Catheter device

Abstract

To permit reliable shutting and opening of a fluid channel.SOLUTION: A catheter device (100) comprises a catheter (68) and lumens (69, 70, 74, 79), and comprises a valve for controlling a fluid flow through a catheter. The valve has a valve train (A, A', B, B', 3, 14, 18) selectively moving a closure element (5, 13, 17) to a first, second or third position. The closure element (5, 13, 17) comprises a movable membrane (5). The movable membrane (5) can close off a valve control space (12) in a fluid-tight manner, and is deflectable such that a feed opening (1a) or a discharge opening (2a) is selectively closable by parts of the membrane (5).SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to the field of mechanics and is particularly advantageously applicable in the field of medical technology.The present invention relates in particular to a catheter device that allows reliable blocking of fluid flow through the catheter, even under various pressure conditions. [Background technology]

[0002] Various shut-off valves for controlling fluid flow are known from the prior art. An industrially developed disposable shut-off valve is disclosed, for example, in US Pat. No. 5,629,499. Simple check valves are known, for example, from US Pat. No. 5,629,499. Such check valves are used, for example, in automotive technology. Such shut-off valves generally have a very limited application area, and they are often designed for only a narrow pressure range, which can lead to problems in the event of either overpressure or underpressure or pressure fluctuations. However, media isolation is also absolutely necessary, meaning that the actual fluid channel, including the shut-off location, must be sealed from other elements of the valve, such as the actuating element, in applications in the medical field, as well as in other specialized fields.

[0003] Furthermore, it is important for applications in the field of medical technology that they be easy to clean and sterilize, or alternatively, in the case where disposable components are used, be easy to replace. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] DE 20 2013 104711 A1 [Patent Document 2] DE 11 2009 003676 T5 Summary of the Invention [Problem to be solved by the invention]

[0005] Therefore, against the background of the prior art, it is an object of the present invention to create a catheter device or valve that allows reliable blocking and opening of fluid channels even at low fluid throughput and under a variety of pressure conditions. [Means for solving the problem]

[0006] This object is achieved by the features of the invention according to the claims. Advantageous embodiments of the invention are specified in the dependent claims.

[0007] It relates firstly to a catheter device comprising a catheter for introduction into a living organism and at least one lumen for directing a fluid flow through a part of the catheter device, in particular a valve for controlling the fluid flow through the catheter, the valve comprising a valve control space in which a feed channel extends to a feed opening and a drain channel extends to a drain opening, the valve comprising a closure element movable within the valve control space in a controlled manner, the closure element closing the drain opening in at least one first position, closing the feed opening in at least one second position and holding open a connecting channel between the feed opening and the drain opening in at least one third position, a valve actuator selectively moving the closure element to at least the first, second or third position, and the at least one lumen connected to the feed channel or the drain channel in a fluid-directing manner.

[0008] As will be explained in more detail below, the catheter device allows for very precise guiding of the irrigation fluid, both in terms of the irrigation direction and in terms of the irrigation volume and flow within the catheter. This is particularly achieved against the backdrop of a flexible, rotatable shaft, which has a suction effect or variable pressure conditions, particularly depending on the installation length and location. Furthermore, perfectly functioning valves are of paramount importance in this field of medical technology. In particular, the coupling to a separation device for removing contamination and wear debris, e.g., metal wear debris, from the irrigation fluid is also controllable. This is possible, for example, in the case of "through-rinsing" of a separation device (and thus a device for capturing / capturing wear debris, etc.), when a temporary direction reversal for cleaning makes sense.

[0009] For example, an example of such a separation device is described in ECP GmbH's parallel application ECP46PCT (file number not yet known), filed on the same day. Moreover, priority is claimed from both earlier applications EP15152201.8 and EP15152205.9. The disclosures of all three patent applications are incorporated herein by reference in their entirety in the form in which they were originally filed ("incorporated by reference").

[0010] One embodiment envisions that the catheter includes a rotatable shaft, which is, for example, flexible, particularly flexible in a manner that can adapt to the curvature of the human aortic arch, so that, for example, when the respective shaft is introduced into the femoral artery and when it is guided further along the aorta, the pump head at the tip of the flexible shaft is introduced into a ventricle of the heart, and also flexible in a manner that the catheter automatically adapts to the curvature of the aortic arch when pushing the catheter in a direction to clean the aorta.

[0011] In one embodiment, the drive device is selected outside the living organism (thus, outside the femoral artery in the above example), and the rotatable shaft extends into the femoral artery, for example into the left ventricle, to drive the pump head of a catheter pump (heart pump) positioned therein.

[0012] Further embodiments contemplate that the catheter includes two or more lumens, at least one lumen designed to direct fluid distally and at least one lumen designed to direct fluid proximally.

