GB2512696A

GB2512696A - Catheter and process for cleaning the catheter

Info

Publication number: GB2512696A
Application number: GB201322272A
Authority: GB
Inventors: Melanie Hoehl; Markus Dorwarth
Original assignee: Robert Bosch GmbH
Current assignee: Robert Bosch GmbH
Priority date: 2012-12-18
Filing date: 2013-12-16
Publication date: 2014-10-08
Also published as: DE102012223558A1; GB201322272D0

Abstract

A catheter has: a treatment channel 11 to introduce a treatment substance into the body of a patient; a catheter tip 10 which surrounds an end of the treatment channel; and a cleaning channel 12. The cleaning channel joins the treatment channel at a connection 13 which may be a valve (figures 11a,12a) operable by a pneumatic, hydraulic or electric control line (13_2, figure 13). In use a cleaning substance is circulated through the cleaning channel and through the treatment channel in the direction away from the catheter tip. The connection between the channels may locate inside or outside of the patients body. Filters (31,32 figures 3a-3c) may reside in either or both channels. The channels may be coaxial or one may be located in the wall of the catheter. There may be multiple lumens in the wall of the catheter (figure 7). Lumen collapse may be prevented by supports (8, figure 8). Pressure, flow or pH sensors may be included and the cleaning process ceased if leakage into the body is indicated.

Description

Catheter and process for cleaning the catheter

Description

The present invention relates to a catheter and to a process for cleaning the catheter.

Prior art

Catheters used in the medical field have already been known for more than 5000 years.

They are used, for example, for flushing, exploring, emptying and filling various hollow organs (such as, for example, the bladder, stomach, intestine, vessels) as well as the heart and ear. The first catheters were made of primitive materials such as, for example, reeds, but products made of tin and bronze were also used. Nowadays, catheters are produced predominantly from modern materials such as, for example, plastics, rubber, silicone, metal, glass, etc. All catheters consist of a catheter tip, which is generally inserted by means of a needle into the body of a patient, and one or more lumeh or connectors. Lumens generally denote tubes which are used, for example, for supplying and removing substances, fluids. Depending on the use, catheters have one or more lumens. The latter include, for example, central venous catheters, which have two to three lumens (distal, medial and proximal lumen). The lumens are brought together by way of connectors before entering the body.

In many patients, catheters are used permanently or at least over a prolonged period of time. Such catheters include, for example, intracardiac catheters; which even in the case of long-term treatments can be replaced only with difficulty. Owing to the use of the catheters over a prolonged period to time, infectious diseases caused by the catheters, including sepsis, are not uncommon, These result in high costs for subsequent treatments, treatment problems and delayed recovery for the patients. In the worst case, the outcome can be fatal. On average, catheter patients have 1.5 infections per year.

Accordingly, there is a considerable need for catheters which are so constructed that their use significantly reduces, and in the best case even prevents, the risks of infection.

Disclosure of the invention

The present invention is defined substantially by features of the independent claims.

Further embodiments of the present invention can be found by way of example in the dependent claims.

The idea of the present invention is to provide a catheter which can be cleaned even while it is located in the body of the patient. There is used to this end, in addition to at least one treatment channel by way of which the treatment substance (e.g. in the form of fluid or the like) is supplied to the patient, at least one cleaning channel. The cleaning channel is so configured that a cleaning substance is passed through it and later (e.g. as close to the catheter tip as possible) is passed into the treatment channel. The catheter is so configured that the cleaning substance does not flow in the direction towthrds the catheter tip, that is to say cannot enter the patients body, but flows back out of the patient's body by way of the treatment channel, thereby cleans the treatment channel and finally flows out of the treatment channel.

By means of the present invention as outlined above, as claimed in the accompanying claims and as described in the present application, regular flushing or cleaning of the* catheter can be carried out. Cleaning can be carried out as often as desired.

Furthermore, complete cleaning is possible. Any suitable cleaning substances can be used for the cleaning, for example antibacterial solutions, saline solutions, etc. Antibiotics can also be used. It is also possible to avoid using antibiotics, owing to their often stressful effect on the patient, for example by using common salt as the cleaning solution, substance. The use of antibiotics can lead to problems in weakened patients in particular, where, for example, the formation of treatment-resistant bacteria strains can be assisted. The possibility of using alternative and no less effective cleaning substances (e.g. saline solution) means that additional stress on the patients (in particular weakened patients) can be avoided. In particular, the creation of potential treatment resistances can thereby be avoided. Furthermore, the present invention provides the permanent security of an antibacterial action. The whole of the catheter, that is to say the whole of the treatment channel (apart from a few mm of dead volume), can be flushed. The dead volume can additionally be monitored for values indicating infections, such as, for example, electrolyte and pH values, whereby any infection can be detected and treated in good time. Severe infections such as, for example, sepsis can be prevented. By means of the present invention it is possible to check and/or monitor (e.g. to the millisecond) whether any of the flushing solution is entering the patient or not. If so, countermeasures can be taken immediately. The, safety of. the cleaning according to the invention is accordingly very high. By means of the present invention there is provided, above all, a catheter by means of which, and by the cleaning of which, catheter infections can be minimised. The treatment costs can also be reduced significantly. Moreover, the catheter can be used in the long term. Long-term use is safe, has a reduced risk of infection and is patient-friendly, because no additional stresses arise for the patient on use of the catheter.

