A CONTAINER, METHOD AND SYSTEM FOR STERILISING A MEDICAL DEVICE

Abstract

The present invention relates to a container, a method and a system for sterilising a medical device. The invention is particularly, although not exclusively, for use with orthopaedic medical devices, such as surgical instruments used in orthopaedic surgical procedures.

Claims

1. A container for a medical device, the container comprising a first wall and a second wall defining an interior of the container, at least one of the first wall and the second wall being flexible, the medical device being housed within the interior of the container, the container having had suction applied to the interior of the container and sealed such that at least one of the first wall or second wall is configured to encase the medical device and wherein the interior of the container has an amount of a liquid sterilizing agent contained therein.

2. A container for a medical device according to claim 1, wherein the container further includes an opening connecting the interior of the container to an exterior of the container through which the medical device can be inserted.

3. A container for a medical device according to claim 2, wherein the container further includes a zip fastener at the opening.

4. A container for a medical device according to claim 2, wherein the opening is configured for applying the suction to the interior of the container.

5. A container for a medical device according to claim 2, wherein the container further includes at least one port connecting the interior of the container to an exterior of the container.

6. A container for a medical device according to claim 5, wherein the at least one port includes a removable tube.

7. A container for a medical device according to claim 5, wherein the at least one port is an aperture formed in the container.

8. A container for a medical device according to claim 5, wherein the first wall and the second wall are sealed together with the at least one port provided in a junction between the sealed first wall and second wall.

9. A container for a medical device according to claim 1, wherein at least one of the first and second walls comprises a transparent or translucent material.

10. A container for a medical device according to claim 1, wherein the first wall and/or the second wall comprise a flexible material having multiple layers.

11. A container for a medical device according to claim 1, wherein the container includes a carry handle.

12. A container for a medical device according to claim 1, wherein the liquid sterilizing agent comprises an agent with microbicidal, and/or fungicidal, and/or virucidal and/or sporicidal properties.

13. A container for a medical device according to claim 1, wherein the medical device is a surgical instrument.

14. A container for a medical device according to claim 13, wherein the container comprises a plurality of surgical instruments.

15. A container for a medical device according to claim 14, wherein the container further includes a template according to which the plurality of surgical instruments are arranged within the container such that the surgical instruments are constrained within the container when sealed and remain in a fixed arrangement relative to each other.

16. A container for a medical device according to claim 15, wherein the template is removably inserted into the interior of the container.

17. A container for a medical device according to claim 1, wherein the medical device is a prosthetic implant.

18. A method of sterilizing a medical device, the method including the steps of: providing a container for the medical device, the container having a first wall and a second wall defining an interior of the container, at least one of the first wall and second wall being flexible, the container further including an opening connecting the interior of the container to the exterior of the container; placing the medical device into the interior of the container; introducing a liquid sterilizing agent into the interior of the container; extracting air from the container; and sealing the container.

19. A method of sterilizing a medical device according to claim 18, wherein the medical device is placed into the interior of the container through the opening.

20. A method of sterilizing a medical device according to claim 18, wherein the liquid sterilizing agent is introduced into the container via the opening.

21.-33. (canceled)

Description

[0082] The invention will now be described by way of example only with reference to the accompanying figures of which:

[0083] FIG. 1 is a schematic representation of the container of the present invention;

[0084] FIG. 2 is a schematic perspective representation of the container having a zip fastener;

[0085] FIG. 3 is a schematic perspective representation of the container during placement of surgical instruments;

[0086] FIG. 4 is a schematic illustration showing the container being filled with a liquid sterilising agent;

[0087] FIG. 5 is a schematic illustration of the container with air and an amount of the liquid sterilising agent being evacuated; and

[0088] FIG. 6 is a schematic illustration of the container being stored prior to collection for use in a surgical procedure.

[0089] A container 1 for use in sterilising surgical instruments 100 comprises a transparent plastic bag 2. In this embodiment, the bag 2 is rectangular in shape, although other shapes could be used.

[0090] The bag 2 comprises a first wall 3 and a second wall 4 sealed around three edges 9, 10, 11 with a fourth side 5 being unsealed before use and defining an opening 6. The first wall 3 and second wall 4 define an interior 19 of the bag 2.

[0091] A port 7, in the form of a flexible plastic tube, is provided along one of the sealed edges.

[0092] The port 7 provides an inlet/outlet as will be described in further detail below. As alternative, the port 7 can be in the form of a simple aperture formed by a lack of a seal without a flexible plastic tube.

