Patent Description:
In urinary catheterization a latex, polyurethane, or silicone tube known as a urinary catheter is inserted into a patient's bladder via the urethra, or via suprapubic catheterization. Alternatively, the catheterization may also take place with placement of a urisheath (condom type catheter). Catheterization allows the patient's urine to drain freely from the bladder for collection, measuring of volume, monitoring and analysis. In a closed urinary drainage system the catheter extends to a urinary drainage bag where its end is coupled to an inlet to a collecting compartment of the urinary drainage bag for collecting the urine in the collecting compartment of the urinary drainage bag. The urinary drainage bag can typically hold between <NUM> liter to <NUM> liter of urine. When the urinary drainage bag is full, or emptied for other reasons, it is in a first alternative example replaced by a new and empty urinary drainage bag by removing the catheter from the inlet of the filled urinary drainage bag and placing the catheter on an inlet of the new urinary drainage bag.

In a second alternative example the urinary drainage bag comprises an outlet through which urine in the compartment of the urinary drainage bag can flow out of. An outlet valve regulates flow of urine out through the outlet. In the second alternative example the urinary drainage bag is emptied by having the outlet valve in an open state. In the second alternative example urine can also be taken from the urinary drainage bag for testing, for measuring of volume and analysis.

Examples of catheter systems and urinary drainage bags are described in the below patent applications and patents:.

The emptying of the urinary drainage bag is a non-sterile process and it is an object of the present invention to improve the emptying of the urinary drainage bag such that the emptying becomes more hygienic and safe for the nursing staff and patients with less risk of infection. It is a second object of the present invention that the emptying becomes sterile. It is also an object of the object of the present invention to dispense of the collected urine in the urinary drainage bag via waste handling methods. It is a further object of the present invention to shield and protect the urine drainage bags' outlet, which is important for overall hygiene reasons.

The above object and advantages together with numerous other objects and advantages, which will be evident from the description of the present invention, are according to a first aspect of the present invention obtained by:.

The receptacle bag may be made from a first foil and a second foil being welded together, i.e. placing the first foil on top of the other and welding them together. The welding is placed proximate the edges of the foils, which means that the welding is between <NUM> - <NUM> from the edges. The foils may be thin polyethylene foils having a thickness between <NUM> - <NUM>. The welded foils have an inner side constituting a side of the receptacle compartment and an outer side facing away from the receptacle bag. The foils may be have a flat rectangular shape. The first foil may comprise a number of foil layers and the second foil may comprise a number of foil layers.

The receptacle bag may formed by stretch blow moulding a preform. The preform may be formed in an injection moulding process. In the stretch blow moulding process the preform is heated above its glass transition temperature and blown, using high pressure air, such that a container part is expanded. The expanded container part constitutes the receptacle compartment. The preform comprises the connector for connection to the urine drainage bag. The preform may be made from polyethylene.

The receptacle bag may be made from a fibrous pulp material by forming two paperboard sheets, which may be glued together. An alternative material for the receptacle bag could be other organic based materials. The receptacle bag can also be formed through the use of a vacuum forming process.

The receptacle bag may comprise a receptacle valve for regulating the flow of urine into the receptacle compartment via the receptacle inlet. When the receptacle valve is in an open state, fluid can flow into the receptacle compartment through the passageway and when the receptacle valve is in a closed state, the passageway is blocked and fluid is prevented from flowing out of the receptacle compartment.

The receptacle valve may be a non-return valve for allowing fluid to flow in only one direction, the direction being into the receptacle compartment. Fluid pressure from the receptacle valve side facing the receptacle compartment results in the receptacle valve closing and fluid pressure from the opposite side results in the receptacle valve opening. When the urinary drainage bag is placed higher than the receptacle bag, gravity alone may act on the urine in the urinary drainage bag causing the urine to flow out of the urinary drainage bag and putting pressure on the receptacle valve such that the receptacle valve opens where after the urine flows further down into the receptacle compartment.

