Apparatus for automatic inflation of a vascular balloon catheter, and a system for performing an angioplasty

Abstract

An apparatus (4) for automatic inflation of a vascular balloon catheter (6) by means of a fluid, having a fluid delivery device (12), a pressure sensor device (16) and a control device (18), wherein the catheter interface (8) is designed in such a way as to be able to be connected to the balloon catheter (6) detachably, in particular without tools, the fluid can flow from the apparatus (4) into the balloon catheter (6) via the catheter interface (8), the fluid delivery device (12) is designed to be able to eject the fluid at the catheter interface (8) out of the apparatus (4) by means of a motor (32), the pressure sensor device (16) is designed to be able to measure a pressure of the fluid ejected from the apparatus (4), and the control device (18) is designed to be able to control an amount of the fluid, expelled from the apparatus (4) by the fluid delivery device (12), as a function of the pressure measured by the pressure sensor device (16), by actuation of the motor (32) of the fluid delivery device (12).

Description

[0001] Device for automatic inflation of a vascular balloon catheter and a system for performing angioplasty

[0002] Description

[0003] Technical area

[0004] The present disclosure relates to a device for automatically inflating a vascular balloon catheter, in particular a vascular angioplasty catheter or a percutaneous transluminal angioplasty catheter (for PTA: percutaneous transluminal angioplasty or PTCA: percutaneous transluminal coronary angioplasty), using a fluid. The device comprises a catheter interface, a fluid delivery device, a pressure sensor device, and a control device. The catheter interface is designed to be detachably connected to the balloon catheter, in particular without tools, such that the fluid can flow from the device into the balloon catheter via the catheter interface. The fluid delivery device is designed to be able to expel the fluid from the device at the catheter interface by means of a motor.The pressure sensor device is configured to measure the pressure of the fluid ejected by the device. The control device is configured to control the amount of fluid ejected from the device by means of the fluid delivery device as a function of the pressure measured by the pressure sensor device by controlling the motor of the fluid delivery device. The present disclosure further relates to a system for performing angioplasty, comprising a device according to the disclosure and a balloon catheter.

[0005] State of the art

[0006] A generic device is used, for example, in the

[0007] EP 0490 979 B1 discloses. The conventional device comprises a catheter interface, a fluid delivery device, a pressure sensor device, and a control device. The fluid delivery device is designed to deliver a fluid via the catheter interface into a balloon catheter. In order to control inflation of the balloon catheter or a balloon of the balloon catheter, a pressure in the balloon catheter or in the balloon can be measured by means of the pressure sensor device. The control device is designed to control the fluid delivery device depending on the pressure measured by the pressure sensor device. In order to deliver the fluid from the balloon catheter, the conventional device comprises a piston syringe that can only be operated manually.

[0008] Inflation of the balloon catheter during angioplasty causes an interruption of blood flow. The problem with conventional devices is that this interruption of blood flow can be excessively long, and if overpressure occurs in the balloon catheter, the removal of the excess fluid from the balloon catheter that caused the overpressure occurs only after a certain time delay.

[0009] CN 108096676 A discloses a tracheal catheter, i.e., a catheter for the windpipe. This balloon operates with overpressures of approximately 25 to 30 mbar.

[0010] DE 102005 060 197 A1 discloses a fully implanted device. For this reason, this device cannot evacuate a balloon catheter, as evacuated gas would be pumped back into the balloon during balloon inflation. Furthermore, it is a floating catheter with a latex balloon that operates only at minimal overpressures of a few millibars.

[0011] DE 102014 003 306 A1 discloses a balloon catheter for trans-anal irrigation. Evacuation is not provided for such a balloon catheter either. US 2007 0 197 963 A1 discloses a device for applying an already evacuated balloon catheter. The device is not intended to, nor is it capable of, evacuating a balloon catheter, as it primarily uses a peristaltic pump. However, such a pump cannot generate a vacuum, as the peristaltic tube would not "reestablish" itself if negative pressure were to build up. However, if the tube is stiffened to create this property, it can no longer be compressed, and thus pumping is no longer possible. A peristaltic pump can only generate minimal negative pressures. According to US 2007 0 197 963 A1, only the balloon of a balloon catheter is deflated and not the catheter of the balloon catheter.

[0012] Disclosure of the invention

[0013] The object of the present invention is therefore to provide a device for the automatic inflation of a balloon catheter, which makes it possible to minimize an interruption period of a blood supply and / or to reduce a quantity of fluid in the balloon catheter in a timely manner.

[0014] This object is achieved by a device having the features of claim 1 and by a system having the features of claim 14. Advantageous further developments are the subject of the subclaims.

[0015] A device according to the disclosure is suitable for automatically inflating a balloon catheter with a fluid. The fluid can be a liquid, in particular a saline solution, and / or a contrast agent. Examples of contrast agents that can be used are lopromide, iodixanol, loxaglate, lohexol, lopamidol, lomeprol, lomeron, gadodiamide, or gadolinium. For dilution, the contrast agent is preferably diluted with the saline solution, e.g., 0.9% NaCl. Gadodiamide or gadolinium can also be used undiluted. A contrast agent to diluent ratio of 1:1 to 1:3, preferably approximately 1:2, is suitable. The device has a catheter interface, a fluid delivery device, a pressure sensor device, and a control device.

