WO2022243440A1 - Système et procédé pour supporter une fonction pulmonaire - Google Patents

Système et procédé pour supporter une fonction pulmonaire Download PDF

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Publication number
WO2022243440A1
WO2022243440A1 PCT/EP2022/063588 EP2022063588W WO2022243440A1 WO 2022243440 A1 WO2022243440 A1 WO 2022243440A1 EP 2022063588 W EP2022063588 W EP 2022063588W WO 2022243440 A1 WO2022243440 A1 WO 2022243440A1
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WO
WIPO (PCT)
Prior art keywords
fluid
line section
line
patient
hose line
Prior art date
Application number
PCT/EP2022/063588
Other languages
German (de)
English (en)
Inventor
Wolfgang Goetz
Original Assignee
Semiflow Medical GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Semiflow Medical GmbH filed Critical Semiflow Medical GmbH
Publication of WO2022243440A1 publication Critical patent/WO2022243440A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1698—Blood oxygenators with or without heat-exchangers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/32—Oxygenators without membranes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/04—Liquids
    • A61M2202/0468—Liquids non-physiological
    • A61M2202/0476—Oxygenated solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/04—General characteristics of the apparatus implanted
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1042—Alimentary tract
    • A61M2210/106—Small intestine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1042—Alimentary tract
    • A61M2210/1064—Large intestine

