A reprocessable compression garment

Abstract

A reprocessed compression garment (120) comprising at least one inflatable chamber (12) is provided. The compression garment further comprises a cleaned connecting fluid tube (15), a cleaned fluid connector (30) in fluid connection with the at least one inflatable chamber (12) via the cleaned connecting fluid tube (15), and an identification component (31) part of the cleaned fluid connector (30). Wherein the length of the cleaned fluid connector (30) is less than 45 mm, the identification component (31) is detectable by a sensor of an external pump (110) when connected to the reprocessed compression garment (120), and wherein an operating pressure of the pump is automatically set by using the identification component (31) located in the cleaned fluid connector (30) of the reprocessed compression garment (120) when connected to the pump (110). (To be published with fig. 1)

Description

[0001] A REPROCESSABLE COMPRESSION GARMENT

[0002] TECHNICAL FIELD

[0003] The present invention relates to a reprocessed compression garment, a connector used by the reprocessed compression garment, a method of reprocessing a compression garment and a compression system.

[0004] BACKGROUND

[0005] It is known that reprocessing of subsequent re-use of various types of medical devices, i.e. compression garment, is both accepted and widespread in certain parts of the world and can provide a number of economic and environmental benefits in reducing healthcare costs and improving environmental impacts such as a reduction in medical product waste.

[0006] Many medical devices that are originally designed and marketed as single-patient use are independently reprocessed by 3rdparty organizations, i.e. other than the original manufacturer, and these devices are then used multiple times and by multiple number of patients.

[0007] The extent and degree of re-use achievable is typically limited by the design, materials and manufacturing processes of the original device and the reprocessing methods and processes used. As a result, there is often a limit to the extended operational life that can be achieved for a particular medical device without introducing increased risks of failure during clinical use or a reduced yield during reprocessing. The requirement for extended operation and multiple uses with multiple cleaning cycles can introduce many factors that are not within the scope of the original design or intended operation. The specific technical problem / technical issue to be solved involves increasing the useful operation life of the compression garment by achieving an increase in the amount of available hours of usage and a tolerance to an increased number of reprocessing cycles.

[0008] In the light of the above, there is a need for an improved medical device, which addresses and mitigates the risk for malfunction when reprocessed.

[0009] SUMMARY OF THE INVENTION

[0010] The present disclosure relates to a reprocessable compression garment, a connector for a reprocessable compression garment, a method of reprocessing a compression garment and a compression system. With the above description in mind, then, an aspect of some embodiments of the present invention is to provide a reprocessable compression system, which seeks to mitigate, alleviate or eliminate one or more of the above-identified deficiencies in the art and disadvantages singly or in any combination.

[0011] An aspect of the present invention relates to a reprocessed compression garment comprising at least one inflatable chamber, a cleaned connecting fluid tube and a cleaned fluid connector in fluid connection with the at least one cleaned inflatable chamber via the cleaned connecting fluid tube and an identification component part of the cleaned fluid connector and wherein the length of the cleaned fluid connector is less than 45 mm, wherein the identification component is detectable by a sensor of an external pump when connected to the reprocessed compression device, wherein an operating pressure of the pump is automatically set by using the identification component located in the cleaned connector of the reprocessed device when connected to the pump.

[0012] An aspect of the present invention relates to a connector for a reprocessable compression device, configured for fluid connection with an inflatable chamber of the compression reprocessable device via a connecting fluid tube comprising an identification component, wherein the length of the connector is less than 45 mm and a diameter less than 17 mm.

[0013] An aspect of the present invention relates to a method of reprocessing a compression device comprising at least one inflatable chamber, a connecting fluid tube and a fluid connector in fluid connection with the at least one inflatable chamber, an identification component applied to the fluid connector, comprising the steps of cleaning the compression device, updating the identification component, testing the compression device and repackaging the compression device.

[0014] An aspect of the present invention relates to a compression system comprising a compression pump and a reprocessed garment adapted to be connected to the compression pump, wherein the reprocessed garment comprising a connector with a plurality of circular ribs reaching outwardly, wherein the compression pump is providing air into the reprocessed garment when detecting a presence of an identification component comprised in the reprocessed garment.

[0015] The features of the above-mentioned embodiments can be combined in any combinations.

[0016] BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Further objects, features and advantages of the present invention will appear from the following detailed description of the invention, wherein embodiments of the invention will be described in more detail with reference to the accompanying drawings, in which:

[0018] FIG. 1 shows a compression system according to an embodiment of the present invention; FIG. 2 shows a reprocessable compression garment according to an embodiment of the present invention;

[0019] FIG. 3 shows a connector according to an embodiment of the present invention,

[0020] FIG. 4a-b shows a compression garment according to an embodiment of the present invention,

[0021] FIG. 5 shows a flowchart according to an embodiment of the present invention, and

[0022] FIG. 6 shows a flowchart according to an embodiment of the present invention.

[0023] DETAILED DESCRIPTION

[0024] Embodiments of the present invention will be described more fully hereinafter with reference to the accompanying drawings, in which embodiments of the invention are shown. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. Like reference signs refer to like elements throughout.