[0013] In some embodiments, 10 to 90 percent of the fluid flow directed distally through a first lumen can be directed proximally back through another lumen. Thus, a so-called "Y-irrigation" delivers fluid flow distally, with some of the irrigation fluid reaching, for example, the distal end of the catheter, into the heart, and then another portion of the irrigation fluid exiting again through each of the other lumens. Even more complex embodiments are possible, whereby the drive device (i.e., a driver positioned, for example, outside the body) is supplied with additional fluid flow, for example, to remove wear debris from the catheter device in areas such as bearings.

[0014] For this reason, embodiments can envisage that one, two, three or more valves are provided, for example, to perform more complex flushing procedures or to consider reversing the flushing direction (e.g., to clean the separation device).

[0015] One embodiment envisions that several valves, for example two valves, are provided, the outlet of the first valve being connected to the supply of the drive device of the catheter device, and there is a second valve, the supply of which is connected to the lumen of the catheter that directs fluid in a proximal direction.

[0016] Different embodiments of the valves in the catheter device 100 are shown in the specific description sections, which in particular relate to embodiments 8, 9, 10, 11, and 12.

[0017] It should also be mentioned that the valve is designed so that the valve driver of the closure element is separable, i.e. so that the valve driver of the closure element can be separated from the rest of the assembly in a tool-free manner, which in particular allows for easier replacement and also ensures sterility at low cost, even with multiple use of parts of the assembly.

[0018] It should also be mentioned that the valve driver can be realized in any manner: apart from a magnetically acting drive, the drive can also be realized in a purely mechanical manner, it can also be realized electrically or inductively, any drive being possible which allows a person skilled in the art to realize the movement of the closure element to the first, second and / or third position.

[0019] Among other things, the present application also relates to a valve for controlling fluid flow through a catheter, the valve comprising a valve control space in which a feed channel extends to a feed opening and a drain channel extends to a drain opening, the valve comprising a closure element movable within the valve control space in a controlled manner, the closure element closing the drain opening in at least one first position, closing the feed opening in at least one second position, and holding open a connecting channel between the feed opening and the drain opening in at least one third position, and a valve actuator selectively moving the closure element to the first, second, or third position. In one design, different valve gap sizes can be activated to control flow in the third or additional valve positions.

[0020] Due to its design, the valve is capable of blocking fluid flow by closing the exhaust opening and by closing the feed opening. The terms feed channel and exhaust channel are chosen to indicate a channel in which the feed channel with its outflow acts as a feed channel under normal or statistically most common circumstances and pressure conditions. The term exhaust channel is similarly defined.

[0021] Due to this, there is the possibility of assisting the closing force in each case by a higher pressure in the feed channel than in the discharge channel and by a higher pressure in the discharge channel than in the feed channel, and therefore due to the pressure difference, there is the possibility that, given an overpressure in the feed channel, the closure body closes the discharge opening, while, given an overpressure in the discharge channel, the closure body closes the feed opening, thereby assisting seating of the sealed closure body. In each of these cases, the closure body is held in the closed position by the pressure difference between the valve control space and the respectively closed channel in addition to the mechanical driving force.

[0022] In certain cases, a supply channel may also function as an exhaust channel, and vice versa, so it is possible to simply refer to the supply channel as the first channel and the exhaust channel as the second channel.

[0023] Reliable sealing is particularly important in systems where alternating pressure conditions or pressure conditions that change over time can be found. Such conditions are found, for example, in catheters used to guide mechanically drivable rotating shafts and / or to flush such catheters. Typically, when flushing or flushing a catheter that guides a rotating shaft, a very low fluid throughput is desired, which leads, among other things, to shaft wear particles being further displaced only in a predetermined direction. Such rotating shafts are often manufactured from a twisted wire bundle, which has a helical shape on its outer contour. This helical shape achieves a irrigation fluid delivery effect surrounding the shaft in the case of rapid shaft rotation, such that a suction effect occurs in addition to the actual rotational motion of the irrigation fluid, which is realized by an irrigant pump. This suction effect changes over time because the shaft contour changes over time due to wear and abrasive friction. This causes changes in pressure conditions in the corresponding irrigation catheter, which may lead to a reversal of the irrigant flow. Therefore, the valve according to the present invention seeks to achieve reliable shutoff / control of such fluid flow independently of pressure conditions. As mentioned above, selective closure of the feed or discharge opening (or the first or second opening) in response to a pressure gradient creates the possibility of achieving closure of the respective fluid channels, and each closed opening can be selected according to its position. Furthermore, the closed position of the closure element at the opening is stabilized by the pressure gradient.

[0024] The design assumes that at least part of the valve is considered as a disposable component. This makes sense, for example, in the field of medical technology. Fluid-conducting components (e.g., the valve control space) can thus be replaceable as a disposable component. For example, expensive components, such as the valve driver of the closure element, which preferably do not come into direct contact with the fluid, are considered as reusable components. Thus, for example, it is possible for the valve control space to become part of the catheter, in particular part of a catheter hose, for example, made of plastic material. Systems that operate in a contactless manner (e.g., magnetically, inductively) or that utilize, for example, the elastic properties of the valve control space to transmit a driving force can be considered, for example, as the valve driver.