In the following figures, the present invention is described more concretely with reference to exemplary embodiments of the present invention. For the purpose of clarity, the same or similar elements in the figures are provided with the same or similar reference numerals. . Fig. I shows a catheter according to an embodiment of the present invention; Fig. 2 shows a catheter according to an embodiment of the present invention; Fig. 3 shows a catheter according to an embodiment of the present invention; Fig. 4 shows a catheter according to an embodiment of the present invention; Fig. 5 shows a catheter according to an embodiment of the present invention; Fig. 6 shows an arrangement of the treatment channel and of the cleaning channel according to an embodiment of the present invention; Fig. 7 shows an arrangement of the treatment channel and of the cleaning channel according to an embodiment of the present invention; Fig. B shows exemplary embodiments of the cleaning channel and/or of the treatment channel according to the present invention; Fig. 9 shows a catheter according to an embodiment of the present invention; Fig. 10 shows a catheter according to an embodiment of the present invention; Fig. 11 shows a pneumatic valve as a connecting element according to an embodiment of the present invention; Fig. 12 shows a pneumatic valve as a connecting element according to an embodiment of the present invention; Fig. 13 shows a channel and a control line of the catheter according to an embodiment of the present invention; Fig. 14 shows an, exemplary embodiment of the cleaning channel according to the present invention; Fig. 15 shows an exemplary embodiment of the treatment channel according to the present invention; Fig. 16 shows a catheter according to an embodiment of the present invention; and Fig. 17 shows steps of a process for cleaning the catheter according to an embodiment of the present invention.

Fig. I shows a catheter according to an embodiment of the present invention. The catheter has at least one treatment channel 11, which is configured to be inserted into a body of a patient and to introduce at least one treatment substance, which is provided for treating the patient, into the body of the patient. The catheter has a catheter tip 10 which surrounds one end of the treatment channel 11 and is configured to be inserted into the body of the patient. The treatment substance is introduced into the treatment channel 11 and passed through the treatment channel 11 in the direction towards the catheter tip 10. The direction of the passage or flow of the treatment substance is shown by way of example by the arrow 111. The treatment substance thereby passes the end of the treatment channel 11 at the catheter tip 10 and thus enters the body of the patient. The catheter further has at least one cleaning channel 12 which is configured to clean the treatment channel 11 and thereby pass a cleaning substance through the cleaning channel 12. The cleaning substance can b! passed through the cleaning channel 12 in the direction towards the catheter tip 10. At a connection 13 of the cleaning channel 12 with the treatment channel 11, the cleaning substance is passed into the treatment channel ii in such a manner that the cleaning substance is then passed through the treatment channel 11 in a direction away from the catheter tip 10. The flow of the cleaning substance through the cleaning channel 12, via the connection 13 and then through the treatment channel 11, is shown by way of example by the arrow 121. *25

It will be appreciated that, when the cleaning substanbe is being passed through the catheter according to the present invention, the passage of the treatment substance is interrupted or stopped. When the treatment substance is being passed through the catheter according to the present invention, passage of the cleaning substance is not carried out.

There can be used as the cleaning substance antibacterial solutions, for example saline solution andlor a different solution (or sufstance). Because the present invention permits high flow rates of the cleaning fluid, the treatment channel 11 can also be cleaned solely by means of saline solution. It is also possible, for example, to use water as the cleaning substance.

The connection 13 can be configured, for example, by means of a connecting element.

The connecting element can be, for example, a valve, it in turn being possible for the valve to be, for example, a pneumatic, hydraulic or electric valve. When one of the terms "connection", "connecting element", "valve", "pneumatic valve", "hydraulic valve" or "electric valve" is used in the description of the present invention, it will be appreciated that other of the terms are also covered by the particular description.

Overall, the present invention permits various suitable configurations of the connection 13. In this manner, a flexible configuration of the catheter is possible.

Overall, the connecting element 13 can be configured to perform and/or to permit at least one of the following functions: to control the passage of the cleaning substance through the cleaning channel 12 in the direction towards the catheter tip 10; to control the passage of the cleaning substance from the cleaning channel 12 into the treatment channel 11; when the cleaning substance has been passed from the cleaning channel 12 into the treatment channel 11, to control the passage of the cleaning substance through the treatment channel 11 in the direction away from the catheter tip 10; and/or to control the passage of the treatment substance through the treatment channel 11 in the direction towards the catheter tip 10. In this manner, effective control of the flows of the substances (of the treatment substance and/or of the cleaning substance) is made possible. Control of the flows of the substances can be changed in a very space-saving manner, which, given that catheters are to inserted into the body of the patient with as little outlay as possible, is very desirable. Furthermore, control can be changed by means of only one element, which brings with it a saving in terms of components for the changing of the catheter and accordingly a simplified construction of the catheter.

By means of the catheter outlined above and shown by way of example in Fig. 1, the above-mentioned positive effects inter alla are achieved. For example, use of catheters that is safer and more free of infections is possible The catheter can be introduced into the body of the patient safely and free of infections over a long period of time. Cleaning of the catheter can be carried out as often as desired (e.g. regularly). There are no further stresses for the patient. Treatment costs are reduced significantly owing to the healthy and safer use of the catheter. Furthermore, treatment with minimal risk and that is more free of additional stresses is made possible by the use of the catheter. Cleaning can also be carried out when the catheter is inserted in the body of the patient.

The embodiment shown in Fig. I is a general embodiment of the catheter. Each of the above explanations relating to the catheter according to Fig. 1 can also be applied correspondingly to all further embodiments of the present invention and can be combined therewith.

Fig. 2a shows a catheter according to an embodiment of the present invention.

According to the present embodiment, the cleaning channel 12 and the treatment.

channel 11 are connected outside the body 2 of the patient, for example by means of the connecting element 13. In this manner, the connection 13 is accessible at all times.

