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
  • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
  • A61M1/3621—Extra-corporeal blood circuits
  • A61M1/3666—Cardiac or cardiopulmonary bypass, e.g. heart-lung machines
  • A61M1/3667—Cardiac or cardiopulmonary bypass, e.g. heart-lung machines with assisted venous return
• • 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
  • A61M25/00—Catheters; Hollow probes
  • A61M2025/0004—Catheters; Hollow probes having two or more concentrically arranged tubes for forming a concentric catheter system
• • 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
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M2025/0175—Introducing, guiding, advancing, emplacing or holding catheters having telescopic features, interengaging nestable members movable in relations to one another

Definitions

• the invention relates to a system for supplying and withdrawing blood, in particular for performing extracorporeal membrane oxygenation (ECMO), an assembly method for a system for supplying and withdrawing blood and a hose body for insertion into a blood vessel of a patient, in particular an infusion cannula.
• ECMO extracorporeal membrane oxygenation
• the blood is enriched with oxygen and carbon dioxide removed, for example by means of an oxygenator such as a membrane oxygenator (ECMO device).
• an oxygenator such as a membrane oxygenator (ECMO device).
• ECMO device membrane oxygenator
• deoxygenated blood is taken from the patient and the oxygenated blood is supplied again.
• EP3277338B1 EP3446738, EP3581217, JP6553730B2, JP2019202159A2,
• the object of the invention is to provide a further developed system for supplying and withdrawing blood, an assembly method and a further developed hose body for introduction into a blood vessel.
• a system according to claim 1 as well as an assembly method and a hose body according to the dependent claims serve to solve the problem.
• Advantageous embodiments emerge from the subclaims.
• a system for supplying and withdrawing blood, in particular for performing extracorporeal membrane oxygenation (ECMO), is used to achieve the object.
• the system comprises a first tube body and a second tube body, with at least one opening for infusing blood into or drainage from a blood vessel being arranged in the region of a proximal end of the first tube body and at least one opening for draining blood in the region of a proximal end of the second tube body Blood is placed from or infused into a blood vessel.
• At least a portion of the first tube body extends axially within the second tube body.
• the first hose body and the second hose body are axially displaceable relative to one another. A particularly precise positioning of the proximal end of the first tube body is made possible in this way.
• the relative axial displaceability leads to a change in a distance between the proximal end of the first tube body and the proximal end of the second tube body. Only the first hose body needs to be shifted alone. When the entire system has been introduced, fine adjustment can thus be carried out without having to move the second hose body with it. This increases the precision with which the system can be adapted to the patient's anatomy.
• the system can be used as follows, the first tube body being used as an infusion cannula and the second tube body being used as a drainage cannula:
• a guide wire is pushed through a vein, in particular the femoral vein, to the heart.
• the second hose body which is or can be connected to the distributor element, is equipped with a so-called introducer.
• An introducer is an elongated, elastic element which is inserted into the second tube body and has an axial longitudinal opening as a means of passage for the guide wire.
• the second tube body is then inserted into the vein together with the internal introducer over the guide wire.
• the introducer together with the guide wire, seals off the second tube body axially so that no or only very little blood reaches the distal end of the second tube body.
• the proximal end of the In this way, the second tube body is positioned in the vein, in particular the femoral vein, or advanced to the inferior vena cava.
• the guide wire is then pulled out in the distal direction and then the introducer is also removed in the distal direction.
• a clamp can be attached in an area of the second tube body between its distal end and the lateral openings from the outside, which clamps off the second tube body in this area, ie temporarily closes it fluidically.
• the distal end can now be connected to the connecting element and / or a connecting line which leads, for example, to an extracorporeal pump and / or oxygenator.
• the first tube body is then pushed through a sealing device, the clamp is removed, and the first tube body is moved further from the distal end of the second tube body in the proximal direction through the second tube body until the first tube body protrudes proximally from the second tube body.
• a guide wire can preferably be introduced again beforehand through the second tube body to the target region, over which the first tube body is then pushed.
• the first tube body is advanced to the inferior vena cava at the junction to the right atrium and positioned there.
• the first tube body has a curved, proximal end in order to release the blood thanks to the fine positioning in the direction of the right atrium.
• the proximal end can be closed and have a side opening for releasing the blood. If the first tubular body comprises a flow element proximally, this can pass through the right ventricle and / or pass the tricuspid valve and / or pulmonary valve.
• the system can be used as follows, the first tube body being used as a drainage cannula and the second tube body being used as an infusion cannula:
• a guide wire is pushed through an artery, in particular the femoral artery.
• an introducer is pushed from the distal end over the guide wire into the second tube body.
• the now sealed second tube body is positioned along the guide wire in the femoral artery.
• the guide wire is removed distally and the introducer is also removed distally.
• a clamp is used to temporarily seal the second tube body until the first tube body is inserted.
• the first tube body is pushed through a sealing device to be externally sealed, and is then pushed axially through the second tube body.
• a guide wire can be used through which the first tube body can be introduced.
• the proximal end of the first tube body is passed through the aortic valve into the left ventricle.
• the path of movement of the tube body typically adapts to the course of the blood vessel when it is advanced through a blood vessel.
• the two tube bodies extend within the section essentially coaxially to one another along a common center line in the axial direction through the body tissue.
• the course of the center line corresponds to the course of the movement path and is usually not exactly straight, but curved. If the proximal end of the first tube body is in the target region (e.g. heart), fine positioning of the proximal end of the first tube body takes place. The fine positioning takes place in that the first tube body is slowly shifted axially relative to the second tube body.
• the second tube body is preferably held so that it cannot move relative to the target region, so that only the first tube body is moved axially forwards or backwards, in particular manually with the surgeon's hand strength. Disturbing influences of friction and collisions of the second tube body with the surrounding tissue when the first tube body moves back and forth can thus be reduced or entirely avoided.
• the position of the first tube body relative to the second tube body is fixed. This can be done using a cable tie, a hose clamp or a fixing device with an integrated sealing device.
• the second tube body is provided for drainage or infusion, ie the second tube body is designed to carry liquid. Blood flows through an opening in the region of the proximal end of the second tube body, which flows axially through the second tube body and is released or supplied to a second connection line at its distal end.