[0025] One design contemplates a third position of the closure element between the first and second positions.

[0026] This has the effect that opening of the fluid channel is possible from each of the closed positions with minimal movement of the closure element, and that each of the two closed positions can be reached in a rapid and reliable manner from the third position with minimal movement of the closure element.

[0027] It is further possible to envisage that the valve-controlled space is closed in a fluid-tight manner on all sides, except for the feed and discharge openings.

[0028] This design provides complete media isolation, ensuring that the valve driver elements do not come into contact with the actual fluid to be controlled.

[0029] This is achieved, for example, by a closure element including a movable membrane that closes the valve control space in a fluid-tight manner and is capable of deflecting in such a manner that the feed opening or the discharge opening can be selectively closed by a portion of the membrane.

[0030] The membrane is peripherally connected to the remaining parts of the valve-controlled space in a fluid-tight manner, in particular by being bonded or welded in a non-flexible condition, so that the membrane forms a closure of the valve-controlled space. The fluid to be controlled can flow through the membrane between the inlet and outlet openings, or vice versa. The membrane is thereby designed in an elastically or plastically deformable manner, in particular so that it can be deflected and pressed against one of the two openings, i.e., the inlet or outlet opening, to such an extent that the membrane, or a part of the membrane, is selectively brought in front of this opening. Closure of the inlet or outlet opening is thereby achieved. The membrane relaxes to open the respective inlet or outlet opening, and in the ideal case, the membrane moves to its initial state by itself or due to its inherent tension.

[0031] In this regard, an advantageous design of the invention provides that the actuating lever of the valve driver deflects the membrane to at least a first position and a second position.

[0032] The actuating lever thus engages below the membrane and deflects it to such an extent that the membrane is clamped between the feed or discharge opening and the actuating lever, closing the respective opening. When the actuating lever of the valve driver is moved back, the membrane is released again from the respective opening.

[0033] Thereby, the actuating lever which presses against the membrane at its end can have, for example, a spherical or ellipsoidal shape, which is particularly well suited to closing the opening in the valve control space during the intervention of the membrane.

[0034] A further advantageous design of the invention can envisage that the closure element can be actuated by a magnetically acting valve driver.

[0035] For example, such a design makes it possible to completely separate the valve itself from the actuation unit, e.g., by having the valve control space separated from the magnetic actuation body by a gas- or fluid-impermeable wall. The complete valve body surrounding the valve control space can again be separated from the elements that create the magnetic field for actuation by an intermediate separation wall.

[0036] The part of the actuating lever that is remote from the valve control space is designed magnetically and can be deflected, for example, by an external magnet.

[0037] Moreover, the invention advantageously provides that the closure element arranged in the valve control space can be designed to be magnetically active and to interact with the magnetic field of the valve driver.

[0038] In this case, the closure element, or part of the closure element, may consist for example of a magnetic body that can be magnetized, or at least of a ferromagnetic material, and can be driven in the magnetic field of an external magnet. In this case, the magnetically active parts of the closure element are covered by a magnetically inactive, fluid-impermeable layer, so that the fluid does not come into contact with the magnetically active parts and the flow of fluid through the valve should be controlled.

[0039] A further advantageous design provides for the parts of the valve control space and the valve driver being mechanically connected to the closure element, except that the feed opening and the discharge opening are closed in a fluid-tight manner, in particular being separable from the device creating the magnetic field of the valve drive.

[0040] Due to this design, it is possible to separate (which preferably means to separate / detach in a non-destructive manner) a part of the valve, including for example the valve control space, as the case may be, from the magnetic field-generating device with little effort, and it can be replaced as a disposable component. The magnetic field-generating device for that part can then be used multiple times.

[0041] A further advantageous design of the invention provides that the closure element is preferably moved into the third position by a resilient spring element.

[0042] The closure element is held in the third position by a resilient spring element, such as a helical spring, and can be brought to the first or second position by the driver against the spring force. It is envisioned that the resilient spring element automatically moves the closure element to the third position after the valve driver is switched off. In this way, an electromagnet is used for actuation, but in the event of a power supply failure, the closure element is not subjected to external forces, and therefore the valve remains stationary in the open position. Furthermore, release of the closure element from the first and second positions is assisted by the resilient spring element.

[0043] Furthermore, the invention can be advantageously designed in that the magnet is provided as part of the separation device directly on the valve control space, in particular inside the closure element. In this case, the magnetic particles and magnetizable particles are bound by the magnet of the separation device in the valve control space, so that they are kept away from the sealing surface of the valve. Thereby, it is possible to envisage in particular that one or more magnets are provided separately from the drive armature of the valve driver, in particular at a distance relative to the drive armature of the valve driver.