Fig. 2b shows a catheter according to an embodiment of the present invention. The cleaning channel 12 and the treatment channel 11 are thereby connected inside the body 2 of the patient, for example by means of the connecting element* 13. In this manner, the dead volume, that is to say the volume in the treatment channel 11 that is not cleaned or flushed using the cleaning channel 12, can be kept as small as possible, which significantly reduces the risk of the occurrence of, possible infections. The connection 13 can also be located directly in the catheter tip 10. For example, the corresponding connecting element 13 can be integrated intothe catheter tip 10. In this manner it is possible to clean the catheter completely without having to remove it. A small dead volume can form only at the catheter tip 10. However, this dead voldme ca'n be reduced by locating the connection 13 in the catheter tip 10 (for example by integrating the connecting element 13 into the catheter tip 10).

In Fig. 2a, the connection 13 can be produced just before the catheter enters the body 2 of the patient, in order significantly to reduce the dead volume and accordingly the risk of infections.

Accordingly, the connection 13 of the cleaning channel 12 and the treatment channel 11 can be arranged in a section of the treatment channel 11 which, after insertion of the catheter, is located outside the body 2 of the patient or inside the body 2 of the patient, the section being a sectiop from the catheter tip 10 to a point of the treatment channel 11 that is located substantially before the entry of the treatment channel 11 into the body 2 of the patient.

In this manner, a flexible configuration of catheters is possible, which can be adapted to given needs and requirements of the use of the catheter. Furthermore, the dead volume is kept as small as possible, which also keeps the possibility of the occurrence of infections as small as possible.

It is to be noted that both the embodiment of Fig. 2a and the embodiment of Fig. 2b can variously be combined with the further embodiments of the present invention.

Fig. 3a shows a catheter according to an embodiment of the present invention. The treatment channel 11 has at least one filtering unit 31 which is configured to filter impurities when the treatment substance is passed through the treatment channel 11 in the direction towards the catheter tip 10. When the cleaning substance is passed through the treatment channel 11, the impurities filtered by the filtering unit 31 are passed out of the treatment channel 11. In this manner, impurities such as, for example, germs can be prevented from reaching the dead volume. With each incorporated filtering unit 31, the risk of contamination of the dead volume and accordingly the risk of infections is reduced significantly.

Fig. 3b shows a catheter according to an embodiment of the present invention.

According to this embodiment, the cleaning channel 12 has at least one filtering unit 32 which is configured to filter impurities when the cleaning substance is passed through the cleaning channel 12 in the direction towards the catheter tip 10. In this manner, potential sources of risk which may be introduced into the body 2 of the patient by way of the cleaning substance are ruled out. This reduces the risk of contamination of the dead volume and consequently also the risk of infections. Each further incorporated filtering unit 32 additionally reduces these risks.

Fig. 3c shows a catheter according to an embodiment of the present invention. Fig. 3c illustrates a combination of the embodiments of Figs. 3a and 3b, that is to say the combined use of the filtering units 31 and 32. The combination brings about a further (improved) reduction of the risks of contamination of the dead volume and accordingly of the risks of the occurrence of infections.

In addition to the embodiments of Figs. 3a to 3c, it is to be noted that at least one of the filtering units 31, 32 can also be arranged in the catheter tip 10 when the connection 13 or the connecting element 13 is arranged in the catheter tip 10. In this case, at least one of the filtering units 31, 32 is so arranged in the catheter tip 10 that the cleaning substance passes through the filtering units 31, 32. If the cleaning substance in the catheter tip 10 passes through a filtering unit 31 of the treatment channel 11, the impurities (e.g. germs) filtered in that filtering unit 31 are flushed out of the treatment channel 11 by the flow 121 of the cleaning substance.

It is to be noted that each of the embodiments of Figs. 3a, 3b, 3c can be combined with any of the embodiments of the present invention.

Fig. 4 shows a catheter according to an embodiment of the present invention. The cleaning channel 12 and the treatment channel 11 are thereby arranged in two separate lumens 42, 41 of the catheter, the cleaning channel 12 being accommodated in the lumen 42 and the treatment channel 11 being accommodated in the lumen 41. In this manner, a stable and safe separation of the two channels 11, 12 is made possible.

Fig. 5 shows a catheter according to an embodiment of the present invention.

According to Fig. 5, the cleaning channel 12 and the treatment channel 11 are arranged in a common lumen 5 of the catheter. In this manner it is ensured that both channels 11, 12 are able to run in the body 2 of the patient because it is simpler to lay one lumen than two lumens in the body 2 of the patient. The dead volume can thus be reduced, which leads to a significant reduction of infection risks.

According to a further embodiment, which is shown in greater detail by way of example in Fig. 6 and Fig. 7, the common lumen 5 has an inner channel and at least one outer channel. The cleaning channel 12 can thereby surround the at least one outer channel, and the treatment channel 11 can surround the inner channel. Alternatively, the cleaning channel 12 can surround the inner channel, and the treatment channel 11 can surround the at least one outer channel. In this manner it is ensured that both channels 11, 12 are able to run in the body 2 of the patient. The dead volume can be reduced as a result. This leads to the desired significant reduction of the infection risks.

Fig. 6 shows an arrangement of the treatment channel 11 and of the cleaning channel 12 according to an embodiment of the present invention. The common lumen 5 is in the form of a twin-walled lumen. The inner channel of the twin-walled lumen is surrounded solely by an inner wall 61 of the twin-walled lumen. The outer channel 62 is arranged between the inner 61 and the outer wall 62 of the twin-walled lumen. The twin-walled common lumen can correspondto two concentric channels (coaxial guides).