• the first tube body is provided for infusion or drainage, ie the first tube body is also designed to carry liquid.
• the oxygen-enriched blood flows axially through the first tubular body, in the case of an infusion cannula from its distal end to its proximal end and through its lateral opening and / or axial opening into a blood-carrying body structure.
• the first tube body and the second tube body are thus set up to conduct fluid independently of one another, each have a separate connection line and each at least one separate opening for supplying or removing blood from or into a blood-bearing body structure.
• the blood discharged distally through the hose body via a connection line is preferably sucked in by an extracorporeal pump, enriched with oxygen by an extracorporeal oxygenator and / or via a further connection line at a distal end of the other hose body for the purpose of infusion through a lateral opening and / or axial opening supplied at the proximal end.
• a hose body is a flexible elongated hollow body.
• a flexible tube body allows it to be elastically bent over a length of 30 cm, in particular 10 cm, particularly preferably at least 5 cm, by an angle of 90 ° compared to a straight, axial extension without kinking. The bend therefore takes place uniformly and continuously without a visible tapering of the cross-section in the interior of the hose body.
• An elastic material in particular biocompatible polyurethane, PVC and / or silicone, is used to produce a hose body. The elastic material used enables the tube body to be elastically stretched in the longitudinal direction by at least 3%.
• a wire running spirally in the axial direction can be integrated into the wall of the hose body as a wire reinforcement, in particular in the case of the first hose body, which in this way also supports the elastic stretching and flexible bending described above.
• the first tube body is so flexible that it is suitable for placement of its proximal end in the inferior vena cava at the junction to the right ventricle or for advancement into the left ventricle via the femoral artery.
• the first tube body and / or the second tube body can be inserted into the patient's body with a Introductory instrument, such as a guide wire, can be guided.
• the first and / or second tube body can additionally be equipped with an introducer which extends axially and in a ring shape between the inner wall of the tube body and the outside of the guide wire.
• the system can also be used for targeted temperature control of blood when performing hyperthermia or hypothermia or to achieve normothermia.
• the system can be used for the perfusion of people or for relieving or bridging the heart.
• the first and / or second tube body is preferably set up in such a way that a blood flow rate of at least 0.5 L / min and / or at most 6 L / min is present during use.
• the system can also be referred to as a dual lumen catheter or double lumen catheter.
• the tube body can also be referred to as a cannula or catheter. Both hose bodies are separate fluid-carrying hose bodies.
• the first tube body delimits a first preferably circular cylindrical cavity for supplying or removing blood.
• An axial opening and / or at least one lateral opening is preferably provided at its proximal end.
• the first cavity corresponds in particular to the entire interior of the first tube body.
• the inside diameter is constant within the section and preferably remains constant up to the proximal end.
• Cross-sections are always aligned perpendicular to the direction of longitudinal extension of the respective element or section. Longitudinal extension is synonymous with axial direction.
• the second tube body extends between a distal, preferably axial opening and a proximal, preferably axial opening.
• both axial openings of the second tube body and / or of the first tube body are completely open, in particular with an opening diameter which corresponds to the inner diameter of the tube body over the predominant or entire length thereof.
• the second tube body and / or the first tube body preferably have essentially the shape of a tube piece.
• the second cavity extends along the portion of the first tube body that extends axially within the second tube body extends.
• the cross-sectional area of the second cavity at an axial point corresponds to the inner cross-sectional area of the second tube body (limited by the inner circumference) minus the total cross-sectional area of the first tube body (limited by the outer circumference).
• the second cavity thus fills that portion of the interior space of the second tube body that is not occupied by the first tube body. If the first and second tubular bodies were ideally aligned coaxially with one another, the second cavity would have an annular cross-section.
• both hose bodies have the same cross-sectional shape, typically a circular profile. Both hose bodies have different diameters.
• the outside diameter D AI of the first tube body is smaller than the inside diameter D E of the second tube body and / or selected so that the inner cross-sectional area p * (DE / 2) 2 is at least 1.8 times, preferably 1.9 times. times, particularly preferably twice, the outer cross-sectional area of the first tube body p * (D A I / 2) 2, in particular minus the wall cross-sectional area of the first tube body, and / or at most 2.3 times, preferably 2.2 times, especially preferably corresponds to 2.1 times.
• the cross-sectional area of the first cavity corresponds essentially to the cross-sectional area of the second cavity, preferably with a tolerance of ⁇ 20%.
• a particularly precise positioning of the proximal end of the first tube body can thus be made possible.
• the first tube body and / or the second tube body comprise a plurality of parts which are connected to one another in particular firmly (that is, they cannot be detached in a non-destructive manner).
• the second tube body with a nominal dimension of 26 Fr has an internal diameter of 7.7 mm ⁇ 10% and thus an internal cross-sectional area of, for example, 46.2 mm 2 .
• the associated first hose body with a nominal dimension of 16 Fr has an external diameter of 5.3 mm ⁇ 10% and thus an external cross-sectional area of, for example, 22.3 mm 2 .
• the second hose body with a nominal dimension of 30 Fr has an inner diameter of 9 mm ⁇ 10% and thus a inner cross-sectional area of, for example, 63.6 mm 2 .
• the associated first hose body with a nominal dimension of 20 Fr has an external diameter of 6.7 mm ⁇ 10% and thus an external cross-sectional area of, for example, 34.9 mm 2 .
• the wall thickness of the first tube body and / or the second tube body is at least 0.3 mm, preferably at least 0.4 mm, and / or at most 0.7 mm, preferably at most 0.6 mm.
• the wall thickness is preferably 0.5 mm.
• the inside diameter of the first tube body is at least 4.0 mm. It has been found that smaller inner diameters are less suitable for the uses described above.
• the first and / or the second tube body have in particular a length of at least 200 mm, preferably 350 mm, and / or at most 1000 mm, particularly preferably 800 mm.
• a proximal end of a tube body is an end pointing towards the center of the patient's body when used as intended.
• the end of the tube body is meant which is set up for introduction into a blood vessel.
• a distal end of a tube body is an end remote from the center of the body, that is to say the end opposite the proximal end of each tube body, which end usually remains outside the patient's body.
