Urine collection bags for urinary catheter systems

ES 2 269 484 T3

DESCRIPTION

Urine collection bags for urinary catheter systems.

Technical scope

The present invention relates to urine collection bags for urinary catheter systems.

In US-A-4 230 115 a urine collection bag as defined in the preamble of claim 1 is disclosed.

Background

Urinary catheter systems generally include a long, flexible, thin tube (the urinary catheter) that is inserted into the urethra, passes the trigone muscle, and is inserted into the bladder, to remove urine from the bladder. Urine flows through the catheter and is collected, for example, in a urine collection bag. When the flow of urine stops, or the bag is full, the catheter is removed from the bladder. Generally, the catheter is lubricated to facilitate insertion. In a closed catheter system, the lubricated catheter is delivered into the urine collection bag, along with a urethral insertion tip, in order to avoid human contact / contamination of the catheter when the catheter is inserted into the urethra. The insertion tip is inserted into the urethra of the patient, and the catheter is extracted from the interior of the bag, sliding the catheter through the bag following the procedure indicated below. Once the inserter tip has been inserted, the user stabilizes the inserter tip with their non-dominant hand (ie, if the user is right handed, they will do so with their left hand). Next, using their dominant hand, the user grasps the catheter with their index fingers and thumb, through the bag, just where the insertion tip ends, and gradually introduces the catheter into the urethra. The user is inserting the catheter by pushing it with his non-dominant hand, while he uses his dominant hand to withdraw the bag without actually removing the catheter from the urethra. Next, the user reduces the pressure exerted by the fingers of his non-dominant hand, and repeats the previous step a number of times until the catheter is inserted in the bladder and the urine begins to flow into the bag.

During this procedure, the catheter has a tendency to back up into the bag as the user attempts to insert it, which can result in an uncomfortable and frustrating situation for the user. This is due in part to the difficulty of grasping the lubricated catheter through the bag material. Many urinary catheter users have problems with the strength of their fingers, due to spinal injuries, making it even more difficult to grasp the catheter. Also, if the bag is made of certain materials, moving the bag in this way may cause a sound that may be embarrassing to the user if the catheter is being used in public toilets.

Summary

The present invention provides a urine collection bag that includes features that allow easy insertion of a urinary catheter into the bladder of a patient. In some embodiments, the urine collection bag is constructed of a soft, flexible material that is comfortable against the user's skin, easy to handle, and generates relatively little noise when in use. In this way, it is possible to use the urine collection bag with a minimum level of discomfort and discreetly, in case of use in public toilets.

The urine collection bag is made of a material that has a surface texture that will allow the user to more easily grasp the catheter through the material of the bag. In some executions, the bag has an elongated neck and slightly rounded edges that provide the user with greater wearing comfort by reducing the friction of the bag with the user's legs, and eliminating sharp angles that could puncture the user.

The invention features a urine collection bag as defined in claim 1.

Different embodiments of this aspect of the invention may include one or more of the features listed below. The surface texture is provided on both opposite surfaces of the parts. The thickness of this surface texture is selected so as to give the plastic material a hardness of somewhat less than 85 Shore A. The minimum thickness of the surface texture is about 25% of the total thickness of the plastic sheet material. It is preferred that the thickness of the surface texture is between 25% and 75% of the total thickness of the plastic sheet material. More preferably, the thickness of said surface texture is between about 40% and 60% of the total thickness of the plastic sheet material. The plastic sheet material includes polyvinyl chloride. The plastic sheet material has a total thickness of between about 0.127 and 0.254 mm (5 to 10 mils). The surface texture gives the sheet material a hardness of between approximately 60 and 85 Shore A.

In some embodiments of this aspect of the invention, the sheet material is a non-noise generating material, eg, polyvinyl chloride.

The invention also features closed catheter systems including the urine collection bags described above.

The term "total thickness", when used herein to refer to a film of textured material, refers to the thickness of this film, including those raised areas of the surface texture (eg, the T dimension₀ of Figure 4A). If the textured film includes a surface texture with raised areas at different heights, the total thickness is measured at the highest point of the textured surface.