According to the embodiment of Fig. 6a, the inner channel is the treatment channel 11 and the outer channel is the cleaning channel 12. According to the embodiment of Fig. 6b, the inner channel is the cleaning channel 12 and the outer channel is the treatment channel 11.

Fig. 7 shows an arrangement of the trea:ment channel 11 and of the cleaning channel 12 according to an embodiment of the present invention. At least one outer channel is formed in the wall 71 of the common lumen. The inner channel is surrounded by the wall 71 of the common lumen.

According to the embodiment of Fig. 7a, the inner channel is the treatment channel 11 and the at least one outer channel in the wall 71 of the common lumen is the at least one cleaning channel 12. According to the embodiment of Fig. 7b, the inner channel is the cleaning channel 12 and the at least one outer channel in the wall 71 of the common lumen is the at least.one treatment channel 11.

According to an embodiment of the present invention, wherein the embodiment can be combined with each of the embodiments explained here, the channels 11, 12 are so configured that: the treatment channel 11 has at least one support element which is configured to prevent the treatment channel 11 from sticking together; and/or the cleaning channel 12 has at least one support element which is configured to prevent the cleaning channel 12 from sticking together. In this manner, the desired flow of the cleaning substance and/or treatment substance is made possible. In particular when using a twin-walled lumen, the channels 11, 12 can stick together as a result of flow forces. The support elements prevent this. Unhindered cleaning of the treatment channel 11 is thereby made possible, which in turn leads to reliable cleaning of the catheter, permits long-term use of the catheter and significantly reduces the risk of the occurrence of possible infections.

Figs. Ba to Og show examples of forms of a channel, which can be a cleaning or treatment channel 11, 12, having at least one support elementS.

Fig. 9 shows a catheter according to an embodiment of the present invention, which builds on the embodiment of Fig. 7. At the end of the common lumen located outside the body. 2 of the patient and/or at the end of the outer channels located at the connection 13, the inner and outer channels are converted into a concentric or coaxial arrangement. There is thus formed at least one section 9 of the common lumen that is of similar construction to the twin-walled configuration of Fig. 6. In this section 9, all the outer channels are brought together to form a single outer channel. The outer channel of the section 9 formed by bringing the outer channels together is formed by the outer and inner wall of the common lumen in section 9, while the inner channel is surrounded by the inner wall. In this manner, it is likewise possible to prevent the channels, which are formed in the wall 71 and surrounded by the wall, that is to saythe outer channels and the inner channel, from sticking together. The section 9 can be, for example, not more than 0.5 cm to 1 cm long, in order optimally to prevent the channels from sticking together. It is to be noted that the present embodiment additionally permits the use of the support elements 8 as shown by way dl example in Fig. 8.

Fig. 10 shows a catheter according to an embodiment of the present invention. The embodiment of Fig. 10 is based on the embodiment of Fig. 9 discussed above, according to which a common lumen having at least one channel formed in its wall 71 (at least one outer channel) and having a channel surrounded by the wall 71 (an inner channel) is converted in a section 9, 9' into a concentric or coaxial form. As is also shown in the embodiment of Fig. 10, the section 9' consists of a twin-walled configuration of the common lumen, the at least one outer channel being converted into a single channel formed between the outer and the inner wall. Fig. 10 shows the regiOn that is always located outside the body 2 of the patient. According to Fig. 10, the section 9' is used to supply the treatment substance and/or the cleaning substance. To that end, an inlet 10_I is arranged in the coaxially formed section, via which inlet 10_i a corresponding substance (e.g. the cleaning substance) is fed into the outer or inner channel.

If the section 9 is located in the region of the common lumen in which the channels are brought together, then the coaxial region can be terminated by the connecting element 13. In this manner, the connecting element 13 of the coaxial section 9 can be used to provide a more simple configuration for bringing together or connecting the treatment channel 11 and the cleaning channel 12..

As already discussed, the connecting element 13 can be, for example, a pneumatic, hydraulic or electric valve. An example of the configuration of a pneumatic valve according to an embodiment is given in Fig. 11.

According to Fig. 11, the cleaning substance flows in the outer channel 11 of the common lumen (in section 9) and the treatment substance flow in the inner channel 12 of the common lumen (in section 9). As indicated by the thick arrow, the pneumatic valve 11_i is closed for the cleaning substance and open for the treatment substance.

If the cleaning substance is supplied via the cleaning channel 12, pressure is exerted on the coupling of the plug 11_i 0, the valve 11_il is closed, whereby the valve 11_li moves back to the valve stop 11_i 3 so that the valve 11_il abuts the valve stop 11_13 and no further treatment substance is able to flow 111, and the valve 11_12 opens so that the cleaning substance is able to flow 121 from the cleaning channel 12 into the treatment channel 11 and can then flow back. As already mentioned, Fig. ii shows the reverse situation, in which the valve 11_lU is open and the valve 11_il is closed. That is to say, the flow iii of the treatment substance exerts pressure on the valve 11_il, so that valve 11_li is open and the valve li_i 2 is closed.

According to Fig. 11, the valves 11_il and 11_12 are pneumatically coupled valves of the pneumatic valve 11_i. A hydraulic or electric valve can also be constructed similarly. The valves 11_il and 112 would thereby be hydraulically or electrically coupled valves.

Figs. lib and lic illustrate the position of the valve 11_i open for the treatment substance in cross-section in regions A and B of Fig. 1 la.