[0016] The catheter interface is designed to be removable and connectable to the balloon catheter, particularly without tools, so that the fluid can flow from the device into the balloon catheter via the catheter interface. The catheter interface can be designed, in particular, as a Luer connector.

[0017] The fluid conveying device is designed to be able to expel the fluid from the device at the catheter interface by means of a motor.

[0018] The fluid delivery device can be designed, in particular, as a piston syringe, and a piston of the piston syringe can be connected to a motor such that the piston can be displaced by the motor. The motor can be designed as a linear motor that transmits a linear movement directly to the piston. Alternatively, the motor can also be designed as a rotary motor. In this case, a gear can be provided, by means of which a rotary movement of the motor can be converted into a linear movement, resulting in a displacement of the piston.

[0019] Alternatively, another form of transmission can be used for the linear movement of the piston, such as a toggle lever, scissor joint or a lever construction to convert a rotary movement of the engine into a linear movement of the piston.

[0020] The motor can in particular be an electric, mechatronic, pneumatic or hydraulic motor.

[0021] The pressure sensor device is designed to be able to measure a pressure of the fluid ejected by the device. In particular, the pressure sensor device can be designed to be able to measure the pressure of the fluid ejected by the device at the catheter interface and / or at the piston of the piston syringe and / or at another suitable location. Preferably, a pressure sensor (as part of the pressure sensor device) can be provided at the catheter interface, in particular on an outer side of the device, which pressure sensor is in fluid communication with the balloon catheter or the balloon of the balloon catheter when a balloon catheter is connected to the device or to the catheter interface of the device. The pressure sensor device or the pressure sensor can be connected to the control device in a wired or wireless manner.

[0022] The control device is designed to be able to control the amount of fluid expelled from the device by means of the fluid delivery device directly (by monitoring the amount) or indirectly (by monitoring a delivery rate of the fluid delivered by the fluid delivery device) as a function of the pressure measured by the pressure sensor device by controlling the motor of the fluid delivery device. In particular, the control device can be designed to be able to achieve a predetermined target pressure in the balloon catheter or in the balloon of the balloon catheter by delivering a corresponding amount of fluid from the device into the balloon catheter.

[0023] According to the disclosure, the fluid conveying device is designed to be able to suck the fluid into the device at the catheter interface by means of the motor.

[0024] In other words, the fluid delivery device is designed, in the state in which a balloon catheter is connected to the device or to the catheter interface of the device, to selectively deliver fluid from the device into the balloon catheter or the balloon of the balloon catheter or to deliver fluid from the balloon catheter or the balloon of the balloon catheter into the device.

[0025] The device can be configured to form a closed system with the balloon catheter when connected to the balloon catheter, meaning that fluid is only transferred between the device and the balloon catheter as needed. Alternatively, the device can also be configured to form an open system with the balloon catheter when connected to the balloon catheter. In particular, in the case of an open system, the device can have a fluid inlet for connecting the device to a fluid source and a fluid outlet for connecting the device to a fluid drain.

[0026] Because the device according to the disclosure is designed to be able to selectively expel or suck in fluid by means of the conveying device, it is advantageously possible to quickly change the volume of a balloon of a balloon catheter during an angioplasty.

[0027] The disclosed device is capable of initially evacuating a balloon catheter, i.e., applying a strong negative pressure to the applied balloon catheter to remove any residual air remaining after flushing the balloon catheter from the balloon catheter and, above all, to prevent it from being reintroduced into it. The air interferes with inflation and is particularly dangerous if the balloon catheter should burst. Unlike inflation fluid, residual air in the balloon catheter would expand explosively at pressures of 10 bar and above, and in the worst case, could injure or even burst the vessel. Furthermore, air in the blood vessels can lead to thrombosis.

[0028] The conveying device may be configured to eject fluid at a speed of 0.33 ml / s or more (1 ml / s) and to suck in fluid at a speed of 10 to 15 ml / s.

[0029] According to one aspect of the disclosure, the control device can be configured to cause the fluid to be sucked in by means of the fluid delivery device when a predetermined threshold value of the pressure measured by the pressure sensor device is exceeded. The predetermined threshold value can correspond to a target pressure that should be present during proper performance of an angioplasty. Alternatively, the predetermined threshold value can also be greater than this target pressure, so that a permissible pressure range or a target pressure range is defined for performing an angioplasty with the target pressure and the predetermined threshold value.

[0030] If a predetermined threshold is provided, which, when exceeded, automatically triggers aspiration of the fluid, the safety of performing angioplasty can be increased.

[0031] According to one aspect of the disclosure, the control device can be designed to prevent suction of the fluid by means of the fluid conveying device after the predetermined threshold value has been exceeded and a subsequent pressure drop in the pressure measured by the pressure sensor device when the predetermined threshold value is reached again.

[0032] If the device is designed in such a way that suction of the fluid is only initiated when a predetermined threshold value is exceeded, it is advantageously possible to reduce or completely eliminate excessive stress on a body tissue of a body lumen during movement of a balloon catheter connected to the device, without excessively reducing a force necessary for dilating the body lumen.

