DE102021112959A1 - System and method to support lung function - Google Patents

Abstract

The invention relates to a system for supporting the gas exchange, the removal of carbon dioxide from the blood and / or the oxygen saturation of the blood of a patient (P), having a gas exchanger (10) with an inlet and an outlet for a first fluid and for a second fluid. The system according to the invention further comprises a conveying device (30) for conveying the first fluid along the line section (40) and a control unit (60) for controlling or regulating the conveying device (30).

Description

The present invention relates to a system according to claim 1 or according to the preamble or generic term of this claim, further to a method according to claim 19.

Lung function support is always necessary when a patient's natural spontaneous breathing is not sufficient to inhale enough oxygen and/or exhale enough carbon dioxide. If this is the case, it is referred to as Acute Respiratory Distress Syndrome. In addition to invasive ventilation, methods and systems such as extracorporeal membrane oxygenation (ECMO) are available for its treatment.

It is an object of the present invention to provide another system for assisting in gas exchange, carbon dioxide removal or oxygen saturation of a patient's blood.

The object of the invention is achieved by a system having the features of claim 1, and also by a method having the features of claim 19.

The present invention relates to a system for assisting in gas exchange or oxygen saturation or decarboxylation of a patient's blood.

The system has a gas exchanger. The gas exchanger has an inlet and an outlet, respectively for a first fluid and for a second fluid. The gas exchanger may be an oxygenator which enriches the first fluid with oxygen and/or removes carbon dioxide therefrom.

The inlet and the outlet of the first fluid are each connected to a first or second hose line or to one end of a line section, or are provided as an alternative to such a connection.

Furthermore, the system preferably has a delivery device, for example a fluid pump, for delivering the first fluid along the first line and/or the line section.

Finally, the system comprises a control unit for controlling or regulating components of the system, e.g. B. the conveyor device, an optional further conveyor device explained below, e.g. B. pump, for pumping a second fluid, etc.

The system according to the invention is designed to flush a body cavity with a first fluid or to introduce the first fluid into the body cavity and also to drain it out again. The first fluid exchanges gas with the patient's body in the body cavity.

• - Bereitstellen eines erfindungsgemäßen Systems;
• - Einführen des ersten Fluids oder des Leitungsabschnitts in ein Darmsegment;
• - Fördern des ersten Fluids entlang der ersten Schlauchleitung oder des Leitungsabschnitts mittels der Fördervorrichtung; und
• - Steuern der Fördervorrichtung mittels der Steuereinheit.

A method is also part of the invention. It includes the following steps:

• - Providing a system according to the invention;
• - introducing the first fluid or the line section into an intestinal segment;
• - Conveying the first fluid along the first hose line or the line section by means of the conveying device; and
• - Controlling the conveyor by means of the control unit.

In the context of the present invention, a patient can be a human or an animal. A patient can be sick or healthy.

In all of the following statements, the use of the expression “can be” or “can have” etc. is to be understood synonymously with “is preferably” or “has preferably” etc. and is intended to explain embodiments according to the invention.

Whenever numerals are mentioned herein, the person skilled in the art understands them to indicate a numerical lower limit. Provided that this does not lead to a discernible contradiction for the person skilled in the art, the person skilled in the art always reads “at least one” or “at least one” when specifying “a” or “an”. This understanding is also encompassed by the present invention, as is the interpretation that a numeral such as "a" can alternatively be meant as "exactly one" wherever this is clearly technically possible for a person skilled in the art. Both are encompassed by the present invention and apply to all numerals used herein.

Advantageous further developments of the present invention are the subject matter of subclaims and embodiments.

Reference herein to an embodiment is an exemplary embodiment of the invention and is not intended to be limiting.

If it is disclosed herein that the object according to the invention has one or more features in a specific embodiment, it is also disclosed herein that the object according to the invention exactly this or expressly does not have these features in other embodiments also according to the invention, e.g. B. in the sense of a disclaimer. For each embodiment mentioned herein, the contrary embodiment, for example formulated as a negation, is also disclosed.

If a method step is mentioned herein, the present disclosure also discloses a device which can be part of the present invention and is intended, used and/or programmed to carry out the method step. The corresponding device can be labeled according to the method step that it carries out, can carry out or can cause.

Embodiments according to the invention can have one or more of the features mentioned above and/or below in any combination, provided that such a feature is not recognized as technically impossible for a person skilled in the art.

When reference is made herein to a body cavity, this may be an intestinal segment as described herein. If an intestinal segment is mentioned here, the statements made in this regard are not limited to an intestinal segment, but can also be related to the body cavity in any embodiments.

