Single use medical ice product

Abstract

A hermetically sealed single use medical ice product 1 comprises a hermetically sealed enclosure 7 surrounding an internal volume 4 that houses a portion of sterile potable water 5. The internal volum

Description

Field of the Invention The present invention relates to a single use potable quality sterile ice product suitable for use in medical applications, such as treatments, consumption and the temporary storage of transplant organs. Background of the Invention The use of ice in medical applications and for consumption in healthcare settings is commonplace in both hospital environments and other healthcare facilities, such as at treatment centres and clinics. The cooling nature of frozen water is often utilized to alleviate pain felt by patients who have undergone surgery or suffered injuries such as heat or friction induced injuries (e.g., burns and scalds) or to reduce swelling. Ice can be applied both externally and internally to provide pain relief to patients. Ice is also utilised to assess swallow reflex of a patient undergoing assessment and as a form of oral hydration for those in care. Ice is also routinely employed to preserve the viability of transplanted organs during the period between their extraction from a donor and their implantation in a recipient. Ice is also used to preserve the viability of tissue, which has become detached from their owner due to an accident, so that the tissue might be surgically reattached to owner. In order to optimise the preservation of the tissue or organ when it is away from its host such are typically placed in direct contact with ice. In most of the above applications the ice comes into direct contact with the patients’ tissue / organs. As a consequence patients can be particularly vulnerable to infection. Ice making machines are highly regarded as environments prone to bacterial proliferation due to their nature, the process of producing ice with mains fed water, the frequent interaction with a user’s ice, the lack of protection from external contamination. As such, unless the water used to produce the ice is both sterile and potable (i.e., consumable) it can contain opportunistic pathogens. However, as water does not exist as ice at room temperature, the sterile and potable water must be processed to form the ice before the ice can be used in accordance with the above described medical applications. It is the process of freezing ice that can introduce the risk of infection to a vulnerable patient. In the past, hospitals and other healthcare facilities have utilised ice machines to produce ice in the required quantities for various medical applications, such as those noted above. However, studies have found ice produced on site in medical facilities, such as hospitals, using ice machines can be a source of infection in these environments. As a result of the studies done, some medical guidance (e.g., English NHS Health technical Memorandum (HTM) 04-01 part B) advises against the installation and use of ice machines in healthcare environments. This has led to some healthcare facilities banning the use of ice altogether. As a result, the general guidance is that ice machines should not be used in augmented care units and instead ice produced in the hospital should be made using water obtained through microbiological point of use filters or boiled water that is poured into sterile ice trays or ice cube bags and then frozen. In the event that ice machines are used in a hospital environment they must be regularly maintained and operated in accordance with manufacturers recommendations. However, despite the above guidance which is not generally practiced due to time, space and resource constraints in UK hospitals, even when the water used to form the ice is originally sterile, the risk of the ice becoming contaminated prior to its use in a medical application remains. Summary of the Invention In view the important medical uses for ice in hospitals and other healthcare facilities, there is a need to provide single use medical ice products capable of delivering the stated medical benefits without the infection risks that currently affect ice produced on site in these healthcare facilities. To this end, the present invention provides a hermetically sealed single use medical ice product in accordance with claim 1. In particular, the present invention provides a hermetically sealed single use medical ice product, said product comprising an enclosure with a hermetic seal that surrounds an internal volume that houses a portion of sterile potable water, said internal volume being configured to accommodate the expansion of the water upon freezing whilst maintaining the hermetic seal; wherein said enclosure further comprising a removable section, separable from the rest of the enclosure by way of a region of weakness, that is configured to expose an opening in the internal volume of the enclosure through which the sterile potable water can be extracted as a single piece of ice. It will be appreciated that hermetically sealing water within the enclosure ensures that the water’s original sterile and potable state is maintained until the removable section of the enclosure is removed to expose the opening through which the water can be extracted as a single block of ice at the point of need without being contaminated in the process. The ability to extract the frozen sterile potable water from the enclosure as a single piece of ice is considered particularly beneficial as it allows the shape of the ice to tailored to suit a particular medical application. For example, the ice may be provided as a block with a large flat surface that can be placed on an external burn or scald. Alternatively, the ice it could be shaped to facilitate its insertion into a patient’s body (e.g., mouth). The plastic material will be sufficiently robust to allow for the ice to be crushed by blunt force impact or via a press to provide