Fig. 12 shows a further pneumatic valve 12_i as a connecting element according to an embodiment of the present invention. According to Fig. 12, the cleaning substance flows in the inner channel 12 of the common lumen (in section 9) and the treatment substance flows in the outer channel 11 of the common lumen (in section 9). According to. Fig. 12, the pneumatic valve 12_i has a guide for the pneumatics 12_14, pneumatically coupled valves 12_il, 12_12 and a valve coupling 12_13. Fig. 12 shows a position closed for the cleaning substance, that is to say no cleaning substance is able to flow 121 through the cleaning channel 12 into the treatment channel 1.1. The flow ill of treatment substance through the treatment channel 11 is permitted. The pneumatically coupled valve 1212 opens under the pressure in the treatment channel 11, whereby the pneumatically coupled valve 12_Il closes beforehand. The pneumatically coupled valve 12_li opens under the pressure in the cleaning channel 12, whereby the pneumatically coupled valve 12_Il closes beforehand, the pneumatically coupled valve 12_il being connected to the valve coupling 12_i 3.

Fig. 12b illustrates the position of the valve 12_I open for the treatment substance in cross-section in region A of Fig. 12. The reference numeral 12_15 indicates the holder of the guide of the pneumatics.

According to Fig. 12, the valves 11_il and 11_i 2 are pneumatically coupled valves of the pneumatic valve 11_i. *A hydraulic or electric valve can also be constructed similarly. The valves 11_il and 1 1_i2 would thereby be hydraulically or electrically coupled valves.

It is to be noted that Fig. 11 and Fig. 12 show exemplary embodiments of pneumatic valves as connecting elements, and that the present invention as a whole permits the use of further suitable embodiments for connecting elements; Fig. 13 shows a channel 13_i and a control line 13_2 of the catheter according to an embodiment of the present invention. According to the present embodiment, the catheter has at least one control line 13_2, which is configured to be* used for controlling the cleaning of the treatment channel 11. The control line 13_2 can be arranged in or at one of the following channels: the cleaning channel 12; the treatment channel 11; a further channel of the catheter. In Fig. 13, the channel in question is provided generally with the reference numeral 13_i. According to Fig. 13a, the control line 13_2 is arranged in a channel 11, 12, 131. According to Fig. 13b, the control line 13_2 is arranged at a channel 11, 12, 13_i in the catheter, that is to say in a lumen (e.g. lumen 42, 41, 5) of the catheter, it being possible for the lumen, in the case of a further channel that is not a treatment channel ii and not a cleaning channel 12, also to be a further lumen (i.e. not lUmen 41, 42, 5).

Considering the embodiment according to Fig. 7, in which at least one outer channel (see channels 12 in Fig. 7a and channels 11 in Fig. 7b) is formed in the wall 71 of the lumen, the control line 1 3_2. can be arranged in one of the outer channels. This channel can also be provided solely for accommodating the control line 13_2. In this case, the wall 71 of the lumen has at least two outer channels.

Considering the embodiment according to Fig. 9, in which the lumen has the coaxial section 9 for bringing together the outer channels formed in the wall 71 (see channels 12 in Fig. 7a and channels 11 in Fig. 7b), an outer channel, which is provided solely for accommodating the control line 13_2, can continue to exist in section 9 or can be combined with the outer channel between the inner and outer wall of the section 9. In the latter case, the control line 13_2 is accommodated in the coaxial section 9 in the outer channel between the inner and outer wall of the section 9.

Is The control line 13_2 can be extended as far as the connecting element 13, in order to avoid contact of the control line 13_2, which can be, for example, an electric line, with the treatment substance (or fluid) or with the cleaning substance (or fluid).

By means of the control line 1 3_2 provided as described above, effective control of the cleaning of the treatment channel 11 can be made possible, in which a complex configuration of the components of the catheter is not necessary. That is to say, the construction of the catheter can be simple without the desired effect of ensuring that infections are reduced being lessened.

The control line 13_2 can be used, for example, to control the connecting element 13 (e.g. an electric valve). For example, the connecting element 13 can be switched to a cleaning state, in which the cleaning substance flows through the cleaning channel 12 for cleaning and then flows through the treatment channel 11 (and flows out), or into a treatment state, in which only the cleaning substance and not the cleaning substance is allowed to flow.

The embodiment of Fig. 13 can be combined with any further exemplary embodiment of the present invention.

Fig. 14 shows an exemplary embodimen: of the cleaning channel 12 according to the present invention. According to Fig. 14, the cleaning channel 12 has at the end opposite the catheter tip 10 a measuring unit 14_I, which is configured to measure the pressure and/or volume of the cleaning substance introduced into the cleaning channel 12 and then passed through the cleaning channel 12. The measuring unit 141 of the cleaning channel 12 can be configured to compare the measured pressure with a limit value for the pressure and, if the measured pressure is lower than the limit value for the pressure, to emit a fault-indicating signal and/or to stop the passage of the cleaning substance through the treatment channel 11 and/or through the cleaning channel 12.

The measuring unit 14_i of the cleaning channel 12 can further be configured to compare the measured volume with a limit value for the volume and, if the measured volume is smaller than the limit value for the volume, to emit a fault-indicating signal and/or to stop the passage of the cleaning substance through the treatment channel ii.

The measuring unit 14_i of the cleaning channel 12 can additionally be configured to stop the passage of the cleaning substance through the treatment channel ii at the connection 13 of the cleaning channel 12 with the treatment channel 11 and/or at the end of the cleaning channel 12 opposite the catheter tip 10.

The fault-indicating signal can be carried out, for example, using the control line 1 3_2.

The measuring unit 14_i can transmit the signal via the control line i3_2 to a unit emitting the signal.