In some embodiments, the system according to the invention also has at least one enterostomy.

In some embodiments, the system further includes a conduit portion for conducting the first fluid in an interior or lumen thereof. The line section can be implanted, inserted or the like into the patient, at least in sections. What is stated herein regarding the implantable line section therefore applies to implantable line sections which remain in the patient's body for a short time (e.g. hourly, daily) or permanently (daily, weekly, etc.). The above terms can therefore be interchanged herein. “Implantable” is therefore not limited to permanent devices.

In some embodiments of the system according to the invention, the line section is arranged in an intestine segment (also: intestine section) of the patient.

The intestinal segment is preferably a small intestine segment.

In some embodiments, the conduit portion is located in a segment of intestine that has been surgically excised from the patient's alimentary canal.

In some embodiments, the line section is arranged in an intestinal segment and surgically connected to the enterostoma, preferably bilaterally.

In some embodiments, the intestinal segment is connected, preferably at both ends, to an enterostomy in the abdominal wall or cover.

In some embodiments, the first fluid is introduced into the intestinal segment via the enterostoma in the abdominal wall.

In some embodiments, the line section has a length of between 2.5 m and 6 m, preferably a length of between 1.5 m and 3.5 m, particularly preferably between 2 m and 2.5 m.

In some embodiments, the system further has both the first hose line and the second hose line, which are provided and/or suitable for establishing a fluid connection between the gas exchanger, the enterostoma and/or the line section.

In some embodiments, the system according to the invention has an ostomy connector or an ostomy plate, which serves to connect the line section and/or the hose line to the enterostoma.

In some embodiments, the line section and/or the hose line is completely or partially filled with the first fluid.

In some embodiments, the system also has at least one connector in order to fluidly connect the line section to the first and/or the second hose line.

In some embodiments, the line section has a large number of openings, in particular on its periphery or lateral surface.

In some embodiments, the system further comprises a lid or closure for closing the ostomy connector or ostomy tray.

In some embodiments, the first fluid is, includes, or consists of perfluorocarbon.

Perfluorocarbon has a binding capacity for CO ₂ that is about three times higher than its binding capacity for O ₂ . It is thus, when exposed to atmosphere, a suitable medium for blood decarboxylation due to the disproportionately higher CO2 partial pressure in the blood when compared to the atmosphere.

In some embodiments, the gas exchange takes place in the gas exchanger between the first fluid and the breathing air as the second fluid.

In some embodiments, the gas exchange in the gas exchanger takes place between the first fluid and a gas provided as the second fluid.

In some embodiments, the flow of the first fluid in the intestinal segment is measured and/or regulated, in particular by means of the system's control unit. Alternatively or additionally, the pressure of the first fluid in the segment of the intestine is measured and/or regulated, in particular by means of the control unit of the system.

In some embodiments, the flow of the first fluid in the line section and/or in the gas exchanger is measured and/or regulated, in particular by means of the control unit of the system. Alternatively or additionally, the pressure of the first fluid in the line section and/or in the gas exchanger is measured and/or regulated, in particular by means of the control unit of the system.

In some embodiments, the pressure and/or flow of the second fluid, e.g. B. in the gas exchanger, measured and / or regulated, in particular by means of the control unit of the system, or caused by this. Alternatively or additionally, the pressure and/or the flow of the first fluid in the line section and/or in the gas exchanger are measured and/or regulated, in particular by means of the control unit of the system.

In some embodiments, the system according to the invention is completely implanted. This means that not only a line section, but also the gas exchanger, the delivery device and the control unit of the system are implanted in the patient.

In some embodiments, the diaphragm directly or indirectly drives the flow of the first and/or the second fluid.

In some embodiments, the intestinal segment is connected to a system that is partially or fully implanted in the abdomen or in a thoracic cavity.

In some embodiments, the system also has a device for emptying the line section and/or the intestinal segment of the first fluid.

In some embodiments, the gas exchanger is optionally connected to a body cavity that is perfused with the first fluid. Gas exchange with the first fluid takes place at the surface of the body cavity.

In some embodiments, the fluid is characterized by a high solubility for gases. In these embodiments, it can be used as a gas transport medium.

In some embodiments of the system according to the invention, the gas exchange takes place via perfluorocarbon as the first fluid with which z. B. a segment of intestine is flushed or should be flushed. Within the perfused organ, e.g. B. the intestinal segment, there is a gas exchange between the perfluorocarbon and the blood via the inner wall of the intestine.