The receptacle compartment is a pouch or a pocket forming an enclosed space for storing urine emptied from the urine drainage bag comprising a volume between <NUM> liter to <NUM> liter. The receptacle compartment may have a larger volume than the urinary drainage bag. A small urinary drainage bag with respect to a receptacle bag may be emptied a number of times into the receptacle bag. For example a one liter urinary drainage bag may be emptied five times into a five liter receptacle bag before the receptacle bag is brought to waste handling. Alternatively, the receptacle bag may extend the overall capacity of the system such that a receptacle bag of five liter and a urinary drainage bag of five liter provides for a system with a capacity of five liter in total.

The connector may comprise a flexible and firm material such as silicone, PVC or PVC-free alternative materials, etc. The connector may be manufactured separate from the receptacle bag and attached to the receptacle bag by nursing staff or it may be attached to the receptacle bag during manufacturing of the receptacle bag.

The connector may be formed as a longitudinal tube. The connector may be manufactured separate from the receptacle bag and attached to the receptacle bag by nursing staff or it may be attached to the receptacle bag during manufacturing of the receptacle bag.

Alternatively the connector may be formed in a two shot molding process, wherein two separate materials are incorporated into one part. A first part of the connector may be made from a first material for coupling to the receptacle bag and a second part of the connector may be made from a second material for coupling to the outlet. The second material is preferably softer than the first material.

A proximal end of the connector with respect to the receptacle bag may be formed as a female funnel. A female funnel has an increasing circumference or radius as the funnel comes towards its end. A distal end of the connector may be formed as a female funnel. The distal end of the connector goes around the outlet tube. The shape of the distal end of the connector may complement or counterpart the shape of the outlet tube such that the distal end can engage the outlet tube.

The distal end may be placed around the outlet or the outlet valve of the urinary drainage bag soon after a patient has been fitted with a closed urinary drainage system and even before any urine has been collected in the urinary drainage bag. In this way the connector may shield the outlet or the outlet valve of the urinary drainage bag and protect against drainage or infection up though the outlet or the outlet valve. The distal end of the connector may provide tension with respect to the outlet or the outlet valve. The distal end of the connector may stretch around the outlet.

The outlet of the urinary drainage bag may project from the urinary drainage bag in the form of an outlet tube. The outlet tube has an outlet passageway for fluid communication between a proximal end and a distal end of the outlet tube with respect to a collecting compartment of the urinary drainage bag such that fluid can flow out of the collecting compartment. The distal end of the outlet tube may have a conical shape or a male funnel shape.

The flow of fluid through the outlet passageway is regulated by the outlet valve of the urinary drainage bag. When the outlet valve is in an open state fluid can flow out of the urinary drainage bag through the outlet passageway and when the outlet valve is in a closed state the outlet passageway is blocked and fluid is prevented from flowing out of the urinary drainage bag. The outlet valve may be operated manually between the open state and the closed state. The outlet valve may be a cross valve. The cross valve comprises a stem and a gate. A handle can be actuated for moving the gate from a closed position to an open position and vice versa. In an alternative solution the cross valve of the urinary drainage bag is substituted by a pull-push opening or another valve type, such as a finger flip or leaver tap. Theses valve type would likewise be possible to insert into the female funnel of the receptacle bag.

According to a further embodiment, a fluid absorbent powder is placed in the receptacle compartment by filling it through a pipe down through the receptacle valve before the connector is coupled to the outlet, i.e. before the receptacle bag is interconnected with the urinary drainage bag. In this way the receptacle bag can be produced as a finished entity with the receptacle valve where after the fluid absorbent powder can be placed in the receptacle compartment after the receptacle bag has been produced, in the form of lose powder or a long sleeve/pouch. The receptacle bag may comprise the pipe for passing the fluid absorbent powder through the first inlet and into the receptacle compartment. The receptacle valve prevents the fluid absorbent powder to come out of the receptacle bag again.