Definitions

  • 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 20.
  • 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.
  • ECMO extracorporeal membrane oxygenation
  • 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 20.
  • 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.
  • 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.
  • a delivery device for example a fluid pump, for delivering the first fluid along the first line and/or the line section.
  • 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.
  • 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.
  • a method is also part of the invention. It includes providing a system according to the invention.
  • a patient can be a human or an animal.
  • a patient can be sick or healthy.
  • 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 expressly does not have this or these features in other embodiments that are also according to the invention, e.g. B. in the sense of a disclaimer.
  • the contrary embodiment for example formulated as a negation, is also disclosed.
  • 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.
  • 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.
  • the system according to the invention also has at least one enterostomy, is connected to it and/or is prepared or prepared via such for its use.
  • 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.
  • the line section is arranged in an intestine segment (also: intestine section) of the patient or provided for this purpose.
  • the intestinal segment is preferably a small intestine segment.
  • the conduit portion is located in a segment of intestine that has been surgically excised from the patient's alimentary canal.
  • the line section is arranged in an intestinal segment and, for example, surgically connected to the enterostoma, preferably bilaterally.
  • the intestinal segment is connected, preferably at both ends, to an enterostomy in the abdominal wall or cover.
  • the first fluid is introduced into the intestinal segment via the enterostoma in the abdominal wall.
  • Lines of the system can be provided or connected accordingly 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.
  • 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.
  • the system according to the invention has an ostomy connector or a Ostomy plate on which / r is used to connect the line section and / or the hose line with the enterostomy.
  • the line section and/or the hose line are completely or partially filled with the first fluid.
  • system further includes at least one connector to
  • the line section has a large number of openings, in particular on its periphery or lateral surface.
  • system further comprises a lid or closure for closing the ostomy connector or ostomy tray.
  • the first fluid is, includes, or consists of perfluorocarbon.
  • Perfluorocarbon has a binding capacity for CO2 that is about three times its binding capacity for O2. It is thus, when brought into contact with the atmosphere, a suitable medium for blood decarboxylation.
  • the gas exchange takes place in the gas exchanger between the first fluid and the breathing air as the second fluid.
  • the gas exchange in the gas exchanger takes place between the first fluid and a gas provided as the second fluid.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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. A connection of the system to extracorporeal, z. B. to the atmosphere, can be provided.
  • the diaphragm directly or indirectly drives the flow of the first and/or the second fluid, or its movement or activity causes that flow.
  • the intestinal segment is connected to a system that is partially or fully implanted in the abdomen or in a thoracic cavity.
  • the system also has a device for emptying the line section and/or the intestinal segment of the first fluid.
  • the gas exchanger is optionally connected to a body cavity that is flushed with the first fluid. Gas exchange with the first fluid takes place at the surface of the body cavity.
  • the fluid is characterized by a high solubility for gases. In these embodiments, it can be used as a gas transport medium.
  • the gas exchange takes place via perfluorocarbon as the first fluid with which z. B. a segment of intestine is flushed or is to be flushed.
  • a segment of intestine is flushed or is to be flushed.
  • the intestinal segment there is a gas exchange between the perfluorocarbon and the blood via the inner wall of the intestine.
  • the first fluid leaves the intestinal segment via an enterostoma 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.
  • the flow and/or the pressure of the first and/or the second fluid in the gas exchanger are measured and regulated.
  • 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.
  • the line section and/or the hose line(s) connected to a segment of the intestine or its lumen via two specially created enterostomata in the abdominal wall.
  • 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.
  • the first fluid e.g. perfluorocarbon
  • 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.
  • the line section is intended for introduction into the body cavity.
  • it can be configured flexibly, at least in sections. He can do this z.
  • Example consist of silicone or silicone, or other suitable material.
  • the line section has in some
  • Embodiments openings which fluidly connect its lumen to an exterior of the line section and / or the system according to the invention at the front.
  • the front side, or only the front side, or at the distal end, or only at the distal end or end section (which accounts for z. B. 15% or the length of the line section) of the line section outlet openings for the first be provided fluid.
  • 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.
  • 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 can be used, which is separate from the first hose line with which the first fluid is connected to the line section or the Intestinal segment is supplied, is present. 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.
  • 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.
  • 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.
  • the system comprises one or more devices measuring or determining the same or different parameters in the same or different ways.
  • 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.
  • the control unit can be in signal communication both with the pressure device and with means for increasing or reducing the pressure, for example with the pumps mentioned herein, individually or in any combination.
  • 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.
  • a partial pressure 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.
  • a monitoring can be provided based on this, which can ensure that an inadmissible or unintentionally high removal of CO 2 with the risk of unintentionally reducing the respiratory drive, is prevented, detected early, etc.
  • 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.
  • 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.
  • 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 in subsequent Uses of the system are used as threshold values or reference values for the specific patient for further treatment using the system.
  • 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.
  • 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.
  • 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.
  • control unit for controlling or regulating the conveyor device has an energy source and/or is connected to one.
  • 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.
  • no external energy source is required, or the energy source is, or derives from, muscle power.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 together with the flushed into the gas exchanger with the first fluid and clog 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.
  • 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 in such a way 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 via a sensor or can be measured.
  • a sensor e.g. B. for the aforementioned purpose, no window.
  • 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.
  • the ostomate is connected to the skin such that the stoma is within the opening of the ostomy tray.
  • this includes an ostomy support and/or at least one connection or connector for lines or hoses, and/or other components.
  • the system contains from 0.51 to 51 of the first fluid, more preferably from 11 to 21.