[0025] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" "comprising," "includes" and / or "including" when used herein, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof. In order to allow for any useful further increase beyond the extended operating life of medical devices, such as compression garments, it is necessary to design and manufacture the original medical device specifically for compatibility with multiple reprocessing cycles and multiple periods of patient use. The present disclosure details such improvements associated with a range of different products known generally as compression garments.

[0026] Further, in order to allow for any useful further increase beyond this extended operating life it is therefore necessary to design and manufacture the original medical device specifically for compatibility with multiple reprocessing cycles and multiple periods of patient use.

[0027] The term ‘compression garment’ can be considered as applying equally to various types of patient-wearable items such as VTE prophylaxis garments / sleeves, IPC compression garments, garments for lymphedema treatment and garments used for other circulatory conditions, garments for the prevention and treatment of leg ulcers as well as other applications such as patient diagnostic purposes and can be considered as within the scope of the invention.

[0028] Some customers do not wish to have reprocessable products, preferring brand new manufactured products, yet others do wish to have reprocessable compatible products. Hence, traditionally this has resulted in the need for two separate types of products using different materials and processes. However, there is an advantage to be gained in achieving efficient manufacturing through the use of common processes and also common sub-assemblies using common materials. This means that a consistent manufacturing process can be used to create both single-use and reprocessable versions of the same product. One example of this is involves the inflatable chambers found in compression garments, these are subjected to significantly differing numbers of inflation cycles and stresses dependent on whether they are used as a single-use or a reprocessable version. Referring to fig 1 , a compression system 100 is shown and a compression garment is shown at 120.

[0029] In an embodiment, the compression garment 120 includes a connector 30 with an identification device 31 , shown in fig 3, the identification device 31 being capable of being configured with different identifying characteristics, a common inflatable chamber assembly 12 can be used in different compression garments 120 including both single-use and reprocessable products. In operation, when the compression garment 120 is connected to a pump 110 the identification device 31 is interrogated, its characteristics being automatically detected and measured and a specific inflation rate and pressure level is therefore provided by the pump 110.

[0030] In an example embodiment, the chamber inflation can be operated either at a lower overall pressure level or with a modified rate of inflation in order to compensate for the increase in fatigue effects on the material or the material welds used to form the inflatable chamber 12. The operation of the inflatable chamber 12 is dependent on the intended product characteristics in terms of the degree of intended re-use and hence device lifetime. This aspect of the invention uses the identification device 31 as a means of setting the expected life characteristics of this essential component of the compression garment 120.

[0031] Operating life enhancements can also be achieved through various improvements in the design, materials, fabrication and operation of a reprocessable compression garment 120 and these can be introduced specifically for a compression garment intended for reprocessing compared to a compression garment intended only for a single patient use. However, this approach typically involves a cost in terms of the changed manufacturing process. The present invention seeks to achieve this using the configurable identification device 31 .

[0032] In an embodiment, the aforementioned adjustment of the delivered inflation rate can also be considered in terms of compensating for the effect on the overall material characteristics. For example, changes in the materials in the inflatable chamber 12 can occur due to many factors such age, cleaning and usage and hence have an effect on the compression delivered to the patient’s anatomy. For example, the expansion rate of materials such as PVC and Pll can change over time and extended use, therefore it can be beneficial if a modified operation, analysis and applied settings are used by a compression system 100 to achieve consistent operation over an extended lifetime of the reprocessable compression garment 120.

[0033] Other aspects of the reprocessable compression garment 120 involve consideration of the fatigue and wear characteristics associated with user adjustable or removable fasteners, such as hook and look materials for example Velcro™. The adjustment of the inflation rate can also be considered in terms of the aging effect of cyclical loading on such fasteners.

[0034] An increase in the useable lifetime of the reprocessed compression garment 120 also allows for improvements in the environmental impact of reprocessed compression garments 120 through the reduction in the need for manufacturing of new compression garments, associated material usage and energy reductions as well as minimizing the material entering the waste stream. It also allows for a beneficial reduction in the overall product cost to the customer as the reprocessable compression garment 120 constructional costs can be spread across multiple uses.

[0035] In order to facilitate this improvement, an increase in the robustness of the construction of reprocessed compression garment is required through a number of design changes, improvements and enhancements. Hence, an improved reprocessable compression garment is presented that physically differs from the compression garments made for single-patient use but which themselves may be reprocessed. As a result, the degree of reprocessing possible can be further increased providing economic and environmental benefits as well as reducing patient risks associated with cross-contamination. These changes involves various differences to a compression garment design and construction including (but not limited to) change of fastener types, fastener sizes, means of mounting of fastener, garment material changes, connector changes, identification component changes as well changes in the way the garment is operated in clinical use by the corresponding pump.

[0036] In one embodiment a reprocessed compression garment 120 is provided. The garment 120 comprising at least one inflatable chamber 12, a cleaned connecting fluid tube 15, a cleaned fluid connector 30 in fluid connection with the at least one cleaned inflatable chamber 12 via the cleaned connecting fluid tube 15, and an identification component 31 part of the cleaned fluid connector 30. The length of the cleaned fluid connector 30 is less than 45 mm. The identification component 31 is detectable by a sensor of an external pump 110 when connected to the reprocessed compression device 120. An operating pressure of the pump is automatically set by using the identification component 31 located in the cleaned connector 30 of the reprocessed device 120 when connected to the pump 110.

