Device, kit, and method for packaging a catheter device with shape-memory material

Abstract

The invention relates to a catheter device (1), preferably for intermittent self-catheterisation, to a kit comprising packaging and such a catheter device, and to a method for packaging a catheter device. The catheter device (1) comprises a catheter tube (2) for insertion into the urinary bladder. The catheter tube (2) is made, at least in part, from a shape-memory material, in particular a shape-memory polymer.

Description

[0001] Catheter device, kit and method for packaging a catheter device

[0002] The invention relates to a catheter device, preferably for intermittent self-catheterization, a kit comprising packaging and such a catheter device, and a method for packaging a catheter device.

[0003] A modern method for bladder emptying is intermittent self-catheterization. This involves inserting a disposable catheter into the bladder several times a day to empty it. Once the urine has completely drained, the catheter is removed and disposed of. The catheter therefore remains in the user's body for only a short time. Depending on fluid intake, the bladder should be emptied four to six times a day. This results in a need for four to six catheters per day. If a user plans to travel, for example, for several weeks, this quickly leads to a three-figure number of catheters that must be carried, thus requiring a considerable amount of space in their luggage.

[0004] There are two main types of catheters available on the market: soft catheters and rigid catheters. Soft catheters pose a very low risk of injury during insertion into the urethra. They can also be packaged compactly, saving space and preventing kinking (for example, in a ring shape). However, soft catheters are more difficult to insert into the urethra, as they are harder to push in if there is significant resistance. Rigid catheters, on the other hand, can be inserted into the urethra very easily. If there is resistance, this is often not a problem. However, rigid catheters cannot be packaged in any other way than straight, as they would otherwise kink. If the straight shaft is kinked, inserting the catheter into the bladder becomes more difficult, as the user can only apply minimal pressure before the shaft kinks again.For this reason, catheters are usually carried in elongated and rigid outer packaging, so that the catheters cannot be carried arbitrarily in travel luggage, but require storage space that allows the catheters to be carried in their outer packaging.

[0005] The present invention is therefore based on the objective of designing and further developing a catheter device or catheter packaging in such a way that, while ensuring good insertion of the catheter, the space required for carrying the catheter is kept as low as possible.

[0006] According to the invention, the aforementioned problem is solved by the features of claim 1. Accordingly, the catheter device in question, which is preferably a catheter device for intermittent self-catheterization, comprises a catheter tube for insertion into the bladder. This catheter tube is made at least partially of a shape-memory material, in particular a shape-memory polymer.

[0007] In accordance with the invention, it has first been recognized that kinking of the catheter tubing is generally only relevant with regard to the insertion of the catheter into the urethra, since the tightness of the catheter tubing is not impaired by kinking, except in extreme situations. Once the catheter tubing is inserted, it is therefore of minor importance whether the catheter has been kinked beforehand. However, with conventional materials, prior kinking makes it more difficult to overcome resistance when inserting the catheter tubing into the urethra. This effect can be overcome by the catheter tubing "remembering" its previous, rigid shape and returning to its original form. This can be achieved by manufacturing the catheter tubing at least partially from a shape-memory material, in particular a shape-memory polymer.When this shape-memory material is stimulated by a stimulus such as the addition of liquid, temperature, light, or electricity, it returns to its original, kink-free shape and can therefore be easily inserted into the urethra. At the same time, the shape-memory material allows the otherwise rigid catheter tube to be packaged in a compact form, such as a spiral, rolled, ring, or serpentine shape, without impairing its insertion.

[0008] The use of a shape memory material is particularly advantageous in catheter devices with at least a partially rigid catheter tube, as the material's shape memory properties allow the rigidity or stiffness of the catheter tube to be restored. Accordingly, the catheter tube can have at least one rigid section. This section, or even the entire catheter tube, can be made of the shape memory material. This restores the advantages of a rigid catheter tube regarding insertion ease.

[0009] Preferably, the catheter tube can have both a rigid section to facilitate insertion and a flexible section to prevent injury. Thus, the catheter tube can have a first, rigid section and a second, flexible insertion aid. At least the first section can be made of shape-memory material. This shape-memory material can then be used to restore the rigid shape of the first section.

[0010] Shape memory materials are materials with the ability to "remember" and return to their original shape after deformation or distortion. These materials possess a special internal structure that allows them to store changes in their shape and return to it when activated by external stimuli. In particular, a shape memory material can be designed to assume a predefined shape after stimulation by at least one of the following: liquid, temperature, light, and electricity. The shape memory material can be selected such that a suitable stimulus triggers the shape memory effect.

