WO2009027665A1 - Container - Google Patents

Container Download PDF

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Publication number
WO2009027665A1
WO2009027665A1 PCT/GB2008/002894 GB2008002894W WO2009027665A1 WO 2009027665 A1 WO2009027665 A1 WO 2009027665A1 GB 2008002894 W GB2008002894 W GB 2008002894W WO 2009027665 A1 WO2009027665 A1 WO 2009027665A1
Authority
WO
WIPO (PCT)
Prior art keywords
container
support member
inlet path
path
inlet
Prior art date
Application number
PCT/GB2008/002894
Other languages
French (fr)
Other versions
WO2009027665A4 (en
Inventor
David Hill
Stuart Hastings
Original Assignee
Rocket Medical Plc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Rocket Medical Plc filed Critical Rocket Medical Plc
Publication of WO2009027665A1 publication Critical patent/WO2009027665A1/en
Publication of WO2009027665A4 publication Critical patent/WO2009027665A4/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/69Drainage containers not being adapted for subjection to vacuum, e.g. bags
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/75General characteristics of the apparatus with filters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2209/00Ancillary equipment
    • A61M2209/08Supports for equipment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00Anatomical parts of the body
    • A61M2210/10Trunk
    • A61M2210/101Pleural cavity

Definitions

  • the present invention relates to a container, particularly to an ambulatory container and more particularly to an ambulatory bag.
  • a drainage bottle or drainage bag Due to its rigidity, a drainage bottle can be used with gravity and/or suction to allow drainage/ venting and is commonly used for stationary applications.
  • a drainage bag is mainly used in ambulatory applications, emergencies, ambulances or military applications or where patients are transported, as drainage bags are more compact, lightweight and flexible than bottles.
  • Flexible drainage bags having a fluid inlet comprising a flutter valve and an outlet for venting gas have been previously described wherein the outlet comprises a rigid tubular member projecting into the bag which has an open end outside the bag.
  • Gas present in the bag for example air being compressed by the liquid entering the bag, gaseous degradation products and/or microbial metabolites can pass from the bag into and through the tubular member and escape out of the bag.
  • a container suitable for connection to a pleural cavity comprising a fluid inlet path and an outlet path wherein the outlet path is selectively permeable for gas and not liquid.
  • the container may be a medical / surgical container or bag.
  • the container is sized and shaped to allow it to be used as an ambulatory container or bag.
  • the container can be a chest drainage container or chest drainage bag.
  • the fluid inlet path comprises a unidirectional valve.
  • the fluid inlet path can be provided by a tube to which a unidirectional valve can be attached.
  • the container is a closed bag of flexible material.
  • the container for example a closed bag, comprises an inlet path arranged to allow fluid to enter the bag and to prevent fluid leaving the bag, and an outlet path wherein the outlet path allows gas to escape from the container, but prevents liquid escaping from the container.
  • any liquid having entered the bag will be maintained inside the bag and cannot contaminate an environment outside of the bag.
  • gas such as air compressed by the liquid entering the container or bag, gaseous degradation products and/or microbial metabolites, can escape the container such that the gas does not accumulate within the container.
  • pressure inside the container is minimised or at least reduced, allowing the liquid to easily enter the container.
  • the bag can be formed from plastics material, for example PVC, latex or the like, by heat sealing two sheets of plastics together around their edge such that walls and edges of the bag are provided.
  • the inlet path and outlet path may separately be provided in either a wall or an edge of the bag.
  • the container can be formed from transparent material.
  • the unidirectional valve can be, for example, a flutter valve, a Heimlich valve or the like.
  • the unidirectional fluid inlet path comprises means to attach the inlet path to a chest catheter, more particularly a percutaneous thoracic catheter.
  • such means can include, a screw attachment, a bayonet attachment, a push fit attachment or the like.
  • the outlet path can include a member comprising apertures arranged such that gas can move through the apertures and the movement of liquid through the apertures is restricted.
  • such a member of the outlet path is moulded and / or embedded into the container but most preferably is welded into the container.
  • suitable mounting means can be used and such is not limited to those exemplified above.
  • the member of the outlet path can have a width in the range from 15 mm to 35mm, such that sufficient apertures are provided by the member of the outlet path to allow a suitable flow rate of gas / gases out of the container.
  • the member comprising apertures can be a flexible membrane.
  • a flexible membrane can provide the container with more flexibility, which may be particularly advantageous where the container is an ambulatory container.
  • a flexible membrane also decreases the likelihood of the outlet path protruding from the container into, for example, a subject wearing the container.
  • the membrane can be at least partially formed from a material selected from the group comprising polyethylene (PE), polypropylene (PP), polyisobutylene (PIB) and/or polytetrafluoroethylene (PTFE).
  • PE polyethylene
  • PP polypropylene
  • PIB polyisobutylene
  • PTFE polytetrafluoroethylene
  • the membrane can be a hydrophobic membrane. This is advantageous as if the membrane is substantially unwettable by the liquid inside the bag, which may be an aqueous liquid, blocking of gas exchange via the apertures is minimised.
  • the membrane is formed of, or coated with, a material which repels fat and lipid (i.e is lipophobic).
  • the membrane is a polyoleophobic membrane, for example polytetrafluoroethylene (PTFE).
  • PTFE polytetrafluoroethylene
  • a PTFE membrane is particularly advantageous, as PTFE provides for good hydrophobicity, non- adhesiveness and good temperature and chemical resistance.
  • the membrane can be provided with a backing material or carrier.
  • the backing material can be woven / nonwoven, paper or PVC.
  • the container can further comprise an adsorbent member which is permeable to gas, but can trap odours, for example, odours, as caused by hydrocarbons, present in the gas. Typically, these odours may be caused by bacteria.
  • the adsorbent member can be positioned such that gas exiting the outlet path passes through or around the adsorbent member.
  • the adsorbent member can be placed in, on or over the outlet path.
  • gas exiting the container via the outlet path passes over or through the adsorbent member, such that undesired odours are substantially removed from the gas before the gas is released into the environment.