[0033] According to one aspect of the disclosure, the fluid can be a liquid, and the device can have a venting device by means of which a gas mixed with the liquid can be discharged from the device. The venting device can be provided, in particular, at the catheter interface. Alternatively, the venting device can also be formed on the fluid delivery device. If liquid is used to inflate the balloon catheter, power transmission from the motor via the fluid to a tissue to be inflated can be improved. If a venting device is provided, this improved power transmission can be advantageously ensured.

[0034] According to one aspect of the disclosure, the control unit can be configured to be able to control or to control the fluid delivery device such that the fluid is delivered at different predetermined delivery rates. In particular, different target delivery rate profiles can be stored in the control device. Preferably, a delivery rate during aspiration of the fluid can be higher than a delivery rate during ejection of the fluid.

[0035] If different predetermined delivery rates are provided, it is possible to adequately adapt the reaction times of the device to different requirements during an angioplasty.

[0036] According to one aspect of the disclosure, the control unit can be configured to regulate the fluid delivery device depending on the pressure measured by the pressure sensor device. In particular, the control unit can be configured such that the pressure measured by the pressure sensor device can reach at least two different predetermined pressure levels. Different pressure levels and / or predetermined sequences of pressure levels can preferably be stored in the control device.

[0037] According to one aspect of the disclosure, the device can have an energy storage device (for storing electrical or mechanical energy) so that in the event of a power failure, not only can the excess pressure be relieved, but a vacuum can also be drawn again so that the balloon catheter can be deflated and / or explanted in this case as well. According to one aspect of the disclosure, the motor of the fluid delivery device can have a tensioning means that is designed to be tensioned when the fluid is expelled and relaxed when the fluid is sucked in. The tensioning means can in particular be a spring, preferably a compression spring.In particular, the fluid conveying device can be designed as a piston syringe and a compression spring can be provided or attached to a piston of the piston syringe in such a way that the compression spring is tensioned when the piston is moved to expel the fluid from the piston syringe (by the motor) and is relaxed when the piston is moved to suck the fluid into the piston syringe.

[0038] If a clamping device is provided in the motor, the operational reliability of the device can be improved. The clamping device is capable of sucking fluid into the device in the event of an interruption in the power supply to the motor.

[0039] According to one aspect of the disclosure, the control device can have a data interface configured to transmit data to and / or from a smartphone, a tablet, or another, in particular, medical device. In particular, the data interface can be configured to enable a wired or wireless connection to the smartphone, the tablet, or the other medical device. Preferably, the data interface can be configured to enable a connection using a transmission standard such as USB, Wi-Fi, NFC, Bluetooth (BT), or Bluetooth Low Energy (BLE).

[0040] Alternatively, the data interface can be designed as a pressure connection, and the control device can be configured to control the fluid delivery device depending on the pressure measured at the pressure connection. If a data interface is provided, operation and / or monitoring of the device according to the disclosure can be implemented cost-effectively.

[0041] According to one aspect of the disclosure, the device may comprise an operating unit connected to the control device or the data interface, which is configured to receive control commands from a person and transmit them to the control device. The operating unit may be connected to the control device or data interface in a wired or wireless manner.

[0042] If the device is equipped with an operating unit, the operability of the device can be ensured in an advantageous manner independently of peripheral devices.

[0043] According to one aspect of the disclosure, the operating unit can be designed in the form of a manual inflation syringe. In particular, the operating unit can have a pistol grip or a toggle-shaped handle. Preferably, the operating unit can have a slide or toggle switch, by means of which the predetermined threshold value for the pressure of the ejected fluid and / or the target pressure can be specified.

[0044] If the operating unit is designed in the form of a manual inflation syringe, familiarization with the device according to the disclosure can be made easier.

[0045] According to one aspect of the disclosure, the operating unit can be an inflation syringe or a piston syringe, by means of which a control fluid can be conveyed by moving a piston to a control fluid interface of the inflation syringe or piston syringe, the device can have a pressure connection that is designed to be connectable to the control fluid interface of the inflation syringe or piston syringe, the pressure sensor device can be designed to measure a pressure of the control fluid, in particular at the pressure connection, and the control device can be designed to control the fluid conveying device as a function of the pressure of the control fluid measured, in particular at the pressure connection. The control fluid interface can be designed, in particular, as a Luer connection point.

[0046] If the data interface is designed as a pressure connection that is compatible with a control fluid interface of an inflation syringe or piston syringe, the control unit can be implemented cost-effectively.

[0047] According to one aspect of the disclosure, the operating unit may have a display configured to display status data of the device. In particular, the operating unit may be configured as a touch-sensitive screen.

[0048] The disclosure further relates to a system for performing angioplasty, in particular a percutaneous transluminal angioplasty (PTA) or a percutaneous transluminal coronary angioplasty (PTCA) with a balloon catheter and a device according to the disclosure.

[0049] According to one aspect of the disclosure, the device may be configured to create a negative pressure or a vacuum in the balloon catheter (ie, in the balloon and / or in the catheter of the balloon catheter) to thereby evacuate the gas or liquid contained in the catheter from the catheter.