[0011] Some catheters have a hydrophilic surface or coating on the catheter tubing. When exposed to a wetting agent, this hydrophilic surface swells slightly, creating a lubricating effect, thus eliminating the need for additional lubricants during insertion. Catheters with a hydrophilic surface / coating are often supplied dry and must be moistened or come into contact with a wetting agent to become ready for use. This can be achieved by dispensing the wetting agent from a container located within the packaging. The catheter tubing itself is coated with a gel that dries out on the surface or is already dry when supplied.The surface of the gel-coated catheter is wetted with liquid, resulting in a ready-to-use state within just a few seconds. This liquid can also be used to create the shape memory effect. For example, thermoplastic polyurethanes (TPU) are known to react with liquids. Accordingly, the catheter tube, or at least its rigid section, can be made of a polyurethane with shape memory properties. Alternatively, other shape memory polymers, such as polylactic acid (PLA) or modified forms of polyethylene (PE) or polypropylene (PP), are conceivable as shape memory materials.

[0012] One aspect of the present invention relates to a kit (or set) comprising such a catheter device and packaging. The catheter device is arranged within the packaging. By using a catheter device with a catheter tube that is at least partially made of a shape-memory material, packaging can be created in which the catheter tube is not necessarily arranged in a straight position.

[0013] In particular, the catheter tubing can be arranged in or with the packaging in a spiral shape, i.e., with a radius that changes (increases or decreases) with each wrap. A spiral shape allows for a flat and compact package size because the catheter tubing does not overlap itself, and the spiral begins with the smallest possible radius. Alternatively, the catheter tubing can be arranged in the packaging in the form of a ring, preferably rolled into a ring with multiple wraps, similar to a lasso. This increases the height of the packaging but allows for a smaller radius. Furthermore, less precision is required when coiling the catheter tubing than with the spiral shape, thus simplifying packaging.

[0014] Alternatively, the catheter tubing can be arranged in a serpentine shape within or alongside the packaging. In this serpentine configuration, the catheter tubing alternates between a first direction and a second direction that is essentially the opposite of the first. This also allows for compact packaging dimensions, although it comes at the cost of the catheter tubing kinking if the radius during the change of direction between the first and second directions becomes very small.

[0015] In principle, the catheter, with its tubing made at least partially of a shape-memory material, can be packaged in various types of packaging. For example, a combination of outer packaging, such as a pouch or bag, which limits the dimensions of the catheter device, and inner packaging, which protects the sterility of the tubing and / or a dried hydrophilic gel, can be used to package the catheter device. In this case, the packaging comprises an outer and an inner package. The tubing is placed inside the inner package within the outer package. The resulting shape of the inner package, which can be tubular to match the shape of the tubing, follows the shape of the tubing.The inner packaging can be arranged in a spiral, ring, or serpentine pattern with the catheter tubing, depending on the tubing's orientation. The catheter tubing, together with the inner packaging, can thus be arranged in a spiral, ring, or serpentine pattern within the outer packaging.

[0016] Alternatively, provided sterility is ensured within the outer packaging, only an outer packaging can be used, and the catheter tubing can be arranged within it without any further inner packaging. In this case, too, the outer packaging can be designed as a pouch or bag and limit the packaging dimensions of the catheter device. The catheter tubing can then be arranged within the outer packaging in a spiral, ring, or serpentine pattern without any inner packaging.

[0017] As a further alternative, a thin, tubular package can be used exclusively, which does not restrict, or only minimally restricts, the dimensions and shape of the catheter device. In this case, the catheter tubing can be packaged in a tubular package. For shipping or additional protection during transport, this tubular package can be placed in a separate outer container, such as luggage or a bag.

[0018] The shape memory material is activated by a so-called stimulus, whereupon the catheter tube assumes the predefined shape, and in particular its original shape. In some embodiments of the present invention, this stimulus can be arranged together with the catheter device in the packaging. Accordingly, the kit can further comprise a stimulation source, such as a pouch containing a liquid or a heat source. This stimulation source can also be arranged in the packaging and configured to stimulate the shape memory material after activation by a user, so that at least a section of the catheter tube assumes the predefined shape. In particular, this can be achieved, as described above, by using a liquid, which is used to wet a dried gel on the catheter tube, also as a stimulus for the shape memory material of the catheter tube.

