Technical Field

[0001] This disclosure relates, generally, to a method and system for remanufacturing and re- sterilizing a catheter.

Background Art

[0002] Any discussion of the prior art throughout the specification should in no way be considered as an admission that such prior art is widely known or forms part of common general knowledge in the field.

[0003] Electrophysiology catheters are commonly used in medical practice to examine and treat the heart. They may be inserted into the cardiovascular system of the patient through small punctures in the skin. Catheters generally include a tubular structure such as a plastic tube with one or more electrodes attached to the tip of the tube and a handle connected to the tubular structure. The electrodes are connected via electrical conductors to instruments such as a monitor or a stimulator.

[0004] During their use in medical procedures catheters are exposed to biological fluids in the human body. Because catheters come in contact with these bodily fluids they are commonly designed to be single use devices to avoid the transfer of viruses or bacteria from one patient to another. Disposing of the catheters after each procedure leads to significant expenses to the patient and the healthcare system as well as creates a substantial amount of medical waste. Therefore, certain institutions reprocess catheters for re-use by cleaning or re-sterilizing.

[0005] Reprocessing single use devices reduces the cost of a procedure and minimises medical waste generated. Reprocessing typically involves multiple stages such as cleaning, drying, sterilization and packaging. These procedures are typically performed in a clean room environment. Setting up a clean room, however, requires substantial effort and expense which makes them inconvenient to have on the premises where the catheters are being used.

Summary

[0006] It is an object of the present invention to overcome or ameliorate at least one of the disadvantages of the prior art, or to provide a useful alternative. [0007] In an aspect, there is provided a system for reprocessing a used catheter which includes a washer-disinfector for washing and disinfecting a catheter, a freestanding laminar flow module having a laminar flow working area for catheter assembly and packaging, and a sterilizer for sterilizing the packaged catheter.

[0008] In an embodiment, the washer-disinfector is directly connected to the laminar flow working area via a first washer door. The washer-disinfector has a second washer door opening to ambient atmosphere.

[0009] In an embodiment, air in the washer disinfector after a cleaning and disinfecting cycle is of substantially the same purity as air in the laminar flow working area.

[0010] In an embodiment, the sterilizer is directly connected to the laminar flow working area via a first sterilizer door. The sterilizer also includes a second sterilizer door opening to ambient atmosphere.

[001 1] In another aspect, there is provided a system configured to enable reprocessing of a used catheter, the system including:

a washer-disinfector configured to wash and disinfect the used catheter;

a freestanding laminar flow module having a laminar flow working area for catheter assembly, testing and packaging, thereby to enable assembly, testing and packaging of the used catheter following washing and disinfecting by the washer-disinfector ; and

a sterilizer for sterilizing the packaged catheter.

[0012] In an embodiment, the washer-disinfector is in sealing connection with the laminar flow module thereby to prevent pollutants from entering the laminar flow working area.

[0013] In an embodiment, the first washer door includes a sealing material to facilitate the sealing connection with the laminar flow module.

[0014] In an embodiment, the sterilizer is in sealing connection with the laminar flow module thereby to prevent pollutants from entering the laminar flow working area.

[0015] In an embodiment, the first sterilizer door includes a sealing material to facilitate the sealing connection with the laminar flow module.

[0016] In an embodiment, the washer-disinfector is a compact freestanding washer- disinfector module releasably connectable to the laminar flow module. [0017] In an embodiment, the sterilizer is a compact freestanding sterilizer module releasably connectable to the laminar flow module.

[0018] In an embodiment, the laminar flow working area is directly under a laminar flow structure including:

an air input; and

a blower, wherein the blower directs air into the laminar flow working area through one or more filters such that the resulting air in the laminar flow working area is free from pollutants.

[0019] In an embodiment, the laminar flow working area is positively pressurised such that no polluting particles flow in the laminar flow working area due to the laminar flow structure.