In an embodiment the fluid absorbent powder is a super absorbent polymer or slush powder, which are polymers that can absorb and retain large amounts of a liquid relative to their own mass. It is likewise possible to use an organic material having similar properties.

The fluid absorbent powder may also be provided in a sachet that that dissolve when it comes into contact with a liquid.

The fluid absorbent powder reacts with the urine when the powder and the urine meet in the receptacle compartment. The reaction results in a gel or a substance with a higher viscosity than the viscosity of the urine. In an embodiment the fluid absorbent powder absorb aqueous solutions such as urine through hydrogen bonding with water molecules.

The fluid absorbent powder stabilizes the urine that has been emptied from the urinary drainage bag and filled into the receptacle compartment of the receptacle bag. The receptacle bag may then be transported to a waste handling facility or to further processing of the patients collected urine output.

The receptacle compartment may contain urine comprising cancer drug. In an embodiment the receptacle bag comprises a barrier around the receptacle compartment for reducing radiation from cancer drug in the urine waste.

According to a further embodiment, the receptacle bag comprises a hanger for hanging the receptacle bag on the urinary drainage bag by placing it at a lower height than a height of the urinary drainage bag.

The hanger may be a lanyard or a cord or a string. As the outlet valve is opened gravity may force the urine from the urinary drainage bag down into the receptacle bag. As the urinary drainage bag is emptied and the receptacle bag is filled the nursing staff does not have to support the increasing weight of the receptacle bag.

The hanger may provide tension between the receptacle bag and the urinary drainage bag such that the connector is less likely to fall off.

The receptacle bag is provided with one or more holes such as two, three or four holes. The one or more holes are located along a first side of the receptacle bag corresponding to a side comprising the receptacle inlet. The hanger extends through the holes and may form a ring or have two ends that can be tied together for forming a closed ring.

The hanger may comprise a handle for holding the receptacle bag with such that nursing staff can carry the receptacle bag from bedside to waste handling point thereby not having to touch the receptacle bag.

In an embodiment the hanger comprises a tie-knot for adjusting the length of the hanger. A width of the hanger is between <NUM> - <NUM> for twisting the hanger and adjusting the length via the twisting.

According to a further embodiment the hanger is supported by the outlet valve. The hanger may be tied to the outlet valve or placed around the outlet valve. This provides for a simple procedure for the nursing staff to attach the receptacle bag to the urinary drainage bag, especially in embodiments where the outlet valve comprises a cross valve.

According to a further embodiment the connector is removed from the outlet and a closure is placed on the connector for closing a passageway into the receptacle compartment. This provides added safety from drainage during transport of a filled receptacle bag. The closure may be a plug or spigot that fits tightly in the passageway. The closure may be a separate entity or attached to the receptacle bag. In an embodiment the closure is attached to the hanger or to a lanyard or string attached to the receptacle bag.

In an embodiment the receptacle bag may comprise a first tube coupled to the receptacle inlet. The first tube is coupled or connected to the receptacle inlet and projects from the receptacle bag. The first tube has a first conduit for fluid communication between a proximal end and a distal end of the first tube such that fluid can flow through the first tube and into the passageway of the receptacle inlet. The distal end of the first tube may have a conical shape or a male funnel shape. A male funnel has a decreasing circumference or radius as the funnel comes towards its end. The connector may be coupled to the first tube at a proximate end of the connector.

According to a second aspect of the present invention the above objects and advantages are obtained by:.

According to a third aspect of the present invention the above objects and advantages are obtained by:.

According to a fourth aspect of the present invention the above objects and advantages are obtained by:.

The invention will be explained in more detail below in connection with advantageous embodiments of the invention with reference to the drawings, in which:.

The present invention wilt now be described more fully hereinafter with reference to the accompanying drawings, in which exemplary embodiments of the invention are shown. The invention may, however, be embodied in 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.