[0044] However, it is also possible to envisage that the magnet of the separation device is combined or connected to one or more magnets of the valve driver, or that a first functional surface of the magnet serves for particle separation, while other functional surfaces serve for valve function.

[0045] Furthermore, the present invention can relate to a protective device for a valve associated with a flowing fluid, characterized in that a separation device with at least one magnetic element for retaining particles located in the fluid is provided along the flow channel for the fluid, in particular along the catheter, in a manner spaced apart from the valve, in particular separated from the valve.

[0046] The separation device may advantageously be arranged upstream of the valve with respect to the main flow direction of the fluid, but the two aforementioned elements may also simply be arranged consecutively with one another, in particular arranged at a distance from one another, and may be structurally separated from one another, for example in the form of two separate structural elements with different housings.

[0047] The valve may be free of magnetic or magnetically acting elements, e.g., may be entirely non-magnetic. It may include sealing surfaces, which should be protected from particles.

[0048] The valve may also include magnetic components, such as a drive magnet or an armature. The magnetic elements of the separation device may be magnets separate from the magnetic components of the valve, or functional surfaces of magnetic construction elements that exclusively have the function of particle separation, while other functional surfaces of the magnetic construction elements may perform other functions of the valve, such as, for example, a drive function. In this latter mentioned case, the magnetic elements of the separation device may be combined with, joined to, or grouped together with the magnetic construction elements of the valve, in particular grouped together in a housing.

[0049] Thus, the functional surfaces of the separation device are able to capture and bind particles, in particular magnetic and / or magnetizable particles, before they reach the valve and therefore impair the valve function, e.g., before they impair the sealing function of the sealing surface.

[0050] The invention is illustrated and explained hereinafter by means of embodiments in the figures of the drawings. [Brief explanation of the drawings]

[0051] [Figure 1] 1 shows a schematic cross-sectional view of a first embodiment of a valve with a magnetic valve driver; [Figure 2] FIG. 2 is a three-dimensional view of the valve arrangement of FIG. 1. [Figure 3] 2 shows a schematic cross-sectional view of a second embodiment of a valve according to the invention; FIG. [Figure 4] FIG. 2 is a diagram of a resilient spring element. [Figure 5]FIG. 4 is a three-dimensional view of the valve arrangement of FIG. 3. [Figure 6] FIG. 1 shows a valve connected to a separation device. [Figure 7] FIG. 10 shows a further valve connected to the separation device. [Figure 8] FIG. 10 shows a drive unit for a functional element that can be driven by rotating a shaft inside a catheter. [Figure 9] 9 shows a modification of the drive unit according to FIG. 8. FIG. [Figure 10] 10A-10C show further designs of drive devices for rotating shafts within catheters. [Figure 11] 10A-10C show further designs of drive devices for rotating shafts within catheters. [Figure 12] 10 shows a modified version of the drive unit according to FIG. 9;

[0052] 1 shows diagrammatically a valve body 11 comprising a feed channel 1, a discharge channel 2 and an actuation lever 3 for deflecting a membrane 5. The membrane 5 closes in a fluid-tight manner a valve control space 12 located within the valve body 11, and the membrane 5 can be selectively pressed by its spherical end 13 against a feed opening 1 a or a discharge opening 2 a to close either the feed channel 1 or the discharge channel 2.

[0053] The drive lever 3 is pivotable about a shaft 7, which is mounted in the drive housing 6 together with a spacer sleeve 8. The drive lever 3 is represented in solid lines in a third position III in which it keeps open the connecting channel between the feed opening 1 a and the discharge opening 2 a, likewise in dashed lines in a first position I in which its spherical end 13 closes the discharge opening 2 a by means of the membrane 5, and in dotted lines in a second position II in which it closes the feed opening 1 a by means of the membrane 5.

[0054] An elastic spring element 10 is represented as a helical spring in the drive housing 6 in the lower part, which connects the end of the drive lever 3 remote from the membrane to the base of the housing 6 and thus holds the drive lever in the third position III.

[0055] Two electromagnets A, B are represented on both sides of the drive housing 6, which, when they are subjected to an electric current, create a magnetic field which acts on the lower part 14 of the drive lever 3 and moves it to a first position I or a second position II, depending on the direction of the magnetic force. The lower part 14 of the drive lever 3 is designed for this purpose in a magnetically active manner, either as a ferromagnetic magnetizable component or as a magnetized component.

[0056] FIG. 2 shows the first housing 15 in a three-dimensional view, which includes or houses the valve body with the valve control space, as well as the membrane and at least part of the drive lever 3; FIG. 2 also shows, in particular, the drive housing 6. The magnets A and B are arranged in the second housing 16, which is movable relative to the first housing 15 and, in particular, separable from it. It is possible to envisage that both housings 15, 16 are connected, for example, that the first housing 15 can be snapped or locked into a holder in the second housing 16. However, it has been found to be advantageous if the first housing 15 is separately removable, so that the parts of the valve device contained therein can be replaced separately, in particular so that they can be treated as disposable valve parts.