flaked or fragmented ice if required. The ability of the enclosure to accommodate the expansion of the sterile potable water as it freezes ensures that the contents of the enclosure remain hermetically sealed throughout the ice production process. This greatly reduces the possibility of the ice being contaminated by external environmental conditions. Preferably the enclosure may be formed from a flexible plastic material that is capable of expanding to accommodate the expansion of the sterile potable water during freezing. Further preferably the enclosure may be formed by a sheet of flexible plastic material that is folded back on itself and bonded with a bonding pattern located at a periphery of the enclosure, said bonding pattern defining a portion of the hermetic seal that surrounds the inner volume of the enclosure. Alternatively, the enclosure may be formed from two sheets of flexible plastic material bonded together with a bonding pattern that extends around a periphery of the enclosure, said bonding pattern defining the entirety of the hermetic seal that surrounds the inner volume of the enclosure. Suitable types of bonding include adhesive and / or heat induced bonding. It is envisaged that using flexible plastic materials, such as low density polyethylene (LDPE) or similar, to form the enclosure enables the inner volume to accommodate the expansion of the sterile potable water as it freezes to form the ice. Also, whilst not essential, it is envisaged that LDPE’s ability to retain flexibility at the lower temperatures required to freeze water, provides further benefits because it allows the ice to broken up whilst keeping the ice hermetically sealed within the enclosure. This facilitates the production of sterile potable crushed ice that is suitable for use in the temporary storage of transplant organs, for example. The region of weakness defines a portion of the enclosure that is configured to fail before the rest of the enclosure in order to control the shape and location of the opening revealed when the removable section is detached from the rest of the enclosure. Preferably the region of weakness may comprise at least one indent or cut-out that extends from a periphery of the enclosure into, but not beyond, the hermetic seal. The indent / cut-out serves to provide a starting point for tearing the removable section from the rest of the enclosure along the region of weakness. It will be appreciated that as the indent extend into but not completely through the bonding pattern that forms hermetic seal the inner volume of the enclosure is retained. This ensures that the hermetic seal formed around the inner volume of the enclosure is sufficient whilst also facilitating the action of tearing the removeable section away from the rest of the enclosure to reveal the opening. Preferably the region of weakness may comprise a path of weakness that extends across an entire length of one dimension of the enclosure. It is envisaged that the region of weakness preferably runs in a straight line from a first edge of the enclosure to a second edge of the enclosure. Therefore, it is more preferable the path of weakness extends in a plane that runs parallel to a perimeter edge of the enclosure. In such preferred arrangements removing the removable section serves to completely remove a portion of the hermetic seal from along one edge of the enclosure. Preferably the path of weakness may be formed by way of a heat treatment applied to the flexible plastic material that forms the enclosure. Alternatively, the path of weakness may be mechanically etched onto the flexible plastic material that forms the enclosure. It is envisaged that the distinction between the region of weakness / path of weakness and the rest of the enclosure serves to control the shape and location of the opening formed when the removable section is torn away from the rest of the enclosure. Preferably the portion of sterile potable water may have a smaller volume than the internal volume of the enclosure; and further preferably the internal volume is at least 10% bigger than the volume of sterile potable water. It is envisaged that as the internal volume of the enclosure is not entirely filled with water provision is made for the water to expand during freezing without bursting the enclosure. Partially filing the enclosure with water can help in accommodating its expansion during freezing regardless of whether enclosure is formed from expandable materials, such as flexible plastic materials. As noted above, accommodating the expansion of the water during freezing ensures that the resultant ice product remains hermetically sealed and sterile until the enclosure is actively opened by tearing along the path of weakness to detach the removable section and reveal the opening. Alternatively, the portion of sterile potable water may completely fill the internal volume of the enclosure. In such embodiments, it is appreciated that the enclosure needs to be formed from materials that are capable of expanding with the water as it turns to ice (e.g., flexible plastic materials like LDPE). Preferably the internal volume of the enclosure may be between 5 and 5,000ml. Ultimately the required internal volume of the enclosure will be determined by the medical application for which the ice product is intended. For example, in embodiments of the present invention that are intended for internal use enclosures with an internal volume of 5 to 50ml might be appropriate. Whereas in those embodiments that are intended for external use on a burn or scald, enclosures with larger internal volumes are considered to be more appropriate. With that said, regardless of the size of the internal volume of the enclosure, the core concept of providing a hermetically sealed single use medical ice product is retained. Preferably the enclosure may be provided with a unique identifying mark that is specific to the medical ice product. In this way each medical ice product