[0037] In order to achieve more capability for extended usage and increased reprocessing cycles, a new type of hook and loop fastener construction 23, shown in fig. 4a-b, with increased durability is provided for a reprocessable compression garment 120 compared to the type used for a single-use garment. Fatigue to the plastic material of the hook and the associated reduced performance of the hook retention feature of the compression garment fastening can occur as a result of multiple applications of the compression garment to a limb resulting in a reduction in the applied force during garment compression but also as a result of the application of higher temperatures during reprocessing. One aspect of the improved fastening involves the orientation of the fastener alignment being in the direction D, shown in fig. 4a, of maximum strain that occurs when the garment is an activated, inflated and hence expanded state with air pressure in the inflatable chamber. This aspect can be further described in terms of the individual hooks being aligned such that the maximum hook retention function is associated with the circumferential direction when the garment is fitted on the patient’s limb. An alternative embodiment involves the use of a ‘mushroom’ shaped hook that has a reduced directionality of engagement and hence unidirectional retention compared to a traditional ‘tooth’ shaped hook which has a more pronounced directionality of engagement and hence retention.

[0038] The individual fastener hooks are aligned in multiples within a group or patch, each patch typically arranged with a high density of hooks (e.g. 250,000 hooks per m2). The larger density of hooks available allow for increased retention of the fastener. In the operation of the compression garment 120, each fastener hook patch 23 is engaged with an area of the corresponding loop material of the garment and is subjected to two different kinds of separation forces, defined as peel and shear forces. A peel force is applied by the user during compression garment fastener removal such as when removing the compression garment from the limb or for positional or tightness adjustment. This peel force is applied largely tangential to the fastener path but is applied largely on a small area of the patch. A shear force is repetitively applied to the fastener patch each cycle as the garment chambers 12 are inflated and the compressive force delivered to the patient’s limb. This force is typically applied every 40-60 seconds and it is essential for consistent clinical performance that the compression garment fastener strength is maintained to avoid losing compressive force into the limb or the garment becoming disconnected from the patient limb.

[0039] The arrangement of hooks within each non-sewn fastener group or patch being arranged such that there are more hooks physically located in the circumferential direction around the limb than there are along the longitudinal length of the group.

[0040] The dimensions of the non-sewn fastener patch are such that it is broadly rectangular and the orientation on the compression garment is such that the longest dimension of each individual fastener patch is circumferential to the limb. One characteristic of each fastener patch is that the broadly rectangular patch has dimensions of approximately 50mm longitudinally x 38mm circumferentially as aligned and located on the compression garment, representing an approximate aspect ratio of 1 :2:1. Multiple fastener patches 23, typically three, are located on the compression garment 120 and are spaced longitudinally along the limb with a space relative to each other.

[0041] In one embodiment, each patch of fastener hooks 23 is located on individual tabs 121 on an extension of material that are extent to main area of the compression garment, i.e. separate to the inflatable area. This is advantageous as it allows for easier fitting of the fastener tabs around the various areas of the limb, providing for easier fastener adjustment to adapt to different leg sizes or to be adjusted in position when the garment is fitted, for example to avoid interference with specific clinically relevant areas, such as individual wound areas.

[0042] There are further advantages to the use of hook patches located on extent tabs for a reprocessable compression garment when considering the area of hook material that is engaged for any given garment and limb combination.

[0043] For any given compression garment size, the use of the patches 23 located on the tabs 121 allows for a wider range of landing positions that the hook can be placed on to the loop material than is the case if the patches are located in the main garment area. This is beneficial during the later aspects of a compression garments multi-use lifecycle for example where loop material can be less effective after multiple reprocessing cycles and prior use.

[0044] This ‘extent tab’ 121 location for the fasteners 23 also provides for flexibility in the design of compression garment 120 by moving the landing / contact points of fasteners away from the areas of the inflatable chambers allowing for more optimal design of the compression garment.

[0045] Compared to the conventional approach of the reprocessing of single patient use garments, a compression garment 120 specifically designed for reprocessing can utilize an improved hook and loop fastener arrangement 23, even if this has an increased manufacturing cost. This can therefore be beneficial over the larger number of fastener mating cycles associated with a higher number of clinical uses as well as being easier to manufacture, more effective in terms of the fastener retention, higher yielding and more tolerant to the process of cleaning when being reprocessed an increased number of reprocessing cycles.

[0046] An improved fastening means 23 is therefore beneficial to extend the operating life. Its introduction does not provide any specific benefit to the initial use of a single patient use or reprocessable compression garment and so it purely addresses the technical challenges that are associated with extended and prolonged use with multiple patients and reprocessing cycles.

[0047] An improved process for mounting this hook material to the compression garment (loop) material is provided. The process can use an adhesive or other form of joining process for the hook element of the hook and loop fastener 23 instead of a traditional sewing process.