[0057] A valve arrangement is shown in FIG. 3 with a valve body 11a surrounding a valve control space 12a in which a closure body 17 is movably mounted. The closure body 17 includes a magnetically active core 17a and a sheath 17b, which is made, in particular, of plastic and surrounds or covers the core 17a, and is connected to a bearing washer 18. The bearing washer is shown in plan view in FIG. 4. It is mounted on the valve body 11a at its periphery and is generally elastic so that it holds the closure body 17 in the intermediate position shown. The bearing washer 18 includes several openings 25 that allow the throughflow of fluid to be controlled by the valve.

[0058] The ends 19, 20 of the closure body 17 are shaped and designed so that, with corresponding deflection of the closure body 17 and with elastic deformation of the bearing washer 18, they can close the feed opening 1a or the discharge opening 2a.

[0059] For this purpose, the sheath 17b of the closure body 17 is made of an elastic material, and in particular may be made of an elastomer, for example. The magnetic core 17a of the closure body 17 is subjected to a force by the magnet devices A', B' which pulls the closure body 17 either in the direction of the feed opening 1a or in the direction of the discharge opening 2a, bringing the valve into the first or second closed position.

[0060] 5, the valve body 11a is represented in a three-dimensional view as a housing, which encloses the valve control space 12a, the feed channel 1 and the discharge channel 2, and the housing 16a containing the magnet devices A' and B'. If the part of the valve device is to be designed as a disposable valve, the housing 11a can be separated from the housing part 16a so that the magnet device can be used several times or continue to be used, while the part of the valve including the valve control space 12a can be replaced.

[0061] 3 shows a valve according to the invention in combination with a fluid control device also according to the invention, which comprises a catheter 21, a rotating shaft 22 passing through the catheter 21, and a flushing device (not shown in detail), the valve body 11a, the valve control space 12a, and the valve with the mechanical parts of the valve driver forming part of the flushing device. Further parts of the flushing device can be, for example, an irrigant pump and an irrigant reservoir, which are not shown in detail. Inlet or outlet channels 1, 2 can be connected to the catheter 21 to allow the irrigant to be guided into or out of the catheter by appropriate actuation of the valve. Also visible in FIG. 3 is the twisted structure of the shaft 22, which can lead to different suction and pressure effects depending on the speed of shaft rotation and shaft wear.

[0062] 6 shows a magnetic valve with a transport channel through which a fluid flows between a feed opening 1' and a discharge opening 2'. A closure body 50 is actuated in the transport channel 88 between a first closed position and a second closed position, with the first closure surface 51 closing the valve opening 51a in the first closed position, while the closure surface 52 closing the valve opening 52a in the second closed position.

[0063] Two armature bodies 53, 54 that can be driven by the magnetic fields of two valve drive coils 55, 56 are integrated into the closure body 50. A magnet 86 of the separation device is axially arranged between and flush with the armature bodies 53, 54. The armature bodies with the magnet body 86 are provided with a common solid material coating 87. Particles that adhere to the solid material coating 87 are shown at 15 by way of example.

[0064] Retaining springs 57, 58 hold the closure body in an intermediate position in the absence of valve drive coil excitation, in which the valve is open. Two plain bearings 59, 60 are provided at the ends of the valve housing to guide the closure body 50.

[0065] FIG. 7 shows a valve with a feed opening 1″, a discharge opening 2″ and a closure body 50′. The closure body 50′ is driven in a transport channel 88′ between a first closed position and a second closed position, with the first closing surface 51′ closing the valve opening 51 a′ in the first closed position, and the closing surface 52′ closing the valve opening 52 a′ in the second closed position. The closure body 50′ is mounted in the valve housing and held in an open intermediate position by a resilient, permeable disc 61. The disc 61 carries separating magnets 86′, 86″, which are connected to valve drive armatures 62, 63 in the closure body 50′ and, together with them, are encased in a protective layer.

[0066] Valve drive armatures 62, 63 can be driven in the magnetic fields of coils 64, 65. In the transport channel, particles can accumulate on a protective layer above a separation magnet and can be retained there.

[0067] The claimed catheter device 100 is now depicted in several alternative embodiments in FIGS. 8-12.

[0068] 8 shows a catheter device 100, which includes a drive unit with a drive armature 66 that is rotationally drivable to drive a rotary shaft 67 within a catheter 68. Lumens are provided radially outward as a delivery channel 69 and radially inward as a return channel 70, which are arranged in a concentric manner with one another within the catheter 68 and disposed on the outer skin of the catheter. The delivery channel 69 and the return channel 70 are separated from one another by a hose-like separating wall 71.