[0050] Brief description of the drawings

[0051] The present invention will be described in more detail below using preferred embodiments with reference to the accompanying drawings. Figure 1 shows a schematic view of a system according to the disclosure according to a first embodiment.

[0052] Fig. 2 shows a schematic view of a fluid conveying device according to the disclosure.

[0053] Fig. 3 shows a schematic view of a system according to the disclosure according to a second embodiment.

[0054] Fig. 4 shows a schematic view of a system according to the disclosure according to a third embodiment.

[0055] Fig. 5 shows a schematic view of an electrical control unit according to the disclosure according to a first embodiment.

[0056] Fig. 6 shows a schematic view of an electrical control unit according to the disclosure according to a second embodiment.

[0057] Fig. 7 shows a schematic view of an electrical control unit according to the disclosure according to a third embodiment.

[0058] Fig. 8 shows a schematic view of a system according to the disclosure according to a fourth embodiment.

[0059] Fig. 9 shows a schematic view of a fluid-mechanical operating unit according to the disclosure according to a first embodiment with a quick release valve in a deactivated position.

[0060] Fig. 10 shows a schematic view of the disclosed fluid-mechanical operating unit according to the first embodiment with the quick-release valve in an activated position. Fig. 11 shows a schematic view of a disclosed fluid-mechanical operating unit according to a second embodiment.

[0061] Fig. 12 shows a schematic view of a fluid-mechanical operating unit according to the disclosure according to a third embodiment with a quick release valve in a deactivated position.

[0062] Fig. 13 shows a schematic view of the disclosed fluid-mechanical operating unit according to the third embodiment with the quick release valve in an activated position.

[0063] Detailed description of preferred embodiments

[0064] Fig. 1 shows a schematic view of a system 2 according to the disclosure according to a first embodiment with a device 4 and a balloon catheter 6.

[0065] The device 4 has a catheter interface 8 in the form of a three-way valve 10, a fluid delivery device 12 in the form of a motorized piston syringe 14, a pressure sensor device 16, a control device 18, and two operating units 20 and 22. The catheter interface 8 does not have to be in the form of a three-way valve 10, but can also be formed by a simple valve, for example.

[0066] The catheter interface 8 or the three-way valve 10 is designed such that the balloon catheter 6 can be connected to the catheter interface 8 or the three-way valve 10 without tools and can be separated from the catheter interface 8 or the three-way valve 10 without tools. The three-way valve 10 has three connection points 24, 26, and 28. The connection point 24 is designed in particular as a Luer connection point that is compatible with a Luer connection point on the balloon catheter 6. The connection point 26 is fluid-mechanically connected to the piston syringe 14 of the fluid delivery device 12.

[0067] The connection point 28 is fluidically connected to the pressure sensor unit 16. If the catheter interface 8 is designed as a simple valve, no connection point 28 is provided. In this case, the pressure is measured before or after the catheter interface 8.

[0068] The control device 18 is connected to the fluid conveying device 12 and the pressure sensor device 16, at least for signaling purposes. Preferably, the fluid conveying device 12 and the pressure sensor device 16 are also supplied with electrical power via the control device 18.

[0069] The operating units 20 and 22 are designed so that a person can give control commands or specifications to the control device 18 and receive status information about the device 4. For this purpose, the operating unit 20 is connected to the control device 18 via a cable, at least for signaling purposes. The operating unit 20 can also be connected to the control device 18 in such a way that the operating unit 20 is or can be supplied with electrical power via the control device 18. The operating unit 22 is or can be connected to the control device 18 via radio.

[0070] In the state shown in Fig. 1, a balloon 30 of the balloon catheter 6 is filled with fluid.

[0071] The pressure prevailing in the balloon 30 can be determined by means of the pressure sensor device 16, which is fluidly connected to the balloon 30 via the connection points 24 and 28 of the catheter interface 8 or the three-way valve 10. In a system according to the first embodiment, the pressure sensor device 16 is designed as a single pressure sensor. The pressure determined by the pressure sensor device 16 can be output, for example in the form of a display, by means of the control device 18 or the operating unit 20 and / or 22 or a corresponding output device.

[0072] By means of the operating unit 20 or 22, a threshold value and / or a target value for the pressure determined by means of the pressure sensor unit 16 can be specified to the control unit 18.

[0073] The control device 18 is designed to control the conveyor device 12 according to the predetermined threshold value and / or the setpoint value.

[0074] If the pressure in the balloon 30 determined by means of the pressure sensor device 16 is lower than the target value, the control device 18 controls the fluid conveying device 12 such that fluid flows from or out of the fluid conveying device 12 via the connection points 26 and 24 of the catheter interface 8 to or into the balloon catheter 6 or the balloon 30.

[0075] If the pressure in the balloon 30 determined by means of the pressure sensor device 16 is greater than or equal to the target value and less than or equal to the threshold value, the control device 18 controls the fluid conveying device 12 such that no fluid flows from or to or into or out of the balloon catheter 6 or balloon 30.

[0076] If the pressure in the balloon 30 determined by the pressure sensor device 12 is greater than the threshold value, the control device 18 controls the fluid delivery device 12 such that fluid flows from or out of the balloon 30 or balloon catheter 6 via the connection points 24 and 26 of the catheter interface 8 to or into the fluid delivery device 12. Fig. 2 shows a schematic view of the fluid delivery device 12. The fluid delivery device 12 has the piston syringe 14 and a motor unit or a motor 32.