In some embodiments, the first fluid leaves the intestinal segment via an enterostomy in the abdominal wall and is fed to a gas exchanger, for example an oxygenator, via a line section. A conveying device is preferably located between the intestinal segment and the oxygenator, for example a pump or bellows, which conveys the first fluid/perfluorocarbon through the hose line(s), the intestinal segment or the line section and the gas exchanger/oxygenator.

In some embodiments, the flow and/or the pressure of the first and/or the second fluid in the gas exchanger are measured and regulated.

In some embodiments, another conveyor, e.g. B. pump for pumping the second fluid, z. B. the air or another gas provided. The flow rate for the second fluid, z. B. the purge gas flow rate (sweep flow) determine the amount or the degree of possible gas exchange. The washing out of CO ₂ is controlled, for example or preferably, via the purge gas flow rate or primarily via the purge gas flow rate.

In some embodiments, the line section and/or the hose line(s) are or are connected to an intestinal segment or its lumen via two enterostomata created specifically for this purpose in the abdominal wall.

In these embodiments, there is preferably a supplying enterostomy, via which the first fluid (e.g. perfluorocarbon) is introduced into the intestinal segment or the line section arranged therein, and a draining enterostomy, via which the first fluid is drained.

In certain embodiments, only an enterstoma is provided, which equally corresponds to the introduction and the evacuation of the first fluid into and out of the body cavity, e.g. B. the intestinal segment is used.

In some embodiments, the line section is intended for introduction into the body cavity. For this purpose, it can be configured flexibly, at least in sections. He can do this z. Example, consist of silicone or silicone, or other suitable material.

In some embodiments, the line section has openings which fluidly connect its lumen to an exterior of the line section and/or the system according to the invention at the front.

In some embodiments, outlet openings for the first fluid can be provided at the front, or only at the front, or at the distal end, or only at the distal end or end section (which makes up e.g. 15% or the length of the line section) of the line section. From the proximal end (that is, coming from the hose lines), the first fluid can flow along the lumen of the line section in a distal direction to its one or more outlet openings, in order to be discharged through them out of the line section and into z. B. to flow into the intestinal segment.

In some embodiments, outlet openings for the first fluid can be provided on the lateral surface or the peripheral side, or only there.

The line section can thus be perforated in whole or in sections.

The system may include a device for aspirating or receiving first fluid from the lumen of the intestinal segment. A recirculation pump may be provided for this purpose. You can be provided to the first fluid z. B. by means of negative pressure from the intestinal segment retrograde, i.e. suction from distal to proximal.

The return pump can be arranged to return the first fluid via a vacuum line within which the first fluid can be conducted extracorporeally.

The second hose line disclosed here, which is separate from the first hose line with which the first fluid is supplied to the line section or the intestinal segment, can be used to return the first fluid after it has left the patient's body. It is pointed out that in some embodiments there is overpressure both in the first hose line and in the second hose line, caused by preferably one and the same pump when the system is in operation. This is different in other embodiments, in particular if the first fluid is introduced into the body cavity and then out again via one enterostoma rather than two. Particularly in such embodiments, the second tubing may be a vacuum line as disclosed herein.

In some embodiments, the second conduit, e.g. B. as a vacuum line, the first line, which is thus at least partially in the lumen of the second line, or vice versa.

In some embodiments, the ostomy connector or the ostomy plate can be designed to allow the first fluid to pass through it via at least one first through-opening in a first direction (e.g. into the intestinal segment) and to pass the first fluid through at least one second through-opening into a second direction (e.g. out of the intestinal segment). The first passage opening and the second passage opening are thus separated from one another.

In certain embodiments, the system comprises one or more devices measuring or determining the same or different parameters in the same or different ways.

In some embodiments the system comprises at least one pressure measuring device as such a device, e.g. B. in the form of one or more pressure gauges. The pressure measuring device can be provided and arranged in order to measure the pressure of the medium (gas, atmosphere, first fluid, etc.) surrounding a component of the system, in particular the line section. By means of such a measurement, the pressure prevailing in the segment of the intestine, which can be primarily determined by the introduction of the first fluid, can be measured when the system is in use. Monitoring can be provided based on this, which can ensure that an impermissibly high pressure application to the inside of the intestinal segment is prevented, detected early, etc. For this purpose, the control unit can be in signal communication with the pressure device as well as with means for increasing or decreasing the pressure, such as with the pumps referred to herein, individually or in any combination.

