DE202021105274U1 - Device for providing drug solutions for the intravesical treatment of infections of the urinary bladder - Google Patents

Abstract

Device (10) for providing drug solutions for the intravesical treatment of infections of the urinary bladder (70),
wherein a first chamber (20) containing a medicament (21) is provided and the medicament (21) is suitable for intravesical treatment of the urinary tract infection,
wherein a solvent (31) is provided which can be mixed with the medicament (21) in order to produce an administrable medicament solution (40)
and two states are provided, namely an initial state (10.1) in which the device (10) can be stored and transported and a use state (10.2) in which the medicament solution (40) is ready for administration,
characterized,
that a second chamber (30) is provided, which in the initial state (10.1) is spatially separated from the first chamber (20),
the solvent (31) being provided in the second chamber (30),
that the contents of the first chamber (20) and the second chamber (30) can be mixed with one another by an operator without the use of tools and without the medicament (21) and / or the solvent (31) being accessible from the outside, whereby the drug solution (40) and the state of use (10.2) are produced
and that the medicament (21) is gentamicin and the solvent (31) is physiological saline solution.

Description

The invention relates to a device for providing medicament solutions for the treatment of infections of the urinary bladder according to the preamble of claim 1. Bacterial bladder infections are among the most common types of inflammation. Antibiotic therapy is usually necessary here. Oral intake of antibiotics, however, often leads to undesirable side effects and, in particular, can also have a negative effect on the gastrointestinal tract. In addition, relatively little of the antibiotic reaches the bladder when administered orally or intravenously. Very effective antibiotics that are very effective against E. coli bacteria, which are responsible for about 80% of all bacterial bladder infections, such as gentamicin, have to be administered intravenously and have a very high risk of side effects that damage the kidney function and / or the inner ear can lead to. Therefore, this and other antibiotics are used very rarely, although they are very effective.

To improve the effectiveness of antibiotic treatment for bladder infections, they are given intravesically. Here, a container is provided in which a drug to be administered, in particular a drug solution, is kept in stock and is introduced directly into the urinary bladder by means of a catheter. This allows the antibiotic to act directly on the focus of inflammation and bypasses the gastrointestinal tract. In addition, the antibiotic is hardly or not at all absorbed by the mucous membrane of the bladder, so that there is no absorption into the body's circulation and, even with a higher dose, organs distant from the bladder cannot develop any undesirable side effects. The bladder mucous membrane acts as an impermeable protective layer.

It is also disadvantageous if the antibiotic has to be administered by trained specialist staff using a urinary catheter. This has to happen more often, especially with acute cystitis, e.g. three times a day. However, some people, especially women, have common bladder infections. In order to effect the regular administration of the medication by specialist staff, a stay or a regular outpatient visit to a hospital or a care facility or regular visits to the patient by care staff would have to take place. However, this is cumbersome and takes away a lot of quality of life for those affected.

Alternatively, it is also possible for those affected to inject the drug into the bladder themselves using a disposable catheter. Self-catheterization can be learned and performed by both men and women. This has the advantage that those affected can give the antibiotic or other medication directly into the bladder themselves at home or elsewhere, regardless of the availability of specialist staff. In addition, for those affected, in whom bacterial bladder infections occur frequently, the dose can be given earlier, as there is no need to go to a doctor or hospital and the dose can therefore also take place regardless of the time and day of the week.

It is still difficult that the drug itself often has to be diluted. In the case of gentamicin, this is available as a solution with a volume of 2 ml. If you were to give it undiluted into the urinary bladder using a disposable catheter, too much active ingredient would remain in the lumen of the catheter. The drug is therefore administered mixed with a solvent. Here the operator must first draw up the antibiotic from an ampoule with a syringe, then draw it up to 20 ml from a second container using the syringe and then inject this mixture through the disposable catheter into the bladder. Alternatively, the antibiotic can also be drawn up in a first syringe and administered through the catheter and then rinsed with a second syringe containing the solvent in order to get the catheter lumen free of active substance. Both methods, however, are very complex and cumbersome and, depending on the mobility of the operator, difficult to carry out. This can lead to contamination and incorrect operation, which must be avoided.

