitch scissors 1 Needle holders 1 Sponge forceps 1 Kochers 1 Ellis tissue forceps 1 Littlewoods 1 Catheters 1 Total 13

[0056] In a further alternative embodiment, the set of surgical instruments may comprise the reduced set of disposable sterilised surgical instruments listed in Table 6 for use in abdominal surgery. The full set of surgical instruments for use in such an intervention are listed in Tables 5A and 5B.

TABLE-US-00007 TABLE 5A The current abdominal hysterectomy set of instruments Forceps Sponge Holding Rampley 6 Towel Clips Bachaus 6 Scissors Mclndoe curved 1 Scissors Mayo Straight 1 Scissors Mayo Curved 5 1 Scissors Boney Curved 7 1 Mayo Needleholder 7 2 Forceps Artery Cairns curved 5 ForcepsArtery Birkett 5 Forceps Artery Spencer Wells straight 9 5 Forceps Artery Roberts 2 Forceps Artery Kocher 9 4 Clamps Hysterectomy Maingot 2 Clamps Hysterectomy Gwilliam Curved 2 Clamps Hysterectomy Gwilliam Straight 2 Forceps Teale Vulsellum 2 Forceps Tissue Lanes 2 Forceps Tissue Allis 2 Forceps Tissue Babcock 2 Forceps Dissecting Boney Toothed 7 1 Forceps Bickford DC 1 Forceps Dissecting Non-Toothed 6 1 Forceps Atraumatic Debakey 8 1 B.P. Handle No. 3 1 B.P. Handle No. 4 2 Forceps Diathermy 8 1 Forceps Diathermy 6 1 Diathermy Lead 1 Retractor Morris 2 Retractor Langenbeck Medium 2 Retractor Worral Bladder 1 Retractor Deaver (Medium) 1 Retractor Balfour Self-Retaining & 3.sup.rd Blade 1 Myomectomy Screw 1 Poole Sucker with Fenestrated Guard 1

TABLE-US-00008 TABLE 5B The current laparotomy set of instruments Current number of Contents instruments Simms Speculum 1 Vulsellum Tissue Forceps 2 Curved Mayo Scissors 1 Set Hegar dialator 3-18 1 Small Curette 1 Medium Curette 1 Large Curette 1 Polpectomy Forceps 1 Ovum Forceps 1 Rampley Sponge Forceps 2 Uterine sound 1 Bonney's Dissecting Forceps non-toothed 1 Medium Receiver 1 Blue Gallipot 1 137 137 Inner Wrap 1 Transportation outer Wrap 1 Total 18

TABLE-US-00009 TABLE 6 Reduced surgical instrument set 40 for abdominal hysterectomy and laparotomy Number of instruments Contents included on the storage array Knife 1 Lange beck 1 Doyens retractor 1 Seif retaking retractor 1 Retractor 1 Bowel 1 Stitch Scissor 1 Mayos 1 Kochers 2 Maingot 2 Gwellim 2 Ellis 4 Spencer Wells 4 Total 22

[0057] In a further alternative embodiment, the set of surgical instruments may comprise the reduced set of disposable sterilised surgical instruments listed in Table 8 for use in termination of pregnancy. The full set of surgical instruments for use in such an intervention is listed in Table 7.

TABLE-US-00010 TABLE 7 Surgical instrument set 40 for termination of pregnancy Number of instruments Contents included on the storage array Sponge Holders 2 Scissors Stitch 1 Forceps Ovum Mclintock 1 Forceps Polyp Bonney 1 Forceps Vulsellum Teals 2 Curette Evans 4 Curette Single Ended Sharp Small 1 Uterine Sound 1 Hawkins Ambler Dilators Set of 11 1 (3 to 13) Sims Speculum 1 Syringe 1 Total 16

TABLE-US-00011 TABLE 8 Reduced surgical instrument set 40 for termination of pregnancy Number of instruments Contents included on the storage array Sponge Holders 2 Forceps Polyp Bonney 1 Forceps Vulsellum Teals 2 Curette Evans 1 Curette Single Ended Sharp Small 1 Uterine Sound 1 Hawkins Ambler Dilators Set of 8 1 Sims Speculum 1 Total 16

[0058] In a further alternative embodiment, the set of surgical instruments may comprise the reduced set of disposable sterilised surgical instruments listed in Table 10 for use in tracheostomy surgery. The full set of surgical instruments for use in such an intervention are listed in Table 9.