In some embodiments, the system has at least one device for measuring a concentration, in particular of a gas, and/or for carrying out a partial pressure measurement, as such a device, e.g. B. in the form of one or more CO ₂ knife. Such a measurement can be used to measure the partial pressure of CO ₂ in the first fluid, in the intestinal segment and/or in the patient's blood, the concentration of CO ₂ , the pH value, the respiratory rate of the patient, and the like when the system is in use. Monitoring can be provided based on this, which can ensure that an impermissibly or unintentionally high withdrawal of CO ₂ with the risk of unintentionally reducing the respiratory drive is prevented, detected early, etc. For this purpose, the control unit can have a signal connection both to the device for measuring and to the means for increasing or reducing the delivery rate, for example with the pumps mentioned here, individually or in any combination. For example, it can be provided that activities that are responsible for the removal of CO ₂ or that promote it are reduced, scaled back or throttled if, for example, one of the monitored parameters exceeds or falls below threshold values or leaves reference ranges or threatens to exceed them /to leave. For example, the flow rate of the first and/or the second fluid can be throttled if the CO ₂ concentration becomes too low, the respiratory rate drops too much, etc.

Such thresholds or reference ranges can be predetermined and e.g. B. in a storage device of the system according to the invention (or standing with this in signal connection).

Such threshold values or reference ranges can be stored individually for each patient.

The system may be configured to store values or ranges of at least one of these parameters itself in that storage device, such as during or after a period of time that the system has been in use with the particular patient. In this way, values recognized individually as acceptable or desired can be stored and used in subsequent uses of the system as threshold values or reference values for the specific patient for further treatment using the system.

In this way, an unintentional decrease in the drive to breathe can advantageously be detected early on the basis of the monitored parameters. It can be counteracted by automatically adjusting technical settings such as flow rates.

In some embodiments, the first fluid contains a pharmacologically active substance, for example an active substance which causes vasodilatation of the vessels supplying the intestinal segment on the lumen side in the intestinal segment and thus local hyperaemia.

In some embodiments, the line section does not have a gas-but liquid-permeable membrane or layer, in particular cylindrical, alternatively in such embodiments it is also not surrounded by such a membrane or layer.

In some embodiments, the control unit for controlling or regulating the conveyor device has an energy source and/or is connected to one. In some embodiments, the control unit may have or be in communication with sensors that allow the control unit to control the pressures, flows and/or temperature in the system of the invention.

In some embodiments, no external energy source is required, or the energy source is, or derives from, muscle power. In some embodiments it is provided, by means of energy converters of the system, that force generated during breathing, e.g. B. is applied by means of the diaphragm to use and convert this if necessary suitable.

In the case of higher breathing activity with increased exertion of force by means of the diaphragm, more force is generated for the delivery device, which thus pumps the first and/or second fluid to an increased extent. In addition, the control unit can have sensors or be connected to them, which enable the control unit to control or regulate the pressures, the flows and/or the temperature in the system according to the invention.

In some embodiments, the system according to the invention comprises a heating device, e.g. B. in the form of a heat exchanger, which is provided, the first fluid, z. B. in the first and / or the second hose line, preferably to body temperature.

In some embodiments, the system includes a filter for filtering the first fluid. The filter can e.g. B. be provided in the first and / or second hose line.

The optional filter for filtering the first fluid can be provided to prevent detached cell components of the intestinal segment from being flushed into the gas exchanger together with the first fluid and clogging it.

An optional filter for filtering the second fluid prevents particles from entering the gas exchanger with the second fluid or purge gas and possibly clogging it.

The arrangement of gas exchanger, delivery device and filter within the system according to the invention described herein is purely exemplary and not to be understood as limiting. Other arrangements of these components are also encompassed by the present invention.

In some embodiments, additional components can be part of the system according to the invention.

The optional further components include, for example, a device for sterilizing the first fluid, e.g. B. a UV radiator.

Such a component can be a filter or a membrane in the circuit of the first fluid, which separates water from the first fluid.

Such a component can be a port for administering medication into the first fluid.

Such a component can be a “window” arranged so that the fluid can be viewed through it and turbidity or any changes can be seen, or that fluorescence, translucency or the like can be assessed or measured via a sensor.

In some embodiments, the line sections of the system are connected to the supplying or discharging enterostoma by means of a connector, for example arranged on an ostomy support. In some embodiments, the ostomate is connected to the skin such that the stoma is within the opening of the ostomy tray.

The system preferably contains 0.5 1 to 5 1 of the first fluid, particularly preferably between 1 1 and 2 1.

In some embodiments, the controller is configured to control gas exchange.