[0020] In another aspect, there is provided a modular workspace arrangement configured to enable reprocessing of a used catheter, the modular workspace arrangement including:

a washer-disinfector unit configured to wash and disinfect the used catheter;

a freestanding laminar flow module directly adjacent the washer-disinfector unit, the freestanding laminar flow module having a laminar flow working area for catheter assembly, testing and packaging, thereby to enable assembly, testing and packaging of the used catheter following washing and disinfecting by the washer-disinfector; and

a sterilizer unit directly adjacent the freestanding laminar flow module, the sterilizer unit being configured to receive and sterilize the packaged catheter.

[0021] In another aspect, there is provided a catheter reprocessing workstation including:

a washer-disinfector unit configured to wash and disinfect a used catheter, the washer-disinfector unit including a containment chamber having:

(i) a first access port configured to receive the used catheter from a non- controlled airspace; and

(ii) a second access port configured to enable removal of a disinfected catheter directly into a controlled airspace;

a freestanding laminar flow module directly adjacent the second access port of the washer-disinfector unit, the freestanding laminar flow module having a laminar flow working area in the controlled airspace, wherein the laminar flow module includes a storage area containing catheter replacement parts; and a sterilizer unit directly adjacent the freestanding laminar flow module, the sterilizer unit including a sterilization chamber in which a catheter is sterilized, the chamber having:

(i) a first access port configured to receive a catheter directly from the controlled airspace of the laminar flow working area; and

(ii) a second access port configured to enable removal of a sterilized catheter; thereby to provide a controlled processing pathway via which a used catheter is reprocessed for subsequent sterile use.

Brief Description of Drawings

[0022] Preferred embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings in which:

[0023] Fig. 1 shows a schematic view of a catheter reprocessing system.

Description of Embodiments

[0024] Figure 1 of the drawings shows a compact system for cleaning, disinfecting and sterilizing catheters. The system 10 includes a washer-disinfector 1 1. The used catheter is disassembled into parts and the individual parts that may be reprocessed are placed in the washer-disinfector 1 1. The washer-disinfector 1 1 has a door 17 opening to the dirty site which is in the ambient atmosphere and a drawer or a rack that can be pulled out, or automatically pushed out, through input door 17.

[0025] The washer disinfector firstly goes through a thorough cleaning process of the catheter parts that is followed by heat disinfection. The washing cycle typically includes washing of the catheter parts with appropriate chemicals and/or detergents by pressurized water. During the disinfection phase, the water temperature is increased close to boiling temperature so that the catheter parts are disinfected thermally. The water temperature and the amount of disinfectants/chemicals used during the washing cycle depend on the type material of the catheter that is being cleaned. Some materials may not endure boiling temperature so more chemicals may be used. During the last phase of the cycle the catheter parts are dried with air that is pushed by a blower 20 trough HEPA filters 21 so that the air is substantially free of dust and other polluting particles, and the catheter parts are substantially free of bacteria and micro-organisms. The atmosphere in the washing machine then becomes equivalent to the laminar flow working area 22. After the cleaning and disinfecting cycle the racks or drawers are accessible through a side door (not shown in Figure 1) opening into the working area 22 manually or automatically after the cycle. The racks and/or drawers can be pulled out manually or they are pushed out automatically through the side door opening to the working area 22. The washer-disinfector has thus two doors, one that opens to the dirty side/ambient atmosphere and another that opens to the clean site i.e. working area 22 where clean room conditions exist.

[0026] The catheter is then assembled at a freestanding laminar flow module 15. The laminar flow module 15 includes a working area 22 that is directly under a laminar flow structure including air input 12 and a blower 13. The blower pushes air trough HEPA filters 14 that are sealed together so that only air that has passed the HEPA filters enters the working area 22. The filtered air is free of dust and other polluting particles and is blown substantially vertically down from the HEPA filters 14 towards the working area 22. The air in the working area 22 is thus as clean as it would be in a laminar flow clean room. The laminar flow working area 22 is positively pressurised so that no polluting particles can flow into the working area 22 because the air flow from the blower through the HEPA filters is so strong. The air in the working area 22 is thus constantly refreshed to ensure its purity. The purity levels of air are checked in both the washer-disinfector and at the working area 22 and they are kept at the same level.