Stopping of the passage of the cleaning substance through the treatment channel ii can further be carried out using the control line i3_2. The measuring unit 14_i can indicate to the connecting element 13 (e.g. the electric valve) via the control line 13_2 that the supply of cleaning substance is to be stopped. In this case, the connecting element 13 can switch to the supply of treatment substance. The measuring unit 14_i can indicate, via the control line i3_2, to an element controlling the inlet 10_i that no cleaning fluid is to be passed through the inlet 10_I into the cleaning channel 12. The flow can then be stopped.

The embodiment of Fig. 14 can be combined with any embodiment of the present invention.

Fig. 15 shows an exemplary embodiment of the treatment channel 11 according to the present invention. According to Fig. 15, the treatment channel 11 has at the end opposite the catheter tip 10 a measuring unit 15_i, which is configured to measure the pressure and/or volume of the cleaning substance passed through the treatment channel 11 and passed out of the treatment channel ii. The measuring unit 15_i of the treatment channel ii can be configured to compare the measured pressure with a limit value for the pressure and, if the measured pressure is lower than the limit value for the pressure, to emit a fault-indicating signal and/or to stop the passage of the cleaning substance through the treatment channel ii. The measuring unit 15_i of the treatment channel 11 can further be configured to compare the measured volume with a limit value for the volume and, if the measured volume is smaller than the limit value for the volume, to emit a fault-indicating signal and/or to stop the passage of the cleaning substance through the treatment channel ii and/or through the cleaning channel 12. The measuring unit 15_I of the treatment channel 11 can additionally be configured to stop the passage of the cleaning substance through the treatment channel 11 at the connection 13 of the cleaning channel 12 with the treatment channel ii and/or at the end of the cleaning channel 12 opposite the catheter tip 10.

The fault-indicating signal can be carried out, for example, using the control line 13_2.

The measuring unit 15_i can transmit the signal via the control line 13_2 to a unit emitting the signal.

Stopping of the passage of the cleaning substance through th! treatment channel ii can further be carried out using the control line 13_2. The measuring unit 15_i can indicate to the connecting element 13 (e.g. the electric valve) via the control line i3_2 that the supply of cleaning substance is to be stopped. In this case, the connecting

B

element 13 can switch to the supply of treatment substance. The measuring unit 15_i can indicate, via the control line 1 3_2, to an element controlling the inlet 10_i that no cleaning fluid is to be passed through the inlet 10_i into the cleaning channel 12. The flow can then be stopped.

The embodiment of Fig. 15 can be combined with any embodiment of the present invention.

With regard to the embodiments of Fig. 14 and Fig. 15, the following is also to be noted, that the measuring unit 14_i, 15_i can carry out the pressure measurement and/or the volume measurement by known methods. For example, a pressure and/or volume sensor integrated at the end of the respective channel 11,12 can be contained in the measuring unit 14_i, 15_i or can be the measuring unit 14_i, 15_i. The value measured by the measuring unit 14_i, 15_i can be evaluated via an electric circuit. It can thereby be distinguished, according to the value measured, whether a fault-indicating signal is to be emitted and/or whether the passage of the cleaning substance through the treatment channel ii and/or through the cleaning channel 12 is to be stopped. In order to have a reference pressure and/or a reference volume, the cleaning substance can be introduced via a pressure-and/or volume-controlled unit (e.g. pressure-controlled syringe).

By means of each of the measuring units 14_i, 15_i it can be checked and/or monitored (e.g. to the millisecond) whether the flow 12i of cleaning substance through the catheter is as expected and optionally whether some of the cleaning substance is entering the body 2 of the patient or not. If the flow i 21 of cleaning fluid is not as expected, countermeasures can be taken immediately. A possible situation where cleaning substance enters the patient's body can thus be detected immediately and appropriate countermeasures can be taken immediately. The safety of the cleaning according to the invention is accordingly very high.

Fig. 16 shows a catheter according to an embodiment of the present invention.

According to Fig. 16, the catheter has in a region of the treatment channel ii between the catheter tip 10 and the connection 13 of the cleaning channel 12 with the treatment channel 11 at least one measuring unit 16_I, by means of which existing and/or possible impurities in the treatment substance passed through the treatment channel 11 are detected. The measuring unit 16_i can also be integrated into the catheter tip 10. The measuring unit 16_i is positioned in the dead volume of the catheter. The (at least one) measuring unit 16_i can carry out, for example, a temperature measurement, a pH value measurement and/or an electrolyte measurement.

Furthermore, the measuring unit 16_i can also be used to control processes and/or reactions for analysis and/or diagnostics. The measuring unit 16_i can, for example, effect the display of fault-indicating signals via the control line i3_2 and/or order the supply of treatment substance to be stopped if the measured values suggest contamination of the treatment substance and/or indicate a possible infection. The use of the control line 1 3_2 corresponds to the above-described use of the control line 1 3_2 by the measuring units 14_i and 15_i. Because the at least one measuring unit 16_i is arranged in the dead volume, through which no cleaning substance flows, a potential infection and/or contamination can be detected and/or predicted in good time. This permits optimal monitoring of the purity of the supplied treatment substance. Infections and more serious secondary diseases such as, for example, sepsis can thus be prevented by the catheter.

The measuring unit 16_i can also be arranged in the region of the treatment channel ii through which the cleaning substance flows, in order to ensure that a potential infection and/or contamination is detected and/or predicted in good time.

The embodiment of Fig. 16 can be combined with any further embodiment of the present invention.