can be tracked through the various stages of its life. Information that could be monitored includes: batch identification, use by date, proposed usage, the date on which the product was made and its source; the date on which the product was frozen and what equipment (e.g., freezer) was used to freeze it. Preferably the shape of the internal volume may be selected from a group consisting of: cube, cuboid, ovoid, cylinder, and cone. In this way, the most appropriate shape for a particular medical application can be employed. In a further aspect of the present invention there is provided an array of distinct hermetically sealed single use medical ice products in accordance with claim 13. In particular the present invention provides an array of distinct hermetically sealed single use medical ice products, said array comprising at least one sheet of flexible material bonded with a bonding pattern that defines a plurality of distinct enclosures, each with a hermetic seal that surrounds an internal volume that houses a portion of sterile potable water; wherein each enclosure further comprising a removable section that is separable from the rest of the enclosure along a region of weakness that is configured to expose an opening in the internal volume of that enclosure through which the sterile potable water can be extracted as a single piece of ice. It is envisaged that arranging the medical ice product of the present invention in an array provides is a more convenient way of storing the product both before, during and after it has been frozen. Preferably the regions of weakness of the enclosures in the array may be configured to allow the hermetic seal of medical ice product to be broken without breaking the hermetic seals of the other medical ice products in the array. In this way not all of the ice in the array needs to be used at the same time and the remaining products in the array can be returned to the freezer for use at a later date whilst ensuring the unused products remain sterile and free from infection. Preferably the array may further comprise at least one additional region of weakness that is configured to allow one or more medical ice products to be removed from the array without breaking the hermetic seal of the remaining medical ice products in the array. In this way, individual medical ice products can be removed from the array at any time without compromising the hermetic seals of the other products in the array. This increases the flexibility of use of the medical ice products in the array. Preferably the region of weakness of each enclosure may overlap with the bonding pattern. Further preferably the region of weakness of each enclosure may comprise at least one indent that extends from a periphery of the enclosure into, but not beyond, the hermetic seal of that enclosure. As noted above, adopting at least one indent (or cut-out) serves to provide a starting point for tearing the removable section from the rest of the enclosure along the region of weakness. Preferably each enclosure in the array may be provided with a unique identifying mark that is specific to that medical ice product. Once again, the use of unique identifying markers on each product can assist with tracking the lifecycle of the medical ice products in the array. The present invention also provides a method of manufacturing an array of hermetically sealed single use medical ice products in accordance with claim 19. In this regard, there is provided a method of manufacturing an array of hermetically sealed single use medical ice products, said method comprising: providing one or more sheets of flexible plastic material and bonding them together with a first peripheral bonding pattern to form a bag with a water-tight seal that extends around the majority of the bag perimeter to define a partially enclosed volume with an opening; filing up to 90% of the partially enclosed volume of the bag with sterile potable water via the opening before bonding the flexible plastic material with a second peripheral bonding pattern to close the opening and seal the sterile potable water within the bag; bonding the first and second sheets of flexible plastic material together with an array bonding pattern to define an array of enclosures, each having a hermetic seal surrounding an internal volume housing a portion of the sterile potable water; and providing each enclosure with a removable section that is separable from the rest of that enclosure by forming a region of weakness in said flexible plastic material, said removable section being configured to expose an opening in the internal volume through which the sterile potable water can be extracted as a single piece of ice. Preferably further the method may further comprise providing at least one additional region of weakness in the flexible plastic material that is configured to allow one or more medical ice products to be removed from the array without breaking the hermetic seal of the other medical ice products in the array. Preferably the step of forming the region of weakness may involve providing the flexible plastic material with at least one indent that extends from a periphery of each enclosure into, but not beyond, the hermetic seal of that enclosure. Preferably the method may further comprise a step of providing a unique identifying mark on the enclosure of each medical ice product in the array. Preferably a heat treatment may be employed to apply the peripheral and / or array bonding pattern(s). Preferably said regions of weakness may be formed by way of a heat treatment and / or mechanical etching. Preferably said regions of weakness may be formed in overlap with the peripheral and / or array bonding pattern(s). Brief Description of the Drawings The present invention will now be described in more detail with reference to the drawings, wherein: Figure 1 shows a first embodiment of the medical ice product of the present invention; Figure 2 shows an end view of