[0069] The irrigation fluid is pumped from a reservoir 73 by a volume-controlled peristaltic pump 72 through a lumen 74, which is designed as a cannula, and a valve 75. Two magnets 76 and 77 actuate the valve, which is activated by a pressure switch 78 to maintain a constant pressure in the feed channel 69. The fluid is then guided through the valve 75, through the housing of the drive armature 66, through the lumen 79, which is designed as a transport channel, and through a separation device 80, where particles are actively filtered from the fluid. The separation device 80 can be constructed similarly to the separation device shown in FIG. 6. From here, the fluid flows outward through the feed channel 69 into the catheter 68 and inward through the return channel 70, from where it flows to a peristaltic pump 81, which aspirates the fluid and guides it into a reservoir 82. However, the peristaltic pump 81 can also serve for backwashing, and for this purpose it can be operated to deliver fluid to the return channel 70 and then via the feed channel 69, through the separation device, back to the valve 75 and into the reservoir 73, for example to remove trapped particles from the separation device.

[0070] FIG. 9 shows a similar construction to that of FIG. 8 , except that in addition to the valve 75 in front of the drive armature 66 and behind the peristaltic pump 72, a second valve 75′ is placed between the return channel 70 and the return pump 80. While FIG. 8 applies to a cleaning system in which an undesired vacuum is not created in the return due to installation components, FIG. 9 can also be applied to a cleaning system in which an undesired vacuum occurs in the return (e.g., due to the winding direction of the flexible shaft). This vacuum is recognized by a sensor, which then closes the valve 75′ to the bottom, thereby ensuring that no medium enters the cleaning circuit from the container 82 via the pump 81. Thus, the separation device is placed between two valves and two fluid delivery devices, at least one of which, and in particular both, can be switched in terms of fluid delivery direction to reverse the flow direction. 10, compared to the construction of FIG. 8, only the peristaltic pump 72 has been replaced by a reservoir 83, which allows gravity flushing by allowing the fluid to flow due to gravity through the valve 75 and further into the catheter 68. Due to its intertwined / twisted construction based on twisted strands, the rotating shaft 84 inside the catheter 68 has a helical (coiled) outer structure which, when rotated, gives itself a pumping effect in the direction away from the drive armature 66. Another variant with a volume-controlled peristaltic pump 72 and reservoir 73 is represented on the right side of FIG. 10, to the right of the dotted line 85, for the delivery of fluid to the catheter 68. The peristaltic pump there delivers, for example, fluid inside the catheter to be introduced into the patient's body, terminating in a heart pump 85 with a rotor 85a. The heart pump, for example, is radially compressed, meaning that as a whole it may be particularly prone to particles reaching it, from which the fluid then flows back.The separation device 80 is in each case provided upstream of the catheter 68 in the flow direction, between this and the delivery device 73, 83, and in particular may be provided upstream of the heart pump 85 in both cases.

[0071] FIG. 11 shows a similar arrangement to that of FIG. 9 , but with gravity delivery 83 instead of peristaltic pump 72. During normal operation, fluid is directed from there through the valve into catheter 68, first outward through feed channel 69 and inward into return channel 70, and from there to peristaltic pump 81, which aspirates the fluid and directs it into reservoir 82. Between return channel 70 and peristaltic pump 81, the fluid first passes through separation device 80, which is disposed between the return channel and the housing of drive armature 66. The fluid then flows over drive armature 66 to peristaltic pump 81. The mounting of the drive armature can be relatively insensitive, so that the throughflow direction of the fluid is not critical here. What is important is that the drive armature housing is supplied with fluid to ensure good lubrication. Moreover, the selected arrangement ensures that magnetic wear particles of the rotating shaft 84 cannot damage the bearings of, in this case, the drive armature.

[0072] FIG. 12 shows a similar construction to FIG. 9, with an additional separation device 80' ensuring that the sealing surface of the valve 75' is not impaired by adhering particles.

[0073] The present application relates, inter alia, to the following aspects: 1. A valve for controlling fluid flow, in particular through a catheter, comprising a valve control space (12, 12a) in which a feed channel (1) extends to a feed opening (1a) and a discharge channel (2) extends to a discharge opening (2a), the valve comprising closure elements (5, 13, 17) movable in a controlled manner within the valve control space (12, 12a), the closure elements (5, 13, 17) being movable in a controlled manner within the valve control space (12, 12a), and the closure elements (5, 13, 17) being movable in a controlled manner within the valve control space (12, 12a). , 13, 17) is provided with a valve driver (A, B, A', B', 3, 14, 18) which selectively moves the closure element (5, 13, 17) to at least the first, second or third position, wherein the closure element (5, 13, 17) closes the discharge opening (2a) in at least one first position (I), closes the feed opening (1a) in at least one second position (II), and holds open the connecting channel between the feed opening (1a) and the discharge opening (2a) in at least one third position (III).