[0077] The piston syringe 14 has a hollow cylinder 34 with a wall 36. The hollow cylinder 34 is open on one side and has an end wall 38 on a side opposite the open side. A piston 40 is inserted into the hollow cylinder 34 at the open side of the hollow cylinder 34. The piston 40 is displaceable within the hollow cylinder 34 and, together with the wall 36 and the end wall 38, encloses a fluid chamber 42. The size of the fluid chamber 42 is variable due to the displaceability of the piston 40 relative to the hollow cylinder 34.

[0078] A fluid outlet 44 is formed on the end wall 38. The fluid outlet 44 is fluid-mechanically connected to the connection point 26 of the catheter interface 8 or the three-way valve 10.

[0079] If the piston 40 is moved toward the end wall 38, fluid located in the fluid chamber 42 is conveyed out of the fluid outlet 44 and to the connection point 26 or the catheter interface. Moving the piston 40 toward the end wall 38 thus causes the fluid to be expelled at the catheter interface 8 or its connection point 24.

[0080] If the piston 40 is moved away from the end wall 38, a negative pressure is generated at the fluid outlet 44, which causes fluid to be sucked in from the connection point 26 or the catheter interface 8, and thus causes fluid to be sucked in at the catheter interface 8 or its connection point 24. If the balloon catheter 6 is connected to the catheter interface, moving the piston away from the end wall causes fluid to be sucked in from the balloon catheter 6 or the balloon 30 to the connection point 24.

[0081] On a circumferential surface of the piston 40, seals 52 are provided between the piston 40 and the wall 36 of the hollow cylinder 34, which seal the fluid chamber 42. On the side of the piston 40 facing away from the end wall 38, a piston rod 54 connected to the piston 40 is provided. An external thread 56 is formed on the piston rod 54 at an end portion of a circumferential surface of the piston rod 54 facing away from the piston 40. On either side of the external thread 56, two gears 58 and 60 belonging to the motor 32 are arranged, which engage with the external thread 56.

[0082] The gears 58 and 60 are configured or aligned with the external thread 56 such that counter-rotation of the gears 58 and 60 causes a translation of the piston rod 54 and the piston 40, respectively. Rotation axes 62 and 64 extend perpendicular to an axial direction or a longitudinal axis of the piston rod 54. The rotation of the gears 58 and 60 is caused by activation of the motor 32.

[0083] On an end face of the piston rod 54 facing away from the piston 40, a coupling part 66 is provided, by means of which the piston rod 54 can be moved relative to the hollow cylinder 4. If the coupling part 66 is rotated by a motor (in particular by means of the motor 32, which is connected to the coupling part 66) when the gears 58 and 60 are stationary, the engagement of the gears 58 and 60 in the external thread 56 causes the piston rod 54 to be displaced relative to the axes of rotation 62 and 64 of the gears 58 and 60. The gears 58 and 60 as well as the coupling part 66 are all driven by the motor 32. Alternatively, it is also possible for the device 12 to be designed such that the gear 58, the gear 60 and / or the coupling part 66 are driven by a respective separate motor.

[0084] In order to be able to determine a position of the piston 40 relative to the hollow cylinder 34, the device 4 has a position measuring device 68 which is connected to the control device 18 by means of a signal (see Fig. 1). Based on a change in the position of the piston 40, the amount of expelled or sucked-in fluid can be determined by means of the control device 18. Fig. 3 shows a schematic view of a system 102 according to the disclosure according to a second embodiment. The system 102 according to the second embodiment differs from the system 2 according to the first embodiment only in that the system 102 according to the second embodiment has only a wired operating unit 20 and no wirelessly connected operating unit 22.

[0085] Fig. 4 shows a schematic view of a system 202 according to the disclosure, according to a third embodiment. The system 202 according to the third embodiment differs from the system 2 according to the first embodiment only in that the system 202 according to the third embodiment has only a wirelessly connected control unit 22 and no wired control unit 20.

[0086] Fig. 5 shows a schematic view of a disclosed operating unit 22 according to a first embodiment. The operating unit 22 is in the form of a tablet having a touch-sensitive screen 70. The operating unit 22 is configured to display on the touch-sensitive screen 70 a field 72 in which a pressure value is specified, a field 74 in which a diameter value of the balloon catheter 6 is specified, and a field 76 in which a slide switch is displayed. The operating unit 22 is configured such that a value in one of the fields 72 or 74 can be changed by first activating one of the fields 72 or 74 by tapping it (see field 72 in Fig. 5) and then changing the value of the activated field by swiping along the field 76.

[0087] Fig. 6 shows a schematic view of a disclosed operating unit 1022 according to a second embodiment. The operating unit 1022 is designed in the form of a slide switch and has a slider 1078 that can be moved along a linear guide 1080. The operating unit 1022 is designed to specify a threshold value or setpoint for the pressure measured by the pressure sensor device 16 to the control device 18 by moving the slider 1078 along the linear guide 1080.

