EP2585159A1

EP2585159A1 - Device for protecting and cleaning the bladder lumen

Info

Publication number: EP2585159A1
Application number: EP11735611.3A
Authority: EP
Inventors: Thomas Lisowsky; Martin Rahe
Original assignee: Agxx Intellectual Property Holding GmbH
Current assignee: Agxx Intellectual Property Holding GmbH
Priority date: 2010-06-23
Filing date: 2011-06-22
Publication date: 2013-05-01
Also published as: US20130158522A1; CA2802556A1; JP2013529488A; WO2011161168A1; DE102010024820A1

Abstract

The invention relates to a device (1), in particular for protecting and for cleaning the bladder lumen, consisting of at least one functional body (2) which can be spatially expanded in a variable manner and can be modified at least partially from a small state into a larger state. Said device (1) protects the bladder lumen from bacterial invasion when the functional body (2) is inserted into the bladder and helps an infected bladder during mechanical cleaning and subsequent healing. The invention also relates to the use of the device (1) for medical, in particular prophylactic and therapeutic purposes.

Description

Device for protecting and cleaning the urinary bladder lumen

Background of the invention

The invention relates to a device, in particular for the protection and cleaning of the urinary bladder lumen, which consists of at least one functional body. The invention further relates to the use of the device for medical, in particular prophylactic and therapeutic, purposes.

State of the art

Microbial contamination of the urine and urinary bladder as well as the urinary bladder epithelia cause manifold and large

Health problems and associated costs. So far, however, apart from the use of strong drugs, there was no way to protect the bladder effectively against colonization with germs or to support an already contaminated urinary bladder in the cure.

Description of the invention

Object of the present invention is therefore, the

Possibility to create the bladder and its lumen

regardless of medication before a microbial

Protecting colonization and healing

To support infectious diseases. The object is achieved by a device of the type mentioned above, which is characterized in that the functional body is variable in its spatial extent, wherein the functional body at least partially from a smaller state to a larger state is convertible. The device according to the invention, as a functional body inserted into the bladder, protects it against germ colonization and supports a germinated bladder during mechanical cleaning and subsequent healing. The device according to the invention can prevent the nesting of germs into the bladder mucosa due to the design. The device according to the invention has the advantage that the access from the urethra and the ureters in the

Bubble chamber is mechanically secured. This prevents the germs from migrating into the bladder via the urethra, and germs that are already in the bladder are prevented from getting into the kidneys. This principle of mechanical security of access is provided by the

Insertion of a sufficiently large contact surface in the particularly vulnerable areas of the bladder

guaranteed. The functional body is for this purpose at least partially from a smaller state in which it can be introduced in the manner of a catheter through the urethra into the bladder in a larger state

convertible so that he has a larger in the urinary bladder

has spatial extension and its protection and

Can perform cleaning function. The functional body is placed over the urethra to a diameter of about 5 mm for introduction into the urinary bladder. A diameter of about 5 mm corresponds to the common size of catheters, which are introduced via the urethra. By the device according to the invention, the geometric problem of a

Functional body enlargement of about 5 mm diameter to the maximum size of the functional body in the bladder after

Introduction and development solved.

In an advantageous embodiment of the invention it is provided that the functional body at least partially from a

Material which is permeable to liquids, preferably a material having holes or pores. As a result, the functional body for urine or urine

passable, so that the physiological functions of

Bladder will not be affected. To the transition of the functional body of the smaller

To facilitate state in the larger state and to allow optimal spatial expansion of the functional body in the bladder is provided in an advantageous embodiment of the invention that the material of the

Functional body is at least partially elastic.

Preferably, the material of the functional body is selected from the group consisting of close-meshed tissue, perforated foil,

fine-pored foam and the like selected. The

Material of the functional body must be selected so that it is permeable to liquids, but does not retain any pathogenic None. In addition, the material must be compatible with the human body and must not trigger allergies.

In a particularly advantageous embodiment of the invention, it is provided that the material of the functional body is a self-unfolding material, so that the functional body in the bladder independently transitions into the larger state without external intervention.

To take an additional action to remove the

To avoid functional body is in an advantageous

Embodiment of the invention provided that the

Functional body is biodegradable.