  • the controller is configured to control or regulate gas exchange.
  • 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 CCk 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.
  • 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.
  • the sensors are part of, or intended for use with, an impedance or bioimpedance meter, which may optionally also be part of the system.
  • sensors are provided which are connected to the patient's skin when the system is used as intended.
  • sensors are optionally provided which z. B. are provided in or on the or the ostomy plate (s) or the connectors.
  • 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. is determined by impedance analysis, the CCk content (e.g. of 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 e.g. 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.
  • 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. to prevent an overinflation observed in COPD patients from occurring in the first place or, if necessary, to be able to reduce 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.
  • 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 best-known example of this is the establishment of a Bluetooth connection, by means of which various devices (e.g. smartphones, headphones) are connected to one another. Pairing is also sometimes referred to as bonding.
  • the system or gas exchanger is mobile.
  • the system or gas exchanger can have a total mass of no more than 3 or 4 kg. Alternatively or in addition, 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.
  • 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.
  • the system comprises more than just one implantable lead section, 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.
  • 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 optionally for removing the first fluid from the intestinal segment.
  • 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 segment in a comparatively short segment of the segment of the intestine that is separated by contraction or peristalsis, it is also possible in such a segment by peristalsis or contraction The gas exchange takes place in a closed, comparatively short segment of the intestine, and the first fluid does not have to flow from one end of the segment of intestine to the other.
  • the system according to the invention is mobile, ie intended to be carried by the patient outside of buildings or outdoors.
  • the system can e.g. B. be carried out independently of a mains voltage and z. B. do not need access to electrical voltage such as sockets etc. provided in the building.
  • this comprises the following steps: introducing the first fluid or the line section into an intestinal segment;
  • the method includes regulating or controlling the delivery rate of the first and/or the second fluid by means of the delivery device and/or additional pumps as a function of values which are collected by the sensors, in particular as a function of at least one physiological parameter such as e.g . B. the respiratory rate, which z. B. is determined by means of impedance analysis, the CO2 content, the patient's acidosis, the pH of the patient's blood.
  • the method further includes performing an impedance analysis, in particular to determine the respiratory rate of the patient.
  • the method further includes establishing a fluid connection between the first tubing and/or the second tubing with a portion of tubing inserted into an intestinal segment.
  • the method further includes establishing fluid communication between the first tubing and/or the second tubing and an enterostomy of the patient.
  • the first and/or the second fluid is/are not in the form of microbubbles or microbubbles, in particular oxygen microbubbles. A source for this cannot be provided either.
  • peritoneal space e.g. B. between the parietal peritoneum and the visceral peritoneum.
  • the system does not include a valve in the first tubing, the second tubing, the implantable tubing segment, and/or the enterostomy, ostomy tray, or ostomy connector. In some embodiments, no valve is provided to access the peritoneal space.
  • 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 (HC0 3 +H + ) is converted to CO2+H2O via carbonic anhydrase.
  • the system of the present invention removes CO 2 from the blood. By removing CO2, carbonic acid in the blood is reduced and the blood is alkalized.
  • 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.
  • FIG. 1 shows a system according to the invention in a first embodiment
  • Fig. 2 shows parts of the system according to the invention of Fig. 1 in detail
  • FIG. 3 shows a system according to the invention in a further embodiment
  • FIG. 4 shows a system according to the invention in a further embodiment.
  • FIG. 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.
  • the torso of patient P can be seen in FIG. 1 with a view of his opened abdominal cavity and the intestine.
  • 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.
  • 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.
  • 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 with it further back to the gas exchanger 10, which has an inlet 13 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 a
  • the inlet 15 can also be provided as an outlet for the second fluid, which has been enriched in the meantime with carbon dioxide.
  • a second outlet (not shown) is provided for the second fluid.
  • the system 100 has a control unit 60 for controlling or regulating the system 100, in particular for controlling the conveyor device 30.
  • Fig. 2 shows parts of the inventive system 100 of FIG. 1 in detail.
  • FIG. 2 shows the intestinal segment 200, here by way of example a segment of the small intestine, which is supplied with blood by means of the mesentery 203 in the abdominal cavity of a patient P (not shown in FIG. 2).
  • 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 stoma plates (21a and 23a, see Fig. 1) of the enterostomata 21, 23 can be designed in such a way that one of the two is attached to it
  • Hose lines 20i, 20o can be connected detachably. 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, as explained in Fig. 1, 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 pass a first fluid, for example perfluorocarbon, for the purpose of gas exchange through the intestinal segment 200 and to saturate the blood of the patient P with oxygen.
  • a first fluid for example perfluorocarbon
  • 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 or associated ports, plasters or connectors.
  • Fig. 3 shows a further embodiment of the system 100 according to the invention, in which only one enterostomy is provided, which is equally suitable 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.
  • openings can be provided on the lateral surface or distributed over the circumference of the line section 40 .
  • the first fluid can thus flow along the lumen of the line section 40 distally up to its outlet opening 41, in order to escape through it from the
  • 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 20o is used here, which optionally the first hose line 20i, with which the first fluid is supplied to the line section 40 or the intestinal segment 200, at least partially surrounds.
  • 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.
  • 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.
  • first hose line 20i is guided in the line section 40 or surrounded by it, but not the second
  • 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. Because of this way different far into that The ends of the two hose lines 20i, 20o that reach into the intestinal segment 200 can thus generate a flow of the first fluid 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 ultimately forms part of a ring closure or a guide for the first Fluid is in a cycle. This can counteract the first fluid remaining at a point in the lumen of the intestinal segment 200, as a result of which the mass exchange of the blood with the first fluid is promoted.
  • Fig. 4 shows a further embodiment of the system 100 according to the invention, which is designed to be completely implantable. At the level of the right lung of patient P is the
  • 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 on the one hand the fluid exchange between
  • the bellows 205 can be designed to be actuated by means of the diaphragm.
  • system 100 may be configured to be monitored and/or serviced via bronchoscopy.