[0048] The thread used in high speed sewing can suffer a reduction in tensile strength and increased elongation after multiple washing cycles associated with garment reprocessing. Hence, by removing the thread from the construction this allows for an increase in durability. Thread when used in a seam construction can also provide increased opportunities for bacteria, small debris such as dust and lint and liquids such as blood to collect and hence can result in a higher bioburden both for a newly manufactured compression garment and a reprocessed compression garment.

[0049] Thus, a compression garment 120, which utilizes either less or no thread, can result in an easier to clean device and a more durable solution.

[0050] The use of an adhesive solution to join the hook material to the garment compared to a welded hook fastener also this avoids damage to the hook area associated with the heat of welding.

[0051] The reprocessable compression garment 120 includes additional elements, which are combined with the hook and loop 23 changes. A connector 30, shown in fig. 3, adapted to be fitted to the reprocessable compression garment 120, which allows a pump 110 to be connected and to provide a fluidic path to the compression garment 120.

[0052] In one embodiment, a connector 30 for a reprocessable compression garment 120 is provided and configured for fluid connection with an inflatable chamber 12 of the compression reprocessable garment 120 via a connecting fluid tube 15. The connector 30 comprises an identification component (31 ), wherein the length L of the connector 30 is less than 45 mm and has a diameter less than 17 mm.

[0053] In one aspect, the length L of the connector 30 is between 43 and 44 mm.

[0054] The connector 30 fitted to the reprocessed compression garment 120 also contains an identification component 31 , shown in fig. 3, the identification component 31 is made of ferrite or brass.

[0055] The identification component 31 fitted to a connector 30 of a compression garment 120 intended for being reprocessed can differ in at least one of size, type, material and position compared to a compression garment intended for single patient use.

[0056] The compression pump 110 responds to the identification component 31 and allows air to flow into at least one inflatable chamber 12 within the reprocessable compression garment 120.

[0057] The compression pump 110 can operate differently for a detected compression garment 120 intended for being reprocessed compared to a detected compression garment intended for single patient uses.

[0058] As examples of the difference in operation, this can be in the areas of inflation, fault detection or display to the user. As examples of this modified operation, the inflation parameters could be modified to accommodate for changes or differences in the initial construction or to accommodate change as a result of reprocessing, such as expansion rate differences in the inflatable changes. The pump 110 can use a modified set of fault and alarm sensing techniques and thresholds for a reprocessed compression garment 120 compared to a single patient use garment. This is beneficial as there could be garment failure modes associated with reprocessing that do not apply to a compression garment intended for single patient use. This allows for product improvements in order to enhance patient safety. A modified pump operation is therefore advantageous for reprocessable compression garments. This modified operation can either be internal and hence transparent to the user or alternately can be displayed on the user interface.

[0059] The pump 110 provides a visible display 111 of the fact that it is a reprocessed compression garment 120.

[0060] Operational aspects of the reprocessed compression garment 110 include that the reprocessed compression garment 120 automatically sets the operating pressure of the pump 110 using the identification component 31 located in the connector 30 of the reprocessed compression garment.

[0061] The reprocessed compression garment 120 operates at an inflation pressure of <65mmHg for application to patient’s leg.

[0062] The reprocessed compression garment can be processed at least 5 cycles.

[0063] In one embodiment, a connector 30, shown in fig. 3, on the reprocessable compression garment 120 that can support an increased number of insertion and removal cycles associated with a longer garment operational life is provided. Each insertion / removal of the connector 30 results in a wear on the sealing interface. The connector 30 is configured to ensure that the connector 30 is more able to handle an increased number of mating cycles (insertion and removal) associated with a reprocessed garment 120.

[0064] Aspects of the connector 30 on the reprocessable compression garment 120 allows for improved cleaning during the reprocessing process due to having less contours and less areas that can trap bacteria, dirt, sweat, grime and blood during clinical use.

[0065] Aspects of the connector 30 on the reprocessable compression garment 120 increase the retention of the connector 30 to a connecting tube 15 of the reprocessable compression garment 120, thereby reducing the opportunity for product failure during normal wear and tear associated with the increased reprocessing cycles I use during the extended product lifetime.

[0066] Aspects of the connector 30 on the reprocessable compression garment 120 ensure that an identification component 31 is retained more effectively, such as increased retention when mounted inside the connector barrel. This is achieved through an increase in the number, dimensions and degree of interference between the connector’s internal ribs located inside the connector barrel and the identification component 31 placed within the barrel.

[0067] There are also different aspects of an identification component 31 mounted within the connector 30 on the reprocessable compression garment 120 compared to an identification component mounted to a connector fitted to a non-reprocessable compression garment. This includes having a physically different type of identification component, material, size or position located within the connector 30. The purpose being that a compression pump 110 can readily differentiate between a garment intended to be reprocessed compared to a garment not intended to be reprocessed. The pump 110 being configured to be able to operate with a mixture of connected garment types - including a combination of both reprocessable and single-patient use. The pump 110 is therefore able to initiate different functions associated with monitoring, fault detection and other aspects of its operation.