Other features and advantages of the invention are described in the corresponding description, as well as in the drawings and in the claims.

Description of the drawings

Fig. 1 is a front plan view of a urine collection bag according to one embodiment of the invention, showing a catheter in broken lines within the urine collection bag. Fig. 1A is similar to Fig. 1 except that the plug and catheter guide have been removed to more clearly show the braking interface tube. Fig. 1B is a sectional view of the bag, along line BB of Fig. 1A (for clarity, the catheter is shown as extending along line BB of Fig. 1A).

Figs. 2-2A are schematic perspective views showing how a user of the bag

ES 2 269 484 T3 urine collection shown in Fig. 1 is removing the catheter from inside the bag.

Figs. 3, 3A, and 3B are, respectively, enlarged top, side, and end views of a braking interface tube used in the urine collection bag shown in Fig. 1.

Fig. 4 is a highly enlarged and detailed view of the top of the textured surface of a film used in the urine collection bag shown in Fig. 1. Fig. 4A is a highly detailed and enlarged view Section of a portion of the bag, showing the opposite textured surfaces.

Figs. 5 and 5A are front plan views of different embodiments of the invention.

Fig. 6 is a front plan view of a urine collection bag, according to another possible embodiment of the invention.

Fig. 7 is a partial plan front view of a urine collection bag according to another possible embodiment of the invention, similar to that shown in Fig. 6. Fig. 7A shows the urine collection bags of Fig. 7, after the bag opening tab has been torn.

Figs. 8-8C are front views in partial plants of urine collection bags, in different possible embodiments of the invention, showing different designs of opening flaps.

Fig. 9 is a front plan view of a urine collection bag according to another possible embodiment of the invention.

Detailed description

With regard to Figs. 1, 1A and 1B, the urine collection bag 10 includes two opposing portions, 11 and 12, of a flexible sheet material (Fig. 1B) that are sealed by seams 14, thereby creating a substantially closed receptacle 13 for contain urine that comes from a patient's bladder. The joints 14 can be sealed, for example, by ultrasonic welding or by heat sealing. Before use, catheter 40 (drawn in dashed lines) is within urine collection bag 10. Catheter 40 includes a catheter tube 42 with a first end 44 for insertion into the patient's urethra, and a second end through which urine from the bladder flows into bag 10. The first end 44 of the catheter tube 42 includes an introducer tip that resides within a braking interface tube 48, which is attached to the base of the insertion tip 47. The function of this tube will be described in detail later. braking interface 48. Second end 46 of catheter tube 42 includes a rigid, non-deformable stop 51 designed to prevent catheter 40 from slipping out of bag 10 through the opening of tube 50 when the catheter is used. There is also a cap 43 to close the bag before and after each use.

The receptacle 13 may be essentially bottle-shaped, that is, it has an elongated and relatively narrow neck 15, shoulders 16, and a relatively wide reservoir area, 18. The neck 15 preferably has a width W (Fig. 1A) of less about 5 cm, more preferably between about 4 and 6 cm, a length L of at least about 8 cm, more preferably between about 8 and 12 cm. The shoulders 16 are slightly curved, preferably with a radius of curvature R between about 0.635 and 2.62 cm (0.25-1.03 inches). This shape has typically been found to increase wearer comfort, minimizing irritation and discomfort from sharp edges and angles. Although the receptacle can be as large as desired, it typically has a volume of at least 1000cc.