the first embodiment of the medical ice product shown in Figure 1; Figure 3 shows a second embodiment of the medical ice product of the present invention; Figure 4 shows an end view of the first embodiment of the medical ice product shown in Figure 3; Figure 5 shows a third embodiment of the medical ice product of the present invention with a call out of the region of weakness; Figure 6 shows a first example of an array of medical ice products according to the present invention; Figure 7 shows a portion of an example of the additional region of weakness provided between the products in the array; Figure 8 shows a second example of an array of medical ice products according to the present invention; and Figure 9 shows a third example of an array of medical ice products according to the present invention. Detailed Description of the Preferred Embodiments The present invention relates to a medical ice product that delivers ice suitable for medical applications with increased safety due to its ability to greatly reduce the risk of patient infections by retaining the water, which is both sterile and potable, within a hermetically sealed enclosure. Upon consideration of the following preferred embodiments, the skilled person will appreciate that the benefits of the present invention can be delivered by enclosures of a range of shapes and sizes, provided that they retain their hermetic seal even after the water they hold turns to ice and expands, and therefore retain the sterile qualities of the ice. It is also considered essential that the enclosures are provided with a region of weakness that enables the enclosure to be opened (by detachment of a removable section) such that the frozen contents of the enclosure can be extracted as a single piece of ice. With the above requirements in mind the preferred embodiments of the various aspects of the present invention will now be described. Figures 1 and 2 show a first preferred embodiment of the medical ice product 1 of the present invention. The product 1 comprises an enclosure formed from two sheets of flexible plastic material 2a and 2b, which are bonded together with a bonding pattern 3 that extends around the periphery of the sheets 2a and 2b to form an inner volume 4 that is surrounded by a hermetic seal. Preferably the flexible plastic material used to make the product 1 is low density polyethylene (LDPE) as this has the necessary characteristics to enable the inner volume to accommodate the expansion of the sterile potable water as it freezes to form the ice. However, the skilled person will appreciate that other flexible plastic materials could also be employed without departing from the general concept of the present invention. The sheets of flexible plastic material are preferably bonded together using heat treatment to form the bonding pattern 3 around the periphery of the product 1. To this end, the sheets may be provided with suitable coatings to help in the bonding process. Alternatively, the sheets of flexible plastic material may be bonded together by a bonding pattern that employs an adhesive. It is envisaged that the skilled person will readily appreciate what bonding approaches can be suitably employed to deliver a bonding pattern that has sufficient strength and sealing qualities to achieve the required hermetic seal around the inner volume 4 of the enclosure. It will be appreciated that hermetically sealing inner volume 4 ensures that sterile potable water 5 held therein is kept free from infection. In order to enable the enclosure’s inner volume 4 to accommodate the expansion of the water as it freezes without bursting the hermetic seal, the inner volume is only partially filled with the water 5. Preferably no more that 90% of the inner volume is filled with water. The rest can be left as just sterile air 6, which can be compressed as the water 5 freezes and expands. Alternatively, the air may be evacuated from the inner volume during the manufacturing process in order to ensure that there is space in the inner volume 4 to accommodate the expansion of the water 5 as it freezes. In a further embodiment, the entire inner volume of the enclosure is filled with water. In such arrangements, it is appreciated that the flexible plastic material used to form the enclosure needs to have sufficient elasticity to accommodate the expansion of the water without the hermetic seal surrounding the inner volume bursting. The periphery of the product 1 is provided with at least one indent or cut-out 9, which serves to provide a region of weakness at which a removable section 8 can be detached from the rest of the enclosure 7. It will be appreciated that the indent / cut-out 9 provides the starting point from which the removable section can be torn away from the rest of the enclosure 8 so as to reveal an opening in the inner volume 4 through which the water 5 can be extracted in the form of a single piece of ice. To this end, it is envisaged that the opening formed by the detachment of the removable section 8 must extend across the entire width of the inner volume 4 of the rest of the enclosure 7. In the case of the embodiment shown in Figures 1 and 2, it will be appreciated that the inner volume 4 is taller that it is wide, whereas in Figures 3 and 4 the inner volume 15 of the shown embodiment is wider than it is tall. However, in both embodiments the opening revealed when the removeable section if detached from the rest of the enclosure is of a sufficient size to enable the water housed in the inner volume to be extracted in the form a single body of ice. The ability to extract the ice from the enclosure as a single block is considered particularly beneficial as it allows different medical ice products to have the shape and size of their inner volumes configured to suit the medical application for which the ice is to be used. For example, the ice extracted from the medical ice products 1,10 shown in Figures 1 to 4, which has a relatively