Patent Application
20120116335
The invention relates to a urine collection bag for use in connection with a catheter, the urine collection bag of which is provided with an anti-reflux valve at the inlet. The invention also relates to a kit of parts comprising a urine collection bag and a catheter.
For a large group of persons, intermittent catheterisation is a daily life procedure that takes place several times a day. Typically, catheters for intermittent catheterisation are used by people suffering from urinary incontinence or by disabled individuals like para- or tetraplegics who may have no control permitting voluntary urination, and for whom catheterisation may be the way of urinating. Using an intermittent catheter, the bladder may be drained through a natural or artificial urinary canal.
The availability of catheter assemblies, which are compact and discreet to transport and dispose of, in addition to being easy to use, even for individuals with reduced dexterity, significantly improves quality of life for a large group of individuals. SpeediCath® Compact Female is a compact catheter, as described above, and is produced by Coloplast A/S.
In some situations, a user may wish to use a catheter with a urine bag connected to it, for example when a patient in a wheel chair is unable to move from the wheel chair to the toilet. Urine bags are typically made from sheets of a foil material joined along the edges. The thickness of the urine bag is therefore very small, but due to the plane dimensions of the urine bag, it is rather indiscreet.
EP0748620 A1 describes a urine collection bag with an insert at an inlet, the insert of which comprises two lamellas which are relatively rigid, yet flexible. The insert further comprises two tubular elements of the same foil material as the bag extending inside the bag. One of these tubular elements extends beyond the other. At the end of each element, the element is welded to itself at discrete points.
The invention relates to a urine collection bag for use in connection with a catheter. The urine collection is made of foil layers and comprises a one-way valve (an anti-reflux valve) at the inlet. The valve is relatively long compared to the width which is contemplated to help keeping the valve closed unless liquid enters from the opening into the inlet and thereby into the valve. An aspect of the invention relates to where the inlet and valve are adapted in width to an outlet from a urinary catheter. Thereby the valve fits snugly at the outlet such that spillage from the catheter should be minimized. The invention also relates to a catheter kit comprising a catheter and a urine collection bag.
In a first aspect, the invention concerns a urine collection bag comprising
A length-width relationship in a foil valve as described above is an advantage when it comes to stopping liquid from exiting the bag. The relatively long length of the valve enables the two additional foil layers to be closed together when they are not separated by an object, such as a catheter.
In an embodiment the width is between 1.5 cm and 2.5 cm.
Another aspect of the invention relates to a urine collection bag comprising
Urinary catheters may be provided with a connector at the outlet of the catheter. In this situation, the width is adapted so that the connector is able to enter into the valve, hence the inlet of the bag. In an embodiment, the length is at least 10 cm. Typically, the connector has a standard size, for example between 10 and 15 mm.
Another way of describing this is that the valve or the inlet of the urine collection bag is configured to receive a catheter with an outlet of a standard size. In particular the urine collection bag is configured to receive a catheter of the type SpeediCath Compact Female as produced by Coloplast A/S. When a catheter of this type is inserted into the inlet of the bag, the inlet will provide a narrow fit around the outlet. This way the outlet is sealed with respect to the collection bag. The outlet of SpeediCath Compact Female is slightly conical and has a largest diameter of approximately 10 mm to 12 mm. The outlet of a standard catheter (the connector) is also conical and has a largest diameter of substantially the same size but may be slightly larger—up to 15 mm.
Both types of catheters fit within the inlet of the bag. A compact catheter such as SpeediCath Compact Female catheter will be able to be entered completely into the bag after it has been used. Thereby the parts to be disposed of are kept together, and the user does not have to pack the catheter and bag separately, which is especially convenient when the products cannot be readily disposed of.
The bag is made of a foil material such as low-density polyethylene (LDPE), which may be blended with ethyl vinyle acetate (EVA). LDPE provides a foil with a slight elasticity so that it springs back to its original configuration when extended slightly. When LDPE is blended with EVA, the foil material provides more surface friction and hence stronger closure of the valve. A slight elasticity of the material may be an advantage in connection with entering an outlet from a catheter into the inlet and valve. When the outlet is entered, it may slightly dilate the diameter of the valve, and due to the elasticity of the material, the valve will contract again to fit tightly around the outlet of the catheter. An example of material suited for the urine collection bag is a polyethylene film of VLLDPE (very low density polyethylene), such as type 98826 from Ulfoss Plastic A/S. The elasticity of the material may be expressed by the modulus of elasticity of the material. The modulus of the abovementioned film may be between 88.5 and 171 MPa according to ASTM D882, depending on the polymer direction compared to the pulling direction. A film—that is a material for the urine collection bag—may have a modulus of elasticity between 80 MPa and 180 MPa when determined according to ASTM D882. Such a film will be suitable for use.