[0019] Another aspect of the present invention relates to a corresponding method for packaging a catheter device, preferably a catheter device for intermittent self-catheterization, with a catheter tube for insertion into the bladder. The catheter tube, which is at least partially made of a shape-memory material, is arranged in a spiral, serpentine, or ring shape within or with a package.

[0020] There are now various ways to advantageously elaborate and further develop the teaching of the present invention. For this purpose, reference should be made, on the one hand, to the claims subordinate to claim 1 and, on the other hand, to the following explanation of preferred embodiments of the invention with reference to the drawing. In conjunction with the explanation of the preferred embodiments of the invention with reference to the drawing, generally preferred embodiments and further developments of the teaching are also explained. The drawing shows

[0021] Fig. 1 shows a schematic view of a catheter device with a catheter tube bent in a serpentine shape;

[0022] Fig. 2 shows a schematic view of a catheter device with a catheter tube that is bent in a spiral shape;

[0023] Fig. 3 shows a schematic view of a kit with a catheter device, an outer packaging and an inner packaging, wherein a catheter tube of the catheter device is arranged rolled up together with the inner packaging in the outer packaging;

[0024] Fig. 4 shows a schematic view of a kit with a catheter device, an outer packaging and an inner packaging, wherein the catheter tube of the catheter device is arranged in a ring shape in the outer packaging together with the inner packaging;

[0025] Fig. 5 shows a schematic view of a kit with a catheter device, an outer packaging and an inner packaging, wherein the catheter tube of the catheter device is arranged in an S-shape together with the inner packaging in the outer packaging; Fig. 6 shows a schematic view of a kit with a catheter device and a tubular packaging in which the catheter tube of the catheter device is arranged, wherein the catheter tube is arranged coiled with the tubular packaging;

[0026] Fig. 7 shows a schematic view of a kit with a catheter device and a tubular packaging in which the catheter tube of the catheter device is arranged, wherein the catheter tube is arranged in a ring shape with the tubular packaging;

[0027] Fig. 8 shows a schematic view of a kit with a catheter device and a tubular packaging in which the catheter tube of the catheter device is arranged, the catheter tube being arranged in an S-shape with the tubular packaging;

[0028] Fig. 9 shows a schematic view of a kit with a catheter device and an outer packaging, wherein a catheter tube of the catheter device is arranged spirally in the outer packaging; and

[0029] Fig. 10 shows a schematic view of a kit with a catheter device and an outer packaging, wherein a catheter tube of the catheter device is arranged in an S-shape in the outer packaging.

[0030] The catheter device and kit according to the invention are explained below with reference to the figures. Fig. 1 shows a schematic view of a catheter device 1 for intermittent self-catheterization with a catheter tube 2. An insertion aid 3, designed as a soft, elastic ball head, is arranged at a distal end of the catheter tube 2. The insertion aid 3 comprises a soft, flexible tip and acts as a guide for inserting the catheter tube into the bladder. The catheter tube 2 itself is stiffer than the insertion aid 3. A connector 4 is arranged at the other end of the catheter tube 2, which serves to connect the catheter tube 2 to a bag tube in the conventional manner. Furthermore, openings 5, 5' are provided in the region of the distal end of the catheter tube 2, through which the bladder can be emptied.Regarding the provision of the insertion aid 3 and the openings 5, 5', reference is made to DE 102 51 733 A1 , DE 102 59 002 B4 and EP 1 485 158 B1.

[0031] The catheter tube 2, and in particular a section of the catheter tube 2 between the introducer 3 and the connector 4, is made of a shape-memory material. Upon activation of the shape-memory material, the catheter tube 2 assumes a desired shape, in this case, in particular, a straight shape. While a straight, rigid shape of the catheter tube 2 is particularly advantageous during insertion because it allows resistance to be overcome, the straight shape may be a disadvantage during transport of the catheter device 1 because it results in a long lateral length in the packaging. By using a shape-memory material, in particular a shape-memory polymer, the otherwise rigid catheter tube 2 can be bent and even kinked during transport, i.e., while it is in the packaging. In Fig.In Figure 1, the catheter tube 2 is bent in a serpentine shape. Figure 2, on the other hand, shows a schematic view of a catheter device 1 with a catheter tube 2 that is bent in a spiral shape. After activation of the shape memory material by a liquid, electricity, heat, or light, the catheter tube 2 returns to its rigid shape, thus facilitating the insertion of the catheter tube 2.

[0032] Figures 3 to 10 show how the catheter device 1 can be arranged in a package. Figure 3 shows a schematic view of a kit with a catheter device 1, an outer package 7, and a tubular inner package 8, 8'. The catheter tube 2 of the catheter device 1 is arranged coiled together with the inner package 8 in the outer package. The inner package 8, 8' includes a section 8' in which a container 6 for a liquid (or for another stimulus) is arranged. The liquid can be used, for example, to wet the catheter tube 2 and thus cause a dried gel applied to the catheter tube 2 to swell and produce a lubricating property. Additionally (or alternatively), the liquid can also be used as a stimulus to activate the shape memory material of the catheter tube 2. While the catheter tube 2 in Figure 3...3 in rolled form with the tubular inner packaging 8, 8' in the outer packaging 7, it is arranged in a ring shape in Fig. 4 and in a serpentine shape (S-shaped) in the outer packaging 7 in Fig. 5.

[0033] In Figures 6 to 8, the catheter tube 2 is shown, together with the container 6, in a tubular package 8, 8', but without an outer packaging. Figure 6 shows the catheter tube 2 coiled within the tubular package, Figure 7 shows the catheter tube 2 arranged in a ring shape, and Figure 8 in a serpentine (S-shaped) shape. Thus, in some embodiments, the kit can also be used without an outer packaging. For example, the catheter device 1 with the tubular package 8 (and optionally with the container 6 in a section 8' of the tubular package) can be carried in luggage or a bag.

[0034] In an alternative embodiment, the tubular packaging can be omitted, and the catheter device 1 (with optional container 6) can be arranged directly in an outer packaging 7, such as a packaging bag or pouch. Figures 9 and 10 show schematic views of kits with a catheter device 1 and an outer packaging 7. In Figure 9, the catheter tube 2 of the catheter device 1 is arranged spirally in the outer packaging 7, and in Figure 10, serpentinely (S-shaped). In both cases, the optional container 6 is also arranged in the outer packaging 7 without further packaging. For further advantageous embodiments of the device according to the invention, reference is made to the general part of the description and to the appended claims to avoid repetition.Finally, it should be expressly pointed out that the exemplary embodiments of the device according to the invention described above serve only to discuss the claimed teaching, but do not limit it to these exemplary embodiments.

[0035] Reference symbol list

[0036] 1 catheter device

[0037] 2 catheter tubes

[0038] 3 Insertion aid

[0039] 4 connector, 5' opening

[0040] 6 containers

[0041] 7 Outer packaging, 8 Tubular packaging

Claims

Claims 1. Catheter device, preferably for intermittent self-catheterization, with a catheter tube for insertion into the bladder, characterized in that the catheter tube is at least partially made of a shape memory material, in particular a shape memory polymer.

2. Catheter device according to claim 1, characterized in that the catheter tube section has a section which is rigid, wherein at least the rigid section is made of the shape memory material.

3. Catheter device according to claim 1 or 2, characterized in that the catheter tube has a first section which is rigid, a flexible insertion aid as a second section, and at least the first section is made of the shape memory material.

4. Catheter device according to one of claims 1 to 3, characterized in that the shape memory material is configured to assume a predefined shape after stimulation by at least one of liquid, temperature, light and electricity.

5. Kit comprising a catheter device according to any one of claims 1 to 4 and packaging, wherein the catheter device is arranged in the packaging.

6. Kit according to claim 5, characterized in that the catheter tube is arranged in a spiral shape in or with the packaging.

7. Kit according to claim 5, characterized in that the catheter tube is arranged in a serpentine shape in or with the packaging.

8. Kit according to claim 5, characterized in that the catheter tube is arranged in the packaging in the form of a ring or rolled up.

9. Kit according to one of claims 5 to 8, characterized in that the packaging comprises an outer packaging and an inner packaging, in particular a tubular inner packaging, and the catheter tubing is arranged in the outer packaging within the inner packaging.

10. Kit according to one of claims 5 to 8, characterized in that the packaging corresponds to an outer packaging and the catheter tube is arranged in the outer packaging without further packaging.

11. Kit according to one of claims 5 to 8, characterized in that the packaging is a tubular packaging.

12. Kit according to any one of claims 5 to 11, comprising a stimulation source, preferably a bag containing a liquid, which is arranged in the packaging and is configured, upon activation by a user, to stimulate the shape memory material so that at least one section of the catheter tube assumes a predefined shape.

13. Method for packaging a catheter device, preferably for intermittent self-catheterization, with a catheter tube, in particular a catheter tube for insertion into the bladder, characterized in that the catheter tube is at least partially made of a shape memory material and is arranged in a spiral shape, in a serpentine shape, rolled or in the form of a ring in or with a packaging.

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