In some embodiments, the control unit includes sensors or is connected to sensors. The sensors are preferably suitable or provided for measuring physiological parameters, in particular those associated with gas exchange. This can be, for example, sensors that measure the oxygenation of the blood, the CO ₂ content of the first fluid and/or the blood and/or the pH of the blood, the heart rate, e.g. B. by ECG (electrocardiogram), the respiratory rate, respiratory activity and / or the like. In certain embodiments, the sensors include pressure sensors (which, for example, measure the fluid pressure in the hoses and lines through which the first fluid flows, the oxygenator and/or in the intestinal segment), and alternatively or additionally sensors for temperature.

In some embodiments, the sensors are part of, or intended for use with, an impedance or bioimpedance meter, which may optionally also be part of the system. For example, in some embodiments sensors are provided which are connected to the patient's skin when the system is used as intended. Alternatively or additionally sensors are optionally provided which z. B. are provided in or on the or the ostomy plate (s) or the connectors. In some embodiments, the sensors are or include electrodes.

The control unit can be programmed to regulate the flow or the delivery rate of the first and/or the second fluid as a function of values which are recorded by the sensors, in particular as a function of one or more of the physiological parameters. So it can be provided that depending on the respiratory rate, which z. B. determined by impedance analysis, the CO ₂ content (z. B. the first and / or second fluid), the patient's acidosis, the pH of the patient's blood, in general, etc. more or less of the first fluid in z. B. the intestinal segment is conveyed in, more or less of the second fluid is conveyed through the gas exchanger, etc., primarily with the aim of not too low but also not too high the respiratory rate, but z. e.g. below an upper predetermined and preferably adjustable limit and/or above a lower predetermined and preferably adjustable limit. In this way, the natural respiratory drive can advantageously be maintained. In this way, for example, the respiratory rate can also be influenced in such a way that the exhalation time is extended in order to increase the time for the alveoli to be ventilated in COPD patients with narrowed airways, e.g. B. a hyperinflation observed in COPD patients not to let it occur in the first place or, if necessary, to be able to dismantle it.

Sensors may be provided in or on wearables, watches, smartphones, etc. worn by the patient in some embodiments. The system may include or be connected to such carriers of sensors. So e.g. B. the smartphone via app or the watch worn on the wrist determine the respiratory rate. A prepared signal connection can transmit the values or evaluations thereof obtained by means of the sensors to the control unit.

If a signal or communication connection between two components is discussed here, this can be understood to mean a connection that exists during use. This can also be understood to mean that there is a preparation for such a signal connection (wired, wireless or implemented in some other way), for example by coupling both components, for example by means of pairing, etc.

Pairing is a process that takes place in the context of computer networks to create an initial link between computer units for the purpose of communication. The most well-known example of this is the establishment of a Bluetooth connection, by means of which various devices (e.g. smartphone, headphones) are connected to one another. Pairing is also sometimes referred to as bonding.

In some embodiments, the system or gas exchanger is mobile.

In order to be mobile, the system or gas exchanger can have a total mass of no more than 3 or 4 kg. Alternatively or additionally, it can have an independent voltage source, a battery, an accumulator or the like or be prepared for the use of one. One or more replacement batteries or accumulators may optionally be included with the system. In some embodiments, the system is designed to be operated with voltage that is not mains voltage, e.g. B. with 12 V, 24 V or the like, in contrast to mains voltage of z. B. 110V, 240V, etc.

In some embodiments, the system includes a carrying device that can facilitate its carrying on or on the body and/or in or on the patient's clothing, such as a carrying strap, tote bag, pocket in clothing, etc.

In some embodiments, the system comprises more than just one implantable lead segment, but e.g. B. two or more. These several line sections can, for. B. be designed as described herein, they can be identical to each other or different from each other. So you can z. B. in their length, the diameter of their lumen and / or the number, size and / or arrangement of their through openings for communication between their lumen and the surrounding exterior differ from each other. In certain embodiments, at least one of the line sections is optionally provided, arranged and/or used for introducing the first fluid into the intestinal segment, and at least another one optionally for removing the first fluid from the intestinal segment. Advantageously, with such a solution one would not have to rely on transporting the first fluid over a comparatively long distance, but instead an exchange in subsections of the intestinal segment could be ensured. The latter can e.g. B. be advantageous when the intestinal segment is partially contracted. If one has an afferent and an efferent line section in a comparatively short intestinal segment of the intestinal segment separated by contraction or peristalsis, the gas exchange could also take place in such a comparatively short intestinal segment closed by peristalsis or contraction, and the first fluid does not have to flow from one to the other flow at the end of the intestinal segment.