• a proximal end of a tube body means with a maximum distance of 20%, in particular 10%, based on the total length of the tube body.
• At least a portion of the first tube body extends axially within the second tube body.
• its longitudinal axis extends in this section parallel to the center line or longitudinal extension of the second tube body.
• a section means an axial area of the hose body.
• the two hose bodies are arranged essentially coaxially in the section in which the first hose body extends axially inside the second hose body, deviations from an ideal coaxial arrangement also being used are detected, for example when the outer circumference of the first tube body touches the inner circumference of the second tube body with a larger diameter. In the event of an axial, relative displacement, the first hose body is guided through the second hose body in the direction of extent.
• the second tube body is conically shaped in the region of its proximal end, for example by reducing the outer diameter. A particularly precise positioning can thus be made possible.
• the first tube body and / or the second tube body do not have an inflatable area or balloon, so they are not balloon catheters.
• the first tube body and the second tube body are also not hollow needles as in syringes or the like.
• the first tube body protrudes over the proximal end of the second tube body and / or over a distal end of the second tube body opposite the proximal end of the second tube body.
• a connection line can also be connected to the distal end of the first hose body outside the second hose body, which also increases the positionability of the hose body.
• the second tube body is shorter than the first tube body and / or the first tube body protrudes both proximally and distally.
• At least one opening for the drainage or infusion of blood is arranged in the region of the proximal end of the second tube body on the wall, in particular the outer wall, of the second tube body.
• the material of the second tube body has a lateral opening.
• a plurality of openings are arranged distributed over the circumference of the second tube body.
• an opening for draining blood is arranged on the front side on the proximal end of the second tube body.
• the opening is in particular ring-shaped and / or is delimited by the outer circumference of the first tube body and the inner circumference of the second tube body at the proximal end of the second tube body.
• the opening arranged on the front side at the proximal end enables blood to flow axially into the second tubular body. The resulting reduced friction enables particularly precise positioning.
• At least one opening for the infusion or drainage of blood is arranged on the front side on the proximal end and / or on the wall of the first tube body.
• the first tube body is axially open at the proximal end, in particular completely open over the entire inner diameter of the tube body. The advantages arising from this have already been explained in the previous paragraph.
• the front end of the first tube body is designed to be closed in terms of flow at the proximal end. For example, a wall part that blocks an axial passage at the proximal end extends radially. In this alternative embodiment, blood can only be released or withdrawn via lateral openings in the wall.
• the proximal end of the first tube body is positioned in the inferior vena cava at the junction to the right atrium in order to release blood there for perfusion of the right atrium.
• This can reduce the fluid pressure downstream in the blood vessel and, for example, avoid a jet stream in the direction of the head through the superior vena cava.
• the distal end of the second tube body is fluidically connected or connectable to a connecting element through which the blood conducted through the second tube body is conducted to a connection line, the first tube body being passed through the connecting element and protruding distally from the connecting element.
• a connection of the connecting element which is provided for connecting the connection line, extends at an angle of greater than 30 ° to the longitudinal extension of the second hose body.
• Connect or connect fluidically means that a blood stream can flow according to plan between the connected or connected components.
• the system has a connector with three ports.
• the first connection is coupled or can be coupled to the second hose body or a line element fluidically connected to the second hose body.
• the second connection is fluidically connected to the second cavity of the second hose body, which extends between an inner surface or inner circumference of the second hose body and an outer surface or outer circumference of the first hose body.
• the third connection is designed to lead the first hose body out of the connecting element.
• the third connection is in particular an outlet through which the first hose body can be passed and emerge from the connecting element.
• a connecting element also referred to as a distributor piece or connector, has several connections that are fluidically connected to one another.
• the connecting element has exactly three connections. It is in particular a fork piece, preferably a Y-piece, which can also be shaped as a T-piece.
• the coupling of the first connection to the second hose body means the particularly tight mechanical connection of the first connection to an inner surface of the second hose body.
• Indirect coupling is also possible, in which the second hose body is fluidically connected to a line element such as a hose section or pipe section and this in turn is coupled or can be coupled to the first connection.
• the first hose body is arranged in the area of the first connection when used as intended. This therefore runs through the first connection without direct attachment.
• the first connection typically points to the patient.
• the second connection is used to take blood. This is drained from the blood vessel by means of the second tube body and guided out of the patient via the second cavity of the second tube body and the second connection.
• the third connection is for leading the first tube body, in particular a distal end of the first tube body opposite the proximal end of the first tube body, out of the Fastener set up. This means that the first hose body protrudes from the third connection or is accessible at the third connection.
• This is used to connect the first tube body to an external device such as, for example, a pump or an oxygenator, so that the pumped and / or oxygen-enriched blood can be guided back to the patient by means of the first tube body.
• the third connection can also be fluidically connected to the second cavity of the second hose body.
• the third connection can also delimit a space with the outer surface of the first tube body, which is filled with blood during operation and is sealed off from an outer surface of the first tube body by a sealing device on the third connection of the connecting element or on a connecting
• This configuration enables simple and safe access to the first and second tube bodies for the purpose of supplying and draining the blood.
• the system can be positioned in this embodiment in such a way that the first hose body can be displaced relative to the connecting element in the area of the third connection, in particular manually, which enables particularly simple and precise positioning.
• the system has a blocking device for blocking a relative, axial displacement of the two hose bodies.
• the blocking device can be a cable tie, a hose clamp or part of a fixing device with an integrated sealing device.
• the blocking device can exert a circumferentially inwardly directed radial force on the second hose body and / or the sealing device, in particular with respect to the outer circumference of the third connection of the connecting element.
• the blocking device is able to temporarily and / or detachably fix the two hose bodies to one another.
• a form-fitting and / or force-fitting blocking can take place.
• Such a blockage is meant that manual axial displacement is not possible or only possible with excessive effort.
• the blocking can be released manually.
• the blocking device is set up for optional blocking, so that, if necessary, the user causes the fixing device to block.
• the Fixing device for producing the blocking and / or releasing the blocking can be actuated by hand. This enables particularly precise positioning.
• the system has a sealing device for externally sealing the first hose body, in particular for sealing an outer surface or the outer circumference of the first hose body from the environment.