[0074] 2. A valve according to embodiment 1, characterized in that the third position (III) of the closure element (5, 13, 17) is between the first and second positions.

[0075] 3. A valve according to embodiment 1 or 2, characterized in that the valve control space (12, 12a) can be separated from the valve driver of the closure element (5, 13, 17).

[0076] 4. A valve according to embodiment 1 and embodiment 2 or 3, characterized in that the valve control space (12, 12a) is closed in a fluid-tight manner on all sides, except for the feed opening (1a) and the discharge opening (2a).

[0077] 5. A valve according to any one of aspects 1 and 2 to 4, characterized in that the closure element (5, 13, 17) comprises a movable membrane (5) that closes the valve control space (12) in a fluid-tight manner and is deflectable so that the feed opening (1 a) or the discharge opening (2 a) can be selectively closed by a portion of the membrane (5).

[0078] 6. A valve according to aspect 5, characterized in that the actuating lever (3, 14) of the valve actuating body (3, 14, 18, A, B, B, B') deflects the membrane (5) in at least the first and second positions.

[0079] 7. A valve according to any one of aspects 1 and 2 to 6, characterized in that the closure element (5, 13, 17) can be actuated by a magnetically acting valve driver (A, A', B, B').

[0080] 8. A valve according to aspect 7, characterized in that the closure element (5, 13, 17) arranged in the valve control space (12, 12a) is magnetically active and interacts with the magnetic field of the valve driver (A, A', B, B').

[0081] 9. A valve according to aspects 6 and 7, characterized in that the actuating lever (3, 14) can be actuated magnetically.

[0082] 10. A valve according to embodiment 7, characterized in that the valve control space (12, 12a) and the parts (3, 14, 18) of the valve driver mechanically connected to the closure element (5, 13, 17) are closed in a fluid-tight manner, except for the feed and discharge openings (1a, 2a), and can be separated from the device (A, A', B, B') that creates the magnetic field of the valve driver.

[0083] 11. A valve according to any one of aspects 1 and 2 to 10, characterized in that the closure element is preferably moved to the third position (III) by a resilient spring element (10, 18).

[0084] 12. A valve according to any one of aspects 1 and 2 to 11, characterized in that the magnet (13'', 13''', 13'''') is provided as part of the separation device directly on the valve control space (12, 12a), in particular inside the closure element (5, 13, 17).

[0085] 13. A valve according to aspect 12, characterized in that one or more magnets (13'', 13''', 13'''') are arranged separately from the driving armature (53, 54, 62, 63) of one valve driver, in particular arranged in a distanced manner relative to the driving armature (53, 54, 62, 63) of one valve driver.

[0086] 14. A catheter comprising a valve according to any one of aspects 1 to 13, wherein the valve control space can be separated from the valve driver of the closure element.

[0087] 15. A protective device for a valve (75, 75') associated with a flowing fluid, characterized in that a separation device (80) with at least one magnetic element (86, 86', 86'') for retaining particles located in the fluid is provided along a flow channel (79, 88) for the fluid, in particular along the catheter, in a manner spaced apart from the valve and in particular separated from the valve.

Claims

1. A catheter device (100) comprising: a catheter (68) for introduction into a living organism, and at least one lumen (69, 70, 74, 79) for directing fluid flow within a portion of said catheter device; a valve for controlling the fluid flow through the catheter, the valve comprising a valve control space (12, 12a); In said valve-controlled space (12, 12a), a feed channel (1) leads to a feed opening (1a) and a discharge channel (2) leads to a discharge opening (2a), The valve comprises a closure element (5, 13, 17), the closure element (5, 13, 17) is movable in a controlled manner within the valve control space (12, 12a); said closure element (5, 13, 17) in at least one first position (I) closes said discharge opening (2 a), in at least one second position (II) closes said feed opening (1 a) and in at least one third position (III) keeps open a connecting channel between said feed opening (1 a) and said discharge opening (2 a), a valve driver (A, A', B, B', 3, 14, 18) is provided to selectively move the closure element (5, 13, 17) to at least the first, second, or third position; the at least one lumen (69, 70, 74, 79) is fluidly connected to the supply channel or the discharge channel; the closure element (5, 13, 17) comprises a movable membrane (5) that is deflectable so as to close the valve-controlled space (12) in a fluid-tight manner and to selectively close the feed opening (1 a) or the discharge opening (2 a) by a portion of the membrane (5); A catheter device (100) characterized by:

2. 10. The catheter device of claim 1, A catheter device, wherein the catheter (68) includes a rotatable shaft.

3. 3. The catheter device of claim 2, A catheter device, characterized in that the rotatable shaft (67) is flexible.

4. 4. A catheter device according to claim 2 or 3, A catheter device characterized in that it is possible to apply a drive device (66, 67) that can be placed outside the living body to drive the shaft.