  • the adsorbent member comprises carbon, activated carbon or similar material.
  • the adsorbent member for example, but not limited to activated carbon, can be chemically treated, to enhance the absorbing properties of the adsorbent member and / or increase the surface area of the adsorbent member.
  • At least one of the container and the adsorbent member can provide means for the removable positioning of the adsorbent member such that gas exiting the container via the outlet path has to pass through or over the adsorbent member.
  • the adsorbent member may be removably positioned in, on or over the outlet path.
  • the container can comprise a sleeve member or pocket into which an adsorbent member can be inserted such that when the adsorbent member is provided in the sleeve, the absorbent member is positioned over the outlet path.
  • the slidable insertion of an adsorbent member into a sleeve member means the adsorbent member can be removed and replaced and / or cleaned as required.
  • the sleeve member into which the adsorbent member can be slideably entered is formed on the outside of the bag and positioned such that gases exiting the outlet path, pass through or over the adsorbent member. This allows replacement of the adsorbent member.
  • At least one of the container and the adsorbent member can comprise a releasable fastening means, such as, but not limited to, a clip, adhesive, a twisted fixing, a bayonet fixing a hook and eye arrangement, a zip, stud fastening, a contact fastener such as VelcroTM or the like to position the adsorbent member relative to the outlet path.
  • a releasable fastening means such as, but not limited to, a clip, adhesive, a twisted fixing, a bayonet fixing a hook and eye arrangement, a zip, stud fastening, a contact fastener such as VelcroTM or the like to position the adsorbent member relative to the outlet path.
  • Removability facilitates the renewal or cleaning of an adsorbent member, for example, the exchange of a first adsorbent member for a second adsorbent member to retain adsorption, when, for example, the adsorbent member in use is substantially saturated.
  • the container and / or the adsorbent member can further comprise a deodorising material which can destroy or mask odours.
  • the outlet path is locatable in at least one wall of the container.
  • the container further comprises a drainage tap.
  • the drainage tap allows for convenient, controlled removal of the liquid from the container.
  • the drainage tap may comprise an attachment means for attaching an additional device, such as, but not limited to at least a second container into which the liquid can be drained.
  • the container comprises a layer of absorbent material such as a cotton or micro-fibre fleece on at least one outside wall of the container.
  • the absorbent layer can be attached to an outside wall of the container, for example an ambulatory bag, which when the container is in use, will be close to a person wearing the container. The layer increases comfort when the bag is placed on or next to the skin.
  • the absorbent layer can be removable, such that the absorbent layer can be cleaned or be replaced by a new layer.
  • the outlet path is a flexible membrane the outlet path may not provide resistance to folding or bending of the inlet path. Folding or bending of the inlet path, where for example the inlet path is a flutter valve, can lead to obstruction of the inlet path.
  • the container can comprise at least one reinforcing member arranged on or in the container such that bending or folding of the inlet path is inhibited.
  • a reinforcing member can be provided alongside the inlet path.
  • the container can comprise an inlet path support member wherein the support member comprises a member formed from semi-rigid or rigid material, the member comprising at least an outer surface and an inner surface wherein the inner surface forms at least one channel having a first end and a second end.
  • the inlet path support member can be provided in the interior or exterior of the container.
  • the inlet path support member can be provided to the exterior of the container.
  • the length of the channel between the first and second ends is greater than the length of a valve portion of the inlet path such that, in use, the support member partially receives and encloses the valve portion of the inlet path.
  • at least 30% of the circumference of the inlet path is surrounded by the support member.
  • the support member minimises the risk of bending or folding of the inlet path and thus of obstruction of the inlet path.
  • the support member partially receives and encloses the inlet path such that at least 40%, at least 50%, at least 60%, at least 70%, at least 80%, at least 90%, at least 100% of the circumference of the inlet path is surrounded by the support member.
  • the primary advantage is that the inlet support member protects a valve portion of inlet path, for example a flutter valve from being bent or folded, particularly when the container is a flexible bag that can be folded and thus minimises the risk that the inlet path is blocked.
  • the inlet support member may be tubular and a passage extends from a first end of the tube to a second end of the tube wherein the passage is sized such that the inlet path can be surrounded by the tubular member without compressing the inlet path.
  • the support member is at least partially transparent. Via the transparent support member the passage can be conveniently inspected for clots or particles congesting the inlet.
  • the support member comprises an aperture extending from the outer surface of the member to the inner surface of the channel or passage, such that, in use, when the support member is positioned over the inlet path, the inlet path is viewable through the aperture.
  • an aperture allows for convenient inspection of the inlet path for obstructions, for example clots or particles congesting the inlet.
  • the support member can be removed and the inlet path cleared of the obstruction.
  • the support member comprises at least one releasable grip means for releasably positioning the support member to the container such that the inlet path is provided within the support member.
  • the releasable grip means can be a protrusion or protrusions for insertion into a portion of the container, for example, but not limited to, a hook, a clip, a tooth, button or a combination thereof.
  • the support member comprises a mounting portion.
  • This mounting portion allows attachment of the container to, for example, clothing of the person wearing the container such as, but not limited to a belt; or allows the hanging of the container on a bed, a stretcher, a mobile stand or the like, thereby providing good mobility and convenient use.
  • the mounting portion may comprise a protrusion or protrusions, a hook, a clip, a tooth, button or a combination thereof.
  • the container additionally comprises a venting outlet which projects through and is sealed to the top edge of the container.
  • the end projecting through the outer surface of the container comprises a valve which allows gaseous venting but not liquid.
  • the gas venting outlet is in the form of a tubular member but any other suitable outlet type may be considered.
  • the inventors having determined a container with the above features, appreciate that conventional ambulatory containers could be provided with these improved features.
  • a second aspect of the invention provides a secondary venting device which is mountable over or provided as part of an outlet of a container for connection to a pleural cavity, such as a chest drainage device, wherein the venting device comprises a member selectively permeable for gas and not liquid and optionally at least one of an adsorbent member and deodorising material.
  • a member selectively permeable for gas, an adsorbent member and a deodorising material for use in the second aspect of the invention can be selected from the examples discussed herein in relation to the first aspect.