large flat surface, would be considered particularly suitable for external use in treating bums and scalds. In contrast, the smaller inner volume 24 of the medical ice product 20 shown in Figure 5, would produce ice that is better suited for internal use, such as in treating patients with oral pain. Returning now to the indent / cut-outs 9, 19 and 29 shown in Figures 1,3 and 5, it will be appreciated that providing them in the periphery of the enclosure provides it with a region of weakness that acts as a starting point to tear a portion of the hermetic seal (as defined by the bonding pattern 3, 13, 23) away and, in so doing, create an opening in the inner volume 4, 14, 24 of the rest of the enclosure 7, 17 that facilitates the extraction of the frozen ice contents. In order to ensure that the water remains hermetically seal until the product is tom open, it is important that the indent / cut-out does not extend all of the way through the hermetic seal defined by the bonding pattern. As will be appreciated from the various embodiments shown in the figures, the indents / cut-outs are located in line with the inner volume such that they start a tear that intersects the inner volume of the enclosure. This positioned of the indent / cut-out makes it easier for a user to detach the removeable section 8 from the rest of the enclosure. Although Figures 1 to 5 show the medical ice product of the present invention a single enclosure, it is envisaged that additional benefit may be achieved by providing the medical ice product of the present invention as part of a larger array of products. Figure 6 shows an array 30 that comprises a plurality of medical ice products 31a-31f attached together. Providing multiple medical ice products in the form of an array provides for convenient handling and freezing of the products when large numbers of the medical ice product are used at a particular location. By way of example, the medical ice product 31a once again comprises two sheets of flexible plastic material (e.g., LDPE) 32 that are bonded together with a bonding pattern 33 that defines a plurality of hermetically sealed inner volumes (e.g., 34a). As shown in Figure 1, each inner volume 34a contains a portion of sterile potable water 35a. As the inner volume 34a is not entirely filled with the water 35a in the shown example, a quantity of sterile air 36a may also be present. However, it is envisaged that the air may be at least partially evacuated, or the inner volume entirely filled with water. In those embodiments where the inner volume is entirely filled with water, the enclosure needs to be formed from flexible plastic materials with sufficient flexibility to accommodate the expansion of the water as it freezes without the hermetic seal bursting. Each medical ice product 31a in the array is once again breakable into two parts, namely the removable section 38a and the rest of the enclosure 37a, along a region of weakness which comprises an indent 39a. In addition to the regions of weakness formed on each medical ice product by the indent 39a, the array is also provided with additional regions of weakness 40 that facilitate the detachment of each product 31a-31f from the array 30. Figure 7 shows an expanded view of one such additional region of weakness 40, which takes the form of a path of weakness defined by a line of perforations 41 located between neighbouring products, in this case product 31c and product 31 d. Although the path of weakness may preferably be formed by a line of perforations that extend from one periphery of the enclosure to the other, alternatively the path of weakness may be formed by a line of thinned flexible plastic material. It is envisaged that the skilled person will appreciate that other approaches may be employed to facilitate the separation of the medical ice products from the array without departing from the general concept of the present invention. In this regard, it considered essential that the additional regions of weakness that essentially serve to define the perimeter of each medical ice product are configured to ensure that each product can be removed without damaging the hermetic seal of any of the other products in the array. For the sake of completeness, Figures 8 and 9 show arrays 41 comprising the medical ice products similar to those shown in Figures 3 and 5 respectively, but with their inner volumes entirely filled with water. In the case of the array 41 shown in Figure 8, each medical ice product 42a-42h is detachable from the other products in the array via the additional regions of weakness 43, which are preferably formed from lines of perforations that run along and across the flexible plastic sheets that are bonded together to form the array 41. In the case of the array 50 shown in Figure 9, each of the medical ice products in the array is provided with a unique marker in the form of a barcode 51. It is envisaged that a variety of unique markers may be employed to help clearly distinguish each medical ice product from the others in the array and possibly even a whole batch of arrays. In addition to the handling benefits of having an array of medical ice products, 5 it is envisaged that arranging the medical ice product of the present invention in an array facilitates more efficient methods of manufacture for the product of the present invention. It is envisaged that by providing each medical ice product with a unique marker it is possible to track the product from its date of manufacture, through its freezing and 10 on to its final use in a medical application. The unique markers can be cross-referenced with a monitoring system, which may or may not be digital, to ensure that the date of freezing of a particular medical ice product is logged. This in term can enable health facilities to ensure that ice is used within a particular period of time. This again helps to ensure that the sterile and potable nature of the water is not degraded 15 overtime.