[0027] Before assembly, the catheter parts that have been washed and disinfected are checked and tested for any defects or deterioration at working area 22. The testing may be completed either manually or automatically. Any parts that are not functioning as they should, or where other deterioration is detected, are replaced by new parts from storage area 18. The catheter is assembled at the working area 22 and packed in appropriate packaging material manually or by a robot. Packaging material is preferably Tyvek® sterile pouches or blister packs that are sealed in the working area 22 by exposing the packs to heat so that the sterile adhesive of the pack melts to seal the packet.

[0028] The packaged catheter is then put into a sterilizer 16. The sterilizer may use any suitable sterilization method including dry-heat, steam, an appropriate sterilizing chemical or ionizing radiation. Similarly to the washer-disinfector, the sterilizer has two doors, a clean door opening to the working area 22 (not shown in Figure 1) and another door 19 opening to ambient atmosphere. The packaged catheter/s are placed on racks or drawers through the clean door opening to the working area 22. During the sterilizing cycle, the sterilizer creates a vacuum and the membrane of the Tyvek® packaging opens to the sterilizing substance. After the sterilizing cycle, the door 19 opens and the racks and the catheters can be accessed by pulling them out manually, or alternatively, they can be automatically pushed out after the cycle. [0029] Another embodiment of the invention provides a catheter reprocessing workstation. The reprocessing workstation includes washer-disinfector unit 11 , a freestanding laminar flow module, and sterilizer unit 16.

[0030] The washer-disinfector unit 11 , which is configured to wash and disinfect a used catheter, includes a containment chamber. The containment chamber includes a first access port or input door 17 configured to receive the used catheter from a non-controlled airspace. The containment chamber also includes a second access port configured to enable removal of a disinfected catheter directly into a controlled airspace.

[0031] The freestanding laminar flow module is located directly adjacent the second access port of the washer-disinfector unit. The laminar flow module includes laminar flow working area 22 in the controlled airspace. The laminar flow module further includes storage area 18 containing catheter replacement parts.

[0032] The sterilizer unit 16, including a sterilization chamber in which a catheter is sterilized, is located directly adjacent the freestanding laminar flow module. The sterilizer chamber includes a first access port configured to receive a catheter directly from the controlled airspace of the laminar flow working area 22. The sterilizer chamber also includes a second access port or door 19 configured to enable removal of a sterilized catheter.

[0033] The catheter reprocessing workstation provide a controlled processing pathway via which a used catheter is reprocessed for subsequent sterile use.

[0034] The advantage of the above described catheter reprocessing system is that the system is a compact structure and it can be easily installed in any area where catheters are used and reprocessing is needed. Each module, the washer-disinfector, the laminar flow working area and the sterilizer, are compact freestanding modules that can be connected and disconnected from one another. This modular feature facilitates the system 10 to be installed and uninstalled, as required, on existing premises where catheters are used such as hospitals. The connection between the laminar flow module 15 and the washer-disinfector 11 or the sterilizer 16 must be a sealing connection so that opening the clean, side door from the washer-disinfector or the sterilizer to the laminar flow working area does not allow any polluting particles to enter the laminar flow working area 22. The side doors and/or the doorframes of each washer-disinfector and the sterilizer are thus surrounded by a sealing material to sealingly connect them to the laminar flow module. The washer-disinfector and the sterilizer are firmly connected to the laminar flow module, for example, by suitable bolts.