  • the secondary venting device can comprise an adhesive portion or other means arranged such that the said venting device can be mounted onto a conventional container connectable to a pleural cavity such that a fluid tight connection between the venting device and an outlet of a container and / or to a container is provided.
  • an inlet path support member wherein the support member comprises at least an outer surface and an inner surface wherein the inner surface forms at least one channel having a first end and a second end, wherein the channel is sized such that the length of the channel between the first and second ends is greater than the length of a valve portion of a container inlet path received by the channel.
  • the inlet support member can be tubular, and comprise a first end, a second end and a passage which extends from the first end of the tube to the second end of the tube wherein the passage is sized such that a container inlet path can be surrounded by the tubular member without compressing the inlet path.
  • the support member is at least partially transparent.
  • the inlet support member can comprise an aperture extending from the outer surface of the support member to the inner surface, such that, in use, when the inlet support member is positioned over an inlet path, the inlet path is viewable through the aperture.
  • the inlet support member comprises at least one releasable grip means for releasably positioning the support member onto a container such that a container inlet path is provided within the support member.
  • the releasable grip means can be a protrusion or protrusions for insertion into a portion of the ambulatory container, a hook, a clip, a tooth, button or a combination thereof.
  • the inlet support member comprises a mounting portion.
  • This mounting portion allows attachment of the support member to, for example, clothing of the person wearing the container such as, but not limited to a belt; or allows the hanging of the container on a bed, a stretcher, a mobile stand or the like.
  • the mounting portion may comprise a protrusion or protrusions for insertion into a portion of the container, a hook, a clip, a tooth, button or a combination thereof.
  • a chest drainage kit comprising: - a chest catheter, and - a container comprising a fluid inlet path and an outlet path wherein the outlet path is selectively permeable for gas but not a liquid.
  • the kit further comprises a unidirectional valve arranged such that fluid can pass through the valve to enter the container, but cannot pass from the container past the valve.
  • the kit can comprise a first portion of tubing extending from the chest catheter to the unidirectional valve, and a second portion of tubing extending from the unidirectional valve to the container such that, in use, the chest catheter is fluidly connected to the container and fluid can move from the chest catheter to the container via the unidirectional valve, but cannot pass from the container to the catheter via the valve.
  • the chest drainage kit can comprise an inlet path support member wherein the support member comprises at least an outer surface and an inner surface wherein the inner surface forms at least one channel having a first end and a second end, wherein the channel is sized such that the length of the channel between the first and second ends is greater than the length of a valve of the container inlet path received by the channel.
  • Figure 1 shows a front view of a conventional ambulatory container
  • Figure 2A shows a front view of a container according to a preferred embodiment of the present invention
  • Figure 2B shows a front view of a container according to a preferred embodiment of the present invention showing more of the inlet tube
  • Figure 3 shows a detailed view of an outlet of a container as shown in Fig. 2;
  • Figure 4 shows a schematic view of an embodiment of an inlet support member for a container according an embodiment of the present invention
  • Figure 5 illustrates an embodiment of an inlet support member
  • Figure 6 illustrates an end view of an embodiment of an inlet support member
  • Figure 7A shows a front view of a container according to an alternative preferred embodiment of the present invention.
  • Figure 7B shows a front view of a container according to an alternative embodiment of the present invention showing more of the inlet tube
  • a conventional ambulatory chest drainage container 10 comprises a bag 12 having an inlet means 14 and an outlet 18.
  • the drainage catheter 16 and the outlet 18 are illustrated entering the bag 12 at a top edge 20 and are fluid tightly sealed to the bag 12.
  • the inlet means can be connected to a drainage catheter 16.
  • the inlet means 14 comprises a flutter valve 22 having a flat flexible plastic sleeve allowing drained liquid from the drainage catheter 16 to enter the bag whilst preventing reflow of the liquid from an interior 24 of the bag into the catheter 16.
  • the outlet 18 comprises a rigid tubular body member 26 having a first opening 28 within the interior 24 of the bag 12 and a second opening 30 outside the bag 12. Gas within the bag can move through the outlet by entering the first opening 28 and moving along the tubular body member 26 to the second opening 30, such that the gas exits the bag 12 into an environment 32.
  • the second opening 30 is protected with a rigid basket 34 with spaces 36 through which the gas can exit the bag 12.
  • the basket 34 protects the second opening 30 from being blocked, e.g. by clothing, but does not inhibit the movement of liquid out of the bag.
  • the tubular member can be used to drain the container to reduce the amount of the liquid in the container.
  • the top edge 20 of the bag 12 comprises a flat seal member 38 having holes 40a, 40b on opposite sides of the bag 12 from which the bag 12 can be hung when in use.
  • FIG 2 a front view of a container 42 according to a preferred embodiment of the present invention is shown.
  • the container 42 comprises a closed bag 42 having an inlet path 14, an outlet path 44 and a drainage tap 46.
  • a drainage catheter 16 is connected to the inlet path 14.
  • the inlet path 14 comprises a unidirectional inlet valve 50 such as a flutter valve 22 (shown in Fig. 1 ).
  • the drainage tap 46 is provided to a second edge 52 of the bag 12.
  • the bag 42 includes two cut-out portions 56a, 56b in a wall 54 of the bag and an outlet path 44 is provided over the cutout portions.
  • the outlet path 44 is fluidly sealed to the wall of the container 42.
  • a detailed view of the outlet path is shown in Figure 3.
  • the outlet path 44 comprises a gas permeable, but liquid impermeable polyoleophobic membrane 58 being fluid tightly connected with the wall 54 having a first surface directed towards the inside of the bag and a second surface directed away from the inside on the bag.
  • adsorbent member 60 overlaying the second surface of the membrane is an adsorbent member 60 wherein the adsorbent member 60 is spaced apart from the bag 42 via the membrane 58.
  • a sleeve 62 having cut-out portions 56a, 56b provided on the wall 54 removably fixes the adsorbent member 60 provided in the sleeve over the membrane of the outlet path, such that, in use, gases exiting the container pass through the adsorbent member.