In some embodiments, the system according to the invention is mobile, ie intended to be carried by the patient outside of buildings or outdoors. In these embodiments, the system can e.g. B. be carried out independently of a mains voltage and z. B. no building-side access to electrical voltage such as sockets, etc. need.

Some or all embodiments according to the invention can have one, several or all of the advantages mentioned above and/or below.

The system according to the invention advantageously supports the natural function of the lungs by taking over part of the gas exchange between blood and breathing air. The system according to the invention can preferably be used in the case of chronic respiratory insufficiency, in which the gas exchange via the lungs no longer takes place sufficiently.

Carbonic acid (HCO ^3- +H ^-1 ) is converted to CO ₂ +H ₂ O via carbonic anhydrase. that invent This system removes CO ₂ from the blood. By removing CO ₂ , carbonic acid in the blood is reduced and the blood becomes alkaline. The device according to the invention thus advantageously reduces respiratory acidosis.

The device according to the invention oxygenates hemoglobin of the erythrocytes and thus increases the oxygen saturation of the blood. The device according to the invention thus advantageously increases the amount of oxygen available to the body and thus reduces hypoxia.

Since contact with blood is not required, there is no risk of thrombosis, embolism, bleeding, infection and/or hemolysis.

• 1 zeigt ein erfindungsgemäßes System in einer ersten Ausführungsform;
• 2 zeigt Teile des erfindungsgemäßen Systems der 1 im Detail;
• 3 zeigt ein erfindungsgemäßes System in einer weiteren Ausführungsform; und
• 4 zeigt ein erfindungsgemäßes System in einer weiteren Ausführungsform.

The device according to the invention is described below using preferred embodiments thereof with reference to the attached drawing. In the figures of the drawing, the same reference symbols designate the same or similar components. However, the invention is not limited to these embodiments. In the figures:

• 1 shows a system according to the invention in a first embodiment;
• 2 shows parts of the system according to the invention 1 in detail;
• 3 shows a system according to the invention in a further embodiment; and
• 4 shows a system according to the invention in a further embodiment.

1 shows a system 100 according to the invention for supporting the gas exchange or the oxygen saturation of the blood of a patient P in a first embodiment.

A gas exchanger 10 of the system 100 has an outlet 11 for a first fluid. The first fluid can in particular consist of perfluorocarbon or have perfluorocarbon, or another fluid, gaseous, liquid or a fluid in some other way.

A delivery device 30 of the system 100, here a fluid pump, delivers the first fluid through the system 100. It will be discussed in more detail below. A first hose line 20i, a second hose line 20o and an optional line section 40 of the system 100 can be completely or partially filled with the first fluid when the system 100 is in use.

In 1 the torso of patient P can be seen with a view of his opened abdominal cavity and intestines. An intestinal segment 200, which can optionally have been surgically removed from the digestive tube, is provided with an enterostomy 21, 23 or connected to it at precisely one end or, as here, at both of its ends.

The enterostomata 21, 23 optionally have stoma plates or connectors 21a, 23a, which are intended to be connectable to the two hose lines 20i, 20o and/or the line section 40 of the system 100.

During use, the first fluid is guided by means of the conveying device 30 from the gas exchanger 10 in the direction of the patient P and through his intestinal segment 200, the first fluid being able to be used as a gas transport medium due to its high solubility for gases.

Within the perfused intestinal segment 200, the gas exchange between perfluorocarbon and the blood of the patient P takes place via the (inner) intestinal wall as a gas exchange membrane. That is, oxygen is delivered to the patient P's blood and the perfluorocarbon in return absorbs carbon dioxide from the patient's blood. It carries this carbon dioxide back with it to the gas exchanger 10, which has an inlet 13 for this purpose.

In the gas exchanger 10, carbon dioxide is removed from the perfluorocarbon and it is enriched with oxygen. For this purpose, the system can have additional pumps, in particular an air or gas pump.

One (or more) filter devices 70 are optionally provided within the two hose line(s) 20i, 20o.

The gas exchanger 10 has a second inlet 15 for ambient air or an alternatively provided gas, for example oxygen or an oxygen mixture. In some embodiments, the inlet 15 can also be provided as an outlet for the second fluid, which has been enriched in the meantime with carbon dioxide. Alternatively, a second outlet (not shown) is provided for the second fluid.

Finally, the system 100 has a control unit 60 for controlling or regulating the system 100, in particular for controlling the conveyor device 30.

2 shows parts of the inventive system 100 of FIG 1 in detail.

In particular, the 2 the intestinal segment 200, here as an example a segment of the small intestine, which by means of the mesentery 203 in the abdominal cavity of a patient P (in 2 not shown) is supplied with blood.