[0068] This represents a key benefit and functional difference between a compression garment 120 specifically and intentionally designed for reprocessing and a garment that is not and is just reprocessed. The above steps also provide for the following advantages:

[0069] Increased hook / loop retention capability during inflation resulting in improved compression force being applied into the limb as the inflatable chamber expands. This mitigates and avoids any reduction in effectivity of the compression garment during the operation life.

[0070] Smaller physical area of loop material than may be otherwise the case, resulting in a beneficial saving of material.

[0071] Removal of a manufacturing process (sewing) and material (thread) for the hook portion of the hook and loop fastener.

[0072] Increased strength in the fixing of the hook material to the loop material compared to sewing process and the resulting thread degradation over time.

[0073] Reduced bioburden introduction into the garment due to the removal of thread.

[0074] A more consistent joining of the hook to the loop material compared to the use of high-speed sewing. The manufacturing variation associated with sewing is avoided.

[0075] Opportunity to have different shaped hook portions that would not be optimal with a sewing process.

[0076] The loop material being able to be supplied in differing colors to allow a visual user coding of garment types I sizes to be implemented.

[0077] The loop material can be positioned, aligned and assembled through the use of non-adhesive means without the use of thread such as ultrasonic, radio frequency welding.

[0078] The adhesive having temperature sensitive characteristics for curing during assembly. The adhesive can have pressure sensitive curing characteristics that allow for the more effective integration of the assembly of garment.

[0079] Manufacturing automation and process improvements including the use of UV light curing to cause the adhesion to occur.

[0080] With a transparent loop material, the adhesive is visible and so can offer other secondary features I benefits including one or more of the following:

[0081] Use of adhesive able to provide a color indication of its cured status for quality purposes during manufacturing, something that is different to inspect with sewing.

[0082] Use of adhesive able to provide a color indication of its ageing status during its extended life.

[0083] The adhesive can become separated at temperatures associated with certain reprocessing processes, this process temperature being beyond that experienced in patient use. The purpose being to prevent use of garments that are not otherwise safe, reliable of capable of being reprocessed due to aspects of their materials, construction or function. Through the removal of the hook and loop, the product can no longer be applied to the patient.

[0084] Alternative approaches are available using dissolvable thread for example, however the moisture often found on a patient limb during use of compression garment (e.g. sweat, blood, urine, wound exudate, saline, water due to washing etc.) could cause the thread to dissolve prematurely during legitimate use.

[0085] In one embodiment, an improved garment performance is provided for extended use during extended operation.

[0086] The garment is re-engineered in order to have a longer lifetime and be more compatible with reprocessing.

[0087] For example, repeated moisture on the thread in a sewn garment (as occurring during multiple washing cycles during reprocessing) can reduce its strength and that of the sewn connection resulting in less effective hook and loop retention and operation during the life of the garment.

[0088] In one embodiment, more consistent results in manufacturing is provided.

[0089] The thread tension achieved during sewing of the loop material can result in different levels of sewing and retention to the garment material. This variation can occur across multiple sewing stations during manufacture, resulting in variation in the manufactured product. This is particularly the case when different sewing machines are in use in different locations or plants or even between different production shifts. The use of an alternative joining process to sewing can provide for more consistency within an individual manufacturing location and between multiple manufacturing locations. This can affect the fastener strength between hook and loop elements during use and over multiple uses of the garment. This aspect can also result in a potential for variation in compression effectiveness between garments and also a variation over the garment lifetime.

[0090] In one embodiment, a separation of materials at end of Life. A compression garment that has fastener patches with a temperature-sensitive glue can be recycled more easily. The dissimilar materials can be more easily separated as part of a recycling process at the end of the garments operating life. This is not possible with a welded construction or with a sewn garment. This can therefore provide for a higher material recovery rate resulting in reduced waste, reduced recycling costs and increased recovered material revenue. The adhesive having temperature sensitive characteristics allowing for removal from the garment material.

[0091] It is known that reprocessing activities are normally completely separate from the original manufacturer of the compression garment. The compression garment is initially manufactured by the original equipment manufacturer who is often not aware of or involved with the operations of a 3rdparty reprocessor. However, the original garment manufacturer, through design and manufacture can directly affect the ease, cost or effectiveness of subsequent reprocessing. Therefore a garment capable of easier reprocessing will be attractive to a 3rdparty reprocessor. This can be a beneficial aspect to OEM manufacturer and reprocessor alike, for example in a partnership. The manufacturer also does have the ability to forge relationships and joint ventures with 3rdparty reprocessing companies e.g. in different geographic regions or where it makes commercial sense in order to provide a cost effective solution to the clinical user. It can therefore be commercially beneficial if the garment is designed and manufactured with the specific intention to be functionally more effective and more compatible with processes used by 3rdparties.

[0092] As a result of ongoing innovation, new materials with improved loop material with increased retention strength are being developed that have improved characteristics. For example, a change in the loop material can be implemented which results in an increased level of retention of the hook and loop closure. Part of the operation of this material can involve a processing step that requires a ‘forming’ step that can be readily combined with other garment constructional aspects. Hence the use of this material is aligned with other assembly processes that therefore require the use of non-sewing processes to mount the material onto the garment. An example being the use of radio frequency (RF) welding to join the loop material to the garment main body, but other alternative processes can be used that utilize an adhesive bond process, for example those based on pressure, adhesive or heat.