  • FIG 4 shows a schematic view of an inlet support member 64 for a container 42 (shown in Figure 2) according to an embodiment of the present invention.
  • the inlet support member 64 comprises a semi-rigid or rigid member 66 having an outer surface 68a, 68b, a first end 70, a second end 72 and a channel 74, which in the embodiment shown, forms a passage extending through the member 66 from the first end 70 to the second end 72.
  • the passage 74 at least a portion of the inlet means 14 (shown in Figure 2) can be at least partially enclosed by the passage 74, which has inner dimensions (e.g. length and width) substantially larger than the inlet means 14, such that a portion of the inlet means 14 are enclosable within the passage 74.
  • a mounting portion 76 by which the inlet support member 64 and the container 42 can be attached to, for example, a patient's clothing or a stand, is located on the second end 72.
  • a releasable grip means 78 of the inlet support member 64 e.g. a pin or a button, fixes the support member 64 to the bag 12, thereby preventing displacement of the support member 64 and/or the inlet means 14.
  • the support member further comprises an aperture 80, which, when the support member is mounted on the container allows a user to view the inlet path to identify blockages in the inlet path and if necessary take action to remove such blockages.
  • FIG. 7 shows a front view of a container 42 according to an alternative preferred embodiment of the present invention.
  • the container 42 comprises a closed bag 42 having an inlet path 14, an outlet path 44 and drainage tap 46.
  • a drainage catheter 16 is connected to the inlet path 14.
  • the inlet path 14 comprises a unidirectional inlet valve 50 such as a flutter valve 22 (shown in Fig. 1 ).
  • the drainage tap 46 is provided to a second edge 52 of the bag 12.
  • the bag 42 includes two cut-out portions 56a, 56b in a wall 54 of the bag and an outlet path 44 is provided over the cutout portions.
  • the outlet path 44 is fluidly sealed to the wall of the container 42.
  • the container 42 also comprises venting outlet 90 formed by a tubular member which projects through and is sealed to the top edge of the container.
  • the lower end of the tubular member is open to the interior of the container or bag.
  • the tubular member is formed from flexible plastics material or the like and includes in association therewith and particularly in gaseous connection therewith, a valve 91 for the controlled and selective expulsion of gas from the interior of the container or bag. Said valve is located in the end of the tubular member which projects out from the interior of the container.
  • An advantage of this particular embodiment is that if the container or bag is for use in connection with the pleural cavity, then should the user experience a coughing fit the venting outlet and associated valve can be selectively controlled and operated by the user to release excess gas from the bag which had accumulated during the coughing fit. As such the container is more comfortable to wear and use. Furthermore, such an embodiment can remove the need for a support member around or adjacent to the inlet path 42 as the venting outlet 90 can itself act as such a support due to its location and close proximity to the inlet path 42 which due to the relatively rigid nature of the venting outlet tubular structure prevents bending of the flutter valve or other such valve within the inlet path 42.

Abstract

A container (42) is provided which is connectable to a pleural cavity said container comprising an inlet path (14) and an outlet path (44) wherein the outlet path is selectively permeable for gas, and not liquid. The container can be of flexible material and the inlet path comprises a unidirectional valve (50) or the like. The outlet path of the container is generally a member welded, moulded and / or embedded into the container. The container's preferred use is as a chest drainage bag but is not limited to such use.

Description

Container
FIELD OF INVENTION
The present invention relates to a container, particularly to an ambulatory container and more particularly to an ambulatory bag.
BACKGROUND
The need to drain liquid and / or gases from a body arises where disease, or injury (including operations) causes a build up of such fluids, particularly in a body cavity, which can interfere with, e.g., organ or tissue function or wound healing.
For example, where liquids and / or gases build up in the pleural cavity, the lungs can be subject to collapse or incomplete expansion. As a result, these liquids and / or gases should be drained and / or vented from the pleural cavity. Drainage and / or venting can be performed through the chest wall, and the drained liquid or gas is normally collected in a rigid or flexible drainage device, such as a drainage bottle or drainage bag. Due to its rigidity, a drainage bottle can be used with gravity and/or suction to allow drainage/ venting and is commonly used for stationary applications. A drainage bag is mainly used in ambulatory applications, emergencies, ambulances or military applications or where patients are transported, as drainage bags are more compact, lightweight and flexible than bottles.
Flexible drainage bags having a fluid inlet comprising a flutter valve and an outlet for venting gas have been previously described wherein the outlet comprises a rigid tubular member projecting into the bag which has an open end outside the bag. Gas present in the bag, for example air being compressed by the liquid entering the bag, gaseous degradation products and/or microbial metabolites can pass from the bag into and through the tubular member and escape out of the bag.
SUMMARY OF THE INVENTION
According to one aspect of the present invention there is provided a container suitable for connection to a pleural cavity comprising a fluid inlet path and an outlet path wherein the outlet path is selectively permeable for gas and not liquid.
The container may be a medical / surgical container or bag. In particular embodiments the container is sized and shaped to allow it to be used as an ambulatory container or bag. In preferred embodiments the container can be a chest drainage container or chest drainage bag.
In preferred embodiments the fluid inlet path comprises a unidirectional valve. However, as will be appreciated, in particular embodiments of the container, the fluid inlet path can be provided by a tube to which a unidirectional valve can be attached.
In preferred embodiments the container is a closed bag of flexible material. In particular embodiments, the container, for example a closed bag, comprises an inlet path arranged to allow fluid to enter the bag and to prevent fluid leaving the bag, and an outlet path wherein the outlet path allows gas to escape from the container, but prevents liquid escaping from the container.
Thereby, any liquid having entered the bag will be maintained inside the bag and cannot contaminate an environment outside of the bag. On the other hand gas such as air compressed by the liquid entering the container or bag, gaseous degradation products and/or microbial metabolites, can escape the container such that the gas does not accumulate within the container. As a result, pressure inside the container is minimised or at least reduced, allowing the liquid to easily enter the container.