• External sealing of the first tube body means that blood from the in particular ring-shaped second cavity of the second tube body at the distal end of the second tube body cannot flow outside along the first tube body up to its distal end along its outer surface, but that this blood flow is stopped by the sealing device . Because the flow of blood along the outer surface of the first tube body is stopped by the sealing device, all of the blood flows from the distal end of the second cavity of the second tube body end to the connection line. In particular, the blood flow is conducted through the connecting element from the distal end of the second tubular body to the connection line.
• the sealing device is preferably set up for sealing around the first hose body.
• the sealing device comprises an elastic ring or an elastic tube piece, preferably with an underfitting compared to the outer diameter of the first tube body.
• the underfitting is preferably at least 0.1 mm and / or at most 0.3 mm.
• the first tube body is surrounded by blood between the sealing device and the distal end of the second tube body.
• the sealing device seals the first hose body from an area of the system, in particular from the connection element or from a connection line to the connection element. The seal serves to avoid an escape of blood and the inlet of air.
• the sealing device is arranged distally from a position at which the first tube body emerges from the second tube body or from an element connected to the second tube body.
• the sealing device is arranged at a point which, when used as intended, is manually accessible from the outside.
• the sealing device is attached directly to the connecting element, in particular to the third connection.
• a connecting line extends between the sealing device and the distal end of the second tube body, the distal end of which preferably adjoins the sealing device and the proximal end is connected to a third connection of the connecting element.
• the sealing device then seals the first hose body from the outside directly against the connecting line and / or the first hose body is passed completely axially through the connecting line.
• the sealing device is preferably a valve that is only able to stop an axial flow of blood outside the first tube body in one axial direction when the first tube body is passed axially through the sealing device.
• the blocking device and the sealing device are implemented in a common fixing device.
• the blocking device and the sealing device are connected to the connecting element via a connecting line.
• the first hose body is carried out axially through the entire connecting line.
• the fixing device enables the outer surface of the first tube body to be sealed off from the connecting line and consequently with the connecting element and the distal end of the second tube body connected to it in terms of flow technology.
• the particularly drained blood from the second cavity of the second tube body consequently flows on the one hand distally into the connecting line, which, due to the sealing device at its distal end, represents a pocket for the blood flow, and via a Y-shaped branch of the connecting element into the connecting line.
• the sealing device thus allows the first tube body to be sealed off from the distal end of the second tube body in a manner that enables particularly precise positioning.
• the first hose body is carried out axially by the following, in particular adjoining, and fluidically connected elements: the sealing device, in particular the connecting line between the sealing device and a third connection of the connecting element, the third connection and a first connection of the connecting element for connecting the distal End of the second tube body.
• a second connection of the connecting element is provided, which is angled in particular in a Y-shape relative to the first connection and third connection and / or, in terms of flow, the distal end of the second Hose body connects to a connection line, in particular for discharging drained blood or supplying oxygenated blood.
• the fixing device has an actuating element for manual actuation of the seal and blocking.
• the fixing device is configured in such a way that a first position and a second position of the actuating element are provided, the first and second positions being different.
• the first position of the actuating element there is a seal (at least extensive and sufficient for proper use), but no blocking, so that the first tube body can be axially displaced relative to the second tube body.
• a frictional resistance that is necessary for a seal is not a blockage, as long as a relative, axial displacement is possible with normal hand strength.
• sealing and blocking take place.
• the fixing device can provide a screw device with a screw as the actuating element for actuation.
• the first position and the second position of the actuating element can correspond to different positions of a screw. In particular, the screw is screwed in more in the second position than in the first position.
• the first tube body and / or the second tube body have at least partially a reinforcement, in particular a wire reinforcement.
• a region of the second tube body for example with a length of at least 2 cm, between the distal end and a lateral opening of the second tube body remains free of wire reinforcement. This enables the use of a clamp for the temporary fluidic closure of the second hose body at this point.
• the first tube body is angled by a fixed curvature in the proximal area, preferably with the aid of an integrated, fixed curvature of at least 30 ° and / or at most 90 °.
• Fixed curvature means a curved section that is stiffened.
• the proximal end of the first tube body is positioned in the inferior vena cava at the junction to the right atrium and is aligned by the curvature in the direction of the right atrium in order to release blood there.
• a curvature between 1 ° and 90 ° degrees, preferably between 20 ° and 65 °, particularly preferably between 30 ° and 55 °, in particular approximately 45 °.
• the curvature extends over a short, axial area, which is in particular shorter than 5 cm.
• the curvature is preferably arranged in the region of the proximal end of the first tube body.
• the area of the tube body between the curve and the proximal end is angled and / or has a length of approximately at least 5 cm and / or at most 15 cm.
• the curvature is in particular arranged at a distance between 5% and 30%, for example between 10% and 25% and in one embodiment between 15% and 20% from the proximal end, based on the total length of the first tube body. This configuration enables particularly precise positioning of the first tube body in regions of the body that are difficult to access.
• a proximal end section of the first tube body is formed by a flow element which is designed such that the flow element can orient itself in the direction of a surrounding blood flow and can move with a blood flow. Positioning in downstream regions can take place particularly precisely in this way.
• the second tube body can be positioned in the atrium of a patient's heart, for example by means of a graft positioner or a guide wire as in the Seldinger technique. The proximal end of the first tube body swims with the blood flow into the pulmonary artery, so that precise positioning can be achieved.
• the flow element is firmly connected to the adjoining hose part of the first hose body, in particular in a materially bonded manner, preferably by means of an adhesive connection.
• the adjoining hose part and the flow element are produced in one piece, the flow element being produced by means of an immersion process.
• the flow element has a wall thickness of at least 0.005 mm, preferably 0.03 mm, particularly preferably 0.08 mm, and / or at most 0.15 mm, preferably at most 0.12 mm. A particularly high degree of flexibility for exact positioning can thus be made possible.
• the flow element has the shape of a flexible hose section, preferably without lateral openings.
• the flow element can be compressed by a flow of blood and maximally up to a cylindrical shape be expanded.
• the flow element is not an expandable balloon or balloon catheter.
• the flow element can have a reduced outside diameter and / or the same inside diameter compared to the adjoining hose part.