[0093] In large scale manufacturing, such as occurs with compression garments, it is advantageous to balance the time requirements of different individual manufacturing process to optimize quality and cost, so this provides a further reason to design out certain time consuming processes such as sewing. The improvements in assembly automation allow for improved efficiency. Use of adhesive instead of thread can also provide for secondary benefits to the loop function such as adhesive with color changing characteristics due to temperature, pressure or age, Modem adhesives are now able to provide additional functions beyond the retention of the loop material.

[0094] The removal of sewing as a process from a garment can also improve the cosmetic look of the resulting garment. For example, it removes the visible join of the loop material on the external surface garment. Also cosmetic failures associated with sewing defects such as sewing path alignment and thread looping are avoided.

[0095] The removal of sewing can ensure that more of the hooks located on the patch are available for use and allow for an increased retention force to be achieved for a given patch area. This is because when the hook area is sewn, the resulting thread occupies some fastener area and the sewing process itself can result in the destruction of hooks, resulting in a lower retention force.

[0096] A sewn joint, when implemented in large manufacturing quantities requires certain shapes, curvatures and minimum dimensions in order to allow for fast and consistent sewing. Sewing also is more efficient when contiguous joints are present, rather than discrete sections of individual joints requiring multiple start and stops of sewing. These requirements can result in other limitations, disadvantages and larger shapes than are optimal and hence limit design flexibility and efficiencies. These limitations are not present to the same degree when alternative bonding processes are used. Hence the design of the garment can utilize other aspects more effectively through the removal of sewing as a process.

[0097] The removal or reduction of sewing content can reduce the material and energy requirements needed for garment construction, which improves the environmental footprint associated with the garment assembly and manufacturing process. The thread itself requires multiple inputs in terms of materials, processing and energy used in its manufacture and supply. Hence the reduction or removal of the thread from the garment can be of yet further benefit to the manufacturer, customer and wider society.

[0098] The removal or reduction in the use of thread used to bind the hook fastener and its replacement with adhesive can help to reduce the bio-burden as a component input into manufacturing as well as that occurring during manufacturing. The reduction in the surface contours associated with a sewn joint is advantageous as these can harbor bacteria and allows for easier reprocessing.

[0099] The removal of a sewn binding around the garment also reduces both the bioburden level from the component parts and reduces the scope for build-up of material during use and complications in cleaning.

[0100] The removal of the thread provides for a smoother inside and outside garment surface that allows for more effective garment cleaning during reprocessing - for example when being wiped with a cloth or brush.

[0101] The disclosure provides a reprocessed compression garment 120, as shown in fig 1 , 2, 4a-b designed for patient care. This garment includes at least one inflatable chamber 12, a cleaned connecting fluid tube 15, and a cleaned fluid connector 30. The fluid connector is in fluid connection with the inflatable chamber via the connecting fluid tube.

[0102] An identification component 31 is part of the cleaned fluid connector. The length of the cleaned fluid connector is less than 45 mm. The identification component is detectable by a sensor of an external pump 110 when connected to the reprocessed compression device. The operating pressure of the pump is automatically set using the identification component located in the cleaned connector of the reprocessed device when connected to the pump.

[0103] In one embodiment, the reprocessed compression garment 120 can be constrained on a limb with at least one non-sewn hook and loop fastener 23, which is mounted on at least one elongate tab of the reprocessed compression device. The length of the cleaned fluid connector can be between 43 and 44 mm, and the dimensions of the identification component can be between 3 and 10 mm.

[0104] The dimensions 3-10 mm is better than larger than 10mm, more retentive on the tube than before, less material, easier mounting on tube, more secure due to extra teeth.

[0105] In one embodiment, the cleaned fluid connector comprise a plurality of teeth 32 reaching outwardly into the inside of the connecting fluid tube 15 for preventing the connector and tube from being separated. The garment can be configured for being mounted on a human limb, comprising an adhesively attached hook and loop fastener 23. The connector is a pneumatic connector, the identification component is located in the pneumatic connector, and the inflatable chamber is configured for pneumatic compression of the limb.

[0106] In one aspect, the compression garment being free from the use of thread.

[0107] In one aspect, the compression garment is comprising a plurality of non-sewn hook-and-loop fasteners 23 for retention to the limb, the hook-and-loop fastener being secured to the compression garment using adhesive.

[0108] In one aspect, the reprocessed compression garment 120, comprising a plurality of temperature-separable hook-and-loop fastener sections.

[0109] In one aspect, the reprocessed compression garment 120, comprising a plurality of hook-and-loop fastener sections where the hooks are aligned in a circumferential manner such that the fastener shear strength is maximized.

[0110] In one aspect, the reprocessed compression garment 120, comprising a welded seam around the periphery of the compression garment, the welded seam forming an edge to the compression device and a defined interface to the user’s limb. In one aspect, the reprocessed compression garment 120, wherein the cleaned fluid connector 30 comprises a plurality of circular ribs 32 reaching outwardly into the inside of the connecting fluid tube 15 for preventing the cleaned fluid connector 30 and fluid tube 15 to be separated.