In a further advantageous embodiment of the invention, it is provided that the functional body is wetted and / or coated at least partially with an antimicrobial substance. In this embodiment, the no when in contact killed with the surface of the functional body, so that an accumulation of pathogens in the bladder prevented and the healing is accelerated. To make the functional body as compact as possible in the smaller state and the transition to the larger

To facilitate state, is provided in an advantageous embodiment of the invention that the functional body in

at least two segments, preferably 4 to 32 segments, is divided. The respective inner layers of the

Functional body are preferably arranged such that they close the interstices of the preceding segments. Because the distances between the segments at

As the functional body volume increases, the segments must overlap in the smaller, folded state. The proposed design principle of segments and

Layers takes into account the geometric problem of a

Functional body enlargement of about 5 mm in diameter (in a preferred introduction form via a guide pin) to the maximum size of the functional body in the bladder after insertion and deployment.

Preferably, the functional body is at least partially folded in the smaller state, rolled up

and / or compressed. In this case, the functional body in the smaller state have a diameter of at most 4-6 mm, preferably about 5 mm. The functional body in the larger state, preferably at least partially

unfolded, rolled up and / or relaxed.

In an advantageous embodiment of the invention it is provided that the functional body has at least two layers, preferably an inner layer and an outer layer. In this case, the inner layer can in particular with one, preferably temporarily, water and / or gas-tight

Be provided coating. When unfolding the

Functional body is introduced for example by means of a fluid (liquid, gas) by means of a pressure spray or other devices from the outside, is ensured by the coating of the inner layer that sufficient for the unfolding pressure within the

Functional body can build. Preferably, the coating dissolves independently after a certain time, so that the gas or liquid exchange within the

Bladder is not affected.

The outer layer can be a textured surface

and / or preferably be provided with nubs, elevations or the like, so that germs and biofilms that colonize the inner bubble wall, mechanically detached and can be removed. These are the low elastic

Stellkräfte of the molding material used to the

structured surface of the outer layer to press lightly against the bladder wall. Due to the constant change of the bladder volume at emptying and filling is a

generates mechanical movement, which causes the detachment and cleaning of germs and biofilms by the close contact between the functional body surface and the bladder wall and by very slight abrasion forces.

In order to facilitate the insertion of the device according to the invention into the urinary bladder and in particular the guidance through the urethra, it is provided in an advantageous embodiment of the invention that the functional body is externally provided with a, preferably shaping, shell.

In an advantageous embodiment of the invention

Device is further provided that in addition a Guide element, preferably a guide pin, is provided which causes sufficient rigidity of the functional body. The functional body can be brought about a guide pin to a diameter of about 5 mm, for example, for introduction into the bladder via the urethra by folding and winding around a guide pin.

The invention further generally relates to the use of the device for medical, in particular prophylactic and therapeutic, purposes. In particular, the invention encompasses the use of the device according to the invention as a type of catheter for protecting and cleaning the device

Bladder lumen. Preferably, the device according to the invention is in the form of a variable in size

Functional body used, the tightly folded allows the introduction into the urinary bladder via the urethra in the manner of known catheter.

The invention will be further described by the following

Illustrated illustrations by way of example.

Brief description of the illustrations

It shows

Figure 1: Schematic representations of a preferred

Embodiment of a device according to the invention - with - Fig. 1A: Overview of the structure of the device;

Fig. 1B: Details of the structure of the device according to Fig. 1A; Fig. IC: functional body folded around support pin;

Fig. 1D: scheme for segmentation of the functional body;

Fig. IE: cross-section through the device according to Fig. IC; Fig. 1F. Longitudinal section through the device of FIG. IC. FIG. 2: Schematic representations for the use of a device according to the invention - with -

Fig. 2A: Scheme for the fully deployed functional body in the urinary bladder;

FIG. 2B: Scheme for introducing the functional body into the bladder; FIG.

FIG. 2C shows details of the fully deployed functional body in the urinary bladder according to FIG. 2A; FIG.

Fig. 2D. An exemplary high-pressure syringe for unfolding the functional body.

Figure 3: Schematic representation of the use of a device according to the invention as a supplement to a already unfolded in the bladder functional body by introducing a second functional body by means of a support pin.