Claims

1. A hermetically sealed single use medical ice product, said product comprising an enclosure with a hermetic seal that surrounds an internal volume that houses a portion of sterile potable water, said internal volume being configured to accommodate the expansion of the water upon freezing whilst maintaining the hermetic seal;wherein said enclosure further comprising a removable section, separable from the rest of the enclosure by way of a region of weakness, that is configured to expose an opening in the internal volume of the enclosure through which the sterile potable water can be extracted as a single piece of ice.

2. The medical ice product of claim 1, wherein the enclosure is formed from a flexible plastic material that is capable of expanding to accommodate the expansion of the sterile potable water during freezing.

3. The medical ice product of claim 2, wherein the enclosure is formed by a sheet of flexible plastic material that is folded back on itself and bonded with a bonding pattern located at a periphery of the enclosure, said bonding pattern defining a portion of the hermetic seal that surrounds the inner volume of the enclosure.

4. The medical ice product of claim 2, wherein the enclosure is formed from two sheets of flexible plastic material bonded together with a bonding pattern that extends around a periphery of the enclosure, said bonding pattern defining the entirety of the hermetic seal that surrounds the inner volume of the enclosure.

5. The medical ice product of any one of claims 2 to 4, wherein the region of weakness comprises at least one indent that extends from a periphery of the enclosure into, but not beyond, the hermetic seal.

6. The medical ice product of any one of claims 2 to 5, wherein the region of weakness comprises a path of weakness that extends across an entire length of one dimension of the enclosure.

7. The medical ice product of claim 6, wherein the path of weakness is formed by way of a heat treatment applied to the flexible plastic material that forms the enclosure.

8. The medical ice product of claim 6, wherein the path of weakness is mechanically etched onto the flexible plastic material that forms the enclosure.

9. The medical ice product of any one of the preceding claims, wherein the portion of sterile potable water has a smaller volume than the internal volume of the enclosure; and preferably the internal volume is at least 10% greater than the volume of sterile potable water.

10. The medical ice product of any one of claims 1 to 8, wherein the portion of sterile potable water completely fills the internal volume of the enclosure.

11. The medical ice product of any one of the preceding claims, wherein the internal volume of the enclosure is between 5 and 5,000ml.

12. The medical ice product of any one of the preceding claims, wherein the enclosure is provided with a unique identifying mark that is specific to the medical ice product.

13. An array of distinct hermetically sealed single use medical ice products, said array comprising at least one sheet of flexible material bonded with a bonding patternthat defines a plurality of distinct enclosures, each with a hermetic seal that surrounds an internal volume that houses a portion of sterile potable water;wherein each enclosure further comprising a removable section that is separable from the rest of the enclosure along a region of weakness that is configured to expose an opening in the internal volume of that enclosure through which the sterile potable water can be extracted as a single piece of ice.

14. The array of claim 13, wherein the regions of weakness of the enclosures in the array are configured to allow the hermetic seal of medical ice product to be broken without breaking the hermetic seals of the other medical ice products in the array.

15. The array of claim 13 or 14, further comprising at least one additional region of weakness that is configured to allow one or more medical ice products to be removed from the array without breaking the hermetic seal of the remaining medical ice products in the array.