Fig. 17 shows steps of a process for cleaning the catheter according to an embodiment of the present invention. The process comprises in step 17_3 the emission of the fault-indicating signal and/or the stopping of the passage of the cleaning substance through the treatment channel ii and/or through the cleaning channel 12 if at least one of the following situations occurs: -if (as shown by 17_i) the measuring unit 14_i of the cleaning Channel 12 determines that the measured pressure of the cleaning substance introduced into the cleaning channel 12 and then passed through the cleaning channel 12 is lower than the limit value for the pressure, and/or if (as shown by 17_i) the measuring unit 14_i of the cleaning channel 12 determines that the measured volume of the cleaning substance introduced into the cleaning channel 12 and then passed through the cleaning channel 12 is smaller than the limit value for the volume; and/or -if (as shown by 17_2) the measuring unit 15_i of the treatment channel ii determines that the measured pressure of the cleaning substance passed through the treatment channel 11 and passed out of the treatment channel ii is lower than the limit value for the pressure, and/or if (as shown by 17_2) the measuring unit 15_i of the treatment channel ii determines that the measured volume of the cleaning substance passed through the treatment channel ii and passed out of the treatment channel ii is smaller than the limit value for the volume.

In step 17_5, the process comprises the emission of a fault-indicating signal and/or stopping of the passage of the treatment substance through the treatment channel 11 if in step 174, by means of the measuring unit 16_i which is arranged in the region of the treatment channel between the catheter tip 10 and the connection 13 of the cleaning channel 12 with the treatment channel ii and/or which is arranged in the treatment channel ii, existing and/or possible impurities are detected in the treatment substance passed through the treatment channel 11.

Steps 17_i to 17_3 relate to the cleaning state of the catheter, that is to say to the situation when the cleaning substance is passed 121 through the catheter. Steps 17_4 and i7_5 relate to the treatment state of the catheter, that is to say to the situation when the treatment substance is passed iii through the catheter.

The present invention as described above and as claimed permits the contamination-free supply of treatment substances and significantly reduces the risk of infections by the use of the catheter according to the invention. H 22

Claims

Claims 1. Catheter having: -at least one treatment channel (ii, 13_i) which is configured to be inserted into a body (2) of a patient and to introduce a treatment substance, which is provided for the treatment of the patient, into the body (2) of the patient; -a catheter tip (10) which surrounds an end of the treatment channel (ii, 13_i) and is configured to be inserted into the body (2) of the patient; and -at least one cleaning channel (12, 13_i), wherein the cleaning channel (12, i3i) is configured to clean the treatment channel (11, 13_i) and thereby pass a cleaning substance through the cleaning channel (12, 13_i), wherein at a connection.(13) of the cleaning channel (12, 13_i) with the treatment channel (11, 13_i) the cleaning substance is passed into the treatment channel (ii, 13_i) in such a manner that the cleaning substance is then passed through the treatment channel (11, 13_I) in a direction away from the catheter tip (10).
2. Catheter according to claim 1, wherein the connection (13) of the cleaning channel (12, 13_I) and the treatment channel (ii, 13_i) is arranged in a section of the treatment channel (ii, 13_i) which, after insertion of the catheter, is located outside the body (2) of the patient or inside the body (2) of the patient, wherein the section is a section from the catheter tip (10) to a point of the treatment channel (ii, 13_i) which is located substantially before the entry of the treatment channel (ii, 13_i) into the body (2) of the patient.
3. Catheter according to any one of the preceding claims, wherein the connection (13) of the cleaning channel (12, 13.1) with the treatment channel (ii, 13_i) is configured by means of a connecting element (13).
4. Catheter according to claim 3, wherein the connecting element (13): -is a valve, wherein the valve can be a pneumatic, hydraulic or electric valve; -is configured to control the passage of the cleaning substance through the cleaning channel (12, 13_i) in the direction towards the catheter tip (10); -is configured to control the passage of the cleaning substance from the cleaning channel (12, 13_i) into the treatment channel (11, 13_i); -is configured, after the cleaning substance has been passed from the cleaning channel (12, 131) into the treatment channel (11, 13_i), to control the passage of the cleaning substance through the treatment channel (11, 13_i) in the direction away from the catheter tip (10); and/or -is configured to control the passage of the treatment substance through the treatment channel (11, 13_i) in the direction towards the catheter tip (10).
5. Catheter according to any one of the preceding claims, wherein: -the treatment channel (ii, 13_i) has at least one filtering unit (31) which is configured to filter impurities when the treatment substance is passed through the treatment channel (ii, 13_i) in the direction towards the catheter tip (10); and/or -the cleaning channel (12, 13_i) has at least one filtering unit (32) which is configured to filter impurities when the cleaning substance is passed through the cleaning channel * (12, 13_i) in the direction towards the catheter tip (10).
6. Catheter according to any one of the preceding claims, wherein: -the cleaning channel (12, 13_i) and the treatment channel (ii, 13_i) are formed in two separate lumens (41, 42) of the catheter; -the cleaning channel (12, 13_i) and the treatment channel (ii, 13_i) are arranged in a common lumen (5) of the catheter; -the common lumen (5) has an inner channel and at least one outer channel, wherein the cleaning channel (12, i3_i) surrounds the at least one outer channel and the treatment channel (11, 13_I) surrounds the inner channel, or wherein the cleaning channel (12, 13_i) surrounds the inner channel and the treatment channel (ii, 13_i) surrounds the at least one outer channel; -the common lumen (5) is a twin-walled lumen, wherein the inner channel is surrounded solely by an inher wall (61) of the twin-walled lumen and the outer channel is formed between the inner wall (6i) and an outer wall (62) of the twin-walled lumen; -the at least one outer channel is formed in the wall (71) of the common lumen (5) and the inner channel is surrounded by the wall (71) of the common lumen (5); -the treatment channel (11, 13_i) has at least one support element (8) which is configured to prevent the treatment channel (11, 13_i) from sticking together; and/or -the cleaning channel (12, 13_i) has at least one support element (8) which is configured to prevent the cleaning channel (12, 13_i) from sticking together.
7. Catheter according to any one of the preceding claims, wherein: -the treatment channel (11, 13_i) has at the end opposite the catheter tip (10) a measuring unit (15_I) which is configured to measure the pressure and/or volume of the cleaning substance passed through the treatment channel (ii, 13_i) and passed outcfthetreatmentchannel(11, 13_i); -the measuring unit (15_i) of the treatment channel (ii, 13_i) is configured to compare the measured pressure with a limit value for the pressure and, if the measured pressure is lower than the limit value for the pressure, to emit a fault-indicating signal and/or to stop the passage of the cleaning substance through the treatment channel (ii, 13_i); -the measuring unit (15_i) of the treatment channel (ii, 13_i) is configured to compare the measured volume with a limit value for the volume and, if the measured volume is smaller than the limit value for the volume, to emit a fault-indicating signal and/or to stop the passage of the cleaning substance through the treatment channel (ii, 13_i) and/or through the cleaning channel (i 2, 13_i); -the measuring unit (i5_1) of the treatment channel (ii, i3_i) is configured to stop the passage of the cleaning substance through the treatment channel (ii, 13_i) at the connection (i3) of the cleaning channel (12, 13_i) with the treatment channel (ii, 13_i) and/or at the end of the cleaning channel (12, i 3_i) opposite the catheter tip (10); -the cleaning channel (i2, 13_i) has at the end opposite the catheter tip (10) a measuring unit (14_i) which is configured to measure the pressure and/or volume of the cleaning substance introduced into the cleaning channel (12, 13_i) and then passed through the cleaning channel (12, 13_i); -the measuring unit (14_I) of the cleaning channel (12, 13_I) is configured to compare the measured pressure with a limit value for the pressure and, if the measured pressure is lower than the limit value for the pressure, to emit a fault-indicating signal and/or to stop the passage of the cleaning substance through the treatment channel (ii, 13_i) and/or through the cleaning channel (12, 13_i); -the measuring unit (14_i) of the cleaning channel (12, 13_i) is configured to compare the measured volume with a limit value for the volume and, if the measured volume is smaller than The limit value for the volume, to emit a fault-indicating signal and/or to stop the passage of the cleaning substance through the treatment channel (Ii, 13_i); and/or -the measuring unit (14_I) of the cleaning channel (12, 13_I) is configured to stop the passage of the cleaning substance through the treatment channel (ii, 13_I) at the connection (13) of the cleaning channel (12, 1.3_i) with the treatment channel (11, 13_i) and/or at the end of the cleaning channel (12, 13_i) opposite the catheter tip (10).