Description of exemplary and preferred embodiments

FIG. 1 shows schematic representations of a preferred embodiment of a device according to the invention. The device 1 comprises a functional body 2, the

For example, from slightly elastic fine tissue, perforated foil or porous foam, preferably with a

antimicrobial coating, may consist. This

Functional body 2 can be used as a temporary implant in the

Bladder 3 of a human are introduced (Fig. 2A to 2C). A functional body 2, which is to fill the entire bladder space to be fully functional, could not pass through the urethra 4 due to its large volume as a catheter. The introduction is therefore preferably in the folded, rolled state in the manner of a

Catheter (Fig. IC). After introduction into the urinary bladder 3, the functional body 2 is unfolded (FIGS. 1A and 1D), so that in close contact with the urinary bladder wall and by filling in the bladder lumen a mechanical cleaning is achieved by utilizing the Bladder breathing can take place (Figures 2A and 2C). The

regular contractions of the bladder lumen in conjunction with the elasticity of the functional body 2 and its filling of the entire bladder lumen lead to a mechanical cleaning of the germ wall particularly problematic bladder wall. The close-meshed, fine-pored tissue of the

Functional body 2 allows the free passage of urine (Fig. 1B). At the same time blocks and prevents the

Functional body 2 the ascending germ migration from the urethra 4 into the bladder 3 and from the bladder 3 into the ureter 5 and kidney 6 (Figures 2A and 2C).

An antimicrobial coating of the functional body tissue can, in an advantageous embodiment of the invention, ensure that the surface of the functional body 2 remains sterile and that germs do not remain on the surface of the body

Function body 2 can grow. Germs that on the

Surface of the functional body 2 meet, are then killed. The fabric structure of the functional body 2

allows the creation of a large contact area with a correspondingly large area with antimicrobial coating, which keeps the tissue area of the functional body 2 sterile. The close-meshed, fine-pored tissue of the functional body 2 allows the free passage of urine. Due to the tightness of the tissue, associated with a variety of cells in

Miniature format, remains only a very small distance between colonized urinary bladder epithelia and germs in the urine.

The outer layer of the functional body 2 is preferably provided with tiny, relatively dimensionally stable dimples 7 (FIG. 1B), which mechanically detach and remove germs and biofilms which colonize the internal bladder wall. For this purpose, the low elastic restoring forces of the fabric material are used to slightly against the structured surface (nubs 7)

Bubble wall to press. Through the constant change of the Bladder volume at emptying and filling becomes one

generates mechanical movement, which causes the detachment and cleaning of germs and biofilms by the close contact between the structured surface of the functional body 2 and the bladder wall and by very slight abrasion forces.

The functional body 2 of the device 1 according to the invention is in an advantageous embodiment of the invention in several

Split segments 8, which allow in the smaller state, a compact design of the functional body 2 and facilitate the transition to the larger state (Fig. IC to 1F). The respective inner layers of the

Functional body 2 are preferably arranged such that they close the intermediate spaces of the preceding segments 8. Because the distances between the segments 8 at

As the functional body volume increases, the segments 8 must overlap in the smaller, folded state.

By this specific arrangement of the segments 8 is

ensures that as far as possible the entire bladder surface is covered without gaps in performance. This must be easy

Stellkräfte by a certain elasticity of the

Fabric materials ensure that the surface of the

Function body 2 can contact the bubble inner wall almost completely. The access of the germs to the

Bladder mucosal membranes and in particular to ureters 5 and urethra 4 can be prevented in any case by an antimicrobial coating. In the interior of the

Functional body 2 have germs that can pass almost exclusively through the urethra 4 in the bladder, no pathogenic significance.

The material of which the functional body 2 consists is preferably provided with bulges 18 which are embossed into the tissue. The dimensional stability of the material should be so be sized so that the structures disappear when pressed into the smaller state (catheter shape).

The inventive device 1 may further include

Guide element comprising the functional body

stabilized. In order to give the functional body 2 for introduction via the urethra 4 sufficient rigidity, it is advantageous to the functional body 2 in the relevant area, for example, a thin guide pin 9 for

Example metal or plastic wrap (Fig. IC, 1D and IE). After insertion into the bladder 3, the guide pin 9 can be pulled out again (FIG. 2B) to pass through the

the channel formed by means of a pressure sprayer 10 (FIG. 2D) or other devices, the unfolding of the

Function body 2 initiate by introducing a fluid. This procedure requires that the inner functional layer be rendered water and / or gas tight during installation with a temporary coating (eg, PVA, acrylate, or other self-dissolving materials).