[0111] In one aspect, wherein the plurality of circular ribs 32 of the reprocessed compression garment, each comprises at least one tooth 33 reaching in the direction of a longitudinal axis (A) outwardly on the outside of the cleaned fluid connector 30 for prevent the cleaned fluid connector 30 and tube 15 to be separated.

[0112] In one aspect, the connector 30 for a reprocessable compression device 120, as shown in fig 1 and 3, configured for fluid connection with an inflatable chamber 12 of the compression reprocessable device 120 via a connecting fluid tube 15 comprising an identification component 31 , wherein the length L of the connector is less than 45 mm and a diameter less than 17 mm.

[0113] In one aspect, the connector according to claim 15, wherein the length L of the connector is between 43 and 44 mm.

[0114] The disclosure describes a pathway 200a for single patient use compression garment subjected to reprocessing, shown in fig 6. The compression garment 120 comprises at least one inflatable chamber 12, a connecting fluid tube 15 and a fluid connector 30 in fluid connection with the at least one inflatable chamber 12, an identification component 31 applied to the fluid connector 31 .

[0115] The pathway 200a for single patient use compression garments includes the following method steps:

[0116] S10a: Initial manufacturing of the compression garment for single patient use.

[0117] S20a: First use by first patient. The compression garment is detected as a single patient use garment by the pump and the pump 110 operates accordingly. S30: 1streprocessing and cleaning process. The reprocessing and cleaning method step includes cleaning the compression garment, updating the identification component, testing the compression garment, and repackaging the compression garment. The fluid connector comprises a plurality of teeth reaching outwardly into the inside of the connecting fluid tube. The step of cleaning includes an added heat process resulting in the tube being softer and the plurality of teeth extending outwardly, increasing grip between the tube and connector.

[0118] S40a: Subsequent uses by subsequent patients. The compression garment 120 is detected by the pump as a single patient use garment and operates accordingly, despite adverse wear effects of previous usage.

[0119] S50a: Subsequent reprocessing and cleaning, the same process as at method step S30.

[0120] S60a: The number N of reprocessing cycles are tested. If max number, N>1 , of cycles has been reached proceed to S70, if not proceed to S40a.

[0121] S70: The end of use has been reached and the compression garment 120 is disposed and recycled.

[0122] The disclosure also describes a pathway 200b for intentionally reprocessable compression garment, shown in fig 7. The reprocessable compression garment 120 comprises at least one inflatable chamber 12, a connecting fluid tube 15 and a fluid connector 30 in fluid connection with the at least one inflatable chamber 12, an identification component 31 applied to the fluid connector 31 .

[0123] S10b: Initial manufacturing of the compression garment for intentionally reprocessable compression garment.

[0124] S20b: First use by first patient. The compression garment is detected as a reprocessable compression garment 120 by the pump 110 and the pump 110 operates accordingly. S30: 1streprocessing and cleaning process. The reprocessing and cleaning method step includes cleaning the compression garment, updating the identification component, testing the compression garment, and repackaging the compression garment. The fluid connector comprises a plurality of teeth reaching outwardly into the inside of the connecting fluid tube. The step of cleaning includes an added heat process resulting in the tube being softer and the plurality of teeth extending outwardly, increasing grip between the tube and connector.

[0125] S40b: Subsequent uses by subsequent patients. The compression garment is detected by the pump 110 as a reprocessable compression garment 120 and operates accordingly, compensating for reduced wear effects of previous usage.

[0126] S50b: Subsequent reprocessing and cleaning, the same process as at method step S30.

[0127] S60b: The number N of reprocessing cycles are tested. If max number M of cycles has been reached, M>N, proceed to S70, if not proceed to S40b.

[0128] S70: The end of use has been reached and the compression garment 120 is disposed and recycled.

[0129] The disclosure provides for a compression system 100 comprising a compression pump 110 and a reprocessed compression garment 120 adapted to be connected to the compression pump 110, as shown in fig 1. The reprocessed compression garment 120 comprises a connector 30 with a plurality of circular ribs 32 reaching outwardly. The compression pump 110 provides air into the reprocessed compression garment 120 when detecting a presence of an identification component 31 comprised in the reprocessed compression garment 120. The compression system 100 can comprise a plurality of compression garments 120 of two types, a first type intended for single-patient use and a second type intended for being reprocessed and reused. Each compression garment 120 has a fluid connector 30 with an identification device 31 , allowing the pump 110 to differentiate the first and second connected type of compression garment 120 and operate accordingly.

[0130] The foregoing has described the principles, preferred embodiments and modes of operation of the present invention. However, the invention should be regarded as illustrative rather than restrictive, and not as being limited to the particular embodiments discussed above. The different features of the various embodiments of the invention can be combined in other combinations than those explicitly described. It should therefore be appreciated that variations may be made in those embodiments by those skilled in the art without departing from the scope of the present invention as defined by the following claims.