• the flow element has a length in the unfolded state in the longitudinal direction of at least 50 mm, preferably 100 mm, and / or at most 250 mm, preferably 200 mm, particularly preferably 150 mm.
• the flow element can be held open by the graft positioner or guide wire.
• the flow element collapses and can swim with the patient's own blood flow in the blood vessel to the target area, where the flow element unfolds due to the perfusion pressure as a result of the blood flow emerging from the first tube body.
• the flow element can, for example, swim with the blood flow from the right atrium into the pulmonary artery and unfold there due to the perfusion pressure.
• Another aspect of the invention relates to an assembly method for a system for supplying and withdrawing blood, in particular according to the aspect of the invention described at the beginning, characterized by the following steps:
• Another aspect of the invention relates to a tubular body for insertion into a blood vessel of a patient, in particular an infusion cannula.
• a proximal end section of the tube body is formed by a flow element which is designed so that the flow element can align in the direction of a surrounding blood flow and move with a blood flow.
• the tube body can be a first tube body according to the aspect of the invention described above be. All of the embodiments and features disclosed above in connection with the aspect of the invention described at the beginning, for example with regard to the configuration of a hose body or the flow element, also apply to this aspect of the invention.
• FIG. 1 a side view of a system according to the invention for supplying and withdrawing blood;
• FIG. 2 a side view of the system in a sectioned illustration
• FIG. 3 a perspective illustration of a detail of a system according to the invention, in particular from FIGS. 1 and 2;
• FIG. 4 a sectional illustration of a detail of a system according to the invention, in particular from FIGS. 1 and 2;
• FIG. 5 an embodiment of a second hose body
• FIG. 6 an embodiment according to the invention of a first hose body
• FIG. 7 a further embodiment according to the invention of a first hose body
• FIG. 8 an embodiment according to the invention of a hose body with a flow element.
• FIG. 1 shows the system 1 according to the invention for supplying and withdrawing blood.
• the first tube body 10 extends from its proximal end 15, which is designed for insertion into a blood vessel of a patient and can optionally have an externally tapering end region, to its distal end 16 with a connection region 17 with a widened diameter for connection to an oxygenator and / or a pump with the aid of a connecting line (not shown).
• the inside diameter and / or outside diameter between the widened connection area 17 and the proximal end 15 or the proximal tapering end area is constant.
• an opening 8 for infusing blood into the blood vessel is arranged on the end face at the proximal end 15.
• openings are provided laterally in the wall of the first hose body 10, which are not shown here.
• the connecting element 30, the connecting line 36 and the fixing device 42, which completely surround the first hose body 10 radially the contour of the first hose body 10 is shown by dot-dash lines.
• the second tube body 20 completely surrounds the first tube body 10 radially within a section and is less than half as long as the first tube body 10. It runs from its proximal end 25 to its distal end 26 connected to the connecting element 30 is set up for insertion into a blood vessel of the patient and is used to drain blood.
• the second tube body 20 has openings 29 arranged in its wall 21 in the region of its proximal end 25 and an axial opening 28 located on the front side at the proximal end.
• the axial opening 28 is circular and extends between the outer surface of the first tube body 10 and the inner surface of the second tube body 20.
• the first tube body 10 protrudes from both the proximal end 25 and the distal end 26 of the second tube body 20.
• the connecting line 36 connects the connecting element 30 to the fixing device 42, as is described in detail below with reference to FIG.
• the first hose body 10 and the second hose body 20 can be displaced relative to one another in the axial direction, as shown by the double arrows of the axial displacement 50 are indicated.
• the axial displacement 50 is clear from a relative movement between the wall 11 of the first tube body 10 and the proximal end 25 of the second tube body 20.
• the distal connection area 17 of the first tube body 10 moves relative to the fixation device 42, the connection area 17 always remaining distal from the fixation device 42 due to its expanded diameter during use.
• a relative displacement changes the distance between the proximal end 15 of the first tube body 10 and the proximal end 25 of the second tube body 20 in the patient's body in order to be able to position the proximal end 15 particularly precisely in a target region in the body. If the second tubular body 20 can no longer be advanced further in the blood vessel because the blood vessel is narrowed, for example due to illness, the first tubular body 10 can nevertheless be advanced and precisely positioned.
• the tube bodies 10, 20 are shown in a straight line for the sake of clarity, they are flexible so that they can be moved and positioned in a blood vessel of the patient.
• FIG. 2 shows the system 1 of FIG. 1 in a sectional view.
• the inner surface 12 of the first tube body 10 defines a first cavity 14 for supplying blood.
• the second cavity 24 of the second tube body for withdrawing blood is arranged between the outer surface 13 of the first tube body 10 and the inner surface 22 of the second tube body 20. Both cavities 14, 24 run coaxially in this idealized representation and have similarly large cross-sectional areas.
• the second tube body 20 is preferably composed of several parts, in particular parts that are glued to one another.
• a distal part which is arranged between a cylindrical proximal section for insertion into the blood vessels of the patient and the connecting element 30, has a larger outer diameter than the cylindrical part which widens conically in the distal direction.
• the first tube body 10 is preferably also composed of a plurality of parts that are preferably glued to one another.
• the Y-shaped connecting element 30, which has three connections 31, 32, 33 that are fluidically connected to one another, is arranged between the second hose body 20 and the connecting line 36.
• the fixing device 42 is connected to the connecting line 36, which in one component has a blocking device 40 for blocking the relative axial displacement 50 of the two hose bodies 10, 20 and a sealing device 41 for sealing an outer surface 13 of the first hose body 10 from the connecting line 36 and thus realized with respect to the distal end 26 of the second tube body 20. An undesired relative movement of the two hose bodies 10, 20 can be prevented by the blocking.
• the connecting element 30, together with the connecting line 36 and the fixing device 42 forms a sealed space which fluidically connects the second cavity 24 to a connection line 37 and enables the first hose body 10 to be guided through this sealed space in a sealed manner.
• the first hose body 10 can be displaced relative to the fixing device 42 and the sealed space in a sealed manner with the aid of the fixing device 42.
• the distal end 16 of the first hose body 10 is connected to a connection line, not shown, to the suction side of a pump.