In preferred embodiments, the bag can be formed from plastics material, for example PVC, latex or the like, by heat sealing two sheets of plastics together around their edge such that walls and edges of the bag are provided. The inlet path and outlet path may separately be provided in either a wall or an edge of the bag. In particular embodiments the container can be formed from transparent material.
Suitably, in preferred embodiments the unidirectional valve can be, for example, a flutter valve, a Heimlich valve or the like. In particular preferred embodiments, the unidirectional fluid inlet path comprises means to attach the inlet path to a chest catheter, more particularly a percutaneous thoracic catheter. As will be appreciated, such means can include, a screw attachment, a bayonet attachment, a push fit attachment or the like.
In particular embodiments of the outlet path which is selectively permeable for gas, the outlet path can include a member comprising apertures arranged such that gas can move through the apertures and the movement of liquid through the apertures is restricted.
In preferred embodiments such a member of the outlet path is moulded and / or embedded into the container but most preferably is welded into the container. However, other suitable mounting means can be used and such is not limited to those exemplified above.
Preferably the member of the outlet path can have a width in the range from 15 mm to 35mm, such that sufficient apertures are provided by the member of the outlet path to allow a suitable flow rate of gas / gases out of the container.
In particular embodiments of the container, the member comprising apertures can be a flexible membrane. This can be advantageous as a flexible membrane can provide the container with more flexibility, which may be particularly advantageous where the container is an ambulatory container. A flexible membrane also decreases the likelihood of the outlet path protruding from the container into, for example, a subject wearing the container.
In particular embodiments, the membrane can be at least partially formed from a material selected from the group comprising polyethylene (PE), polypropylene (PP), polyisobutylene (PIB) and/or polytetrafluoroethylene (PTFE).
In some embodiments the membrane can be a hydrophobic membrane. This is advantageous as if the membrane is substantially unwettable by the liquid inside the bag, which may be an aqueous liquid, blocking of gas exchange via the apertures is minimised.
In other embodiments the membrane is formed of, or coated with, a material which repels fat and lipid (i.e is lipophobic). In certain embodiments, the membrane is a polyoleophobic membrane, for example polytetrafluoroethylene (PTFE). A PTFE membrane is particularly advantageous, as PTFE provides for good hydrophobicity, non- adhesiveness and good temperature and chemical resistance. In particular embodiments the membrane can be provided with a backing material or carrier. Suitably the backing material can be woven / nonwoven, paper or PVC.
In particular embodiments, the container can further comprise an adsorbent member which is permeable to gas, but can trap odours, for example, odours, as caused by hydrocarbons, present in the gas. Typically, these odours may be caused by bacteria.
In such embodiments, the adsorbent member can be positioned such that gas exiting the outlet path passes through or around the adsorbent member.
Suitably, in particular embodiments, the adsorbent member can be placed in, on or over the outlet path. In such embodiments, in use, gas exiting the container via the outlet path passes over or through the adsorbent member, such that undesired odours are substantially removed from the gas before the gas is released into the environment. In particular embodiments the adsorbent member comprises carbon, activated carbon or similar material.
In embodiments, the adsorbent member, for example, but not limited to activated carbon, can be chemically treated, to enhance the absorbing properties of the adsorbent member and / or increase the surface area of the adsorbent member.
In particular embodiments of the container, at least one of the container and the adsorbent member can provide means for the removable positioning of the adsorbent member such that gas exiting the container via the outlet path has to pass through or over the adsorbent member. For example the adsorbent member may be removably positioned in, on or over the outlet path.
In particular embodiments, the container can comprise a sleeve member or pocket into which an adsorbent member can be inserted such that when the adsorbent member is provided in the sleeve, the absorbent member is positioned over the outlet path. As will be appreciated, the slidable insertion of an adsorbent member into a sleeve member means the adsorbent member can be removed and replaced and / or cleaned as required.
In specific embodiments wherein the container is a closed bag the sleeve member into which the adsorbent member can be slideably entered is formed on the outside of the bag and positioned such that gases exiting the outlet path, pass through or over the adsorbent member. This allows replacement of the adsorbent member.
In other embodiments, at least one of the container and the adsorbent member can comprise a releasable fastening means, such as, but not limited to, a clip, adhesive, a twisted fixing, a bayonet fixing a hook and eye arrangement, a zip, stud fastening, a contact fastener such as Velcro™ or the like to position the adsorbent member relative to the outlet path.
Removability facilitates the renewal or cleaning of an adsorbent member, for example, the exchange of a first adsorbent member for a second adsorbent member to retain adsorption, when, for example, the adsorbent member in use is substantially saturated. In particular embodiments, the container and / or the adsorbent member can further comprise a deodorising material which can destroy or mask odours.
In a preferred embodiment, the outlet path is locatable in at least one wall of the container. An advantage is that convenience in wearing or handling of the container, for example a bag, is provided, as, for example, potential interference of the outlet with other objects, such as clothing of a subject wearing and/or handling the bag, is reduced.
In another preferred embodiment the container further comprises a drainage tap. The drainage tap allows for convenient, controlled removal of the liquid from the container.
Furthermore, the drainage tap may comprise an attachment means for attaching an additional device, such as, but not limited to at least a second container into which the liquid can be drained.
In a preferred embodiment, the container comprises a layer of absorbent material such as a cotton or micro-fibre fleece on at least one outside wall of the container. Preferably, the absorbent layer can be attached to an outside wall of the container, for example an ambulatory bag, which when the container is in use, will be close to a person wearing the container. The layer increases comfort when the bag is placed on or next to the skin. Additionally, in specific embodiments, the absorbent layer can be removable, such that the absorbent layer can be cleaned or be replaced by a new layer. In embodiments of the container wherein the outlet path is a flexible membrane the outlet path may not provide resistance to folding or bending of the inlet path. Folding or bending of the inlet path, where for example the inlet path is a flutter valve, can lead to obstruction of the inlet path.
In particular embodiments of the container, wherein the container is flexible, the container can comprise at least one reinforcing member arranged on or in the container such that bending or folding of the inlet path is inhibited.
In particular embodiments a reinforcing member can be provided alongside the inlet path.