Claims

CLAIMS1 . A reprocessed compression garment (120) comprising:- at least one inflatable chamber (12);- a cleaned connecting fluid tube (15);- a cleaned fluid connector (30) in fluid connection with the at least one inflatable chamber (12) via the cleaned connecting fluid tube (15), and- an identification component (31 ) part of the cleaned fluid connector (30); and wherein the length of the cleaned fluid connector (30) is less than 45 mm, wherein the identification component (31 ) is detectable by a sensor of an external pump (110) when connected to the reprocessed compression garment (120), wherein an operating pressure of the external pump (110) is automatically set by using the identification component (31 ) located in the cleaned fluid connector (30) of the reprocessed compression garment (120) when connected to the external pump (110).

2. The reprocessed compression garment (120) according to claim 1 , wherein the reprocessed compression garment (120) being constrained on a limb with at least one non-sewn hook and loop fastener (23), the hook and loop fastener (23) being mounted on at least one elongate tab of the reprocessed compression garment (120).

3. The compression garment (120) according to claim 1 , wherein the length (L) of the cleaned fluid connector (30) is less than 45 mm4. The compression garment (120) according to claim 1 , wherein the length (L) of the cleaned fluid connector (30) is between 43 and 44 mm.

5. The reprocessed compression garment (120) according to claim 1 , wherein the dimensions of the identification component (31 ) is between 3 and 10 mm.

6. The reprocessed compression garment (120) according to claim 1 , comprises one inflatable chamber (17a).

7. The reprocessed compression garment (120) according to claim 1 , wherein the cleaned fluid connector (30) comprises a plurality of teeth (32) reaching outwardly into the inside of the connecting fluid tube (15) for preventing the cleaned fluid connector (30) and connecting fluid tube (15) from being separated.

8. The reprocessed compression garment (120) according to claim 1 , wherein the cleaned fluid connector (30) comprises a plurality of circular ribs (32) reaching outwardly into the inside of the connecting fluid tube (15) for preventing the cleaned fluid connector (30) and fluid tube (15) to be separated.

9. The reprocessed compression garment according to claim 13, wherein the plurality of circular ribs (32) each comprises at least one tooth (33) reaching in the direction of a longitudinal axis (A) outwardly on the outside of the cleaned fluid connector (30) for prevent the cleaned fluid connector (30) and tube (15) to be separated.

10. The reprocessed compression garment (120) according to claim 1 , configured for being mounted on a human limb, comprising a plurality non-sewn hook-and-loop fasteners (23), wherein the cleaned connector (30) is a pneumatic connector, the identification component (31 ) is located in the pneumatic connector (30) and the inflatable chamber (12) is configured for pneumatic compression of the limb.

11. The reprocessed compression garment (120) according to claim 1 , wherein the reprocessed compression garment (120) being free from the use of thread.

12. The reprocessed compression garment (120) according to claim 1 , comprising a plurality of non-sewn hook-and-loop fasteners (23) for retention to the limb, the hook-and-loop fastener being secured to the compression garment using adhesive.

13. The reprocessed compression garment (120) according to claim 1 , comprising a plurality of temperature-separable hook-and-loop fasteners (23).

14. The reprocessed compression garment (120) according to claim 1 , comprising a plurality of hook-and-loop fasteners (23) where the hooks are aligned in a circumferential manner such that the fastener shear strength is maximized.

15. The reprocessed compression garment (120) according to claim 1 , comprising a welded seam around the periphery of the compression garment (120), the welded seam forming an edge to the compression garment (120) and a defined interface to the user’s limb.

16. A connector (30) for a reprocessable compression garment (120), configured for fluid connection with an inflatable chamber (12) of the reprocessable compression garment (120) via a connecting fluid tube (15), wherein the connector (30) comprises an identification component (31 ), wherein the length (L) of the connector (30) is less than 45 mm and has a diameter less than 17 mm.

17. The connector according to claim 16, wherein the length (L) of the connector is between 43 and 44 mm.

18. A method of reprocessing a compression garment (120) comprising at least one inflatable chamber (12), a connecting fluid tube (15) and afluid connector (30) in fluid connection with the at least one inflatable chamber (12), an identification component (31 ) applied to the fluid connector (31 ), comprising the steps: cleaning the compression garment (120); updating the identification component (31 ); testing the compression garment (120); and repackaging the compression garment (120).

19. The method according to claim 18, wherein the fluid connector (30) comprises a plurality of teeth (32) reaching outwardly into the inside of the connecting fluid tube (15), wherein the step of cleaning comprising an added heat process resulting in the tube being softer and the plurality of teeth (32) extending outwardly increasing grip between the tube (15) and connector (30).

20. A compression system (100) comprising a compression pump (110) and a reprocessed compression garment (120) adapted to be connected to the compression pump (110), wherein the reprocessed compression garment (120) comprising a connector (30) with a plurality of circular ribs (32) reaching outwardly, wherein the compression pump (110) is providing air into the reprocessed compression garment when detecting a presence of an identification component (31 ) comprised in the reprocessed compression garment (120).

21. The compression system of claim 20, comprising a plurality of compression garment (120) of two types, a first type intended for singlepatient use and a second type intended for being reprocessed and reused, wherein each compression garment (120) having a fluidconnector (30) with an identification device (31 ), the identification device (31 ) allowing the pump to differentiate the first and second connected type of compression garment (120) and operate accordingly.

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