However, if you already have a ready-made solution consisting of the antibiotic and the solvent, it is usually not durable, but only for a few weeks. It is therefore not easy, in particular for those affected who frequently suffer from such cystitis, to always keep enough medicament in stock for self-catheterization in order to be able to administer the medicament immediately in the event of a bacterial cystitis.

the WO 2007/106356 A2 describes a device for self-catheterization, by means of which fluids can be administered into the urinary bladder. This device is also intended for the instillation of medicaments into the urinary bladder, which medicaments can be administered to themselves by an operator. The disadvantage here is that an antibiotic solution often cannot be kept for a long time, as already mentioned. This leads to the fact that no longer durable drug solution has to be disposed of or that the operator, if necessary, has to laboriously produce the solution himself.

the EP 1 551 355 B1 , WO 2008/132431 , WO 2019/094591 and WO 2020/222139 each described catheter systems in which drugs such as antibiotics can be administered directly intravesically, sometimes by specialist staff to affected persons. The drug can be injected into the catheter via a syringe. However, there is also no description of the possibility of keeping a drug solution available for a longer period of time in case of need. This is also less of a problem when it is operated by specialist staff, since the trained staff can also produce the drug solution spontaneously if necessary.

The object of the invention is therefore to create a device for providing drug solutions for intravesical treatment, which can be prepared and administered at home by those affected if necessary without risk of contamination and which has a longer shelf life. This object is achieved by the characterizing features of claim 1, which have the following special meaning.

In addition to a first chamber, a second chamber is also provided, the first chamber containing the medicament and the second chamber containing a solvent. In the initial state, both chambers are spatially separated from one another so that their contents cannot mix. An operator can then mix the ingredients of both chambers with one another without using tools and without the risk of contamination. Neither of the two chambers has to be opened for this, so that the contents of both chambers are not accessible from the outside. In this way, the state of use can be established easily and safely by an operator. Gentamicin is used as a drug, which is dissolved in physiological saline as a solvent. This combination is very effective for the intravesical treatment of bacterial bladder infections and there are hardly any side effects, even with high doses, as gentamicin is hardly absorbed by the urinary bladder and thus does not get into the body's circulation so it could cause side effects in organs distant from the bladder. For example, dosages of 20 mg, 40 mg or 80 mg gentamicin per drug administration can be provided.

The device according to the invention has several advantages. In this way, the drug can be given directly into the bladder by an affected person, which usually takes place at an earlier point in time than if a doctor first had to be consulted. This early self-therapy often leads to faster and better healing of bacterial cystitis. In addition, the highly effective gentamicin can be administered directly where the inflammation is without causing harmful side effects. Due to the separate storage of gentamicin and saline solution, both can be kept for up to several years and can be stored well and mixed if necessary.

A connecting sleeve is preferably provided, by means of which the finished drug solution can then be introduced into a single-use urinary catheter. This also makes it easier for an operator with restricted mobility to administer the finished drug solution. The administration can thus be carried out cleanly and without contamination. The connecting sleeve can be arranged directly on the device or it can be attached to the outlet of the device as an adapter. A stepped cone adapter, which is inexpensive to manufacture and easy to use, can serve as an adapter. By using the connecting sleeve - pre-installed or as an adapter - the drug solution can be used with any commercially available single-use catheter, so that every operator can use his preferred catheter version and does not have to buy special catheters or get used to it.

In a first preferred embodiment, the device has approximately the shape of a syringe which comprises two chambers arranged one behind the other. In the initial state, these are spatially separated from one another, the first chamber containing the antibiotic and the second chamber containing the solvent. The syringe is closed with an injection plunger and a stopper connected to it. If the injection plunger is moved, the contents of the first and second chambers mix and produce the drug solution. The operation of the injection plunger is simple and the dosage of the drug and the solvent are predetermined. Contamination can be ruled out because both chambers are not accessible from the outside during the mixing process.

This mixing process can be carried out, for example, in a syringe which has an essentially cylindrical body in which the first chamber and the second chamber are separated from one another by an intermediate stopper. In one area, the body has an outward widening. If the intermediate stopper is then moved along with the actuation of the injection plunger, it meets the widening at one point and no longer separates the two chambers from one another. The drug and solvent can then mix, creating the drug solution. The device thus comes into its state of use. Of course, other possibilities of a syringe designed with two chambers are also included in the concept of the invention includes, for example, the provision of one or more weak points in the intermediate stopper, which yield when the injection plunger is actuated and make the contents of both chambers accessible to one another.

Another preferred embodiment provides that the two chambers are provided in containers that are spatially separated from one another but can be connected to one another. This is also useful when different drugs or different dosages are to be administered. If, for example, the solvent is identical, the container with the appropriate medicament or with the desired dosage can in each case be coupled to the container that contains the solvent. This also lowers manufacturing and storage costs.