Preferably, as shown in Figs. 4 and 4A, the interior surfaces 20, 22 of the parts 11, 12 include a surface texture, for example, with a diamond-shaped pattern, as shown in Fig. 4. The surface texture provides the interior surfaces with a plurality of cavities 24 of thickness T, which is less than the total thickness T₀ sheet material. The surface texture of the sheet material serves two purposes. First, the cavities 24 act as hinges, significantly increasing the flexibility of the sheet material. This increased flexibility is beneficial in the case that the material used is rigid, and / or if it is desired to use a relatively thick sheet of material, for example, to facilitate its treatment or for reasons of resistance. Second, the surface texture makes it easier for the user to grasp the catheter through the bag when the user proceeds to insert the catheter, as indicated above in the Background section. As noted above, it is often difficult for the user to grasp a slippery, lubricated catheter through the sheet material. Since a surface texture increases the size of the available surface area, grip is markedly improved. Furthermore, during the gripping process, the cavities 24 act as small reservoirs where the lubricant is deposited, while the raised areas between them act as pressure points that grip the catheter.

The surface texture is on the internal surfaces 20 and 22, to provide a better grip; however, this surface texture can be applied to both the inner and outer surfaces 28 and 30.

The thickness of the surface texture, that is, the difference between T0 and T, will depend on the degree of flexibility that is desired, which in turn normally depends on the stiffness of the sheet material before the surface texture is applied to it. The two main variables that influence the stiffness of the sheet material are the thickness of the sheet (T0) and its hardness. The thicker and harder the material, the stiffer it will be. Normally, it is preferable that the surface texture has a thickness of at least 25% of the thickness T0, and preferably between 40% and 60%. If the plastic sheet material has an initial hardness (before surface texture is applied) of between approximately 60 and 80 Shore A, and a thickness of between approximately 0.127 and 0.254 mm (5-10 mils), the thickness will normally be between approximately 40% and 60%. If it is not necessary to increase flexibility, for example if a flexible material such as polyethylene is used, the thickness of the surface texture need only be enough to provide a better grip.

Preferred plastic sheet materials include extrudable thermoplastics, such as polyvinyl chloride (PVC), high and low density polyethylenes, and polypropylenes. PVC is preferred for some executions, due to its flexibility, soft3

ES 2 269 484 T3 ra, ease of treatment and its hypoallergenic and biocompatible properties. A suitable PVC is 78 Shore A PVC 2222 FS / 1-78 Clear 0202 Polyvinyl Chloride, available from Alpha Gary Corporation. Appropriate plastic materials are manufactured with polymer grades suitable for human contact. Preferably, once the surface texture has been imparted to the material, it has a hardness of between about 60 to 85 Shore A, more preferably between about 75 to 81 Shore A. The hardness of the material will determine, in addition to its flexibility, the level of noise that will be generated when handling the bag. If the material is too hard, the bag will make a lot of noise when handled, and it can also be difficult to handle. If it is too soft, the material may have a tendency to give itself away when bearing weight, thus distorting the accuracy of the markings on the bag for measuring liquid content. Some polyethylenes tend to be "noisy" when used for bags. If polyethylene is used, it is preferable that a relatively quiet grade is selected.

Typically, preferred materials are between about 0.127 and 0.254 mm (5 to 10 mils) thick. If the sheet material is too thin, it can be difficult to carry out sealing 14 (the edges of the parts forming the receptacle are sealed), while if it is too thick it can be difficult to achieve the desired degree of flexibility.

In Figs. 4-4A an appropriate surface texture is schematically shown. This surface texture is formed by the linear criss-crossing of areas of depression, creating a pattern of raised areas, usually diamond-shaped. Many other surface textures can be used, provided the desired levels of flexibility and / or grip are provided. Those skilled in the art can easily identify many other suitable surface textures, as well as include any other texture that can be applied to the surface of a metal roll, such as (but not limited to) squares, rectangles, triangles, ellipses, polygons, crystals, circles, snowflakes.

The surface texture can be implanted by extruding the sheet material and then passing it through a set of rollers that print the texture and proceeding to wind it, or use any other technique that is desired.