[0088] Fig. 7 shows a schematic view of a disclosed operating unit 2022 according to a third embodiment. The operating unit 2022 is designed in the form of a compressible ball. The operating unit 2022 is configured to specify a threshold value or target value for the pressure measured by the pressure sensor device 16 according to the degree of compression of the control device 18.

[0089] The control units 22, 1022, and 2022 shown in Figures 5, 6, and 7 are designed as cordless control units. Alternatively or additionally, it is also possible for the control units 22, 1022, and 2022 to be designed to be connected to the control device 18 via a cable.

[0090] Fig. 8 shows a schematic view of a system 302 according to the disclosure in accordance with a fourth embodiment. The system 302 according to the third embodiment differs from the systems 2, 102, and 202 according to the first three embodiments only in that the system 302 according to the fourth embodiment has a fluid-mechanical (i.e., a hydraulic or pneumatic) operating unit 3022 instead of an electrical or electronic operating unit 20, 22, 1022, or 2022. In accordance with the fluid-mechanical operating unit 3022, it is equipped with a pressure port 378 and a pressure sensor 380, which is fluid-mechanically connected to the pressure port 378 and signal-wise connected to the control device 18. Preferably, the pressure sensor 380 is formed as part of a pressure sensor unit 316 according to the disclosure.

[0091] The pressure connection 378 is designed to be connectable to the operating unit 3022. Fig. 9 shows a schematic view of the fluid-mechanical operating unit 3022 according to a first embodiment.

[0092] The operating unit 3022 is designed in the form of a manual inflation syringe 3024.

[0093] The inflation syringe 3024 has a hollow cylinder 3026 with a wall 3028. The hollow cylinder 3026 is open on one side and has an end wall 3030 on a side opposite the open side. A piston 3032 is inserted into the hollow cylinder 3026 at the open side of the hollow cylinder 3026. The piston 3032 is displaceable within the hollow cylinder 3026 and, together with the wall 3028 and the end wall 3030, encloses a fluid chamber 3034. The size of the fluid chamber 3034 is variable due to the displaceability of the piston 3032 relative to the hollow cylinder 3026.

[0094] A fluid outlet 3036 is formed on the end wall 3030, which represents a control fluid interface according to the disclosure. The fluid outlet 3036 is fluid-mechanically connected or connectable to the pressure connection 378.

[0095] If the piston 3032 is moved toward the end wall 3030, fluid located in the fluid chamber 3034 (ie, a control fluid according to the disclosure) is conveyed from the fluid outlet 3036 and to the pressure port 378. By moving the piston 40 toward the end wall 38, a pressure at the pressure port 378 is thus increased.

[0096] When the piston 3032 is moved away from the end wall 3030, a negative pressure is generated at the fluid outlet 3036, which causes fluid to be sucked in from the pressure port 378 and thus reduces the pressure at the pressure port 378.

[0097] On a circumferential surface of the piston 3032, seals 3038 are provided between the piston 3032 and the wall 3028 of the hollow cylinder 3026, which seal the fluid chamber 3034. On the side of the piston 3032 facing away from the end wall 3030, a piston rod 3040 connected to the piston 3032 is provided. An external thread 3042 is formed on the piston rod 3040 at an end portion of a circumferential surface of the piston rod 3040 facing away from the piston 3032. On the side of the hollow cylinder 3026 facing away from the end wall 3030, a threaded block 3044 is connected to the hollow cylinder 3026 via a rocker arm 3046. The threaded block 3044 is pivotally connected to the rocker arm 3046, and the rocker arm 3046 is pivotally connected to the hollow cylinder 3026. The threaded block 3044 has a threaded portion 3048 on a side facing the external thread 3042 of the piston rod (see Fig.10), which is designed to be able to be brought into engagement with the external thread 3042. The threaded block 3044 and the rocker arm 3046 together form a quick-release device, which is designed to be able to be brought into a deactivated position by means of the rocker arm 3046, in which the threaded block 3044 or its threaded section 3048 is engaged with the external thread 3042 (see Fig. 9), and to be able to be brought into an activated position by means of the rocker arm 3046, in which the threaded block 3044 or its threaded section 3048 is not engaged with the external thread 3042 (see Fig. 10). Preferably, the quick release or its rocker arm 3046 is pre-tensioned by means of a spring (not shown) such that the quick release is pre-tensioned into its deactivated position and only by overcoming the pre-tension is it possible to adjust the quick release to its activated position.

[0098] On an end face of the piston rod 3040 facing away from the piston 3032, a rotary handle 3050 is provided, by means of which the piston rod 3040 can be manually moved relative to the hollow cylinder 3026. If the rotary handle 3050 is manually turned when the quick release is in the deactivated position (see arrows in Fig. 9), the engagement of the threaded section 3048 in the external thread 3042 causes the piston rod 3040 to be displaced relative to the threaded block 3044 and thus to the hollow cylinder 3026. In the activated position of the quick release, the threaded block 3044 and the external thread 3042 are disengaged, so that the piston rod 3040 is axially displaceable and a, in particular faster, displacement of the piston 3032 is possible by moving the rotary handle 3050 in the axial direction of the piston 3032 (see double arrow in Fig. 10).