Specifically, the medicament can then be provided in a first container, for example a vial, and the solvent in a second container, which is designed as a flexible bag, such as an instillation bag or the like. Each of the two containers has a connector by means of which it can be connected to the other container. In order to connect the containers to one another via the connecting pieces, the containers do not have to be opened. This prevents contamination or loss of the contents of the container through spillage or the like. By attaching the connecting pieces to one another, at least one predetermined breaking point is opened on one or both of the containers and the contents of both containers are directly or indirectly accessible to one another. In this way, the drug solution can then be produced and the state of use of the device can be brought about.

Between the two connection pieces of the first and the second container, a supply hose that has a blockage can also be provided. As a result, the ingredients of the two chambers cannot yet mix when the connecting pieces have been brought into operative connection with one another, but only after the blockage in the supply hose has been released. In this way, the point in time at which the drug solution is prepared can be determined in a more targeted manner. The blockage preferably has a rupture mechanism that releases the blockage. This is particularly easy if the feed hose is kinked or bent at the level of the blockage.

Furthermore, a drain hose can be provided on one or both containers. This is used to deliver the finished drug solution in the containers into the disposable catheter. The drainage hose can also advantageously have a connection grommet directly. Alternatively, an adapter can be attached to the drain hose, which forms the connection nozzle.

The drainage tube can also have a blockage so that the drug solution is only dispensed from the containers when it can be introduced into the disposable catheter. Here, too, a blockage can be provided, similar to that already described. Instead of a blockade with a predetermined breaking point, however, any other conceivable blockage is also possible.

• 1: eine erfindungsgemäße Vorrichtung in einem ersten Ausführungsbeispiel in Vorderansicht ohne Medikament und Lösemittel,
• 2: die Vorrichtung aus 1 mit Befüllung im Ausgangszustand,
• 3: die Vorrichtung aus 1 und 2 beim Mischvorgang der Medikamentenlösung,
• 4: die Vorrichtung aus 3 mit Adapter und Einwegkatheter,
• 5: eine zweite Ausführungsform der Vorrichtung in Seitenansicht im Ausgangszustand,
• 6: die Vorrichtung aus 5 mit zusammengebrachten Behältern,
• 7: die Vorrichtung gemäß 5 und 6 bei der Herstellung der Medikamentenlösung,
• 8: die Vorrichtung aus 5 bis 7 mit fertiger Medikamentenlösung,
• 9: die Vorrichtung aus 5 bis 8 im Verwendungszustand,
• 10: die Vorrichtung aus 5 bis 9 bei der Verabreichung durch einen Einwegkatheter in die Harnblase.

Further advantages and embodiments of the invention emerge from the subclaims, the further description and the drawings. In the drawings, the invention is shown in two exemplary embodiments. Show it:

• 1 : a device according to the invention in a first embodiment in front view without medicament and solvent,
• 2 : the device off 1 with filling in the initial state,
• 3 : the device off 1 and 2 during the mixing process of the drug solution,
• 4th : the device off 3 with adapter and disposable catheter,
• 5 : a second embodiment of the device in side view in the initial state,
• 6th : the device off 5 with containers brought together,
• 7th : the device according to 5 and 6th in the preparation of the drug solution,
• 8th : the device off 5 until 7th with ready-made drug solution,
• 9 : the device off 5 until 8th in the state of use,
• 10 : the device off 5 until 9 when administered through a disposable catheter into the urinary bladder.

1 shows a first embodiment of the device 10 those in the form of a syringe 50 is executed. The cylindrical body 51 the syringe 50 is through an intermediate plug 52 in a first chamber 20th and a second chamber 30th divided. The syringe 50 will end up with an injection plunger 58 connected stopper 54 locked. The body 51 the syringe 50 exhibits a broadening 53 which is wider than the intermediate plug 52 .

the 2 shows the same device 10 that are also in 1 shown, however, here is the drug 21 in the first chamber 20th brought in, shown schematically by horizontal lines, and the solvent 31 into the second chamber 30th , shown schematically by black elliptical dots. The intermediate plug 52 separates the two chambers 20th , 30th structurally from each other. The device 10 is here in the initial state 10.1 . Due to the spatial separation of the drug 21 , i.e. gentamicin, and solvents 31 , so physiological saline solution, is the device 10 Longer shelf life, as the two individual components do not spoil as quickly. The syringe is not used until it is needed or used 50 actuated by the operator holding the injection plunger 58 in the direction of actuation 57 moved as in 3 shown. By moving the injection plunger 58 becomes the associated plug 54 and thus also the intermediate plug 52 with moves. The intermediate plug 52 then inevitably comes into the area of broadening 53 . This area is wider than the outer circumference of the intermediate plug 52 so that the intermediate stopper the two chambers 20th , 30th no longer separates and seals against each other. Therefore, the medication is mixed up 21 and the solvent 31 , as the 3 indicates. During this mixing, the drug solution becomes 40 manufactured. This intermixing is very simple because one operator takes the drug 21 and the solvent 31 does not have to measure or handle multiple containers for the medication solution 40 to manufacture. There the syringe 50 If it is pre-assembled, it does not have to be opened before the mixing process, which could lead to contamination.