[0093] In this embodiment, one or both the first wall 3 and the second wall 4 are made of a flexible, transparent, or translucent, material so that the contents of the bag 2 are visible to a user. The material might be a polymer such as a PVC, a polyethylene, a cellulose material such as a cellophane, a polyester such as polyethylene terephthalate, a nylon or a combination, for example in a blend or layered/laminated structure. The material used forms a gas barrier and a liquid barrier.

[0094] The material could be coloured or clear. It could be partially transparent i.e. in a pattern or with opaque areas for labelling. The material can be single layer, or multiple layers i.e., two or more layers. An example of the material that would be suitable would be that used to make bags sold under the FoodSaver brand by Sunbeam Products Inc. Such bags are five layer polyethylene with an outer layer of nylon. These can be subject to heating through, for example, immersion in boiling water or in a microwave.

[0095] In an alternative, one of the first wall 3 and the second wall 4 could be made of a more rigid material, while the other of the first wall 3 and second wall 4 could be of a flexible material.

[0096] A carry handle 8 is formed along one 10 of the sealed edges. In the embodiment described herein, the carry handle 8 is formed by forming an elongate aperture 12 in a portion of flexible material formed integrally with the bag 2 at the one edge 10 so that the carry handle 8 is integral with the bag 2. As an alternative, the carry handle could be provided separately of any suitable configuration which would enable the bag 2 to be held in the hand, or suspended on a trolley or inside a carry case.

[0097] In an alternative embodiment, the opening 6 can include a zip fastening mechanism 13.

[0098] The bag 2 is used to store and sterilise surgical instruments as described below.

[0099] Prior to containment of the surgical instruments 100, the bag 2 is unsealed at the opening 6.

[0100] Soiled instruments 100 are returned for sterilisation from the operating room in caddies. In accordance with usual procedures, the surgical instruments 100 are hand-rinsed and inspected for damage and dismantled. The surgical instruments 100 are then decontaminated and disinfected in appropriate reprocessing equipment, such as a washer-disinfector, in which they are washed, rinsed and dried in accordance with usual (regulated) protocols and procedures.

[0101] After the surgical instruments 100 are washed, rinsed and dried, an operator assembles any surgical instruments 100 as required, inspects each surgical instrument 100 and provides a checklist of the surgical instruments 100 to be stored in the bag 2. Their function is usually checked and they are lubricated as required.

[0102] Once the surgical instruments 100 are assembled and checked, the operator places the surgical instruments 100 into the bag 2 via the opening 6.

[0103] The surgical instruments 100 are laid out in an appropriate arrangement so that each of the surgical instruments 100 are clearly visible through the bag 2.

[0104] To facilitate the correct placement of the instruments, the bag 2 is laid on top of a two-dimensional, or three-dimensional, layout template 14. Alternatively, the template 14 can be placed inside the bag 2.

[0105] A three-dimensional template has recesses or formations, which are thermoformed or vac-formed, and into which the instruments can be placed.

[0106] The template 14 indicates the surgical instruments 100 to be contained within the bag 2 and their relative layout. The layout is indicated graphically, thus clearly assisting the operator to include the correct instruments. This is illustrated schematically in FIG. 3. Alternatively, the layout can be indicated by means of alphanumeric symbols, such as words or codes.

[0107] The bag 2 can also contain labels, RFID tracking tags, barcodes, accessories, QRcode, optical markers for virtual reality/augmented reality systems.

[0108] Once all of the surgical instruments 100 are placed in the bag 2, the opening 6 is sealed so that all the surgical instruments 100 are contained within the bag 2. This sealing is carried out using heat sealing, although other sealing mechanisms could be used, for example using a zip fastening mechanism 13.

[0109] A liquid sterilising agent 15 is then fed into the bag 2 under gravity through the port 7. This is done by connecting a container 16 of sterilising agent by means of a flexible tube 17 to the port 7. A sufficient amount of sterilising agent 15 is fed into the bag 2 to ensure that all of the surgical instruments 100 within the bag 2 are covered with sterilising agent 15. To assist, the bag can be placed on an inclined surface 21 to assist in ensuring that the sterilising agent 15 runs throughout the interior 19 of the bag 2 so as to cover all of the surgical instruments 100. This part of the process is illustrated in FIG. 4.

[0110] Alternatively, the bag 2 can be manually manipulated by shaking or other movement of the bag 2 so that the surgical instruments are in contact with the sterilisation agent 15 and such that contact between the sterilising agent 15 and the surfaces of the surgical instruments 100 is maximised.

