A DISPOSABLE CONTAINER FOR SURGICAL INSTRUMENTS

Abstract

A single use disposable container for surgical instruments is provided for transporting sterile instruments to the point of use. The single use container comprises a base section having a base and an upstanding wall extending from the base. A lid section is provided that is configured to close the base section. The container is formed from a biodegradable thermoformed pulp material that is gas and steam permeable. At least the base section includes a surfactant proof barrier on at least the inner surface of the pulp material to protect the pulp material of the container from cleaning fluid applied to the instruments. The lid includes a double walled rim that assists in protecting the instruments stored therein.

Claims

1.-37. (canceled)

38. A single use disposable container for surgical instruments, the container from a being formed from a pulp material and comprising: a base section having a base and an upstanding wall extending from the base, and a lid section configured to close the base section; wherein the base section includes a securing lip defined around the upper edge of the upstanding wall; and the lid includes a roof, an inner wall extending downwardly from the roof to a lower edge of the lid, an outer wall spaced outwardly of the inner wall and connected to the inner wall at the lower edge of the lid, the outer wall extending upwardly from the lower edge of the lid to an upper end of the outer wall, and a securing lip at the upper end of the outer wall configured to secure over the securing lip of the base section, wherein the lid is configured such that when it is in the closed position the lower edge of the lid is located within the enclosure at a position below the securing lip of the base section, with at least part of the outer wall being seated against the inner surface of the upstanding walls of the enclosure.

39. A single use disposable container according to claim 32, wherein at least one of the inner surface of the base section and the inner surface of the lid includes a surfactant proof barrier.

40. A single use disposable container according to claim 39, wherein the surfactant proof barrier may comprise at least one of a fluorocarbon and a coating of surfactant proof resin.

41. A single use disposable container according to claim 38, wherein the container is formed from a thermoformed pulp material.

42. A single use disposable container according to claim 38, wherein the pulp material is gas and steam permeable

43. A single use disposable container according to claim 38, wherein and the lid and the enclosure are integrally moulded and the lid is hingedly connected to an upper edge of the upstanding wall.

44. A single use disposable container according to claim 38, wherein the upstanding wall of the base section tapers outwardly in the upward direction towards its upper edge and the outer wall tapers outwardly away from the inner wall in the upwards direction at substantially the same angle as the upstanding wall of the base such the outer wall is configured to nest against the inner surface of the upstanding wall when the lid is closed.

45. A single use disposable container according to claim 44, wherein the inner wall tapers outwardly away in the downwards direction towards its base.

46. A single use disposable container according to claim 44, wherein the upstanding wall curves downwardly in the outwards direction at its upper edge to define the securing lip.

47. A single use disposable container according to claim 46, wherein a flange extends horizontally outwards from the distal end of the securing lip of the enclosure and a flange extends horizontally outwards from the distal end of the securing lip of the lid that is arranged to seat on top of the flange of the enclosure when the lid is closed.

48. A single use disposable container according to claim 47, wherein at least one locking tab extends from the upstanding wall of the enclosure, and the securing lip of the lid includes a corresponding slot arranged to receive the locking tab when the lid is closed.

49. A single use disposable container according to claim 38, wherein the outer wall of the lid nests against the upstanding wall in the closed configuration in a tight push fit arrangement to hold the lid in the closed configuration.

50. A method of transporting a medical instrument, the method comprising: providing a disposable single use container according to claim 38; following use of said medical instrument, placing the contaminated medical instrument in the base section of the container; closing the base section with the lid to enclose the instrument within the container; and transporting the instrument within the container away from the location of use.

51. A method according to claim 50, further comprising applying a cleaning solution to the instrument while it is contained within the base section, prior to closing the base section.

52. A method according to claim 51, wherein at least the base section includes a surfactant proof barrier on at least the inner surface of the pulp material to protect the base section from the cleaning solution.

53. A method according to claim 50, further comprising the steps of: prior to use of the instrument, sealing the instrument within a sterilising bag; placing the sterilising bag containing the instrument within the single use disposable container; and placing the container containing the instrument into a steriliser and exposing the container to a sterilising gas such that said gas permeates the enclosure and sterilises the instrument contained therein.

54. A method according to claim 53, wherein the container is closed when the instrument is received therein and the container is placed into the steriliser in the closed condition and the sterilised instrument is transported to a point of use within the closed container.