• the fixing device 42 has an actuating element 43 which is designed as a screw element with a radially circumferential grip area. In a first unscrewed position, there is sufficient sealing, but no significant blocking. As a result, the axial displacement 50 can take place in order to precisely set the distance between the two proximal ends 15, 25 from one another. In a screwed-in second position of the actuating element 43, the blocking takes place and the sealing force is further increased.
• FIG. 3 shows in detail the protrusion of the first tube body 10 beyond the proximal end 25 of the second tube body.
• the axial displacement 50 is also marked here with a double arrow.
• the pattern that is generated by the lateral openings 29 and their size is selected, inter alia, in such a way that an aesthetic appearance is achieved, which increases the acceptance of the system.
• the second tube body 20 is tapered in the region of its proximal end 25, as can be seen from the section delimited by a line.
• FIG. 4 shows an enlarged view of the connecting element 30 from FIG. 2.
• the first connection 31 of the connecting element 30 is connected to the second hose body 20, so that the second cavity 24 of the second hose body 20 is in fluidic communication with the interior of the connecting element 30.
• the second connection 32 is also in fluidic connection with the second cavity 24 of the second hose body, so that a connection line 37 for draining blood can be connected to the second connection 32, which can be fluidically connected to the suction side of an extracorporeal pump.
• the third connection 33 is used to lead the inner first hose body 10 out of the connecting element 30.
• the first cavity 14 located in the first hose body 10 is also separated from the second cavity 24 of the second hose body 20 in the area of the connecting element 30 by the first hose body 10.
• the connecting line 36 connected to the third connection 33 is in fluidic connection with the second cavity of the second hose body 20, so that it is also filled with blood when used as intended, but forms a kind of dead end for the blood flow and only overcomes through the Y-shaped branch the second connection 32 can be discharged.
• the connecting line 36 is shorter than three times the length of a connection 31, 33 via which the connecting line 36 is postponed.
• the connecting element 30 also has an inlet opening 35 closed by a screw valve for adding medicaments and / or withdrawing blood.
• the third connection 33 is in particular arranged coaxially with the first connection 31, so that the first hose body 10 is not bent or kinked when it is passed through.
• FIG. 5 shows an embodiment of the second tube body 20 with a large number of openings 29 arranged in the wall 21 in the region of the proximal end 25, each of which has a diameter that is less than half, preferably less than a quarter of the outer diameter of the second tube body 20 is equivalent to.
• the side openings 29 are arranged in annular rows with two or exactly two side openings 29 per row and / or each row is offset by a maximum of 90 ° or exactly 90 ° in the circumferential direction, aesthetic reasons also playing a role in the design of this pattern .
• lateral openings 29 are only provided on a proximal, cylindrical part of the second tube body 20 with a particularly constant inner diameter, which is axially connected directly to a proximal, particularly conical part and a cylindrical, distal part, particularly with a constant inner diameter.
• Figures 6 and 7 each show a first hose body 10, which can be a component of a system according to the invention.
• a first hose body 10 which can be a component of a system according to the invention.
• lateral openings 18 are provided in the wall.
• the proximal end 15 itself is also open, that is to say configured as an axial opening which, in the other embodiments, is normally as large as the inner diameter.
• the first hose body 10 has a fixed curvature 19 of approximately 45 °, so that the first hose body 10 is angled between the curvature 19 and the distal end 15, but remains flexible in the angled area like a hose body 10 without a curvature is.
• the 7 has a reinforcement in the form of a wire reinforcement 45 along almost its entire extent, which is formed in particular by a spiral wire integrated in the wall.
• a wire reinforcement 45 along almost its entire extent, which is formed in particular by a spiral wire integrated in the wall.
• the first hose bodies 10 of the exemplary embodiments shown in FIGS. 1 to 4 are also equipped with the wire reinforcement 45.
• the cylindrical part of the second tube body, which is distal to the cylindrical part adjoining the lateral openings 29, can be equipped with a wire reinforcement 45.
• FIG. 8 shows a hose body 60 - in particular an alternative embodiment of the first hose body 10 from FIG. 1 the proximal end section of which is formed by a flow element 61 which is designed such that the flow element 61 can orient itself in the direction of a surrounding blood flow and can move with a blood flow.
• the flow element 61 has the same inside diameter as the adjoining hose part of the hose body 60 and / or is in particular non-detachable, preferably cohesively connected to it.
• the flow element 61 is so thin-walled and flexible that after being introduced into a blood vessel with the blood flow contained therein it is moved or carried downstream and in this way enables an exact positioning at a certain position in the blood vessel.
• the flow element 61 forms an aesthetic end to the hose body 60.
• the dashed line indicates the wall thickness of the adjoining hose part which is at least four times greater than that of the flow element 61, the wall of which is shown as a solid line due to its small thickness.
• a conical transition of the adjacent hose part to the flow element 61 reduces friction and collisions and in this way supports precise positioning in the target region.
• the wavy expansion of the flow element 61 represents a snapshot when the flow element 61 is traversed by drainage blood and the course in the axial direction adapts to the flow course.
• Wall 11 inner surface 12 outer surface 13 first cavity 14 proximal end 15 distal end 16
• Wall 21 inner surface 22 outer surface 23 second cavity 24 proximal end 25 distal end 26 axial opening 28 lateral opening 29
• Connection element 30 first connection 31 second connection 32 third connection 33
• the second tube body has a side opening through which the first tube body can exit the second tube body.
• the first tube body can be guided out of the second tube body through the side opening of the latter.
• the exit does not take place through the axial opening at the proximal end of the second tube body.
• the side opening is designed in particular as an elongated hole. It can be limited in the longitudinal direction, that is to say on its short sides, by semicircular edges. It can be limited in the transverse direction, i.e. on its long sides, by straight edges.
• the first hose body is pretensioned.
• a pretensioned hose body assumes a curved shape along its longitudinal axis or center line in an unloaded state.
• An unloaded state exists when the hose body is not deformed by an external force or an externally acting moment.
• a hose body is in an unloaded state that floats freely in a water bath or is held in the air.
• the proximal section of a pretensioned first tube body assumes a curved shape along its longitudinal axis or center line, ie it curves themselves.