Braking interface tube

To use the urinary catheter 40, the insertion tip 47 must be inserted into the urethra of the patient and the catheter is extracted from the interior of the urine collection bag 10, sliding the catheter through the bag following the procedure indicated below. Once the inserter tip 47 has been inserted, the user stabilizes the inserter tip with their non-dominant hand 102, as shown in FIG. 2. Next, using their dominant hand 100, the user grasps the catheter tube 42 through the bag with their index finger and thumb, about 2.54-3.08 cm (1-2 inches) below the braking interface tube 48 (described below) and gradually introduces the catheter into the urethra. As shown in Fig. 2A, the user is inserting the catheter tube 42, grasping it with his non-dominant hand 102, while using his dominant hand 100 to withdraw the bag 10 without actually removing the tip of the catheter 44 from the urethra. Next, the user reduces the pressure exerted by the fingers of his non-dominant hand, and repeats the previous step several times until the catheter is inserted into the bladder and urine begins to flow into the bag.

During this procedure, the non-dominant hand grasps the catheter tube 42 by the stop interface tube 48. The stop interface tube 48 has an opening 50 having a beveled edge, with an angle of inclination A (Fig. 3A) . The value of this angle varies between 15 and 45 degrees measured between the horizontal H (a horizontal line along the upper surface 52 of the brake interface tube 48) and the X axis of the beveled edge. If the beveled edge was created by cutting the tube, the angle A will normally be slightly different from the angle at which the cut was made on the tube, due to flattening and deformation of the tube during cutting.

This beveled edge typically results in an open elliptical surface 54. When the user holds the catheter tube 42 with the non-dominant hand, the user places his thumb on the bag portion 11, either over the opening 54 or on the surface. top 52, and your index finger on the opposite side of the bag, on part 12, approximately in line with the thumb. In this way, the thumb causes the bag portion to press directly on the catheter tube 42, while the index finger presses the bag against the lower surface 56 of the braking interface tube, which, in turn, presses the tube. 42. When the user wishes to stop the catheter tube, the user brings his index finger and thumb together to press the stop interface tube against the catheter tube. The inventor has discovered that the beveled geometry of the braking interface tube, as well as the manner in which it is arranged, allows the user to securely grasp the catheter tube 42 through the bag during step (b), providing an effect of “braking” that generally prevents the tube from being reintroduced into the bag during this stage. The ability to brake the catheter tube during the removal process increases user comfort and facilitates insertion. In addition, the beveled edge of the opening 50 acts as a contoured stopper allowing the catheter to be fully removed using the textured sheet, without reaching a sharp stop point. This feature maximizes passage length (the length of catheter that is removed at each extraction stage), as well as control of the catheter during the insertion process.

The beveled edge of the tube also acts as an accommodation (in addition to preventing leakage) for the narrowest part of the deformable stop 51, when the catheter is completely withdrawn from the bag. Thanks to this sealing mechanism, possible leakage of liquid through the insertion tip, which would fall on the patient, his clothes or his bedding, is minimized or completely eliminated. Thanks to the presence of lubricant, the deformable stop 51 can be disengaged from the beveled edge with ease, when the user wishes to do so.

A stopper interface tube 48 may be supplied in a urine collection bag that does not have the textured surfaces described in previous paragraphs. However, it is preferable that the bag has both characteristics, since the textured surfaces enhance the braking effect that is obtained.

ES 2 269 484 T3 has when the braking interface tube is pressed against the flexible material of the bag.

Suitable materials for the braking interface tube are resilient thermoplastics such as PVC, polyethylene, polyurethanes, silicones and coextrusions of these materials. A preferred material is PVC; A suitable grade of this material is USP Class VI medical grade, marketed by Alpha Gary Corporation, product code 2222C65. Preferred materials have a hardness of less than approximately 80 Shore A, more preferably between approximately 40 and 80 Shore A, and most preferably this value is between approximately 50 and 70 Shore A. Generally , the thickness of the tube walls will be approximately between 0.89 and 1.02 mm. As a general rule, the thicker the wall, the softer the tube material should be. The hardness and thickness of the wall are selected so that the user, pressing with his fingers, can easily bring the walls of the braking interface tube together, in order to grip the catheter as described in the previous paragraphs. .