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  • Health & Medical Sciences (AREA)
  • Emergency Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Urology & Nephrology (AREA)
  • Anesthesiology (AREA)
  • Engineering & Computer Science (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)

Abstract

L'invention concerne un système de support d'échange gazeux, l'élimination du dioxyde de carbone du sang et/ou la saturation en oxygène du sang d'un patient (P), le système comprenant un échangeur de gaz (10) présentant une entrée et une sortie pour un premier fluide et pour un second fluide, respectivement. Le système selon l'invention comprend également : un dispositif de distribution (30) pour distribuer le premier fluide le long de la partie de ligne (40) ; et une unité de commande (60) pour la commande en boucle ouverte ou en boucle fermée du dispositif de distribution (30).
PCT/EP2022/063588 2021-05-19 2022-05-19 Système et procédé pour supporter une fonction pulmonaire WO2022243440A1 (fr)

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DE102021112959.1A DE102021112959A1 (de) 2021-05-19 2021-05-19 System und Verfahren zur Unterstützung der Lungenfunktion

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140316331A1 (en) * 2013-04-18 2014-10-23 The Regents Of The University Of Colorado, A Body Corporate System and methods for ventilation through a body cavity
US20160235902A1 (en) * 2015-02-12 2016-08-18 Boston Scientific Scimed, Inc. Gas exchange devices and related methods of use
US20180311071A1 (en) * 2005-10-21 2018-11-01 Daniel R. BURNETT Method and apparatus for peritoneal oxygenation

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070093697A1 (en) 2005-10-21 2007-04-26 Theranova, Llc Method and apparatus for detection of right to left shunting in the cardiopulmonary vasculature
EP3581217A1 (fr) 2014-10-02 2019-12-18 CardiacAssist, Inc. Oxygénation par membrane extracorporelle veino-artérielle avec ventilation de l'artère pulmonaire
DE102020204194A1 (de) 2020-03-31 2021-09-30 Martin Stock System für eine intrakorporale Oxygenierung und isotonische Kochsalzlösung oder Dialyselösung zur Verwendung als Gasaustauschmedium bei einer intrakorporalen Oxygenierung

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20180311071A1 (en) * 2005-10-21 2018-11-01 Daniel R. BURNETT Method and apparatus for peritoneal oxygenation
US20140316331A1 (en) * 2013-04-18 2014-10-23 The Regents Of The University Of Colorado, A Body Corporate System and methods for ventilation through a body cavity
US20160235902A1 (en) * 2015-02-12 2016-08-18 Boston Scientific Scimed, Inc. Gas exchange devices and related methods of use

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