• a pretensioned first tube body can have the effect that a proximal section of the first tube body can align and extend in a radial direction away from the second tube body after exiting the side opening. In this way, the proximal end of the first tube body can be pushed forward in a targeted manner into blood vessels and / or cavities which lie to the side of the second tube body.
• the first hose body is pretensioned in such a way that in the unloaded state there is a bend by an angle of at least 30 ° and / or at most 270 °. With an angle of at least 30 °, cavities on the side can be reliably reached. With a bend of at most 270 °, the proximal end of the first tube body can be inserted into laterally located, curved blood vessels or cavities without significantly damaging the vessel wall or tissue. With a bend of 270 ° in the unloaded state, the vessel does not also need to be bent in the same way.
• the bend is a bend introduced within a locally limited area in order to provide a pretensioned first hose body.
• the bend is preferably introduced by subsequent plastic deformation or is already introduced during the primary shaping of the first tube body.
• the bend is introduced plastically in such a way that the bend can be brought into the state without bending elastically, for example by applying an external force or by an internal or external guide.
• the angle is at most 90 ° or is between 45 ° and 60 ° (in the unloaded state).
• the angle is generally measured between the proximal portions of the first and second tube bodies as viewed from the side opening.
• the proximal end of the first tube body forms the angle to the proximal section of the second tube body, which extends proximally from the side opening.
• the proximal portion of the second tube body extends proximally from the side opening in a substantially straight line.
• the angle is 0 °.
• An angle of 0 ° means that the proximal end of the first tube body is aligned coaxially with the second tube body.
• the pretensioning causes the proximal end of the first tube body to emerge laterally from the side opening and form an angle to the proximal section of the second tube body. If the first tube body is then advanced further in the second tube body, the angle increases further depending on how great the pretensioning of the first tube body is. When the proximal end of the first tube body has reached the desired position, the angle can, for example, have increased to 270 ° in the unloaded state. In use, i.e.
• the proximal section of the second tube body has the same orientation as an essentially straight, distal section of the first tube body between the distal one End of the first tube body and the bend.
• the bend can be a curved area with a length of at least 20 mm, preferably at least 25 mm, and / or at most 80 mm, preferably at most 60 mm (in the unloaded state after exiting the side opening of the second tube body).
• the bend has a substantially constant radius. The radius of the bend is preferably at least 25 mm and / or at most 60 mm.
• the first tube body has a bend which was introduced into the first tube body in such a way that a proximal section of the first tube body bends in the unloaded state by a maximum of 360 ° or a maximum of three turns of 360 ° each.
• the bend introduced can extend over the entire, proximal section of the first tube body, which is carried out and exits from the side opening during use. In this way, for certain purposes of use, the dimensional stability can be optimized when it is introduced into particularly curved vessels which extend laterally from the second tube body.
• the first tube body pretensioned in such a way that the first tube body is curved from the proximal end to the distal end in the unloaded state.
• this increases the frictional resistance when it is pushed into the second hose body.
• the area of the introduced bend which leads to a (locally limited) bend or curvature in the unloaded state, is limited to an area of the first tube body that is in particular less than a third of the total length of the first tube body.
• the first tube body is pretensioned in such a way that it reaches the side opening during a relative movement between the first tube body and the second tube body in which the proximal end of the first tube body is moved in the interior of the second tube body in the proximal direction and the side opening Pushing forward through the side opening emerges from the second tube body.
• the movement in the proximal direction means the movement from the distal end in the direction of the proximal end of the second tube body.
• a preload can be implemented for example by a bend in the hose body, which is then for example by a straight one Guide wire or introducer is forced into a rectilinear shape or is forced into the course of the second tube body by being guided through the second tube body within the guided area.
• the first tube body is elastic and / or flexible in such a way that it can be brought into a substantially straight shape despite its bias by a straight introducer, guide wire and / or the second tube body arranged around it.
• the first hose body and / or the second hose body has at least partially a reinforcement, in particular a wire reinforcement.
• the first tube body is moved axially in the proximal direction through the second tube body, which is already arranged in the body, until its proximal end reaches the side opening. There is no advancement to the axial opening at the proximal end of the second tube body. Then the introducer or guide wire arranged in the first tube body can be removed, which keeps it in a substantially straight shape or orientation. By removing the introducer or guide wire, the pretensioning of the proximal section of the first tube body now acts on the second tube body from the inside. If the first tube body is now advanced further relative to the second tube body, the proximal end of the first tube body automatically moves out of the side opening of the second tube body as a result of the pretensioning.
• the first tube body is arranged within the second tube body in such a way that the orientation of the bend points in the direction of the side opening.
• the proximal end of the second tube body can have an axial opening and / or one or more lateral openings can be arranged in the region of the proximal end.
• the side opening can also be designed in such a way that, in addition to the passage of the first tube body, it also provides a flow path for body fluid. In this case, proximal openings in the second tube body are not absolutely necessary.
• the side opening has a width that is at least 65% and / or at most 100% of the diameter of the second tube body, in particular at least 80% and / or at most 95%.
• the width becomes perpendicular to the Center line or longitudinal extension of the second tube body measured.
• the width of the side opening is at least 102% and / or at most 140% of the diameter of the first tube body, in particular at least 105% and / or at most 130% and for example at least 110% and / or at most 120%.
• the width can for example be at least 4 mm and / or at most 10 mm, in particular at least 6 mm and / or at most 8 mm.
• the side opening has a length that is at least 10 mm, preferably at least 20 mm and / or at most 60 mm, preferably at most 50 mm. In one embodiment, the length of the side opening is 30 to 40 mm. In a further embodiment, the side opening has a length that is greater than that by a factor of at least 1.5 and / or at most 8, in particular at least 2.5 and / or at most 6, and for example at least 3 and / or at most 4 Diameter of the second tube body. The length of the side opening is measured along the longitudinal extension direction of the second tube body.
• a center point of the side opening is at a distance from the proximal end of the second tube body by a factor of at least 1.5 and / or at most 6, in particular at least 2 and / or at most 4.5, and for example at least 2.2 and / or is at most 3.5 greater than the length of the side opening. This is a position that is optimally adapted to the anatomy and further improves the precision of the introduction.
• the second tube body has a taper.