The continued use of the syringe 50 then shows 4th . The mixing process is shown here in exactly the same way as in 3 and is therefore not over yet. This is also indicated here by the arrow 57 shown showing the direction of actuation of the syringe 50 shows. The actuation of the injection plunger 58 needs to be done further for the drug to take off 21 and the solvent 31 mix completely. Then the syringe can 50 with their outlet 56 either directly or, as shown here, with the interposition of an adapter 55 , the connecting grommet 42 forms, to a urinary catheter 41 be connected. The adapter 55 is here a stepped cone adapter, with other forms of adapter 55 possible are. Handling the syringe 50 , the adapter 55 and the disposable catheter 41 is very simple and so can catheterization and administration of the drug solution 40 can also be carried out independently at home by an affected operator without assistance. This has great benefits in curing bacterial bladder infections.

Another preferred embodiment of the invention show 5 until 10 . The two chambers 20th , 30th are in two separate containers 60 , 61 intended. The drug 21 is shown here schematically in the form of black squares, the solvent 31 as circles outlined in black. The level of the substances shown does not indicate the level of the container 60 , 61 again, but is also to be understood schematically. The first container 60 assigns the first chamber 20th and is shaped like a bottle here. The second container 61 assigns the second chamber 30th and has the shape of a flexible bag like an instillation bag. On both containers 60 , 61 is one connector each 62 provided, by means of which the two containers 60 , 61 can be connected to each other. This can be a screw, clip, or plug connection, for example. All possibilities of fastening the two containers 60 , 61 are included in the subject matter of the invention. the 1 shows the device in its initial state 10.1 .

On the second container 61 , you can see a feed hose 63 that with the connector 62 is connected and a drain hose 64 , the one with a connecting sleeve 42 connected is. These two hoses 63 , 64 each have a blockage 66 on, which ensures that no liquid enters the respective hose 63 , 64 can happen. Only when the blockage 66 is eliminated, there is a flow through the hose 63 , 64 possible. The blockages used here 66 exhibit a rupture mechanism 65 when kinking or bending the hose 63 , 64 is triggered.

How to use the device 10 show the following figures. First there is a connection between the first container 60 and the second container 61 by means of the connecting pieces 62 manufactured. By kinking the feed hose 63 - indicated here by an arrow - then becomes the blockage in this 66 by the rupture mechanism 65 solved. The second container, which is designed as a flexible bag, is then used 61 squeezed so that the solvent 31 in the first container 60 with the interposition of the feed hose 63 and the connectors 62 is brought how 7th shows. This is where the drugs mix 21 and the solvent 31 and make the drug solution 40 here. After that, the drug solution 40 again in the second container 61 brought, also by means of a compression of the second container 61 you of natural gravity, as in 8th shown. If then the drug solution 40 completely in the second container 61 located how 9 shows, it can be introduced into the urinary bladder by inserting the drain hose 64 existing blockage 66 is released, again by kinking the drain hose 64 . The schematic administration then shows 10 . The drug solution 40 is in the second container 61 who as Instillation bag is formed, the blockage 66 in the drain hose 64 is released and the connecting sleeve 42 is in a urinary catheter 41 brought in. The drug solution is then used over this 40 into the urinary bladder shown here very schematically 70 directed to treat bacterial cystitis.

Finally, it should be pointed out that the embodiments shown here are only exemplary configurations of the invention. This is not limited to this. Rather, changes and modifications are still possible. The two chambers can also be connected to one another in other ways in order to produce the finished drug solution.