[0099] To operate the device 4 in the system 302 using the operating unit 3022, the size of the fluid chamber 3034 is varied by changing the axial position of the piston 3032 relative to the hollow cylinder 3026 using the rotary handle 3050 (either with the quick-release valve activated or deactivated), thereby varying the pressure of the fluid at the fluid outlet 3036 and thus at the pressure port 378. This pressure variation is measured by the pressure sensor 380. The control device 18 of the device 4 of the system 302 is designed to convert the pressure measured at the pressure port 378 or the pressure variation measured at the pressure port 378 into a control command for the motor 32 of the fluid delivery device 12, so that a corresponding pressure or a corresponding pressure variation is generated in the balloon catheter 6.“Convert” means in particular that the pressure generated by the fluid conveying device 12 is higher than the pressure generated manually by the operating unit 3022 and / or that a pressure curve generated by the fluid conveying device 12 is smoothed compared to a pressure curve generated manually by the operating unit 3022.

[0100] Fig. 11 shows a schematic view of a fluid-mechanical operating unit 4022 according to the disclosure, according to a second embodiment. The fluid-mechanical operating unit 4022 according to the second embodiment differs from the fluid-mechanical operating unit 3022 according to the first embodiment in that a rocker arm 4046 of the fluid-mechanical operating unit 4022 according to the second embodiment is articulated or pivotally connected to a trigger 4052. By providing a trigger 4052, it is possible to provide a pistol grip (not shown) on an inflation syringe 4024 of the operating unit 4022, thus improving the operability of the operating unit 4022. Apart from the differences described, the fluid-mechanical operating unit 4022 according to the second embodiment corresponds to the fluid-mechanical operating unit 3022 according to the first embodiment.

[0101] Fig. 12 shows a schematic view of a fluid-mechanical operating unit 5022 according to the disclosure in accordance with a third embodiment with a quick-release valve in a deactivated position. Fig. 13 shows a schematic view of the fluid-mechanical operating unit 5022 according to the third embodiment with the quick-release valve in an activated position.

[0102] The fluid-mechanical operating unit 5022 according to the third embodiment differs from the fluid-mechanical operating unit 3022 according to the first embodiment in that a threaded block 5044 is designed as an eccentric, which is rotatably mounted on a hollow cylinder 5026 such that a rotational axis of the threaded block 5044 is parallel to a longitudinal axis of a piston rod 5040. The threaded block 5044 has a recess 5054 through which the piston rod 5040 extends.

[0103] The recess 5054 is formed eccentrically such that an inner surface of the recess 5054 formed as a threaded section 5048 engages with an external thread 5042 of the piston rod 5040 in a first position of the threaded block 5044 relative to the hollow cylinder 5024 (see Fig. 12) and is not engaged with an external thread 5042 of the piston rod 5040 in a second position of the threaded block 5044 rotated relative to the hollow cylinder 5024 compared to the first position (see Fig. 13).

[0104] In the fluid-mechanical operating unit 5022 according to the third embodiment, the quick-release valve is thus formed solely by the threaded block 5044. A rocker lever, as in the fluid-mechanical operating units 3022 and 402 according to the first two embodiments, is not necessary. Apart from the differences described, the fluid-mechanical operating unit 5022 according to the third embodiment corresponds to the fluid-mechanical operating unit 3022 according to the first embodiment.

[0105] List of reference symbols

[0106] 2 System according to the first embodiment

[0107] 4 Device

[0108] 6 balloon catheters

[0109] 8 Catheter interface

[0110] 10 Three-way valve

[0111] 12 Fluid conveying device

[0112] 14 piston syringe

[0113] 16 Pressure sensor device

[0114] 18 Control device

[0115] 20 Wired control unit

[0116] 22 Radio-connected control unit

[0117] 24 Catheter-side connection point of the three-way valve

[0118] 26 Fluid conveyor side connection point of the three-way valve

[0119] 28 Pressure sensor side connection point of the three-way valve

[0120] 30 balloons

[0121] 32 Motor of the fluid conveying device

[0122] 34 hollow cylinder of the piston syringe

[0123] 36 Conversion of the piston syringe

[0124] 38 Front wall of the piston syringe

[0125] 40 piston of the piston syringe

[0126] 42 Fluid chamber of the piston syringe

[0127] 44 Fluid outlet of the piston syringe

[0128] 52 Seal between piston and wall

[0129] 54 Piston rod

[0130] 56 External thread of the piston rod

[0131] 58, 60 Gear of the engine

[0132] 62, 64 rotation axis

[0133] 66 Coupling part on the piston rod

[0134] 68 position meters

[0135] 70 touch-sensitive screen

[0136] 72 to 76 field on the touch-sensitive screen 102 System according to the second embodiment