The functional body 2 should only stay in the bladder 3 for a limited time of up to 3 months to the

To initiate purification and the healing process and

secure. After cleansing the bladder 3 and the

Bladder lumen of germs becomes the functional body 2

preferably removed. So that the functional body 2 does not have to be removed from the outside by another intervention, it can be applied in the form of biodegradable materials, so that they decompose with time in the urine into the smallest particles which are flushed out via the urethra 4 with the urine , The degradation of the

Support material that is merely coated with an antimicrobial coating is much easier to apply

realize when using compound materials because the antimicrobial coating is not mixed with the carrier polymer and thus can not exert any interfering influence. FIG. 3 shows a further embodiment of the device according to the invention and its use. One after the other, individual elements 11, 12, 13, 14, 15, 16, 17 of the functional body 2 are respectively pushed over the guide pin 9 into the interior of the preceding functional body element. By dividing and folding the elements 11, 12, 13, 14, 15, 16, 17, the catheter can be kept very thin. The second, smaller element 12 can thus be introduced into the cavity of the larger element 11 folded around the guide pin 9 via the urethra 4 as required, for a larger contact area. Taking advantage of the memory effect preformed materials or by dissolving solidifying substances or the like, the overall structure of the functional body is built together in the bladder and adapts flexibly, for example by mechanical bias to the urinary bladder epithelia of the bladder periphery. According to this principle, differently functionalized layers can also be installed. Thus, for example, the outer membrane could be a surface that is provided with an additional antimicrobial principle for sterilizing the urinary bladder 3 or the urinary bladder surface.

The structural design of the device 1 according to the invention with the aid of the fine-meshed fabric of the functional body 2 in the multi-layered construction with minimal distances, preferably with antimicrobial coating, is technically feasible with existing materials and methods. Reference sign list

I device 2 functional body

3 bladder

4 urethra

5 ureters

6 kidneys

7 pimples

8 segments

9 guide pin

10 pressure syringe

II element

12 element

13 element

14 element

15 element

16 element

17 element

18 bulges

Claims

claims

1. Device (1), in particular for protection and for

Cleaning of the urinary bladder lumen, at least consisting of a functional body (2), which is variable in its spatial extent, wherein the functional body (2) is at least partially convertible from a smaller state to a larger state.

2. Device according to claim 1, characterized in that the functional body (2) consists at least partially of a material suitable for liquids

is permeable, preferably a material having holes or pores.

3. Apparatus according to claim 1 or 2, characterized

in that the material of the functional body (2) is selected from the group consisting of close-meshed fabric, perforated foil, fine-pored foam and the like

is selected.

4. Device according to one of claims 1 to 3, characterized in that the material of the functional body (2) is a self-unfolding material.

5. Device according to one of claims 1 to 4, characterized in that the functional body (2) is biodegradable.

6. Device according to one of claims 1 to 5, characterized in that the functional body (2) is at least partially wetted with an antimicrobial substance and / or coated.

7. Device according to one of claims 1 to 6, characterized in that the functional body (2) in

at least two segments (8), preferably 4 to 32 segments (8), is divided.

8. Device according to one of claims 1 to 7, characterized in that the functional body (2) in the smaller state at least partially folded, rolled up and / or compressed.

9. Device according to one of claims 1 to 8, characterized in that the functional body (2) in the smaller state has a diameter of at most 4-6 mm, preferably about 5 mm.

10. Device according to one of claims 1 to 9, characterized in that the functional body (2) has at least two layers, preferably an inner

Layer and an outer layer, and that the inner layer is provided with a, preferably temporary, gas and / or waterproof coating and / or the outer layer has a textured surface, preferably with nubs (7), surveys or the like is provided.

11. Device according to one of claims 1 to 10, characterized in that the functional body (2) is provided on the outside with a, preferably shaping, shell.

12. Device according to one of claims 1 to 11, characterized in that in addition a guide element, preferably a guide pin (9), is provided.

13. Use of the device according to one of claims 1 to 12 as a kind of catheter for protection and for

Purification of the urinary bladder lumen.