55. A method according to claim 54, further comprising returning the instrument to the container following use and providing the container with an indicia indicating the contents of the enclosure are contaminated, and following the step of sterilising the instrument, applying an indicia to the container to indicate that the contents are sterile and ready for use.

56. A method according to claim 55, further comprising: following sterilisation, placing the container inside a sterile peel pouch; placing an indicia indicative of a contaminated condition within the pouch; and following use removing the contaminated indicia from the pouch and applying the indicia to the container to indicate the contaminated condition of the instrument.

57. A method according to claim 56, further comprising: following sterilisation, placing an indicia indicative of a contaminated condition within the pouch and then wrapping the container with a sterility wrap; following use removing the contaminated indicia from the container and applying the indicia to the container to indicate the contaminated condition of the instrument.

58. A method of sterilising a surgical instrument comprising: placing a surgical instrument within a single use disposable container according to claim 38; and placing the container containing the instrument into a steriliser and exposing the enclosure to a sterilising gas such that said gas permeates the enclosure and sterilises the instrument contained therein.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0045] The present invention will now be described by way of example only with reference to the following illustrative figures in which:

[0046] FIG. 1 shows a plans and side view of a container according to an embodiment of the invention;

[0047] FIG. 2 shows a section view of an enclosure according to an embodiment of the invention;

[0048] FIG. 3 shows a section view off an enclosure according to an embodiment of the invention; and

[0049] FIG. 4 is a section view through line A-A of FIG. 1.

[0050] Referring to FIG. 1, a container 1 for surgical instruments comprises a container body 2 and a lid 4. The container body 2 comprises a base 6 and upstanding walls 8 a-d defining an open enclosure. The body 2 and lid 4 are connected along a common edge 10 corresponding to the edge 8 b of the body 2, by a hinge 12. The body 2 and lid 4 are formed as a single piece from a moulded pulp material and the hinge 12 is a living hinge integrally moulded with the body 2 and lid 4.

[0051] A series of spaced corrugated ridges 14 extend across the width of the base 6 between the side walls 8a and 8b. The ridges re-inforce the base and provide impact absorption for an instrument support on the base 2.

[0052] A pair of tabs 16 project from the upper edge of the outer side wall 8a of the base 2. The lid 4 includes a pair of corresponding slots 18 arranged to receive the tabs 16. The tabs 16 and slots 18 define a catch arrangement for holding the lid 4 in the closed position.

[0053] The lid 4 and body 2 form a clamshell arrangement, with the hinged lid fitting over the upper edge of the body 2 to close the container. As shown in FIG. 2 the walls 8 taper outwardly in the upwards direction. At their upper edge the walls 8a-d curve outwardly and downwardly defining a curved upper lip 20 having a downwardly extending portion 22 at the end of the lip 20 that is spaced outwardly from the adjacent wall 8. A flange 24 extends horizontally outwards from the lower end of the lip 20. The lid 4 includes a roof 24 and an inner wall 26 extending downwardly from the roof 24. At the lower end 28 of the inner wall 26 the lid 4 curves upwardly defining an outer wall 30. The outer wall 30 is spaced outwardly from the inner wall 26 with a channel 32 being defined therebetween. The inner wall 26 extends downwardly to a depth whereby the lower end of the inner wall 26 is below the height of the upper lip 20 of the body 2 when the lid 4 is closed.

[0054] The inner wall 26 tapers outwardly in the downward direction towards the lower edge 28. The outer wall 30 tapers outwardly in the upward direction towards the lip 32 at the same angle as the walls 8. Hence the outer wall 30 is configured to seat parallel against the inner surface of the adjacent wall 8 of the body 2. The outer wall 30 extends upwardly to the height of the upper lip 20 and curves over and conforms to the shape of the inner edge of the lip 20. The lid 4 then curves downwardly defining an outer lip 32 that is spaced outwardly of the outer edge of the lip 20. A flange 34 extends outwardly from the lower edge of the lip 32 and is arranged to seat on the flange 24 of the body 2, the flange 34 of the lid extending outwardly the same distance as the flange 24 of the body, such that the lid 4 and body 2 have the same peripheral shape. A channel 36 is defined between the downwardly extending lip 32 and the outer wall 30 with the lip 32 defining the outer wall of the channel and the outer wall 30 defining the inner wall of the channel 36. The lip 20 of the body is received within the channel 36.