In embodiments of the container, the container can comprise an inlet path support member wherein the support member comprises a member formed from semi-rigid or rigid material, the member comprising at least an outer surface and an inner surface wherein the inner surface forms at least one channel having a first end and a second end. The inlet path support member can be provided in the interior or exterior of the container. Preferably the inlet path support member can be provided to the exterior of the container. Preferably, the length of the channel between the first and second ends is greater than the length of a valve portion of the inlet path such that, in use, the support member partially receives and encloses the valve portion of the inlet path. Preferably at least 30% of the circumference of the inlet path is surrounded by the support member.
In preferred embodiments no substantial compression of said inlet path occurs when, in use, the inlet path is received by the channel. Advantageously, the support member minimises the risk of bending or folding of the inlet path and thus of obstruction of the inlet path.
In particular embodiments the support member partially receives and encloses the inlet path such that at least 40%, at least 50%, at least 60%, at least 70%, at least 80%, at least 90%, at least 100% of the circumference of the inlet path is surrounded by the support member.
The primary advantage is that the inlet support member protects a valve portion of inlet path, for example a flutter valve from being bent or folded, particularly when the container is a flexible bag that can be folded and thus minimises the risk that the inlet path is blocked.
In one embodiment, the inlet support member may be tubular and a passage extends from a first end of the tube to a second end of the tube wherein the passage is sized such that the inlet path can be surrounded by the tubular member without compressing the inlet path.
In a preferred embodiment, the support member is at least partially transparent. Via the transparent support member the passage can be conveniently inspected for clots or particles congesting the inlet.
In another embodiment, the support member comprises an aperture extending from the outer surface of the member to the inner surface of the channel or passage, such that, in use, when the support member is positioned over the inlet path, the inlet path is viewable through the aperture. Advantageously, such an aperture allows for convenient inspection of the inlet path for obstructions, for example clots or particles congesting the inlet. In particular embodiments, should an obstruction be detected in the inlet path, the support member can be removed and the inlet path cleared of the obstruction.
Suitably, in particular embodiments, the support member comprises at least one releasable grip means for releasably positioning the support member to the container such that the inlet path is provided within the support member. In suitable embodiments the releasable grip means can be a protrusion or protrusions for insertion into a portion of the container, for example, but not limited to, a hook, a clip, a tooth, button or a combination thereof.
Suitably, in particular embodiments the support member comprises a mounting portion. This mounting portion allows attachment of the container to, for example, clothing of the person wearing the container such as, but not limited to a belt; or allows the hanging of the container on a bed, a stretcher, a mobile stand or the like, thereby providing good mobility and convenient use.
For example, the mounting portion may comprise a protrusion or protrusions, a hook, a clip, a tooth, button or a combination thereof.
In a further preferred embodiment the container additionally comprises a venting outlet which projects through and is sealed to the top edge of the container. The end projecting through the outer surface of the container comprises a valve which allows gaseous venting but not liquid.
In one embodiment the gas venting outlet is in the form of a tubular member but any other suitable outlet type may be considered. The inventors having determined a container with the above features, appreciate that conventional ambulatory containers could be provided with these improved features.
Accordingly, a second aspect of the invention provides a secondary venting device which is mountable over or provided as part of an outlet of a container for connection to a pleural cavity, such as a chest drainage device, wherein the venting device comprises a member selectively permeable for gas and not liquid and optionally at least one of an adsorbent member and deodorising material.
As will be appreciated, a member selectively permeable for gas, an adsorbent member and a deodorising material for use in the second aspect of the invention can be selected from the examples discussed herein in relation to the first aspect.
In suitable embodiments, the secondary venting device can comprise an adhesive portion or other means arranged such that the said venting device can be mounted onto a conventional container connectable to a pleural cavity such that a fluid tight connection between the venting device and an outlet of a container and / or to a container is provided.
According to a third aspect of the invention, there is provided an inlet path support member wherein the support member comprises at least an outer surface and an inner surface wherein the inner surface forms at least one channel having a first end and a second end, wherein the channel is sized such that the length of the channel between the first and second ends is greater than the length of a valve portion of a container inlet path received by the channel. In one embodiment the inlet support member can be tubular, and comprise a first end, a second end and a passage which extends from the first end of the tube to the second end of the tube wherein the passage is sized such that a container inlet path can be surrounded by the tubular member without compressing the inlet path.
In embodiments of the inlet support member, the support member is at least partially transparent.
In other embodiments the inlet support member can comprise an aperture extending from the outer surface of the support member to the inner surface, such that, in use, when the inlet support member is positioned over an inlet path, the inlet path is viewable through the aperture.
Suitably, in particular embodiments, the inlet support member comprises at least one releasable grip means for releasably positioning the support member onto a container such that a container inlet path is provided within the support member. In suitable embodiments the releasable grip means can be a protrusion or protrusions for insertion into a portion of the ambulatory container, a hook, a clip, a tooth, button or a combination thereof.
Suitably, in particular embodiments, the inlet support member comprises a mounting portion. This mounting portion allows attachment of the support member to, for example, clothing of the person wearing the container such as, but not limited to a belt; or allows the hanging of the container on a bed, a stretcher, a mobile stand or the like. For example, the mounting portion may comprise a protrusion or protrusions for insertion into a portion of the container, a hook, a clip, a tooth, button or a combination thereof. According to a fourth aspect of the present invention there is provided a chest drainage kit comprising: - a chest catheter, and - a container comprising a fluid inlet path and an outlet path wherein the outlet path is selectively permeable for gas but not a liquid.
In embodiments of the kit, the kit further comprises a unidirectional valve arranged such that fluid can pass through the valve to enter the container, but cannot pass from the container past the valve.
In particular embodiments the kit can comprise a first portion of tubing extending from the chest catheter to the unidirectional valve, and a second portion of tubing extending from the unidirectional valve to the container such that, in use, the chest catheter is fluidly connected to the container and fluid can move from the chest catheter to the container via the unidirectional valve, but cannot pass from the container to the catheter via the valve.