The urine collection bag described above according to a first or second aspect of the invention may in one embodiment have a relationship between a most narrow width of the inlet and the length of the inlet such that the length is less than 3.5 times the width. In a related embodiment, the length is between 4 cm and 8 cm. Such a length will enable the outlet of the catheter placed in the valve to keep the valve open all the way to the end of it. Thereby urine exiting through the catheter and the outlet will unhindered enter into the collection bag.
The urine collection bag may in another embodiment have a relationship between a most narrow width of the inlet and the length of the inlet such that the length is more than 4 times the width. In a related embodiment, the length is more than 10 cm. If the valve is so long, then the catheter outlet placed in the valve will not be able to keep the valve open all the way to the end of it. Thereby, urine flowing from the bag towards the catheter will be prevented from flowing back into the catheter and further into the bladder. The bag is not a sterile product. Therefore, urine which has been in contact with the bag may be contaminated. Thus it should be avoided that urine returns into the bladder. By having an extra long valve, the back-flow is prevented—even if the user were to hold the bag above the catheter outlet.
The urine collection bag comprises a collecting lumen at an end of the bag. The opening into the bag is placed opposite the collecting lumen in the longitudinal direction of the bag. When the bag is held in the normal use-position the opening is uppermost and the collecting lumen is lowermost. The top of the bag is defined as the end including the opening and the bottom as the opposite end. In the normal use-position, the normal flow direction will be downwards, such that the collecting lumen is placed below the opening. When referring to below or above, the referral is in line with the normal flow direction. The width direction of all parts of the bag is defined as the direction transverse to the longitudinal direction—that is the direction transverse to the normal flow direction. The longitudinal direction of all parts of the bag is defined as the direction from top to bottom—that is the direction along the normal flow direction.
The foil-valve is made of four layers of foil welded together in the longitudinal direction leaving a gap between them. This gap functions as the inlet. At the opening, the four layers are welded together two and two in the transverse direction leaving two flaps extending into the bag at the inside. With this configuration liquid (in this case urine) can flow into the opening and through the gap (the inlet) and further down below the foil-valve. When the foil-valve is turned upside down, the two free flaps will close the gap between them so as to close the inlet. Thereby liquid (urine) cannot exit the bag.
The material for the bag is flexible and bendable so that it may be packed (for example by folding) in a configuration taking up as little space as possible. The bag can easily be folded into a configuration that is small enough to fit in a small bag or a hand.
Because the bag is made of only a few pieces of foil, only a small amount of material is used to make a bag. No further attachments need to be fitted into the bag. Furthermore, a foil bag consisting essentially only of welded foil layers, is cheap and easy to produce.
The urine collection bags may be provided with two flaps at the inlet for tying a knot around the inlet. Such flaps tied in a knot provide an increased security against spilling of urine. A knot tied with these flaps is an advantage in cases where a user has used the bag in a place where it cannot be emptied and disposed of—for example when the bag has been used in another room than a toilet or bathroom. When the flaps are tied at the inlet, the bag is completely closed and no urine can flow out. The user now has the possibility of transporting the bag to a place where it can be emptied and disposed of.
In an embodiment, the flaps are attached to the urine collection bag at tearable joints prior to use. Thereby the flaps on the bag are always available for use. In a related embodiment, the tearable joints are provided as perforation lines. These perforations may extend substantially along the inlet to a point below the opening of the bag. Thereby, when the perforations are torn, the flaps are still attached to the bag and readily provide for the possibility of tying a knot at the inlet.
The collection bag may be provided with holes for hanging or holding the bag. Such holes are typically provided at the top of the bag. The holes for hanging or holding have a curvature, and the tearable joints at the flaps may terminate in this curvature. Due to the curvature, the flaps will not have a direction for tearing further at the inlet.