The intestinal segment 200 was surgically removed from the digestive tube and provided with an enterostomy 21, 23 at each of its two ends. The ostomy plates (21a and 23a, see 1 ) of the enterostomata 21, 23 can be designed in such a way that one of the two hose lines 20i, 20o can be detachably connected to it. Connectors suitable for this purpose can be provided on the enterostomata 21, 23 and/or the hose lines 20i, 20o.

The two hose lines 20i, 20o can then how to 1 executed, be connected to a gas exchanger 10, a conveyor device 30 and/or a filter device 70 of the system 100 according to the invention in order to conduct a first fluid, for example perfluorocarbon, through the intestinal segment 200 for the purpose of gas exchange and thus to saturate the blood of the patient P with oxygen.

The line section 40 can be provided, but does not have to be. The gas exchange could also take place via the intestinal wall without a line section 40 by connecting the two hose lines 20i, 20o to the respective enterostomata 21, 23.

3 shows another embodiment of the system 100 according to the invention, in which only one enterostomy is provided, which is equally responsible for the introduction and the evacuation of the first fluid into and out of the body cavity, e.g. B. the intestinal segment 200 is used.

The line section 40 is here—at least in sections—preferably designed to be flexible. It has at least one opening 41 which fluidly connects its lumen to an exterior of the line section 40, here by way of example at the front.

As explained above, such openings can be provided on the lateral surface or distributed over the circumference of the line section 40 .

From the proximal end (i.e. coming from the tubing line 20i), the first fluid can thus flow along the lumen of the line section 40 distally up to its outlet opening 41—here only one as an example—in order to flow out through it out of the line section 40 and into z. B. to flow into the lumen of the intestinal segment 200 .

In this embodiment, the system 100 has a device for aspirating or taking up first fluid from the lumen of the intestinal segment 200, here in the form of a recirculation pump 90. It can be provided to pump the first fluid z. B. by means of negative pressure from the intestinal segment retrograde, i.e. suction from distal to proximal.

The return pump 90 can be arranged to return the first fluid via a vacuum line within which the first fluid can be routed extracorporeally.

The second hose line 200, which here optionally surrounds the first hose line 20i, with which the first fluid is fed to the line section 40 or the intestinal segment 200, is used here to return the first fluid after it has left the patient's body, at least in sections.

The ostomy plate 80 is designed here, for example, to guide the first fluid through it via at least one first through-opening 81 in a first direction into the intestinal segment 200 and through at least one second through-opening 83 in a second direction out of the intestinal segment 200. First through-opening 81 and second through-opening 83 are separated from one another, the first through-opening 81 is circular here, for example, and the second through-opening 83 surrounds it in an annular manner here, for example.

In some embodiments, the system 100 includes at least one pressure measurement device, e.g. B. in the form of one or more pressure gauges 43. The pressure measuring device can be provided and arranged to measure the pressure of the medium (gas, atmosphere, first fluid, etc.) surrounding a component of the system 100, in particular the line section 40.

Can be seen in 3 that in any embodiment, the first hose line 20i is guided in the line section 40 or is surrounded by it, but not the second hose line 20o. Alternatively, the second hose line 20o could also be routed from the line section 40, but preferably not reaching as far distally as the first hose line 20i. Due to the ends of the two hose lines 20i, 20o reaching different distances into the intestinal segment 200 in this way, a flow of the first fluid can be generated within the lumen of the intestinal segment 200 after it has left the line section 40 through the one or more through-openings 41, which is ultimately part of a ring closure or a guide of the first fluid in a circuit. This can counteract the first fluid remaining at a point in the lumen of the intestinal segment 200 whereby the mass exchange of the blood with the first fluid is promoted.

4 shows a further embodiment of the system 100 according to the invention, which is designed to be completely implantable. The gas exchanger 10 can be seen at the level of the right lung of the patient P. The left lung is labeled 301.

The system is connected with its inlet 15 and its outlet for the second fluid to the breathing air carrying structures of the patient's body, e.g. B. it is in fluid communication with the trachea.

A bellows 205 can be designed to serve on the one hand the fluid exchange between the gas exchanger 10 and the atmosphere via the trachea and/or on the other hand to pump the first fluid (e.g. perfluorocarbon) through the intestinal segment 200 .

In some embodiments of the system 100 according to the invention, the bellows 205 can be designed to be actuated by means of the diaphragm.