[0035] The catheters can be reprocessed within the above described, compact, system without any special environmental conditions other than power, water and air conditioning. Typically, catheters are reprocessed in a clean room particularly designed for reprocessing purposes. Clean rooms are very expensive to build and maintain. They take up substantial space and they use high amounts of power. Therefore, hospitals have not been reprocessing the used catheters themselves but are giving them to a third party reprocessing company which takes the catheters to their premises for cleaning, disinfecting and re-sterilization. Maintaining premises with clean room is expensive and transport from the hospitals to the reprocessing sites involves further costs. The reprocessing system and method described above can use a compact laminar flow cabinet or a booth, and the building and maintenance costs will be much smaller than those in relation to a full clean room. The system also allows the catheter users to be self- sufficient and able to perform the reprocessing themselves without a third party being involved which results in further cost reductions.

[0036] It will be appreciated that the terms "releasably connectable", "removably attached" and the like, as used herein, refers to arrangements whereby two modules are configured in such a manner as to enable their connection/attachment, and enable that connection/attachment to be reversed without necessarily damaging either module. That is, the connection/attachment is repeatable. This is significant in the context of a modular system.

[0037] Reference throughout this specification to "one embodiment", "some embodiments" or "an embodiment" means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, appearances of the phrases "in one embodiment", "in some embodiments" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment, but may. Furthermore, the particular features, structures or characteristics may be combined in any suitable manner, as would be apparent to one of ordinarily skill in the art from this disclosure, in one or more embodiments.

[0038] As used herein, unless otherwise specified the use of ordinal adjectives "first", "second", "third", etc., to describe a common object, merely indicate that different instances of like objects are referred to, and are not intended to imply that the objects so described must be in a given sequence, either temporally, spatially, in ranking, or in any other manner.

[0039] In the claims below and the description herein, any one of the terms comprising, comprised of or which comprises is an open term that means including at lest the elements/features that follow, but not excluding others. Thus, the term comprising, when used in the claims, should not be interpreted as being limitative to the means or elements or steps listed thereafter. For example, the scope of the expression a device comprising A and B should not be limited to devices consisting only of elements A and B. Any one of the terms including or which includes or that includes as used herein is also an open term that also means including at lest the elements/features that follow the term, but not excluding others. Thus, including is synonymous with and means comprising.

[0040] It should be appreciated that in the above description of exemplary embodiments of the invention, various features of the invention are sometimes grouped together in a single embodiment, FIG., or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that the claimed invention requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less that all features of a single foregoing disclosed embodiment. Thus the claims following the Detailed Description are hereby expressly incorporate into this Detailed Description, with each claim standing on its own as a separate embodiment of this invention.

[0041] Furthermore, while some embodiments described herein include some but not other features included in other embodiments, combination of features of different embodiments, as would be understood by those skilled in the art. For example, in the following claims, any of the claimed embodiments can be used in any combination.

[0042] In the description provided herein, numerous specific details are set forth. However, it is understood that embodiments of the invention may be practiced without these specific details. In other instances, well-known methods, structures and techniques have not been shown in detail in order not to obscure an understanding of this description.

[0043] Similarly, it is to be noticed that the term coupled, when used in the claims, should not be interpreted as being limited to direct connections only. The terms "coupled" and "connected", along with their derivatives, may be used. It should be understood that these terms are not intended as synonyms for each other. Thus the scope of the expression a device A coupled to a device B should not be limited to devices or systems wherein an output of device is directly connected to an input of device B. It means that there exists a path between an output of A and an input of B which may be a path including other devices or means. "Coupled" may mean that two or more elements are either in direct physical or electrical contact, or that two or more elements are not in direct contact with each other but yet still co-operate or interact with each other.

[0044] Thus, while there has been described what are believed to be the preferred embodiments of the invention, those skilled in the art will recognize that other and further modifications may be made thereto without departing from the spirit of the invention, and it is intended to claim all such changes and modifications as falling within the scope of the invention. For example, any formulas given above are merely representative of procedures that may be used. Functionality may be added or deleted from the block diagrams and operations may be interchanged among functional blocks. Steps may be added or deleted to methods described within the scope of the invention.

[0045] It will be appreciated by persons skilled in the art that numerous variations and/or modifications may be made to the disclosure as shown in the specific embodiments without departing from the scope of the disclosure as broadly described. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive.