Catheter device

Abstract

A catheter device, preferably for intermittent self-catheterization, having a flexible catheter tube (1) for insertion into the bladder and an outer holding means (4) for fixing the catheter tube (1) in place in the inserted state, is characterized in that the holding means (4) is designed as a preferably flat holding strip (4) which can be fastened or is fastened at a defined point on the catheter tube (1) and which is dimensioned in such a way that it can be fixed to the upper end of the thigh of the person using it.

Description

[0001] CATHETER DEVICE

[0002] The invention relates to a catheter device, preferably for intermittent self-catheterization, with a flexible catheter tube for insertion into the urinary bladder and an external holding means for fixing the catheter tube in the inserted state.

[0003] For bladder emptying in cases of incontinence, for example, in people with paraplegia, urinary catheters are commonly used. If their hands are mobile, the user can insert the catheter themselves. For those with limited mobility, the catheter is inserted by trained personnel or medical professionals.

[0004] A modern method of 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 only remains in the user's body for a short time. Depending on fluid intake, the bladder should be emptied four to six times a day. This means that bladder emptying via intermittent self-catheterization must also be performed at night, and the user cannot sleep through the night. Although many users try to keep the entire process of bladder emptying via intermittent self-catheterization as short as possible at night, most of them have trouble falling back asleep. In the long term, the reduced and unrefreshing sleep has a negative impact on the user's physical and mental state.Leaving the disposable catheter in the urethra or bladder overnight is not possible, as the catheter is eventually carried out by the bladder itself and the urethral mucosa. Furthermore, movement by the person wearing the catheter often leads to inadvertent withdrawal of the catheter, at least from the bladder area. People who are unable to catheterize themselves or who do not wish to use a catheter to empty their bladder several times a day, especially at night, can have an indwelling catheter inserted. The indwelling catheter is inserted through the urethra and is fitted with an internal retaining device, usually a balloon, that secures the catheter in the bladder and prevents the catheter tube from slipping out of the bladder. An indwelling catheter typically remains in the user's body for several weeks. This poses some risks.The longer the catheter remains in the body, the more likely it is to form a bacterial film between the urethra and the catheter tube. These bacteria can cause infections that can affect the urethra, bladder, and / or kidneys. To prevent this, the indwelling catheter can be regularly flushed with a disinfectant solution. Regular flushing of the bladder is also necessary. Furthermore, if the catheter remains in place for an extended period, it can become clogged due to encrustation, making urinary drainage impossible.

[0005] DE 10 2021 214 927 A1 discloses a catheter device comprising external retaining means for securing at least part of the catheter tube in the urethra and bladder when inserted. The intention is to allow the catheter device to remain in the user's body or bladder for several hours, while ensuring that the catheter tube cannot be accidentally transported out, particularly during sleep. The external retaining means provided therein can also be attached to the user's thigh, in close proximity to the penis. This should already sufficiently ensure sleep through the night. The document does not specify the specific design of the retaining means.

[0006] The invention is based on the fundamental idea that external holding means are provided to secure the catheter tube, as already indicated in DE 10 2021 214 927 A1. Internal holding means that secure the catheter tube within the user's body, e.g., in the bladder, such as balloon structures that would be formed after the catheter tube is inserted into the bladder, are not required; in fact, they can be avoided, since this is solely concerned with the external fixation of the catheter tube.

[0007] The invention takes up the basic idea from DE 10 2021 214 927 A1 (publication of an application by the applicant) and concretizes it.

[0008] According to the state of the art in printed documents, the catheter tube can be secured to the thigh of the person using it while it is inserted, but it is not specified in what form this can be done and with what specific measures.

[0009] The invention is therefore based on the object of designing and developing a catheter device of the generic type in such a way that simple and safe handling is possible, while allowing the catheter to be left inserted overnight. This applies in particular to any possible limitations on the user's handling of the catheter device.

[0010] Furthermore, the catheter device according to the invention should differ from the prior art.

[0011] The catheter device according to the invention, according to claim 1, provides that the holding means is designed as a preferably flat holding strap that can be or is attached to the catheter tube at a defined location. The holding strap ensures secure attachment and, if appropriately dimensioned, prevents unwanted constriction of blood circulation through the leg. The holding strap is preferably flat. It can be attached to the thigh of the user near the upper end of the thigh.

[0012] According to the previously discussed design, the catheter according to the invention is suitable for remaining in the body or with its front section in the bladder for several hours, particularly during the night or sleep phase. Movements by the person wearing the catheter are irrelevant with regard to secure positioning of the catheter, since the fixation at the upper end of the thigh prevents the catheter from being accidentally pulled out of the bladder, at least during normal movements. Thus, the catheter can be used excellently throughout the entire sleep phase at night. This also applies to use by women.

[0013] The retaining strap is particularly advantageously designed to be elastic. It can generally be designed as a ring-shaped retaining strap, which can be shortened or extended to fit the thigh using a suitable adjustment mechanism. However, this has the disadvantage that the retaining strap must be positioned over the foot and the entire length of the leg up to the upper end of the thigh.

[0014] Therefore, it is advantageous for handling purposes to design the retaining strap as an open-ended strap, which can be connected to a loop by the user or an assistant using a holding / closing mechanism and adjusted in length. This creates an adjustable loop that can be ideally adapted to the individual diameter of the thigh.

[0015] A secure hold of the retaining strap on the thigh is facilitated by the fact that the retaining strap is coated on the inside, at least in certain areas, with an anti-slip material. For example, the retaining strap can be siliconized on the inside, as is the case with hold-up nylon stockings. This measure also prevents the retaining strap from "wandering" during use, for example, during sleep at night. This ensures secure positioning of the catheter tube.

[0016] As described above, it is ensured that the retaining strap is attached to the catheter tube at a defined location, namely to ensure the catheter tube's position through the ureter into the bladder. To ensure secure positioning of the retaining strap on the catheter tube, it is further advantageous if the retaining strap can be secured to the retaining strap itself to form a closed loop. This connection can be made using a needle felt or an adhesive connection. A mechanical connection using hooks, snap fasteners, etc. is also conceivable.

[0017] The catheter tube can be provided with an integral holder for the retaining strap, defining the attachment point for the retaining strap on the catheter tube. It is also conceivable that the holder can be subsequently attached to the catheter tube, or can be attached at any time.

[0018] At the distal end of the catheter tube, a connector is generally provided for connecting another tube. This additional tube leads to a bag tube, such as a urine collection container, or is connected to such a collection container. It is particularly advantageous to use the connector to attach the retaining strap, provided that the length of the catheter tube up to the connector is designed such that the connector can be positioned, or can be positioned, at a suitable location on the user's thigh when the catheter tube is inserted.

[0019] To secure the retaining strap, the connector can have a special receptacle or be equipped with a special receptacle to which the retaining strap can be plugged or clipped, or through which the retaining strap can be pushed, ensuring secure positioning of the connector and thus the catheter tube. In other words, the receptacle can be an integral part of the connector or can be connected to the connector distally or proximally. For example, the receptacle on the side facing away from the catheter tube can be plugged or pushed onto a flange of the connector, with the connector having a connection piece for the bag tube that protrudes or extends through the receptacle.In any case, it is conceivable that the holder comprises a bracket, a tab or a closed eyelet with a slit-shaped passage through which the retaining strap can be guided and thus the catheter tube can be fixed to the thigh of the person using it via the connector.

[0020] The passage in the receptacle advantageously extends axially or parallel to the connector or the catheter tube, so that the catheter tube can be easily aligned axially to the thigh of the person using it.

[0021] According to the above explanations, the connector can have an insertion opening on one side for inserting the catheter tube and a slip-on sleeve on the other side for attaching the bag tube. It is conceivable that an annular flange is provided on the connector that overlaps the attached end of the bag tube, with an internal flow path extending between the insertion opening and the slip-on sleeve.

[0022] The connector is advantageously designed as a single piece and can be injection-molded from plastic. The holder for the retaining strap can be an integral part of the connector. In accordance with the above explanations, it is also conceivable for the holder to be a separate component, also injection-molded from plastic, that can be attached to the connector, the catheter tube, or the bag tube, surrounding the latter.

[0023] In principle, the catheter itself can be designed in any desired manner. The catheter is preferably a ready-to-use gel catheter. This use of the gel catheter is intended to prevent the surface from drying out during insertion and thus preventing adhesion in the urethra during use over several hours.

[0024] There are now various possibilities for advantageously embodying and developing the teaching of the present invention. For this purpose, reference is made, on the one hand, to the claims subordinate to claim 1 and, on the other hand, to the following explanation of the preferred embodiment of the invention with reference to the drawing. In conjunction with the explanation of a preferred embodiment of the invention with reference to the drawing, a generally preferred embodiment and development of the teaching is also explained. The drawing shows:

[0025] Fig. 1 shows a schematic view of a catheter device according to the invention with catheter tube, connector, retaining strap, bag tube and urine collection container in the ready-to-use state,

[0026] Fig. 2 in a schematic view, enlarged, the catheter device according to the invention according to Fig. 1 in the area of ​​the catheter tube together with connector and receptacle without retaining band and

[0027] Fig. 3 in a schematic view, again enlarged and sectioned, the catheter device according to the invention in the region of the connector with receptacle.

[0028] Fig. 1 shows a schematic view of an embodiment of a catheter device according to the invention, which is used for intermittent self-catheterization. The catheter device comprises, as its essential components, a flexible catheter tube 1, which is used for insertion into the bladder. The catheter tube 1 is a ready-to-use gel catheter with a soft, elastic ball head 2 at its distal end. This ball head 2 serves a kind of pilot function when inserting the catheter tube into the bladder.

[0029] Furthermore, openings 3 are provided in the region of the distal end of the catheter tube 1, through which the bladder can be emptied. Regarding the provision of the ball head 2 and the openings 3, reference is made to DE 102 51 733 A1, DE 102 59 002 B4 and EP 1 485 158 B1. Fig. 1 further clearly shows that the catheter device has external holding means 4, which are designed as a relatively wide holding strap in order to prevent constriction on the thigh of the person using it. The holding strap 4 serves to be secured near the upper end of the thigh of the person using it. Advantageously, the holding strap 4 can be opened and its diameter adjusted by means of a needle felt connection 5.

[0030] The retaining strap 4 is elastic, and the loop defined by it is adjustable as described above. The inside of the retaining strap 4 has a siliconized surface 6 to ensure it can be positioned securely on the user's thigh.

[0031] The retaining strap 4 is associated with a connector 7, which serves in a conventional manner to connect the catheter tube 1 to a bag tube 8. The connector 7 serves to secure the retaining strap 4 and, for this purpose, comprises a receptacle 9. This receptacle can be an integral part of the connector 7.

[0032] Fig. 1 also shows the bag tube 8 connected to the connector 7, to whose free end a urine collection container 10 is connected. The urine collection container 10 is a bag with a closable or openable outlet 11 for emptying the urine collection container 10.

[0033] Fig. 2 shows a schematic view of part of the previously discussed catheter device, namely the catheter tube 1 with ball head 2 and the openings 3.

[0034] At the distal end of the catheter tube 1, the connector 7 is arranged, which in turn serves to receive and fix the retaining strap 4. Attached to the opposite side of the connector 7 is the bag tube 8, of which only a short section is shown in Fig. 2.

[0035] Fig. 3 shows the area around connector 7 enlarged and in section. The catheter tube 1 is inserted into a plug-in area 12 of connector 7. The flow path within catheter tube 1 continues through connector 7.

[0036] On the side of the connector 7 opposite the insertion area 12, a further insertion area 14 is provided, which serves for inserting a part of the receptacle 9, so that in this embodiment, the receptacle 9 can be inserted into the connector 7 with an insertion socket 15. The actual receptacle for the retaining strap (not shown) lies outside the connector 7.

[0037] On the end of the receptacle 9 opposite the connector 7, a pin 16 is formed for insertion, onto which the bag tube 8 can be plugged. A circumferential shoulder 17 of the receptacle 9 extends over this pin 16 and covers the bag tube 8 when plugged in.