List of reference symbols

10

contraption

10.1

Initial state

10.2

Usage condition

20th

First chamber

21

drug

30th

Second chamber

31

Solvent

40

Drug solution

41

Urinary catheter

42

Connection grommet

50

syringe

51

Body of 50

52

Intermediate plug

53

Broadening

54

Plug

55

adapter

56

Outlet

57

Actuation direction of 50

58

Injection plunger

60

First container, vial

61

Second container, pouch

62

Connector

63

Feed hose

64

Drain hose

65

Rupture mechanism

66

blockade

70

bladder

QUOTES INCLUDED IN THE DESCRIPTION

This list of the documents listed by the applicant was generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Patent literature cited

• WO 2007/106356 A2 [0007]
• EP 1551355 B1 [0008]
• WO 2008/132431 [0008]
• WO 2019/094591 [0008]
• WO 2020/222139 [0008]

Claims (12)

Device (10) for providing drug solutions for the intravesical treatment of infections of the urinary bladder (70), wherein a first chamber (20) containing a drug (21) is provided and wherein the drug (21) is suitable for the intravesical treatment of the urinary tract infection, wherein a solvent (31) is provided which can be mixed with the medicament (21) in order to produce an administrable medicament solution (40) and two states are provided, namely an initial state (10.1) in which the device (10) can be stored and transported and a use state (10.2) in which the medicament solution (40) is ready for administration, characterized in that a second chamber (30) is provided, which in the initial state (10.1) is spatially separated from the first chamber (20), wherein in the second chamber (30) the solvent (31) is provided that the contents of the first chamber (20) and the second chamber (30) by an operator without the use of tools and without the medicament (21) and / or the solvent (31) being accessible from outside can be mixed with one another, whereby the medicament solution (40) and the state of use (10.2) are produced and that the medicament (21 ) Gentamicin and the solvent (31) is physiological saline. Device (10) according to Claim 1 , characterized in that a connecting sleeve (42) is provided, by means of which the drug solution (40) can be introduced into a urinary catheter (41) Device (10) according to Claim 2 , characterized in that an adapter (55) is provided as the connecting sleeve (42), which adapter can be arranged on an outlet (56) of the device (10). Device (10) according to one of the Claims 1 until 3 , characterized in that the device (10) has approximately the shape of a syringe (50) which comprises two chambers (20, 30) which are spatially separated from one another in the initial state (10.1) and in each case the medicament (21) or contain the solvent (31), the chambers (20, 30) being closed by a stopper (54) connected to an injection plunger (58) and, when the syringe (50) is actuated by moving the injection plunger (58), the contents of the first Mix the chamber (20) and the second chamber (30) with one another and the medicament solution (40) can be produced in this way. Device (10) according to Claim 4 , characterized in that the syringe (50) has a substantially cylindrical body (51) and the two chambers (20, 30) lie one behind the other in the actuation direction (57) of the syringe (50), whereby they are in the initial state (10.1) of the device (10) are separated from one another by an intermediate stopper (52) so that in one area the body (51) has an outward widening (53) and that when the stopper (54) of the syringe (50) is actuated, it also has the intermediate stopper ( 52) moved with and in the area where the intermediate plug (52) reaches the widening (53) of the body (51) the two chambers (20, 30) are no longer spatially separated from one another but are connected to one another via the widening (53), whereby the medicament (21) and the solvent (31) mix with one another and produce the medicament solution (40). Device (10) according to one of the Claims 1 until 3 , characterized in that the first chamber (20) and the second chamber (30) are provided in containers (60, 61) that are spatially separated from one another but can be connected to one another. Device (10) according to Claim 6 , characterized in that in the initial state (10.1) the drug (21) is arranged in a first container (60), preferably designed as a small bottle, and the solvent (31) is arranged in a second container (61), in particular designed as a flexible bag, each of the two containers (60, 61) has a connection piece (62) to which the respective other container (61, 60) can be attached. Device (10) according to Claim 7 , characterized in that both containers (60, 61) can be fastened to one another via the connecting pieces (62) without opening the containers (60, 61) beforehand, a predetermined breaking point being opened during fastening on at least one of the containers (60, 61) and the contents of the two chambers (20, 30) for the preparation of the medicament solution (40) and for bringing about the state of use (10.2) are directly or indirectly accessible to one another. Device (10) according to one of the Claims 7 or 8th , characterized in that a feed hose (63) is provided between the connection pieces (62) on the first container (60) and on the second container (61), which has a blockage (66) which comprises a rupture mechanism (65). Device (10) according to one of the Claims 7 until 9 , characterized in that a drain hose (64) is provided on the first container (60) and / or on the second container (61) which has a blockage (66) which comprises a rupture mechanism (65). Device (10) according to Claim 10 , characterized in that a connecting sleeve (42) is provided on the drain hose (64). Device (10) according to one of the Claims 9 or 10 , characterized in that the breaking mechanism (65) is triggered by kinking or bending the drainage hose (64) or the feed hose (63) and thereby releases the blockage (66).

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