[0055] The upper surface of the lip 20 seats against the inner surface of the channel 36. The outer wall 30 is configured to nest closely against the wall 8 in a tight push fit arrangement. As shown in FIG. 3, the tabs 16 extend outwardly from the outer wall 8a of the body 2 in an upwardly inclined angle to a height above the flanges 24 and 34 to the height of the slot 18 formed in the outer wall defining the lip 32. A horizontal locking portion 38 projects from the end of the tab 18 which inserts into the slot 18 to prevent the lid 4 from lifting upwardly thereby holding the lid 4 closed.

[0056] FIG. 4 shows a cross section A-A of FIG. 1. The container 1 is moulded in the open position shown in FIG. 4 from a pulp fibre material. In this horizontal position it can be seen that the base 28 of the channel 32 defined by the inner wall 26 and outer wall 30 of the lid 4 extends to a greater height than the upper rim 21 of the lip 20, such that when the lid 4 is folded closed the base 28 is located below the upper rim 21. The heights of the inner wall 26 and outer wall 30 may be selected such that the base 28 of the channel 32 extends all the way to the base 6 where maximum security of the contents is required. The double walled arrangement formed by the inner 26 and outer 30 walls of the lid 4 provides lateral impact cushioning for the contents of the container, and well as effecting a secure closures and seal with the walls 8 of the body 2.

[0057] In use an instrument is selected from storage for use in the operating theatre and placed into a permeable sealed bag, such as a paper/plastic peel pouch bag that is able to withstand a sterilisation process such as high temperature steam sterilisation process as used in autoclaving, or sterilisation using a gas such as ETO (ethylene oxide). The sealed bag is then placed into a container 1. The container 1, including the bagged and sealed instrument is placed into a sterilisation unit such an autoclave chamber. The pulp fibre material of the container is gas permeable, meaning it allows the gas and/or steam to penetrate, and does not thermally shield the contents, ensuring that the instrument is properly exposed to the high temperature sterilisation environment. Once the sterilisation process has been completed the sterile instrument is housed within the container 1 and is kept from human contact and/or contact with other instruments during transport to the point of use within the operating theatre. The container thereby helps maintain sterility as well as preventing damage to the instrument.

[0058] Once the sterile instrument(s) has been placed in the container 1, the container 1 may be processed in one of the following ways at this stage:

i. A green tamper proof label indicating the instrument's ready to use condition is placed on the exterior of the container 1. A red label indicating the instrument's soiled instrument condition is placed inside the container 1 for later use.
ii. A green tamper proof label indicating the instrument's ready to use condition is placed on the exterior of the tray. The container 1 is then placed inside of a sterile peel pouch. A red label indicating the instrument's soiled instrument condition is placed inside the pouch for later use.
iii. A red label indicating the instrument's soiled instrument condition is placed inside the container 1 for later use. The container is then wrapped with an approved sterility wrap.
iv. The container 1 is placed inside of a wrapped tray or closed container system. In this case the container 1 is inside of a larger tray holding 70-90 instruments. The Single Cycle container 1 only holds a handful of the most delicate instruments.

[0059] The instrument is removed from the container 1 at the point of use. Following use the contaminated instrument may be returned to the container 1. An indicator is provided to indicate that the contents are used and contaminated. The indicator may be a sleeve, a sticker, a stamp or any other suitable means of indicating the state of the contents. Once the instrument has been placed within the container 1 a cleaning fluid is applied to the instrument to remove bulk contaminants and mitigate the impact of fluid drying on the instruments. The container 1 includes a surfactant proof barrier which prevents the surfactant solution from penetrating the pulp. The surfactant proof barrier may include a fluorocarbon. The fluorocarbon may be applied to the pulp within the slurry and/or may be applied to the pulp post-forming such as by spray application. The surfactant proof barrier may also or alternatively include a coating of surfactant proof resin. The surfactant proof resin is preferably applied to at least the inner surface of the base prior to thermoforming.

[0060] Following application of the cleaning fluid the lid 4 is closed to securely contain the instrument or instruments and a red tamper proof label is applied to the exterior of the tray to indicate that the instruments are contaminated and represent a biohazard. The tray is now in compliance to be transported through the hospital corridors. The instrument is transported for cleaning within the container 1 which prevents damage to the instrument during transit as well as preventing the spread of contaminants and preventing the risk of injury from the instruments. When the instrument is removed for cleaning on arrival at the Sterile Processing Department the container 1 may be disposed of, obviating the requirement for additional cleaning operations to clean and sterilise the container.