16. The array of claim 13, 14 or 15, wherein the region of weakness of each enclosure overlaps with the bonding pattern.

17. The array of claim 16, wherein the region of weakness of each enclosure comprises at least one indent that extends from a periphery of the enclosure into, but not beyond, the hermetic seal of that enclosure.

18. The array of any one of claims 13 to 17, wherein each enclosure in the array is provided with a unique identifying mark that is specific to that medical ice product.

19. A method of manufacturing an array of hermetically sealed single use medical ice products, said method comprising:providing one or more sheets of flexible plastic material and bonding them together with a first peripheral bonding pattern to form a bag with a water-tight seal that extends around the majority of the bag perimeter to define a partially enclosed volume with an opening;filing up to 90% of the partially enclosed volume of the bag with sterile potable water via the opening before bonding the flexible plastic material with a second peripheral bonding pattern to close the opening and seal the sterile potable water within the bag;bonding the first and second sheets of flexible plastic material together with an array bonding pattern to define an array of enclosures, each having a hermetic seal surrounding an internal volume housing a portion of the sterile potable water; andproviding each enclosure with a removable section that is separable from the rest of that enclosure by forming a region of weakness in said flexible plastic material, said removable section being configured to expose an opening in the internal volume through which the sterile potable water can be extracted as a single piece of ice.

20. The method of claim 19, further comprising the provision of at least one additional region of weakness in the flexible plastic material that is configured to allow one or more medical ice products to be removed from the array without breaking the hermetic seal of the other medical ice products in the array.

21. The method of claim 19 or 20, wherein the step of forming the region of weakness involves providing the flexible plastic material with at least one indent that extends from a periphery of each enclosure into, but not beyond, the hermetic seal of that enclosure.

22. The method of claim 19, 20 or 21, further comprising a step of providing a unique identifying mark on the enclosure of each medical ice product in the array.

23. The method of any one of claims 19 to 22, wherein a heat treatment is employedto apply the peripheral and / or array bonding pattern(s).5 24. The method of any one of claims 19 to 23, wherein said regions of weakness are formed by way of a heat treatment and / or mechanical etching.

25. The method of any one of claims 19 to 23, wherein said regions of weakness are formed in overlap with the peripheral and / or array bonding pattem(s).20Application No: GB2408488.1Claims searched: 1-25Examiner: Tara MeachamDate of search: 10 March 2025Patents Act 1977: Search Report under Section 17Documents considered to be relevant:Category Relevant to claims Identity of document and passage or figure of particular relevance X 1-25 CN 209827202 U (FIRST AFFILIATED HOSPITAL KUNMING MEDICAL UNIV) paragraph [0023]; Fig.l, 2. X 1-25 MI 20011463 Al (TRABUCCO) see detailed description; FIG. 1-6. X 1-25 WO 2021 / 062504 Al (GESUALDO) paragraph [0018], [0020], [0033] - [0035]; FIGURE 1-3. X 1-25 US 7682639 Bl (HINES) column 2, line 9 to column 3, line 5; Fig. 1-6. X 1-25 Survive It, 4th December 2020, SOS Water Sachet 125ml, survive-it.co.nz, [online], available from: https: / / survive-it. co. nz / product / sos-water-sachet-125ml / [accessed 04 / 02 / 2025]; see product details and images. X 1-25 Water Parent, 27th April 2023, Made in USA - Anti Burst Emergency Water Rations Packets, Amazon.co.uk, [online], available from: https: / / www.amazon.co.uk / Made-USA-Emergency-Rations- Survival / dp / B08Z6275S7 / [accessed 06 / 03 / 2025]; see product details and images.Categories:v Au Document indicating lack of novelty or inventive step A Document indicating technological background and or state of the art. Y Document indicating lack of inventive step if combined with one or more other documents of same category. p Document published on or after the declared priority date but before the filing date of this invention. & Member of the same patent family E Patent document published on or after, but with priority date earlier than, the filing date of this application.Field of Search:Search of GB, EP, WO &US patent documents classified in the following areas of the UKCX :Worldwide search of patent documents classified in the following areas of the IPC____________A61F_______________________________________________________The following online and other databases have been used in the preparation of this search report21INTERNET, SEARCH-PATENTInternational Classification:Subclass Subgroup Valid From A61F 0007 / 10 01 / 01 / 2006

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