[0137] 202 System according to third embodiment

[0138] 302 System according to fourth embodiment

[0139] 378 pressure connection

[0140] 380 pressure sensor

[0141] 1022 Control unit according to second embodiment

[0142] 1078 sliders

[0143] 1080 linear guide

[0144] 2022 Electrical control unit according to third embodiment

[0145] 3022 Fluid-mechanical control unit according to the first embodiment

[0146] 3024 Inflation injection

[0147] 3026 Hollow cylinder of the inflation syringe

[0148] 3028 Conversion of the inflation injection

[0149] 3030 Front wall of the inflation syringe

[0150] 3032 Inflation syringe plunger

[0151] 3034 Fluid chamber of the inflation syringe

[0152] 3036 Fluid outlet of the inflation syringe

[0153] 3038 Seal between piston and wall

[0154] 3040 piston rod

[0155] 3042 External thread of the piston rod

[0156] 3044 threaded block

[0157] 3046 rocker arm

[0158] 3048 threaded section

[0159] 3050 Rotary handle on the piston rod

[0160] 4022 Fluid-mechanical control unit according to the second embodiment

[0161] 4024 Inflation injection

[0162] 4032 Inflation syringe plunger

[0163] 4046 rocker arm

[0164] 4052 deduction

[0165] 5022 Fluid-mechanical control unit according to the third embodiment

[0166] 5026 Hollow cylinder of the inflation syringe

[0167] 5032 Inflation syringe plunger

[0168] 5040 Piston rod 5042 External thread

[0169] 5044 threaded block

[0170] 5048 threaded section

[0171] 5054 recess

Claims

Claims 1. A device (4) for automatically inflating a vascular balloon catheter (6), in particular a vascular angioplasty catheter, by means of a fluid, comprising a catheter interface (8), a fluid delivery device (12), a pressure sensor device (16), and a control device (18), wherein the catheter interface (8) is configured to be connected to the balloon catheter (6) in such a way, in particular without tools, that the fluid can flow from the device (4) into the balloon catheter (6) via the catheter interface (8), the fluid delivery device (12) is configured to expel the fluid from the device (4) at the catheter interface (8) by means of a motor (32), the pressure sensor device (16) is configured to measure a pressure of the fluid expelled by the device (4), and the control device (18) is configured,to be able to control a quantity of fluid ejected from the device (4) by means of the fluid conveying device (12) as a function of the pressure measured by the pressure sensor device (16) by controlling the motor (32) of the fluid conveying device (12), characterized in that the fluid conveying device (12) is designed to be able to suck the fluid into the device (4) at the catheter interface (8) by means of the motor (32).

2. Device (4) according to claim 1, characterized in that the control device (18) is designed to cause the fluid to be sucked in by means of the fluid conveying device (12) when a predetermined threshold value of the pressure measured by the pressure sensor device (16) is exceeded.

3. Device (4) according to claim 2, characterized in that the control device (18) is designed to prevent suction of the fluid by means of the fluid conveying device (12) after the predetermined threshold value has been exceeded and a subsequent pressure drop in the pressure measured by the pressure sensor device (18) when the predetermined threshold value is reached again.

4. Device (4) according to one of claims 1 to 3, characterized in that the fluid is a liquid and the device (4) has a venting device (46) by means of which a gas mixed with the liquid can be discharged from the device (4).

5. Device (4) according to one of claims 1 to 4, characterized in that the control unit (18) is designed to be able to control the fluid conveying device (12) in such a way that the fluid is conveyed at different predetermined conveying rates.

6. Device (4) according to one of claims 1 to 5, characterized in that the control unit (18) is designed to be able to regulate the fluid conveying device (12) as a function of the pressure measured by the pressure sensor device (16), in particular in such a way that at least two different predetermined pressure levels are achieved.

7. Device (4) according to one of claims 1 to 6, characterized by an energy storage device for storing electrical energy so that in the event of a power failure, excess pressure can be reduced and a vacuum can be drawn.

8. Device (4) according to one of claims 1 to 6, characterized in that the motor (32) of the fluid conveying device has a tensioning means which is designed to be tensioned when the fluid is ejected and to be relaxed when the fluid is sucked in.

9. Device (4) according to one of claims 1 to 8, characterized in that the control device (18) has a data interface which is designed to be able to transmit data to and / or from a smartphone, a tablet or another device.

10. Device (4) according to claim 9, characterized in that the device (4) has an operating unit (20; 22; 1022; 2022; 3022; 4022; 5022) connected to the data interface, which is designed to receive control commands from a person and to transmit them to the control device (18).

11. Device (4) according to claim 10, characterized in that the operating unit (3022; 4022; 5022) is designed in the form of a manual inflation syringe.

12. Device (4) according to claim 11, characterized in that the operating unit (3022; 4022; 5022) has an inflation syringe (3024; 4024; 5024), by means of which a control fluid can be conveyed to a control fluid interface of the inflation syringe (3024; 4024; 5024) by moving a piston (3032; 4032; 5032), the data interface is designed as a pressure connection (378) which can be connected to the control fluid interface of the inflation syringe (3024; 4024; 5024), the pressure sensor device (316) is designed to be able to measure a pressure of the control fluid at the pressure connection (378), and the control device (18) is designed to be able to control the fluid conveying device (12) as a function of the pressure of the control fluid measured at the pressure connection (378).

13. Device (4) according to one of claims 10 to 12, characterized in that the operating unit (22) has a display (70) which is designed to be able to display status data of the device (4).

14. System (2; 102; 202; 302) for performing an angioplasty with a balloon catheter (6) and a device (4) according to one of claims 1 to 13.

15. System (2; 102; 202; 302) according to claim 14, characterized in that the device (4) is designed to induce a negative pressure or a vacuum in the balloon catheter.

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