Another embodiment relates to the foil valve which is provided with constrictions on the sides of the valve. By the sides of the valve is meant the longitudinal direction of the welds facing the inlet of the bag. The constrictions function as a stop for an outlet from a catheter so that when the catheter is inserted in the inlet—and thereby in the valve—the user will feel a certain resistance at the constrictions. In this way, the user will know that the outlet is inserted adequately. Two or more sets of constrictions may be provided. The first set of constrictions may be placed approximately 2 cm below the inlet of the bag.
If the length of the valve is less than 3.5 times the width, this position of the constrictions corresponds to 0.8-0.9 of the length of the valve, below the opening. In other words the constrictions are placed closer to the lower end of the valve than to the opening into the valve. When the constrictions are placed at this point, then the outlet of the catheter is able to keep the valve open all the way to the length. This may be an advantage because the flow of urine will always be able to flow into the bag as it is open beneath the catheter in the normal flow direction. The normal flow direction is defined as a flow direction from the opening of the bag, through the valve and into the bag.
If the length is more than 4 times the width, the position of the constrictions corresponds to less than half the length of the valve such as 0.3-0.4 times the length. Using the definition above for the normal flow direction, the constrictions are placed less than halfway through the valve in the normal flow direction. When the constrictions are placed at this point, then the outlet of the catheter is prevented from keeping the valve open all the way to the end of the valve. When the catheter is to be inserted, the user fits the catheter in the bag at the constriction. During insertion of the catheter into the urethra, the bag may be kept in a higher position than the catheter. By having the constrictions at that position the valve below the catheter in the normal flow direction will open for urine entering into the bag in the normal flow direction, but will be closed for urine coming from the bag—that is, against the normal flow direction—even with catheter placed in the valve at the constrictions.
In an embodiment, the urine collection bag is provided with a tear tab for opening into an outlet from the bag. The tear tab may be sized so that a user can grab and pull it with two fingers so it opens into an outlet. The outlet may be placed in the top part of the bag. When holding the bag at the top and tearing it open by the tear tab into the outlet, urine will not flow out of the bag.
The bag may be provided with at least one lobe for holding or handling the bag during use and emptying. In an embodiment, the holding lobe(s) may be provided with a hole for hanging the bag. In some situations, for example when tying knots, emptying, tearing the tab, and so on, it may be an advantage to have such a lobe on the bag. It may be difficult to handle a bag filled with liquid without having a lobe or other part to hold. Users who have poor hand dexterity may find it advantageous that the holding point is provided with a hole for hanging the bag. They can then hang the bag from a hook or similar means when they need to handle it. One of the holding lobes may be placed opposite the outlet of the bag. This holding lobe may then be used for holding or hanging the bag while it is emptied.
Another aspect of the invention relates to a kit of parts comprising a catheter and a urine collection bag as described above.
In an embodiment, the catheter is of the type SpeediCath Compact Female as distributed by Coloplast A/S.
Such a kit of parts can be packed and stored together taking up very little space which may be an advantage for the user when travelling or being away from home in general. In a kit of parts, the outlet of the catheter and the inlet of the bag are designed to fit together so that the catheter is closely connected to the bag when it is used. This configuration helps prevent spillage because the parts are able to stay connected even if the user should lose grip of one of the parts. All the liquid exiting the catheter is “forced” to flow into the bag.
The bag of
Furthermore, the cutting process may also provide a predefined cut 20 for tearing open into an outlet 21 by pulling at a tab 22. When the tab 22 is pulled in the arrow's direction, the predefined cut 20 will function as a direction for a tear line and extend as indicated by the dotted line 23. Thereby the outlet 21 will eventually be opened, and the liquid contained in the bag 1 can be poured out.
Finally, two additional side holes 24, 25 may be provided in the same cutting process. The side holes 24, 25 may be made again by providing a cut line 26, 27 around a hole-flap. The first side hole 24 may be used for holding the bag during tearing of the tab 22. The second side hole 25 may be used for holding the bag while pouring out the liquid contained in the bag. The two side holes 24, 25 are placed outside the inner contour 30 defining the collecting volume 5 of the bag. They are placed in lobes 31, 32 of welded foil layers extending from the inner contour 30 such that the outer contour 33 are not congruent with the inner contour 30. Likewise, the tab 22 is a lobe of welded foil layers extending from the inner contour.
| Number | Date | Country | Kind |
|---|---|---|---|
| PA 2009 00607 | May 2009 | DK | national |
| PA 2009 70064 | Jul 2009 | DK | national |
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/DK10/50102 | 5/12/2010 | WO | 00 | 1/25/2012 |