Using the closed catheter system

To obtain a urine sample, catheter 40 is withdrawn through stopper interface tube 48 and insertion tip 47, as described above, and inserted into the urethra of the patient. The catheter 40 is then gradually introduced into the urethra until the catheter reaches the bladder and urine begins to flow into the bag 10.

Once it has been used, it is possible to tear the bag 10 by means of the tab 60 located at the base of the neck of the bag. The urine in bag 10 can then be poured into a sample collection container for analysis.

Other embodiments are within the scope of the following claims.

For example, if the surface texture makes the bag translucent or opaque, it may be desirable for the bag to have a transparent window on one or both of the bag faces 11 and 12. (The degree of visibility through the surface texture will generally depend on the thickness of the texture, the transparency of the plastic and the manufacturing process used). This can be accomplished, for example, by applying the texture onto the film selectively in the machine direction during the film extrusion process. To simplify processing, the window may be in the form of a continuous transparent stripe, eg, longitudinal stripe 200 of Fig. 5, or transverse stripe 200A of Fig. 5A.

This window allows the user to better observe the stored urine and assess if it is too dark, cloudy, or if there are particles floating in it, indicating that the user should drink more water, as a first preventive measure against a urinary tract infection (UTI) . Having a visual reference often allows the user to protect themselves against a UTI by being able to take preventive measures in advance.

A possible alternative to the window or transparent strip is to apply the texture only on one of the parts 10 and 12, and leave the other part without texture.

In addition, the tab 60, shown on one side of the reservoir 18, Fig. 1, can be positioned anywhere else on the bag, to facilitate emptying of urine from the bag. For example, as shown in Fig. 6, a tab 202 can be placed on the neck portion of bag 215. This location allows an opening for emptying 204 to be created (Fig. 7A) on one side of the neck of the bag, instead of in the deposit area 18, as occurs in the embodiment shown in Fig. 1.

Preferably, the tab 202 is loosely attached to the neck 215 by a grooved groove 201, which allows the tab to be gently ripped by pulling it in the direction of the user (off the page, in Fig. 7), to arrive at the situation shown in FIG. 7A, which results in the opening for emptying 204. The tearing begins at the notch A (FIG. 7). The pour opening 204 typically has a nominal length of approximately 0.75-1.25 inches (1.9-3.2 cm), resulting in an aperture diameter of approximately 1.1-1.25 inches. 2 cm (0.45-0.8 inches), assuming the resulting opening was circular (in practice it is usually roughly elliptical).

This emptying opening, located in the neck of the bag, allows the user, or a caregiver, to empty the bag by holding it by the reservoir part, and directing the emptying opening downward. Being able to empty the bag with one hand allows wheelchair patients to use the other hand to control their wheelchair. The position of the tab on one side of the neck of the bag, with the tear direction in the opposite direction to where the patient is, allows the patient to take advantage of the own weight of the bag filled with urine in their favor, instead of hold it against you, as would be the case for other tear tab locations.

Another alternative arrangement that would allow the patient to empty the bag with one hand would be to place the tear tab at the bottom of the reservoir.

18. In this case, the user would hold the bottle by the neck to empty the bag.

The tear tab can have any other desired design. In Figs. 6, 7, 8 and 8C show examples of suitable designs that allow the tear-off tab to be easily torn off (as shown in Fig. 7A), while preventing it from being inadvertently pulled off or fluid leaks from the bag. The tear tab may have a hole into which the user can insert one of their fingers to pull the tab, such as holes 206 shown in Figs. 6, 7, 8 and 8C. The tear tab shown in Fig. 8C includes a hollow area 207 to facilitate gripping. Alternatively, the tear tab may have raised grooves or other structures that assist the user in holding the tab, such as grooves 208 in Figs. 8A and 8B.

The urine collection bag may also include other features designed to make the bag easier to grip during emptying, especially when the user needs to hold the bag with one hand. For example, as shown in Fig. 9, the bag may include a tab 210 at its distal end 212, with an opening 214 through which the user can insert one or more fingers to hold the bag while proceeding to remove it. emptied.