In suitable embodiments the chest drainage kit can comprise an inlet path support member wherein the support member comprises at least an outer surface and an inner surface wherein the inner surface forms at least one channel having a first end and a second end, wherein the channel is sized such that the length of the channel between the first and second ends is greater than the length of a valve of the container inlet path received by the channel.
An embodiment of the present invention will now be described, by way of example only, with reference to the accompanying figures, in which: Figure 1 shows a front view of a conventional ambulatory container
Figure 2A shows a front view of a container according to a preferred embodiment of the present invention;
Figure 2B shows a front view of a container according to a preferred embodiment of the present invention showing more of the inlet tube;
Figure 3 shows a detailed view of an outlet of a container as shown in Fig. 2;
Figure 4 shows a schematic view of an embodiment of an inlet support member for a container according an embodiment of the present invention;
Figure 5 illustrates an embodiment of an inlet support member;
Figure 6 illustrates an end view of an embodiment of an inlet support member;
Figure 7A shows a front view of a container according to an alternative preferred embodiment of the present invention; and
Figure 7B shows a front view of a container according to an alternative embodiment of the present invention showing more of the inlet tube;
As illustrated in Figure 1 , a conventional ambulatory chest drainage container 10 comprises a bag 12 having an inlet means 14 and an outlet 18. The drainage catheter 16 and the outlet 18 are illustrated entering the bag 12 at a top edge 20 and are fluid tightly sealed to the bag 12. As illustrated, the inlet means can be connected to a drainage catheter 16.
Further, as illustrated by Figure 1 , the inlet means 14 comprises a flutter valve 22 having a flat flexible plastic sleeve allowing drained liquid from the drainage catheter 16 to enter the bag whilst preventing reflow of the liquid from an interior 24 of the bag into the catheter 16.
The outlet 18 comprises a rigid tubular body member 26 having a first opening 28 within the interior 24 of the bag 12 and a second opening 30 outside the bag 12. Gas within the bag can move through the outlet by entering the first opening 28 and moving along the tubular body member 26 to the second opening 30, such that the gas exits the bag 12 into an environment 32. The second opening 30 is protected with a rigid basket 34 with spaces 36 through which the gas can exit the bag 12. The basket 34 protects the second opening 30 from being blocked, e.g. by clothing, but does not inhibit the movement of liquid out of the bag. Indeed, the tubular member can be used to drain the container to reduce the amount of the liquid in the container.
The top edge 20 of the bag 12 comprises a flat seal member 38 having holes 40a, 40b on opposite sides of the bag 12 from which the bag 12 can be hung when in use.
In Figure 2 a front view of a container 42 according to a preferred embodiment of the present invention is shown. The container 42 comprises a closed bag 42 having an inlet path 14, an outlet path 44 and a drainage tap 46. A drainage catheter 16 is connected to the inlet path 14. The inlet path 14 comprises a unidirectional inlet valve 50 such as a flutter valve 22 (shown in Fig. 1 ). To a second edge 52 of the bag 12, the drainage tap 46 is provided. The bag 42 includes two cut-out portions 56a, 56b in a wall 54 of the bag and an outlet path 44 is provided over the cutout portions. The outlet path 44 is fluidly sealed to the wall of the container 42. A detailed view of the outlet path is shown in Figure 3. The outlet path 44 comprises a gas permeable, but liquid impermeable polyoleophobic membrane 58 being fluid tightly connected with the wall 54 having a first surface directed towards the inside of the bag and a second surface directed away from the inside on the bag. As shown in Figure 3, overlaying the second surface of the membrane is an adsorbent member 60 wherein the adsorbent member 60 is spaced apart from the bag 42 via the membrane 58. A sleeve 62 having cut-out portions 56a, 56b provided on the wall 54 removably fixes the adsorbent member 60 provided in the sleeve over the membrane of the outlet path, such that, in use, gases exiting the container pass through the adsorbent member.
Figure 4 shows a schematic view of an inlet support member 64 for a container 42 (shown in Figure 2) according to an embodiment of the present invention. The inlet support member 64 comprises a semi-rigid or rigid member 66 having an outer surface 68a, 68b, a first end 70, a second end 72 and a channel 74, which in the embodiment shown, forms a passage extending through the member 66 from the first end 70 to the second end 72. Within the passage 74, at least a portion of the inlet means 14 (shown in Figure 2) can be at least partially enclosed by the passage 74, which has inner dimensions (e.g. length and width) substantially larger than the inlet means 14, such that a portion of the inlet means 14 are enclosable within the passage 74. A mounting portion 76, by which the inlet support member 64 and the container 42 can be attached to, for example, a patient's clothing or a stand, is located on the second end 72. When the inlet support member 64 is positioned over the inlet means 14, a releasable grip means 78 of the inlet support member 64, e.g. a pin or a button, fixes the support member 64 to the bag 12, thereby preventing displacement of the support member 64 and/or the inlet means 14. As illustrated in Figure 5, in the embodiment of the support member shown, the support member further comprises an aperture 80, which, when the support member is mounted on the container allows a user to view the inlet path to identify blockages in the inlet path and if necessary take action to remove such blockages.
Figure 7 shows a front view of a container 42 according to an alternative preferred embodiment of the present invention. The container 42 comprises a closed bag 42 having an inlet path 14, an outlet path 44 and drainage tap 46. A drainage catheter 16 is connected to the inlet path 14. The inlet path 14 comprises a unidirectional inlet valve 50 such as a flutter valve 22 (shown in Fig. 1 ). To a second edge 52 of the bag 12, the drainage tap 46 is provided. The bag 42 includes two cut-out portions 56a, 56b in a wall 54 of the bag and an outlet path 44 is provided over the cutout portions. The outlet path 44 is fluidly sealed to the wall of the container 42.