<FIG> shows a traditional closed urinary drainage connected to a patient <NUM>. A catheter <NUM> extends to a urinary drainage bag <NUM> where its end is coupled to a first inlet <NUM> to a collecting compartment <NUM> of the urinary drainage bag <NUM> for collecting urine <NUM> in the collecting compartment <NUM> of the urinary drainage bag <NUM>. It should be noted, that the dimension and position of the urinary drainage bag <NUM> in <FIG>, <FIG> and <FIG> are not actually proportions of the urinary drainage bag <NUM> or receptacle bag <NUM>, but are used for the purpose of showing in which context the invention is used.

The collecting compartment <NUM> is a pouch or a pocket forming an enclosed space for collecting urine comprising a volume between <NUM> liter to <NUM> liter.

The outlet <NUM> of the urinary drainage bag <NUM> projects from the urinary drainage bag <NUM> in the form of an outlet tube. The outlet tube has an outlet passageway for fluid communication between a proximal end and a distal end of the outlet tube with respect to a collecting compartment <NUM> of the urinary drainage bag <NUM> such that fluid can flow out of the collecting compartment. The distal end of the outlet tube has a conical shape (male funnel shape).

The flow of fluid through the outlet passageway is regulated by the outlet valve <NUM>. When the outlet valve <NUM> is in an open state fluid can flow out of the urinary drainage bag <NUM> through the outlet passageway and when the outlet valve <NUM> is in a closed state the outlet passageway is blocked and fluid is prevented from flowing out of the urinary drainage bag <NUM>. The outlet valve <NUM> may be operated manually between the open state and the closed state. The outlet valve <NUM> may be a cross valve. The cross valve comprises a stem and a gate. A handle can be actuated for moving the gate from a closed position to an open position and vice versa.

<FIG> is a perspective of an example of a receptacle bag <NUM> for emptying the urinary drainage bag <NUM>. In the example shown in <FIG> the receptacle bag <NUM> has been made by welding two rectangular PE foils together. The foils has been welded together <NUM> to <NUM> from the edge of the foils.

In the top of the receptacle bag a first tube <NUM> has been welded on in order to provide for a passageway into a receptacle compartment <NUM> for storing urine emptied from the urinary drainage bag <NUM>.

The receptacle compartment <NUM> comprises a fluid absorbent powder <NUM> for stabilizing urine. The fluid absorbent powder was placed in the receptacle bag <NUM> via a pipe.

The receptacle bag <NUM> comprises a receptacle valve for regulating a flow of urine from the urinary drainage bag into the receptacle compartment <NUM>.

The receptacle bag <NUM> was made with a hanger <NUM> for hanging the receptacle bag <NUM> on the urinary drainage bag <NUM>. The hanger <NUM> is a lanyard. A closure <NUM> for closing a passageway into the receptacle bag was attached to the hanger <NUM>. The closure comprised a closure end <NUM> in the form of a plug, which has a conical shape and is tapered.

A connector was coupled to the receptacle inlet. The connector comprises a first end <NUM> for engaging with the first tube <NUM> and a second end <NUM> for engaging with an outlet <NUM> or an outlet valve <NUM> of the urinary drainage bag <NUM>. The first end <NUM> comprises a female funnel for placement around the first tube <NUM>. The second end <NUM> comprises a female funnel for placement around the outlet <NUM> or the outlet valve <NUM> of the urinary drainage bag.

In another example the connector and inlet tube are made as an integral unit in one piece that can be coupled to the receptacle bag in a welding process. The connector provides a passageway into the receptacle compartment. The connector is to extend from the receptacle bag and have a free end in the shape of a female funnel.

<FIG> is a perspective of the receptacle bag <NUM> connected to the urinary drainage bag <NUM>. The outlet valve <NUM> is set to an open state such that urine can flow from the collecting receptacle compartment <NUM> of the urinary drainage bag <NUM> through the outlet <NUM> and into the receptacle compartment <NUM> of the receptacle bag <NUM>. As the urine flows into the receptacle compartment <NUM> it reacts with the fluid absorbent powder <NUM>. The reaction results in a gel or a substance with a higher viscosity than the viscosity of the urine.