8-Catheter according to any one of the preceding claims, wherein there is arranged in a region of the treatment channel (ii, 13_i) between the catheter tip (10) and the connection (13) of the cleaning channel (12, 13_i) with the treatment channel (ii, 13_i) at least one measuring unit (16_i) by means of which existing and/or possible impurities in the treatment substance passed through the treatment channel (Ii, 13_I) are detected.20. . . . . 9. Catheter according to any one of the preceding claims, wherein the catheter has at least one control line (i3_2) which is configured to be used for controlling the cleaning of the treatment channel (ii, 13_i) and which is arranged in or at one of the following channels: the cleaning channel (12, 13_i); the treatment channel (Ii, 13_i); a further channel of the catheter.-10. Process for cleaning a catheter according to any one of claims 7 to 9, wherein the process comprises the emission (17_3) of the fault-indicating signal and/or the stopping (17_3) of the passage of the cleaningt substance through the ireatment channel (11,13_i) and/or through the cleaning channel (12, 13_I) if at least one of the following situations occurs: . -if the measuring unit (14_i) of the cleaning channel (12. 13_I) determines (17_i) that the measured pressure of the cleaning substance introduced into the cleaning channel (12, 13_i) and then passed through the cleaning channel (12, 13_i) is lower than the limit value for the pressure, and/or if the measuring unit (14_i) of the cleaning channel (12, 13-1) determines (17_i) thatthe measured volume of the cleaning substance introduced into the cleaning channel (12, 13_I) and then passed through the cleaning channel (12, 13_i) is smaller than the limit value for the volume; and/or -if the measuring unit (15_I) of the treatment channel (II, 13_I) determines (i7_2) that the measured pressure of the cleaning substance passed through the treatment channel (ii, 13_i) and passed out of the treatment channel (11, 13_i) is lower than the limit value for the pressure, and/or if the measuring unit (15_i) of the treatment channel (ii, 13_i) determines (i7_2) that the measured volume of the cleaning substance passed through the treatment channel (11, 13_I) and passed out of the treatment channel (II, 13_i) is smaller than the limit value for the volume; and/or wherein the process comprises the emission (i7_5) of a fault-indicating signal and/or stopping (17_5) of the passage of the treatment substance through the treatment channel (ii, 13_i) if, by means of the measuring unit (16_i) which is arranged in the region of the treatment channel (Ii, 13_i) between the catheter tip (iO) and the connection (13) Of the cleaning channel (12, 13_i) with the treatment channel (ii, i3_i), existing and/or possible impurities in the treatment substance passed through the treatment channel (11, 13_i) are detected (i7_4).11. Catheter substantially as hereinbefore described with reference to the accompanying dtawings.12. Process for cleaning a catheter, substantially as hereinbefore described with reference to the accompanying drawings.