[0038] Fig. 3 clearly shows an elongated recess 18 in the receptacle 9, through which the retaining strap (not shown in Fig. 3) can be threaded and thus securely fixed at a defined location. This ensures a secure connection of the retaining strap to the catheter device or to the distal end of the catheter tube 1.

[0039] With regard to further advantageous embodiments of the catheter device according to the invention, reference is made to the general part of the description and to the appended claims in order to avoid repetition.

[0040] Finally, it should be expressly pointed out that the above-described embodiment of the catheter device according to the invention serves only to explain the claimed teaching, but does not limit it to the embodiment.

[0041] 1 flexible catheter tube

[0042] 2 Ball head at the distal end of the catheter tube

[0043] 3 openings in the area of ​​the distal end of the catheter tube

[0044] 4 Holding devices, holding strap

[0045] 5 Needle felt connection

[0046] 6 siliconized surface

[0047] 7 Connector

[0048] 8 bag tube

[0049] 9 Holder (for the retaining strap)

[0050] 10 urine collection containers

[0051] 11 Outlet (on the urine collection container)

[0052] 12 Insertion area in the connector for the catheter tube

[0053] 13 Flow path

[0054] 14 Insertion area for the

[0055] Recording in the connector

[0056] 15 plug-in sockets

[0057] 16 pins

[0058] 17 Shoulder

[0059] 18 elongated recess in the holder

Claims

Claims 1. Catheter device, preferably for intermittent self-catheterization, with a flexible catheter tube (1) for insertion into the bladder and an external holding means (4) for fixing the catheter tube (1) in the inserted state, characterized in that the holding means (4) is designed as a preferably flat holding band (4) which can be or is fastened to the catheter tube (1) at a defined point and which is dimensioned such that it can be fixed to the upper end of the thigh of the person using it.

2. Catheter device according to claim 1, characterized in that the retaining band (4) is elastic.

3. Catheter device according to claim 1 or 2, characterized in that the retaining strap (4) is designed in the sense of a preferably adjustable or adjustable loop.

4. Catheter device according to one of claims 1 to 3, characterized in that the retaining band (4) is coated on the inside at least in regions with an anti-slip material, for example siliconized.

5. Catheter device according to one of claims 1 to 4, characterized in that the retaining band (4) can be connected to the catheter tube (1) or to the retaining band (4) itself to form a closed loop by means of a needle felt connection (5).

6. Catheter device according to one of claims 1 to 5, characterized in that an integral or there-attached receptacle (9) for the retaining band (4) is provided on the catheter tube (1).

7. Catheter device according to one of claims 1 to 6, wherein a connector (7) for connecting a further tube, which for example in the sense of a bag tube (8) leads to a urine collection container (10) or is connected to it, is provided at the distal end of the catheter tube (1), characterized in that the connector (7) also serves to fasten the retaining strap (4).

8. Catheter device according to claim 7, characterized in that the connector (7) carries a special receptacle (9) or is equipped with a special receptacle (9) to which the retaining band (4) can be plugged or clipped or through which the retaining band (4) can be pushed.

9. Catheter device according to claim 8, characterized in that the receptacle (9) is designed as a bracket, tab or closed eyelet with a slot-shaped passage.

10. Catheter device according to claim 9, characterized in that the passage extends axially or parallel to the connector (7) or catheter tube (1).

11. Catheter device according to one of claims 7 to 10, characterized in that the connector (7) comprises on one side an insertion opening for inserting the catheter tube (1) and on the other side a push-on sleeve for attaching the bag tube (8) and optionally an annular flange overlapping the attached end of the bag tube (8), wherein an inner flow path (13) extends between the insertion opening and the push-on sleeve.

12. Catheter device according to one of claims 7 to 11, characterized in that the connector (7) is made in one piece, preferably by injection molding from plastic.

13. Catheter device according to one of claims 1 to 12, characterized in that the catheter is designed as a preferably ready-to-use gel catheter.

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