The hanger <NUM> is a lanyard or a cord or a string. As the outlet valve <NUM> is opened gravity may force the urine from the urinary drainage bag <NUM> down into the receptacle compartment <NUM> of the receptacle bag <NUM>. As the urinary drainage bag <NUM> is emptied and the receptacle compartment <NUM> is filled the nursing staff does not have to support the increasing weight of the receptacle bag.

The receptacle bag <NUM> is provided with one or more holes such as two, three or four holes. The one or more holes are located along a first side of the receptacle bag corresponding to a side comprising the receptacle inlet. The lanyard extends through the holes and may form a ring or have two ends that can be tied together for forming a closed ring.

The lanyard comprises a tie-knot for adjusting the length of the lanyard. A width of the lanyard is between <NUM> - <NUM> for twisting the lanyard and adjusting the length via the twisting. The lanyard is placed around the outlet valve. The outlet valve is a cross valve.

The distal end of the connector is placed around the distal end of the outlet tube such that urine from the drainage bag may be funneled into the receptacle bag. This reduces the risk of spillage from where the outlet tube and the connector overlap each other. This would be the case where a separate adapter is used to interconnect the drainage bag and the receptacle bag. The system comprising the drainage bag and the receptacle bag consist of one single overlap of interconnected tubes, i.e. the connector is integral with the receptacle bag, and it is placed directly over the outlet tube of the drainage bag, and there are no adapters.

<FIG> is a perspective of the closed urinary drainage and the receptacle bag <NUM> after the content of the urinary drainage bag <NUM> has been emptied into the receptacle bag <NUM>.

The closure <NUM> is placed the connector <NUM> for closing a passageway in the connector <NUM> and to provide added safety from drainage during transport of a filled receptacle bag.

The closure <NUM> is a plug having a conical shape that fits tightly in the passageway of the connector <NUM>.

<FIG> is a perspective of a receptacle bag <NUM> in its packaging <NUM> wherein the packaging <NUM> is partly opened to allow the connector <NUM> to extend out of the packaging and be connected with the urinary drainage bag <NUM>. The packaging comprises a mark for indicating a part of the packaging to be opened. The mark is located between a first side <NUM> and a second side <NUM>. The first side <NUM> being opposite the second side <NUM>. The difference between the distance from the mark to the first side <NUM> and the distance from the mark to the second side <NUM> is less than <NUM> %. The receptacle bag <NUM> is placed in the packaging with connector <NUM> located between the first side <NUM> and the second side <NUM> and closer to the mark than to the first side <NUM> or the second side <NUM>.

The urinary drainage bag <NUM> comprises a cross valve which together with the outlet tube from the urinary drainage bag has a cross shaped cross section. The cross valve comprises a first arm <NUM> and a second arm <NUM>. The first arm extends a first distance from outlet tube and the second arm extends a second distance from the outlet tube. The first distance and the second distance are at least <NUM>.

<FIG> is a perspective of an example of a receptacle bag <NUM> for emptying the urinary drainage bag <NUM>. A distal end of the outlet tube with respect to the urinary drainage bag comprises a female part <NUM> of a bayonet coupling for coupling with a male part <NUM> on the second end <NUM> of the connector <NUM>. The section of <FIG> surrounded by a dashed circle is shown as an enlarged section in <FIG>. In an alternative embodiment not shown, the male part is formed inside the second end of the connector <NUM> allowing the second outlet <NUM> of the urinary drainage bag to be inserted into the connector <NUM> of receptacle bag <NUM>, whereby the second outlet <NUM> is rotated, eg. <NUM> degree, for obtaining a connection between the receptacle bag <NUM> and the urinary drainage bag <NUM>.