In some embodiments, the system 100 may be configured to be monitored and/or serviced via bronchoscopy.

reference list

100

system

10

gas exchanger; oxygenator

11

outlet

13

inlet

15

inlet for second fluid; optionally also: outlet for CO ₂

20i

first hose line

20o

second hose line

21

enterostomy

21a

ostomy connector

23

enterostomy

23a

ostomy connector

30

Delivery device for the first fluid

40

implantable lead section

41

Outlet opening of the line section

43

pressure measuring device; pressure sensor

50

Pump; gas pump

60

control unit

70

filter device

80

ostomy plate

81

first passage opening

83

second passage opening

90

recirculation pump

200

intestinal segment

203

mesentery

205

bellows

301

lung

P

patient

Claims (22)

A system (100) for assisting in gas exchange, decarboxylation, or oxygenation of a patient's (P) blood, comprising: - A gas exchanger (10) with an inlet (13) and an outlet (11) for a first fluid and an inlet (15) and an outlet for a second fluid; - either a first hose line (20i) connected to the outlet (11) for the first fluid and a second hose line (20o) connected to the inlet (13) for the first fluid; or a line section (40) for insertion into an intestinal segment (200); - A conveying device (30) for conveying the first fluid along the first hose line (20i) or the line section (40); and - A control unit (60) for controlling or regulating the conveyor device (30). system (100) after claim 1 , further comprising: - an enterostomy (21, 23). System (100) according to any one of the preceding claims, further comprising: - A line section (40) that can be implanted or inserted at least in sections into the patient (P) for guiding the first fluid in an interior or lumen thereof. system (100) after claim 3 , wherein the line section (40) is arranged in an intestine segment (200) or provided for this purpose. system (100) after claim 4 wherein the conduit section (40) is located in an intestinal segment (200) which has been surgically removed from the alimentary canal. System (100) according to one of claims 3 until 5 , wherein the line section (40) is arranged in an intestinal segment (200), is surgically connected to the enterostoma (21, 23), preferably on both sides, or is connected to the first hose line (20i) and the second hose line (20o) or to connection is associated with this. System (100) according to one of claims 3 until 6 , wherein the line section (40) has a length between 5 cm and 4 m, preferably between 50 cm and 2 m. System (100) according to one of the preceding claims, wherein both the first hose line (20i) and the second hose line (20o) are connected in fluid communication with the gas exchanger (10) and/or the line section (40). System (100) according to one of the preceding claims, comprising an ostomy connector (21a, 21b) or an ostomy plate (80) for connecting the line section (40) and/or the hose line(s) (20i, 20o) to the enterostoma (21, 23). System (100) according to one of the preceding claims, wherein the line section (40) and/or the hose line(s) (20i, 20o) is completely or partially filled with the first fluid. System (100) according to one of claims 3 until 10 , further comprising a connector (21a, 23a) for connecting the line section (40) to the first and/or the second hose line (20i, 20o). System (100) according to one of claims 3 until 11 , wherein the line section (40) has a large number of openings, in particular on its periphery or lateral surface. System (100) according to one of claims 2 until 12 , further comprising a lid or closure for closing the ostomy connector (21a, 21b) or the ostomy plate (80). System (100) according to any one of the preceding claims, wherein the first fluid is or contains perfluorocarbon. The system (100) of any preceding claim, wherein the system (100) is fully implanted. System (100) according to one of the preceding claims, further comprising a device for emptying the line section (40) and/or the intestinal segment (200) of the first fluid. system (100) after Claim 16 wherein the device is or comprises a recirculation pump (90). System (100) according to one of the preceding claims, further comprising at least one sensor for determining at least one parameter, in particular pressure, temperature and/or CO ₂ partial pressure, pH, pulse and/or respiratory rate. System (100) according to any one of the preceding claims, further comprising or connected to a device for performing an impedance analysis. A method of assisting in gas exchange, decarboxylation or oxygen saturation of a patient's (P) blood, comprising the steps of: - Providing a system (100) according to the invention; - introducing the first fluid or the line section (40) into an intestinal segment (200); - Conveying the first fluid along the first hose line (20i) or the line section (40) by means of the conveying device (30); and - Controlling the conveyor (30) by means of the control unit (60). procedure after claim 20 , with the following further step: - Regulating or controlling the delivery rate of the first and/or the second fluid by means of the delivery device (30) and/or further pumps depending on values which are collected by the sensors, in particular depending on at least one physiological parameters such as B. the respiratory rate, which z. B. is determined by impedance analysis, the CO ₂ content, the acidosis of the patient, the pH of the patient's blood. procedure after claim 20 or 21 , with the following further step: - Carrying out an impedance analysis, in particular for determining the respiratory rate of the patient.

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