TABLE-US-00012 TABLE 9 The current tracheostomy set of instruments Contents No. Retractor West self-retaining 2 Rampley sponge holding forceps 2 Bachaus towel clips 5 Lahey Forcep 1 Needleholder Stifles 1 Needleholder Gillies 1 Tissue Forceps Allis 2 Artery Forceps Cairns, curved 5 Artery Forceps Halstead mosquito, curved 5 Scissors Iris, sharp, straight 1 Scissors Strabismus, blunt, straight 1 Scissors Strabismus, blunt, curved 1 Scissors McIndoe, curved 1 Tracheal dilator 1 Dissecting forceps McIndoe, non-toothed 1 Dissecting forceps Gillies, toothed 1 Magil sucker no 3 2 Skin hook Gillies 2 Skin hook Kilner 1 Retractor Kilner catspaw 2 Retractor double hook, blunt 2 Retractor single hook, blunt 1 Cricoid hook, sharp 1 Probe Dissector Watson Cheyne 1 Bard parker handle no 3 1 Bard parker handle no 4 1 Retractors Langenbeck, small & medium 2 ea Total 72

TABLE-US-00013 TABLE 10 Reduced surgical instrument set 40 for tracheostomy Number of instruments Contents included on the storage array Surgical knife 1 Tooth forceps 1 Dissecting scissor 1 Surgical retractors 1 Cricoid hook 1 Bipolar diathermy 1 Cuffed and non-cuffed tracheostomy tubes 1 Dressings 1 Total 8

[0059] In a further alternative embodiment, the set of surgical instruments may comprise the reduced set of disposable sterilised surgical instruments listed in Table 12A or 12B for use in tonsil and adenoid surgery. The full set of surgical instruments for use in such an intervention are listed in Table 11.

TABLE-US-00014 TABLE 11 The current Tonsil & adenoids set of instruments Current number of Contents instruments Negus Tonsil Artery Forceps, large curve 1 Negus Tonsil Artery Forceps, small curve 1 Birkett Straight Artery Forceps 1 Birkett Curved Artery Forceps 1 Denis Browne Tonsil Holding Forceps 1 Luc's Tonsil Holding Forceps 1 McIndoes Scissors 1 Wilson Scissors 1 Mollisons Tonsil Dissector/retractor 1 Gwynne Evans Tonsil Dissector 1 Negus Ligature pusher 1 Adenoid Curette & spiked cage 1 Adenoid Curette 4 Waughs Dissecting Forceps Non-toothed 1 Waughs Dissecting Forceps Toothed 1 Boyle Davis Gag 1 Split blade, varying sizes 4 Draffin bipods 2 Yankauer Sucker 1 Towel Clip ball and socket 2 Bi-polar forceps & Lead 1 ea Total 18

TABLE-US-00015 TABLE 12A First reduced surgical instrument set 40 for use in tonsil and adenoid surgery Number of instruments Contents included on the storage array Boyle Davis mouth gag 1 Tongue depressor 1 St Clair Ad curette 1 Denis Brown Ts holding forceps 1 Negus curved forceps 1 Berkett forceps 1 Knot pusher 1 Pillar retractors 1 Scissors 1 Total 9

TABLE-US-00016 TABLE 12B Second reduced surgical instrument set 40 for use in tonsil and adenoid surgery Number of instruments Contents included on the storage array Bipolar dissection for Tonsellectomy 1 Suction diathermy 1 Gag and tongue depressor 1 Tonsellectomy holder 1 Yanker suction 1 Total 5