In addition the container 42 also comprises venting outlet 90 formed by a tubular member which projects through and is sealed to the top edge of the container. The lower end of the tubular member is open to the interior of the container or bag. The tubular member is formed from flexible plastics material or the like and includes in association therewith and particularly in gaseous connection therewith, a valve 91 for the controlled and selective expulsion of gas from the interior of the container or bag. Said valve is located in the end of the tubular member which projects out from the interior of the container. An advantage of this particular embodiment is that if the container or bag is for use in connection with the pleural cavity, then should the user experience a coughing fit the venting outlet and associated valve can be selectively controlled and operated by the user to release excess gas from the bag which had accumulated during the coughing fit. As such the container is more comfortable to wear and use. Furthermore, such an embodiment can remove the need for a support member around or adjacent to the inlet path 42 as the venting outlet 90 can itself act as such a support due to its location and close proximity to the inlet path 42 which due to the relatively rigid nature of the venting outlet tubular structure prevents bending of the flutter valve or other such valve within the inlet path 42.
It is recognised that various alterations and modifications, and / or additions may be introduced into the constructions and arrangements of the part described above without departing from the scope of the present invention as defined by the appended claims.

Claims

Claims
1. A container connectable to a pleural cavity comprising an inlet path and an outlet path wherein the outlet path is selectively permeable for gas, and not liquid.
2. The container as claimed in claim 1 wherein the container is a chest drainage bag.
3. The container as claimed in claims 1 or 2, wherein the inlet path comprises a unidirectional valve.
4. The container as claimed in any preceding claim wherein the container is a closed bag of flexible material.
5. The container as claimed in any one of the preceding claims, wherein the outlet path is a member moulded and / or embedded into the container.
6. The container as claimed in any one of claims 1 to 4, wherein the outlet path is a member welded into the container.
7. The container as claimed in claims 5 or 6, wherein the member is a hydrophobic membrane.
8. The container as claimed in claim 7, wherein the hydrophobic membrane is an oleophobic membrane.
9. The container as claimed in any one of the preceding claims wherein the container further comprises an adsorbent member which is permeable to gas exiting the outlet path and can trap odours.
10. The container as claimed in claim 9, wherein the adsorbent member comprises activated carbon or similar material.
11. The container as claimed in claims 9 or 10, wherein at least one of the container and the adsorbent member comprises means for the removable positioning of the adsorbent member such that gas exiting the outlet path has to pass through or over the adsorbent member.
12. The container as claimed in any one of claims 9 to 11 , wherein the container comprises a sleeve member into which an adsorbent member can be inserted such that when the adsorbent member is provided in the sleeve, gas exiting the outlet path has to pass through or over the adsorbent member.
13. The container as claimed in any one of the preceding claims wherein the container further comprises a deodorising material.
14. The container as claimed in any one of the preceding claims wherein the container further comprises a drainage tap.
15. The container as claimed in any one of the preceding claims wherein the container further comprises a layer of absorbent material on at least one wall of the container.
16. The container as claimed in any one of the preceding claims wherein the container further comprises a gas venting outlet.
17. The container as claimed in claim 16 wherein the gas venting outlet comprises a valve for control and selective expulsion of gas from the container.
18. The container as claimed in any one of the preceding claims wherein the container comprises at least one reinforcing member arranged to inhibit obstruction of the inlet path.
19. The container as claimed in any one of the preceding claims wherein the container further comprises an inlet path support member, wherein the support member comprises a member formed from semi-rigid or rigid material, the member comprising at least an outer surface and an inner surface, wherein the inner surface forms at least one channel having a first end and a second end, wherein the length of the channel between the first and second ends is greater than the length of the inlet path such that, in use, the support member partially receives and encloses the inlet path, such that at least 30% of the circumference of the inlet path is surrounded by the support member.
20. The container as claimed in Claim 19, wherein the inlet support member is tubular having a first end, a second end and a passage which extends from the first end to the second end wherein the passage is sized such that the inlet path can be surrounded by the tubular member without compressing the inlet path.
21. The container as claimed in Claim 19 or Claim 20, wherein the support member is at least partially transparent.
22. The container as claimed in any one of Claims 19 to 21 , wherein the support member comprises an aperture extending from the outer surface of the member to the inner surface, such that, in use, when the support member is positioned over the inlet path, the inlet path is viewable through the aperture.
23. The container as claimed in any one of Claims 19 to 22, wherein the support member comprises at least one releasable grip means for releasably positioning the support member to the container such that the inlet path is provided within the support member.
24. The container as claimed in any one of Claims 19 to 23, wherein the support member comprises a mounting portion.
25. A container substantially as hereinbefore described with reference to Figures 2 to 3 of the accompanying drawings.
26. A container substantially as hereinbefore described with reference to Figure 7 of the accompanying drawings.
27. A venting device which is mountable over an outlet of a container connectable to a pleural cavity, wherein the venting device comprises a member selectively permeable for gas and not liquid.
28. The venting device as claimed in Claim 27 further comprising an adhesive portion for mounting the venting device on to a container.
29. An inlet path support member for arrangement around an inlet path to a container connectable to a pleural cavity, wherein the inlet path support member comprises at least an outer surface and an inner surface, wherein the inner surface forms at least one channel having a first end and a second end, wherein the channel is sized such that the length of the channel between the first and second ends is greater than the length of a container inlet path received by the channel.
30. The inlet path support member as claimed in Claim 29, wherein the inlet support member is tubular, having a first end and second end and a passage which extends from the first end to the second end, wherein the passage is sized to be arranged around a container inlet path received by the passage without compressing the inlet path.
31. The inlet path support member as claimed in claims 29 or 30 wherein the member is at least partially transparent.
32. The inlet path support member as claimed in any one of Claims 29 to 31 further comprising an aperture extending from the outer surface to inner surface such that, in use, when the support member is positioned over an inlet path, the inlet path is viewable through the aperture.
33. The inlet path support member as claimed in any one of Claims 29 to 32 further comprising at least one releasable grip means for releasably positioning the support member onto a container.
34. An inlet path support member substantially as hereinbefore described with reference to Figures 4, 5 and 6 of the accompanying drawings.
PCT/GB2008/002894 2007-08-28 2008-08-27 Container WO2009027665A1 (en)

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GB2452393A (en) 2009-03-04
GB0716610D0 (en) 2007-10-10
GB2452393B (en) 2009-12-02
WO2009027665A4 (en) 2009-05-07

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