• the taper is arranged in the area of the side opening.
• it can be arranged in such a way that part of the side opening is located in front of the taper and part of the side opening is located behind the taper. This further facilitates the leading out of the first tube body.
• the side opening is shaped in such a way that a leak in the second tube body occurs through the side opening when the first tube body is led out through the side opening.
• a proximal section of the first tube body which extends from (including) the bend to the proximal end of the first tube body, is longer than the longitudinal extension of the side opening of the second tube body and / or longer than the proximal section of the second tube body between it Side opening and its proximal end.
• This proximal section of the first tube body is preferably at least 65 mm and / or at most 125 mm long.
• the distance between the side opening and the proximal end of the second tube body is preferably at least 60 mm and / or at most 120 mm.
• the first tube body has a further area with a further pretension, which is arranged in particular between the area of the pretension and the proximal end of the first tube body.
• the second hose body has a further, i.e., second, bend along its longitudinal axis or center line. Typically, this bend is also such that the first tube body can be brought into a straight alignment by means of a guide wire and / or introducer. What is described above in connection with the pre-tensioning also applies to the further pre-tensioning. This configuration facilitates the adaptation to the anatomy of the patient and thus the introduction into the body.
• Another aspect of the invention is a system for supplying and withdrawing blood, in particular for performing extracorporeal membrane oxygenation (ECMO).
• the system includes a first tube body and a second Hose body. At least a portion of the first tube body extends axially within the second tube body.
• the second tube body has a side opening through which the first tube body can exit from the second tube body. A precise positioning of the proximal end of the first tube body can be achieved in this way.
• the proximal end of the first tube body can for example be pushed very precisely through the tricuspid valve into the right ventricle of the heart and optionally further through the pulmonary valve into the pulmonary artery and placed there, while the second tube body extends from the inferior vena cava to the superior vena cava or from the superior vena cava extends into the inferior vena cava, for example, to suck blood from the superior vena cava.
• the side opening is then at the level of the tricuspid valve during use.
• the first tube body and the second tube body are axially displaceable relative to one another.
• at least one opening for infusing blood into or draining it from a blood vessel is arranged in the region of a proximal end of the first tubular body.
• at least one opening for the drainage of blood from or infusion into a blood vessel is arranged in the region of a proximal end of the second tubular body.
• a proximal end section of the first tube body can be formed by a flow element which is designed in such a way that the flow element can orient itself in the direction of a surrounding blood flow and can move with a blood flow. This can, for example, flow through the tricuspid valve with the blood flow through the atrium into the right ventricle.
• the flow element can unfold there, i.e. it can assume a tubular shape.
• Another aspect of the invention is an assembly method for a system for supplying and withdrawing blood. This comprises an axial relative movement between a first hose body and a second hose body, at least a portion of the first hose body extending axially inside the second hose body. During the relative movement, the proximal end of the first tube body is moved in the interior of the second tube body in the proximal direction and reaches the side opening. The proximal end of the first tube body exits the second tube body through the side opening.
• the first tube body has an essentially straight shape before exiting. This can be achieved by means of an introducer or guide wire arranged in the first tube body and / or the second tube body.
• first tube body including an introducer or guide wire and the second tube body.
• the introducer or guide wire can be removed in order to deform the first tube body from the straight shape to a curved shape.
• the pretensioned first tube body is deformed back, which causes the first tube body to bend.
• the introducer or guide wire is removed when the proximal end of the first tube body reaches the side opening.
• the first tube body can be introduced together with the second tube body.
• it can be introduced into the second tube body that has already been introduced.
• FIG. 9 to 12 show:
• FIG. 9 a first side view of a second hose body of a further embodiment of the system.
• FIG. 10 a second side view of the second hose body
• FIG. 11 a side view of a further embodiment of the system
• FIG. 12 a perspective illustration of the embodiment.
• FIG. 9 and FIG. 10 show a second tube body 20 with a side opening 70 for laterally leading out the first tube body from different sides.
• the side opening 70 has a length L of 35 mm and a width B of 6.3 mm or 7.6 mm. It is arranged in such a way that there is a distance A of 90 mm between its center point and the proximal end 25 of the second tube body 20.
• the side opening 70 lies in the region of a taper 74 of the second tube body.
• the distal end of the side opening 70 is located in a region of the second tube body 20 with a diameter D2 of 9 mm or 10.3 mm, corresponding to 27 Fr or 31 Fr.
• the proximal end of the side opening 70 is located in a region of the second tube body 20 with a smaller diameter D1. This can be, for example, 0.5 to 1.5 mm less than D2.
• the second tube body has an axial opening 28 at its proximal end 25. Lateral openings 29 are also arranged in the region of the proximal end 25.
• a connecting element 30 with a first connection 31, a second connection 32 and a third connection 33 is shown on the right.
• FIGS. 11 and 12 show an embodiment of the system 1.
• the second hose body 20 corresponds to the second hose body 20 shown in FIGS.
• the proximal end 15 of the first tube body 10 is thus arranged to the side of the proximal end 25 of the second tube body 20.
• the two hose bodies are movable relative to one another.
• the first hose body 10 has a uniform bend 72 with a radius of 35 mm.
• a straight section of the first tube body 10 is arranged in the proximal direction. This forms an angle ⁇ of 81 ° with the second hose body 20.
• the angle ⁇ is measured between the sections of the two tube bodies 10, 20 that are proximal from the side opening 70. It can be seen that the first hose body 10 is guided inside the connecting element 30 through the first connection into the connecting element 30 and is passed through this in the distal direction through the third connection 33.

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• Health & Medical Sciences (AREA)
• Heart & Thoracic Surgery (AREA)
• Vascular Medicine (AREA)
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• Pulmonology (AREA)
• Biomedical Technology (AREA)
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Citations (21)

• 2020
  • 2020-02-25 DE DE102020202401.4A patent/DE102020202401A1/de active Pending
  • 2020-11-19 CN CN202080097086.8A patent/CN115243739A/zh active Pending
  • 2020-11-19 EP EP20811551.9A patent/EP4110424A1/de not_active Withdrawn
  • 2020-11-19 WO PCT/EP2020/082626 patent/WO2021170267A1/de unknown

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