<FIG> is a perspective of an enlarged section of the section encircled by a dashed circle in <FIG>. The enlarged section shows female part <NUM> of a bayonet coupling for coupling with a male part <NUM> on the second end <NUM> of the connector <NUM>.

<FIG> is a perspective of an example of a preform <NUM> of a receptacle bag to be produced in a stretch blow moulding process. The preform comprises a container part <NUM> and a neck <NUM>. The preform is formed in an injection moulding process. In the stretch blow moulding process the preform is heated above its glass transition temperature and blown, using high pressure air, such that the container part is expanded. The neck <NUM> comprises the connector <NUM> for connection to a urine drainage bag. It should be noted that the non-return valve is not shown in <FIG>.

<FIG> is a perspective of an example of a receptacle bag <NUM> that has been produced in a stretch blow moulding process. The receptacle bag <NUM> comprises a neck and a receptacle compartment <NUM>. The neck <NUM> comprises the connector <NUM> for connection to a urine drainage bag.

<FIG> is a perspective of an example of a preform <NUM> of a receptacle bag to be produced in a stretch blow moulding process. The preform comprises a closure <NUM> at distal end of a tether <NUM>. The tether comprises a loop at a proximal for placement around a neck of the preform.

<FIG> is a perspective of an example of a preform <NUM> of a receptacle bag to be produced in a stretch blow moulding process. The preform comprises a tether <NUM> and a hanger <NUM>. The tether comprises a loop <NUM>. A distal end of the hanger comprises an anchor for placement in the loop <NUM>.

<FIG> is a perspective of a drainage system for wound drainage such as drainage of abdominal, chest or thorax-related excess bodily fluids. A catheter is placed in the wound and may lead to a three way valve (not shown) or <NUM>-ways stop cock. The stop cock has three ports (openings connected to each other via an internal tubing). The catheter is inserted into the first port. The second port is a center port with a needleless connector for taking samples of the bodily fluid, and the third port is a connection to a tube <NUM> leading to a receptacle bag <NUM> as described above.

The tube is a polymer tube having a first tube end, and a second tube end. The polymer tube has a length between <NUM> to <NUM>, such as <NUM> to <NUM>, and preferably <NUM>.

The receptacle bag comprises a receptacle compartment for storing the liquid. It has a receptacle inlet into said receptacle compartment. The receptacle inlet is constituted by a connector having a distal end with respect to the receptacle compartment. The distal end defines a female funnel for receiving the polymer tube, i.e. the first tube end defines a male funnel which is placed in the female funnel. The receptacle bag may contain a volume between <NUM> - <NUM>.

The second tube end comprises a male luer lock fitting <NUM> for connecting to a female luer on the stop cock. The male luer lock fitting comprises an internal thread.

Claim 1:
A drainage bag system for urinary collection comprising
- a urinary drainage bag (<NUM>) encompassing
a first inlet (<NUM>) and an inlet valve for regulating a flow of urine from a catheter (<NUM>) into said urinary drainage bag (<NUM>) via said first inlet,
an outlet (<NUM>) and an outlet valve (<NUM>) for regulating a flow of urine (<NUM>) out of said urinary drainage bag (<NUM>),
- a receptacle bag (<NUM>) of a foil or sheet material for emptying said urinary drainage bag (<NUM>), said receptacle bag encompassing
a receptacle compartment (<NUM>) for storing urine, and
a connector for providing a connection between said receptacle bag (<NUM>) and said urinary drainage bag (<NUM>), said connector providing a second inlet constituting a receptacle inlet to said receptacle compartment (<NUM>) when connected to said receptacle bag (<NUM>) such that urine can flow into said receptacle compartment (<NUM>),characterized in that
said receptacle bag comprising a non return valve for regulating the flow of urine into said receptacle compartment via said receptacle inlet, wherein said receptacle compartment (<NUM>) comprises a fluid absorbent powder (<NUM>) for stabilizing urine.