5. The catheter device according to any one of claims 1 to 4, A catheter device characterized in that the catheter (68) is designed as a catheter pump.

6. A catheter device according to any one of claims 1 to 5, The catheter (68) comprises two or more lumens (69, 70, 74, 79), at least one lumen (69) designed to direct fluid in a distal direction and at least one lumen (70) designed to direct fluid in a proximal direction.

7. 7. The catheter device of claim 6, A catheter device characterized in that 10 to 90 percent of the fluid flow directed in the distal direction through a first lumen can be directed back in the proximal direction through another lumen (70).

8. 8. The catheter device of claim 7, A catheter device wherein a portion of the fluid is delivered distally and another portion of the fluid exits again through another lumen.

9. A catheter device according to claim 4 or any claim dependent thereon, A catheter device, characterized in that a lumen is led at least partially through said drive device (66, 67).

10. A catheter device according to any one of claims 1 to 9, A catheter device characterized in that it is provided with one, two, three or more valves (75, 75').

11. A catheter device according to any one of claims 1 to 10, A catheter device characterized in that a first valve (75) is provided, the outlet of which is connected to a supply of the catheter device, and a second valve (75') is present, the supply of which is connected to a lumen (69) that directs fluid in the proximal direction.

12. A catheter device according to any one of claims 1 to 11, A catheter device characterized in that the third position (III) of the closure element (5, 13, 17) is between the first and second positions.

13. A catheter device according to any one of claims 1 to 12, A catheter device characterized in that the valve control space (12, 12a) can be separated from the valve driver of the closure element (5, 13, 17).

14. A catheter device according to any one of claims 1 to 13, A catheter device characterized in that the valve-controlled spaces (12, 12a) are closed in a fluid-tight manner on all sides except for the feed opening (1a) and the discharge opening (2a).

15. A catheter device according to any one of claims 1 to 14, a membrane that is peripherally connected to the rest of the valve-controlled space and that, when unflexed, forms a closure of the valve-controlled space, allowing fluid to flow past the membrane between the inlet and outlet openings, and that is configured to flex to an extent that a portion of the membrane can be selectively positioned in front of the inlet or outlet opening to close the inlet or outlet opening.

16. A catheter device according to any one of claims 1 to 15, A catheter device, wherein the membrane is configured to open the delivery opening and the discharge opening in a relaxed state and to transition to the relaxed state by its own inherent tension.

17. A catheter device according to any one of claims 1 to 16, A catheter device characterized in that the actuating lever (3, 14) of the valve actuating body (A, A', B, B', 3, 14, 18) deflects the membrane (5) at least in the first and second positions.

18. 18. The catheter device of claim 17, the part of the actuating lever (3, 14) remote from the valve control space is magnetic and is deflected by an external magnet; A catheter device comprising:

19. A catheter device according to any one of claims 1 to 18, A catheter device characterized in that said closure elements (5, 13, 17) can be actuated by magnetically acting valve drivers (A, A', B, B').

20. 20. The catheter device of claim 19, The catheter device is characterized in that the closure elements (5, 13, 17) arranged in the valve control spaces (12, 12a) are magnetically active and interact with the magnetic field of the valve drivers (A, A', B, B').

21. 20. A catheter device according to claims 18 and 19, A catheter device, characterized in that the actuating lever (3, 14) is magnetically actuable.

22. A catheter device according to any one of claims 19 to 21, 10. A catheter device, comprising: a valve control space separated from the magnetically actuated valve driver by a gas-impermeable wall, a fluid-impermeable wall, or a gas-impermeable and fluid-impermeable wall.

23. A catheter device according to any one of claims 19 to 22, The catheter device is characterized in that the valve control space (12, 12a) and the parts (3, 14, 18) of the valve driver that are mechanically connected to the closure element (5, 13, 17) are closed in a fluid-tight manner except for the feed opening and the discharge opening (1a, 2a) and can be separated from a device (A, A', B, B') that creates a magnetic field for the valve driver.

24. A catheter device according to any one of claims 1 to 23, A catheter device characterized in that the closure elements are moved by elastic spring elements (10, 18).

25. 25. The catheter device of claim 24, A catheter device, characterized in that the closure element is moved to the third position (III) by the elastic spring element (10, 18).

26. A catheter device according to any one of claims 1 to 25, A catheter device characterized in that a magnet (13'', 13''', 13'''') is provided directly in the valve control space (12, 12a) as part of a separation device.

27. 27. The catheter device of claim 26, The magnet (13'', 13''', 13'''') is provided as part of the separation device, directly in the valve control space (12, 12a), inside the closure element (5, 13, 17).

28. 28. The catheter device of claim 27, A catheter device characterized in that one or more of the magnets (13'', 13''', 13'''') of the drive armature (53, 54, 62, 63) of one of the valve drivers are arranged separately and in a spaced apart manner.

Images