[0111] Once the required amount of sterilising agent 15 has been fed into the bag 2, the, or another, flexible tube 17 is connected between a vacuum pump 18 and the port 7. The vacuum pump 18 is operated to remove air and the majority of the sterilising agent 15 from the interior 19 of the bag 2. In removing the air, a vacuum is formed within the interior 19 and the flexible walls 3, 4 of the bag 2 collapse to restrain the surgical instruments 100 in place. An amount of liquid sterilising agent 15 will remain in the interior 19 of the bag 2.

[0112] The term vacuum in this context is used to mean that after the air is extracted from the interior 19 of the bag 2, the interior 19 is at a lower pressure atmospheric pressure and, preferably, significantly lower.

[0113] The use of vacuum pumps to remove air from collapsible bags is known in the art and need not be described in any further detail herein except as is relevant to the present invention.

[0114] In this way, each of the surgical instruments 100 in the bag 2 remains in contact with a small amount of sterilising agent 15 remaining in the bag 2 and which serves to maintain the sterilisation process, while the provision of a vacuum in the interior 19 of the bag 2 fixes the position and the layout of the surgical instruments 100 within the bag 2.

[0115] The flexible tube that forms the port 7 is then removed and the bag 2 is sealed on all four sides to maintain the vacuum within the bag 2 and to keep the sterilising agent 15 surrounding the surgical instruments 100. Preferably, the flexible tube 7 contains a one-way valve, a faucet/tap or finger-operated valve to ensure that the vacuum is maintained within the bag 2. Where the port 7 is formed as an aperture in the seal of the first wall 3 and second wall 4, the aperture is sealed during or immediately after the vacuum had been applied.

[0116] Alternatively, the bag 2 can be provided without a port 7 and the opening 6 can be used for inserting the surgical instruments 100 and also for placing the sterilising agent 15 in the bag 2 and for extracting the air.

[0117] If required, the bag 2 can be placed inside a second bag (not shown) with a vacuum suction applied to remove the air from between the first bag 2 and the second bag to provide additional robustness and a further layer of protection. This enables aseptic transfer in which one non-sterile nurse cuts open the bag 2 and holds it open and then a second sterile nurse reaches in to retrieve the inner bag which is still sterile. Both bags contain the sterilising agent 15.

[0118] The assembled bag 2 can then be stored on a hanging rack or rail 22 or in a cabinet for selection when required.

[0119] An operator, such as a heath professional or technician, is able to simply look at the bags 2 hanging on the rail 22 and select the correct bag 2 containing the surgical instruments 100 required for the particular procedure.

[0120] The bag 2 is then carried using the carry handle to the operating theatre for use in the procedure.

[0121] In use, the bag 2 is opened using sterile scissors and the surgical instruments 100 can be removed and used.

[0122] The bag 2 can be reused to store the instruments 100 after use, keeping them together for reprocessing. If the bag 2 contains a template 14, the template 14 can be used as a shadow board to indicate where the instruments are to be placed. Alternatively, the bag can be disposed of.

[0123] The sterilising agent can also include a lubricant if required. In addition, the sterilising agent could include an anti-oxidation agent to prevent corrosion of the instruments 100.

[0124] The sterilising agent 15 may comprise an agent with anti-microbial properties. The anti-microbial agent may contain one or more of glutaraldehyde, iodine, povidone-iodine, an alcohol (for example ethanol), trichlorophenol, sodium hypochlorite, and 5-chloro-2-(2,4-dichlorophenoxy)phenol (triclosan). The anti-microbial agent may be provided in an aqueous solution. This list is not limiting and other suitable agents could be used.

[0125] Additionally, the surgical instruments 100 can be given a final rinse after the bag 2 is opened so as to remove residual chemical sterilising agents. This can be done by running sterile water through the bag 2 through the port 7 or the opening 6.

[0126] If an anti-microbial sterilising agent is used, a neutralizing agent can be placed in the bag 2 with the sterilising agent. The neutralizing agent can be any suitable chemical agent which can react with the sterilising agent after a predetermined time delay to neutralize the anti-microbial sterilising agent. For example, this could be an agent that is oxidised in response to contact with the anti-microbial agent to leave a neutral residue. Low concentration hydrogen peroxide can reduce to water and, as such, would be considered self-neutralizing.

[0127] In an alternative, the liquid sterilising agent can be replaced at the stage where the air is being extracted from the bag 2 as long as a proportion of the liquid sterilising agent remains in the bag. For example, air or a sterile lubricant could be inserted into the bag. Alternatively, a disinfecting agent could be used as the replacement fluid. An example could be a mixture of phenol and halogenated phenol compounds manufactured under the trade mark TCP.